NAVIGATING CONFLICTS ABOUT LIFE- SUSTAINING TREATMENT IN A HEALTH SYSTEM WITH LIMITED RESOURCES: RECONCILING LAW, POLICY AND PRACTICE
Eliana Close BSc (First Class Hons), MA
Submitted in fulfilment of the requirements for the degree of
Doctor of Philosophy
School of Law, Faculty of Law Queensland University of Technology 2020
KEYWORDS
Conflict resolution – distributive justice – life-sustaining medical treatment – end-of-life law – end-of-life policy – futile treatment – medical ethics – non-beneficial treatment – procedural fairness – rationing – resource allocation – shared decision making – transparency – treatment disputes – withholding of treatment – withdrawal of treatment
i
ABSTRACT
This thesis by published papers examines the legal and ethical issues that arise when doctors make decisions about whether or not to provide life-sustaining treatment to adult patients who are critically ill. Approximately 30% of Australians die after a decision to withhold or withdraw life-sustaining treatment, including mechanical ventilation, cardiopulmonary resuscitation, dialysis and artificial nutrition and hydration. Often these decisions are straightforward. However, when a patient or substitute decision maker seeks treatment that doctors believe is ‘non-beneficial’, ‘potentially inappropriate’ or ‘futile’, the situation is more complex. How is benefit defined and who decides what is in the patient’s interests? What role do scarce resources play in doctors’ decisions? Does the concept of ‘futility’ operate as a mask for bedside rationing? While significant literature has addressed the concept of ‘futility’ in end-of-life decisions, the tensions between patient interests and scarce resources and how the Australian regulatory system responds to them remain unexplored.
The central aim of this thesis is to determine whether the current regulatory mechanisms that govern, or purport to govern, decisions about life-sustaining treatment in Australia adequately promote transparent and procedurally-fair decision making and conflict resolution, or whether an alternative regulatory response is needed. This issue is examined from a number of perspectives in a series of six publications. The thesis combines an analysis of laws and policies with a qualitative study of doctors’ perceptions, to situate the regulatory critique within what occurs in practice.
As a whole, this thesis reaches two primary conclusions. First, doctors perceive that resource considerations can impact end-of-life decision making (sometimes under the guise of ‘futility’) and this creates ethical tensions that should be addressed by the regulatory system. Second, existing laws and professional guidance about life-sustaining treatment in Australia do not sufficiently promote transparent and procedurally-fair decisions. To address these conclusions, an improved regulatory framework is needed to better distinguish between patient interests and distributive justice as two distinct non-treatment rationales. On the legal front, this thesis argues that a new legal framework is needed to shift decision making power to patients and families, while also promoting the development of explicit resource allocation policies that doctors can rely on when treatment is extremely unlikely to work. On the policy front, the thesis contends that the Australian regulatory system would be improved by an
ii
overarching policy on decisions about life-sustaining treatment to promote consistent terminology and guidance about decision making and dispute resolution. To achieve this, engagement with a broad cohort of stakeholders is necessary, including medical professionals, lawyers, patients, families and the community.
iii
TABLE OF CONTENTS
Keywords ...... i Abstract ...... ii Table of Contents ...... iv Original and Significant Contributions to Knowledge...... vi List of Publications ...... vii Statement of Original Authorship ...... viii Acknowledgements ...... ix A Note on the Thesis ...... xi Chapter 1: Introduction ...... 2 1.1 Focusing on Conflicts About Life-Sustaining Treatment ...... 2 1.2 Aims of the Thesis ...... 6 1.3 Objectives of the Thesis: How the Aims Will be Achieved ...... 7 1.4 Structure of the Thesis ...... 10 1.5 Linking the Publications ...... 12 1.6 Connection Between the Publications and the Thesis Objectives ...... 24 1.7 Key Concepts ...... 28 1.8 Methodological Approach ...... 37 1.9 Scope ...... 41 1.10 Significant and Original Contributions to Knowledge ...... 45 1.11 Conclusion ...... 48 Chapter 2: Review of the Literature and Current Law ...... 49 2.1 Introduction ...... 49 2.2 The Medical Context: Withholding and Withdrawing Life-Sustaining Treatment ...... 50 2.3 The Healthcare System Context: A Backdrop of Scarce Resources ...... 59 2.4 Ethical Rationales for Non-Treatment Decisions ...... 62 2.5 Law on Withholding or Withdrawing Futile Treatment ...... 68 2.6 Critique of the Law ...... 78 2.7 Medical Policies on Withholding and Withdrawing Life-Sustaining Treatment ...... 80 2.8 Summary of Gaps in the Literature ...... 82 2.9 Conclusion ...... 83 Chapter 3: Futile or ‘Disputed’ Treatment Chapter ...... 85 Chapter 4: Doctors’ Perceptions of Practice Paper ...... 86 Chapter 5: Charlie Gard Paper ...... 88 Chapter 6: Critique of Legal Models Chapter ...... 94
iv
Chapter 7: Medical Futility Policy Analysis...... 121 Chapter 8: Balancing Patient and Societal Interests Policy Analysis ...... 159 Chapter 9: Conclusion ...... 188 9.1 Introduction ...... 188 9.2 Cumulative Effect of the Publications ...... 189 9.3 Synthesis of Recommendations ...... 202 9.4 Significance of Findings ...... 208 9.5 Directions for Future Research ...... 209 9.6 Concluding Comments ...... 211 Appendix A – Statements of Contribution ...... 213 Bibliography ...... 223
v
ORIGINAL AND SIGNIFICANT CONTRIBUTIONS TO KNOWLEDGE
This thesis makes an original and significant contribution to knowledge in the following ways: 1. It critically evaluates the concept of futility as a basis for decisions about life- sustaining treatment and identifies concerns about transparency and procedural fairness relating to both patient and society; 2. It provides the first empirical analysis to investigate doctors’ perceptions of the relationship between futility and resource constraints in practice, providing evidence that resource allocation considerations influence end-of-life decision making and are something the regulatory system should address; 3. It is the first study to examine all existing legal models for making decisions about potentially life-sustaining treatment and critique them against key values, demonstrating weaknesses in all current paradigms; 4. It is the first study to comprehensively identify and critically analyse all of the publicly-available medical policies in Australia that address decisions to withhold or withdraw life-sustaining treatment, demonstrating that policies are inconsistent and provide insufficient guidance to promote transparent and procedurally-fair decisions; and, 5. It is the first study to closely scrutinise the regulatory framework against what occurs in practice, providing meaningful recommendations for reform that are grounded in the reality of medical practice, rather than based primarily on theoretical considerations.
vi
LIST OF PUBLICATIONS
Ben White, Lindy Willmott and Eliana Close, ‘Futile, Non-Beneficial, Potentially Inappropriate or “Disputed” Treatment’ in Nathan Emmerich et al (eds), Contemporary European Perspectives on the Ethics in End of Life Care (Springer, 2020) Eliana Close, Ben P White, Lindy Willmott, Cindy Gallois, Malcolm Parker, Nicholas Graves, Sarah Winch, ‘Doctors’ Perceptions of how Resource Limitations Relate to Futility in End-of-Life Decision Making: A Qualitative Analysis’ (2019) 45 Journal of Medical Ethics 373
Eliana Close, Lindy Willmott and Benjamin P White, ‘Charlie Gard: In Defence of the Law’ (2018) 44(7) Journal of Medical Ethics 476
Ben White, Lindy Willmott, Eliana Close and Jocelyn Downie, ‘Withholding and Withdrawing Potentially Life-Sustaining Treatment: Who Should Decide?’ in Ian Freckelton and Kerry Petersen (eds), Tensions and Traumas in Health Law (Federation Press, 2017) 454
Eliana Close, Malcolm Parker, Lindy Willmott, Ben P White, Andrew Crowden, ‘Australian Policies on Medical “Futility” or “Non-Beneficial” Treatment at the End of Life: A Qualitative Content Analysis’ (2019) 27(2) Journal of Law and Medicine 415
Eliana Close, Ben P White, Lindy Willmott, ‘Balancing Patient and Societal Interests in Decisions About Life-Sustaining Treatment: An Australian Policy Analysis’ Journal of Bioethical Inquiry (under review)
vii STATEMENT OF ORIGINAL AUTHORSHIP
The work contained in this thesis has not been previously submitted to meet requirements for an award at this or any other higher education institution. To the best of my knowledge and belief, the thesis contains no material previously published or written by another person except where due reference is made.
Signature: QUT Verified Signature
Date: 27 March 2020
viii
ACKNOWLEDGEMENTS
In those inevitable moments when this PhD felt slow-moving, I was buoyed by the thought that one day I would have the pleasure of writing the acknowledgements section. There are a number of people who I would like to thank.
I have enormous gratitude and admiration for my supervisors (and close friends and mentors) Professor Lindy Willmott and Professor Ben White. They have helped shape and guide this research from its inception, with their great insight and expertise. I am so fortunate to have found them when I moved to Brisbane many years ago. I have had their unwavering personal support throughout this thesis and beyond, and I look forward to our continued collaborations.
I am also indebted to my co-authors, who provided valuable interdisciplinary perspectives. In particular I would like to acknowledge Emeritus Professor Cindy Gallois and Emeritus Professor Malcolm Parker for their contributions and mentorship. I also owe great thanks to Professor Jocelyn Downie for her constant encouragement.
This thesis would not have been possible without the insights of the 96 doctors who candidly shared their experiences. I would also like to acknowledge the support I received from an Australian Research Program Training Scholarship and a top-up scholarship from the National Health and Medical Research Council’s Centre of Research Excellence in End of Life Care at QUT, led by Distinguished Professor Patsy Yates. Two of the publications in this thesis built on work that was part of the Australian Research Council Linkage Project, Futile Treatment at the End of Life (LP10100096), funded in partnership with the Royal Brisbane and Women’s Hospital (RBWH). Thank you to Leonie Callaway (RBWH), Michael Daly (Princess Alexandra Hospital) and John Fraser (The Prince Charles Hospital) for their assistance at each hospital site.
I am fortunate to have had an incredible postgraduate community in the Faculty of Law at QUT. In particular, thank you to Associate Professor Shih-Ning Then for her friendship, mentorship, and helpful feedback. I am also grateful to Dr Kylie Pappalardo. Finding her excellent writing group in the middle of my candidature brought new opportunities for self- reflection and connection to an exceptionally supportive group of postgraduate students.
ix
To my wonderful family, you have provided the best kind of distraction from this research, and have spurred me on to try to make it the best it could be. I conducted the interviews for this thesis while eight months pregnant with Benjamin, and it gave me the impetus and urgency to get them done prior to his arrival. Watching his sense of wonder at the world and emerging love of learning brings me immense joy. Lily was born in the middle of my PhD and it is hard to fathom how she has grown up so fast. It has been a lovely refrain to hear her ask me innumerable times over the last six months, ‘when are you going to finish your PhD?’ To my husband David, I could not ask for a more encouraging partner. Thank you for everything you have done, especially in supporting me through the end stages of this work.
Finally, I would also like to acknowledge my parents, Renata, David, Jim and Iris. You have all given me an incredible amount of love and the most solid foundation. I am lucky to have all four of you.
x
A NOTE ON THE THESIS
This thesis originated from the Australian Research Council Linkage Grant LP120100096, Futile Treatment at the End of Life: Legal, Policy, Sociological, and Economic Perspectives (the ‘ARC Futility Project’). I was a Senior Research Assistant and Research Fellow on the project, which was led by a multi-disciplinary team of Chief Investigators headed by Professor Lindy Willmott and Professor Ben White (who subsequently became my PhD supervisors). The Chief Investigators had expertise in law (Professor Lindy Willmott and Professor Ben White), psychology (Emeritus Professor Cindy Gallois), medicine (Emeritus Professor Malcolm Parker), health economics (Professor Nicholas Graves) and sociology (Associate Professor Sarah Winch). The partner organisation on the ARC Futility Project was the Royal Brisbane and Women’s Hospital (‘the RBWH’), the largest hospital in Queensland. As part of the project I conducted a series of 96 in-depth qualitative interviews with doctors in 11 different specialties at the RBWH and two other tertiary hospitals in Brisbane. The interviews were focused on exploring doctors’ perspectives on how they defined ‘futile’ treatment and the reasons they might provide it. In the interviews I was struck by how some doctors repeatedly reiterated concerns about the appropriate use of scarce health resources when discussing the provision of futile treatment, but struggled to properly frame these considerations in their existing decision-making paradigms, which are meant to be centred only on the patient. From those interviews I generated the idea for this thesis: a multi-disciplinary account of how the Australian regulatory system approaches the tension between individual and societal interests in decisions about life-sustaining treatment, grounded in doctors’ descriptions of their practice.
The body of the thesis consists of six publications, two that are linked to the ARC Futility Project, and four that are independent of it. The two publications that are linked to the ARC project are an empirical analysis of the qualitative interviews, which I conducted specifically for this thesis, and a policy analysis that was co-authored by part of the project team. I also contributed to a wider series of publications from the ARC project. These publications do not formally comprise part of the thesis but I mention them because they are relevant contributions to the literature (see Chapter 2) and also address the wider context of decisions to withhold or withdraw life-sustaining treatment. In the interests of completeness, I list these publications (which are in addition to the six publications that are part of this thesis):
xi
1. Cindy Gallois, Lindy Willmott, Ben White, Sarah Winch, Malcolm Parker, Nicholas Graves, Nicole Shepherd and Eliana Close, ‘Futile Treatment in Hospital: Doctors’ Intergroup Language’ (2015) 34(6) Journal of Language and Social Psychology 657.
2. Lindy Willmott, Ben White, Eliana Close et al, 'Futility and the Law: Knowledge, Practice and Attitudes of Doctors in End of Life Care' (2016) 16(1) QUT Law Review 54.
3. Benjamin P White, Lindy Willmott, Eliana Close et al, ‘What Does “Futility” Mean? An Empirical Study of Doctors’ Perceptions’ (2016) 204(8) Medical Journal of Australia 318.e1.
4. Lindy Willmott, Benjamin P White, Cindy Gallois, Malcolm Parker, Nicholas Graves, Sarah Winch, Leonie Callaway, Nicole Shepherd, and Eliana Close, ‘Reasons Doctors Provide Futile Treatment at the End of Life: A Qualitative Study’ (2016) 42 Journal of Medical Ethics 496.
5. Hannah E Carter, Sarah Winch, Adrian G Barnett, Malcolm Parker, Cindy Gallois, Lindy Willmott, Ben P White, Mary Anne Patton, Letitia Burridge, Gayle Salkield, Eliana Close, Leonie Callaway and Nicholas Graves, ‘Incidence, Duration and Cost of Futile Treatment in End-of-Life Hospital Admissions to Three Australian Public-Sector Tertiary Hospitals: A Retrospective Multicentre Cohort Study’ (2017) 7(10) BMJ Open e017661.
6. Hannah E Carter, Xing Lee, Cindy Gallois, Sarah Winch, Leonie Callaway, Lindy Willmott, Ben White, Malcolm Parker, Eliana Close, Nicholas Graves, ‘The Factors Associated with Non-Beneficial Treatments in End of Life Hospital Admissions: A Multicentre Retrospective Cohort Study’ (2019) 9 BMJ Open e030955.
On an administrative note, to retain the individual structure of the publications in the thesis I have included published versions of the articles where possible. Three exceptions are Chapter 3 (the Futile or Disputed Treatment Chapter), Chapter 7 (the Medical Futility Policy Analysis) and the Chapter 8 (the Balancing Patient and Societal Interests Policy Analysis). The Futile or Disputed Treatment Chapter is part of an edited book that is going to print at the time I am submitting this thesis. The Medical Futility Policy Analysis is an unedited pre-print manuscript of the article which was released in the December 2019 issue of the Journal of Law
xii
and Medicine. The Balancing Patient and Societal Interests Policy Analysis was submitted to the Journal of Bioethical Inquiry and under review at the time I completed the thesis.
The inclusion of publications in the thesis has created a few idiosyncrasies in formatting and citations. The publications use the citation format required by the journals or books they were published in; I have not attempted to standardise the citation style. The thesis chapters that are not part of the published works use the Australian Guide to Legal Citation (4th edition), as does the bibliography.
Since a PhD by published papers requires a close connection between the published works, there is necessarily a degree of repetition between some of the material in the thesis as a whole. For example, section 1.7.1 of the Key Concepts section in Chapter 1 addresses the concept of ‘futile treatment’, as does the Futile or Disputed Treatment Chapter and the section labelled ‘Tensions and traumas around treatment disputes’ in the Critique of Legal Models Chapter. Nevertheless, where this topic is repeated it is approached from different angles and to varying degrees of depth. The scale and mode of this thesis required this overlap in order to constitute a cohesive and integrated work.
xiii
PART 1
Introduction & Literature Review
1
Chapter 1: Introduction
I thought that as long as their heart was still beating … that a hospital wouldn’t push so hard to get life support off. It’s been a very stressful, sad time for us … [I was told they] had to cancel two operations because of my dad. … I had [a staff member] say ... ‘What you're doing to your father is cruel.’ … They play with you, they try to play with your mind psychologically and put you under a lot of stress in order to switch that life support off. – Magdy Messiha1
To inflict this kind of assault on him without a reasonable hope of benefit is an abomination … I can't do it. – Dr Anand Kumar2
1.1 FOCUSING ON CONFLICTS ABOUT LIFE-SUSTAINING TREATMENT
This thesis by published papers is focused on one core issue: the regulation of doctors’ decisions to withhold or withdraw potentially life-sustaining treatment from adult patients who are approaching the end of their lives. Major societal changes, including the rapidly ageing population, health consumerism, and relentless advances in medical technologies, have highlighted the need for a responsive and just regulatory framework. However, how to regulate these issues is not straightforward, and whether the current system in Australia adequately takes account of patient and societal interests is understudied. This thesis therefore explores the tensions that arise when navigating the interests of patients, substitute decision makers, doctors and society, and how well the Australian regulatory system reconciles these different perspectives.
The question of how to regulate decisions to forgo life-sustaining treatment is topical and significant. Approximately 30% of Australian deaths are preceded by a decision to
1 Natasha Wallace, Ruth Pollard and Kristy Needham, Hospital Removes Life Support After Court Bid Fails, Sydney Morning Herald
2
withhold or withdraw life-sustaining treatments,3 including mechanical ventilation, artificial nutrition and hydration, dialysis, and cardiopulmonary resuscitation. This equates to over 45,000 deaths annually,4 a number which is expected to double in the next 25 years as the population ages.5 These decisions are part of mainstream medical practice, yet remain challenging for medical professionals, patients and substitute decision makers alike. While medical technologies can now keep patients alive in very poor states of health, it can be difficult to determine what treatment is ‘worth’ pursuing and when to shift to a palliative focus. Patients or their substitute decision makers and doctors may reach different views about how to proceed, grounded in their own values, culture and religious beliefs. This can lead to a patient, or more commonly, a substitute decision maker (often the patient’s family member), requesting treatment that doctors strongly believe is ‘futile’ or ‘non-beneficial’ and would be against the patient’s interests to provide. This thesis is focused on these challenging doctor-initiated non-treatment decisions, which are legally and ethically more complex than treatment refusals by patients with decision-making capacity.
The concept of ‘medical futility’ gained traction in the 1990s as a central rationale for withholding or withdrawing life-sustaining treatment, despite patient or family requests.6 The notion retains currency today, despite decades of debate and a growing shift towards alternative terminology.7 Proponents argue if a treatment is ‘futile’, in other words, unlikely or unable to confer sufficient benefit to the patient, then doctors are under no obligation to provide it. The concept is reflected in laws and policies across jurisdictions.8 Yet, futility’s primacy in clinical and regulatory paradigms raises two concerns, which lie at the heart of
3 Helga Kuhse et al, ‘End-of-Life Decisions in Australian Medical Practice’ (1997) 166(4) Medical Journal of Australia 191. Australia lacks more recent population-level data on the rates of various medical end-of-life decisions. 4 Australian Bureau of Statistics, ‘3302.0: Deaths, Australia, 2018’ (2019)
3
this thesis. First, apart from treatment that physiologically will not work, deciding whether or not to provide life-sustaining treatment is a value-laden exercise. Individuals can hold different views about what constitutes a benefit, what is a life ‘worth’ living, and what chance of achieving an outcome is worth taking. Futility, which appears objective, is therefore a questionable basis to trigger doctors’ unilateral powers to withhold or withdraw life- sustaining treatment. Secondly, labelling a treatment ‘futile’ or ‘non-beneficial’ can obscure another (ethically valid) rationale for ceasing active treatment: distributive justice. In publicly-funded health systems such as Australia, decisions to prolong life-sustaining treatment are made against a backdrop of scarce resources. When a patient, or more commonly, a substitute decision maker, requests potentially life-sustaining treatment that is extremely unlikely to confer a benefit, there can be reasonable moral disagreement about whether or not that treatment is in the patient’s best interests.9 However, it is undeniable that such treatment is not cost-effective. Yet, medical, legal and ethical paradigms are focused on the individual patient, therefore arguments for non-treatment based on distributive justice are not transparently articulated or addressed.
Conflicts over life-sustaining treatment in the ICU are common, with some arguing they have reached ‘epidemic’ proportions.10 Disagreements over life-sustaining treatment occasionally become intractable and escalate to court. High-profile court cases over life- sustaining treatment in Australia,11 and abroad,12 have highlighted two key issues:
the need for transparent and fair decision-making processes and dispute resolution mechanisms, which appropriately recognise that decisions about life- sustaining treatment are value-laden; and,
greater clarity about when decisions are based on distributive justice and when society’s interest in the efficient use of scarce resources should outweigh a patient or substitute decision maker’s request for treatment that doctors believe is ‘futile’ or ‘non-beneficial’.
9 Dominic Wilkinson and Julian Savulescu, ‘Current Controversies and Irresolvable Disagreement: The Case of Vincent Lambert and the Role of “Dissensus”’ (2019) 45(10) Journal of Medical Ethics 631 (‘Current Controversies’). 10 Ann C Long and Randall J Curtis, ‘The Epidemic of Physician-Family Conflict in the ICU and What We Should Do About It’ (2014) 42(2) Critical Care Medicine 461. 11 Messiha v South East Health [2004] NSWSC 1061 (‘Messiha’); Northridge v Central Sydney Area Health Service [2000] NSWSC 1241 (‘Northridge’). 12 Great Ormond Street Hospital v Yates [2017] EWHC 972 (Fam); Re Lambert, No. E1917330 (Cour de cassation, 28 June 2019).
4
To investigate whether the regulatory system appropriately addresses these issues, more insight into how doctors conceive of the relationship between futility and resource constraints is needed. There is no empirical research (in Australia or elsewhere) on whether doctors who treat adult patients at the end of life perceive the label futility masks resource-based decisions, despite longstanding theoretical concerns. Likewise, little is known about doctors’ perceptions of the interplay between patient interests and distributive justice in decisions to forgo life- sustaining treatment.
There is also very little research into how the Australian regulatory system addresses these issues. While the legal position (at least for treatment that doctors believe is ‘futile’) is relatively well-canvassed in the literature, there is a lack of attention to the different legal models for decision making and whether these models promote transparent and procedurally- fair decisions that address the underlying reasons for doctors’ decisions in practice. There is also nearly no scholarship on the Australian policy environment on withholding and withdrawing life-sustaining treatment from adult patients, notwithstanding significant policy developments internationally, which have recommended restricting the scope of the term ‘futile’.13 In the last five years, several Australian medical colleges have published new statements on decisions about life-sustaining treatment, which makes this inquiry into the content of these policies a particularly timely investigation.
To address these knowledge gaps, this thesis examines the law, policy and practice in relation to doctors’ decisions to withhold or withdraw life-sustaining treatment from critically- ill adult patients. It identifies the basis for concerns that doctors’ decisions about life-sustaining treatment are not sufficiently transparent or procedurally-fair and investigates the primary ethical rationales that doctors use to justify decisions to withhold or withdraw life-sustaining treatment in practice. It then uses these understandings to critique the current Australian regulatory regime. Cumulatively, the thesis argues the current system of laws and policies needs reform to better promote transparent and procedurally-fair decision making, which both recognises that decisions about life-sustaining treatment are often value-laden and raise concerns about scarce resources.
13 Bosslet et al, ‘Multi-Society Statement’ (n 7).
5
1.2 AIMS OF THE THESIS
This thesis aims to determine whether the current regulatory mechanisms that govern (or purport to govern) doctor-initiated decisions to forgo life-sustaining treatment in Australia adequately promote transparent and procedurally-fair decision making, or whether a new or additional regulatory response is needed. To address this central aim, the thesis will consider the following key research questions:
1. What is the nature of the concerns that doctors’ decisions to withhold or withdraw potentially life-sustaining treatment are not sufficiently transparent or procedurally-fair?
2. What ethical rationales do doctors rely on when they recommend withholding or withdrawing life-sustaining treatment from adult patients at the end of life and how are they conceptualised in practice?
3. What are the current legal models that address decisions to withhold or withdraw life-sustaining treatment and to what extent do they promote transparent and procedurally-fair decisions?
4. What professional guidance is available to doctors making decisions to withhold or withdraw life-sustaining treatment and to what extent do they promote transparent and procedurally-fair decisions?
The answers to these questions will inform an assessment of the overarching research question:
What, if any, reform is needed to promote increased transparency and procedural fairness in the regulatory regime that governs, or purports to govern, decisions to withhold or withdraw life-sustaining treatment for adult patients at the end of life?
The thesis uses a multidisciplinary approach to investigate the research questions to present a multi-faceted account of doctor-initiated decisions to withhold or withdraw life- sustaining treatment, which is grounded in both theory and practice. It does this by:
examining the ethical bases and terminology that doctors use to justify withholding or withdrawing life-sustaining treatment from adult patients, both from a doctrinal and empirical perspective;
6
investigating the relevant legal models for regulating disputes about withholding or withdraw life-sustaining treatment and evaluating which best address the stated ethical bases for decisions; and
evaluating the professional guidance given to doctors about how to approach decisions to withhold or withdraw life-sustaining treatment and what to do in the event of conflict.
This approach informs an appraisal of whether a new (or alternate) regulatory approach is needed in Australia to promote more transparent and procedurally-fair decision making, for the benefit of patients, substitute decision makers, doctors and society. By grounding the analysis in an empirical account of medical practice, the thesis provides new insight into the deficiencies of the current regulatory regime. While I do not set out to provide a comprehensive solution to all of these deficiencies, the thesis provides a number of recommendations as a foundation for further work.
1.3 OBJECTIVES OF THE THESIS: HOW THE AIMS WILL BE ACHIEVED
This thesis has a number of specific objectives, corresponding to each of the research questions. This section sets out these specific objectives.
Research Question 1. What is the nature of the concerns that doctors’ decisions to withhold or withdraw potentially life-sustaining treatment are not sufficiently transparent or procedurally-fair?
This research question aims to identify barriers to transparent and procedurally-fair decisions about potentially life-sustaining treatment, to ground an evaluation of the regulatory regime. A procedurally-fair decision-making process is important for decisions about life- sustaining treatment because it improves the quality of decision making.14 This is a core principle of natural justice, targeted at ensuring patients (and their substitute decision makers) have fair notice of and opportunity to participate in and influence decisions about treatment. A more substantial discussion of what is meant by transparent and procedurally-fair decisions is in section 1.7, which addresses the key concepts that inform the thesis.
14 See generally Jocelyn Downie, Lindy Willmott and Benjamin P White, ‘Cutting the Gordian Knot of Futility: A Case for Law Reform on Unilateral Withholding and Withdrawal of Potentially Life-Sustaining Treatment’ (2014) 26(1) New Zealand Universities Law Review 24, 10-11.
7
The thesis argues that there are two primary threats to transparent and procedurally-fair decisions in the current paradigm. First, in most Australian jurisdictions, doctors are empowered to unilaterally withhold or withdraw life-sustaining treatment they regard to be ‘futile’ or ‘non-beneficial’. However, apart from treatment that is physiologically futile,15 whether a treatment is beneficial depends on the patient’s values. Therefore futility is an imprecise and uncertain basis to grant unilateral decision-making power. Secondly, a related concern is that decisions about life-sustaining treatment involve the allocation of scarce resources, yet this is not discussed or disclosed.
To address this research question, the thesis will:
Review and critically analyse the literature on the concept of ‘futility’ as a basis for withholding or withdrawing life-sustaining treatment (Objective 1.1);
Evaluate whether the term ‘futility’ is a useful construct in end-of-life decisions (Objective 1.2); and
Identify ways that the current decision-making paradigm lacks transparency and procedural fairness (Objective 1.3).
Research Question 2. What ethical rationales do doctors rely on when they recommend withholding or withdrawing life-sustaining treatment from adult patients at the end of life and how are they conceptualised?
This research question aims to identify the ethical rationales that doctors use in practice as a basis for withholding or withdrawing life-sustaining treatment, and investigate how doctors conceptualise them. Theoretical literature suggests there are three distinct ethical rationales that can justify decisions to withhold or withdraw life-sustaining treatment, two of which are doctor-initiated.16 The first doctor-initiated rationale for not providing treatment is that it is against the patient’s interests (sometimes referred to as ‘futile’ or ‘non-beneficial’ treatment).17
15 Physiologically futile treatment is the very narrow category of treatment that ‘cannot accomplish the intended physiologic goals’, for example, antibiotics for a virus or cardiopulmonary resuscitation (‘CPR’) for a person who died hours before: see, eg, Bosslet et al, ‘Multi-Society Statement’ (n 7). See also Françoise Baylis, ‘Expert Testimony by Persons Trained in Ethical Reasoning: The Case of Andrew Sawatzky’ (2000) 28 Journal of Law, Medicine & Ethics 224. Baylis terms this futilewill not work treatment and notes, ‘the benefit of this definition is that it is as close as possible to a value-free, ‘objective’ understanding of the term…’: at 227. 16 The third rationale is the patient has refused the treatment (autonomy), which is outside the scope of this thesis. See further discussion in section 1.8, Scope. 17 The thesis uses the phrase ‘patient interests’ from the ethical literature as distinct from the related legal concept of ‘best interests’. See, eg, Wilkinson and Savulescu, ‘Knowing When to Stop’ (n 6) 163-164.
8
The second, and more controversial, doctor-initiated rationale is limiting life-sustaining treatment on the basis of distributive justice. This could arise when the treatment is very unlikely to work and is therefore not cost-effective. There is theoretical literature that suggests these two non-treatment rationales, patient interests and distributive justice, are conflated in practice. Some commentators also suggest the concept of ‘futility’ can mask conscious or unconscious rationing.18
Despite these theoretical concerns, there is a lack of empirical evidence about whether doctors perceive distributive justice is relevant to decisions about life-sustaining treatment for adult patients. There is also a lack of empirical evidence to support the theoretical assertion that futility is used to mask rationing decisions. Doctors’ perceptions of the ethical rationales they rely on in practice will inform the evaluation of the regulatory system.
To address this research question, the thesis will:
Investigate doctors’ perceptions of the extent to which resource factors influence determinations of futility for adult patients (Objective 2.1); and
Examine how doctors conceptualise the relationship between resource constraints and futility (Objective 2.2).
Research Question 3. What are the current legal models that address decisions to withhold or withdraw life-sustaining treatment and to what extent do they do they promote transparent and procedurally-fair decisions?
This research question is targeted at critically examining existing legal models that apply when a patient or substitute decision maker wants treatment that a doctor does not want to provide. It is designed to investigate various ways to allocate decision making power and the extent to which these models adequately promote transparent and procedurally-fair decisions.
To address this research question the thesis will:
Identify the values that should anchor regulatory responses to decisions about life-sustaining treatment (Objective 3.1);
18 Rationing can be defined as ‘the implicit or explicit mechanisms that allow people to go without beneficial services’: Peter A Ubel and Susan Dorr Goold, ‘“Rationing” Health Care: Not All Definitions Are Created Equal’ (1998) 158(3) Archives of Internal Medicine 209, 210. Section 1.7.3 addresses how rationing is used as a key concept in this thesis.
9
Identify all current legal models that determine who has decision-making authority over whether potentially life-sustaining treatment is provided (Objective 3.2);
Identify legal mechanisms for dispute resolution when there is a dispute about life-sustaining treatment (Objective 3.3); and
Evaluate whether the current legal model of decision making and dispute resolution needs reform to align with the articulated values (Objective 3.4).
Research Question 4. What professional guidance is available to doctors making decisions to withhold or withdraw life-sustaining treatment and to what extent does it promote transparent and procedurally-fair decisions?
This research question is aimed at evaluating the current Australian policy environment to determine the extent to which it promotes transparent and procedurally-fair decisions. To address this research question, the thesis will:
Identify all relevant publicly-available medical policies that address doctors’ decisions to withhold or withdraw life-sustaining treatment from adult patients (Objective 4.1);
Analyse what guidance the policies provide about the decision-making criteria (including the role of resources in decisions) (Objective 4.2);
Analyse what guidance the policies provide about the decision-making process and dispute resolution (Objective 4.3); and
Critically evaluate whether the current policy approach is sufficiently transparent and procedurally fair (Objective 4.4).
1.4 STRUCTURE OF THE THESIS
This thesis encompasses six publications and three chapters that link them together. The six publications (two book chapters and four journal articles) form the body of the thesis and make up Chapters 3 to 8, respectively. The publications are not listed chronologically, but rather are sequenced thematically to provide a coherent research narrative. This section provides a high-level overview of how the thesis is structured, and the next section provides a detailed description of each publication and how it connects to the research objectives.
10
The thesis is structured into five parts (Table 1, section 1.4.1). Part 1 provides important context for the publications. It sets out the research aims and parameters (this chapter), and situates the thesis within the relevant literature and legal framework (Chapter 2). Part 2 marks the start of the publications and identifies the context of doctor-initiated decisions to withhold or withdraw life-sustaining treatment, from both a doctrinal and an empirical perspective (Chapters 3 and 4). Chapter 3 evaluates the core concept of futility and discusses concerns about transparency and fairness associated with it and other related concepts. Chapter 4 then empirically investigates doctors’ perceptions of their practice, and examines how they conceptualise the relationship between futility and resource considerations.
The remainder of the thesis evaluates the extent to which Australian laws and policies adequately address the theoretical concerns and the empirical ‘reality’ of practice set out in Part 2. Part 3 is focused on the law and is made up of two publications that evaluate legal models for decision making about life-sustaining treatment against core values. Part 4 is focused on policy, and is comprised of two publications that identify and analyse relevant publicly- available government policies and professional guidelines. Part 5 concludes the thesis and reiterates how the publications are linked, synthesising the recommendations for reform. The thesis ends with some suggested areas for future research. As required by a thesis by published papers, a Statement of Contribution of Co-authors for each of the publications is included in Appendix A.
There is necessarily some overlap between the parts of the thesis, since some of the publications address multiple research questions, and each publication must necessarily stand on its own. For example, the Charlie Gard Paper provides both context about decision making and an analysis of the courts as a legal mechanism for dispute resolution, and therefore spans both Part 2 and Part 3. Nevertheless, it is situated within Part 3 since the paper is focused on critiquing the legal position.
Table 1. Structure of the thesis
Chapter and Title Short Title
PART 1 – INTRODUCTION AND LITERATURE REVIEW
Chapter 1 - Introduction -
Chapter 2 - Literature Review -
11
PART 2 – THE NATURE OF DOCTOR-INITIATED DECISIONS TO WITHHOLD OR WITHDRAW LIFE-SUSTAINING TREATMENT
Chapter 3 - Ben White, Lindy Willmott and Eliana Close, ‘Futile or ‘Futile, Non-Beneficial, Potentially Inappropriate or Disputed “Disputed” Treatment’ in Nathan Emmerich, Pierre Mallia, Treatment Bert Gordijn and Francesca Pistoia (eds), Contemporary Chapter’ European Perspectives on the Ethics in End of Life Care (Springer, 2020)
Chapter 4 - Eliana Close et al, ‘Doctors’ Perceptions of how ‘Doctors’ Resource Limitations Relate to Futility in End-of-Life Perceptions of Decision Making: A Qualitative Analysis’ (2019) 45 Journal Practice Paper’ of Medical Ethics 373
PART 3 – EVALUATING LEGAL MODELS FOR DECISION MAKING
Chapter 5 - Eliana Close, Lindy Willmott and Benjamin P ‘Charlie Gard White, ‘Charlie Gard: In Defence of the Law’ (2018) 44(7) Paper’ Journal of Medical Ethics 476
Chapter 6 - Ben White, Lindy Willmott, Eliana Close and ‘Critique of Legal Jocelyn Downie, ‘Withholding and Withdrawing Potentially Models Chapter’ Life-Sustaining Treatment: Who Should Decide?” in Ian Freckelton and Kerry Petersen (eds), Tensions and Traumas in Health Law (Federation Press, 2017) 454
PART 4 – IDENTIFYING AND ASSESSING THE AUSTRALIAN POLICY ENVIRONMENT
Chapter 7 - Eliana Close et al, ‘Australian Policies on ‘Medical Futility Medical “Futility” or Non-Beneficial Treatment at the End of Policy Analysis’ Life: A Qualitative Content Analysis’ (2019) 27(2) Journal of Law and Medicine 415
Chapter 8 - Eliana Close, Ben P White and Lindy Willmott, ‘Balancing ‘Balancing Patient and Societal Interests in Decisions About Patient and Life-Sustaining Treatment: An Australian Policy Analysis’ Societal Interests submitted to the Journal of Bioethical Inquiry Policy Analysis’
PART 5 – CONCLUSION
Chapter 9 - Conclusion -
1.5 LINKING THE PUBLICATIONS
This section provides a detailed overview of the six publications listed in Table 1, above, and how they meet the objectives of the thesis to form a unified body of literature. As a whole,
12
the thesis argues that existing regulatory mechanisms, which are centred on ‘futility’ (or a like concept), lack transparency and procedural fairness because:
1. they mask the value-laden nature of decisions about life-sustaining treatment; and,
2. they fail to adequately support decision makers to separate distributive justice considerations from patient interests.
The concerns are first introduced and explored in the Futile or Disputed Treatment Chapter, and then each of the subsequent publications addresses one or both of them (Figure 1). The Doctors’ Perceptions of Practice Paper is focused primarily on the second concern, the lack of transparency about distributive justice. Both legal papers, the Charlie Gard Paper and the Critique of Legal Models Chapter, each address both concerns. In contrast, the two policy papers divide the issues, and each address one of the concerns respectively.
Section 1.5.1, below, provides a graphical map depicting how each of the publications corresponds to one or both of these concerns (Figure 1). Sections 1.5.2-1.5.7 then describe each of the publications in more detail, and how they meet the objectives of the thesis. For ease of reference, section 1.6 provides a tabular overview summarising how the publications connect to each research question and objective (set out in section 1.2 and 1.3, above).
1.5.1 Map of Publications
Figure 1. Map of how each publication corresponds to the ‘mask’ of futility
13
1.5.2 Futile or Disputed Treatment Chapter By critically examining and tracing the development of ‘futility’ in end-of-life decision making, the Futile or Disputed Treatment Chapter provides the foundation for the thesis. The chapter serves several functions. As a preliminary matter, it introduces the typical features of a ‘futility dispute’, a situation in which a patient or substitute decision maker wants ongoing life-sustaining treatment that the medical team does not want to provide. The chapter discusses different ways doctors might express the medical opinion that treatment should be limited, including that treatment is ‘futile’, that it is ‘non-beneficial’, or that it is ‘inappropriate’. The chapter then focuses on futility, a central justification for withholding or withdrawing life- sustaining treatment. The chapter canvasses key debates in the literature, from efforts to define the concept of futility to studies that examine it empirically. It observes that there is a lack of consensus in the bioethical literature about what futility means and demonstrates that its continued currency has been thoroughly questioned. The chapter identifies several primary concerns with how futility is used in practice, namely:
1. That it is often used to refer to treatment that is not strictly ineffective or useless (as the literal meaning of the word would suggest), but rather involves an assessment about whether the treatment is ‘worth’ pursing;
2. That most futility judgments therefore involve subjective judgments about the degree of benefit and acceptable outcomes; and,
3. That labelling such treatment ‘futile’ may impede transparent and procedurally- fair decision making, since the label appears objective and can obscure the underlying values that drive decisions.
Secondly, the chapter discusses ‘procedural approaches’ to decision making as a main mechanism that were developed to address these concerns about futility. In the absence of consensus as to what constitutes futile treatment, procedural approaches are intended to set out a fair process to arrive at a just decision that appropriately involves patients and substitute decision makers. The chapter also discusses criticisms of procedural approaches, including that they can lack criteria upon which to make a decision and that fair outcomes can be impeded by the structure of the process.
The third function of the chapter is to add to the current literature by considering whether futility is a worthwhile concept. The chapter demonstrates futility is a concept that doctors
14
continue to use in practice. It achieves this by charting recent empirical studies on doctors’ views, a topic that has not received much attention in previous literature. Nevertheless, the chapter argues a more fruitful approach is to focus on how to resolve disputes about life- sustaining treatment, rather than on continued attempts to provide a unitary definition. The chapter endorses a proposed model for dispute resolution (which is expanded on in the Charlie Gard Paper and the Critique of Legal Models Chapter).19 We argue that doctors’ unilateral powers to stop life-sustaining treatment should be restricted to situations when the sought-after treatment is either physiologically futile (in other words, it will not work), or when there is a lawful excuse for not doing so. One such excuse is relying on a fair and transparent resource allocation policy that supports denying the treatment. In all other situations, life-sustaining treatments should be provided at a patient or substitute decision maker’s request. This provides patients and substitute decision makers with a stronger position in the decision-making process, but still ensures that their ability to insist on low efficacy treatment is not unlimited.
The fourth function of the chapter is to advance new terminology to better promote transparency and procedural fairness in disputes about life-sustaining treatment. The chapter proposes a terminological shift when discussions about life-sustaining treatment escalate. When there is a dispute, and a patient or substitute decision maker does not accept the doctor’s recommendation, words such as ‘futile’, ‘non-beneficial’ or ‘potentially inappropriate’ should be avoided because they unduly preference the medical opinion. The chapter suggests the label ‘disputed treatment’ as a more neutral alternative. Promoting a neutral stance in the context of a dispute is important, because of the significant power imbalance between doctors and patients (or their substitute decision makers).
Finally, the chapter also discusses the longstanding unmet calls in the literature to address the relationship between futility and scarce resources. The chapter argues that resource considerations are connected to futility in two ways. First, providing futile treatment uses resources that could be used more effectively elsewhere. Secondly, limited resources can provide a stand-alone rationale for limiting life-sustaining treatment (though this is currently not made transparent).
The Futile or Disputed Treatment Chapter substantially addresses research question 1, identifying and critically exploring concerns about transparency and fairness in doctors’
19 This model was first proposed in Downie, Willmott and White, (n 14).
15
decisions to withhold or withdraw life-sustaining treatment. It achieves the objectives of: reviewing and critically analysing the literature on the core concept of futility as a basis for withholding or withdrawing life-sustaining treatment (Objective 1.1); evaluating whether it is a useful construct in end-of-life decisions (Objective 1.2); and identifying barriers to achieving transparent and procedurally-fair decisions in the current paradigm (Objective 1.3).
1.5.3 Doctors’ Perceptions of Practice Paper Chapter 4 of the thesis, the Doctors’ Perceptions of Practice Paper, builds on the context provided in the Futile or Disputed Treatment Chapter. It provides empirical evidence about how decisions about life-sustaining treatment are made, as perceived by doctors who care for patients at the end of life. A significant part of the thesis is concerned with evaluating the regulatory system against this ‘reality’20 of medical practice. The empirical component of the thesis involves 96 semi-structured, face-to-face interviews with doctors, which I conducted in three tertiary public hospitals in metropolitan Brisbane.21 The doctors were primarily consultants, rather than registrars, and worked in 11 different medical specialties: emergency medicine (15); intensive care (12); oncology (10); palliative care (10); internal medicine (9); renal medicine (9); respiratory medicine (9); surgery (8); cardiology (5); geriatric medicine (5); and medical administration (4). I conducted these interviews as part of the ARC Futility Project (addressed in the Note on the Thesis), and the interviews were focused on how doctors conceptualise futile treatment and the reasons they provide it.
The Doctors’ Perceptions of Practice Paper reports on an analysis of these interviews, which I conducted specifically for this thesis. The paper explores doctors’ views on whether resource constraints influence decisions to withhold or withdraw life-sustaining treatment. In the introduction, the paper reviews literature that sets out the two distinct ethical rationales doctors can rely on when initiating a decision to withhold or withdraw life-sustaining treatment: patient interests and distributive justice. The paper describes concerns in the literature that these two non-treatment rationales are not sufficiently distinguished in practice. It also notes that there is very little empirical literature that explores doctors’ perceptions of the relationship between futility and resource constraints in practice.
20 I describe my ontological and epistemological approach in section 1.8.2. 21 Further description of the methodological approach is in section 1.8.
16
The paper then sets out the qualitative methodology and presents the results of the analysis. Doctors’ views were coded into three primary themes:
1. Perceptions of the relevance of resources to doctors’ current practice;
2. Perceptions of the relationship between resources and the concept of futility; and
3. Resource-related distress and recommendations to address it.
On the first theme, the Doctors’ Perceptions of Practice Paper found that participants’ views diverged over whether resources were relevant to decisions about life-sustaining treatment. Some doctors maintained resources were rarely or never relevant, while others believed they should be considered as one of many factors. On the second theme, the conceptual relationship between futility and resource constraints, doctors’ responses again varied. Importantly, some perceived futility encompasses considerations about scarce resources, yet this was not always disclosed or recognised. A few doctors thought the concept of futility can sometimes conceal both conscious and unconscious rationing. This finding suggests some decisions lack sufficient transparency. Finally, on the third theme, the paper found some doctors felt conflicted by being a gatekeeper of scarce resources without appropriate regulation that supported decisions based on distributive justice. This also contributes to the lack of transparency in decisions to limit life-sustaining treatments.
The Doctors’ Perceptions of Practice Paper addresses research question 2 by establishing that doctors perceive both patient interests and distributive justice are relevant rationales for withholding or withdrawing life-sustaining treatment (Objective 2.1). Some doctors believed resource factors influenced determinations of futility and a few perceived that the concept of futility masked conscious and unconscious rationing in practice, where distributive justice is the primary basis for the decision (Objective 2.2). Significantly, this paper empirically validates the theoretical concern that doctors do not always distinguish between patient interests and distributive justice as non-treatment rationales. This finding was reinforced by some doctors’ desire for more support for rationing decisions at the bedside. To address these findings the paper argues the regulatory system should promote more transparency about distributive justice as a non-treatment rationale. This article is therefore at the centre of the thesis and provides the basis for analysing both the legal system and the policy environment. The thesis argues that the regulatory system should acknowledge and respond to
17
both non-treatment rationales, rather than focusing solely on patient interests, since doctors indicate they use both in practice.
1.5.4 Charlie Gard Paper Part 3 of the thesis evaluates existing legal models that govern decisions about potentially life-sustaining treatment against the context and empirical findings provided in Part 2. The Charlie Gard Paper is the first of two papers (along with the Critique of Legal Models Chapter) to examine the legal position. It was published in the Journal of Medical Ethics in a special edition on the high-profile case of the infant Charlie Gard. The Charlie Gard case is a paradigm example of a ‘futility dispute’, in which parents or substitute decision makers insist on treatment that doctors believe is futile. Although the Charlie Gard Paper addresses a dispute over life-sustaining treatment for a child, the reasoning also applies to the Australian adult context (the focus of this thesis). Section 1.9 of this chapter provides additional justification for this scope.22
For context, Box 1 provides a brief description of the Charlie Gard case, since very few details of the case appear in the Charlie Gard Paper. The case is also mentioned in the Futile or Disputed Treatment Chapter and the Medical Futility Policy Analysis.
Box 1. Overview of the Charlie Gard case
Charlie Gard was a full-term infant, born apparently healthy.23 Within weeks, his parents noticed signs of muscle weakness and at two months of age he was admitted to the Great Ormond Street Hospital (GOSH) in London with poor feeding, insufficient growth and respiratory failure. Charlie was admitted to intensive care and diagnosed with an extremely rare mitochondrial disorder called infantile onset encephalomyopathic mitochondrial DNA depletion syndrome (MDDS). Charlie had an extremely poor prognosis and doctors expected him to die in infancy. He was paralysed, deaf, unable to breathe without ventilatory support, and his heart, liver and kidneys were affected. Charlie’s parents learned of an experimental treatment (nucleoside supplementation) that had been used with some success in other forms of MDDS. However, given Charlie’s condition, the treating
22 I provide further justification for the focus on adults in section 1.9. 23 Great Ormond Street Hospital v Yates [2017] EWHC 972 (Fam). See also Dominic Wilkinson and Julian Savulescu, ‘Hard Lessons: Learning from the Charlie Gard Case’ (2017) 44 Journal of Medical Ethics 438 (‘Hard Lessons’).
18
team at GOSH determined that the experimental treatment and further ICU support would be futile.
Charlie’s parents raised money to take him to a specialist in the United States who was willing to provide the experimental treatment. In response, the hospital applied to the Family Division of the High Court for an order to withdraw life support and provide palliative care. The High Court ruled in favour of GOSH24 and a series of further proceedings all confirmed this position.25 Eventually, Charlie’s parents abandoned their request for the experimental treatment but wanted Charlie to be moved home to receive palliative care before doctors withdrew the ventilator. The High Court ruled against this26 and Charlie was transferred to a hospice, where he died just a few days before his first birthday.
The focus of the Charlie Gard Paper is on one particular line of argument that arose in response to the Gard case, namely that existing legal processes do not adequately address disputes about life-sustaining treatment. The paper classifies criticisms commentators have levelled at court involvement in disputes about life-sustaining treatment into three categories:
1. That the law does not sufficiently address issues of limited healthcare resources;
2. That the best interests standard (used for decision making in children, but also in adults who lack capacity) is problematic; and
3. That the courts are poorly-suited to resolve disputes about life-sustaining treatment.
The paper considers each of these criticisms and concludes that they are mostly unfounded. First, contrary to some prior claims, legal mechanisms do exist that would support doctors and health authorities using distributive justice as a rationale for limiting life-sustaining treatment. A central mechanism is an action for judicial review.27 Typically courts defer to
24 Great Ormond Street Hospital v Yates [2017] EWHC 972 (Fam). 25 Yates v Great Ormond Street Hospital [2017] EWCA Civ 410; Great Ormond Street Hospital v Yates [2017] EWHC 1909; Gard v the United Kingdom (App no 39793/17) [2017] ECHR 605. 26 Great Ormond Street Hospital v Yates [2017] EWHC 1909 (Fam). 27 See generally Fiona McDonald and Deanna Sedgwick Fincher, ‘The Legal Framework of the Australian Health System’ in Ben White, Fiona McDonald and Lindy Willmott (eds), Health Law in Australia (Thomson Reuters, 3rd ed, 2018) 75, 96-98. Note that there is a lack of litigation in Australia about rationing or resourcing decisions, compared to other jurisdictions such as the United Kingdom. See Emily Jackson, Medical Law: Text,
19
health authorities on how to allocate scarce resources, provided their decisions are made using a fair process.28 However, for the courts to consider resourcing issues, doctors or hospitals must first articulate transparent resource-based rationales for limiting life-sustaining treatment in discussions with the patient or family or in court filings. This does not normally occur in practice; clinical decisions about life-sustaining treatment are typically only framed in terms of patient interests. The scope of issues that the courts can consider is defined by the parties so thus far courts have not addressed scarce resources in many disputes about life-sustaining treatment.
Second, the paper argues that the court’s focus on a patient’s best interests is largely defensible but would be improved with better articulation of the values that underlie decisions. The application of the best interests test would be more transparent and fair if courts were less deferential to doctors’ opinions and explicitly recognised the normative nature of decisions about potentially life-sustaining treatment.
Third, the paper defends the role of the courts in disputes about life-sustaining treatment, as independent arbiters with an important public precedent-setting function. Although court processes can involve delay, there are important reasons to allow parties to appeal decisions. Appeals guard against arbitrary and idiosyncratic decision making. The court process also plays a key role in promoting transparent decisions, which can be examined by other parties in future disputes. The paper argues that for intractable disputes, a judicial or quasi-judicial process would best advance the key values that should guide regulatory choices in this area.
After largely dismissing these criticisms of the law, the Charlie Gard Paper articulates a new legal model of decision making (first mentioned in this thesis in the Futile or Disputed Treatment Chapter) that would better promote a number of core values.29 These values are set out in Table 2, below. As emphasised in the aims and objectives, this thesis has a particular focus on procedural fairness (which encompasses transparency) and distributive justice.
Cases, and Materials (Oxford University Press, 4th ed, 2016) 74-89; Christopher Newdick, Who Should We Treat? Rights and Rationing in the NHS (Oxford University Press, 2nd ed, 2005) ch 5. 28 McDonald and Sedgwick Fincher (n 27) 98. 29 These values were articulated in Downie, Willmott and White (n 14). The classification (into values centred on the individual patient, those promoting the integrity of the regulatory system and those recognising viewpoints external to the patient) is set out in the Charlie Gard Paper.
20
Table 2. Values articulated in the Charlie Gard Paper
Core values for regulating decisions about life- Focus of the values sustaining treatment Values centred on the The value of human life individual patient Autonomy Equality Values promoting the Adherence to the rule of law (including that the integrity of the regulatory law is certain, clear and consistent); system Procedural fairness (including transparency) Access to justice Values recognising Distributive justice viewpoints external to Conscience the patient Humility
The paper provides a case for why this proposed model is a legal structure that would better reflect these core values. The model gives presumptive authority to parents (or substitute decision makers) rather than doctors, with a few exceptions. One exception is when the sought- after treatment is physiologically futile (in other words, it will not work) and therefore is properly in the doctor’s domain. Another is when the doctors (or hospital administrators) rely on a valid resource allocation policy to deny treatment.
The Charlie Gard Paper addresses several of the objectives of research question 3, which is aimed at evaluating the extent the current legal mechanisms for decision making address concerns about transparency and procedural fairness. First, the paper sets out and categorises the values that the legal system should address, including but not limited to procedural fairness (which, as articulated, encompasses transparency) (Objective 3.1). Second, the paper identifies legal mechanisms for dispute resolution when there is a conflict about life- sustaining treatment, including the courts, tribunals and ethics committees (Objective 3.3). Third, the paper defends the role of the courts in disputes about life-sustaining treatment as public forums with a precedent-setting function (Objective 3.4). Finally, the paper contends that a shift in how decisions are made to give more power to substitute decision makers would better promote transparent and procedurally-fair decisions (Objective 3.4). This shift would encourage more explicit resource-based decisions, as valid resource allocation policies could trump the wishes of substitute decision makers for potentially inappropriate treatment.
21
1.5.5 Critique of Legal Models Chapter The Critique of Legal Models Chapter builds on the analysis in the Charlie Gard Paper. The chapter briefly lists the values that should anchor the legal framework, which were catalogued in the Charlie Gard Paper (Objective 3.1). The chapter then identifies a number of legal models for determining who has decision making authority over whether potentially life- sustaining treatment is provided, and critiques each model against the core values. The models sit on a spectrum, with on one end doctors having unilateral decision-making power to withhold or withdraw life-sustaining treatment (the Australian common law position), and on the other end a model that requires consent to limit life-sustaining treatment (reflected in the Queensland guardianship legislation).
The Critique of Legal Models Chapter argues that each decision-making model represents a compromise between the core values, and none adequately promote both procedural fairness and transparency about distributive justice as a non-treatment rationale. The chapter therefore describes a new model (the same one set out in the Charlie Gard Paper), situated on the spectrum of identified models, which better reflects the articulated values. This model gives more decision-making power to patients and substitute decision makers, while at the same time promoting appropriate mechanisms for addressing distributive justice. As noted above, the model’s first constraint on the wishes of patients or substitute decision makers is that doctors do not have to provide treatment that is physiologically futile. The second is that doctors do not have to provide treatment when there is a lawful excuse, including when the doctor relies on a valid resource allocation policy. The chapter expands on the argument provided in the Charlie Gard Paper as to why this legal model would promote more transparent and procedurally-fair decisions. Procedural fairness is promoted because the patient or substitute decision maker has decision-making authority over those decisions that involve an assessment over whether treatment is ‘worth’ pursuing. Transparency about distributive justice is promoted because this model would encourage governments and hospital administrators to develop transparent resource allocation policies that doctors can rely on in practice to ground treatment refusals.
The Critique of Legal Models Chapter satisfies the objectives of research question 3. It identifies the values that should anchor regulatory responses to decisions about life-sustaining treatment (Objective 3.1) and identifies all existing legal models that determine who has decision-making authority over potentially life-sustaining treatment (Objective 3.2). By
22
discussing the courts and ethics committees as potential options for dispute resolution it also partially addresses Objective 3.3, identifying legal mechanisms for dispute resolution. Finally, the chapter evaluates the current legal models of decision making in Australia based on core values (Objective 3.4).
1.5.6 Medical Futility Policy Analysis The Medical Futility Policy Analysis is one of two publications that addresses research question 4, which is aimed at evaluating the current Australian policy environment to determine the extent to which it promotes transparent and procedurally-fair decisions. While medical policies have been used in other jurisdictions to set out a procedural approach for responding to disputes about futile treatment, the policy environment in Australia is understudied.
Using a qualitative document analysis method, the Medical Futility Policy Analysis identifies and analyses all publicly-available policies on withholding and withdrawing life- sustaining treatment in Australia. A total of 23 policies were identified and divided into three categories: 1) Commonwealth government policies; 2) State and Territory government policies; and 3) professional guidance. The paper examines how the policies define futile treatment (or a similar concept), and the guidance provided about the decision-making process and how to navigate disputes. The paper establishes that the Australian policy environment lacks consistent guidance about terminology for decisions to withhold or withdraw life- sustaining treatment. While most policies mention futility or a like concept, there is insufficient recognition that judgments about life-sustaining treatment are often value-laden. The paper also finds that although policies contemplate a consensus-based approach, there is a marked lack of guidance about how to navigate conflicts when they occur. Many policies do not acknowledge the potential for conflict at all. The current policy guidance is problematic because existing medical policies do not sufficiently promote transparency about the values underlying decisions or provide doctors with clear and consistent instructions for how to resolve disputes.
The Medical Futility Policy Analysis addresses several of the objectives of research question 4. It identifies all relevant publicly-available policies (Objective 4.1), and analyses the guidance about futility (or a like concept) (Objective 4.2) and the decision-making process and dispute resolution (Objective 4.3). The paper also contributes to research question 1. It contains a section that reviews the problems with futility as a concept (Objective 1.1) and discusses the thrust in the literature towards a ‘procedural approach’ to resolving disputes (Objective 1.3).
23
1.5.7 Balancing Patient and Societal Interests Policy Analysis The focus of the Medical Futility Policy Analysis is on the first concern identified by the Futile or Disputed Treatment Chapter, whether policies sufficiently recognise that decisions about life-sustaining treatment are value-laden. In contrast, the Balancing Patient and Societal Interests Policy Analysis is focused on the second concern, the extent to which medical policies navigate both patient and societal interests. The paper analyses a subset of policies from the Medical Futility Policy Analysis, examining only those that refer to doctors’ duties to consider resource allocation when making decisions.
The paper determines only eight policies on withholding and withdrawing life-sustaining treatment mention resource allocation (Objective 4.2). Of the policies that mention resources, the majority only provide high-level statements of principle, with no guidance for how to implement these principles in practice. A few policies include clinical guidance for decision- making, however this is largely unhelpful. The article finds there is limited guidance about using distributive justice as a non-treatment rationale (Objective 4.4). The findings in this paper reinforce doctors’ perceptions in the Doctors’ Perceptions of Practice Paper that there is insufficient regulatory support for resource-based decisions. The paper concludes by providing some directions for how policies could be reformed to better promote transparent and procedurally-fair decisions (Objective 4.4).
The Balancing Patient and Societal Interests Policy Analysis also contributes to research question 1, by identifying concerns about transparency in doctors’ decisions. The paper demonstrates how doctors’ competing obligations to patient and society are framed in policies on withholding and withdrawing life-sustaining treatment and concludes most policies avoid explicitly confronting doctors’ role in rationing treatment at the bedside (Objective 1.3).
1.6 CONNECTION BETWEEN THE PUBLICATIONS AND THE THESIS OBJECTIVES
Section 1.5 described each of the publications and how they addressed the research questions and objectives of the thesis. For ease of reference Table 3, below, provides an overview of how each research question and objective is addressed by the six publications.
24
Table 3. The relationship between the objectives of the thesis and its publications
Objective Relevant section of the thesis
Research Question 1. What nature of the concerns about transparency and procedural fairness in doctors’ decisions to withhold or withdraw life-sustaining treatment?
Objective 1.1: Review and critically Futile or Disputed Treatment Chapter analyse the literature on the concept of (Chapter 3)
‘futility’ as a basis for withholding or Critique of Legal Models Chapter withdrawing life-sustaining treatment. (Chapter 6), article pages 459-462
Medical Futility Policy Analysis (Chapter 7), Section II, ‘The Role of “Medical Futility”, thesis pages 126-129 and Section V(B), ‘Terminology’, thesis pages 140-147
Objective 1.2: Evaluate whether the term Futile or Disputed Treatment (Chapter ‘futility’ is a useful construct in end-of- 3) life decisions.
Objective 1.3: Identify ways that the Futile or Disputed Treatment (Chapter current decision-making paradigm could 3) be more transparent and fair. Doctors’ Perceptions of Practice Paper (Chapter 4), Introduction, article pages 373-374
Charlie Gard Paper (Chapter 5), article pages 477-479
Critique of Legal Models Chapter (Chapter 6), chapter pages 459-463
Medical Futility Policy Analysis (Chapter 7), thesis pages 153-158
25
Balancing Patient and Societal Interests Policy Analysis (Chapter 8), Introduction, thesis pages 161-163
Research Question 2. What are the ethical rationales that doctors rely on in practice when they recommend withholding or withdrawing life-sustaining treatment from adult patients at the end of life, and how are they conceptualised?
Objective 2.1 Investigate doctors’ Doctors’ Perceptions of Practice Paper perceptions of the extent to which (Chapter 4) resource factors influence determinations about futility for adult patients.
Objective 2.2: Examine how doctors Doctors’ Perceptions of Practice Paper conceptualise the relationship between (Chapter 4) resource constraints and futility.
Research Question 3. To what extent do the current legal mechanisms for resolving disputes address concerns about transparency and procedural fairness?
Objective 3.1 Identify the values that Charlie Gard Paper (Chapter 5), article should anchor regulatory responses to pages 477-478 decisions about life-sustaining Critique of Legal Models Chapter treatment. (Chapter 6), chapter pages 473-474
Objective 3.2: Identify all possible legal Critique of Legal Models Chapter models that determine who has decision- (Chapter 6), ‘Possible legal models for making authority over whether decision making’, chapter pages 463- potentially life-sustaining treatment is 472 provided.
Objective 3.3 Identify legal mechanisms Charlie Gard Paper (Chapter 5), article for dispute resolution when there is a pages 476-477, 479 dispute about life-sustaining treatment Critique of Legal Models Chapter (Chapter 6), chapter page 464
26
Objective 3.4: Evaluate whether the Charlie Gard Paper (Chapter 5), article current legal model of decision making pages 477-479 and dispute resolution needs reform in Critique of Legal Models Chapter relation to the articulated values. (Chapter 6), chapter pages 473-478
Research Question 4. What professional guidance is available to doctors making decisions to withhold or withdraw life-sustaining treatment and to what extent does this address concerns about transparency and procedural fairness?
Objective 4.1: Identify all relevant Medical Futility Policy Analysis publicly-available medical policies that (Chapter 7), thesis pages 130-140 address doctors’ decisions to withhold or withdraw life-sustaining treatment from adult patients.
Objective 4.2: Analyse the policy Medical Futility Policy Analysis guidance provided about the criteria (Chapter 7), thesis pages 134-152 doctors should use when making Balancing Patient and Societal Interests decisions about life-sustaining treatment Policy Analysis (Chapter 8), thesis pages (including the role of resources in 165-182 decisions).
Objective 4.3: Analyse the policy Medical Futility Policy Analysis guidance provided about the decision- (Chapter 7), thesis pages 147-152 making process and dispute resolution.
Objective 4.4: Critically evaluate Medical Futility Policy Analysis whether the current policy approach is (Chapter 7), thesis pages 153-158 sufficiently transparent and Balancing Patient and Societal Interests procedurally-fair. Policy Analysis (Chapter 8), thesis pages 176-182
27
The remainder of this chapter provides a description of the key concepts that inform the thesis, its methodological approach, scope, and significant and original contributions to knowledge.
1.7 KEY CONCEPTS
This section describes the key concepts of futile treatment, distributive justice, rationing, transparent and procedurally-fair decisions, and regulation as they will be applied in this thesis. With many of these key concepts, there is extensive debate about their scope and definition, and it is not possible to go into all of these debates here. For the purpose of this thesis, in this section I acknowledge these debates and adopt an appropriate definition or usage to frame the research. My position on these terms is set out here but some of these issues are also explored further in the literature review in Chapter 2 and in the various publications.
1.7.1 Futile treatment The concept of futility is discussed at length in Chapter 3, the Futile or Disputed Treatment Chapter and is also addressed in the Critique of Legal Models Chapter (Chapter 6) and the Medical Futility Policy Analysis (Chapter 7). This section will therefore only provide a brief introduction to futility as central basis for withholding or withdrawing life-sustaining treatment. This overview is included here to provide a basis for further discussion in this chapter and in Chapter 2, the literature review.
In the 1990s, clinicians and ethicists became interested in futility as a rationale for doctors to limit life-sustaining treatment.30 The term was used as an ‘ethical trump card’31 to delineate a doctor’s discretion to unilaterally withhold or withdraw life-sustaining treatment. If a measure was futile, then doctors should not provide it and were justified in refusing a patient’s or family member’s request. Strictly, the word ‘futile’ means something that is ‘[i]ncapable of producing any result; failing utterly of the desired end through intrinsic defect; useless, ineffectual, vain’,32 but bioethical debate about the meaning of the term demonstrates it is used to denote something broader than this. Futility has been used to describe situations when:
30 Helft, Siegler and Lantos (n 6). 31 Charles Weijer and Carl Elliott, ‘Pulling the Plug on Futility: Futility is not the Ethical Trump Card That Some Would Like It to Be’ (1995) 310(6981) BMJ 683. 32 OED Online (online at 29 September 2019), ‘futile’.
28
A treatment is incapable of having an effect (ie physiological futility);33
The burdens of a treatment outweigh the benefits;34
A treatment will confer a very small benefit, despite a high chance of success;35 and
A treatment has a very small chance of success, though potentially significant benefit.36
The latter three scenarios involve assessments of how likely it is that a treatment will confer a benefit (sometimes labelled ‘quantitative futility’) and the quality or nature of that benefit (sometimes called ‘qualitative futility’).37 There is broad consensus that judgments about ‘benefit’, ‘burden’ and the chance of success are highly normative, and depend on a patient’s values. Therefore, many argue that futility is a controversial basis upon which to confer unilateral decision-making power to doctors.38
This thesis recognises that ‘futility’ is a vexed term. In particular, the Futile or Disputed Treatment Chapter discusses how there has been a shift in the literature away from the term ‘futile’ towards other terminology including ‘non-beneficial treatment’, and ‘potentially inappropriate treatment’. This thesis recognises this shift but uses the term ‘futile’ in the literature review in Chapter 2, and to frame the publications. This is for a few reasons. First, the term is still used in practice, is reflected in laws and policies, and is recognised by doctors.39
33 See, eg, Robert M Veatch, ‘Terri Schiavo, Son Hudson, and “Nonbeneficial” Medical Treatments’ (2005) 24(4) Health Affairs 976; Bosslet et al, ‘Multi-Society Statement’ (n 7). 34 See, eg, John D Lantos et al, ‘The Illusion of Futility in Clinical Practice’ (1989) 87 American Journal of Medicine 81. Ben White et al, ‘What Does “Futility” Mean? An Empirical Study of Doctors’ Perceptions’ (2016) 204(8) Medical Journal of Australia 318.e1. 35 See, eg, Baylis (n 15) 228-229. 36 Ibid. See also Lawrence J Schneiderman, Nancy S Jecker and Albert R Jonsen, ‘Medical Futility: Its Meaning and Ethical Implications’ (1990) 112(12) Annals of Internal Medicine 949. Schneiderman, Jecker and Jonsen propose, ‘when physicians conclude (either through personal experience, experiences shared with colleagues, or consideration of published empiric data) that in the last 100 cases a medical treatment has been useless, they should regard that treatment as futile’: at 949. 37 See, eg, Schneiderman, Jecker and Jonsen (n 36); Lawrence J Schneiderman, ‘Defining Medical Futility and Improving Medical Care’ (2011) 8 Journal of Bioethical Inquiry 123. 38 See, eg, Robert D Truog, Allan S Brett and Joel Frader, ‘The Problem with Futility’ (1992) 326 New England Journal of Medicine 1560; Joanna Manning, ‘Withdrawal of Life-Sustaining Treatment from a Patient in a Minimally Conscious State’ (2012) 19(3) Journal of Law and Medicine 430, 433; Gabriel T Bosslet, Bernard Lo and Douglas B White, ‘Resolving Family-Clinician Disputes in the Context of Contested Definitions of Futility’ (2018) 60(3) Perspectives in Biology and Medicine 314. 39 See eg, Ben White et al, ‘What Does “Futility” Mean? An Empirical Study of Doctors’ Perceptions’ (2016) 204(8) Medical Journal of Australia 318.e1; Downar et al (n 7).
29
Secondly, it grounds the thesis in the literature and criticisms around the term, which enables further critique.
Two publications, the Futile or Disputed Treatment Chapter and the Medical Futility Policy Analysis, evaluate futility as a concept and argue for an alternative approach to terminology. In addition to the phrase ‘disputed treatment’, proposed in the Futile or Disputed Treatment Chapter, the thesis also endorses the approach in a recent international critical care policy, known as the ‘Multi-Society Statement’.40 This policy advocates limiting the word ‘futile’ (and doctors’ authority to unilaterally refuse a treatment) to the narrow category of interventions that are physiologically futile (in other words, they will not work).41 When there is some chance of success of achieving the effect sought by the patient, or some evaluative component to the decision, the term ‘potentially inappropriate treatment’ should be used. Restricting the usage of futility fosters more precise language and more transparent decision making. This argument is expanded on in the Medical Futility Policy Analysis.
1.7.2 Distributive justice This thesis relies on distributive justice as one of two valid doctor-initiated non-treatment rationales. In their seminal text, Beauchamp and Childress define distributive justice as the ‘fair, equitable and appropriate distribution of benefits and burdens determined by norms that structure the terms of social cooperation’.42 In other words, distributive justice refers to the socially acceptable distribution of goods. It is a subset of the principle of justice, one of the four core tenets of Beauchamp and Childress’ theoretical framework for medical ethics, along with autonomy, beneficence, and non-maleficence.43 In this ‘four principles’ approach, no one principle takes precedence, but must be balanced to arrive at justifiable clinical-ethical decisions in any given context.44
While a detailed exploration is beyond the scope of this research, I recognise that there are different theories of distributive justice, corresponding to different schools of economic
40 Bosslet et al, ‘Multi-Society Statement’ (n 7). 41 Physiologically futile treatment is the narrow category of treatment that ‘cannot accomplish the intended physiologic goals’: ibid. See footnote 15 for further detail. 42 Tom L Beauchamp and James F Childress, Principles of Medical Ethics (Oxford University Press, 7th ed, 2013) 250. 43 Ibid 13. 44 Beauchamp and Childress (n 42), 19-22; Ian Kerridge, Michael Lowe and Cameron Stewart, Ethics and Law for the Health Professions (Federation Press, 4th ed, 2013) 125.
30
thought.45 Each theory has implications for policy choices about how to allocate scarce resources. For example, applying different approaches to distributive justice in an ICU setting could lead to a range of allocation principles including:
equality (treating people equally, for example by holding a lottery for who gets an ICU bed or organ for transplantation);
prioritarianism (favouring the worst off, for example, the sickest first or the youngest first);
utilitarianism (maximising total benefits, for example via the greatest number of lives saved or the number of life-years saved); and,
promoting or rewarding social usefulness (including rewarding those who contributed to society, or those who have value to society in the future).46
In the healthcare context, different theories of justice could be set out explicitly, for example in triage policies,47 or could be reflected in individual clinical decisions.48
This thesis employs the concept of distributive justice in a broad sense, without taking a position on any one allocation approach. In this thesis distributive justice refers to concern about the efficient use of scarce resources and concern for other patients that are competing for the same scarce resource. It is used in broad terms to describe one of the two primary rationales for doctors’ decisions to withhold or withdraw life-sustaining treatment. This conceptualisation of patient interests and distributive justice as two distinct doctor-initiated non-treatment rationales is well-established in the literature.49 Since the thesis employs distributive justice in this broad sense, it is not necessary to delve further into the various allocation principles listed
45 See generally Michael Allingham, Distributive Justice (Routledge, 1st ed, 2014) ch 1. Well-known theories include Robert Nozick’s libertarianism, John Rawls’ egalitarianism (justice as fairness), Ronald Dworkin’s equality of resources approach. Another theory is Amartya Sen’s capabilities approach: Amartya Sen, Inequality Reexamined (Russell Sage, 1995). 46 Govind Persad, Alan Wertheimer and Ezekiel J Emanuel, ‘Principles for Allocation of Scarce Medical Interventions’ (2009) 373(9661) The Lancet 423, 423-426. 47 Tony Hope, John McMillan and Elaine Hill, ‘Intensive Care Triage: Priority Should Be Independent of Whether Patients are Already Receiving Intensive Care’ (2012) 26(5) Bioethics 259. 48 Anke JM, Oerlemans et al, ‘Rationing in the Intensive Care Unit in Case of Full Bed Occupancy: A Survey Among Intensive Care Unit Physicians’ (2016) 16(1) BMC Anesthesiology 25. 49 See, eg, Tony Hope, David Sprigings and Roger Crisp, ‘“Not Clinically Indicated”: Patients’ Interests or Resource Allocation?’ (1993) 306(6874) BMJ 379; Wilkinson and Savulescu, ‘Hard Lessons’ (n 23) 439; Wilkinson and Savulescu, ‘Knowing When to Stop’ (n 6).
31
above, but an awareness of them is important for the later policy review in the Balancing Patient and Societal Interests Policy Analysis (Chapter 8).
1.7.3 Rationing Although healthcare rationing is a ‘morally charged term’,50 the thesis argues it is necessary and morally acceptable, provided it is done in a fair and transparent way.51 In Australia, as in the rest of the world, health care resources are scarce and cannot meet the myriad of demands on the health care system.52 Consequently, health resources must be rationed to appropriately respond to these competing demands. There is copious literature discussing the meaning of rationing, and the term remains contested.53 This thesis adopts Ubel and Goold’s broad view of rationing: ‘the implicit or explicit mechanisms that allow people to go without beneficial services’.54 In the ICU, Truog et al similarly define rationing as ‘the allocation of healthcare resources in the face of limited availability, which necessarily means that beneficial interventions are withheld from some individuals’.55
Different mechanisms for rationing exist and operate at different levels in the health care system. Governments and hospitals often ration explicitly, for example by making policies about what medications to subsidise and what services to offer.56 Rationing also can occur implicitly, without reference to explicit principles or policies.57 This thesis examines a variety of implicit rationing known as ‘bedside rationing’, which can be defined as the exclusion of specific patients from a medically beneficial service or treatment primarily to further the
50 Ubel and Goold (n 18). 51 Robert D Truog et al, ‘Rationing in the Intensive Care Unit’ (2006) 34(4) Critical Care Medicine 958; Norman Daniels, ‘Accountability for Reasonableness’ (2000) 321(7272) BMJ 1300. 52 See generally Leonard M Fleck, ‘Just Caring: Health Care Rationing, Terminal Illness and the Medically Least Well Off’ [2011] Journal of Law, Medicine and Ethics 156, 157-161. 53 See, eg, Rebekah J Walker and Leonard E Egede, ‘Rationing of Care: Conceptual Ambiguity and Transparency in Data Collection and Synthesis’ (2016) 31(12) Journal of General Internal Medicine 1415. 54 Peter A Ubel and Susan Dorr Goold, ‘“Rationing” Health Care: Not All Definitions Are Created Equal’ (1998) 158(3) Archives of Internal Medicine 209, 210. See also Peter A Ubel, Pricing Life: Why It’s Time for Health Care Rationing (MIT Press, 2000) 28. 55 Truog et al (n 51) 959. 56 Keith Syrett, Law, Legitimacy and the Rationing of Health Care: A Contextual and Comparative Perspective (Cambridge University Press, 2007) 54-55. 57 Implicit rationing is characterised by a lack of transparency about the allocative decision and includes situations when an individual (for example, a clinician) does not perceive they are rationing: Ibid 52-54. Coast asserts implicit rationing occurs ‘when care is limited and where neither decisions about which forms of care are provided or the bases for those decisions are clearly expressed’: Joanna Coast, ‘The Rationing Debate: Rationing within the NHS Should be Explicit - The Case Against’ (1997) 314(7087) BMJ 1118, 1118. Similarly, Locock argues that ‘in implicit rationing the reasoning involved is not clearly stated to anyone except (or possibly including) the person making the decisions, or active decision-making is avoided altogether’: Louise Locock, ‘The Changing Nature of Rationing in the UK National Health Service’ (2000) 78(1) Public Administration 91, 93.
32
financial interest of others (society, the doctor, or an organisation).58 Triage decisions are a well-recognised form of explicit rationing, but other types of decisions at the bedside also represent rationing, even if they are not recognised as such. Part of the challenge in investigating rationing in the context of futility is rationing can be a matter of perspective. When a patient or substitute decision maker perceives a potential benefit, denying the treatment could be interpreted as rationing, even though the doctor reasons it is not warranted on ‘clinical grounds’. Indeed, Truog et al argue many rationing decisions are construed as medical decisions. They state:
Appeals to the standard of care, to what is medically appropriate, or to what is necessary vs. merely beneficial are complex claims that seek to combine assessments about medical effectiveness, social utility, and economic feasibility into a judgment about whether an intervention should be provided. The advantage of these strategies is that they allow clinicians to believe they are not rationing; the disadvantage is that they justify denial of potentially beneficial treatments for reasons that may be implicit, unexamined, and unarticulated— even to physicians themselves— under the guise of presumably objective medical criteria.59
Ideally, as discussed in the next section, prioritisation decisions should be made according to transparent principles that reflect a coherent and fair approach. This thesis broadly endorses Daniels and Sabin’s ‘accountability for reasonableness’ framework, which provides that resource allocation decisions should possess four attributes: publicity; relevance; revision; and the opportunity for appeal.60 One concern, which this thesis investigates, is that bedside rationing often lacks this transparent basis. Consequently, there is a lack of opportunity to meaningfully engage with, evaluate, or challenge rationing decisions.
1.7.4 Transparency and procedural fairness This thesis examines the extent to which current regulatory mechanisms for withholding or withdrawing life-sustaining treatment promote transparency about the underlying non- treatment rationale or rationales. Greater transparency in health care is lauded as a solution to a multitude of policy concerns. However, despite the ubiquity of transparency in bioethical
58 Ubel and Goold (n 18) 75; Ubel (n 18) 112. 59 Truog et al (n 51) 959. 60 A detailed analysis of Daniels and Sabin’s framework is beyond the scope of this thesis. While it is the dominant paradigm for legitimate resource allocation decisions, note that it has also been subject to critique. See, eg, Alex Friedman, ‘Beyond Accountability for Reasonableness’ (2008) 22(2) Bioethics 101; Jennifer L Gibson, Douglas K Martin, and Peter A Singer, ‘Priority Setting in Hospitals: Fairness, Inclusiveness, and the Problem of Institutional Power Differences’ (2005) 61(1) Social Science & Medicine 2355.
33
discourse, its meaning is conceptually slippery.61 Persad argues transparency as a concept is not an end in itself, but rather should be construed as means to achieving a valuable goal. He states
For transparency to merit its status as a topic of interest for bioethics and law, it must be defined in a way that captures some aspect of what we care about … Even if we are pluralists about what is valuable, rather than transparency being an object of value in itself, transparency is more likely to serve as a means to achieving valuable ends, such as better health or improved patient autonomy.62
Persad defines transparency as ‘clarity … easy access to relevant information’, noting that the metaphor behind the concept suggests ‘transparency involves simple access rather than concealment or obscurity’.63
Adopting Persad’s definition, in this thesis transparency is a core vehicle to achieve the valuable goal of procedurally-fair health care decisions. A procedurally-fair decision-making process originates from the ‘hearing rule’ of natural justice.64 Downie, Willmott and White argue procedurally-fair decision making about life-sustaining treatment requires frank engagement with patients or their substitute decision makers and a fully-informed decision- making process. They note,
The importance of the treating team consulting with the patient (or the patient’s family) in decision‐making about whether to withhold or withdraw treatment has been widely recognised in academic commentary as well as by the judiciary.65
This thesis consequently conceives of transparency as a mechanism of accountability for health care decision making. The concept of transparency as a vehicle for procedural fairness in this thesis is threefold:
As it relates to the patient’s values, transparency involves articulating the value judgments behind decisions to withhold or withdraw life-sustaining treatment to foster better dialogue to inform shared decision-making;
61 Govind Persad, ‘Transparency Trade-offs: Priority Setting, Scarcity, and Health Fairness’ in Holly Fernandez Lynch et al (eds), Transparency in Health and Health Care in the United States (Cambridge University Press, 2019) 45-47. 62 Ibid 45. 63 Ibid. 64 Robin Creyke et al, Control of Government Action: Text, Cases & Commentary (LexisNexis Butterworths, 5th ed, 2019), 633-638. 65 Downie, Willmott and White (n 14) 34.
34
As it relates to fair resource allocation procedures, transparency involves disclosing the resource-related rationale and process for the decision so it can be scrutinised and is available for challenge, thereby increasing participation and trust; and
As it relates to where patient interests and distributive justice may conflict, transparency involves articulating the circumstances when distributive justice outweighs patient or substitute decision maker requests for life-sustaining treatment, so they are open to challenge.
Some argue that disclosing or engaging in resource-based decisions impugns trust and places healthcare providers in a conflict of interest.66 This thesis argues, however, that because these decisions are already being made, a better approach is to disclose them, so they are open to scrutiny. Disclosing them would enhance trust in the health care system, by giving the public a voice in the process.67 Moreover, some research suggests that both patients and health professionals desire a more transparent approach to rationing decisions.68 More research is needed on how best to disclose resource-based decisions, and how to support health professionals in doing so, but I acknowledge here that it could be accomplished in a variety of ways. For example, doctors at the bedside could rely on specific resource allocation policies, or these could be communicated by a third party, such as a clinically-focused hospital administrator, to better separate resource considerations from those of patient interests when communicating to families or substitute decision makers.
1.7.5 A broad view of regulation The overall aim of the thesis is to consider the extent to which the Australian regulatory system promotes transparent and procedurally-fair decisions about life-sustaining treatment, which are responsive to the ethical rationales doctors use in practice. Regulatory theory recognises there are a broad range of regulatory instruments and techniques that are used to
66 Marcia Angell, ‘The Doctor as Double Agent’ (1993) 3(3) Kennedy Institute of Ethics Journal 279; Norman G Levinsky, ‘The Doctor’s Master’ (1984) 311(24) New England Journal of Medicine 1573. See also Coast (n 57). 67 See, eg, Michael Young et al, ‘Rationing in the Intensive Care Unit: To Disclose or Disguise?’ (2012) 40(1) Critical Care Medicine 261, 263. 68 Amanda Owen-Smith, Joanna Coast and Jenny Donovan, ‘The Desirability of Being Open about Health Care Rationing Decisions: Findings from a Qualitative Study of Patients and Clinical Professionals’ (2010) 15(1) Journal of Health Services Research and Policy 14.
35
control social behaviour.69 The focus of this thesis is on two of these: law and medical policies. This thesis defines ‘policy’ as a written statement of principle intended to guide doctors’ decisions about clinical/ethical aspects of withholding or withdrawing life-sustaining treatment.70 The word ‘policy’ therefore includes professional and ethical guidelines, position statements, standards, and other documents.
The focus on both law and policy relies on a wide view of regulation. Traditionally, regulation was framed as a ‘command-and-control’ model of state-backed laws enforced by sanctions.71 However, contemporary scholarship acknowledges the relevance of broader mechanisms, ‘decentred’ from the state.72 While law was historically the central regulatory mechanism, this decentred view holds that governance and regulation is a product of interactions of ‘webs of influence’ that operate outside of the law.73 This view of regulation is defined by Black as:
… a process involving the sustained and focused attempt to alter the behaviour of others with the intention of producing a broadly identified outcome or outcomes, which may involve mechanisms of standard-setting, information-gathering and behaviour- modification.74
The thesis accepts that the traditional command-and-control focus on law as regulation is an incomplete explanation of what shapes behaviour in the health care context.75 While the law sets baseline standards, other regulatory mechanisms, such as medical policies, are designed to elevate this minimum standard to provide a model for best practice. For example, for withholding or withdrawing life-sustaining treatment the law might establish the baseline position that doctors do not have to provide treatment they deem is futile. However, professional guidelines could dictate doctors must engage in thorough consultation with substitute decision makers before limiting treatment, thereby improving on the minimum
69 See generally Bronwen Morgan and Karen Yeung, An Introduction to Law and Regulation (Cambridge University Press, 2007) Chapter 3. 70 Eliana Close et al, ‘Australian Policies on “Futile” or “Non-Beneficial” Treatment at the End of Life: A Qualitative Content Analysis’ (2019) 27(2) Journal of Law and Medicine 415. 71 Christine Parker and John Braithwaite, ‘Regulation’ in Mark Tushnet and Peter Cane (eds) The Oxford Handbook of Legal Studies (Oxford University Press, 2005) 119, 127. 72 See, eg, Julia Black, ‘Critical Reflections on Regulation’ (2002) 27 Australian Journal of Legal Philosophy 1. 73 Ibid 8. 74 Ibid 26. 75 Parker and Braithwaite (n 71) 130-131.
36
standard set by law. Another reason why policy is an important regulatory mechanism to study is because it is considered by the courts as part of what defines good medical practice.76
Although this thesis rests on law and policy as two key regulatory mechanisms, I also acknowledge that the relationship between them is complex,77 and their normative force may vary. The law might be ineffective, because doctors are unaware or mistaken about its scope or do not accept its moral authority.78 Likewise, policy may also have limited impact on practice.79 This thesis does not seek to resolve these issues. Rather, I argue that the content and structure of law and policy is a distinct investigation, worthy of attention on its own. Questions about whether laws and policies are known and followed are an independent inquiry, outside of the scope of this thesis. Indeed, each investigation points to separate (albeit related) solutions. If the content and structure of regulatory mechanisms are flawed, this points to improving them. When laws and policies are not known, this suggests the need for improved promulgation and persuasion about their legitimacy (provided they are, in fact, legitimate).
1.8 METHODOLOGICAL APPROACH
The thesis uses a combination of doctrinal and empirical methods to address the research questions. This section provides a brief overview of these methods. A significant contribution of this thesis is the analysis of qualitative interviews with doctors who make end-of-life decisions, to ground the law and policy analysis in doctors’ descriptions of their practice. The methodology for the data collection and analysis is set out in the Doctors’ Perceptions of Practice Paper, however some more detail on the convergent interviewing method is provided here. Additionally, there was not scope in the Doctors’ Perceptions of Practice Paper to describe my ontological and epistemological stance, so section 1.8.2 also briefly addresses this.
76 See, eg, James Downar, Eliana Close and Robert Sibbald, ‘Do Physicians Require Consent to Withhold CPR that they Determine to be Nonbeneficial?’ (2019) 191(147) CMAJ E1289. See also McDonald, Fiona, ‘The Legal System and the Legitimacy of Clinical Guidelines’ (2017) 24 Journal of Law and Medicine 821. 77 Carol A Heimer, ‘The Unstable Alliance of Law and Morality’ in Steven Hitlin and Stephen Vaisey (eds), Handbook of the Sociology of Morality (Springer, 2010) 179. Heimer explains, ‘Although law is a very special kind of normative system, it nevertheless must co-exist with other normative systems. These overlapping normative systems sometimes support or reinforce each other but at other times are in fierce competition’: at 179. See also Emily Jackson, ‘The Relationship Between Medical Law and Good Medical Ethics’ (2015) 41 Journal of Medical Ethics 95. 78 See, eg, Lindy Willmott et al, ‘Futility And The Law: Knowledge, Practice and Attitudes of Doctors in End of Life Care’ (2016) 16(1) QUT Law Review 54. 79 See, eg, Donna Goodridge, ‘End of Life Care Policies: Do They Make A Difference in Practice?’ (2010) 70(8) Social Science and Medicine 1166. Cf Shih-Ning Then, Children As Tissue Donors: Regulatory Protection, Medical Ethics and Practice (Springer, 2018), 214-217, in which doctors indicated professional guidelines did impact practice.
37
1.8.1 Overview of methodology This thesis uses several methods to examine the research questions from multiple perspectives: literature review; legal doctrinal research; semi-structured qualitative interviews; and qualitative document analysis.
Literature review and doctrinal legal research
Chapter 2, the literature review, uses doctrinal legal research to set out the Australian legal position on withholding and withdrawing futile treatment from adult patients at the end of life. The legal position is well-established and provides a basis for the comparative analysis of legal models of decision making in Chapter 6, the Critique of Legal Models Chapter. Chapter 2, the literature review, and Chapter 3, the Futile or Disputed Treatment Chapter, also investigate the bioethical literature to identify barriers to transparent and procedurally-fair decisions about life-sustaining treatment.
Semi-structured qualitative interviews
Chapter 4, the Doctors’ Perceptions of Practice Paper, is an analysis of semi-structured qualitative interviews with doctors experienced in end-of-life care. The participants worked across eleven specialties in three hospitals in metropolitan Brisbane. Qualitative interviews are an appropriate methodology to investigate the research questions because futility is a multi- faceted concept and there is very little literature that explores how doctors conceptualise the relationship between futility and resource constraints. The interviews provide rich data through ‘thick descriptions’ of doctors’ practice.80 In other words, doctors’ interpretation of their practice and the reasons behind it.
The interviews used the convergent interviewing method, which is designed to investigate concepts that are hard to define.81 This method, which was originally used for research into business organisation and change practices, has useful application into social science and multidisciplinary health research.82 It is both a way of designing research and an interviewing technique.
80 Joseph G Ponterotto, ‘Brief Note on the Origins, Evolution and Meaning of the Qualitative Research Concept “Thick Description”’ (2006) 11(3) The Qualitative Report 538, 543. 81 Robert Dick, Convergent Interviewing (Interchange, 1990); S Michelle Driedger et al, ‘Finding Common Ground in Team-Based Qualitative Research Using the Convergent Interviewing Method’ (2006) 16(8) Qualitative Health Research 1145. 82 Driedger et al (n 81) 1146.
38
The convergent interviewing technique starts out with a very general question in the area of interest, and after each interview researchers develop more targeted questions to explore areas of convergence (ie agreement) and divergence (ie disagreement) between interviews. Ultimately, once participants reach agreement and no new disagreements or issues emerge, the interviews achieve saturation and stop.83 The key feature of the convergent interviewing method is this continual process of analysis and iteration around themes as the interviews progress, which contextualises the research and keeps it flexible.84 Another central feature of convergent interviewing is prior familiarity with the field of literature.85 In contrast to a grounded theory approach, which develops and ‘discovers’ the theory through data collection and analysis, convergent interviewing is used to elaborate or improve knowledge within a field.86 Having prior knowledge also enables the researcher to develop rapport with the interview subjects.
The interviews were analysed using thematic analysis, as described in the Doctors’ Perceptions of Practice Paper.
Qualitative content analysis
Part 4 of the thesis uses qualitative content analysis methods to examine Australian policies on withholding and withdrawing life-sustaining treatment. Qualitative, rather than quantitative, content analysis was chosen as it is best suited to the research questions, which were focused on how the policies presented criteria for decision making and guidance about how to resolve disputes.87 As described in the paper, the Medical Futility Policy Analysis uses Altheide’s content analysis method to provide structure and rigour to the analysis.88 The Balancing Patient and Societal Interests Policy Analysis examines a subset of documents from the Medical Futility Policy Analysis and uses thematic analysis89 given the smaller sample size did not require the same level of categorisation that Altheide’s method provides.
83 Ibid 1152. 84 Ibid 1151. 85 Ibid 1149. 86 Ibid. 87 David L Altheide and Christopher J Schneider, Qualitative Media Analysis (SAGE Publications, 2nd ed, 2013) ch 3. 88 Ibid; David Altheide et al, ‘Emergent Qualitative Document Analysis’ in Sharlene Nagy Hesse-Biber and Patricia Leavy (eds), Handbook of Emergent Methods (Guildford Press, 2010) 127. 89 Virginia Braun and Victoria Clarke, ‘Using Thematic Analysis in Psychology’ (2006) 3(2) Qualitative Research in Psychology 77.
39
1.8.2 Ontological and epistemological approach My ontological and epistemological approach provides a lens through which to view the empirical findings of this thesis. I endorse Maxwell’s ‘critical realist’ stance, which combines a realist ontology with a constructivist epistemology.90 By adopting a realist ontology I recognise ‘there is a real world that exists independently of our perceptions, theories, and constructions’.91 By endorsing a constructivist epistemology I also accept, ‘…our understanding of the world is inevitably a construction from our own perspectives and standpoint’92 and there is ‘no possibility of attaining a single, ‘correct’ understanding of the world’.93
By subscribing to this stance, I recognise that my research is influenced by my own experiences and values. I also accept that my study will only capture part of the complex ‘reality’ of decisions to withhold or withdraw life-sustaining treatment. Nevertheless, this is a valuable exercise because doctors’ perceptions of their practice are ‘experiences and lived meanings of the subjects’ everyday world’.94 As I noted above, the interviews are rich data because they provide ‘thick descriptions’, in other words, doctors’ interpretation of their practice and the reasons behind it.95
A strength of this research approach, combined with the convergent interviewing methodology, is that it is specifically oriented toward recognising diversity in viewpoints and engages in what Maxwell calls ‘a deliberate search for variability.’96 This avoids a potential pitfall of qualitative research: a methodological bias towards uniformity. Maxwell notes
The sample size and sampling strategies in qualitative studies are often inadequate to identify and characterize the actual diversity that exists in the setting or population studied, and lead to simplistic generalizations.97
90 Joseph A Maxwell, A Realist Approach for Qualitative Research (SAGE Publications, 2012), 3-5. For an application of this stance in other socio-legal work see Shih-Ning Then, Children As Tissue Donors: Regulatory Protection, Medical Ethics and Practice (Springer, 2018), 13. 91 Maxwell (n 90) 5. 92 Maxwell (n 90) vii. 93 Maxwell (n 90) 5. 94 Steinar Kvale, Doing Interviews (SAGE Qualitative Research Kit, 2007) 11. 95 Ponterotto (n 80) 543. Ponterotto describes thick descriptions at 539 as ‘recording the circumstances, meanings, intentions, strategies, motivations, and so on that characterize a particular episode’ and notes at 543 that ‘[t]hick description accurately describes observed social actions and assigns purpose and intentionality to these actions, by way of the researcher’s understanding and clear description of the context under which the social actions took place’. 96 Maxwell (n 90) 66. 97 Ibid 64-65.
40
The qualitative research in this thesis therefore is aimed at offering insight into doctors’ diverse perspectives of practice, to ‘understand the processes, meanings, and local contextual influences involved in the phenomena of interest.’98
1.9 SCOPE
This thesis investigates the extent to which the current system of Australian laws and policies about decisions to withhold or withdraw life-sustaining treatment for adult patients adequately promotes transparent and procedurally-fair decision-making. There are a variety of issues that are linked to or relevant to this topic that the thesis does not address. These issues are described below.
1.9.1 Decisions about life-sustaining treatment for children Outside of the adult context, decisions about life-sustaining treatment can also lead to disputes in cases of critically-ill infants or children. Indeed, some of the most recent high- profile futility disputes have involved infants.99 There is a distinct body of literature about legal and ethical aspects of decisions relating to children, which raises some unique issues. One area of debate is whether parents should be allowed to make decisions for their children that occasion a serious risk of harm.100 This is related to literature that has considered whether parents should be able to consent to risky or novel experimental treatment on the small chance that it may save the child’s life.101 Another line of research is focused on debating resource- based thresholds for potentially inappropriate treatment of neonates in intensive care.102
The focus of this thesis is on decisions about life-sustaining treatment in adult patients, rather than children. However, there is overlap between some of the clinical-ethical issues that arise in infants and decisions for adults. The Charlie Gard Paper addresses arguments raised about Charlie Gard, an infant in the United Kingdom. Part of this paper therefore discusses a
98 Ibid 94. 99 Ian Freckelton, ‘Futility of Treatment for Dying Children: Lessons from the Charlie Gard Case’ (2017) 25 Journal of Law and Medicine 7. 100 See, eg, Dominic Wilkinson and Tara Nair, ‘Harm Isn’t All You Need: Parental Discretion and Medical Decisions for a Child’ (2016) 42(2) Journal of Medical Ethics 116; Giles Birchley, ‘Harm is All You Need? Best Interests and Disputes about Parental Decision-Making’ (2016) 42(2) Journal of Medical Ethics 111. 101 See Wilkinson and Savulescu, ‘Hard Lessons’ (n 23). 102 See, eg, Dominic Wilkinson, Stavros Petrou and Julian Savulescu, ‘Expensive Care? Resource-Based Thresholds for Potentially Inappropriate Treatment in Intensive Care’ (2018) 35(1) Monash Bioethics Review 2; Dominic Wilkinson, Stavros Petrou and Julian Savulescu, ‘Rationing Potentially Inappropriate Treatment in Newborn Intensive Care in Developed Countries’ (2018) 23(1) Seminars in Fetal and Neonatal Medicine 52; Tatiana Flessas and Emily Jackson, ‘Too Expensive to Treat? Non-Treatment Decisions at the Margins of Viability’ (2019) 27(3) Medical Law Review 461.
41
different cohort and different laws than those which are the focus of the thesis. However, the arguments made in the Charlie Gard Paper apply equally in the Australian adult context and so this paper has been included in the thesis.
Despite the overlap between children and adults, it is important to acknowledge one key distinction between these populations: information about past wishes or values. An adult might have previously expressed wishes to live in a certain way (for example, to be kept alive on a ventilator) or, conversely, to refuse treatment in certain circumstances.103 There is also information decision makers can draw on about the way an adult lived their life prior to becoming ill. There is no such information to draw on in the case of infants. Consequently, considering a patient’s values can be a very different exercise when comparing adults versus children. This is why much of the literature on children has focused on the parents’ wishes, debating the role of harm, and debating resources-based thresholds for intervention. Nevertheless, for many adults who lack capacity their prior wishes are unknown,104 so the analogy with children remains instructive.
1.9.2 Treatment refusals initiated by patients or substitute decision makers In Australia, as in many other Western countries, withholding or withdrawing life- sustaining treatment from critically ill patients is part of standard medical practice and can be legally and ethically uncontroversial.105 As discussed in the overview of the Charlie Gard Paper in section 1.4.4, there are three accepted ethical rationales that can justify withholding or withdrawing potentially life-sustaining treatment. The two doctor-initiated non-treatment rationales–patient interests and distributive justice–are at the heart of this thesis. The other ethical rationale (also recognised by law) that can justify stopping life-sustaining treatment is when the patient or substitute decision maker refuses it. In other words the treatment is being withdrawn on the basis of autonomy.106 There is a body of research that examines treatment
103 Wilkinson and Savulescu, ‘Hard Lessons’ (n 23). 104 There is low uptake of advance care planning in Australia. See, eg, Ben White et al, ‘Prevalence and Predictors of Advance Directives in Australia’ (2014) 44 Internal Medicine Journal 975; Ben P White et al, ‘Prevalence of Advance Care Directives in the Community: A Telephone Survey of Three Australian States’ (2019) 49 Internal Medicine Journal 1261. 105 This can be contrasted with other countries, including Japan and China, where such decisions are more controversial: Bagheri (n 8) 3-6. 106 There are many conceptualisations of autonomy, but most are centred on individual liberty and the capacity for intentional action: Kerridge, Lowe and Stewart (n 44) 128-131. Cf Jocelyn Downie and Jennifer Llewellyn, ‘Relational Theory & Health Law and Policy’ [2008] Health Law Journal 193.
42
refusals, including when facilitated by a patient’s advance directive.107 It is settled law that a patient with the requisite decision making capacity can refuse life-sustaining treatment, even if it will lead to their death and regardless of their reasons for the decision.108 However, a dispute can arise because doctors challenge a patient or substitute decision maker’s reasons for stopping treatment, or question the patient’s decision making capacity. This ethical justification is beyond the scope of the thesis, even though occasionally disputes about withholding or withdrawing life-sustaining treatment do arise in response to refusals.
This thesis is focused on the more common type of dispute over life-sustaining treatment: situations when a patient or substitute decision maker wants treatment that a doctor believes is ‘futile’ or ‘non-beneficial’. This type of futility dispute raises questions about the tension between patient interests and distributive justice, which do not arise when treatment is refused.
1.9.3 Institutional responses to withholding or withdrawing life-sustaining treatment As discussed in the descriptions of the Medical Futility Policy Analysis (section 1.5.6) and the Balancing Patient and Societal Interests Policy Analysis (section 1.5.7), this thesis examines Australian non-institutional policies on withholding and withdrawing life-sustaining treatment. There is a body of literature (primarily international) studying institutional policies on life-sustaining treatment, which is outside the scope of this thesis. This includes studies looking at the form, content, and application of do-not-resuscitate orders,109 hospital policies on futility,110 and triage. There is also literature on the process of developing new policy responses at the institutional level.111 While some of these issues are related to the work in this thesis, institutional policies are excluded because they are focused on a specific context and organisational structure. This thesis focused on policies at a higher level to chart the Australian
107 See generally Lindy Willmott, Ben White and Shih-Ning Then, ‘Withholding and Withdrawing Life- Sustaining Medical Treatment’ in Ben White, Fiona McDonald and Lindy Willmott (eds), Health Law in Australia (Thomson Reuters, 3rd ed, 2018) 571, 588-590. 108 See, eg, Brightwater Care Group v Rossiter (2009) 40 WAR 84; Hunter and New England Area Health Service v A [2009] NSWSC 761; Re B (Adult: Refusal of Medical Treatment) [2002] 2 All ER 449; Re C (Adult: Refusal of Medical Treatment) [1994] 1 WLR 290. 109 See, eg, Andrew M Courtwright et al, ‘Experience With a Hospital Policy on Not Offering Cardiopulmonary Resuscitation When Believed More Harmful Than Beneficial’ (2015) 30(1) Journal of Critical Care 173; K Boyd et al, ‘The Relationship Between Age and the Use of DNR Orders in Critical Care Patients: Evidence for Age Discrimination’ (1996) 156(16) Archives of Internal Medicine 1821; M Levinson et al, ‘Comparison of Not For Resuscitation (NFR) Forms Across Five Victorian Health Services’ (2014) 44(7) Internal Medicine Journal 671. 110 See, eg, Arthur U Rivin, ‘Futile Care Policy - Lessons Learned From Three Years’ Experience in a Community Hospital’ (1997) 166(6) Western Journal of Medicine 389; Joke Lemiengre et al, ‘Institutional Ethics Policies on Medical End-of-Life Decisions: A Literature Review’ (2007) 83(2) Health Policy 131. 111 Peter A Singer et al, ‘Hospital Policy on Appropriate Use of Life-Sustaining Treatment’ (2001) 29(1) Critical Care Medicine 187.
43
policy environment from the top down. As noted in the Medical Futility Policy Analysis, more research is needed on the institutional policy context across Australia.
1.9.4 Alternative dispute resolution mechanisms This thesis recognises a range of methods that are available to navigate disputes about life-sustaining treatment, including discussion at the bedside, resolution by an independent ethics committee, and adjudication by courts or tribunals. While these methods are all discussed in the thesis to some degree, it does not go into detail about other formal methods of alternative dispute resolution, for example mediation or conciliation.112 Some studies have looked more deeply at these alternative methods to address conflict over life-sustaining treatment and processes designed to improve trust,113 and to navigate dissensus.114 There is also literature examining the deliberations of hospital ethics committees to better understand the drivers of conflict over life-sustaining treatment.115 However, this thesis is focused on looking in detail at legal and policy approaches, rather than exploring various alternative dispute resolution mechanisms.
1.9.5 Multi-disciplinary study focused on law and policy As described above, this thesis explores the extent to which regulation addresses the ethical rationales doctors rely on in practice when making decisions to withhold or withdraw life-sustaining treatment. While the publications draw on ethical debates and arguments that shape law and policy, the study does not have an ethics focus. There is a substantial body of literature debating and discussing the ethics of withholding and withdrawing life-sustaining treatment. This includes arguments that address: whether withholding and withdrawing are ethically equivalent;116 the ethical acceptability of prolonging treatment for the sake of family
112 See, eg, Timothy Bowen, ‘Using Mediation in Situations of Withholding or Withdrawing Life-Sustaining Treatment: A New South Wales Perspective’ (2009) 17(1) Journal of Law and Medicine 74; Kate Curnow and Lisa Toohey, ‘A Focus on Process: Procedures to Address Disputes about End of Life Decisions’ (2013) 24 Australasian Dispute Resolution Journal 45. 113 See, eg, Brian D Leland et al, ‘Futility Disputes: A Review of the Literature and Proposed Model for Dispute Navigation Through Trust Building’ (2017) 32(9) Journal of Intensive Care Medicine 532. 114 Dominic Wilkinson, Robert Truog and Julian Savulescu, ‘In Favour of Medical Dissensus: Why We Should Agree to Disagree About End-of-Life Decisions’ (2016) 30(2) Bioethics 109; Wilkinson and Savulescu, ‘Current Controversies’ (n 9). 115 Rosalind McDougall, Lauren Notini and Jessica Phillips, ‘Conflicts Between Parents and Health Professionals About a Child’s Medical Treatment: Using Clinical Ethics Records to Find Gaps in the Bioethics Literature’ (2015) 12(3) Journal of Bioethical Inquiry 429. 116 See, eg, Robert D Truog and Andrew McGee, ‘Withholding and Withdrawing Life-Sustaining Treatment and the Relevance of the Killing Versus Letting Die Distinction’ (2019) 19(3) American Journal of Bioethics 34.
44
(relational autonomy);117 cultural impacts on ethical dilemmas in medical decision making;118 the role of conscientious objection in intensive care;119 and the definition of death.120 Many of these debates touch on some of the issues that arise in this thesis. However, these ethical arguments are ultimately not the focus of this work, which is a multi-disciplinary study of law and policy.
1.10 SIGNIFICANT AND ORIGINAL CONTRIBUTIONS TO KNOWLEDGE
This thesis undertakes an original multi-disciplinary investigation of the legal models and medical policies that regulate decisions to withhold or withdraw life-sustaining treatment. It makes significant contributions to knowledge in the field of medico-legal decision making in five ways, set out in Box 2.
Box 2. Significant and original contributions to knowledge
This thesis: 1. Widens the focus beyond patient interests. It critically evaluates the concept of futility as a basis for decisions about life-sustaining treatment and identifies concerns about transparency and procedural fairness that span both patient-related and societal impacts. 2. Provides empirical evidence of doctors’ practice. It provides the first empirical analysis to investigate doctors’ perceptions of the relationship between futility and resource constraints in practice, providing concrete evidence that resource allocation issues influence end-of-life decision making and are something the regulatory system should address. 3. Evaluates existing legal models. It is the first study to examine all existing legal models for making decisions about potentially life-sustaining treatment and critique them against key values, demonstrating weaknesses in all current paradigms. 4. Comprehensively reviews Australian medical policies. It is the first study to comprehensively identify and critically analyse all of the publicly-available medical policies in Australia that address decisions to withhold or withdraw life-sustaining treatment, demonstrating that policies are inconsistent and provide insufficient guidance to promote transparency and procedural fairness. 5. Provides a regulatory critique grounded in empirical evidence. It is the first study to closely scrutinise the regulatory framework against what occurs in practice, providing
117 See, eg, Robert D Truog, ‘Is It Always Wrong to Perform Futile CPR?' (2010) 362(6) New England Journal of Medicine 477. 118 See, eg, DC Malloy et al, ‘Ethical Decision-Making About Older Adults And Moral Intensity: An International Study Of Physicians’ (2008) 34(4) Journal of Medical Ethics 285. 119 See, eg, Dominic Wilkinson, ‘Conscientious Non-Objection in Intensive Care’ (2017) 26(1) Cambridge Quarterly of Healthcare Ethics 132. 120 See, eg, Andrew McGee and Dale Gardiner ‘Differences in the Definition of Brain Death and Their Legal Impact on Intensive Care Practice’ (2019) 74(5) Anaesthesia 569; Robert D Truog, Thaddeus Mason Pope and David S Jones, ‘The 50-Year Legacy of the Harvard Report on Brain Death’ (2018) 320(4) JAMA 335.
45
meaningful recommendations for reform that are grounded in the reality of medical practice, rather than based primarily on theoretical considerations.
1) Widens the focus beyond patient interests First, while there is a substantial body of literature that considers the core concept of futility as a basis for withholding or withdrawing life-sustaining treatment, the research in this thesis takes that literature further. It does this by drawing more attention to the role of societal interests in decisions about life-sustaining treatment. While there have been long-standing calls to look more deeply at the relationship between rationing and futility, few studies have looked at this issue comprehensively. Much of the literature focused on patient-related factors and problems with futility. The thesis recognises that both patient interests and distributive justice are important aspects the regulatory system should address.
The thesis makes a further contribution by critically evaluating futility as a concept, and adding to the traditional streams of futility literature, which were typically limited to three categories: (a) defining futility theoretically; (b) developing empirical thresholds to use in clinical practice; and (c) advancing a procedural approach. The thesis adds a fourth category to this framework: empirical studies that examine doctors’ definitions of futility in practice. It also contributes a new term to describe sought-after treatment in an intractable dispute: disputed treatment. This term promotes procedural fairness in disputes because it does not favour the doctor’s or patient’s (or their substitute decision maker’s) position.
2) Provides empirical evidence of doctors’ practice Second, this thesis is grounded in an empirical investigation of doctors’ perceptions of practice. This study is the first to provide empirical evidence to support the longstanding theoretical assertion that some doctors incorporate resource considerations into their assessments of futility. This is significant because it provides a foundation for the later critique that the current regulatory system, which is almost exclusively focused solely on patient interests, ignores this clinical reality.121 These findings bolster recent arguments, prompted by high-profile conflicts about life-sustaining treatment, that the regulatory system should confront the resource implications of decisions about life-sustaining treatment.
121 In an editorial in the Journal of Medical Ethics, John McMillan (Editor-in-Chief) highlighted the Doctors’ Perceptions of Practice Paper and noted, ‘[g]iven that all healthcare professionals who work in publicly funded systems do so within resource constraints, it’s timely to consider how and whether scarcity influences their assessment of futility’: John McMillan, ‘Clinical Ethics and the Duty of Care’ (2019) 45 Journal of Medical Ethics 355.
46
3) Evaluates existing legal models Third, the evaluation of legal models in this study, which is more thorough and wide- ranging than attempted elsewhere, has identified two practically-significant features that should guide regulatory reform. One is that the diversity of potential regulatory models for decisions about life-sustaining treatment (all of which are expressed in various jurisdictions worldwide) indicates that the default position in Australia that the doctor should be ultimate decision maker should not be construed as immovable. The other is that there is a trend towards more transparency in medical decision-making generally, and this should be better reflected in the legal framework.
The thesis endorses and builds on the discussion of a model developed elsewhere by Downie, Willmott and White, emphasising the importance of this model as a mechanism to better promote distributive justice.122 The thesis argues that decisions would be more transparent and procedurally-fair if patients or substitute decision makers had presumptive authority over decisions about life-sustaining treatment, with two important exceptions. One is when the requested treatment is physiologically futile; in other words, it will not work. The other is when there is a lawful excuse, which includes situations when there is a valid resource allocation policy. By shifting the presumptive decision-making authority, this legal model better recognises the value-laden nature of decisions about life-sustaining treatment while at the same time promoting distributive justice.
4) Comprehensively reviews Australian medical policies Fourth, this study is also significant as it is the first to comprehensively identify and critically analyse all of the publicly-available medical policies in Australia that address decisions to withhold or withdraw life-sustaining treatment. Prior to this analysis there was only very limited research that examined medical policies on life-sustaining treatment. The study provides new insight into a range of guidance documents, many of which have been issued for the first time in the last five years. The analysis demonstrates that the Australian policy environment lacks coherent guidance and ignores the potential for disputes about life- sustaining treatment. There is also unsatisfactory guidance about reconciling patient interests and distributive justice. The thesis provides recommendations for policy reform that would
122 Downie, Willmott and White (n 14) 33.
47
better promote transparent and procedurally-fair decision making. There has been no such comprehensive policy critique to date.
5) Provides a regulatory critique grounded in empirical evidence Finally, this is the first study to closely scrutinise the regulatory framework against what occurs in practice. The thesis provides meaningful recommendations for reform that are grounded in the reality of medical practice, rather than solely on theoretical discourse. The multi-disciplinary nature of the research therefore achieves practical as well as theoretical impact. A strength of this thesis’ methodology is that it is specifically targeted at elucidating diverse perspectives. This enables a regulatory critique that recognises the lived complexity of practice. By recognising doctors perceive their decisions are influenced by competing patient and societal concerns, this research demonstrates the need for more regulatory supports in practice, which adds to a mere doctrinal critique.
1.11 CONCLUSION
This thesis seeks to draw attention to an under-examined area of law, policy and practice, which impacts decisions for many adults at the end of their lives. One of the key arguments I advance throughout the thesis is that the current system of laws and policies fails to adequately recognise the relevance of societal considerations in decisions about life-sustaining treatment, and in doing so does not provide an adequate regulatory response. Existing medical and legal paradigms are focused squarely on the patient, which is problematic. The existing models ignore the doctor’s role as ‘dual agent’, juggling sometimes competing obligations to patient and society. Policy guidance also largely ignores the potential for conflict about life-sustaining treatment, where more guidance is needed. To properly navigate decision making about life- sustaining treatment and conflicts there should be a greater recognition in medical policies of the value-laden nature of ‘futility’. There should also be more emphasis on consistent procedural resolutions for disputes which incorporate resource constraints as a distinct consideration. Ultimately, to promote more transparent and fair decisions about potentially life- sustaining treatment, greater attention to normative questions about the appropriateness of life- sustaining treatment for the critically-ill is also needed from the community.
48
Chapter 2: Review of the Literature and Current Law
2.1 INTRODUCTION
The goals of this chapter are to provide medical and legal context for the remainder of the thesis and to describe key deficiencies in the literature, which the publications aim to fill. There is a vast bioethical and clinical literature on decision-making about life-sustaining treatment, and there has been some research analysing the Australian legal position. However, as this chapter describes, there is very little scholarship examining how the Australian regulatory system approaches tensions between patient interests and distributive justice. Significantly, there is also a lack of empirical evidence to support the theoretical assertion that futility and rationing are conflated in practice.
The chapter is divided into several sections. Section 2.2 briefly describes the medical context of decisions to withhold or withdraw life-sustaining treatment, including the demographic changes that have prompted a rise in medical decisions at the end of life. Section 2.3 positions decisions about life-sustaining treatment in their broader context and provides a high-level overview of health spending and rationing in the Australian health system.
After providing this context, the chapter then examines literature that is directly relevant to the thesis. Section 2.4 introduces and discusses the three primary ethical rationales for withholding or withdrawing life-sustaining treatment, two of which (patient interests and distributive justice) are the foundation for the thesis. Section 2.5 describes the legal context that governs decisions to withhold or withdraw futile treatment, both at common law and under state and territory guardianship legislation. Section 2.6 then sets out criticisms of the Australian legal position from the literature. Section 2.7 discusses the small amount of current literature on Australian medical policies on withholding and withdrawing life-sustaining treatment.
In section 2.8, the chapter concludes with a summary of the key gaps in the literature. As this is a PhD by published papers most of the publications are now part of the relevant literature.1 These papers are not included in this literature review, however, which is aimed at
1 At the time I submitted this thesis, the Balancing Patient and Societal Interests Analysis (Chapter 8) was under review in the Journal of Bioethical Inquiry.
49
positioning the doctoral work within the broader field. Nevertheless, the final section of this chapter, section 2.8, refers to the six publications and identifies how these publications have addressed some of the deficiencies identified in this chapter.
2.2 THE MEDICAL CONTEXT: WITHHOLDING AND WITHDRAWING LIFE- SUSTAINING TREATMENT
2.2.1 Background: The rise of medical end-of-life decisions The landscape of death and dying is changing significantly, creating unique challenges for decision making at the end of life. Demographically, the Australian population is ageing. Birth rates are declining, and individuals have a longer average life expectancy due to improvements in sanitation and medical technology.2 Older adults are accounting for an increasingly greater proportion of the community each year.3 In the next 25 years the number of Australians who die annually is expected to nearly double, growing faster than the population.4 Causes of death have shifted away from accidents and acute causes towards terminal illnesses including ischaemic heart disease, dementia, chronic lower respiratory disease, and cancer.5
These technological and demographic shifts have prompted a rise in medical decisions made at or near the end of life. Death has become extremely medicalised and institutionalised.6 Although 70% of Australians wish to die at home, less than 20% do, with the majority dying in hospitals and residential aged care facilities.7 Many Australians will experience disability and decline before death, with a period of repeated hospital admissions.8 The medicalisation and institutionalisation of death has led to complex questions about when to stop ‘active’
2 Australian Bureau of Statistics, ‘3222.0: Population Projections, Australia, 2017’ (2018)
50
medical interventions and shift to a palliative approach, and how to plan for death. These questions are informed by patients’ values, family views, and cultural, religious and medical norms. However, approximately 15-20% of deaths occur in the ICU, which can pose a challenge for holistic end-of-life care.9
Medical end-of-life decisions take several forms including withholding and withdrawing potentially life-sustaining treatment (also called ‘non-treatment decisions’), alleviating pain and symptoms with opioids in doses with potential life-shortening effect, and more rarely, euthanasia and physician-assisted suicide.10 These decisions precede the majority of deaths in Australia (although recent population-level data on the rates of various decisions is lacking). In 1997, Kuhse et al conducted a survey of doctors and estimated that medical end-of-life decisions preceded 64.8% of all Australian deaths,11 a number which is expected to rise with the ageing population.12
2.2.2 Non-treatment decisions This thesis is focused one kind of medical end-of-life decision: the choice to withhold or withdraw life-sustaining treatment, also known as a ‘non-treatment decision’. Life-sustaining treatment is generally accepted to mean medical treatment that can keep a person alive.13 In some jurisdictions this is defined in legislation.14 For example, in Queensland a ‘life-sustaining measure’ is:
health care intended to sustain or prolong life and that supplants or maintains the operation of vital bodily functions that are temporarily or permanently incapable of independent operation.15
9 Steven A Trankle, ‘Is a Good Death Possible in Australian Critical and Acute Settings?: Physician Experiences with End-of-Life Care’ (2014) 13 BMC Palliative Care 41. 10 See, eg, Luc Deliens et al, ‘End-of-Life Decisions In Medical Practice In Flanders, Belgium: A Nationwide Survey’ (2000) 356(9244) The Lancet 1806; Agnes van der Heide et al, ‘End-of-Life Decision-Making in Six European Countries: Descriptive Study’ (2003) 362(9381) The Lancet 345. 11 Helga Kuhse et al, ‘End-of-Life Decisions in Australian Medical Practice’ (1997) 166(4) Medical Journal of Australia 191. 12 Swerissen and Duckett (n 6) 6-7. This increase has eventuated in the Netherlands (where rates medical end-of- life decisions are regularly tracked). The percentage of deaths that were preceded by an end-of-life decision increased from 39% in 1990 to 58% in 2015: van der Heide et al (n 10). 13 For more discussion of the meaning of life-sustaining treatment in various jurisdictions, see Lindy Willmott, Ben White and Shih-Ning Then, ‘Withholding and Withdrawing Life-Sustaining Medical Treatment’ in Ben White, Fiona McDonald and Lindy Willmott (eds), Health Law in Australia (Thomson Reuters, 3rd ed, 2018) 571, 572-573, 591-592. 14 Powers of Attorney Act 1998 (Qld) and Guardianship and Administration Act 2000 (Qld), Sch 2, s 5A(2); Guardianship and Administration Act 1990 (WA), s 3(1). 15 Guardianship and Administration Act 2000 (Qld), Sch 2, s 5A(2).
51
Life-sustaining treatment is a broad term that includes cardiopulmonary resuscitation (‘CPR’), assisted ventilation, artificial nutrition and hydration, and organ failure treatments (including haemodialysis, peritoneal dialysis, haemofiltration, and extracorporeal membrane oxygenation).16 It can also refer to drug therapies (including antibiotics, chemotherapy, and corticosteroids), surgical procedures (including transplantation or implantation), or blood transfusions.17
Decisions to withhold or withdraw life-sustaining treatment are a common part of end- of-life medical practice. Kuhse et al’s 1997 study on the prevalence of medical end-of-life decisions in Australia estimated decisions to withhold or withdraw life-sustaining treatment preceded 28.6% of all deaths.18 Extrapolated to the most recent death statistics this would equate to over 45,000 deaths per year.19 Of a random sample of Australian doctors from specialties who treat patients at the end of life, 77% reported withholding or withdrawing treatment taking into account that this would probably or certainly hasten the end of the patient’s life.20 International studies suggest decisions to forgo life-sustaining treatment precede most deaths in the intensive care unit21 and most deaths in the emergency department.22 Typically patients lack decision making capacity when these decisions are made, due to dementia, coma, delirium or disorders of consciousness.23 This poses unique challenges
16 See generally, Willmott, White and Then (n 13) 572. 17 Note that blood transfusions are excluded from the definition of life-sustaining measure in Queensland: Guardianship and Administration Act 2000 (Qld), Sch 2, s 5A(3). 18 Kuhse et al (n 11). This figure is consistent with data from Europe that suggest non-treatment decisions precede up to 28% of all deaths, however the studies used a different methodology so a relative comparison must be treated with caution: van der Heide et al (n 10). 19 Australian Bureau of Statistics, ‘3302.0: Deaths, Australia, 2018’ (2019)
52
because medical decisions must be made by a substitute decision maker and a patient’s wishes may be unclear or unknown.24
2.2.3 The challenges of shared decision making Non-treatment decisions can be difficult to navigate in practice. The paradigm method used to make health care decisions of all kinds is known as ‘shared decision making.’ White et al define shared decision making as a communication process between clinicians and patients or surrogates that involves five aspects:
1. Discussing the nature of the decision;
2. Identifying and exchanging relevant medical information and information about a patient’s values;
3. Confirming understanding of the information;
4. Discussing preferred decision-making roles; and
5. Reaching consensus about a treatment decision that is most aligned to the patient’s values and preferences.25
Some recent end-of-life policy documents have endorsed shared decision making for decisions to withhold or withdraw life-sustaining treatment,26 and there is evidence that it leads to greater family satisfaction with decisions.27 An empirical study showed that many substitute decision makers desire control over value-laden decisions in ICUs (as opposed to more
24 There are a range of potential substitute decision makers depending on the particulars of a case including those appointed by the patient or under legislation. A court or tribunal can also act as the decision maker. See, eg, Guardianship and Administration Act 2000 (Qld), s 9. 25 Douglas B White et al, ‘Towards Shared Decision Making at the End of Life in Intensive Care Units’ (2007) 167 Archives of Internal Medicine 461, 462. 26 See, eg, NSW Department of Health, End-of-Life Care and Decision-Making – Guidelines (Guideline No GL2005_057, 22 March 2005)
53
technical medical decisions).28 Clinicians,29 patients and substitute decision makers30 report preferring consensus-based, rather than unilateral, approaches to decision making.
Despite the benefits of shared decision making, and the desire of substitute decision makers to engage in it, there are well-documented problems with implementing it in practice. White et al audiotaped 51 physician-family meetings about major end-of-life treatment decisions in four hospitals in the United States and determined that only 2% of decisions met all criteria for shared decision making.31 A systematic review by Couët et al also found low rates of patient involvement; few health professionals consistently facilitate patient engagement and adjust their recommendations to patient preferences.32 In a study of four Australian ICUs, Anstey et al found staff and substitute decision makers had incongruent perceptions about whether patients were receiving an appropriate level of care.33
Reasons for inadequate shared decision making include doctor-related factors such as poor communication skills, negative attitudes, and a lack of knowledge.34 It can also result from patient-driven factors such as unrealistic expectations about the benefits of treatment and a lack of awareness about the knock-on effects of a single decision.35 Similarly, substitute decision makers may be unaware of a patient’s values and preferences, or may have unrealistic expectations.36 There is low uptake of advance care planning instruments in Australia, 37 despite
28 Sara K Johnson et al, ‘An Empirical Study of Surrogates’ Preferred Level of Control Over Value-Laden Life Support Decisions in Intensive Care Units’ (2011) 183(7) American Journal of Respiratory and Critical Care Medicine 915. 29 James Downar et al, ‘Nonbeneficial Treatment Canada: Definitions, Causes, and Potential Solutions from the Perspective of Healthcare Practitioners’ (2015) 43 Critical Care Medicine 270, 275. 30 Daren K Heyland et al, ‘Understanding Cardiopulmonary Resuscitation Decision Making: Perspectives of Seriously Ill Hospitalized Patients and Family Members’ (2006) 130(2) CHEST 419; Johnson et al (n 28). 31 White above n 126. 32 Nicolas Couët et al, ‘Assessments of the Extent to which Health-Care Providers Involve Patients in Decision Making: A Systematic Review of Studies Using the OPTION Instrument’ (2015) 18(4) Health Expectations 542. 33 Matthew H Anstey et al, ‘A Comparison of the Opinions of Intensive Care Unit Staff and Family Members of the Treatment Intensity Received by Patients Admitted to an Intensive Care Unit: A Multicentre Survey’ (2019) 32(5) Australian Critical Care 378. 34 Mieke Visser, Luc Deliens and Dirk Houttekier, ‘Physician-Related Barriers to Communication and Patient- and Family-Centred Decision-Making towards the End of Life in Intensive Care: A Systematic Review’ (2014) 18 Critical Care 604. 35 See, eg, JJ You et al, ‘Barriers to Goals of Care Discussions with Seriously Ill Hospitalized Patients and their Families: A Multicenter Survey of Clinicians’ (2015) 175(4) JAMA Internal Medicine 549. 36 Elie Azoulay, Marine Chaize and Nancy Kentish-Barnes, ‘Involvement of ICU Families in Decisions: Fine- Tuning The Partnership’ (2014) 4(1) Annals of Intensive Care 1. 37 See, eg, Ben P White et al, ‘Prevalence of Advance Care Directives in the Community: A Telephone Survey of Three Australian States’ (2019) 49 Internal Medicine Journal 1261; Ben White et al, ‘Prevalence and Predictors of Advance Directives in Australia’ (2014) 44 Internal Medicine Journal 975.
54
evidence it benefits patients, families and healthcare providers alike.38 Consequently, substitute decision makers may have difficulty representing what the patient would want. Another significant barrier to shared decision making is a lack of time,39 which can exacerbate these issues and compound a lack of trust in the medical team. Patients and their families may also have variable degrees of willingness to engage in shared decision making, and some may prefer a doctor-driven model.40
2.2.4 Variability in end-of-life decisions due to doctor-related factors Linked to problems with shared decision making is a body of literature that establishes doctor-related variability of end-of-life decisions. This provides important context to considering how to regulate disputes about life-sustaining treatment. It can be contrasted with literature that characterises end-of-life decisions as ‘medical-clinical judgments’, rather than decisions that are value-laden.41
Variation occurs when similarly-situated patients receive different treatment, leading to a problem described as ‘the roster lottery’.42 Wilkinson and Truog explain that the roster lottery:
…implies that how a patient’s death is managed, and even potentially whether or not they die, is influenced by which physician happens to be on call … this appears worryingly arbitrary.43
There is a body of literature that demonstrates clear variation in end-of-life decisions due to doctor-related factors, both in response to hypothetical scenarios and doctors’ perceptions of their own and others’ practice. Doctor-related factors that influence end-of-life treatment
38 Karen M Detering et al, ‘The Impact of Advance Care Planning on End of Life Care in Elderly Patients: Randomised Controlled Trial’ (2010) 340(7751) BMJ c1345. 39 Arwen H Pieterse, Anne M Stiggelbout and Victor M Montori, ‘Shared Decision Making and the Importance of Time’ (2019) 322(1) JAMA 25. 40 Lesley F Degner and Jeffrey A Sloan, ‘Decision Making During Serious Illness: What Role do Patients Really Want to Play?’ (1992) 45(9) Journal of Clinical Epidemiology 941; Vanessa N Madrigal et al, ‘Parental Decision-Making Preferences in the Pediatric Intensive Care Unit’ (2012) 40(10) Critical Care Medicine 2876. 41 See, eg, Martin L Smith, ‘Medical Inappropriateness Review: Appropriately Performed by a Medical Committee’ (2008) 18(2) Health Matrix 234, 241. Smith argues, ‘determinations and judgments about the medical appropriateness of specific treatments are first and foremost medical-clinical judgments; judgments based on the medical-clinical assessment and status of the patient, and the medical-clinical information, data and known risks and harms related to the treatment's effectiveness, ineffectiveness and burdens for the given clinical situation’. 42 Dominic JC Wilkinson and Robert D Truog, ‘The Luck of the Draw: Physician-Related Variability in End- Of-Life Decision-Making in Intensive Care’ (2013) 39(6) Intensive Care Medicine 1128, 1129 (‘The Luck of the Draw’). 43 Ibid.
55
decisions include personal background,44 religion,45 culture and country of origin46 and medical specialty.47 In addition, a patient’s characteristics, including likability, age, race or religion can affect how the doctor decides to treat them.48 Institutional and family dynamics also play a role.49 Other factors include ICU culture and practice.50
Doctor-related variability can influence what options are presented to patients or substitute decision makers and how they are presented. It can also influence the recommendations given.51 Medical professionals indicate they perceive different doctors have different thresholds for when they recommend withholding or withdrawing life-sustaining treatment.52
Wilkinson and Truog explain that in some situations this variation is ethically problematic, for example when it is a result of implicit or explicit bias, and in others it is not, for example when differences are driven by the patient’s values and preferences.53 However, when there is ambiguity about the appropriate course of action, this variability suggests that end-of-life decisions should be driven by the patient’s wishes and values. They state:
For the hypothetical cases given to physicians in surveys there is genuine uncertainty about the right course of action. Clinicians, professional groups, ethicists, courts, and families review the same evidence and reach completely different conclusions. We are
44 H Hinkka et al, 'Factors Affecting Physicians’ Decisions to Forgo Life-Sustaining Treatments in Terminal Care’ (2002) 28 Journal of Medical Ethics 109. 45 David W Frost et al, ‘Patient and Healthcare Professional Factors Influencing End-of-Life Decision-Making During Critical Illness: A Systematic Review’ (2011) 39(5) Critical Care Medicine 1174. 46 Chad G Ball et al, ‘The Impact of Country and Culture on End-of-Life Care for Injured Patients: Results From an International Survey’ (2010) 69(6) The Journal of Trauma: Injury, Infection, and Critical Care 1323. 47 Malcolm H Parker, Colleen M Cartwright and Gail M Williams, ‘Impact of Specialty on Attitudes of Australian Medical Practitioners to End-of-Life Decisions' (2008) 188(8) Medical Journal of Australia 450. 48 See, eg, Thomas Fassier et al, ‘Who Am I to Decide Whether This Person Is to Die Today? Physicians’ Life- or-Death Decisions for Elderly Critically Ill Patients at the Emergency Department–ICU Interface: A Qualitative Study’ 68(1) Annals of Emergency Medicine 28; Michelle van Ryn et al, ‘Physicians’ Perceptions of Patients’ Social and Behavioral Characteristics and Race Disparities in Treatment Recommendations for Men With Coronary Artery Disease’ (2006) 96(2) American Journal of Public Health 351; Terry E Hill, ‘How Clinicians Make (or Avoid) Moral Judgments of Patients: Implications of the Evidence for Relationships and Research’ (2010) 5 Philosophy, Ethics, and Humanities in Medicine 11. 49 See, eg, Wilkinson and Truog, ‘Luck of the Draw’ (n 42) 1128-1129; Michelle van Ryn and Steven S Fu, ‘Paved With Good Intentions: Do Public Health and Human Service Providers Contribute to Racial/Ethnic Disparities in Health?’ (2003) 93(2) American Journal of Public Health 248. 50 Caroline M Quill et al, ‘Variation in Decisions to Forgo Life-Sustaining Therapies in US ICUs’ (2014) 146(3) CHEST 573. 51 David R Brush et al, ‘Recommendations to Limit Life Support: A National Survey of Critical Care Physicians’ (2012) 186(7) American Journal of Respiratory and Critical Care Medicine 633. 52 Lindy Willmott et al, ‘Reasons Doctors Provide Futile Treatment at the End of Life: A Qualitative Study’ (2016) 42(8) Journal of Medical Ethics 496; MR Larochelle et al, ‘Hospital Staff Attributions of the Causes of Physician Variation in End-of-Life Treatment Intensity’ (2009) 23 Palliative Medicine 460. 53 Wilkinson and Truog, ‘The Luck of the Draw’ (n 42) 1130.
56
not suggesting that there should be a uniform approach to ELDM [end-of-life decision making]. Nevertheless, the appropriate response to moral uncertainty is to be guided by the wishes and values of the patient, not by those of the physician.54
Similarly, when a patient’s wishes or values are unknown, Wilkinson and Truog argue that the substitute decision maker should guide decision making. This literature supports the argument in this thesis that regulatory frameworks for withholding and withdrawing life- sustaining treatment should promote patient values.
2.2.5 Disputes over non-treatment decisions This thesis is focused on situations when a patient or substitute decision maker wants treatment that a doctor believes is inappropriate.55 Sometimes labelled ‘medical futility disputes’, Pope indicates these conflicts have three common characteristics.56 First, they usually involve life-sustaining treatment for patients in the ICU. Second, disputes typically arise between doctors and substitute decision makers; these patients normally lack decision- making capacity. Third, such disputes are characterised by entrenched positions. The substitute decision maker strongly feels life-sustaining treatment should be provided, while the health professional believes doing so would be medically and ethically wrong.
Conflict in the ICU is common (although few disputes actually reach the courts). In Australia the prevalence of conflicts over life-sustaining treatment is difficult to quantify, due to a lack of data on the rate of disputes at the bedside.57 However, Australian healthcare professionals perceive end-of-life conflicts are a regular part of practice.58
Commentators in the United States have described ICU conflicts as reaching ‘epidemic proportions’.59 In a study of four ICUs in the United States, Schuster et al found that in 63% of
54 Ibid. 55 While the thesis is focused on disputes between substitute decision makers (or more rarely, patients) and health professionals, it is also important to recognise that disputes can also arise within and between medical teams. See, eg, Elie Azoulay et al, ‘Prevalence and Factors of Intensive Care Unit Conflicts: The Conflicus Study’ (2009) 180(9) American Journal of Respiratory and Critical Care Medicine 853 (‘The Conflicus Study’). 56 Thaddeus Mason Pope, ‘Dispute Resolution Mechanisms for Intractable Medical Futility Disputes’ (2016) 58 New York Law School Law Review 347 (‘Dispute Resolution Mechanisms’). 57 CRELS Report (n 26) 5. 58 See, eg, Laura Anne Brooks, Elizabeth Manias and Patricia Nicholson, ‘Barriers, Enablers and Challenges to Initiating End-of-Life Care in an Australian Intensive Care Unit Context’ (2017) 30(3) Australian Critical Care 161; Trankle (n 9). 59 C Ann Long and Randall J Curtis, ‘The Epidemic of Physician-Family Conflict in the ICU and What We Should Do About It’ (2014) 42(2) Critical Care Medicine 461.
57
cases either doctors or substitute decision makers reported conflict.60 However, stakeholder perspectives diverged in individual cases; there was little agreement between doctors and substitute decision makers in a given case about whether conflict had occurred. There also high rates of ICU conflict documented in other countries. In a large cross-sectional study, Azoulay et al analysed survey data from health professionals in 323 ICUs in 24 countries and found 71.6% reported conflicts within the previous week.61. Fifty-three percent of respondents perceived these conflicts were severe. Caring for patients at the end-of-life was one factor associated with disputes, in particular problems that arose with the decision-making process.
There is a significant amount of literature on factors that contribute to disputes about life- sustaining treatment. Common factors include a breakdown in communication,62 disagreement over goals of treatment,63 and failure to build or maintain trust.64 A significant factor in the most intractable disputes is religion.65 Other factors include guilt, grief, filial duty, a belief in miracles, and economic or racial distrust.66
2.2.6 Dispute resolution mechanisms Existing mechanisms for resolving or ending disputes range from those implemented by doctors at the bedside to more formal mechanisms such as courts and tribunals. At one end of the spectrum, a doctor could make a unilateral decision to cease or withhold treatment (for example, by putting a do-not-resuscitate order on a patient’s chart or using a ‘slow code’).67 Another method is to engage in consensus-building through a process of shared decision
60 Rachel A Schuster et al, ‘Investigating Conflict in ICUs: Is the Clinicians’ Perspective Enough?’ (2014) 42(2) Critical Care Medicine 328. 61 Azoulay et al, ‘The Conflicus Study’ (n 55). 62 Catherine M et al Breen, ‘Conflict Associated with Decisions to Limit Life-Sustaining Treatment in Intensive Care Units’ (2001) 16(5) Journal of General Internal Medicine 283; John M Luce and Douglas B White, ‘The Pressure to Withhold or Withdraw Life-sustaining Therapy from Critically Ill Patients in the United States’ (2007) 175(11) American Journal of Respiratory and Critical Care Medicine 1104. 63 Nathalie Danjoux Meth, Bernard Lawless and Laura Hawryluck, ‘Conflicts in the ICU: Perspectives of administrators and clinicians’ (2009) 35(12) Intensive Care Medicine 2068. 64 Brian D Leland et al, ‘Futility Disputes: A Review of the Literature and Proposed Model for Dispute Navigation Through Trust Building’ (2017) 32(9) Journal of Intensive Care Medicine 532. 65 Lucas S Zier et al, ‘Surrogate Decision Makers’ Responses to Physicians’ Predictions of Medical Futility’ (2009) 136(1) CHEST 110; Joe Brierley, Jim Linthicum and Andy Petros, ‘Should Religious Beliefs be Allowed to Stonewall a Secular Approach to Withdrawing and Withholding Treatment in Children?’ (2013) 39 Journal of Medical Ethics 573. See also Thaddeus Mason Pope, ‘The Case of Samuel Golubchuk: The Dangers of Judicial Deference and Medical Self-Regulation’ (2010) 10(3) American Journal of Bioethics 59, 60. 66 Thaddeus Mason Pope, ‘Medical Futility Statutes: No Safe Harbor to Unilaterally Refuse Life-Sustaining Treatment’ (2007) 75(1) Tennessee Law Review 1, 10. 67 See, eg, John D Lantos and William L Meadow, ‘Should the “Slow Code” Be Resuscitated?’ (2011) 11(11) American Journal of Bioethics 8; James Downar, Eliana Close and Robert Sibbald, ‘Do Physicians Require Consent to Withhold CPR that they Determine to be Nonbeneficial?’ (2019) 191(147) CMAJ E1289.
58
making or negotiation. This can lead to doctors ‘caving to surrogates’ and providing treatment against their conscience,68 or alternatively escalating the dispute to other mechanisms. These include engaging hospital administrators, hospital ethics committees, or mediation,69 and legal mechanisms such as adjudication by courts or tribunals.70 Notably, Australia has much lower uptake of clinical ethics committees than other countries.71
2.3 THE HEALTHCARE SYSTEM CONTEXT: A BACKDROP OF SCARCE RESOURCES
The final point of relevant context is that complex decisions about life-sustaining treatment are made in a health system with limited resources. A detailed description of the Australian health system is beyond the scope of this thesis, but this section provides a brief overview of both the macro- and micro-context.
2.3.1 Health spending in Australia In general, health spending in Australia is substantial. In 2017-18 it was 10% of the GDP, approximately $185.4 billion.72 Despite popular rhetoric that end-of-life care is driving up health spending, it only makes up a fraction of the total health budget, with approximately $5 billion a year spent on the last 12 months of life.73 However, costs associated with the ageing population are growing. As the death rate rises, the health and social care costs of dying are anticipated to double to greater than $10 billion per year.74 The societal burden of carrying these costs is also expected to rapidly increase.75 These changes warrant regulatory procedures and structures in place in advance to manage them.
68 Pope, ‘Dispute Resolution Mechanisms’ (n 56) 356-359. Pope notes that if a medical professional believes a substitute decision maker is not appropriately representing the patient’s interests they can pursue legal mechanisms for ‘surrogate replacement’. However, a challenge in many cases, particularly those driven by religious motivations, is that the substitute decision maker is representing what the patient would have wanted. 69 Timothy Bowen, ‘Using Mediation in Situations of Withholding or Withdrawing Life-Sustaining Treatment: A New South Wales Perspective' (2009) 17(1) Journal of Law and Medicine 74. 70 Pope, ‘Dispute Resolution Mechanisms’ (n 56) 359-366; Paula Chidwick, Robert Sibbald and Laura Hawryluck, ‘Best Interests at End of Life: An Updated Review of Decisions made by the Consent and Capacity Board of Ontario’ (2013) 28 Journal of Critical Care 22. 71 Ainsley J Newson, ‘The Value of Clinical Ethics Support in Australian Health Care’ (2015) 202(11) Medical Journal of Australia 568. 72 Australian Institute for Health and Welfare, Health Expenditure Australia 2017-18 (AIHW, 25 September 2019) 13 < https://www.aihw.gov.au/reports/health-welfare-expenditure/health-expenditure-australia-2017- 18/contents/data-visualisation> (‘AIHW Health Expenditure’). 73 Swerissen and Duckett (n 6) 21. 74 Ibid. 75 In 2013 Australia’s ‘dependency ratio’ was 50%. In other words, there were 50 people of working age (those aged 15-64) for 100 dependents (those aged 65+). In 2033 this dependency ratio will increase to 59% and in 2063 to 65%. See Australian Bureau of Statistics, ‘Does Size Matter? - Population Projection 20 and 50 years
59
2.3.2 Societal implications of providing futile or non-beneficial treatment Making appropriate decisions about when to limit life-sustaining treatment is important, for a number of reasons related to the patient, family, and health professionals, but there are also implications for society. The time prior to death is resource-intensive.76 One study from New South Wales found that people aged 65 and over used approximately 10.3% of all hospital days and 8.9% of hospital inpatient costs in their last year of life.77 These costs are at least partly attributable to decision-making about life-sustaining treatment. There is a tendency towards an ‘investigation and intervention spiral’ in the last 6 months of life.78 This can be halted by end-of-life discussions between doctors and patients or substitute decision makers, which are associated with reduced costs.79
A related body of literature has specifically examined the costs of providing perceived futile treatment to patients at the end of life. Using focus groups of clinicians to define futility, these studies found futile treatment at the end of life is common and costly.80 A recent Australian study estimated the costs of perceived futile bed days represents an annual national health system cost of $A153.1 million.81 Huynh et al also determined that futile treatment has an opportunity cost to other patients.82 At the time that perceived futile treatment was provided, other patients waited hours or days to get into the ICU, and two patients died waiting for transfer. Therefore, decisions about how and when to withhold or withdraw life-sustaining treatment appear to affect not just patients, but also society’s interest in the efficient use of scarce resources.
from 2013’ (2014)
60
2.3.3 Rationing health expenditure in Australia Healthcare resources are limited, therefore some form of rationing is inevitable. Rationing can be defined as ‘implicit or explicit mechanisms that allow people to go without beneficial services’.83 As noted in section 1.7.3, this thesis argues that rationing healthcare resources is appropriate, provided it is done in a transparent and fair manner. It is beyond the scope of this research to engage in the vast theoretical and empirical literature on rationing, but there are a few important points that provide relevant context for this thesis.
First, Australia engages in rationing publicly-funded healthcare at a variety of levels: Commonwealth; states and territories; local health regions; and at the point of care provision.84 This primarily occurs implicitly, but some mechanisms are more explicit.85 For example, the Commonwealth Government’s Pharmaceutical Benefits Advisory Committee (PBAC), which conducts cost-effectiveness analyses on pharmaceuticals, and the Medical Services Advisory Committee (MSAC), which assess applications for listing on the Medicare Benefits Schedule.86 Despite these mechanisms, there are calls to make Australian rationing mechanisms more explicit.87
The second key point is that, in contrast to the Australian position, some jurisdictions adopt a much more explicit approach to rationing health resources. For example, the United Kingdom has a systematic national-level approach through its National Institute for Health and Care Excellence (NICE).88 NICE makes explicit recommendations to the National Health Service about what treatments should be publicly-funded (including medications, devices, procedures, and therapies). The guidance also incorporates social value judgments that the advisory committees consider.89 It is important to note however, that even in systems where
83 Peter A Ubel and Susan Dorr Goold, ‘“Rationing” Health Care: Not All Definitions Are Created Equal’ (1998) 158(3) Archives of Internal Medicine 209, 210. See also Peter A Ubel, Pricing Life: Why It’s Time for Health Care Rationing (MIT Press, 2000) 28. 84 Elizabeth Martin, Rationing in Healthcare (Deeble Institute for Health Policy Research, 2015) 5
61
rationing is more explicit, some degree of resource allocation decisions are necessarily made by clinicians at the bedside.90 The relationship between bedside rationing and decision making about life-sustaining treatment is discussed further in section 2.4.2, below.
The third contextual point is that clinicians in Australia have a great degree of discretion over resource allocation decisions at the bedside. They decide who gets what resources, the extent of treatment provided and for how long. Unlike countries with much more limited resources, whether or not a patient is allocated a health resource depends largely on the clinician. Although these decisions are made within the constraints set by government and institutional decision makers, ultimately doctors’ decisions have a significant impact on the distribution of resources.91 This in turn affects hospital budgets, many of which are based on an ‘Activity Based Funding Model’, which provides funding based on the number and mix of cases a hospital treats.92
2.4 ETHICAL RATIONALES FOR NON-TREATMENT DECISIONS
With the above medical and healthcare context in mind, this section of the chapter is focused on the two ethical non-treatment rationales that underlie doctor-initiated decisions to withhold or withdraw life-sustaining treatment. This research aims to identify concerns about transparency and procedural fairness in these decisions. These concerns rest on a need for clarity about the ethical rationales that doctors rely on to justify non-treatment decisions in practice. This section therefore identifies the underlying ethical rationales discussed in the literature and discusses the tensions between them. It also describes existing empirical literature that supports the existence of these tensions.
2.4.1 Ethical rationales for withholding or withdrawing life-sustaining treatment In Australia, as in many other Western countries, withholding or withdrawing life- sustaining treatment from critically ill patients is part of mainstream medical practice.93 There are three accepted ethical rationales to justify withholding or withdrawing potentially life-
‘Can the NICE “End-of-Life” Premium Be Given a Coherent Ethical Justification?’ (2013) 38(6) Journal of Health Politics, Policy and Law 1129, 1130-1131. 90 Samia Hurst et al ‘Prevalence and Determinants of Physician Bedside Rationing: Data From Europe’ (2006) 21(11) Journal of General Internal Medicine 1138. 91 Martin (n 84) 7. 92 Ibid. 93 As noted in section 1.9.2, this can be contrasted with other countries, including Japan and China, where such decisions are more controversial: Alireza Bagheri (ed), Medical Futility: A Cross-National Study (Imperial College Press, 2013) 3-6.
62
sustaining treatment. The first rationale is that the patient does not want the treatment; in other words, it is stopped or not started on the basis of autonomy.94 The second rationale for not providing the treatment is it is against the patient’s interests,95 for example because the treatment will cause disproportionate harm or is unlikely to sufficiently benefit the patient. The third, and most controversial, rationale is that providing the treatment offends distributive justice because it is not an efficient use of scarce health resources.
The focus of the thesis is on how the Australian regulatory system responds to the tension between the latter two rationales for withholding or withdrawing life-sustaining treatment, which are doctor-initiated: patient interests and distributive justice. It examines situations when a patient or substitute decision maker wants treatment that a doctor believes is ‘futile’ or ‘non- beneficial’. Therefore, as noted in section 1.9.2, the first ethical rationale, which arises when a patient refuses life-sustaining treatment, is not relevant.
2.4.2 Tensions between patient interests and distributive justice The focus of literature on futility is largely centred on patient interests. Research has examined how futility should be defined, who has the ultimate decision-making authority, and what to do in the event of a dispute.96 One aspect that has been consistently on the fringe of this body of work is how to address the tension between futility and scarce resources. There is a small body of literature that suggests doctors do not sufficiently distinguish between patient interests and distributive justice in their decisions about critically-ill patients in practice.97 A related concern in some literature is that the concept of futility could mask rationing decisions.
94 There are many conceptualisations of autonomy, but most are centred on individual liberty and the capacity for intentional action: Ian Kerridge, Michael Lowe and Cameron Stewart, Ethics and Law for the Health Professions (Federation Press, 4th ed, 2013) 128-131. Cf Jocelyn Downie and Jennifer Llewellyn, ‘Relational Theory & Health Law and Policy’ [2008] Health Law Journal 193. As noted in section 1.9.2, at law, an adult with decision making capacity to refuse medical treatment can refuse life-sustaining treatment, even if it results in their death and regardless of the reasons for the decision. See, eg, Brightwater Care Group v Rossiter (2009) 40 WAR 84. Life-sustaining treatment can also be refused using an advance health directive. See generally Willmott, White and Then (n 13) 588-590. 95 Note that this rationale is referred to as ‘interests’ or ‘patient interests’ to distinguish it from the specific legal concept of ‘best interests’. 96 This is discussed in Chapter 3, the Futile or Disputed Treatment Chapter. 97 Tony Hope, David Sprigings and Roger Crisp, ‘“Not Clinically Indicated”: Patients’ Interests or Resource Allocation?’ (1993) 306(6874) BMJ 379; Michael A Rubin and Robert D Truog, ‘What to Do When There Aren’t Enough Beds in the PICU’ (2017) 19(2) AMA Journal of Ethics 157 (‘What to Do’). See also Jeffrey P Burns and Robert D Truog, ‘Futility: A Concept in Evolution’ (2007) 132(6) CHEST 1987 (‘Concept in Evolution’), in which the authors note ‘[f]ailure to distinguish between the rationale behind the concepts of futility and rationing has been an important source of confusion in the literature for the past 20 years’.
63
In an early article, Hope, Sprigings and Crisp discuss these issues using an example of cardiac surgery in elderly patients, emphasising the importance of separating the two ethical rationales for non-treatment.98 They argue that a decision that a particular treatment is ‘not clinically indicated’ may conceal two separate ethical assumptions: 1) that the intervention is not of overall benefit to the patient (‘not in the patient’s interests’); and 2) that limited resources should not be used for this patient (‘not the right use of resources’). Each rationale has distinct implications. If the surgery is not in a patient’s interests, the patient should be given relevant information and allowed to choose how to proceed. However, if the surgery is not the right use of resources, then the resource allocation principles on which the decision is based should be made clear.99
Wilkinson and Savulescu make a similar argument about the importance of distinguishing between patient interests and distributive justice in the ICU when invoking the concept of futility.100 They contend it is important to be forthright with families about the reasons why treatment is considered medically inappropriate. They rightly assert that patient interests and distributive justice are ‘ultimately [the] only two ethical justifications for refusing to provide treatment that a patient or their surrogate wants provided.’101 Both reasons can arise in the same case.102 Like Hope, Sprigings and Crisp, Wilkinson and Savulescu stress that the underlying justification for the decision has implications for decision making and resolving disputes. When a judgement is based on the patient’s interests, the patient’s own values should be given considerable weight. In contrast, if the decision is based on distributive justice, then the patient’s values are less important and what is critical is a fair and reasonable rationale for restricting treatment. Ideally, decisions based on limited resources should be rooted in explicit consensus guidelines or hospital policy.
Rubin and Truog expand on the concern that doctors do not sufficiently distinguish between patient interests (futility) and distributive justice (rationing), using a case study in the paediatric intensive care unit (‘PICU’). They emphasise the main conceptual distinction is the
98 Hope, Sprigings and Crisp (n 97). 99 Ibid 379-381. The authors discuss challenges and implications of various resource allocation theories including quality adjusted life years (QALYs), needs theories, ‘sanctity of life’ theory, the lottery theory, and market forces. 100 DJC Wilkinson and J Savulescu, ‘Knowing When to Stop: Futility in the ICU’ (2011) 24(2) Current Opinion in Anaesthesiology 160, 164 (‘Knowing When to Stop’). 101 Ibid citing Stuart J Youngner, ‘Who Defines Futility?’ (1988) 260(14) JAMA 2094. 102 See further Dominic Wilkinson, ‘Beyond Resources: Denying Parental Requests for Futile Treatment’ (2017) 389(10082) The Lancet 1866. Wilkinson graphically demonstrates how patient interests and distributive justice rationales overlap and can arise in the same case.
64
frame of comparison.103 Rationing involves looking at how to distribute resources amongst multiple patients or populations, while futility is focused on complex judgments about medical benefit and the values of a single patient. A helpful example provided by Rubin and Truog is:
…a rationing decision might involve which patients in an ICU are most likely to benefit when only one unit of blood is available and multiple patients are in need of a transfusion, while a futile or inappropriate treatment decision might involve considering if a particular patient should be receiving any blood—not because another patient in the PICU needs it, but because it might not provide any benefit to that patient.104
Another way of conceptualising this distinction is that futility involves looking at a particular patient and asking ‘will this work?’ while rationing requires considering the collective demands of the health system and asking ‘is it worth it?’.105 Burns and Truog argue that a key concern with procedural approaches to futility is they might not adequately make this distinction between futility and rationing.106
Wilkinson and Savulescu build on their earlier argument in an article on the recent French case of Vincent Lambert, who was left in a vegetative state due to a motorcycle accident over a decade ago. Lambert was the subject of a series of court applications between his parents, staunch Catholics who sought continued life-sustaining treatment (artificial nutrition and hydration), and his treating team and wife, who thought it should be discontinued.107 Wilkinson and Savulescu argue that in cases like Lambert’s dispute resolution processes must recognise both patient interests and distributive justice as non-treatment rationales and the inevitable value clashes involved in them. If the patient’s wishes are known, then there is a good argument that they should be followed. However, they argue:
Even if Lambert had wished to continue to be treated, there is a reason not to do this: distributive justice. People do not have the right to demand limited community or
103 Rubin and Truog, ‘What to Do’ (n 97) 160. 104 Ibid 160. 105 Burns and Truog, ‘Concept in Evolution’ (n 97) 1889. 106 Ibid 1989. 107 Dominic Wilkinson and Julian Savulescu, ‘Current Controversies and Irresolvable Disagreement: The Case of Vincent Lambert and the Role of “Dissensus”’ (2019) 45(10) Journal of Medical Ethics 631 (‘Current Controversies’). See also Dominic Wilkinson, Robert Truog and Julian Savulescu, ‘In Favour of Medical Dissensus: Why We Should Agree to Disagree About End-of-Life Decisions’ (2016) 30(2) Bioethics 109.
65
medical resources such as artificial nutrition and hydration, nursing and hospital care. Such resources should be allocated according to reasonable objective values.108
In Lambert’s case, there was moral disagreement about what was in his interests, but it was clear that providing ongoing care was less cost-effective than other life-saving interventions.109 In their view, rather than trying to reach consensus, a ‘dissensus’ process is needed that recognises reasonable disagreement about what is in a patient’s interests and separates out distributive justice as a distinct consideration.
Futility as a mask for rationing
Beyond concerns that doctors confuse the two doctor-initiated non-treatment rationales, a narrower related concern in the literature is that doctors use the concept of futility to mask rationing, consciously or unconsciously. There is a body of theoretical literature debating this. Some argue futility and rationing are clearly distinguishable.110 In contrast, others contend futility obscures rationing decisions in practice. For example, Orentlicher argues that futility decisions are ‘rationing decisions in disguise’, which enable society to ignore the necessity of rationing.111 He argues:
By resting authority for futility decisions in the hands of physicians (the technical experts), society can create the illusion that the decisions are based on scientific data rather than on the sacrifice of one moral value (treatment of all in need of care) in favour of another moral value (the allocation of medical resource to patients who will derive the most benefit from care).112
Similarly, Bernat contends:
108 Wilkinson and Savulescu, ‘Current Controversies’ (n 107) 633. 109 Wilkinson and Savulescu explain that providing nursing home care to persons in a vegetative state costs £90 000 - £120 000 per year, well in excess of the usual quality-adjusted life years (QALY) threshold using for judgments about novel therapies in the National Health Service (NHS). Ibid citing Adam Formby, Richard Cookson and Simon Halliday, Cost Analysis of the Legal Declaratory Relief Requirement for Withdrawing Clinically Assisted Nutrition and Hydration (CANH) from Patients in the Permanent Vegetative State (PVS) in England and Wales (CHE Research Paper, Centre for Health Economics, University of York, 2015) and DT Wade, ‘Using Best Interests Meetings for People in a Prolonged Disorder of Consciousness to Improve Clinical and Ethical Management’ (2018) 44 Journal of Medical Ethics 336. 110 See, eg, Nancy S Jecker and Lawrence J Schneiderman, ‘Futility and Rationing’ (1992) 92(2) The American Journal of Medicine 189; Rubin and Truog, ‘What to Do’ (n 97); 111 David Orentlicher, Matters of Life and Death: Making Moral Theory Work in Medical Ethics and the Law (Princeton University Press, 2001), ch 10. Orentlicher argues that such decisions might be morally justified, based on Calabresi and Bobbit’s ‘tragic choices’ concern. Orentlicher notes, ‘Calabresi and Bobbit observe that when socieites are faced with the need to ration critical, but scarce, resources, they often employ methods to hide the fact that some fundamental values will be sacrificed in the allocation process’: at 158, citing Guido Calabresi and Philip Bobbit, Tragic Choices (WW Norton, 1st ed, 1978). 112 Ibid 158.
66
Some physicians summarily, but disingenuously, assert that a treatment is futile based not on valid outcome studies but because of a veiled consideration of rationing of scarce medical resources.113
Bernat provides one (now very dated) example of a case in which this was voiced more openly. In the Wanglie case,114 an early medical futility dispute from the United States, the treating physician indicated he opposed continued treatment for Mrs Wanglie (who was permanently unconscious) not because it was futile, but because of his professional duty as a steward of scarce medical resources.115
There is a body of empirical evidence that doctors ration critical care at the bedside, though none of these studies have looked at the relationship between rationing and the concept of futility. The literature that exists on bedside rationing varies on the prevalence and factors that influence decisions, however.116 One study found that doctors are more likely to ration when there is a small expected benefit, a low chance of success, poor quality of life, and when the patient is over 85, all factors that are often present in non-treatment disputes.117 It also appears that doctors are uncomfortable with the idea of rationing, and tend to internalise resource limits and characterise resource-based decisions as medical ones.118 Strech et al conducted a systematic review of surveys of doctors and found conflicting evidence for doctors’ willingness to ration at the bedside.119 In 16 studies the proportion of doctors who reported they were willing to do so varied widely from 9% to 94% of respondents.120 The
113 James L Bernat, ‘Medical Futility: Definition, Determination and Disputes in Critical Care’ (2005) 2(2) Neurocritical Care 198, 202. 114 Re Helga Wanglie, (Hennepin Cty, Minn. 1991). 115 Ibid citing Steven H Miles, ‘Informed Demand for Non-Beneficial Medical Treatment’ (1991) 325(7) New England Journal of Medicine 512. 116 Factors that influence decisions include perceptions of scarcity, bed availability, and triage principles. See, eg, Andrew B Cooper et al, ‘Scarcity: The Context of Rationing in an Ontario ICU’ (2013) 41(6) Critical Care Medicine 1476; René Robert et al, ‘Influence of ICU-Bed Availability on ICU Admission Decisions’ (2015) 5(1) Annals of Intensive Care 1; Tasnim Sinuff et al, ‘Rationing Critical Care Beds: A Systematic Review' (2004) 32(7) Critical Care Medicine 1588; Nicholas S Ward et al, ‘Perceptions of Cost Constraints, Resource Limitations, and Rationing in United States Intensive Care Units: Results of a National Survey’ (2008) 36(2) Critical Care Medicine 471; Daniel Strech et al, ‘Are Physicians Willing to Ration Health Care? Conflicting Findings in A Systematic Review of Survey Research’ (2009) 90 Health Policy 113; Daniel Strech, Matthis Synofzik and Georg Marckmann, ‘How Physicians Allocate Scarce Resources at the Bedside: A Systematic Review of Qualitative Studies’ (2008) 33(1) Journal of Medicine and Philosophy 80. 117 Hurst et al (n 90). 118 Keith Syrett, Law, Legitimacy and the Rationing of Health Care: A Contextual and Comparative Perspective (Cambridge University Press, 2007) 69; WB Schwartz et al, ‘The Painful Prescription’ (1986) 315(18) The New England Journal of Medicine 1169. 119 Strech et al (n 116). 120 Note that as this is self-reported data it may not actually reflect rates of rationing in practice. The studies also varied in the degree to which doctors preferred different rationing strategies. Concrete evidence is challenging to
67
review demonstrated that doctors were not comfortable with withholding beneficial treatment from patients, via explicit or implicit strategies. This may suggest that doctors are more tolerant of rationing when it is unacknowledged, which lends some plausibility to the theoretical assertion that doctors use futility to mask rationing.
Although it is established that doctors ration at the bedside, at least to some extent, the relationship between rationing and the concept of futility remains unclear. Some studies indicate doctors’ definitions of futility or non-beneficial treatment are limited to only patient- related factors.121 However, a few other studies determined doctors incorporate resource considerations into their definition of futility. For example, Sibbald et al found some doctors cited ‘the use of considerable resources without benefit to the patient.’122 Similarly, Jox et al include ‘financial costs’ and ‘organisational expenses’ in their diagram depicting factors doctors identified as part of the definition of medical futility. The paper did not discuss these aspects, however. A qualitative study by White et al, which I co-authored, found eleven doctors included resources in their definition of futility, but did not expand on what that meant.123 That study was the impetus for the Doctors’ Perceptions of Practice Paper, which aimed to better clarify the relationship between futility and scarce resources, and in particular whether doctors perceive the concept of futility masks rationing.
2.5 LAW ON WITHHOLDING OR WITHDRAWING FUTILE TREATMENT
With the preceding medical context and ethical rationales in mind, this next section provides an overview of the legal position of doctors who seek to limit life-sustaining treatment against objections of patients or substitute decision makers. The law is settled and there is a body of literature critiquing it, which I will discuss in section 2.6. This overview demonstrates two points about the law that are central to this thesis. First, the prevalent legal position in Australia (which applies in all jurisdictions except Queensland124) is that doctors have
obtain because it is difficult to define ‘rationing’ and some studies asked whether doctors take cost into account (which is somewhat broader than denying a patient a benefit). 121 See, eg, Downar et al (n 29); Thanh H Neville et al, ‘Differences Between Attendings’ And Fellows’ Perceptions Of Futile Treatment In The Intensive Care Unit At One Academic Health Center: Implications For Training’ (2015) 90(3) Academic Medicine 324. 122 Robert Sibbald, James Downar and Laura Hawryluck, ‘Perceptions of “Futile Care” Among Caregivers in Intensive Care Units’ (2007) 177(10) CMAJ 1201. 123 Ben White et al, ‘What Does “Futility” Mean? An Empirical Study of Doctors’ Perceptions’ (2016) 204(8) Medical Journal of Australia 318.e1. 124 As discussed below, the Guardianship and Administration Act 2000 (Qld) and the Powers of Attorney Act 1998 (Qld) (‘the Queensland guardianship legislation’) modify the common law position for patients who lack capacity.
68
unilateral authority to withhold or withdraw life-sustaining treatment they regard as futile. Secondly, often because of the way the parties frame their claims, the law has not grappled with distributive justice as a rationale for withholding or withdrawing life-sustaining treatment.
2.5.1 Legal duties to provide life-sustaining treatment The legal position of doctors who seek to withhold or withdraw life-sustaining treatment is grounded in their well-established duties to provide life-sustaining treatment in certain circumstances. These duties exist in both civil and criminal law.125 At civil law, under the general law of negligence a doctor is required to use reasonable care and skill in the treatment of their patients.126 This includes providing life-sustaining treatment when it would be reasonable to keep a person alive, and withholding or withdrawing such treatment when it is no longer reasonable to provide it.127 What is reasonable depends on all of the circumstances of the case. An additional possible source of civil law duties is human rights legislation, which exists in three Australian jurisdictions.128 However, in Australia this area of law has not had traction in disputes about life-sustaining treatment.129
Turning to the criminal law, doctors also have obligations to provide life-sustaining treatment under the criminal law duty to provide the ‘necessaries of life’.130 The duty, which
125 Airedale NHS Trust v Bland [1993] AC 789 at 881-885 per Lord Browne-Wilkinson. 126 Rogers v Whitaker (1992) 175 CLR 479. For more discussion on the nature of this duty and how civil liability legislation enacted in various Australian jurisdictions has impacted the common law see Tina Cockburn and Des Butler, ‘Negligence’ in Ben White, Fiona McDonald and Lindy Willmott (eds), Health Law in Australia (Thomson Reuters, 3rd ed, 2018) 271. 127 These cases can also lead to professional sanctions if handled inappropriately. Providing treatment that was ‘futile, of no beneficial effect and/or not reasonably required’ and failing to appropriately shift to palliative care resulted in a finding of professional misconduct in Medical Board of Australia v Siow [2016] SAHPT 1
69
exists at common law131 or under statute,132 depending on the jurisdiction, arises when a doctor has care or charge of a person who is unable to care for themselves. This is the principal source of potential criminal liability for doctors’ involved in decisions to forgo life-sustaining treatment.133 If a medical treatment is not a ‘necessary of life’, then this duty does not apply.134 Likewise, the duty does not arise if the doctor does not have care or charge of a person who is unable to care for themselves.135
2.5.2 Australian common law position on demands for ‘futile’ treatment It is settled law that a patient with capacity can exercise their autonomy and refuse life- sustaining treatment, even if this results in their death, however, the reverse is not true. A longstanding principle of medical law is that autonomy is a negative right. At common law, a patient or substitute decision maker cannot compel a doctor to provide treatment the doctor believes is futile or ‘against good medical practice.’136 This is because the courts have established that a doctor’s judgment that a treatment is futile relieves the doctor of the legal duties to provide it. There are two routes the courts have used to support this conclusion. First, courts have held that providing futile treatment is not in a patient’s best interests.137 This typically arises in the context of an adult who lacks decision-making capacity, under the court’s parens patriae jurisdiction. The second route that some cases have relied on is the criminal
131 The duty exists at common law in jurisdictions that lack a Criminal Code, namely, the Australian Capital Territory, New South Wales, South Australia and Victoria. 132 Northern Territory (Criminal Code Act 1983 (NT), Schedule 1, s 149), Queensland (Criminal Code Act 1899 (Qld), Schedule 1, s 285), Tasmania (Criminal Code (Tas), Schedule 1, s 144), and Western Australia (Criminal Code (WA), s 262). 133 See eg Brightwater Care Group v Rossiter (2009) 40 WAR 84; Auckland Area Health Board v Attorney General [1993] 1 NZLR 235; Re RWG [2000] QGAAT 2, [55]-[63]; Re HG [2006] QGAAT 26, [101]-[107]; Re SAJ [2007] QGAAT 62, [54]. Another source of potential criminal liability is criminally negligent manslaughter, see Bronitt S and McSherry B, Principles of Criminal Law (4th ed, Thomson Reuters, Pyrmont, 2017), 557-561. 134 Willmott, White and Downie (n 129) 909. 135 For more detail on this aspect see Ben White, Lindy Willmott and John Allen, ‘Withholding and Withdrawing Life-Sustaining Treatment: Criminal Responsibility for Established Medical Practice?’ (2010) 17 Journal of Law and Medicine 849. In most cases of conflict, decisions about withholding and withdrawing life- sustaining treatment involve a person who lacks capacity, so this issue will not arise. 136 Willmott, White and Downie (n 129). See also Joanna Manning, ‘Q: Can a Court or Patient Demand Treatment? A: Yeah but No’ (2018) 25 Journal of Law and Medicine 626 (‘Yeah but No’). Manning notes that this principle is based on both deference to medical expertise, and on the role of doctors as gatekeepers of scarce health care resources: at 627. 137 Application of Justice Health; Re a Patient [2011] NSWSC 432; Melo v Superintendent of Royal Darwin Hospital (2007) 21 NTLR 197; In the matter of Herrington; Re King [2007] VSC 151; Messiha v South East Health [2004] NSWSC 1061. For an analysis of ‘best interests’ in cases that address limiting life-sustaining treatment for adults who lack decision making capacity see Lindy Willmott, Ben White and Malcolm K Smith, ‘“Best Interests” and Withholding and Withdrawing Life-Sustaining Treatment from an Adult Who Lacks Capacity in the Parens Patriae Jurisdiction’ (2014) 21(4) Journal of Law and Medicine 920.
70
law. In these cases, doctors are relieved of their criminal law obligations to provide life- sustaining treatment because treatment that is futile or non-beneficial does not amount to a necessary of life.138 The bulk of cases have been about best interests, the meaning of which will be discussed further in section 2.5.4.
2.5.3 Queensland guardianship legislation alters the common law position In most Australian jurisdictions the common law position set out above prevails, giving doctors the authority to unilaterally withhold or withdraw life-sustaining treatment they believe to be futile.139 In Queensland, however, this position is altered by the Guardianship and Administration Act 2000 (Qld) (‘GAA’)140 and the Powers of Attorney Act 1998 (Qld) (‘PAA’)141 (collectively ‘the Queensland guardianship legislation’). For adults who lack decision making capacity, the legislation specifies that consent must be obtained from a substitute decision maker (or other authority)142 to provide ‘health care’.143 ‘Health care’ of an adult is defined under the GAA and PAA to include:
…withholding or withdrawal of a life-sustaining measure … if the commencement or continuation of the measure for the adult would be inconsistent with good medical practice.144
138 Auckland Area Health Board v Attorney General [1993] 1 NZLR 235. 139 In some jurisdictions the common law position is codified in statute. See, eg, Medical Treatment Planning and Decisions Act 2016 (Vic), s 8 which states that a ‘[h]ealth practitioner cannot be compelled to provide particular medical treatment or futile or non-beneficial medical treatment’ by an advance care directive, decision by a medical treatment decision maker. What constitutes ‘futile’ or ‘non-beneficial’ treatment is not defined in the Act. See also Consent to Medical Treatment and Palliative Care Act 1995 (SA), ss 4B, 17(2). 140 Guardianship and Administration Act 2000 (Qld) (‘GAA’). 141 Powers of Attorney Act 1998 (Qld) (‘PAA’). 142 For adults who lack capacity, there is a hierarchy of decision-makers who can potentially decide whether life- sustaining treatment should be withheld or withdrawn. See Willmott, White and Then (n 13) 592-606. 143 Under section 79 of the GAA it is an offence to carry out health care without consent (or appropriate authorisation). 144 GAA, Sch 2, s 5(2). Note that section 5(3) of Sch 2 specifies that ‘health care’ does not include: first aid treatment; a non-intrusive examination made for diagnostic purposes; the administration of non-prescription drugs (provided this is normally self-administered and at the appropriate dosage); or psychosurgery.
71
Therefore, even if a doctor believes a life-sustaining measure145 is futile (in other words, providing it would be inconsistent with good medical practice),146 consent from an appropriate decision maker is still required to withhold or withdraw it.147
This consent requirement does not mean that doctors are compelled to provide treatment they object to, however. If a substitute decision maker refuses to consent to the withholding or withdrawing of life-sustaining measures, there are various legal mechanisms that hospitals or doctors can use to resolve the dispute. A doctor or hospital could argue that by failing to consent the substitute decision maker is acting contrary to the ‘health care principle’ of the GAA.148 The GAA empowers the Public Guardian to provide consent in these circumstances.149 A doctor could also apply to the Queensland Civil and Administrative Tribunal,150 or to the Supreme Court151 for consent to withhold or withdraw life-sustaining treatment.
There is very little case law on the consent requirement in the Queensland guardianship legislation as it relates to decisions about futile treatment. Only one coronial case has considered it, which confirmed the legal position that consent is required to withhold or withdraw life-sustaining treatment under the GAA.152
2.5.4 The meaning of ‘best interests’ As noted at the outset of this chapter, disputes about life-sustaining treatment primarily involve patients who lack decision-making capacity.153 There are two typical types of court
145 As noted in section 2.2.2, above, a ‘life-sustaining measure’ is defined in the GAA as ‘health care intended to sustain or prolong life and that supplants or maintains the operation of vital bodily functions that are temporarily or permanently incapable of independent operation’: Sch 1, s 5A(1). The GAA indicates specifically that cardiopulmonary resuscitation, assisted ventilation, and artificial nutrition are life-sustaining measures, but a blood transfusion is not: ss 5A(2), (3). 146 ‘Good medical practice’ is defined to mean ‘good medical practice for the medical profession in Australia having regard to— (a) the recognised medical standards, practices and procedures of the medical profession in Australia; and (b) the recognised ethical standards of the medical profession in Australia’: GAA, Sch 2, s 5B. 147 Note, however, that consent is not required to withhold or withdraw life-sustaining treatment in an acute emergency, provided the doctor is not aware of a present or past objection: GAA, s 63A. Artificial nutrition and hydration are excluded from the definition of life-sustaining measure under the emergency provision: at s 63A(4). 148 Ibid Sch 1, s 12. The health care principle is a foundation of the Queensland guardianship legislation and provides power for a health matter must be exercised ‘(a) in the way least restrictive of an adult’s rights; and (b) only if the exercise of power— (i) is necessary and appropriate to maintain or promote the adult’s health or wellbeing; or (ii) is, in all the circumstances, in the adult’s best interests.’ 149 Ibid s 43. 150 Ibid ss 81(1)(f), 115. 151 Ibid ss 79(1)(c), 240. 152 Inquest into the Death of June Woo [2009] QCC (COR 2713/02, 1 June 2009). 153 In rare instances a patient who retains capacity might also request treatment that doctors assess is futile. In R (on the application of Burke) v The General Medical Council [2005] EWCA 1003] the English Court of Appeal affirmed the position that doctors have no obligation to provide treatment they believe is not clinically indicated.
72
application in such disputes. The first is to seek a declaration from the court that it would be lawful to withhold or withdraw life-sustaining treatment.154 The second, used more commonly in Australia, is to apply to the court in its parens patriae jurisdiction.155 In either type of application, the key question for the court is what is in the patient’s best interests.156
In the seminal English case of Airedale NHS Trust v Bland (‘Bland’) the House of Lords considered the meaning of best interests in the context of withholding and withdrawing life- sustaining treatment.157 Tony Bland was a 17 year-old man who was left in a persistent vegetative state (‘PVS’)158 after he was crushed and deprived of oxygen in a throng of people in the Hillsborough football stadium disaster. Bland had significant cortical brain damage and was left completely unaware of his surroundings, with no prospect of recovery. Despite this lack of awareness, he retained brainstem function, which controlled his heartbeat, breathing, and digestion. He was kept alive with artificial nutrition and hydration using a nasogastric tube. Sir Thomas Bingham MR described his condition in the following terms:
Mr Bland lies in bed in the Airedale General Hospital, his eyes open, his mind vacant, his limbs crooked and taut. He cannot swallow, and so cannot be spoon-fed without a high risk that food will be inhaled into the lung. He is fed by means of a tube, threaded through the nose and down into the stomach, through which liquefied food is mechanically pumped. His bowels are evacuated by enema. His bladder is drained by catheter. He has been subject to repeated bouts of infection affecting his urinary tract and chest, which have been treated with antibiotics. Drugs have also been administered to reduce salivation, to reduce muscle tone and severe sweating and to encourage gastric emptying. A tracheostomy tube has been inserted and removed. Urino-genitary problems have required surgical intervention.159
154 Application of Justice Health; Re a Patient (2011) 80 NSWLR 354; Cairns and Hinterland Hospital and Health Service v JT [2015] 2 Qd R 348 (Supreme Court). For further discussion of the nature of declaratory relief, see Willmott, White and Then (n 13), 585-588. 155 For a discussion of cases on withholding and withdrawing life-sustaining treatment under the parens patriae jurisdiction see Willmott, White and Then (n 13) 582-585. 156 Or, in cases invoking criminal law duties, what constitutes a necessary of life. As the majority of cases are focused on best interests, this is the focus of this section. 157 Airedale NHS Trust v Bland [1993] AC 789. Note that Bland involved a declaration as to lawfulness because the parens patriae jurisdiction for adults was revoked by legislation. See Lord Goff’s comments in Bland at 862-863 discussing Re F (Mental Patient: Sterilisation) [1990] 2 AC 1. 158 This is known as ‘post-coma unresponsiveness’ in Australia: National Health and Medical Research Council, Ethical Guidelines for the Care of People in Post-Coma Unresponsiveness (Vegetative State) or a Minimally Responsive State (Australian Government, 2008)
73
Given that Bland was a youth, he had not contemplated or provided any previous indication of what he would want in this type of tragic circumstance. His parents and the hospital authority agreed that further life-sustaining treatment was not appropriate but sought declarations from the court that it would be lawful to withdraw artificial feeding. The House of Lords granted the declarations, ruling that further life-sustaining treatment was not in Bland’s best interests because it was ‘futile’.160 Lord Goff reasoned that artificial nutrition and hydration was futile because it merely prolonged Bland’s life and had no ‘therapeutic purpose … because the patient is unconscious and there is no prospect of any improvement in his condition.’161 Since the treatment was not in Bland’s best interests, the doctors therefore had no duty to provide it. Lord Goff (with whom Lord Keith and Lord Lowry agreed) indicated
… the question is not whether it is in the best interests of the patient that he should die. The question is whether it is in the best interests of the patient that his life should be prolonged by the continuance of this form of treatment.162
In Australia, there have been only a very small number of court cases to consider withholding or withdrawing life-sustaining treatment from adult patients who lack capacity.163 Willmott et al distil a number of themes from these cases on the meaning of ‘best interests’.164 First, many have affirmed the approach in Bland that ‘futile’ treatment is not in a patient’s best interests.165 For example, in Messiha v South East Health166 the court ruled that treatment was futile because there was no real prospect that Messiha would recover. Second, treatment that causes excessive pain or other burdens that outweigh the benefits is not in a patient’s best interests. Third, quality of life considerations, specifically the patient’s ability to engage meaningfully with the world, appear to be an implicit part of a best interests assessments.
160 Airedale NHS Trust v Bland [1993] AC 789, 869. 161 Ibid. Lord Goff concluded: ‘… in the end … it is the futility of the treatment which justifies its termination.’ 162 Ibid 868. Also see Lord Browne-Wilkinson at 884. 163 Application of Justice Health; Re a Patient [2011] NSWSC 432; Slaveski v Austin Health [2010] VSC 493; Australian Capital Territory v JT [2009] ACTSC 105; Melo v Superintendent of Royal Darwin Hospital (2007) 21 NTLR 197; Re Herrington; Re King [2007] VSC 151; Queensland v Astill (unreported, Supreme Court of Queensland, Muir J, 18 January 2006); Messiha v South East Health [2004] NSWSC 1061; Northridge v Central Sydney Area Health Service [2000] NSWLR 1241. 164 Willmott, White and Smith (n 137). See also Lindy Willmott et al, ‘Withholding and Withdrawing Life- Sustaining Treatment in a Patient’s Best Interests: Australian Judicial Deliberations’ (2014) 201(9) Medical Journal of Australia 545. 165 A criticism of these cases is strictly speaking, life-sustaining treatment was not ‘futile’ because it could keep Tony Bland and Magdy Messiha alive. Rather, better language would be that the proposed treatments were ‘inappropriate’. 166 [2004] NSWSC 1061.
74
Fourth, the views and wishes of the patient were relevant, but not determinative.167 Fifth, the interests of others, including possible distress of health professionals, or the wise use of resources are not relevant (this will be considered in more detail below). Finally, the courts have traditionally sided with doctors’ assessments of what constitutes ‘futile’ treatment, even when the family strongly disagrees. In only one Australian case the court ruled the doctors had reached a premature conclusion, based on an inappropriate diagnosis, and ordered doctors to continue life-sustaining treatment.168
Notably, some recent United Kingdom authority appears to suggest a departure from the approach in Bland, placing more focus on the individual patient’s subjective values and wishes.169 However, these authorities have not been considered in this context in Australia.
2.5.5 The relevance of resource considerations to decisions about best interests The previous section discussed how predominantly disputes over life-sustaining treatment that reach the courts are best interests applications. They are therefore centred on the ethical rationale of patient interests identified in section 2.3.1 of this thesis. In these decisions there is very little judicial commentary on the role of the other ethical rationale for doctor- initiated non-treatment decisions: distributive justice. As noted above, Willmott et al observe that resources generally are not relevant to cases that contemplate withholding or withdrawing life-sustaining treatment.170 A few Australian cases have specified, obiter, that a lack of
167 For example, in Re Herrington [2007] VSC 151 the court considered the patient’s partner’s representations that Herrington would have wanted continued treatment. However, the ruling sided with the medical determination that treatment was futile. In the United Kingdom although the Mental Capacity Act 2005 stipulates that a person’s previously expressed views must be taken into account, these are still not determinative. See Emily Jackson, ‘The Minimally Conscious State and Treatment Withdrawal: W v M’ (2013) 39 Journal of Medical Ethics 559. 168 Northridge v Sydney Area Health Service (2000) 50 NSWLR 549. 169 See, eg, Aintree University Hospitals v James [2013] UKSC 67 in which the Supreme Court of the United Kingdom ruled the English Court of Appeal and had erred in finding that the test to assess the patient’s wishes was an objective one. Lady Hale (on behalf of the court) said at ‘[a] treatment may bring some benefit to a patient even if it has no effect upon the underlying disease or disability … It was not futile if it enabled a patient to resume a quality of life which the patient would regard as worthwhile … Insofar as it was possible to ascertain the patient’s wishes and feelings, his beliefs and values or the things which were important to him, these should be taken into account because they were a component in making the choice which was right for him as an individual human being’: [43]-[45]. See also Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust v TG [2019] EWCOP 21 in which Cohen J stressed, ‘the law has moved on since Bland… [and] …the decision maker and so the judge must be wary of giving weight to what he thinks is prudent or what he would want for himself or his family, or what he thinks most people would or should want … if the decision that P would have made, and so their wishes on such an intensely personal issue can be ascertained with sufficient certainty it should generally prevail over the very strong presumption in favour of preserving life’: at [19]. 170 Willmott, White and Smith (n 137); Willmott et al (n 164).
75
institutional resources does not inform an assessment of a patient’s best interests.171 In Northridge, the court noted that ‘the exercise of the parens patriae jurisdiction should not be for the benefit of others… including a health care system that is intent on saving costs.’172
These authorities provide clear statements (albeit obiter ones) that resources are not relevant to a patient’s best interests. However, the Australian courts have not fully addressed the legal position on whether doctors could use distributive justice as a distinct rationale to withhold or withdraw life-sustaining measures. At an institutional or health service level, generally health authorities are permitted to ration medical treatment as they see fit, provided this is accomplished fairly and transparently.173 Indeed, in Bland Hoffmann LJ suggested it would be open to the health authority to limit potentially life-sustaining treatment on the basis of resources. He stated:
The resources of the National Health Service are not limitless and choices have to be made. This qualification on the moral duty to provide care did not enter into the argument in this case at all. The Airedale NHS Trust invited us to decide the case on the assumption that its resources were unlimited and we have done so. But one is bound to observe that the cost of keeping a patient like Anthony Bland alive is very considerable and that in another case the health authority might conclude that its resources were better devoted to other patients. We do not have to consider such a case, but in principle the allocation of resources between patients is a matter for the health authority and not for the courts.174
Similarly, in TS & DS v Sydney Children’s Hospitals Network (Mohammed’s case)175 (a dispute in which the parents of an infant with a rare mitochondrial disease opposed doctors’
171 Northridge v Central Sydney Area Health Service [2000] NSWLR 1241, [22]; Messiha v South East Health [2004] NSWSC 1061, [9]; TS & DS v Sydney Children’s Hospitals Network (‘Mohammed’s case’) [2012] NSWSC 1207, [64]. 172 Northridge v Central Sydney Area Health Service [2000] NSWLR 1241, [22]. 173 There is substantial commentary about health rationing and the role of the courts in the United Kingdom, where there have been a number of cases of judicial review of rationing decisions (both by doctors and government authorities, not limited to the end-of-life context). See Jackson, Medical Law (n 88) 74-83. The United Kingdom courts have traditionally deferred to health authorities’ judgments about resources, although more recently have been more willing to intervene. This same extensive case law does not exist in Australia. See Fiona McDonald and Deanna Sedgwick Fincher, ‘The Legal Framework of the Australian Health System’ in Ben White, Fiona McDonald and Lindy Willmott (eds), Health Law in Australia (Thomson Reuters, 3rd ed, 2018) 75, 96-98. 174 Airedale NHS Trust v Bland [1993] AC 789, 833. See also Lord Mustill who noted, obiter that the argument to consider the best interests of the community ‘…was never squarely put, although hinted at from time to time. In social terms it has great force and will have to be faced in the end. But this is not a task which the courts can possibly undertake’: at 896. 175 TS & DS v Sydney Children’s Hospitals Network (Mohammed’s Case) [2012] NSWSC 1207.
76
recommendations to withdraw life-sustaining treatment) the court alluded to the possibility that resource issues could be relevant. Justice Garling said:
It was not suggested by the hospital that there was any financial reason, or any reason relating to a shortage of resources, beds or facilities which would preclude Mohammed being provided with mechanical ventilation if that was in his best interests. There may be occasions when such issues arise. If they do, there are undoubtedly complex questions of public health policy to be considered, and also whether, a Court is best fitted to engage in that area of discourse. Fortunately, in this case, this issue did not arise.176
It appears that the courts have not considered resource scarcity in these cases primarily because parties have framed the claims as best interests applications.177 Comments in a few cases suggest doctors and health authorities are reluctant to frame claims as involving resource allocation. This could be because these decision makers are uncomfortable with putting a price on life.178 Another risk is that the distributive justice rationale will distract families from the arguments based on patient interests. For example, in Messiha there was evidence that one of the doctors had mentioned to the family that the ICU bed was needed for other patients. Justice Howie indicated this was not relevant to what was in Messiha’s best interests, stating:
… [during a conversation with the family] there was a reference made by Dr Jacques to the availability of the Unit’s resources for other patients who were awaiting treatment in the Unit. This was unfortunate because it led to the possibility that the family believed that the decision concerning the future treatment of the patient was, in part at least, being determined by reference to what should, arguably, have been an irrelevant matter, at least so far as the welfare of the patient was concerned. If the availability of places in the Unit was raised as a matter to be taken into account by Dr Jacques or other hospital staff in determining the future treatment of the patient, it was insensitive to the feelings of the family members and might have been taken as a form of pressure on the family to agree with the hospital’s decision.179
176 Ibid [64]. 177 Although note that in the seminal case of R v Cambridge Health Authority, ex parte B [1995] EWCA 49 (Civ), the health authority justified its decision to refuse the cancer treatment because it was against the child’s best interests. The media and the court nevertheless focused on the resource allocation aspect. See Jackson, Medical Law (n 88) 75-76. 178 See, eg, David A Asch and Peter Ubel, ‘Rationing by Any Other Name’ (1997) 336(23) New England Journal of Medicine 1668. 179 Messiha v South East Health [2004] NSWSC 1061, [9].
77
In a similar vein, a recent development in cases about life-sustaining treatment is to seek publication bans to protect the identities of the parties (including the doctors and hospital involved). In The Hospital v S (a minor),180 the court noted such orders were necessary in response to ‘accusations of causing an unlawful death and of making decisions based upon resource considerations, rather than in the best interests of the patient.’ These were made against medical practitioners in a previous case and led to threats against a doctor and the doctor’s children.
2.6 CRITIQUE OF THE LAW
The previous section set out the literature that describes the legal position on demands for futile life-sustaining treatment. This section sets out the literature that critiques both the common law and the legal position in the Queensland guardianship legislation. The authorities diverge in their critique of existing models. Some criticise doctors’ unilateral ability to withhold or withdraw life-sustaining treatment, while others criticise the Queensland model, which requires consent. There is limited literature that evaluates different models of decision making as a whole.
2.6.1 Critique of doctors’ ability to unilaterally withhold or withdraw life-sustaining treatment There has been relatively little critique of the Australian legal position on futile treatment. In a comprehensive review, Downie et al argue that the common law on futility in Australia needs reform to better align with core values underpin the legal framework on withholding or withdrawing life-sustaining treatment.181 They critiqued the law against those values and found that the law had problems of complexity and inconsistency. Different legal bases have been used to find that doctors do not have to provide futile treatment, and there is not a uniform approach across Australia.182 They also identified conceptual problems with futility and the covert allocation of health resources. As discussed in section 2.4.5, the Australian legal system requires that doctors make decisions solely about individual patients, even though this is not what happens in practice. They argue an alternative model is needed to better reflect these core values, including distributive justice.
180 The Hospital v S (a minor) [2019] NSWSC 642. 181 Jocelyn Downie, Lindy Willmott and Benjamin P White, ‘Cutting the Gordian Knot of Futility: A Case for Law Reform on Unilateral Withholding and Withdrawal of Potentially Life-Sustaining Treatment’ (2014) 26(1) New Zealand Universities Law Review 24. 182 Willmott, White and Downie (n 129).
78
In contrast to Downie et al’s position, some authors have defended the Australian common law position on futile treatment. For example, Skene argues the fundamental legal principle that patients and substitute decision makes are not legally entitled to demand futile treatment is sound.183 She defends the lack of emphasis on what the patient’s preferences would have been, citing the approach in Bland,184 and argues the key question is the medical team’s assessment of the patient’s condition and prognosis. However, as noted above, this argument is undermined by recent case law in the United Kingdom which places increasing emphasis on the patient’s values,185 and the bioethical consensus that most decisions about life-sustaining treatment are value-laden.
2.6.2 Critique of the Queensland consent model There is also literature that critiques the legal position in the Queensland guardianship legislation, which requires consent to withhold or withdraw life-sustaining measures from patients who lack capacity. Lawrence et al186 base their critique on the Queensland coronial case of June Woo, an 82-year-old woman with chronic respiratory failure who died after doctors issued a not-for-resuscitation order (‘NFR’). In that case, the Coroner found that while Woo’s medical care was appropriate, there were concerns about the extent to which the family had been consulted about the NFR. The Coroner confirmed that the Queensland guardianship legislation requires that the family should have given consent for the NFR. Ultimately, at the time Woo died, the Coroner determined sufficient discussions had taken place to amount to ‘tacit consent’ for the order.
Lawrence et al argue that the Queensland position creates challenges for medical staff who believe that resuscitation would be against good medical practice. In effect, the law ‘places clinicians in the difficult position of potentially having to choose between complying with the law and best medical practice’. They also argue the law can place unwarranted burdens on families, lead to distress of medical staff and cause a patient to experience harmful and invasive
183 Loane Skene, ‘The Schiavo and Korp Cases: Conceptualising End-of-Life Decision-Making’ (2005) 13 Journal of Law and Medicine 223. 184 Skene references Lord Goff in Bland, who stated evidence of the patient’s wishes is not relevant when a patient does not have awareness of their condition. Although note, as briefly discussed in section 2.5.4, English authorities appear to now be departing from this approach. 185 See section 2.5.4. 186 Sean Lawrence et al, ‘Autonomy Versus Futility? Barriers to Good Clinical Practice in End-of-Life Care: A Queensland Case’ (2012) 196(6) Medical Journal of Australia 404.
79
treatment before death. These arguments have been echoed in Canada in response to the Supreme Court decision of Cuthbertson v Rasouli.187
Conversely, Stewart defends the consent requirement as ‘the best way to assess futility’, which is an inherently subjective concept.188 Stewart argues this provides better balance between the power of doctors and substitute decision makers. It also provides more clear pathways for conflict resolution, since disputes automatically trigger the intervention of the adult guardian (now the public guardian), with avenues for appeal.
Notably, both sides of the critique of the Queensland position focus on the positions of patients, substitute decision maker and doctors, but do not address issues of distributive justice. An advantage to the values-based approach advocated by Downie et al, which this thesis offers an expanded rationale for, is that it also considers distributive justice in designing the regulatory regime. 189
2.6.3 Literature evaluating legal models A related area of literature about legal responses to futility is commentary on specific legal models of dispute resolution.190 Pope has discussed the Texas procedural model in detail, and has provided a taxonomy of American ‘futility laws’, categorising each state into red, yellow and green traffic lights, depending on whether the jurisdiction permits doctors to unilaterally stop life-sustaining treatment.191 Pope’s article is the only taxonomy of dispute resolution models in the literature, but it does not include any discussion of how to balance resource considerations with the views of doctors and patients or their substitute decision makers.
2.7 MEDICAL POLICIES ON WITHHOLDING AND WITHDRAWING LIFE- SUSTAINING TREATMENT
An aim of this thesis is to look at another source of regulation beyond the law and examine whether Australian medical policies promote transparent and procedurally-fair
187 [2013] 3 SCR 341. See James Downar et al, ‘Withholding and Withdrawing Treatment in Canada: Implications of the Supreme Court of Canada’s Decision in the Rasouli Case’ (2014) 186(16) CMAJ E622. 188 Cameron L Stewart, ‘A Defence of the Requirement to Seek Consent to Withhold and Withdraw Futile Treatments’ (2012) 196(6) Medical Journal of Australia 406. 189 Downie, Willmott and White (n 181); Chapter 5, Charlie Gard Paper; Chapter 6, Critique of Legal Models Chapter. 190 See, eg, Thaddeus Mason Pope, ‘Texas Advance Directives Act: Nearly a Model Dispute Resolution Mechanism for Intractable Medical Futility Conflicts’ (2016) 16(1) QUT Law Review 22. 191 Ibid.
80
decisions to withhold or withdraw life-sustaining treatment. As discussed in the Futile or Disputed Treatment Chapter, there is bioethical consensus that futility policy is one way to address the challenges associated with decisions about limiting life-sustaining treatment.192 Medical policies can supplement the legal position and set out a procedural approach to decisions, which can promote more fairness and transparency.193 Additionally, analysing the content of policies is important because whether a doctor acted in accordance with policy is also relevant to court decisions about life-sustaining treatment.194
There is very little academic discussion in Australia analysing policy responses to futility in the adult context, however. Bhatia and Tibballs have analysed policies on neonatal decision making and suggest that Australia lacks an appropriate overarching policy framework to promote transparent decisions.195 Martin provides some analysis of the (now outdated) 2007 Australian Medical Association (‘AMA’) policy on the end of life care, noting that Australian guidelines largely have a qualitative focus and ‘sidestep the issue of quantifying probabilities of success and defining specific goals.’196 However, Martin’s chapter was written in 2013 and this policy was since updated.197 Indeed, several Australian medical societies and colleges have recently developed and refined their policies on futility and end-of-life care, with some Australian medical colleges issuing their first ever end-of-life policy statement in 2016.198
192 See, eg, Alireza Bagheri, ‘Regulating Medical Futility: Neither Excessive Patient’s Autonomy Nor Physician’s Paternalism’ (2008) 15(1) European Journal of Health Law 45; Bernat (n 113). 193 See, eg, Cameron Stewart, ‘Futility Determination as a Process: Problems with Medical Sovereignty, Legal Issues and the Strengths and Weakness of the Procedural Approach’ (2011) 8(2) Journal of Bioethical Inquiry 155; Thomas A. Faunce and Cameron Stewart, ‘The Messiha and Schiavo Cases: Third-Party Ethical Interventions in Futile Care Disputes’ (2005) 183(5) Medical Journal of Australia 261; Robert D Truog, ‘Counterpoint: The Texas Advance Directives Act is Ethically Flawed: Medical Futility Disputes Must be Resolved by a Fair Process’ (2009) 136(4) CHEST 968; S Moratti, ‘The Development of “Medical Futility”: Towards a Procedural Approach Based on the Role of the Medical Profession’ (2009) 35(6) Journal of Medical Ethics 369. 194 See, eg, Northridge v Central Sydney Area Health Service [2000] NSWLR 1241; Inquest into the Death of June Woo [2009] QCC (COR 2713/02, 1 June 2009); Fiona McDonald, ‘The Legal System and the Legitimacy of Clinical Guidelines’ (2017) 24 Journal of Law and Medicine 821. 195 Neera Bhatia and James Tibballs, ‘Deficiencies and Missed Opportunities to Formulate Clinical Guidelines in Australia for Withholding or Withdrawing Life-Sustaining Treatment in Severely Disabled and Impaired Infants’ (2015) 12(3) Journal of Bioethical Inquiry 449. 196 Dominique Martin, ‘Medical Futility in Australia’ in Alireza Bagheri (ed), Medical Futility: A Cross- National Study (Imperial College Press, 2013) 119. 197 Australian Medical Association, Position Statement on End of Life Care and Advance Care Planning (5 September 2014) 81 Despite these policy advancements, there appears to be no recent commentary analysing the current overarching medical futility policy environment in Australia.199 The lack of commentary on medical futility policies in Australia is striking, given policy advances internationally.200 2.8 SUMMARY OF GAPS IN THE LITERATURE This chapter has identified several key gaps in the literature on decision making and disputes about withholding and withdrawing life-sustaining treatment, which this thesis aims to address. First, section 2.4 identified that there are only a small number of articles that consider distributive justice as a non-treatment rationale that the regulatory system should respond to. The importance of distributive justice is discussed in the Charlie Gard Paper. It is also addressed the Futile or Disputed Treatment Chapter, which synthesises the literature on futility and adds to it by articulating concerns about distributive justice. The Futile or Disputed Treatment Chapter also adds to the theoretical literature on futility by making a case for using the term ‘disputed treatment’ in intractable disputes. Second, section 2.4 of this chapter also recognised the lack of an empirical basis to support the theoretical assertion that the concept of futility can act as a mask for rationing. It discussed how several studies examining doctors’ definitions of futility indicated they included resources but did not specify what this meant. The Doctors’ Perceptions of Practice Paper aims to address both of these issues. It is the first study to look deeply at how doctors conceptualise the relationship between futility and resources. Third, while the legal position in Australia is settled, and there is a body of literature critiquing it, an overarching analysis of the various existing models of decision making, which takes into account distributive justice, is lacking. While the legal position (at least for treatment that doctors believe is ‘futile’) is relatively well-canvassed and critiqued in the literature, there is a lack of attention to the different legal models for decision making and how well these life-position-statement.pdf>; Royal Australasian College of Surgeons, Position Paper: End of Life Care (RACS, 2016) 82 support doctors’ underlying non-treatment rationales in practice. The Critique of Legal Models Chapter aims to address this gap by both identifying all existing models and critiquing them against key values. The chapter, along with the Charlie Gard Paper, advocates for a new model that better recognises both procedural fairness and distributive justice. Finally, there is a significant dearth of literature on Australian medical futility policies. It is not known how Australian medical futility policies define futility, whether they clarify the distinction between futility and resource rationales, or whether they give clear guidance about the decision-making process and how to resolve disputes. The Medical Futility Policy Analysis and the Balancing Patient and Societal Interests Policy Analysis seek to fill this gap by conducting a comprehensive analysis of Australian medical futility policies and how they approach decision making criteria, dispute resolution and resource allocation. 2.9 CONCLUSION Part 1 described the research problem, research questions and objectives of the thesis. It also discussed the gaps in the literature this thesis aims to fill. The next section, Part 2, is the start of the published works and is comprised of the Futile or Disputed Treatment Chapter and the Doctors’ Perceptions of Practice Paper. Part 2 identifies the context of doctor-initiated decisions to withhold or withdraw life-sustaining treatment, including barriers to transparent and procedurally-fair decisions, and doctors’ perceptions of their practice. 83 PART 2 The Nature of Doctor-Initiated Decisions to Withhold or Withdraw Life-Sustaining Treatment 84 Chapter 3: Futile or ‘Disputed’ Treatment Chapter ‘Futile, Non-Beneficial, Potentially Inappropriate or “Disputed” Treatment’ Ben White, Lindy Willmott and Eliana Close In Nathan Emmerich, Pierre Mallia, Bert Gordijn and Francesca Pistoia (eds), Contemporary European Perspectives on the Ethics in End of Life Care (Springer, 2020) Due to copyright restrictions, this chapter is not available here. 85 Chapter 4: Doctors’ Perceptions of Practice Paper ‘Doctors’ Perceptions of how Resource Limitations Relate to Futility in End-of-Life Decision Making: A Qualitative Analysis’ Eliana Close, Ben P White, Lindy Willmott, Cindy Gallois, Malcolm Parker, Nicholas Graves, Sarah Winch (2019) 45 Journal of Medical Ethics 373 Due to copyright restrictions, this article is not available here. Please consult https://jme.bmj.com/content/45/6/373. Alternatively, the accepted version of the manuscript can be found at https://eprints.qut.edu.au/129271/. 86 PART 3 Evaluating Legal Models for Decision Making 87 Chapter 5: Charlie Gard Paper ‘Charlie Gard: In Defence of the Law’ Eliana Close, Lindy Willmott and Benjamin P White (2018) 44(7) Journal of Medical Ethics 476 88 89 90 91 92 93 Chapter 6: Critique of Legal Models Chapter ‘Withholding and Withdrawing Potentially Life-Sustaining Treatment: Who Should Decide?’ Ben White, Lindy Willmott, Eliana Close and Jocelyn Downie in Ian Freckelton and Kerry Petersen (eds), Tensions and Traumas in Health Law (Federation Press, 2017) 454 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 PART 4 Identifying and Assessing the Australian Policy Environment 120 Chapter 7: Medical Futility Policy Analysis ‘Australian Policies on Medical “Futility” or Non-Beneficial Treatment at the End of Life: A Qualitative Content Analysis’ Eliana Close, Malcolm Parker, Lindy Willmott, Ben P White, Andrew Crowden (2019) 27(2) Journal of Law and Medicine 415 (Note that this is a pre-publication manuscript version of the published article) 121 Eliana Close PhD Candidate Australian Centre for Health Law Research Faculty of Law, Queensland University of Technology 2 George St, Brisbane QLD 4000 Correspondence to: [email protected], +61 478 125 825 Malcolm Parker Emeritus Professor School of Medicine, The University of Queensland [email protected] Lindy Willmott Professor Australian Centre for Health Law Research Faculty of Law, Queensland University of Technology [email protected] Ben White Professor Australian Centre for Health Law Research Faculty of Law, Queensland University of Technology [email protected] Andrew Crowden Associate Professor School of Historical and Philosophical Inquiry, The University of Queensland [email protected] Acknowledgments: The authors wish to acknowledge Emeritus Professor Cindy Gallois, Professor Nicholas Graves, Associate Professor Sarah Winch and Professor Leonie Callaway for their input into the early stages of the analysis. Eliana Close was supported by funding from the Australian Research Training Program and the NHMRC Centre of Research Excellence in End-of-Life Care. Part of this research was also funded by the Australian Research Council Linkage Projects scheme (LP121000096) and the Royal Brisbane and Women’s Hospital. 122 AUSTRALIAN POLICIES ON “FUTILE” OR “NON-BENEFICIAL” TREATMENT AT THE END OF LIFE: A QUALITATIVE CONTENT ANALYSIS A challenge in end-of-life care is requests by patients or their substitute decision makers for treatment that doctors consider is “futile” or “non-beneficial”. Concerns that these concepts are uncertain and subjective have led to calls for medical policies to clarify terminology and to provide procedural solutions to prevent and address disputes. This article provides a comprehensive analysis of how Australian medical guidelines and policies on withholding or withdrawing potentially life-sustaining treatment address futility. The paper demonstrates that while the concept is found throughout medical policies and guidelines, the terminology employed is inconsistent. There is also variability in the extent of guidance given about unilateral decision making and mechanisms for dispute resolution. This is problematic, given that the question of further treatment can often only be determined in relation to the individual patient’s goals and values. We conclude by advocating for the development of a unified policy approach to futile or non-beneficial treatment in Australia. Keywords: withholding and withdrawing life-sustaining treatment; end of life; policy; medical guidelines; futile treatment; non-beneficial treatment; dispute resolution I. INTRODUCTION An estimated 28.6% of all Australian deaths are preceded by a decision to forgo life- sustaining treatment including mechanical ventilation, cardiopulmonary resuscitation, artificial nutrition and hydration and medication.1 The National Consensus Statement on Essential Elements for Safe and High-Quality End-of-Life Care stipulates these decisions should be shared between the medical team and the patient or their substitute decision maker.2 However, barriers to shared decision making mean that many end-of-life discussions do not adequately address a patient’s values and goals of care.3 A breakdown in shared 1 Kuhse H et al, “End-of-Life Decisions in Australian Medical Practice” (1997) 166(4) Med J Aus 191. 2 Australian Commission on Safety and Quality in Health Care, National Consensus Statement: Essential Elements For Safe And High-Quality End-Of-Life Care (ACSQHC, 2015), https://www.safetyandquality.gov.au/wp-content/uploads/2015/05/National-Consensus-Statement-Essential- Elements-forsafe-high-quality-end-of-life-care.pdf (“National Consensus Statement”). 3 Barriers include poor communication skills, a lack of time for proper discussions and doctors’ own aversion to death. See, eg, Scheunemann LP et al, “Clinician-Family Communication About Patients’ Values and 123 decision making can precipitate disputes between doctors4 and patients or their substitute decision makers, which occasionally become intractable and require resolution by the courts. Recently, conflicts between parents and hospitals over the medical treatment of the infants Charlie Gard5 and Alfie Evans6 drew international attention and became the subject of extensive bioethical and legal discourse.7 Beyond the paediatric context, futility disputes over adults have also escalated to courts in Australia,8 New Zealand,9 the United States,10 the United Kingdom,11 Canada12 and elsewhere.13 Despite the high-profile nature of contentious cases, court involvement in disputes about life- sustaining treatment is relatively rare. While conflicts over life-sustaining treatment appear common, most are resolved without recourse to courts or tribunals, through communication and negotiation between doctors, patients (or their substitute decision makers) and occasionally other stakeholders including hospital administrators.14 Ethical and professional guidelines that set out how doctors should approach these decisions are therefore an Preferences in Intensive Care Units” (2019) 179(5) JAMA 676; White DB et al, “Toward Shared Decision Making at the End of Life in Intensive Care Units: Opportunities For Improvement” (2007) 167(5) Arch Intern Med 461. 4 In this article we use the term “doctor” (the term commonly used in the policies reviewed) to refer to a medical practitioner as defined under the Health Practitioner Regulation National Law Act 2009 (Cth): “a person who is registered under this Law in the medical profession”. 5 Great Ormond Street Hospital for Children NHS Foundation Trust v Yates [2017] EWHC 972 (Fam). 6 Alder Hey Children’s NHS Foundation Trust v Evans [2018] 2 FLR 1223; [2018] EWHC 308 (Fam). 7 See, eg, Savulescu J, “Is it in Charlie Gard's Best Interest to Die?” (2017) 389(10082) Lancet 1868; Wilkinson D, “Beyond Resources: Denying Parental Requests for Futile Treatment” (2017) 389(10082) Lancet 1866; Close E, Willmott L and White BP, “Charlie Gard: In Defence of the Law” (2018) 44(7) J Med Ethics 476; Freckelton I, “Responding Better to Desperate Parents: Warnings from the Alfie Evans Saga” (2018) 25(4) J Law Med 918; Wilkinson D and Savulescu J, “Alfie Evans and Charlie Gard—Should the Law Change?” (2018) 361 BMJ k1891. 8 See, eg, Messiha v South East Health [2004] NSWSC 1061; Northridge v Central Sydney Area Health Service [2000] NSWSC 1241. 9 See, eg, Shortland v Northland Area Health Service [1998] 1 NZLR 433 (CA). 10 See, eg, Betancourt v. Trinitas Hospital, 1 A 3d 823, 827 (NJ Super Ct App Div, 2010). 11 See, eg, W v M [2011] EWHC 2443; Aintree University Hospitals NHS Foundation Trust v James [2013] UKSC 67; R (Tracey) v Cambridge University Hospitals NHS Foundation Trust [2014] EWCA Civ 822; Briggs v Briggs [2016] EWCOP 53. 12 See, eg, Wawrzyniak v Livingstone, 2019 ONSC 4900; Cuthbertson v Rasouli, [2013] 3 SCR 341; Golubchuk v. Salvation Army Grace Hospital, 2008 MBQB 49. 13 See, eg, In re Lambert (Cour de cassation June 2019). See also Bagheri A (ed), Medical Futility: A Cross- National Study (Imperial College Press, 2013). 14 Pope TM, “Texas Advance Directives Act: Nearly A Model Dispute Resolution Mechanism for Intractable Medical Futility Conflicts” (2016) 16(1) QUT Law Rev 22 at 27-29. There is a lack of data on the rates of conflicts over life-sustaining treatment in hospital and the degree to which external (court or tribunal) resolution is sought, since many cases do not result in public judgements. 124 important source of regulation.15 Sometimes colloquially referred to as “medical futility policies”, these guidelines can serve a variety of regulatory functions. They can have a prescriptive function to provide information, establish terminology and set standards of good practice. They can also be used reactively to navigate conflicts, both by those involved and their institutions, and by external adjudicators. Medical futility policies are considered in the deliberations of clinical ethics committees,16 and are used as a benchmark in court proceedings17 and coronial inquests.18 Some guidelines also translate (or attempt to translate) legal standards into practice, and can elevate the minimum standard set by law to promote better, more ethical decision-making.19 Finally, medical futility policies can also play an important role in fostering access to justice and transparent decision making, which includes informing actors about dispute resolution options both inside and outside of the health service.20 However, whether Australian medical futility policies have the potential to fulfil any of these regulatory functions depends on their content and scope.21 This issue is the focus of this article. In contrast to the United States and Europe, where a significant medical futility policy released in 2015 has generated extensive commentary,22 there has been very little research on 15 We ascribe to a broad definition of regulation, defined as “influencing the flow of events”: Parker C and Braithwaite J, “Regulation” in Tushnet M and Cane P (eds), The Oxford Handbook of Legal Studies (Oxford University Press, 2005) 119 at 119-123. 16 Newson AJ, “The Value of Clinical Ethics Support in Australian Health Care” (2015) 202(11) Med J Aus 568. 17 See generally McDonald F, “The Legal System and the Legitimacy of Clinical Guidelines” (2017) 24 J Law Med 821 at 822-823. 18 See, eg, Inquest into the death of Jaxon McGrorey-Smith, New South Wales State Coroner's Court, 14 November 2018; Inquest into the death of Mrs June Woo, Queensland Office of State Coroner, 1 June 2009. 19 See generally Parker and Braithwaite, n 15 at 123. There are also instances where the law is more demanding than ethical standards or professional guidelines. For further discussion see Jackson E, “The Relationship Between Medical Law and Good Medical Ethics” (2015) 41 J Med Ethics 95. 20 A significant power imbalance can exist between patients (and their substitute decision makers) and other actors in the health care system, which can be compounded by differences in culture, religion and socio- economic resources. See Curnow K, “End-of-Life Decision-Making in a Health Services Setting: An Access to Justice Lens” (2016) 23(4) J Law Med 886. Social injustice can also be perpetuated by bias (often implicit) and discrimination, see Kirby J, “Balancing Legitimate Critical-Care Interests: Setting Defensible Care Limits Through Policy Development” (2016) 16(1) Am J Bioethics 38 at 41. 21 It also depends on whether policies are promulgated and have sufficient normative force, which some studies have questioned. See, eg, Goodridge D, “End of Life Care Policies: Do They Make A Difference in Practice?” (2010) 70(8) Soc Sci Med 1166. 22 Bosslet GT et al, “An Official ATS/AACN/ACCP/ESICM/SCCM Policy Statement: Responding to Requests for Potentially Inappropriate Treatments in Intensive Care Units” (2015) 191(11) Am J Respir Crit Care Med 1318. This policy was debated in a special edition, see Montello M, “Introduction to the Special Issue” (2018) 60(3) Perspect Biol Med 293. 125 Australian medical futility policies.23 This study seeks to fill this gap by critically reviewing publicly-available Australian policies that are intended to guide doctors’ behaviour when making decisions about withholding or withdrawing life-sustaining treatment from adult patients. The article first sets out the conceptual challenges with futility and outlines the approach adopted by the recent international statement mentioned above,24 as a comparator to the Australian context. The article then describes the qualitative document analysis methodology used to collect, categorise and analyse all of the publicly-available medical policies, guidelines and frameworks that are intended to guide doctors’ decisions to forgo life-sustaining treatment. The remainder of the paper presents the results of the analysis and discusses gaps and opportunities in the Australian medical futility policy environment. The article concludes by arguing that Australia would benefit from a more uniform approach to futility that gives clear guidance to doctors about terminology and how to prevent and address disputes. II. THE ROLE OF MEDICAL FUTILITY The concept of medical futility dates back to Hippocrates, who instructed doctors “to refuse to treat those who are ‘overmastered’ by their diseases, realising that in such cases medicine is powerless”.25 The modern interest in futility arose much more recently, in the late 1980s and early 1990s.26 Advances in medical technology, including the proliferation of the intensive care unit, expanded doctors’ ability to sustain the lives of critically-ill patients. As medical technology developed, there was increasing awareness of the need to limit excessive treatment provided by overzealous doctors to patients who were extremely unlikely or unable 23 Martin D, “Medical Futility in Australia” in Bagheri A (ed), Medical Futility: A Cross-National Study (Imperial College Press, 2013) 119; Levinson M et al, “Comparison of Not For Resuscitation (NFR) Forms Across Five Victorian Health Services” (2014) 44(7) Int Med J 671; Mills AC et al, “Testing a New Form to Document ‘Goals‐Of‐Care’ Discussions Regarding Plans for End‐Of‐Life Care for Patients in an Australian Emergency Department” (2018) 30(6) Emerg Med Australas 777. For an Australian review of paediatric policies see, Bhatia N and Tibballs J, “Deficiencies and Missed Opportunities to Formulate Clinical Guidelines in Australia for Withholding or Withdrawing Life-Sustaining Treatment in Severely Disabled and Impaired Infants” (2015) 12(3) J Bioeth Inq 449. 24 Bosslet et al, n 22. 25 Kerridge I, Lowe M and Stewart C, Ethics and Law for the Health Professions (Federation Press, 4th ed, 2013) at 409. 26 Helft PR, Siegler M and Lantos J, “The Rise and Fall of the Futility Movement” (2000) 343(4) N Eng J Med 293; Wilkinson DJC and Savulescu J, “Knowing When to Stop: Futility in the ICU” (2011) 24(2) Current Opinion in Anaesthesiology 160; White B et al, “Withholding and Withdrawing Potentially Life-Sustaining Treatment: Who Should Decide?” in I Freckelton and K Petersen (eds), Tensions and Traumas in Health Law (Federation Press, 2017) 454 at 458-462. 126 to recover.27 At the same time, a normative shift away from medical paternalism towards shared decision making meant futility was also used to combat demands for excessive treatment from patients or their substitute decision makers.28 The central premise was that if treatment was “futile”, that is, unlikely to sufficiently benefit the patient, then doctors were under no legal or ethical obligation to provide it. In this sense, “futile” is not merely descriptive, but rather an indication of the doctor’s obligations. Engelhardt and Kushf explain, “[t]o describe a situation as futile is to determine that it does not merit a particular intervention.”29 In 1992, Truog et al described the concept of futility as one of the “newest additions to the lexicon of bioethics.”30 While nearly a decade later Helft et al maintained that interest in the topic had waned,31 persistent attention remains,32 and empirical studies demonstrate that doctors are familiar with the term and use it in practice.33 However, there has been no consensus in the medical or ethical literature about what futility means or about empirical markers to delineate it. 34 Different definitions proposed include: Physiological futility – Treatment that has no physiologic effect (for example, antibiotics for a virus or cardiopulmonary resuscitation for a patient who is in rigor mortis).35 Quantitative futility – Treatment that has a very low chance of conferring a benefit, for example in less than 1 in 100 cases.36 Qualitative futility – Treatment that fails to result in an acceptable quality of life,37 or achieving an effect that the patient can appreciate as a benefit.38 27 Brody BA and Halevy A, “Is Futility a Futile Concept?” (1995) 20(2) J Med Philos 123. 28 Helft, Siegler and Lantos, n 26 at 294; Wilkinson and Savulescu, n 26 at 161; White et al, n 26 at 459-462. 29 Engelhardt HT and Khushf G, “Futile Care for the Critically Ill Patient” (1995) 1(4) Curr Opin Crit Care 329 at 330. See also Bosslet GT, Lo B and White DB, “Resolving Family-Clinician Disputes in the Context of Contested Definitions of Futility” (2018) 60(3) Perspect Biol Med 314. 30 Truog RD, Brett AS and Frader J, “The Problem with Futility” (1992) 326(23) N Engl J Med 1560 at 1560. 31 Helft, Siegler and Lantos, n 26. 32 White et al, n 26 at 459-462. 33 See, eg, White B et al, “What Does “Futility” Mean? An Empirical Study of Doctors’ Perceptions” (2016) 204(8) Med J Aus 318; Sibbald R, Downar J and Hawryluck L, “Perceptions of ‘Futile Care’ Among Caregivers in Intensive Care Units” (2007) 177(10) CMAJ 1201. 34 Helft, Siegler and Lantos, n 26; Wilkinson and Savulescu, n 26. 35 Brody and Halevy, n 27; Bosslet et al, n 22. 36 Schneiderman LJ, Jecker NS and Jonsen AR, “Medical Futility: Its Meaning and Ethical Implications” (1990) 112(12) Ann Intern Med 949. 37 Brody and Halevy, n 27. 38 Schneiderman LJ, “Defining Medical Futility and Improving Medical Care” (2011) 8(2) J Bioeth Inq 123. 127 Imminent demise futility – Treatment that might confer some physiologic effect, but cannot halt impending death.39 Lethal condition futility – Treatment that will address a symptom but will not change the progress of an underlying lethal condition.40 The Oxford English Dictionary defines “futile” as “[i]ncapable of producing any result; failing utterly of the desired end through intrinsic defect; useless, ineffectual, vain”.41 In contrast, the definitions above (with the exception of physiological futility) demonstrate that the concept is used to denote treatment beyond that which is strictly incapable of having an effect. On this basis, many commentators are critical of futility as a concept justifying a unilateral medical determination because in most circumstances assessing whether or not to withhold or withdraw life-sustaining treatment is a subjective exercise that depends on a patient’s values and on the goals of treatment.42 For example, a patient who is in a persistent vegetative state might have previously expressed strong views that life was worth prolonging, no matter her condition, and so not regard continued treatment as futile. By contrast, this treatment could be considered futile by another person who believed that such a life was not worth living. The criticism that futility is a flawed concept has prompted two key responses. The first is a semantic shift, away from the determinate-sounding “futility” towards terms that are either more neutral (eg “non-beneficial treatment”43) or terms that are more explicitly subjective (ie “potentially inappropriate treatment”44 or “disputed treatment”45). Indeed, although futility still appears in many of the policies considered in this paper, academic literature increasingly 39 Brody and Halevy, n 27. 40 Brody and Halevy, n 27. 41 OED Online, futile, adj (September 2019, Oxford University Press, subscription service), https://www.oed.com. 42 See, eg, Bosslet et al, n 22; Helft, Siegler and Lantos, n 26. Empirical studies have also confirmed doctors perceive futility is often subjective, favouring a qualitative approach. See eg, White et al, n 33; Close E et al, “Doctors’ Perceptions of How Resource Limitations Relate to Futility in End-Of-Life Decision Making: A Qualitative Analysis” (2019) 45(6) J Med Ethics 373. 43 Nates JL et al, “ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research” (2016) 44(8) Crit Care Med 1553; Brett AS and McCullough LB, “Getting Past Words: Futility and the Professional Ethics of Life-Sustaining Treatment” (2018) 60(3) Perspect Biol Med 319. 44 Bosslet et al, n 22. 45 White B, Willmott L and Close E, “Futile, Non-Beneficial, Potentially Inappropriate or ‘Disputed’ Treatment” in Emmerich N et al (eds), Contemporary European Perspectives on the Ethics of End of Life Care (Springer, forthcoming). 128 adopts these other terms, in particular, “non-beneficial treatment”.46 In this paper, these terms will be used interchangeably but reflecting the terminology of the policies being analysed, “futile treatment” or “futility” is predominantly used. The second response is to advocate for a “procedural approach” to decisions.47 A procedural approach is directed at establishing fair and transparent processes to arrive at a shared decision or to resolve disputes. In Texas, this is a binding process set out in legislation.48 More commonly, procedural approaches are laid out in policies set by hospitals, governments or other professional bodies such as medical associations.49 A procedural approach typically includes avenues for appeal and review, such as: obtaining a second opinion; review by a hospital ethics committee; transfer to another medical practitioner or institution; and advising patients or substitute decision makers of their right to access the courts.50 III. A KEY INTERNATIONAL APPROACH As mentioned in the introduction, a number of international critical care organisations produced a significant medical futility policy in 2015, commonly referred to as the “Multi- Society Statement.”51 Led by the American Thoracic Society (“ATS”), part of the impetus for the Multi-Society Statement was that existing professional statements on managing end-of- life conflict differed considerably in their definition of “futility” and recommendations for management. The Statement notes, “[c]onflicting guidance from professional societies is problematic because it may exacerbate confusion about this topic among clinicians and policymakers.”52 Recognising that these are complex decisions that warrant clear guidance 46 See, eg, Nates et al, n 43; Downar J et al, “Nonbeneficial Treatment Canada: Definitions, Causes, and Potential Solutions from the Perspective of Healthcare Practitioners” (2015) 43(2) Crit Care Med 270; Cardona- Morrell M et al, “Non-Beneficial Treatments in Hospital at the End of Life: A Systematic Review on Extent of the Problem” (2016) Int J Qual Health Care 1. 47 Bosslet et al, n 26; Moratti S, “The Development of ‘Medical Futility’: Towards a Procedural Approach Based on the Role of the Medical Profession” (2009) 35(6) J Med Ethics 369; Stewart C, “Futility Determination as a Process: Problems with Medical Sovereignty, Legal Issues and the Strengths and Weakness of the Procedural Approach” (2011) 8(2) J Bioeth Inq 155. 48 Advance Directives Act, Texas Health and Safety Code §§ 166.001 – 166.166 (1999). 49 White D and Pope T, “Medical Futility and Potentially Inappropriate Treatment” in Younger SJ and Arnold RM, The Oxford Handbook of Ethics at the End of Life (Oxford University Press, 2018). 50 Stewart, n 47; White and Pope, n 49. 51 Bosslet et al, n 22. 52 Bosslet et al, n 22 at 1320. 129 for clinicians, the ATS assembled a working group of several medical societies53 to develop a framework for decision making and provide recommendations for preventing and addressing disputes. This policy is a useful benchmark for an Australian analysis as it illustrates these two trends discussed in the preceding section: changes in terminology and a procedural approach to decisions. The most significant recommendation in the Multi-Society Statement is to narrow the scope of “medical futility” by drawing a distinction between treatments that are “futile” (which “cannot accomplish the intended physiological goal”) and those that are “potentially inappropriate” (which “have at least some chance of accomplishing the effect sought by the patient, but clinicians believe that competing ethical considerations justify not providing them”).54 The policy sets out clear procedures for each category of treatment. This approach recognises that the majority of decisions about life-sustaining treatment involve potentially inappropriate treatment (warranting a process of negotiation with patients or their substitute decision makers), not treatment that is physiologically futile (which doctors rightly should unilaterally refuse to provide). While this policy has critics,55 in our view Pope rightly argues that by narrowing the scope of the term “medical futility”, the statement “offers a richer and more precise vocabulary that facilitates better ethical decision-making.”56 As such, it is an important reference point for critical analyses of policy work on this topic. Therefore, with this key international comparator in mind, the remainder of this paper will evaluate the extent to which Australian medical futility policies address both terminology and the decision- making process. IV. METHODOLOGY 53 The policy was issued by the American Thoracic Society, and approved by the American Association of Critical Care Nurses (ACCN), the American College of Chest Physicians (ACCP), the European Society for Intensive Care Medicine (ESICM), and the Society of Critical Care Medicine (SCCM). See Bosslet et al, n 22. 54 Bosslet et al, n 22 at 1319. The Multi-Society Statement also discusses “legally discretionary and legally proscribed treatments”, those governed or prohibited by specific laws, policies or procedures. 55 See, eg, Schneiderman, Jecker and Jonsen, n 386. 56 Pope TM, “Medical Futility and Potentially Inappropriate Treatment: Better Ethics with More Precise Definitions and Language” (2018) 60(3) Perspect Biol Med 423. Elsewhere, several of the authors advocate for a process that distinguishes physiological futility from value-laden decisions. See White B et al, n 26 at 476- 478; White, Willmott and Close, n 45. 130 There is very little discourse about Australian medical policies on futility,57 and to our knowledge no comprehensive audit exists of current policies about withholding and withdrawing life-sustaining treatment from adult patients. We therefore set out to study Australian policies about forgoing life-sustaining treatment to determine what guidance about futility is provided to Australian doctors who make end-of-life decisions. We aimed to identify existing policies on withholding and withdrawing life-sustaining treatment and critically examine the extent to which they address medical futility (or a similar concept) at the end of life, and how it is labelled and conceptualised. We also aimed to evaluate to what extent the policies provide guidance about the decision-making process, including the scope of unilateral decision making and how to resolve disputes. We adopted Altheide’s five-stage document analysis method to address some of the challenges of complex health policy analysis.58 This is a widely-recognised qualitative document analysis method that Altheide et al describe as “an integrated method, procedure, and technique for locating, identifying, retrieving, and analysing documents for their relevance, significance, and meaning.”59 Altheide et al’s five stages are: 1) document sampling; 2) data collection; 3) data coding and organisation; 4) data analysis; and 5) reporting. A Stage 1: Document sampling This review targeted current publicly-available medical policies in all Australian jurisdictions that address decisions to withhold or withdraw life-sustaining treatment. We defined “policy” broadly, as a written statement of principle intended to guide doctors’ decisions about clinical/ethical aspects of withholding or withdrawing life-sustaining treatment.60 Using this broad definition of “policy”, we included documents intended as mere guidance or 57 The few studies that exist are limited to institutional policies or do not purport to constitute a comprehensive review. See, eg, Martin D, n 23; Levinson M et al, n 23; Mills AC et al, n 23. 58 Walt G et al, “‘Doing’ Health Policy Analysis: Methodological and Conceptual Reflections and Challenges” (2008) 23(5) Health Policy Plan 308. 59 Altheide D et al, “Emergent Qualitative Document Analysis” in Hesse-Biber SN and Leavy P (eds), Handbook of Emergent Methods (Guildford Press, 2010) 127. The method was pioneered in the 1990s in the context of sociological studies of mass media, but has been used more widely since and was recently employed in a study on Australian health policy research: Esbati A et al, “Legislation, Policies and Guidelines Related to Breastfeeding and the Baby Friendly Health Initiative in Australia: A Document Analysis” (2018) 42(1) Aust Health Rev 72. 60 We developed this from the definition of “institutional policy” in Goodridge, n 21 at 1166: “declarations of the organizations’ deeply held values … instructing employees on how to conduct business in a legal, ethical and safe manner.” 131 information, not just policies in a formal, binding sense. Documents meeting these criteria were primarily professional guidelines, health department policies, position statements, ethical statements and frameworks, but broader documents aimed at a wider audience, including health consumers and medical administrators, were included in the initial sampling if they purported to provide specific guidance for doctors. We also examined relevant reports intended to inform policy development. Overarching medical codes of ethics were included when they made specific statements about withholding or withdrawing life-sustaining treatment or about futility. We excluded institutional policies, such as those from hospitals and aged care facilities, since these are typically not publicly available.61 Strategy documents targeted solely at stakeholders other than doctors and those focused on aspects of end-of-life care other than withholding and withdrawing life-sustaining treatment were excluded, for example, strategies on focused solely on palliative care,62 and advance care directives.63 We also excluded purely clinical guidelines directed to specific therapies, such as Choosing Wisely Australia,64 and organ allocation policies.65 Legislation and training modules and education programs for doctors were also excluded as these are distinct from policies. B Stage 2: Data collection 61 Survey methodology is usually required to locate institutional policies. See, eg, Lemiengre J et al, “Institutional Ethics Policies on Medical End-Of-Life Decisions: A Literature Review” (2007) 83(2) Health Policy 131. 62 See, eg, Palliative Care Australia, National Palliative Care Standards (5th ed, PCA, 2018), http://palliativecare.org.au/wp-content/uploads/dlm_uploads/2018/11/PalliativeCare-National-Standards- 2018_Nov-web.pdf. 63 See, eg, The Clinical, Technical and Ethical Principal Committee of the Australian Health Ministers’ Advisory Council, A National Framework for Advance Care Directives (Australian Health Ministers Advisory Council, 2011), http://www.coaghealthcouncil.gov.au/Portals/0/A%20National%20Framework%20for%20Advance%20Care%2 0Directives_September%202011.pdf; Queensland Government, Department of Health, Advance Care Planning: Clinical Guidelines (Queensland Health, 2018), https://www.health.qld.gov.au/__data/assets/pdf_file/0037/688618/acp-guidelines.pdf. 64 See, eg, Choosing Wisely Australia, The Royal Australian College of General Practitioners: Tests, Treatments and Procedures Clinicians and Consumers Should Question (NPS MedicineWise, 2015-2016), http://www.choosingwisely.org.au/recommendations/racgp. 65 See, eg, The Transplantation Society of Australia and New Zealand, Clinical Guidelines for Organ Transplantation from Deceased Donors (TSANZ, 2019), https://www.tsanz.com.au/TSANZ_Clinical_Guidelines_Version%201.3[6986].pdf; National Health and Medical Research Council, Ethical Guidelines for Organ Transplantation From Deceased Donors (NHMRC, 2016) https://www.nhmrc.gov.au/about-us/publications/ethical-guidelines-organ-transplantation-deceased- donors. 132 As a starting point, we identified the bodies that would be likely to have policy on end-of-life care, including Australian peak medical bodies and medical colleges, and national, state and territory governments. AC did an initial review, which EC revisited and updated in 2019.66 For the more recent review, EC searched the relevant bodies websites using a range of terms including: “futile treatment”; “futility”; “non-beneficial treatment”; “inappropriate treatment”; “withhold*”; “withdraw*”; “treatment limitation”; “end of life and policy or guideline”; “resuscitation”; “goals of care”; “dispute or conflict”. EC also examined the professional guidelines and resources sections of all fifteen Australian specialist medical colleges,67 and searched the health department websites for each Australian state and territory. The above terms were also queried using the Google search engine, and in MEDLINE/PUBMED and Scopus academic databases in combination with the term “Australia”. C Stage 3: Data coding and organisation Based on the initial searches, EC created a database of documents that potentially met the inclusion criteria. EC and MP reviewed and discussed all documents that did not clearly meet the inclusion criteria and arrived at a final list of policies to include in this review, which all authors agreed on. These were assigned to one of three groups: Category 1: Commonwealth government documents; Category 2: State/Territory government documents; and Category 3: Professional organisation documents. Documents were grouped into these categories to facilitate ease of comparison across documents by similar authors and to more easily identify which policies would apply to a given doctor in a specific specialty in a specific jurisdiction. For example, while the Category 66 Results of the review are current as of 1 November 2019. 67 Australian Health Practitioner Regulation Agency, Approved Programs of Study (AHPRA & National Boards) https://www.ahpra.gov.au/education/approved-programs-of- study.aspx?ref=medical%20practitioner&type=specialist. The colleges are: the Australasian College for Emergency Medicine (ACEM); the Australasian College of Dermatologists (ACD); the Australasian College of Sport and Exercise Physicians (ACSEP); the Australia and New Zealand College of Anaesthetists (ANZCA); the Australian College of Rural and Remote Medicine (ACRRM); the College of Intensive Care Medicine of Australia and New Zealand (CICM); the Royal Australasian College of Medical Administrators (RACMA); the Royal Australasian College of Obstetricians & Gynaecologists (RANZCOG); the Royal Australasian College of Physicians (RACP); the Royal Australasian College of Surgeons (RACS); the Royal Australian and New Zealand College of Ophthalmologists (RANZCO); Royal Australian and New Zealand College of Psychiatrists (RANZCP); the Royal Australian and New Zealand College of Radiologists (RANZCR); the Royal Australian College of General Practitioners (RACGP); and the Royal College of Pathologists of Australia (RCPA). 133 1 policies would in theory apply to all doctors across Australia, an intensive care doctor working in Queensland would be subject to only the Queensland documents from Category 2 and the relevant professional organisation documents in Category 3. D Stage 4: Data analysis Once the list of policies was settled EC uploaded them into NVivo 12 (QSR International Pty Ltd, 2018) and developed a list of initial codes, which formed the basis for the protocol. EC coded the policies by comparing and contrasting key differences between the policies and between the categories.68 EC also developed Excel matrices to summarise the policies and facilitate comparisons of how futility was defined and guidance given about the decision- making process.69 E Stage 5: Report Stage 5 of Altheide’s method is synthesising and interpreting the results, which is set out in the next two sections. V. RESULTS The results are grouped into three main themes: A) the scope and source of medical futility policies in Australia; B) terminology used to describe futility or a like concept; and C) the extent of guidance about the decision-making process and dispute resolution. A Scope and source of Australian medical futility policies Across Australia, we located 23 policies that met the inclusion criteria (Table 1). Ten policies were from State and Territory governments (Category 2). Another ten policies were from professional organisations (Category 3), with five of these from national medical associations and societies (Category 3a) and five from medical colleges (Category 3b). There were three relevant policies issued by the Commonwealth Government (Category 1). 68 Altheide DL and Schneider CJ, “Process of Qualitative Document Analysis” in SAGE Publications (ed), Qualitative Media Analysis (2nd ed, 2013). 69 Miles M, Huberman M and Saldaña J, Qualitative Data Analysis: A Methods Sourcebook (3rd ed, SAGE Publications, Thousand Oaks, CA, 2014). 134 Table 1. Current Australian policies that address decision making about withholding or withdrawing life- sustaining treatment and/or futile treatment at the end of life Source Name of document (year) Brief Description Category 1 – Commonwealth Government Australian National Consensus Statement: 40-page document setting out suggested practice Commission on Essential Elements for Safe and for end-of-life care in acute settings, including Safety and Quality in High-Quality End-of-Life Care guiding principles and corresponding actions. Health Care (2015)70 Medical Board of Good Medical Practice: A Code 25-page code setting out the standards of Australia of Conduct for Doctors in professional and ethical conduct for all registered Australia (2014)71 doctors in Australia. Section 3.12 is dedicated to end-of-life care. National Health and Ethical Guidelines for the Care 66-page ethical framework to guide decision Medical Research of People in Post-Coma making for persons in post-coma Council Unresponsiveness (Vegetative unresponsiveness (PCU) or a minimally State) or a Minimally responsive state. Responsive State (2008)72 Category 2 – State and Territory Governments New South Wales End-of-Life Care and Decision- 17-page document setting out a process for Government, Making – Guidelines (2005)73 reaching end-of-life decisions. Includes Department of Health principles and recommendations for shared decision making. Conflict Resolution in End of 56-page report providing recommendations for Life Settings (CRELS): Final how to navigate end-of-life conflicts in the CRELS Project Working Group hospital setting. Report Including Consultation Summary (2010)74 Using Resuscitation Plans in 21-page policy directive describing the standards End of Life Decisions (2014)75 and principles for the use of resuscitation plans 70 National Consensus Statement, n 2. 71 Medical Board of Australia, Good Medical Practice: A Code of Conduct for Doctors in Australia (MBA, 2014), https://www.medicalboard.gov.au/Error/404.htm?aspxerrorpath=/documents/default.aspx (“MBA Code”). The MBA Code originated as a document drafted by the Australian Medical Council, the national accreditation body for the medical professional. The Code was then adopted and subsequently updated by the MBA. We have included the Medical Board of Australia in Category 1 since it is supported by the Australian Health Practitioner Regulation Agency, a statutory body of the Commonwealth Government. The Code is issued under s 39 of the Health Practitioner Regulation National Law Act 2009 (Cth), which states “A National Board may develop and approve codes and guidelines—(a) to provide guidance to health practitioners it registers...” 72 National Health and Medical Research Council, Ethical Guidelines for the Care of People in Post-Coma Unresponsiveness (Vegetative State) or a Minimally Responsive State (NHMRC 2008), https://www.nhmrc.gov.au/about-us/publications/ethical-guidelines-care-people-post-coma-unresponsiveness (“NHMRC Guidelines”). 73 New South Wales Health, End-of-Life Care and Decision-Making – Guidelines (NSW Health, 2005), https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/GL2005_057.pdf (“NSW End-of-Life Guidelines”). 74 New South Wales Health, Conflict Resolution in End of Life Settings (CRELS): Final CRELS Project Working Group Report Including Consultation Summary (NSW Health, 2010), https://www.health.nsw.gov.au/patients/acp/Publications/conflict-resolution.pdf (“CRELS Report”). While CRELS Report notes it “is not a guideline, but rather a blueprint that outlines areas warranting further investigation, strengthened practice or new initiatives required to meet that goal”, we have included this document in this review since it fits our broad definition of “policy” set out in Section IV. 75 New South Wales Government, Department of Health, Using Resuscitation Plans in End of Life Decisions (PD2014_030) (NSW Health, 2014), 135 (orders to use or withhold resuscitation measures) in patients 29 days and older. Queensland End-of-Life Care: Guidelines 176-page reference document intended to support Government, for Decision-Making About health professionals, administrators, policy- Department of Health Withholding and Withdrawing makers, decision-managers who are involved in Life-Sustaining Measures from decision-making about life-sustaining measures. Adult Patients (2018) 76 South Australia Providing Medical Assessment 33-page policy directive directed at assisting Government, and/or Treatment Where Patient health professionals to meet their legal Department of Health Consent Cannot be Obtained obligations when providing medical assessment Policy Directive (2014)77 or treatment to patients who cannot consent due to a lack of voluntariness, communication difficulties or impaired decision-making capacity. Consent to Medical Treatment 39-page policy guideline aimed at providing and Health Care Policy guidance in meeting legislative requirements Guideline (2014)78 under guardianship and health care consent legislation, including avenues for dispute resolution. Resuscitation Planning – 7 Step 25-page policy directive aimed at health Pathway (2016)79 professionals and consumers that sets out a transparent process to make and document decisions about resuscitation and other life- sustaining treatments. Tasmanian Medical Goals of Care Plan80 A state-wide initiative aimed to ensure patients Government, who are unlikely to benefit from curative Department of Health treatment receive appropriate care. Includes links to “Principles – Medical Goals of Care” and https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2014_030.pdf (“NSW Health Resuscitation Plan Policy”). 76 Queensland Government, Department of Health, End-of-Life Care: Guidelines for Decision-Making about Withholding and Withdrawing Life-Sustaining Measures from Adult Patients (Queensland Health, 2018), https://www.health.qld.gov.au/__data/assets/pdf_file/0033/688263/acp-guidance.pdf (“Queensland Health Guidelines”). This resource also includes two companion “short form” resources listed on the Queensland Health website, which we have analysed with the guidelines as a whole, since they are included as an appendix. For standalone resources see: Withholding and Withdrawing Life-Sustaining Measures: Legal Considerations for Adult Patients (https://www.health.qld.gov.au/__data/assets/pdf_file/0038/688268/measures-legal.pdf); Flowcharts for Providing Health Care and Withholding/Withdrawing Life-Sustaining Measures (https://www.health.qld.gov.au/__data/assets/pdf_file/0036/688266/wwlsm-flowcharts.pdf). 77 South Australia Government, Department of Health, Providing Medical Assessment and/or Treatment Where Patient Consent Cannot be Obtained Policy Directive (SA Health, 2014), https://www.sahealth.sa.gov.au/wps/wcm/connect/Public+Content/SA+Health+Internet/Health+topics/Health+c onditions+prevention+and+treatment/End+of+life/ (“SA Policy on Treatment Without Consent”). 78 South Australia Government, Department of Health, Consent to Medical Treatment and Health Care Policy Guideline (SA Health, 2014), https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/clinical+resources/clinical +topics/end+of+life+for+health+professionals/consent+to+medical+treatment+for+health+professionals (“SA Consent to Medical Treatment Policy”). 79 South Australia Government, Department of Health, Resuscitation Planning – 7 Step Pathway (SA Health, 2016), https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/clinical+resources/clinical +topics/end+of+life+for+health+professionals/resuscitation+plan+7+step+pathway+for+health+professionals (“SA Resuscitation Planning Policy”). The URL includes several short companion resources to this policy. 80 Tasmanian Government, Department of Health, Medical Goals of Care Plan (undated, last accessed 3 November 2019), https://www.dhhs.tas.gov.au/palliativecare/health_professionals/goals_of_care (“Tasmanian Goals of Care Plan”). 136 “Guidance Notes – Completion of Medical Goals of Care Plan”. Victorian A Guide to the Medical 26-page guidance about the Medical Treatment Government, Treatment Planning and Planning and Decisions Act 2016 (Vic), a Department of Health Decisions Act 2016 for Health framework for decision making for persons who Practitioners81 lack decision-making capacity. Western Australia The End-of-Life Framework: A 20-page framework for end-of-life care in Government, Statewide Model for the Western Australia, intended to provide guidance Department of Health Provision of Comprehensive, to clinicians. Includes a section on responding to Coordinated Care at End-Of- clinical deterioration and addresses conversations Life In Western Australia82 about goals of care. Category 3 – Professional Organisations Category 3a - National Medical Associations and Societies Australian Medical Position Statement on End of 10-page position statement setting out policy Association Life Care and Advance Care across a number of end-of-life care Planning (2014)83 considerations, including withholding and withdrawing life-sustaining treatment, advance care planning and palliative care. Code of Ethics (2004, 7-page code of ethics intended to complement the editorially revised 2006, revised MBA code of conduct for doctors. The Code sets 2016)84 out the ethical standards expected of the medical profession. The Doctor’s Role in 3-page position statement setting out principles Stewardship of Health Care for the appropriate management of health care Resources (2016)85 resources. The statement includes a section on “unwanted tests, treatments and procedures”, which addresses treatment that is not medically beneficial. Australian Guideline 10.5 – Legal and 14-page guideline intended for first-aiders, first- Resuscitation Council Ethical Issues Related to responders, and health professionals. Addresses (ANZCOR) Resuscitation (2015)86 legal and ethical issues surrounding resuscitation. Australian and New Statement on Care And 148-page statement intended to support intensive Zealand Intensive Decision-Making at the End For care staff who care for critically-ill patients. The Care Society statement provides a framework for best practice (ANZICS) 81 Victorian Government, Department of Health and Human Services, A Guide to the Medical Treatment Planning and Decisions Act 2016: For health practitioners (2nd ed, Victorian Government, 2019), https://www2.health.vic.gov.au/hospitals-and-health-services/patient-care/end-of-life-care/advance-care- planning/medical-treatment-planning-and-decisions-act (“Victorian Guide to the MTPD”). 82 Western Australia Government, Department of Health, The End-of-Life Framework: A Statewide Model for the Provision of Comprehensive, Coordinated Care at End-of-Life in Western Australia (WA Health, 2016), https://ww2.health.wa.gov.au/~/media/Files/Corporate/general%20documents/End%20of%20Life/PDF/The- End-of-Life-Framework.pdf (“WA End-of-Life Framework”). 83 Australian Medical Association, Position Statement on End of Life Care and Advance Care Planning (AMA, 2014), https://ama.com.au/position-statement/end-life-care-and-advance-care-planning-2014 (“AMA End-of-Life Statement”). 84 Australian Medical Association, Code of Ethics (AMA, 2016), https://ama.com.au/position-statement/code- ethics-2004-editorially-revised-2006-revised-2016 (“AMA Code”). 85 Australian Medical Association, The Doctor’s Role in Stewardship of Health Care Resources (AMA, 2016), https://ama.com.au/position-statement/doctors-role-stewardship-health-care-resources-2016 (“AMA Stewardship Statement”). 86 Australian Resuscitation Council and New Zealand Resuscitation Council, Guideline 10.5 – Legal and Ethical Issues Related to Resuscitation (ANZCOR, 2015), https://resus.org.au/guidelines/ (“Australian Resuscitation Council Guideline”). 137 Life for the Critically Ill for caring for patients at the end of life in (2014)87 Australia and New Zealand. Category 3b – Medical Colleges Australasian College Policy on End of Life and 8-page document aimed at supporting health for Emergency Palliative Care in the professionals in the emergency department. It Medicine (ACEM) Emergency Department (2016)88 also aims to encourage emergency departments to implement systems and processes to recognise and respond to patients at the end of life. Australian College of Position Statement - Rural End 4-page document setting out principles for Rural and Remote of Life Care and Advance Care doctors working in rural settings to provide Medicine (ACRRM) Planning (2015)89 optimal end-of-life care, tailored to patients’ wishes. College of Intensive Statement on Withholding and 3-page document setting out 14 principles related Care Medicine of Withdrawing Treatment (IC-14) to withholding and withdrawing life-sustaining Australia and New (2003, last reviewed in 2013)90 treatment. Zealand (CICM) Royal Australasian Improving Care at the End of 57-page document providing recommendations College of Physicians Life: Our Roles and for quality patient-centred end-of-life care. (RACP) Responsibilities (2016)91 Royal Australasian Position Paper - End of Life 3-page document describing the RACS position College of Surgeons Care (2016)92 on palliative care, informed choice and low (RACS) efficacy procedures, and advance care planning in the surgical context. There is not scope in this paper to address the background of each of these policies in detail, though we acknowledge their provenance potentially influences their regulatory force and legitimacy.93 However, there are a few points to note about the overall policy environment. 87 Australian and New Zealand Intensive Care Society, Statement on Care and Decision-Making at the End for Life for the Critically Ill (1st Edition, ANZICS, 2014), https://www.clinicalguidelines.gov.au/portal/2434/anzics- statement-care-and-decision-making-end-life-critically-ill (“ANZICS Statement”). 88 Australasian College for Emergency Medicine, Policy on End of Life and Palliative Care in the Emergency Department (ACEM, July 2016), https://acem.org.au/getmedia/d55cb8ce-2d26-49d5-823a-f7f07b5c19cc/P455- PolicyonEoLandPalliativeCareinED-Jul16.aspx (“ACEM Policy”). 89 Australian College of Rural and Remote Medicine, Position Statement - Rural End of Life Care and Advance Care Planning (ACRRM, 2015), https://www.acrrm.org.au/the-college-at-work/position- statements/policy/2015/12/20/college-position-statement-on-rural-end-of-life-care-and-advance-care-planning (“ACRRM Statement”). 90 College of Intensive Care Medicine of Australia and New Zealand, Statement on Withholding and Withdrawing Treatment (2003, last reviewed in 2013), https://cicm.org.au/CICM_Media/CICMSite/CICM- Website/Resources/Professional%20Documents/IC-14-Statement-on-Withholding-and-Withdrawing- Treatment.pdf. This statement is a joint statement with ANZICS, originally adapted from the prior ANZICS policy in 2003 and republished by CICM in 2013. It is no longer part of the materials on the ANZICS website, so we have categorised it here as a CICM policy. 91 Royal Australasian College of Physicians, Improving Care at the End of Life: Our Roles and Responsibilities (RACP, 2016), https://www.racp.edu.au/docs/default-source/advocacy-library/pa-pos-end-of-life-position- statement.pdf (“RACP Statement”). 92 Royal Australasian College of Surgeons, Position Paper - End of Life Care (RACS, 2016), https://umbraco.surgeons.org/media/1642/2017-07-28_pos_fes-pst-057_end_of_life_care.pdf (“RACS Position Paper”). 93 McDonald, n 17. 138 First, the length, scope and purpose of existing guidelines varies widely, some documents being short position statements (eg the AMA End-of-Life Statement), others longer, more comprehensive, end-of-life decision-making guidelines (eg the Queensland Health Guidelines, the ANZICS Statement), and others broad codes of conduct not specific to end-of- life care (eg the MBA Code and the AMA Code) (Table 1). Notably, with the exception of the ANZICS Statement and the RACP Statement, the majority of professional organisation statements (Category 3) are much shorter than the documents in Categories 1 and 2. A second aspect to note is that state and territory governments have variable approaches to policies specific to withholding or withdrawing life-sustaining treatment. New South Wales and Queensland have policy documents dedicated to making decisions about life-sustaining treatment (Table 1). In contrast, the policies from the ACT, Victoria and Tasmania are narrower. These jurisdictions have adopted a “goals of care” framework, an approach intended to reduce futile treatment,94 but do not have a document focused on the ethical challenges of decisions to forgo treatment. Western Australia also references goals of care in its broad end-of-life framework, but the document is high-level and does not provide additional guidance about withholding and withdrawing life-sustaining treatment. South Australia has several discrete policies about withholding resuscitation, and implementing legal obligations when providing treatment to patients with and without capacity, but has no single policy on decision making about life-sustaining treatment. There were no relevant documents on the ACT or Northern Territory government or health department websites. The third attribute of the Australian non-institutional futility policy environment is that most professional organisations from specialties that make end-of-life decisions now have a dedicated end-of-life policy. Five of the fifteen specialist medical colleges in Australia have a document focussed on end-of-life decision making (Table 1).95 Several of these were issued or updated in the last five years, with the Australasian College for Emergency Medicine, the Australian College of Rural and Remote Medicine, the Royal Australasian College of Physicians and the Royal Australasian College of Surgeons all issuing new statements in 94 The Goals of Care approach is influenced by Physician Orders for Life Sustaining Treatment, widely used in the United States. See Thomas RL, Zubair MY, Hayes B, and Ashby MA, “Goals of Care: A Clinical Framework for Limitation of Medical Treatment” (2014) 201(8) Med J Aust 452. 95 The remaining ten colleges have no current publicly-available policy statements or guidance documents on end-of-life decisions for adult patients. This finding was mostly expected since, aside from the Australia and New Zealand College of Anaesthetists (ANZCA) (which recently withdrew its end-of-life policy) and the Royal Australian College of General Practitioners (RACGP), none of these colleges deal with patients at the end of life as part of their core practice. 139 2015 or 2016. The most comprehensive of the professional organisation documents is from the Australian and New Zealand Intensive Care Society,96 which is unsurprising given that many ethical dilemmas in relation to decisions to withhold or withdraw life-sustaining treatment arise in the ICU for patients who lack capacity. B Terminology The first domain we examined was the terminology used as a criterion for withholding or withdrawing life-sustaining treatment. Overall, some Australian medical policies appear to follow the trend in the bioethical literature by phasing out the term “futile”, however this is not universal and the term is still retained, even in recently published documents. Across all categories the policy documents employ inconsistent terminology, with some policies retaining the language of ‘futility’ and some moving away from the term. 1 Policies that use the label “futile treatment” Nearly one third of the policies (7/23) use the term “futile treatment”. The policies use similar definitions, centred on patient benefit (e.g., “no benefit” or weighing benefits versus burdens), with some subtle differences (Table 2). For example, a few statements define futility narrowly (“produces no benefit”97) while others frame it somewhat more broadly, for example, incorporating quantitative assessments about the treatment’s potential effect (“potentially affords no benefit”98). The former phrase is more categorical, while the latter is a probabilistic, prognostic statement, with more scope for differing assessments. This is a small but important distinction, and if taken literally potentially provides scope for reasonable disagreement in practice. This is especially the case when there is no clear process set out for how to operationalise the definition. 96 ANZICS Statement, n 87. 97 NHMRC Guidelines, n 72 at 35 [emphasis added]. See also; AMA End-of-Life Statement, n 83 at 3, 5. 98 Queensland Health Guidelines, n 76 at 5 [emphasis added]. 140 Table 2. Australian policies addressing withholding or withdrawing treatment that use “futile” Policy Definition of futility Category 1 – Commonwealth government NHMRC Guidelines “It is always necessary to consider whether a treatment or intervention may be overly burdensome or futile … Overly burdensome treatment is distinct from a level of care for health and life that carers may be regarded as obliged to provide … Treatment is futile only if it produces no benefit to the patient (i.e. does not slow down the progress of disease, sustain the patient’s life, reduce disability and improve health, or relieve the patient’s distress or discomfort).”99 Category 2 – State and territory governments CRELS Report “The term ‘futile’ treatment is used in clinical practice, despite its persisting (NSW) ambiguity in medical ethics literature. There remains ongoing debate about what constitutes futile treatment … A more inclusive approach is needed to exploring divergent views between treating professionals and a family where arguably ‘futile’ treatment is at issue in an EOL [end-of-life] conflict.”100 Queensland Health Futile treatment is “medical treatment that potentially affords no benefit and Guidelines would cause the patient harm.”101 The Guidelines also endorse the definition in the AMA End-of-Life Statement (see below).102 SA Resuscitation “It is ethically important not to harm patients approaching the end of life by Planning Policy providing burdensome or futile investigations and/or treatments that can be of no benefit.”103 “Futile” is not defined, but later the policy quotes the Consent Act 1995 (SA), stating that a medical practitioner… “is under no duty to use, or to continue to use, life sustaining measures in treating the patient if the effect of doing so would be merely to prolong life in a moribund state without any real prospect of recovery or in a persistent vegetative state (whether or not the patient or the patient's representative has requested that such measures be used or continued)…”104 Category 3 – Professional organisations AMA End-of-Life “Futile Treatment - Treatment that no longer provides a benefit to a patient, or Statement the burdens of providing the treatment outweigh the benefits … In end of life care, medically futile treatment can be considered to be treatment that gives no, or an extremely small, chance of meaningful prolongation of survival and, at best, can only briefly delay the inevitable death of the patient.”105 Australian No definition provided. “Although healthcare personnel are under no obligation Resuscitation Council to inform, offer or provide treatment considered to be futile to a victim, the Guideline reasons for such should be documented in the victim’s clinical record.”106 99 NHMRC Guidelines, n 72 at 35. 100 CRELS Report, n 74 at 25. 101 Queensland Health Guidelines, n 76 at 5. 102 Queensland Health Guidelines, n 76 at 41. 103 SA Resuscitation Planning Policy, n 79 at 4. 104 SA Resuscitation Planning Policy, n 79 at 12. 105 AMA End-of-Life Statement, n 83 at 3, 5. 106 Australian Resuscitation Council Guideline, n 86 at 13. 141 RACS Position Paper No definition provided. “Judging whether an intervention will be futile or of little benefit to the patient is often uncertain and … difficult … [which] can be compounded where there are differing views regarding the benefits of an intervention, or where there are cultural differences contributing to misunderstanding.”107 Notably, with the exception of the NHMRC Guidelines, none of the policies draw the distinction in the Multi-Society Statement between physiologically futile treatment and treatment that involves a value judgment. The NHMRC Guidelines distinguish between “futile” and “overly burdensome” treatment and note that the word “futile” is ambiguous and “may in fact obscure, rather than clarify, the nature of the decision being made”.108 Consequently, the statement limits the word “futile” to its dictionary definition “incapable of producing any result; ineffective; useless; not successful”, stating [t]reatment is futile only if it produces no benefit …. In contrast, “overly burdensome treatment” is informed by the patient’s and family’s particular circumstances, their experience of illness and its remedies, and their culture, beliefs and preferences.109 Arguably, even this definition falls short of distinguishing physiological futility since something that produces “no benefit” still requires a value judgment as to what counts as a benefit (versus a physiologically futile treatment that has no effect). Several statements use the term “futile” without defining it. For example, the Australian Resuscitation Council Guideline does not define futility despite indicating healthcare personnel are “under no obligation to inform, offer or provide treatment considered to be futile to a victim...”.110 While this statement broadly reflects the law in relation to withdrawing or withholding treatment in acute emergencies in Australia,111 it does not indicate how a first responder is to make the determination of futility in practice. Other statements acknowledge that futility is used to make assessments that are value-laden, including the NHMRC Guidelines, the CRELS Report, the Queensland Health Guidelines, 107 RACS Position Paper, n 92 at 2. 108 NHMRC Guidelines, n 72 at 35. 109 NHMRC Guidelines, n 72 at 35. 110 Australian Resuscitation Council Guideline, n 86 at 13. 111 See generally Willmott L, White B and Then SN, “Withholding and Withdrawing Life-Sustaining Medical Treatment” in White B, McDonald F and Willmott L, Health Law in Australia (3rd ed, Lawbook Co, Sydney, 2018) pp 607 ̶ 608. 142 and the RACS Position Paper.112 Other policies briefly address this but could go further in recognising it. For example, while the AMA End-of-Life Statement defines futility,113 it does not mention (at least in this section) that the values of the patient, substitute decision maker or doctor could influence decisions. The Statement does instruct doctors to “discuss their reasons for determining a treatment to be medically futile with the patient (and/or the SDM [substitute decision maker] … before coming to a decision”114 but the phrase “discuss their reasons” [emphasis added] is framed from the doctor’s perspective and does not explicitly encourage the doctor to explore the other stakeholders’ views. The advantage of the approach in the Multi-Society Statement, which none of the Australian policies fully reflect, is that limiting the word “futile” to physiological futility carves out a narrow category of cases that is solely within the doctor’s discretion. The existing policies that retain the word “futile”, even those that acknowledge decisions about life-sustaining treatment are value-laden, fail to capture this important distinction. 2 Policies that use language other than “futile treatment” Thirteen policies use terminology other than “futile treatment”.115 In place of “futile”, the majority discuss patient benefit, either describing weighing benefits and burdens or directing doctors to refrain from providing “non-beneficial” treatment or treatment that is of “negligible benefit” or “no benefit”. Other terms include treatment that is “not in the person’s best interests”, “ineffective therapy”, “inappropriate treatment”, or the somewhat ambiguous phrase “limits of medicine” (Table 3). 112 For example, the RACS Position Paper explains futility is an uncertain, culturally influenced, value- dependent concept and subject to interpretation: n 92 at 2. The Queensland Health Guidelines explain that futility “should not be seen as offering a value-free point of clinical closure” but should be a trigger to re- evaluate goals of treatment and strengthen communication: n 76 at 42. 113 Note that the AMA End-of-Life Statement was issued in 2014, but in the most recent iteration of the AMA Code, revised in 2016, the AMA has dropped the term “futile” in favour of the phrase “of no medical benefit”. This could indicate the word “futile” will also be removed from the next version of its end-of-life policy. 114 AMA End-of-Life Statement, n 72 at 5. 115 Note that 3 policies do not discuss futility or a like concept: SA Consent to Medical Treatment Policy; SA Policy on Treatment Without Consent; WA End-of-Life Framework. 143 Table 3. Australian policies that address withholding or withdrawing treatment that use terminology other than “futile” Policy Term used Definition Category 1 – Commonwealth government National Consensus Nonbeneficial “Interventions that will not be effective in treating a Statement treatment patient’s medical condition or improving their quality of life. …Nonbeneficial treatment is sometimes referred to as futile treatment, but this is not a preferred term.”116 MBA Code Limits of medicine “…good medical practice involves: 3.12.13 Understanding the limits of medicine in prolonging life and recognising when efforts to prolong life may not benefit the patient.” 3.12.14 Understanding that you do not have a duty to try to prolong life at all cost. However, you do have a duty to know when not to initiate and when to cease attempts at prolonging life, while ensuring that your patients receive appropriate relief from distress.”117 Category 2 - State and territory governments NSW End-of-Life Negligible prospect of “Health professionals are under no obligation to provide Guidelines benefit treatments that … are unreasonable, in particular, those that offer negligible prospect of benefit ...”118 Inappropriate requests for continuing “At times a family or a patient requests a test or treatment intervention that appears unreasonable or inappropriate … … where the patient’s condition continues to deteriorate … where the treatment would not be successful in producing the clinical effect … [or] where the treatment might successfully produce a clinical effect, but still fail to serve important patient goals such as independence from life- support devices, survival in order to leave hospital, or improvement from permanent unconsciousness.”119 NSW Resuscitation Negligible benefit CPR should not be instituted if it is of “negligible benefit”, Plan Policy in other words where it “… offers no benefit or where the Burdens versus benefits are small and overwhelmed by the burden to the benefits patient … Given that judgments about the benefits of otherwise of a therapy ultimately reflect the values, beliefs and hopes/goals of the patient, any decision to withhold resuscitation on clinical grounds alone must be carefully considered, properly justified and documented.”120 116 National Consensus Statement, n 2 at 34. 117 MBA Code, n 71 at 7. 118 NSW End-of-Life Guidelines, n 73 at 2. 119 NSW End-of-Life Guidelines, n 73 at 9. 120 NSW Resuscitation Plan Policy, n 75 at 4. 144 Tasmanian Goals of Greater risk of “… limitation of treatment should be considered [when]: … Care Plan complications than medical treatment aimed at life prolongation will neither benefits significantly prolong life expectancy, nor improve the quality of life … therapy carries a greater risk of Treatment will not complications than possible benefits … [or when the significantly prolong patient or substitute decision maker or Advance Care life or improve quality Directive] states that they do not wish to have certain, or all of life life prolonging treatment.”121 Victorian Guide to Clinically indicated “…up to the health practitioner to determine whether the MTPD treatment is clinically indicated…”122 Category 3 – Professional organisations AMA Code No medical benefit “Where a patient’s death is deemed to be imminent and where curative or life-prolonging treatment appears to be of no medical benefit, try to ensure that death occurs with comfort and dignity.”123 AMA Stewardship Not medically “…it is important for the doctor to elicit the patient’s Statement beneficial or clinically values and goals of care (this is particularly relevant to end appropriate of life care) … It is also important for doctors to ensure patients’ expectations of care are realistic and that they understand the appropriateness (or not) of recommending certain tests, treatments and procedures. Doctors are not required to offer treatment options they consider neither medically beneficial nor clinically appropriate.”124 ACCRM Statement Aggressive treatments “Doctors are legally and ethically bound to make decisions that the person might based on the best interests of the patient. This can mean not have wanted aggressive treatments that the person might not have wanted. Sadly, it is now possible for people to be kept alive under circumstances that may cause unnecessary suffering and may be contrary to their wishes.”125 ACEM Policy No medical benefit Uses definition from the National Consensus Statement, see Category 1, above. RACP Statement Benefits versus harms “Withholding or withdrawing treatments … not benefiting the patient: physicians have a duty to consider the benefits Inappropriate treatment and harms of any treatments … before instituting them. The benefits and harms of ongoing treatment should also be Potentially harmful regularly reviewed. They should not be provided if they are treatment not offering benefit to the patient.”126 “Knowing when to withhold or limit treatment that is inappropriate or potentially harmful to the patient is a key component of good end-of-life care.”127 121 Tasmanian Goals of Care Plan, n 80, Guidance Notes. 122 Victorian Guide to the MTPD, n 81 at 9. 123 AMA Code, n 84, s 2.1.14. 124 AMA Stewardship Statement, n 85, s 2.2.2-2.2.3. 125 ACCRM Statement, n 89 at 2. 126 RACP Statement, n 91 at 6. 127 RACP Statement, n 91 at 15. 145 CICM Statement Benefits versus “The benefits of intensive care treatment include the burdens prolongation of life and the minimisation of disability. The potential benefits of treatment must be weighed against the Ineffective therapy burden, which might include pain, suffering, and compromise of dignity. In most situations, assessment of the potential benefits and burdens of treatment is based on probability rather than certainty … There is no obligation to initiate therapy known to be ineffective, nor to continue therapy that has become ineffective.”128 ANZICS Statement Burdens versus “There is no ethical or legal obligation to provide benefits treatments where considered medical opinion is that the burdens to the patient outweigh any potential benefits.”129 Not being beneficial, not in best interests “Using language that describes the treatment as ‘not being beneficial’, ‘over-burdensome’ or ‘not in the person’s best interests’ [instead of ‘futile’] enables clinicians to provide a clear message that the decision is about the effectiveness of the treatment, not the person’s worth…”130 Some documents simply substitute the term “futile” with “non-beneficial”. For example, in the most recent AMA Code the word “futile” , which appeared in the previous edition,131 was replaced with “of no medical benefit”. While eliminating the word “futile” avoids the risk that patients or substitute decision makers could perceive this term pejoratively, this technique is still potentially problematic since “benefit” is also highly normative. Statements that include the term benefit without defining it suffer the same problem as futility; these policies should state how benefit is defined, and clarify either that they are referring to physiological futility or that that this is a value- dependent judgment which requires engagement with substitute decision makers and patients. Three policies go further than simply replacing futility with another term and explicitly reject the term “futile”. The National Consensus Statement and the ACEM Policy use “nonbeneficial treatment”, and state “futile treatment … is not a preferred term”.132 However, neither document explains why this is not a preferred term. A better approach is in the ANZICS Statement, which provides clear reasons for rejecting the term “futile” including that 128 CICM Statement, n 90 at 1. 129 ANZICS Statement, n 87 at 10. 130 ANZICS Statement, n 87 at 44. 131 See Australian Medical Association, Code of Ethics (AMA, 2006), https://ama.com.au/tas/ama-code-ethics- 2004-editorially-revised-2006, s 1.4. 132 National Consensus Statement, n 2 at 34; ACEM Policy, n 88 at 2. 146 it is ambiguous, highly subjective and hard to refute by the person or family, and has negative connotations about the person’s worth.133 Notably, none of the statements using other terminology make the distinction drawn in the Multi-Society Statement between treatments that are physiologically futile (ie will have no effect) from those that are potentially inappropriate. C Guidance about the decision-making process and dispute resolution The second substantive aspect we reviewed was the extent of guidance the policies provided about the decision-making process. There were two main findings. First, a number of policies make broad statements that could be interpreted as authorising unilateral decisions. Second, while many policies provide some procedural strategies to facilitate shared decision making, very few endorse a set procedure including mechanisms for appeal in the event of a dispute. Overall, policies primarily focused on dispute prevention and there was insufficient policy guidance about dispute resolution. 1 Extent to which policies authorise unilateral decisions A theme in many policies was that doctors are not obliged to provide futile or nonbeneficial treatment, with 10/23 of the policies containing such a phrase. Such statements broadly reflect the legal position in most Australian jurisdictions (except Queensland, where consent is required to withhold or withdraw life-sustaining treatment from adults who lack capacity, even if that treatment is considered futile or against good medical practice).134 However, as we noted in the introduction, policies can serve a variety of regulatory functions. While one such function is to promote compliance with legal standards, another is to step beyond the necessarily bare requirements of the law to promote a richer standard of high quality and safe care.135 There is a gap between the basic legal proposition that doctors in most Australian jurisdictions are not required to provide treatment that they deem futile and how to achieve appropriate shared decision making. A problem with making these assertions in isolation is that these policy statements can obscure the evaluative nature of decisions to forgo treatment. 133 The ANZICS Statement, n 87 at 128 defines futility as: “…the inability of a treatment to achieve the goals of care. As a concept, futility is subjective and probably not particularly helpful in discussions with families and patients”. 134 See generally Willmott, White and Then, n 111 at pp 606-607. While a legal audit is beyond the scope of this article, note that very few of the policies address the Queensland legal exception. 135 Parker and Braithwaite, n 15 at 123. 147 Rubin argues that this creates a “risk of an extraordinary abuse of power as well-meaning health care professionals … make what are ultimately value decisions for their patients. … not out of a lack of respect or caring for patients, but because the underlying value assumptions … are not seen as such or called into question.”136 A few of the policies provide statements that could be interpreted in isolation as supporting unilateral decision making, without adequate regard to the views of patients and substitute decision makers. For example, the MBA Code states that doctors have a “duty to know when not to initiate and when to cease attempts at prolonging life” and that they must take “reasonable steps to ensure that support is provided to patients and their families, even when it is not possible to deliver the outcome they desire.” These statements are framed from the doctor’s perspective and do not encourage an exploration of the underlying value assumptions in such decisions. However, this lack of detailed guidance could be a function of the scope of the MBA Code itself which is intended to be a high-level statement of obligations for the profession as a whole. The typically longer policy documents at the State/Territory level provide more guidance, but there is a risk that doctors receive conflicting advice if statements about unilateral decision making are not qualified in context. For example, the Queensland Health Guidelines appear inconsistent. The document says at several points statements such as “remember that doctors are under no legal or ethical obligation to offer or attempt treatments that are considered futile…”137 However, it later steps back from this general position and states, Ultimately, judgements on whether … treatment is potentially futile are … at least partially subjective. Recent procedural approaches … accept that it is not possible to be objective … and therefore [fair] processes … [incorporating an] individual patient’s best interests … should prevail.138 136 Rubin SB, “If we think it's futile, can't we just say no?” (2007) 19(1) HEC Forum 45. Also see Downie J and McEwen K, “The Manitoba College of Physicians and Surgeons Position Statement on Withholding and Withdrawal of Life-Sustaining Treatment (2008): Three Problems and a Solution” (2009) 17 Health Law J 115. 137 This statement also appears to conflict with the law in Queensland that stipulates, except in acute emergencies, doctors need consent to withhold or withdraw life-sustaining treatment from patients who lack capacity: Guardianship and Administration Act 2000 (Qld), s 66. This is because “health care” is defined in Sch 2, s 5 as including “withholding or withdrawal of a life-sustaining measure… if the commencement or continuation of the measure… would be inconsistent with good medical practice”. 138 Queensland Health Guidelines, n 76 at 42. 148 The frequent repetition of the edict that doctors do not have to provide futile treatment (which could be construed as authorising unilateral decisions) is at odds with the later paragraph about the lack of objectivity involved in decisions about life-sustaining treatment. A better approach is to include a caveat with the statements that while doctors are under no legal or ethical obligation to offer or attempt futile treatment, it is still good medical practice to engage in shared decision making. The New South Wales Health policies use this strategy and refrain from making isolated statements about unilateral decisions. For example, the NSW Resuscitation Plan Policy states that agreement is not required to withhold interventions of “negligible benefit” but states it is still good clinical practice to discuss why they are not being offered. 2 Guidance about the decision-making process and dispute resolution Twenty-one policies address some aspect of the decision-making process for withholding and withdrawing life-sustaining treatment.139 Most described building consensus, rather than setting out a step-by-step process for resolving disputes with mechanisms for appeal and review (features of a formalised procedural approach to decisions mentioned in Section II). While policies provided high-level suggestions about dispute options, these statements were typically broad and there was very little specific guidance in many policies about dispute resolution mechanisms. (a) A consensus-based process Many of the policies that addressed the decision-making process adopt a consensus-based approach, including setting goals of care. Several emphasise this should start with consensus in the treating team, followed by involvement of the patient or substituted decision maker(s). For example, the NSW End-of-Life Guidelines note achieving consensus in the treating team can reduce subjectivity or bias and this avoids placing additional stress on the family who may feel they carry the decision-making burden. Similarly, the ANZICS Statement contemplates that the medical team must determine which “options are clinically indicated” and recommend a plan that is consistent with the “known wishes of the patient”.140 Another 139 The only policies that did not provide guidance about the decision-making process were the AMA Code and the MBA Code. 140 ANZICS Statement, n 86 at 63. 149 consensus-based approach is the “Goals of Care” framework adopted in Tasmania, Western Australia and parts of Victoria (which replaces “not-for-resuscitation orders”).141 A few policies also mention using screening tools to assist decision making, including Criteria for Screening and Triaging to Appropriate aLternative care (CriSTAL) and the Supportive and Palliative Care Indicators Tool (SPICT) to identify patients at risk of dying.142 Several also mention the importance of taking cultural considerations into account, or developing local policies to promote this.143 (b) Guidance about dispute resolution Although the policies discuss consensus-based approaches, many do not address what to do when consensus is not forthcoming. At what point should clinicians escalate a dispute to informal or formal dispute resolution processes or is there a point when treatment can simply be unilaterally withheld or withdrawn? While many of the policies provide preventative strategies for dispute avoidance, very few contain comprehensive guidance for dispute resolution. In addition to the importance of clinical consensus, the main recommendations for dispute avoidance included appropriate communication strategies and advance care planning. The emphasis on these strategies is important, since communication breakdown is a catalyst for disputes.144 However, dispute resolution should not be ignored because conflicts within families, between health professionals, and between decision makers and health professionals do occur and contribute to poor patient outcomes.145 Policies varied widely in the extent to which they addressed dispute resolution. Some of the policies did not mention the possibility for conflict.146 Others acknowledged that conflict about life-sustaining treatment can arise, although many statements addressed this in a very 141 Thomas et al, n 94; Tasmanian Goals of Care Plan, n 80; WA End-of-Life Framework, n 82. 142 ACEM Policy, n 88 at 3; RACP Statement, n 91 at 39-41; Queensland Health Guidelines, n 76. 143 See eg, CICM Statement, n 90, s 14; ACCRM Statement, n 89 at 2; ACEM Statement, n 88 at 3, 6; RACP Statement, n 91 at 9; RACS Position Paper, n 92 at 2; ANZICS Statement, n 87 at 19, 23, 32-33. 144 Breen CM et al, “Conflict Associated with Decisions to Limit Life-Sustaining Treatment in Intensive Care Units” (2001) 16(5) J Gen Intern Med 283; Fassier T and Azoulay E, “Conflicts and Communication Gaps in the Intensive Care Unit” (2010) 16(6) Curr Opin Crit Care 654. 145 See, eg, Downar et al, n 46. 146 AMA Code, n 71; AMA Stewardship Statement, n 85; MBA Code, n 71; RACS Position Paper, n 92; Tasmanian Goals of Care Plan, n 80. 150 general way.147 For example, the ACCRM Statement only alludes to the possibility for disputes, stating “…there are clear … challenges to communicating effectively … and a risk that discussions will exacerbate distress and misunderstanding.”148 The ACEM Statement is more explicit and instructs emergency department staff to inform themselves about “[c]onflict resolution, and knowledge of the relevant mediation services.” The National Consensus Statement is also high-level but provides a few more avenues for dispute resolution, including legal processes. It instructs doctors to seek advice or support when “a clinician feels pressured – by the patient, family, carer or another health professional – to provide [nonbeneficial] interventions”149 and suggests that when “managing conflict, complex family dynamics or ethical dilemmas, responders may require access to a person who is skilled in mediation, the rights of the person, bioethics and/or the law.”150 These broad statements could be a consequence of the authorship and scope of the policies themselves, as many of these are short position statements, or in the case of the National Consensus Statement, principles for best practice. This might indicate that specific conflict resolution guidance is left to the institutional level.151 Nevertheless, this is a gap in the guidance provided to doctors which is addressed more comprehensively in some of the other policies. Notably, in many of the policies the dispute resolution options provided are hospital- centric, with few listing the options of second opinion external to the hospital, transfer or legal avenues. In contrast to the above examples, a few other policies do provide more guidance about dispute resolution. The purpose of the CRELS Report was to address a lack of detailed guidance about consensus building and dispute resolution in the NSW End-of-Life Guidelines, and accordingly the conflict resolution guidance in this document was the most comprehensive. The CRELS Report includes a detailed flow chart for how to approach conflict with mechanisms for review and appeal.152 The model is a consensus-building process, but recommends early escalation to the Guardianship Tribunal depending on the 147 ACCRM Statement, n 89; WA End-of-Life Framework, n 82. 148 ACCRM Statement, n 89 at 2. 149 National Consensus Statement, n 2 at 15. 150 National Consensus Statement, n 2 at 19. 151 The National Consensus Statement, n 2 at 22, advocates that as part of organisational governance “a formal policy framework should exist… [that includes] clear dispute resolution processes, including access to mediation, bioethics and legal support in situations of complex end-of-life decision‑making or conflict.” This is contemplated at the institutional level. 152 CRELS Report, n 74 at 8. 151 dynamics of the conflict. It also provides for referral for an expert second opinion and consultation with a clinical ethics committee as a step prior to accessing legal avenues. The ANZICS Statement, the Queensland Health Guidelines and the South Australia Health policies (Table 1) also provide more detailed dispute resolution guidance. The ANZICS Statement has a chapter dedicated to managing conflict, including clear steps that clinicians should take prior to initiating a court action.153 These include: taking time and ongoing discussion; “external” second opinion (“from a health professional with relevant expertise in the patient’s condition who is demonstrably independent from the medical team”), or referral to a clinical ethics committee; facilitation (a senior member of the hospital administration, a senior clinician or another person); patient transfer; tribunal application; and court action. Importantly, the ANZICS Statement instructs doctors to facilitate access to legal processes, stating, family members and substitute decision makers should be specifically informed of this option and be offered assistance for court costs if the institution brings legal proceedings. Aside from the ANZICS Statement, the CRELS Report, the Queensland Health Guidelines and the SA Health policies, very few policies provided guidance about tribunals or courts as dispute resolution options. For example, the NHMRC Guidelines have a short section on “Misunderstanding and Conflict” but do not mention legal avenues for dispute resolution in that section (though earlier in the document mention an application can be made to court if doctors believe that a person’s representative is not acting in their best interests). Doctors’ lack of knowledge of end-of-life law154 suggests that a mention of legal avenues in addition to other means of resolving disputes is important. While the detailed processes vary by jurisdiction, policies could use the ANZICS approach of flagging appropriate tribunals and the courts as options. Likewise, the ANZICS Statement was the only policy to mention doctors or institutions informing patients about legal avenues, an important part of facilitating appropriate access to justice.155 As the CRELS Report notes, “[t]he Courts and tribunals will always be needed to resolve a very small proportion of intractable EOL conflict.” Early engagement with specialist legal advice can be important in the case of building conflict.156 153 ANZICS Statement, n 87, 76-88. Note that this section is endorsed and partly reproduced in the RACP Position Paper, n 91, Appendix H. 154 White B et al, 'The Knowledge and Practice of Doctors in Relation to the Law That Governs Withholding and Withdrawing Life-Sustaining Treatment from Adults Who Lack Capacity' (2016) 24 J Law Med 356. 155 Curnow, n 20. 156 Linney M et al, 'Achieving Consensus Advice for Paediatricians and Other Health Professionals: On Prevention, Recognition and Management of Conflict in Paediatric Practice' (2019) 104(5) Arch Dis Child 413. 152 VII. STRENGTHS AND AREAS FOR FURTHER DEVELOPMENT 1 Strengths of the Australian approach Before addressing the gaps in non-institutional Australian policies on withholding and withdrawing life-sustaining treatment, we identify three positive aspects to the current position. First, in the last five years a number of medical professional organisations have drafted new specific policies about decisions to withhold or withdraw life-sustaining treatment. Although there is still scope for improvement, this is a positive step towards the recommendation in the National Consensus Statement that “policies and processes should be in place regarding… limitations of medical treatment”.157 Second, there is increasing recognition that “futility” or “non-beneficial treatment” is dependent on goals of care and the patient’s values and so is subjective. For example, the ANZICS Statement thoroughly explores the challenges of futility and recommends comprehensive procedures to navigate this complexity. Another example are the amendments made to the AMA End-of-Life Statement due to concern that the default position did not recognise the subjectivity of futility assessments.158 While above we argued that the AMA End-of-Life Statement should go further and include a clearer explanation of how futility can be affected by both doctor and patient values, this is still a step forward. A third positive aspect is that most of the policies mentioned reducing futile treatment and provided strategies to prevent it. Fostering appropriate decision making that takes into account both considered medical judgments and the patient’s wishes should be the ultimate goal of policies that address withholding or withdrawing life-sustaining treatment. A key part of this is addressing the many doctor-related reasons for providing futile treatment, including poor communication, seeing death as a failure and the “treatment imperative”.159 The focus on strategies to prevent futile treatment is commendable. There is, however, opportunity now for many of these policies to provide more widespread and concrete guidance about how to address disputes when they occur. 157 National Consensus Statement, n 2 at 23. 158 Australian Medical Association, “Of Death and Dying ̶ The Discussion We Must Have (16 September 2014) https://ama.com.au/ausmed/death-and-dying-%E2%80%93-discussion-we-must-have. 159 Willmott L et al, “Reasons Doctors Provide Futile Treatment at the End of Life: A Qualitative Study” (2016) 42(8) J Med Ethics 496. 153 2 Gaps and areas for further development Despite these strengths, this review identified a number of gaps and scope for improvements in the current policy regime. Each of the challenges could be addressed by a multi-society consensus approach that provides uniform, concrete procedural guidance for doctors making these decisions. This would better promote consistent, transparent decision making that balances the interests of doctors, patients, substitute decision makers and society. The first observation is that Australian medical futility policies are highly fragmented. They come from a variety of sources, with different aims and content. Doctors in Australia are provided with differing guidance depending on the specialty and the jurisdiction that they work in. The inconsistency across jurisdictions and specialties could cause confusion for doctors who are a mobile workforce. A consensus statement, akin to the Multi-Society Statement,160 could provide a consistent national approach. A second area for improvement is in terminology, which currently is inconsistent. Changes in terminology and conceptualisations of futility unsurprisingly have tracked developments in the bioethical and clinical literature, although generally have lagged behind given the timing cycles of policy development. The drift away from futility has occurred in an ad hoc and unsystematic way, however, partly due to the multiple sources of policy. The variation in definitions and terminology is problematic because it could perpetuate confusion about the meaning and scope of futility among clinicians, policymakers, and institutions.161 It may also potentially diminish the policies’ normative force.162 A doctor who is subject to a number of different policies with varying interpretations of futility can be confronted with a case where treatment is both futile and not futile depending on which approach is preferred. When forced to choose in this way, a doctor might also be tempted to ignore the advice, and simply rely on “clinical intuition” to drive judgment. This is troubling in the context of empirical research that suggests that values and goals of care are not sufficiently discussed in discussions with critically ill patients or their substitute decision makers.163 160 Bosslet et al, n 22. 161 See, eg, Bosslet et al, n 22. 162 Goodridge, n 21. 163 Scheunemann et al, n 3; White et al, n 3. See also Bloomer MJ, Hutchinson AM and Botti M, “End-of-life care in hospital: an audit of care against Australian national guidelines” (2019) 43(5) Aus Health Rev 578. 154 A unified approach to futility is one way to address the terminological variation, but such an approach must be carefully crafted. Many (but not all) policies have replaced “futile treatment” with other expressions, including “non-beneficial treatment”, with some explicitly doing so because of the problems with futility as a concept. However, this does not fully address the criticisms articulated in Section II. “Non-beneficial”, like “futility”, is problematic because what constitutes a “benefit” depends on the treatment goal and could be influenced by the doctor’s own values. Instead of simply shifting to “non-beneficial treatment” Australian policies should limit the use of the word “futile” to physiological futility and draw a clear terminological and procedural distinction, between this and treatment that is value-laden (perhaps labelling value-laden decisions as “potentially inappropriate treatment”164 or “disputed treatment” 165). A third area for improvement is in the extent of guidance about the decision-making process and informal and formal mechanisms for dispute resolution. This study found very few Australian medical policies that address decisions to withhold or withdraw life-sustaining treatment provide procedural solutions which involve set mechanisms for external review and appeal. These might exist at the institutional level, where ethics committees are situated, however there is scope for procedural best practice approaches to be modelled in non- institutional policy documents as well. A drawback of institutional-level futility policies is that they lack public transparency and higher-level policies have the potential to establish best practices with information that is relevant to specific jurisdictions and medical specialties. A procedural approach would avoid reducing complex medical practice into simple statements such as “doctors do not have to provide futile treatment” and would provide clearer regulatory guidance. Policies currently place significant emphasis on strategies to prevent futile treatment, including fostering communication skills and promoting advance care planning, but many lacked sufficient guidance about dispute resolution. Prevention strategies are critical, but only address one aspect of these challenging decisions. The dispute resolution guidance in some statements consisted primarily of very short statements about seeking mediation, or being familiar with institutional dispute resolution policies. In our view, policies on withholding 164 Bosslet et al, n 22. 165 White, Willmott, and Close, n 45. 155 and withdrawing life-sustaining treatment should provide both proactive and reactive dispute resolution guidance, even if the scope of the policy is relatively brief. The goal of both types of strategy should be to provide supportive mechanisms for both families and clinicians in stressful situations. Guidance should clearly indicate available legal avenues as options beyond seeking a second opinion, mediation or clinical ethics committee. Although legal mechanisms should be seen as a last resort, courts and tribunals will always be needed to resolve the small proportion of intractable disputes. This serves an important public precedent-setting function.166 Legal mechanisms are also important because when consensus is not forthcoming, harm to the patient can result. Indeed, doctors cite fear of legal repercussions as one reason they provide treatment that they believe is futile or non- beneficial.167 Finally, to help level the power differential between doctors and patients or their substitute decision makers, guidance should also advise doctors to inform patients and families of their ability to pursue legal avenues in the event of intractable disputes. Again, drafting a consensus statement that resembles the Multi-Society Statement could be one way to implement these recommendations in practice. VIII. CONCLUSION Decisions to withhold or withdraw life-sustaining treatment are a regular part of end-of-life practice in hospital settings and can be fraught with legal, clinical and ethical complexity. One tension is when patients, or more commonly, their substitute decision makers, want treatment that doctors believe is “futile” or not in the patient’s best interests. There is consensus in the bioethical literature that decisions about life-sustaining treatment are highly normative and influenced by a patient’s values and differing conceptions of medical best practice. Medical policies have the potential to provide consistent terminology and clear procedures to facilitate more ethical and transparent decision making in this area.168 Unfortunately, this study found that in Australia the policy environment is fragmented, both in the source and nature of guidance provided. While there are other regulatory mechanisms that may fill these gaps – for example, hospital-based policies (which this review did not address) or unwritten best practices – these other mechanisms lack public transparency.169 166 Close, White and Willmott, n 7. 167 Willmott et al, n 159; Sibbald et al, n 33; Downar et al, n 46. 168 Pope, n 56. 169 A recent review of end-of-life care in Australian hospitals identified a lack of systems and processes to implement the National Consensus Statement at the hospital level, see Bloomer, Hutchinson and Botti, n 163. 156 This article examined the state of the Australian medical futility policy environment and identified a number of opportunities for improvement. Although some authors have resisted the creation of a unified policy,170 we believe this option should be explored in the Australia context for several reasons. A unified policy would address the fragmentation and differences across Australian jurisdictions and practice areas. Although most disputes occur in the intensive care unit, it could be drafted to address practice across hospital departments or even in wider health care settings. It would also bring Australia in line with developments internationally.171 If such a statement is drafted it should possess several attributes. First, it should be drafted by a multi-disciplinary working committee involving representatives from medicine, nursing, allied health, law, bioethics, health policy, health consumers, and the broader community. This process could be initiated by government or by a group of professional organisations. The focus of such an exercise should be on both the process for decision making, terminology and on improved avenues for external appeal. It could also be used to develop explicit standards of practice for given clinical situations. Second, any consensus statement should integrate the principles from the National Consensus Statement and leverage the expertise in the ANZICS Statement and the CRELS Report. Both have provided considered, careful approaches to the problem of futility, including avenues for dispute resolution, although there remains scope to promote a refined approach to terminology. Third, the focus of the statement should be on clarifying terminology and setting out a clear process for dispute resolution. One approach would be to do as the Multi-Society Statement does and limit the term “futile” to treatment that is physiologically futile. The policy should clearly set out corresponding procedural steps to respond to requests for physiologically futile treatment and treatment that is potentially inappropriate or disputed, including escalation to internal and external tribunals and courts when necessary. Decisions about life-sustaining treatment are relatively widespread and conflicts are not uncommon, especially in the ICU. Medical policies and guidelines are just one part of appropriately regulating these disputes to achieve better outcomes for patients, families and health professionals. Establishing improved terminology and pathways for decision making is 170 CRELS Report, n 74 at 36. 171 Bosslet et al, n 22. 157 an important starting point to help medical professionals meet their legal and ethical obligations and facilitate more procedurally fair decisions which recognise patient values. 158 Chapter 8: Balancing Patient and Societal Interests Policy Analysis ‘Balancing Patient and Societal Interests in Decisions about Life-Sustaining Treatment: An Australian Policy Analysis’ Eliana Close, Ben P White, Lindy Willmott Submitted to the Journal of Bioethical Inquiry https://www.springer.com/journal/11673 159 Balancing Patient and Societal Interests in Decisions about Potentially Life-Sustaining Treatment: An Australian Policy Analysis Abstract Background: This paper investigates the content of Australian policies that address withholding or withdrawing life-sustaining treatment to analyse the guidance they provide to doctors about the allocation of resources. Methods: All publicly available non-institutional policies on withholding and withdrawing life-sustaining treatment were identified, including codes of conduct, and government and professional organisation guidelines. The policies that referred to resource allocation were isolated and analysed using qualitative thematic analysis. Eight Australian policies addressed both withholding and withdrawing life-sustaining treatment and resource allocation. Results: Four resource-related themes were identified: 1) doctors’ ethical duties to consider resource allocation; 2) balancing ethical obligations to patient and society; 3) fair process and transparent resource allocation; and 4) legal guidance on distributive justice as a rationale to limit life-sustaining treatment. Conclusion: Of the policies that addressed resource allocation, this review found broad agreement about the existence of doctors’ duties to consider the stewardship of scarce resources in decision making. There was disparity in the guidance about how to reconcile competing duties to patient and society. There is a need to better address the difficult and confronting issue of the role of resources in decisions about life-sustaining treatment. Keywords Medical futility; End-of-life care; Clinical decision-making; Healthcare rationing; Resource allocation 160 Introduction In response to recent high-profile disputes, clinicians and ethicists have argued that limited medical resources are relevant to decisions to withhold or withdraw life-sustaining treatment (Truog 2017; Wilkinson and Savulescu 2019), a view shared by some members of the public (Brick et al. 2019). Although most doctor-initiated decisions to limit life-sustaining treatment are based on the rationale that ongoing active treatment is “futile” or “non-beneficial” (and therefore not in the patient’s best interests), distributive justice affords a distinct ethical justification for non-treatment, particularly in publicly-funded healthcare systems (Truog 2017; Wilkinson and Savulescu 2019). Interventions that provide little or no benefit consume scarce healthcare resources, which could be used more efficiently by others (Huynh et al. 2014; Carter et al. 2017). Even so, how to incorporate resource considerations into current decision-making paradigms is debated, and the degree of doctors’ involvement in allocation decisions is controversial (Truog et al. 2006; Scheunemann and White 2011). Some argue doctors are exclusively patient advocates and it is unethical to limit treatment that may provide a benefit (Levinsky 1984; Angell 1993). Medical policies are a regulatory mechanism to set out doctors’ duties to consider resources in their decisions but little is known about the content of policies that address withholding or withdrawing life-sustaining treatment in Australia. This article therefore sets out to investigate the question: what professional guidance is given to doctors about the role of scarce resources when making decisions about withholding and withdrawing life-sustaining treatment? Despite increasing discourse about the importance of resource management, reliance on resource allocation as a basis for non-treatment can be difficult in practice. The prospect that resource allocation is relevant to end-of-life decision making remains taboo, raising the spectre of “death panels” and unjustified age and disability discrimination (Truog et al. 2006; Scheunemann and White 2011; Cohen 2012). This taboo may partly explain why interests- based and resource-based rationales for limiting life-sustaining treatment are not sufficiently distinguished in practice (Rubin and Truog 2017). Indeed, some doctors perceive that the concept of futility masks both conscious and unconscious rationing (Close et al. 2019), the “withholding … of a medically beneficial service because of that service's cost to someone other than the patient” (Ubel and Goold 1997).1 Health resources are limited, therefore 1 While a detailed conceptual discussion is beyond the scope of this article, we note that definitions of rationing, like definitions of futility, are contested (Walker and Edege 2016). 161 rationing is necessary and justifiable, provided it is accomplished transparently using fair processes (Daniels 2000; Scheunemann and White 2011). However, evidence that doctors ration at the bedside (Hurst et al. 2006; Ward et al. 2008), sometimes under the guise of futility (Close et al. 2019), suggests the requisite transparency is lacking. This negatively impacts the profession as well as patients and families, and some doctors report feeling conflicted by the “gatekeeper” to treatment role that can be thrust upon them, absent explicit resource allocation policies to support decisions (Close et al. 2019). A second source of difficulty is that the legal basis for using resourcing as a justification for withholding or withdrawing life-sustaining treatment is largely untested. Since legal disputes over life-sustaining treatment are typically brought under the court’s parens patriae jurisdiction, which is focused on an individual patient’s best interests, resource issues are usually not argued by the parties nor do they form part of the court’s deliberations. In several cases, Australian courts have commented that resources are not relevant to best interests (Willmott et al. 2014).2 Nevertheless, the courts traditionally support rationing decisions, provided they are made transparently and founded on fair administrative policies or processes (Close, Willmott, and White 2018).3 The challenge in this area is that often these explicit policies do not exist. A third source of difficulty is what constitutes “patient best interests” or “rationing” can be matters of perspective. Conflicts over life-sustaining treatment typically arise when the degree of benefit to the patient is marginal or uncertain; doctors have a clinical rationale for saying the treatment is unwarranted. From the viewpoint of the person seeking treatment, who perceives some benefit or chance of a benefit, denying such treatment could not be justified on a “best interests” basis so could be regarded as rationing. However, from the 2 For example, in Northridge v Central Sydney Area Health Service [2000] NSWLR 1241, O’Keefe J stated at [22] “The exercise of the parens patriae jurisdiction should not be for the benefit of others (Re Eve (1987) 31 DLR (4th) 1 at 34), including a health care system that is intent on saving on costs.” Similarly, in Messiha v South East Health [2004] NSWSC 1061 at [9] Howie J noted that a reference made by the treating doctor about the availability of the intensive care unit resources was “… arguably … an irrelevant matter, at least so far as the welfare of the patient was concerned … and might have been taken as a form of pressure on the family to agree with the hospital’s decision.” 3 Rationing policies could include guidelines about organ transplantation or dialysis. However courts can still be reluctant to engage with whether a decision can be challenged on the basis of scarce resources. See Manning and Paterson (2005) criticism of Shortland v Northland Health Ltd, a New Zealand case in which a patient was denied access to dialysis. The High Court (unreported, 6 November 1997, Salmon J) indicated that resources were only a minor factor and the Court of Appeal ([1998] 1 NZLR 433, 443) denied there was any resource element to the decision. 162 doctor’s viewpoint, denying the treatment amounts to a decision to forgo “inappropriate” or “futile” treatment on “clinical grounds”, rather than one based on rationing. Therefore, parallel resource considerations could be construed as responsible stewardship. When a genuine clinical rationale exists to recommend treatment withdrawal, doctors are reluctant to also invoke parallel resource-based rationales, as these could be perceived as a form of pressure on families to “free up the bed”. In the absence of a clear decision-making paradigm or policies that support taking resource factors into account, the typical path is either to “cave-in” to surrogates and accede to a request for treatment that the doctor believes is inappropriate (Pope 2016), or continue to negotiate treatment withdrawal, under the guise that this is solely a clinical decision and the patient’s interests are the only ones at stake. Commentators have urged that resource-based rationales for non-treatment should be clearly distinguished and disclosed to promote more transparent decision-making processes and enhance trust in the medical system (Truog et al. 2006; Young et al. 2012). Medical policies can help doctors distinguish between distributive justice and patient interests, and promote fair and transparent processes to guide decision making (Rubin and Truog 2017; Bosslet et al. 2015). Policies are an important regulatory mechanism because they have both legal and ethical weight; depending on their provenance they can be persuasive or even determinative in court (McDonald 2017). However, to our knowledge very little literature (Martin 2013; Levinson et al. 2014) has examined Australian policies on withholding and withdrawing life- sustaining treatment for adult patients. Therefore, the purpose of this paper is to analyse publicly-available Australian policies on withholding and withdrawing life-sustaining treatment to determine the extent of guidance they provide about distributive justice. We set out to investigate the extent to which publicly-available policies address scarce resources as a factor in decision making, distinct from a patient’s interests, what they say about the doctor’s role in making resource-based decisions, and whether they promote a transparent and fair approach when allocating resources at the bedside. Methods This research builds on a broader study we conducted on Australian policies targeted at doctors’ decisions to withhold or withdraw life-sustaining treatment from adult patients at the end of life (Close et al., submitted). The earlier study identified all non-institutional policies on withholding and withdrawing treatment from adults in Australia, and examined how they 163 defined futility (or a similar criterion for limiting life-sustaining treatment) and the extent of guidance provided about resolving disputes over potentially life-sustaining treatment. The data collection strategy for the broader review is briefly described below, followed by the methodology for this paper, which uses a subset of policies from the broader review. Inclusion and Exclusion Criteria for the Broader Review To locate current publicly-available policies in all Australian jurisdictions, we defined “policy” broadly, as a written statement of principle intended to guide doctors’ decisions about withholding or withdrawing life-sustaining treatment in clinical practice. This included documents such as position statements, codes of conduct and professional guidance. To focus only on policies that provide ethical guidance about doctors’ decisions to stop or not start life-sustaining treatment we excluded documents focused primarily on other aspects of end- of-life care, including advance care directives and palliative care. We also excluded purely clinical guidelines focused on specific therapies.4 Twenty-three policies met inclusion criteria for the broader analysis. These were issued by the Commonwealth government, State and Territory governments, and professional organisations such as medical colleges and societies. Method for this Study As mentioned above, the broader review analysed the policies’ terminology and guidance about decision making and dispute resolution. For this narrower paper we sought to extract only those policies from the broader review that addressed resource issues. EC read each policy in full and compiled a list of policies that made statements about resource allocation. To ensure this list was comprehensive, EC conducted text queries on the database of policies from the broader review with NVivo qualitative software (QSR International, version 12) using the following list of keywords developed by all authors: “resource”, “resources”, “allocate”, “allocation”, “justice”, “ration”, “rationing”, “steward”, “stewardship”. EC reviewed the results of these keyword searches in context to develop a final list of documents for this analysis. 4 Examples of clinical guidance documents excluded are: Choosing Wisely Australia (e.g., https://www.racgp.org.au/advocacy/position-statements/view-all-position-statements/clinical-and-practice- management/responding-to-patient-requests-for-tests); organ allocation guidelines (e.g., https://www.tsanz.com.au/organallocationguidelines/); and dialysis policies (see, e.g., https://kidney.org.au/advocacy/advocacy-and-policy/resources-publications/publications/clinical-guidelines). 164 Data Analysis EC conducted a thematic analysis using NVivo to code the relevant policies into primary themes (Braun and Clarke 2006). EC also created an Excel matrix to assist with analysing the data and developing the themes (Miles, Huberman, and Saldaña 2014). BW independently reviewed the policies and extracts that mentioned resource issues and a final list of themes was generated through iterative discussion between all authors. Results Eight out of twenty-three policies from the broader review met inclusion criteria, containing guidance about both withholding and withdrawing life-sustaining treatment and resource allocation. The policies vary markedly in length (ranging from three to 176 pages) and scope (Table 1). Five out of eight policies focus specifically on end-of-life decision making, while the remaining three policies are overarching professional codes of conduct. Of the five policies that focus on end-of-life care, the Australian Medical Association’s Position Statement on End of Life Care and Advance Care Planning (“AMA End-of-Life Statement”) provides the least guidance about resource allocation, only very briefly mentioning that “limited health care resources should be used responsibly, fairly, and effectively to ensure all patients receive appropriate end of life care” (Australian Medical Association 2014, sec. 4.2). The College of Intensive Care Medicine Statement (“CICM Statement”) (authored jointly in 2003 with the Australian and New Zealand Intensive Care Society (ANZICS) and reissued in 2013), a short statement of fourteen principles for withholding and withdrawing life- sustaining treatment, is also limited to high-level guidance. The ANZICS Statement on Care and Decision-Making at the End of Life for the Critically Ill (“ANZICS Statement”), the National Health and Medical Research Council Ethical Guidelines for the Care of People in Post-Coma Unresponsiveness (Vegetative State) or a Minimally Responsive State (“NHMRC Guidelines”), and the Queensland Health End-of-Life Care Guidelines (“Queensland Health Guidelines”) are more comprehensive, including whole sections devoted to resource considerations. 165 Table 1. Australian medical policies that address resource allocation in the context of withholding and withdrawing life-sustaining treatment Name of policy Brief description Length of Includes Includes section(s) on statements concrete resources of principle guidance about about resources resources Australian Medical Seven-page Code of Ethics One section ✔ - Association Code of Ethics, intended to promote values for with three 2004, Editorially revised in the profession as a whole, subsections 2006, Revised in 2016 from the peak membership (eight lines in (“AMA Code”) body for Australian doctors total) Australian Medical Three-page position statement Entire ✔ - Association Position aimed at promoting statement Statement, The Doctor’s appropriate stewardship of Role in Stewardship of resources by doctors in Health Care Resources, 2016 individual clinical decisions (“AMA Stewardship across all areas of practice Statement”) Australian Medical Ten-page position statement Two ✔ - Association Position on a range of end-of-life subsections Statement, End of Life Care issues, except for euthanasia (five lines in and Advance Care Planning, and physician-assisted suicide total) 2014 (“AMA End-of-Life Statement”) Australian and New Zealand 148-page comprehensive Two sections ✔ ✔ Intensive Care Society guidelines on withholding and (~three (ANZICS) ANZICS withdrawing life-sustaining pages); also Statement on Care and treatment from the peak mentions Decision-Making at the End professional society distributive of Life for the Critically Ill, representing intensive care justice and 2014 (“ANZICS Statement”) doctors in Australia and New resources in Zealand other sections College of Intensive Care Three-page joint statement Two sections ✔ - Medicine and ANZICS from the College of Intensive (seven lines in Statement on Withholding Care Medicine (the body total) and Withdrawing Treatment, responsible for intensive care Issued in 2003, republished medicine specialist training by CICM in 2013 (IC-14) and education in Australia and (“CICM Statement”) New Zealand) and ANZICS, containing fourteen principles for withholding and withdrawing life-sustaining treatment Medical Board of Australia Twenty-five page document One section ✔ - Code of Conduct, 2014 setting out the standards of with four (“MBA Code”) professional and ethical subsections conduct for all registered (twelve lines), doctors in Australia, from the and another national body responsible for subsection registering and regulating (two lines) Australian doctors National Health and Medical Sixty-six page clinical-ethical One section; ✔ ✔ Research Council Ethical guidelines from the NHMRC, also mentions 166 Guidelines for the Care of an Australian national distributive People in Post-Coma government agency justice and Unresponsiveness responsible for developing resources in (Vegetative State) or a high-quality clinical other sections Minimally Responsive State, guidelines for use throughout 2008 (“NHMRC Australia Guidelines”) Queensland Health, End-of- 176-page comprehensive Two sections ✔ ✔ life care: Guidelines for clinical guidelines on (~three pages decision-making about withholding and withdrawing total); also withholding and life-sustaining treatment, from mentions withdrawing life-sustaining the Queensland State distributive measures from adult Government Department of justice and patients, 2018 (“Queensland Health resources in Health Guidelines”) other sections Our analysis of the resource-related extracts in the policies resulted in four primary themes: 1) the existence and nature of doctors’ ethical duties to consider resource allocation; 2) guidance about balancing conflicting obligations in practice; 3) comments about fair process and transparency; and 4) legal guidance about using distributive justice as a basis to withhold or withdraw life-sustaining treatment. Theme One: Doctors’ Ethical Duties to Consider Resource Allocation All eight policies include a statement that doctors have ethical duties to consider the wise use of medical resources. Although the policies vary in length and breadth, these high-level statements of principle converged on a few uncontroversial areas. The broad codes of conduct emphasise doctors should practise stewardship, described as reducing waste including non- beneficial treatments or investigations. For example, the MBA Code states, “[p]roviding good patient care includes … [e]nsuring that the services you provide are necessary and likely to benefit the patient” (Medical Board of Australia 2014, sec. 5.2.1). Likewise, the AMA Code (Australian Medical Association 2016a, sec. 4.4.1) and the AMA Stewardship Statement emphasise, “eliminating tests, treatments or procedures that are unnecessary, inappropriate or unwanted by the patient” (Australian Medical Association 2016b, sec. 1.5). Some policies also mention doctors should be aware of opportunity cost and equity. For example, the MBA Code stipulates good medical practice includes understanding that decisions “can affect the access other patients have to healthcare resources” (Medical Board of Australia 2014, sec. 5.2.4). The ANZICS Statement explicitly provides the duty to consider the fair and efficient use of resources is shared between health professionals, patients and families, emphasising that “resources must be used wisely for the benefit of the whole community as well as for 167 individual patients” (Australian and New Zealand Intensive Care Society 2014, 12). This suggests that resource considerations could be part of shared decision making discussions. Theme Two: Balancing Ethical Obligations to Patient and Society In two out of the eight policies (the AMA End-of-Life Statement and the MBA Code), guidance about resource allocation is limited to short high-level statements of principle about the need to consider resource management. In contrast, six out of eight policies go further (to varying degrees) and provide guidance about how to reconcile duties to patient and society. The Patient Comes First Five policies contain a statement that any conflict between distributive justice concerns and patient welfare should be resolved in favour of the patient: the AMA Code; the AMA Stewardship Statement; the MBA Code; the Queensland Health Guidelines; and the ANZICS Statement. For example, the AMA Code notes doctors “have responsibilities to other patients and the wider community” but also instructs doctors to “[p]ractise effective stewardship … [but] remember, however, that your primary duty is to provide the patient(s) with the best available care” (Australian Medical Association 2016a, sec. 1.6, 4.4.1). The ANZICS Statement likewise mentions that “a doctor’s duty is to always act in the patient’s best interests” and later, “pressure on beds … and … resource allocation … are not relevant to the decision as to what represents the patient’s best interests” (Australian and New Zealand Intensive Care Society 2014, 24, 46). Distributive Justice Can Outweigh Other Ethical Considerations In contrast to the preceding position (patient interests always come first), four of the policies indicate, as a matter of principle, that distributive justice can sometimes outweigh other ethical considerations, including a patient’s autonomy. These were: the ANZICS Statement; the CICM Statement; the Queensland Health Guidelines; and the NHMRC Guidelines. Indeed, some policies attempt to endorse both propositions. For example, while the Queensland Health Guidelines emphasise the legal and ethical importance of putting a patient’s interests first, elsewhere the policy also states that the principle of beneficence (defined as “the duty to do the best for the person or to act in their best interests”) can be outweighed by concerns about justice. The Guidelines indicate available resources are a 168 factor in determining what is reasonable to offer a patient and observe doctors, being employed by the public, must exercise … concern for the wellbeing of the total society … [including] the wise use of scarce resources and some recognition of the financial and clinical limits to … medicine. Thus, beneficence may be overridden... (Queensland Health 2018, 105). The two intensive care policies, the CICM Statement and the ANZICS Statement, also advise that decisions based on distributive justice can be justifiable. In comparison to the position that the patient’s interests always outweigh societal interests, the CICM Statement briefly states the ethical principles of … respect for human life and dignity, patient autonomy, justice, beneficence and non- maleficence … are sometimes in conflict. Resolution … depends on the particulars of the situation (including the likely patient outcome), and the philosophical viewpoints of those involved. (College of Intensive Care Medicine of Australia and New Zealand 2003, sec. 2). The CICM Statement does not expand on what is meant by the philosophical viewpoints of those involved, but this could refer to doctors having different assessments to patients or families. It could also suggest that doctors with different values will reach different decisions in some cases, and that this could encompass different viewpoints about the wise use of scarce resources. The ANZICS Statement also indicates in individual cases ethical principles (autonomy, beneficence, non-maleficence, and justice) can conflict and stipulates no single principle always outweighs the others (Australian and New Zealand Intensive Care Society 2014, 12). The Statement emphasises the importance of distributive justice but notes this “is infrequently acknowledged or discussed publicly” (Australian and New Zealand Intensive Care Society 2014, 30). It discusses how distributive justice often conflicts with autonomy and beneficence, asserting Intensivists experience a conflict between their duty to different patients, within and outside the ICU. … limited availability of treatment (for example intensive care beds) sometimes means that treatment that is desired or would be of benefit cannot be provided (Australian and New Zealand Intensive Care Society 2014, 31). 169 While the ANZICS Statement seems to accept that some patients could be denied potentially beneficial treatment because of resource scarcity, the policy explains that this should not result in patients’ deaths. The Statement clarifies, “[t]riage … where the number of casualties exceeds the available resources, is not a feature of intensive care under normal circumstances” and “intensive treatment is not so scarce … as to justify allowing preventable deaths” (Australian and New Zealand Intensive Care Society 2014, 30). Disaster situations aside, the Statement further instructs “[p]rovision for existing patients who need ongoing care is mandatory … [and] rationing of resources is not part of the current debate” (Australian and New Zealand Intensive Care Society 2014, 30). Nevertheless, the ANZICS Statement foreshadows “as the gap between potential and affordable widens, there will need to be increasing community discussion around this topic” (Australian and New Zealand Intensive Care Society 2014, 31). Resource Constraints and Futile or Non-Beneficial Treatment Five policies link resource allocation to treatment that is technically possible but that doctors believe is futile or non-beneficial. This occurs in a few ways. First, all five policies instruct doctors to consider resources in choosing what treatment to offer and advise doctors to manage patient and family expectations about what constitutes “reasonable” life-sustaining treatment. For example, the AMA Stewardship Statement states doctors should: … ensure patients’ expectations of care are realistic and that they understand the appropriateness … certain tests, treatments and procedures. Doctors are not required to offer treatment options they consider neither medically beneficial nor clinically appropriate (Australian Medical Association 2016b, sec. 2.2.3). The AMA Stewardship Statement does not, however, provide guidance about what to do if patients or substitute decision makers disagree with that clinical assessment. The second way futility is linked to resources, related to the first, is guidance about how to respond to patient or family requests for life-prolonging treatment. For example, the ANZICS Statement and the Queensland Health Guidelines indicate such providing treatment in response to such requests has an opportunity cost. The Queensland Health Guidelines state, …challenges could arise if … patients or their families request potentially life- prolonging treatment to be continued for as long as technically possible … [absent a] 170 realistic hope of recovery. Complying … [may] be at the expense of other patients [with]… a reasonable chance of recovery... (Queensland Health 2018, 111). The third link to futility is that the NHMRC Ethical Guidelines explicitly incorporate resources into their definition of “overly burdensome treatment” (which along with “futile treatment” they instruct doctors not to provide). The Guidelines state treatment may be overly burdensome when … the burden of treatment for the patient is disproportionate to the likely benefits. … [t]hese decisions may also need to take into account the burden or cost of the treatment and the availability of resources for the family and/or community (National Health and Medical Research Council 2008, sec. 6.2.2). None of the other policies explicitly mention resources in their definition of futile or non- beneficial treatment, or a like concept. This could be because persons with disorders of consciousness present a unique clinical context, as the NHMRC Guidelines discuss. These individuals are totally (or substantially) unaware of their environment and partly or completely dependent on life-sustaining treatment. They may have an uncertain trajectory and can be artificially kept alive in very poor health states for a significant number of years. Therefore, “… high levels of treatment or care may involve significant burden to the community and its resources” (National Health and Medical Research Council 2008, sec. 6.2.1). For this reason, the Guidelines advise clinicians to explain to families that sometimes …after a treatment has been tried for a reasonable time without sustainable benefit, it may need to be withdrawn, although [the patient may deteriorate] (National Health and Medical Research Council 2008, sec. 6.2.1). Summary of Theme Two Overall, the Queensland Health Guidelines, the NHMRC Guidelines, the CICM Statement and the ANZICS Statement all indicate that resource considerations could take precedence over patient-focused factors in some circumstances (or at least should play a role in decision making, in particular when treatment is of little or no benefit). However, these policies refrain from explicitly endorsing rationing clearly beneficial treatment outside of situations of absolute scarcity when triage is required. These are difficult conflicts to resolve, particularly in the abstract in a policy setting, and it may be that an in-principle endorsement of bedside 171 rationing is tempered by the practical realities that treatment will be provided to patients absent explicit resource constraints or clear policies or community agreement about the bounds of acceptable practice. Theme Three: Fair Process and Transparent Resource Allocation Six of the eight policies mention transparency or a fair process for allocating resources. In four of these, the statements are brief and contemplate health rationing by higher authorities, without addressing doctors’ own role in rationing at the bedside (Australian Medical Association 2016a, 2016b; College of Intensive Care Medicine of Australia and New Zealand 2003; Medical Board of Australia 2014). For example, the AMA Code instructs doctors to “[u]se your knowledge and skills to assist those responsible for allocating health care resources, advocating for their transparent and equitable allocation” (Australian Medical Association 2016a). Likewise, the CICM Statement provides “[c]ommunities have the right to regulate access to public resources, even if this entails the non-provision of potentially beneficial healthcare” (College of Intensive Care Medicine of Australia and New Zealand 2003, sec. 4). These statements appear to indicate that policy-makers endorse resource allocation by hospital or government authorities, but are reluctant to address rationing by doctors at the bedside. In comparison, the ANZICS Statement seems to engage more with the potential for bedside rationing, which is not surprising given that the intensive care environment is a routinely different context. The Statement calls for transparent policies to guide decisions about resource management, which are developed with community input and have processes for oversight and appeal, however it acknowledges that “in practice, decisions may need to be made in the absence of clear, relevant, applicable policies” (Australian and New Zealand Intensive Care Society 2014, 31). Under the heading “[g]uidance regarding distributive justice”, the ANZICS Statement briefly endorses “accountability for reasonableness”, a widely-promulgated framework to promote legitimate resource allocation decisions in healthcare (Australian and New Zealand Intensive Care Society 2014, 31; Daniels 2000). The Statement instructs intensivists to consider reasonableness, defined as “the ability to justify the decisions made” and accountability “accepting responsibility for decisions made”, as core principles for making fair decisions about resources (Australian and New Zealand Intensive Care Society 2014, 32; Daniels 2000). The heading “[p]ractical suggestions to support 172 distributive justice”, provides further suggestions for best practice in the absence of resource allocation policies. This section instructs doctors to consult with senior intensivists about any decision to decline admission to patients who could potentially benefit. The Statement also says that whenever possible intensive care should be made available to those “who are likely to benefit” (even if transfer to another hospital is required) and instructs intensivists who need to choose between patients to prioritise “those with the greatest chance (and magnitude) of benefit from intensive care admission, and the highest chance of harm without admission” (Australian and New Zealand Intensive Care Society 2014, 31). The Queensland Health Guidelines also include a section on transparency and accountability for end-of-life decisions but do not mention resource allocation specifically in this context. Elsewhere, the Guidelines caution doctors against discriminating against elder adults in particular, noting a number of potential biases, including that resources should be rationed in this population to be used more effectively elsewhere. Other policies make more general statements about avoiding discrimination, but do not make the same link to resources. Overall, the importance of transparency and fairness is a theme that is mentioned in most of the policies. However, aside from the ANZICS Statement, there is very little detail about how to implement fair resource allocation strategies in the absence of formal policies. This may suggest policymakers at this level are reluctant to engage with the notion of doctors rationing at the bedside, especially in professional codes of conduct such as the MBA and AMA Codes. It may also be that there is little capacity to provide granular advice in these overarching statements. Theme 4: Legal Guidance on Distributive Justice as a Rationale to Limit Life-Sustaining Treatment The ANZICS Statement and the Queensland Health Guidelines are the only policies that address the legal position on using resource allocation as a basis for withholding and withdrawing life-sustaining treatment. The ANZICS Statement includes a chapter on the legal framework of end-of-life care, which draws a distinction between decisions based on patient interests and decisions based on resources. The subsection “Resource pressures”, briefly addresses the tension between resources and best interests from a legal perspective, and correctly identifies (citing dicta 173 from Messiha and Mohammed’s case)5 that the current legal position appears to be that resources are not relevant. It states, “[w]hile … pressure on beds (and by extension, resource allocation) are a fact of life … [these issues are] … not relevant to … the patient’s best interests” (Australian and New Zealand Intensive Care Society 2014, 46). The Queensland Health Guidelines also address the legality of basing a decision purely on distributive justice in a 3-page section entitled, “Can resource allocation be used to justify withholding or withdrawing medical treatment?” The section indicates doctors may be faced with situations when it might be ethically appropriate to limit potentially life-sustaining treatment because of distributive justice. The Guidelines provide, “making the best possible use of resources inevitably means that some patients, whose lives might potentially be prolonged, may not receive all possible life-sustaining treatment” (Queensland Health 2018, 110). More specifically, the Guidelines indicate that doctors’ difficult role in balancing resources “… takes into account the likelihood of prolonging life leading to a significant recovery for one patient against the likelihood of merely delaying death for a short period of time or prolonging the dying process for another” (Queensland Health 2018, 111). The Guidelines acknowledge, however, that this is untested in the courts and “using resource allocation as an excuse … would most likely be challenged legally … arguably … under a range of different legislation” (Queensland Health 2018, 111). The Guidelines also hypothesise that “it is highly unlikely the courts would expect all possible treatment to be given to prolong a life irrespective of costs or the impact on other patients” but instruct the most senior doctor/consultant to meticulously document the reasoning that led to the decision (Queensland Health 2018, 111). The Guidelines urge doctors to support their decisions with “clinical evidence, second or expert opinions, and … other relevant national guidelines” (Queensland Health 2018, 111). Presumably this is to encourage best medical practice but also to ensure that the decision is well-reasoned, engages multiple opinions and is well- documented to give the best opportunity for success in the face of a possible legal challenge. Overall, these comments appear to acknowledge the clinical reality that sometimes 5 As noted in footnote 2, in Messiha the court stated that resources were “an irrelevant matter, at least so far as the welfare of the patient was concerned”: Messiha v South East Health [2004] NSWSC 1061. In TS & DS v Sydney Children’s Hospitals Network (Mohammed’s case) [2012] NSWSC 1207 the court acknowledged that there could be cases when resource-based non-treatment rationales are used. Garling J stated at [64], “[t]here may be occasions when such issues arise. If they do, there are undoubtedly complex questions of public health policy to be considered, and also whether, a Court is best fitted to engage in that area of discourse. Fortunately, in this case, this issue did not arise.” 174 potentially life-sustaining treatment could be limited because of a lack of cost-effectiveness or the needs of other patients, but instruct doctors to tread carefully if this is the case. Notably, the Queensland Health Guidelines make other comments that sit awkwardly with these statements about potentially defensible resource-based decisions. The Guidelines discuss the difficult ethical situation of patients who are severely or irreversibly brain- damaged, noting (as the NHMRC Guidelines do) that resources used to support these patients cannot be used for the benefit of others. They note that the British Medical Association Guidance on withholding and withdrawing life-sustaining measures (“BMA Guidance”) grapples with advice about ongoing life-sustaining treatment for these patients, but ultimately leaves judgement up to the treating doctor. The Queensland Health Guidelines quotes the BMA Guidance as follows, It is very concerning that … cost factors probably have a disproportionate influence on decision making for this very vulnerable patient group and … the lack of a clear societal consensus on this most vexed area may unfairly leave doctors open to criticism (Queensland Health 2018, 112). The Queensland Health Guidelines then go on to caution doctors against rationing treatment. They state not doing the best for a patient with resources that are available would likely result in negligence claims, therefore, … health professionals should never use lack of current or indeed future resources to deny treatment … To do so establishes a conflict since … the choice to treat the patient (or not) is being compared with the treatment for another (future) patient whose condition and prognosis is unknown. (Queensland Health 2018, 112). While the Guidelines are navigating a difficult area, it is hard to reconcile the statement “health professionals should never use lack of current or indeed future resources to deny treatment” with the statement “making the best possible use of resources inevitably means that some patients, whose lives might potentially be prolonged, may not receive all possible life-sustaining treatment.” The Guidelines seem to draw a distinction between rationing clearly beneficial treatment at the bedside (which the first excerpt says is not permitted) from decisions about marginally beneficial treatment (which the second excerpt appears to indicate 175 can be legitimately denied on the basis of resources). However, this is a difficult distinction to maintain because what constitutes a benefit is often subjective. Both the ANZICS Statement and the Queensland Health Guidelines grapple with the challenging question of the legality of using resource constraints as a basis for withholding or withdrawing potentially inappropriate treatment. This is difficult to do in the absence of the law definitively determining a proper role for resources in these decisions, despite the clinical reality that resourcing can be relevant. This could explain why the Queensland Health Guidelines appear to make inconsistent statements. Discussion This review has highlighted a number of deficiencies in how non-institutional Australian policies on withholding and withdrawing life-sustaining treatment approach tensions between distributive justice and patient interests. The analysis, drawing on the above four themes, leads to three key findings. First, as a threshold issue many policies from the broader review lacked guidance about resource allocation, and the ones that did address this varied in the extent of guidance they provided. Second, there was broad convergence about the principles that should guide practice in this area. Third, despite the agreement about relevant principles, the policies provided very little practical guidance for resource allocation and rationing. Overall, the results accord with doctors’ perceptions that appropriate regulatory support for their gatekeeper to treatment role at the bedside is largely absent (Close et al. 2019), and reflects insufficient public and government engagement with the resource implications of decisions to withhold or withdraw life-sustaining treatment. Variable (or Lack of) Guidance About Resource Allocation The first key finding was that policies on withholding and withdrawing life-sustaining treatment varied in the degree of content they provide about resource allocation. Overall, most of the policies from the broader review lacked guidance, with only eight out of twenty- three addressing the issue. Although this paper has focused on analysing those policies that do address resourcing, an important finding is many Australian policies on life-sustaining treatment do not consider this issue at all. 176 Of the eight policies that considered resource allocation, five only engage at an “in principle” level and do not provide concrete guidance to doctors making these decisions (Table 1). Only three policies consider both resource allocation at an in principle level and aim to provide some concrete clinical guidance to doctors: the ANZICS Statement; the NHMRC Guidelines; and the Queensland Health Guidelines (Table 1). While practical detail is beyond the intended scope of several of the policies, the broad medical codes of conduct in particular, it is striking that so few of the policies provided concrete guidance to operationalise duties to manage resources. Moreover, as Hawryluck argues, although it can be said that high-level policies are “mission-like statements … not meant to be used practically on a daily basis”, these statements define good practice and should therefore provide practical and concrete guidance for navigating difficult ethical issues (Hawryluck 2006). High-Level Agreement in Principle The second key finding was that the policies demonstrated broad agreement on core principles. They showed broad support for several uncontroversial principles relating to resource management: the existence of doctors’ duties to society and other patients; the importance of not wasting resources; and the desirability of transparent resource allocation policies drafted by higher authorities. There was also support for doctors not providing treatment that is of little or no benefit. Turning to the first area of convergence, all eight policies supported the abstract notion that doctors have ethical duties beyond just the patient, both to other patients and to the health system as a whole (Theme 1). However, they varied in their instruction about how these duties should be reconciled if they come into conflict with the patient’s interests (Theme 2). At one end of the spectrum, the AMA End-of-Life Statement and the MBA Code provide no guidance and only make a trite and obvious statement that doctors should use healthcare resources wisely. The CICM Statement and the NHMRC Guidelines are somewhat more specific and indicate that justice is one factor that should be taken into account (and could take precedence) when making decisions about life-sustaining treatment, but do not indicate how this should be balanced against other considerations. In contrast, the other four policies all include a statement that doctors should always prioritise patient interests (though four of these made statements elsewhere that appeared to conflict with this guidance). 177 The second area where the policy guidance converged was in support of responsible stewardship (in other words, waste avoidance). This aligns with ethical literature that promotes the rhetoric that reducing waste will achieve a shared decision that is best for both the patient and for society (Brody 2012). The policies frame stewardship (avoiding wasteful care, which is permissible), as ethically distinct from rationing (denying beneficial care, which is impermissible, except for extreme exceptions such as triage after a natural disaster). The third area where the policies converged was in support of transparent processes for resource allocation (Theme 3). Several policies emphasised the need for transparent resource allocation decisions, but these suggest decision making at an administrative or institutional level. Most of the policies did not provide guidance for doctors about rationing at the bedside (the ANZICS Statement and the Queensland Health Guidelines being exceptions). Although bedside rationing is controversial, there is significant evidence that it occurs regularly in practice (Hurst et al. 2006; Ward et al. 2008). The policies rightly promote fair administrative decision-making processes, but by ignoring or rejecting doctors’ role in rationing resources at the bedside they miss an opportunity to provide guidance to deal with ethical issues doctors face in practice. Lack of Practical Guidance about Resource Allocation The third key finding was that the policies lacked practical instruction about resource allocation. Key ways in which this guidance fails to adequately help doctors making these decisions are: inadequate direction when doctors are faced with conflicting duties in practice; conflicting guidance about duties in practice versus in principle; insufficient instruction about futile treatment; and failing to provide a clear statement of the legal position. The first way that policies lacked practical guidance was that the statements of principle are inadequate when doctors are faced with conflicting duties in practice. A closer examination of each of the principles articulated above reveals that they are of little or no use on their own when faced with ethical dilemmas surrounding withholding or withdrawing life-sustaining treatment. In other words, the policies fail to provide sufficient instruction for how to resolve the problem of “dual agency”, what Tilburt refers to as “medicine’s modern-day pipe dream”: upholding patients’ best interests while simultaneously ensuring the just distribution of healthcare resources (Tilburt 2014). 178 Several policies instructed doctors to consider resources but put the patient first. In theory, this advice appears straightforward, but in practice it is unsatisfactory. Such a strategy amounts to what Tilburt terms “functional bunkering”, in other words, “saying physicians are committed to multiple norms, but … acting as if the only thing that really matters is primacy of patient welfare” (Tilburt 2014, 34). Tilburt rightly argues that the problem with bunkering as a strategy to address dual agency is it ignores the implicit value judgements in deciding what is “medically indicated”. In other words, the AMA’s instruction to “practice effective stewardship… [but] remember … to provide the patient(s) with the best available care” is a judgement call, both in terms of what is in the patient’s interests and the resources that are available. However, the statements fail to clarify that best available care is often value-laden. More general statements, such as CICM’s, that simply instruct doctors to balance various ethical principles, are also unhelpful because they do not provide guidance about how to weigh competing considerations or what to do in case of conflict. There is a similar problem with how the policies endorse stewardship but reject rationing. Some commentators argue that stewardship and rationing are indeed distinct (Cassel and Tilburt 2013; Brody 2012). Yet, others contend there is considerable overlap (Fleck 2016; Ubel 2015). In particular, such a strict distinction is difficult to maintain in the context of disputes about life-sustaining treatment. When a patient or substitute decision maker seeks treatment that has the potential to confer a benefit (even if it is a marginal benefit), what counts as “wasteful” healthcare, and who has the moral authority to make this judgement? (Fleck 2016) A doctor might believe a treatment is wasteful and futile or non-beneficial, but a substitute decision maker might believe the treatment is beneficial and is being rationed. What counts as waste is highly normative and subject to shifts over time as the use of technology develops. What is “standard” practice is broadening, with life-sustaining technology routinely used in cases in which it was once unheard of (Lantos 2018). The policies reviewed, in particular the ones that are limited to statements of principle only, fail to provide sufficient guidance about the normative nature of “waste” or “benefit.” Turning to the second area where the policies lacked practical guidance, there were several places where the concrete guidance in the ANZICS Statement and the Queensland Health Guidelines appears to conflict with statements of principle in the same documents. For 179 example, the ANZICS Statement rejects rationing at the bedside (except when triage is necessary) and yet elsewhere says distributive justice can outweigh principles of autonomy and beneficence. The Queensland Health Guidelines makes similar conflicting statements. Another deficiency was inadequate instruction about whether resources should be taken into account when deciding to withhold or withdraw “futile” treatment. The Queensland Health Guidelines, the ANZICS Statement and the NHMRC Guidelines all suggested that doctors should refrain from providing treatment that is futile or non-beneficial and in some parts of the guidance, this was linked to the importance of conserving resources. The Queensland Health Guidelines use the vague phrase, “the financial and clinical limits of medicine”. The NHMRC Guidelines are also potentially problematic, because they suggest resources are part of the definition of “overly burdensome treatment”. While resources could be a factor in decision making for persons with disorders of consciousness, this should be treated as a separate and distinct rationale from the patient’s interests (Wilkinson and Savulescu 2019). This part of the NHMRC Guidelines blurs this line. A final issue is how the policies address the legal position on using resource pressures as a justification for withholding or withdrawing life-sustaining treatment. The ANZICS Statement and the Queensland Health Guidelines both include a section on the legal position, but both could improve their guidance. The ANZICS Statement correctly indicates resource availability is not a factor the courts use to assess patient’s best interests. However, the Statement fails to mention in the same section that courts typically uphold resource-based decisions about life-sustaining treatment if they are made according to clear policy. The Queensland Health Guidelines are also potentially misleading because they make two apparently conflicting statements. On one hand, the Guidelines indicate that doctors should never use resources as a basis for denying treatment for any patient. On the other hand, they say using resources efficiently means that some patients, “whose lives may potentially be prolonged, may not receive all possible life-sustaining treatment.” Both the ANZICS Statement and the Queensland Health Guidelines attempt to provide concrete guidance in an area where the legal position is largely untested. Therefore, the failure to provide a clear position is perhaps justifiable. It could also be a symptom of the “political” nature of policy documents, which attempt to provide flexible standards for 180 practice and address a number of different aims. Notably, the ANZICS Statement acknowledges that resources issues are important, but not talked about, perhaps indicating the policy drafters were trying their best to provide certainty in an area that lacks sufficient legal guidance. Need for Improved Policy Guidance It is well-established that doctors are gatekeepers of life-sustaining treatments, with different preferences and values about how resources should be allocated and what treatments are “potentially inappropriate” or “futile” (Wilkinson and Truog 2013; Bosslet et al. 2015). In a medical system that is ostensibly centred on the patient, some doctors experience moral distress from being thrust reluctantly into making allocation decisions absent appropriate supports (Close et al. 2019). Recognising societal interests in decisions about life-sustaining treatment requires a justifiable framework, yet our analysis has demonstrated that Australia needs improved regulatory guidance. On the legal front, Australian case law has not had the opportunity to engage meaningfully with the resource implications of decisions to withhold or withdraw life-sustaining treatment. This is partly due to the lack of cases that reach the courts and how cases have been framed by parties in terms of best interests, but also because of a lack of clear policies for decision makers to rely on. Policy is a regulatory mechanism that has the potential to elevate the minimum standard set by law and promote best practice (Parker and Braithwaite 2005, 123; Jackson 2015), but developing a suitable approach to considering resourcing in the context of decisions to withhold or withdraw life-sustaining treatment is challenging, especially absent the requisite legal foundation. Despite the ethical complexity and clinical diversity involved, this is an issue that policymakers and the community should grapple squarely with, and indeed, is one that the courts would likely endorse, provided policy is developed and applied in a fair and consistent manner (Close, Willmott, and White 2018). Policies already exist to ration access to specific types of scarce resources including organs for transplant and dialysis, but more engagement with the “messier” issue of broader end-of- life decisions is warranted. This is needed by the health system, which has limited resources, and also by doctors who are making these decisions (Close et al. 2019). It is also important for patients to be confident that when treatment decisions are based on resources, they comply with fair and transparent policies. Elsewhere we argue this could be achieved through 181 a shift in the legal framework to develop explicit resource allocation policies which can justify withholding or withdrawal of treatment (White et al. 2017; Close, Willmott, and White 2018). Another approach could be to develop a consensus statement setting out situations when treatment should not be provided on the basis of distributive justice (Hawryluck 2006; Bosslet 2015). Limitations and Areas for Further Research This study examined publicly-available policies that address withholding or withdrawing life- sustaining treatment. A limitation is that institutional policies were not included. Nevertheless, the focus on publicly-available policies is important because these documents set out principles and best practices that are intended to be incorporated into institutional- level policies. Moreover, most institutional policies are not open to public scrutiny. Future research on the content of institutional policies on withholding or withdrawing in the Australian context would provide further insight into how decisions about limiting life- sustaining treatment are regulated in practice. The extent to which doctors engage with these policies in practice is another area for further research. Conclusion Several Australian medical policies that address withholding and withdrawing life-sustaining treatment clearly set out that doctors have responsibility for allocating scarce resources. These statements suggest that when significant resources are being expended on potentially inappropriate treatment at end-of-life, doctors should also be aware of the impact on other patients and society. However, the policies largely failed to address the more difficult question of how to implement this guidance when patient interests and societal interests conflict. Overall, the findings of this study demonstrate a lack of legal and government engagement with the resource implications of decisions about life-sustaining treatment and rationing at the bedside. Clearer policies are needed to support doctors to balance their ethical duties to be both responsible stewards of limited medical resources and promoting the welfare of multiple patients. 182 References Angell, M. 1993. The doctor as double agent. Kennedy Institute of Ethics Journal 3(3): 279– 286. Australian and New Zealand Intensive Care Society. 2014. ANZICS statement on care and decision-making at the end of life for the critically ill. Edition 1.0. https://www.anzics.com.au/wp-content/uploads/2018/08/ANZICS-Statement-on- Care-and-Decision-Making-at-the-End-of-Life-for-the-Critically-Ill.pdf. Accessed November 6, 2019. Australian Medical Association. 2014. Position statement on end of life care and advance care planning. https://ama.com.au/position-statement/end-life-care-and-advance-care- planning-2014. Accessed November 6, 2019. Australian Medical Association. 2016a. AMA Code of Ethics 2004. Editorially revised 2006. Revised 2016. https://ama.com.au/position-statement/code-ethics-2004-editorially- revised-2006-revised-2016. Accessed November 6, 2019. Australian Medical Association. 2016b. AMA Position Statement - The Doctor's Role in Stewardship of Health Care Resources. https://ama.com.au/position- statement/doctors-role-stewardship-health-care-resources-2016. Accessed November 6, 2019. Bosslet, G.T., T.M. Pope, G.D. Rubenfeld, et al. 2015. An official ATS/AACN/ACCP/ESICM/SCCM policy statement: Responding to requests for potentially inappropriate treatments in intensive care units. American Journal of Respiratory and Critical Care Medicine 191(11): 1318–1330. doi: 10.1164/rccm.201505-0924ST. Braun, V., and V. Clarke. 2006. Using thematic analysis in psychology. Qualitative Research in Psychology 3(2): 77–101. doi: 10.1191/1478088706qp063oa. Brick, C., G. Kahane, D. Wilkinson, L. Caviola, and J. Savulescu. 2019. Worth living or worth dying? The views of the general public about allowing disabled children to die. Journal of Medical Ethics. ePub ahead of print, October 15. doi:10.1136/medethics- 2019-105639. Brody, H. 2012. From an ethics of rationing to an ethics of waste avoidance. New England Journal of Medicine 366(21): 1949. Carter, H.E., S. Winch, A.G. Barnett, et al. 2017. Incidence, duration and cost of futile treatment in end-of-life hospital admissions to three Australian public-sector tertiary hospitals: a retrospective multicentre cohort study. BMJ Open 7: e017661. doi: 10.1136/bmjopen-2017-017661. Cassel, C.K., and J.C. Tilburt. 2013. Why the ethics of parsimonious medicine is not the ethics of rationing. JAMA 309(8): 773–774. Close, E., M. Parker, L. Willmott, B.P. White, A. Crowden. Submitted. Australian policies on “futile” or “non-beneficial” treatment at the end of life: A qualitative content analysis. Journal of Law and Medicine. Close, E., B.P. White, L. Willmott, et al. 2019. Doctors’ perceptions of how resource limitations relate to futility in end-of-life decision making: a qualitative analysis. Journal of Medical Ethics 45: 373–379. doi: 10.1136/medethics-2018-105199. 183 Close, E., L. Willmott, and B.P. White. 2018. Charlie Gard: In defence of the law. Journal of Medical Ethics 44(7): 476–480. Cohen, A.B. 2012. The debate over health care rationing: Déjà vu all over again? Inquiry 49(2): 90–100. doi: 10.5034/inquiryjrnl_49.02.06. College of Intensive Care Medicine of Australia and New Zealand. 2003, last reviewed in 2013. Statement on withholding and withdrawing treatment. https://cicm.org.au/CICM_Media/CICMSite/CICM- Website/Resources/Professional%20Documents/IC-14-Statement-on-Withholding- and-Withdrawing-Treatment.pdf. Accessed November 6, 2019. Daniels, N. 2000. Accountability for reasonableness. BMJ 321(7272): 1300-1301. doi: 10.1136/bmj.321.7272.1300. Fleck, L.M. 2016. Choosing wisely is parsimonious care just rationing? Cambridge Quarterly of Healthcare Ethics 25(3): 366–376. doi: 10.1017/S0963180115000705. Hawryluck, L. 2006. Ethics review: Position papers and policies - Are they really helpful to front-line ICU teams? Critical Care 10(6): 242–245. doi: 10.1186/cc5095. Huynh, T.N., E.C. Kleerup, P.P. Raj, and N.S. Wenger. 2014. The opportunity cost of futile treatment in the ICU. Critical Care Medicine 42(9): 1977–82. Lantos, J. 2018. Intractable disagreements about futility. Perspectives in Biology and Medicine 60(3): 390–399. doi: 10.1353/pbm.2018.0013. Levinson, M., A. Mills, A.M. Hutchinson, G. Heriot, G. Stephenson, and A. Gellie. 2014. Comparison of not for resuscitation (NFR) forms across five Victorian health services. Internal Medicine Journal 44(7): 671–675. doi: 10.1111/imj.12458. Levinsky, N.G. 1984. The doctor’s master. The New England Journal of Medicine 311(24): 1573–1575. doi: 10.1056/NEJM198412133112412. Manning, J., and R. Paterson. 2005. Prioritization: Rationing health care in New Zealand. The Journal of Law, Medicine & Ethics 33(4): 681–697. doi: 10.1111/j.1748- 720X.2005.tb00536.x. Martin, D. 2013. Medical futility in Australia. In Medical futility: A cross-national study, edited by A. Bagheri, 119–144. London: Imperial College Press. McDonald, F. 2017. The legal system and the legitimacy of clinical guidelines. Journal of Law and Medicine 24:821–836. Medical Board of Australia. 2014. Good medical practice: A code of conduct for doctors in Australia.https://www.medicalboard.gov.au/Codes-Guidelines-Policies/Code-of- conduct.aspx. Accessed November 6, 2019. Miles, M.B., A.M. Huberman, and J. Saldaña. 2014. Qualitative data analysis: a methods sourcebook. 3rd ed. Thousand Oaks, CA: SAGE Publications. National Health and Medical Research Council. 2008. Ethical guidelines for the care of people in post-coma unresponsiveness (vegetative state) or a minimally responsive state. Australian Government. https://www.nhmrc.gov.au/about- us/publications/ethical-guidelines-care-people-post-coma-unresponsiveness. Accessed November 6, 2019. 184 Parker, C., and J. Braithwaite. 2005. Regulation. In The Oxford handbook of legal studies, edited by M. Tushnet and P. Cane, 119–145. Oxford: Oxford University Press. Pope, T.M. 2016. Texas advance directives act: Nearly a model dispute resolution mechanism for intractable medical futility conflicts. QUT Law Review 16(1): 22–53. doi: 10.5204/qutlr.v16i1.639. Queensland Health. 2018. End-of-life care: Guidelines for decision-making about withholding and withdrawing life-sustaining measures from adult patients. https://www.health.qld.gov.au/__data/assets/pdf_file/0033/688263/acp-guidance.pdf. Accessed November 6, 2019. Rubin, M.A., and R.D. Truog. 2017. What to do when there aren’t enough beds in the PICU. AMA Journal of Ethics 19(2): 157–163. Scheunemann, L.P., and D.B. White. 2011. The ethics and reality of rationing in medicine. Chest 140(6): 1625–1632. doi: 10.1378/chest.11-0622. Tilburt, J.C. 2014. Addressing dual agency: Getting specific about the expectations of professionalism. The American Journal of Bioethics 14(9): 29–36. doi: 10.1080/15265161.2014.935878. Truog, R.D. 2017. The United Kingdom sets limits on experimental treatments: The case of Charlie Gard. JAMA 318(11): 1001–1002. Truog, R.D., D.W. Brock, D.J. Cook, et al. 2006. Rationing in the intensive care unit. Critical Care Medicine 34(4): 958–963. doi: 10.1097/01.CCM.0000206116.10417.D9. Ubel, P.A. 2015. Why it’s not time for health care rationing. Hastings Center Report 45(2): 15–19. doi: 10.1002/hast.427. Ubel, P.A., and S. Goold. 1997. Recognizing bedside rationing: Clear cases and tough calls. Annals of Internal Medicine 126(1): 74–80. doi: 10.1059/0003-4819-126-1- 199701010-00010. Walker, R.J., and L.E. Egede. 2016. Rationing of care: conceptual ambiguity and transparency in data collection and synthesis. Journal of General Internal Medicine 31 (12):1415–1416. doi: 10.1007/s11606-016-3801-4. Ward, N.S., J.M. Teno, J.R. Curtis, G.D. Rubenfeld, and M.M. Levy. 2008. Perceptions of cost constraints, resource limitations, and rationing in United States intensive care units: Results of a national survey. Critical Care Medicine 36(2): 471–476. doi: 10.1097/CCM.0B013E3181629511. White, B., L. Willmott, E. Close, and J. Downie. 2017. Withholding and withdrawing potentially life-sustaining treatment: Who should decide? In Tensions and traumas in health law, edited by I. Freckelton and K. Petersen, 454–478. Alexandria, NSW: Federation Press. Wilkinson, D., and J. Savulescu. 2019. Current controversies and irresolvable disagreement: The case of Vincent Lambert and the role of “dissensus”. Journal of Medical Ethics 45: 631–635. doi: 10.1136/medethics-2019-105622. Wilkinson, D.J.C., and R.D. Truog. 2013. The luck of the draw: physician-related variability in end-of-life decision-making in intensive care. Intensive Care Medicine 39(6): 1128–1132. doi: 10.1007/s00134-013-2871-6. 185 Willmott, L., B. White, M.K. Smith, and D.J.C. Wilkinson. 2014. Withholding and withdrawing life-sustaining treatment in a patient’s best interests: Australian judicial deliberations. Medical Journal of Australia 201(9): 545–547. Young, M.J., S.E.S. Brown, R.D. Truog, and S.D. Halpern. 2012. Rationing in the intensive care unit: To disclose or disguise? Critical Care Medicine 40(1): 261–266. doi: 10.1097/CCM.0b013e31822d750d. 186 PART 5 Conclusion 187 Chapter 9: Conclusion 9.1 INTRODUCTION Decisions to withhold or withdraw potentially life-sustaining treatment involve more than just medical judgment. They invoke important normative considerations about the patients’ interests and have implications for how society’s scarce health resources are used. Examining how the regulatory system navigates the tensions between patient and societal interests in these decisions is critical. The pace and scale of technological change and the ageing population means that decisions to withhold or withdraw life-sustaining treatment are likely to become more frequent. It is therefore important to confront whether the regulatory system promotes transparent and procedurally-fair decision making, which adequately gives voice to the patient’s values, distinguishes considerations of scarce health resources and encourages clarity in the underlying rationales for non-treatment. This thesis set out to examine the extent to which laws and policies in Australia promote transparent and procedurally-fair decisions to withhold or withdraw life-sustaining treatment. The study adopted a multi-disciplinary approach to acquire a deeper understanding of the law, policy and practice surrounding these complex decisions for adult patients. Part 1 reviewed the relevant literature and provided an overview of the Australian legal approach to withholding and withdrawing treatment that a doctor thinks is futile. Part 2 identified the context of doctor- initiated decisions to withhold or withdraw life-sustaining treatment, including concerns that the subjectivity of these decisions is not sufficiently transparent and that rationing can be masked by the concept of futility. It also examined doctors’ perceptions of their practice and found that doctors take resources into account when making decisions, and perceive futility can mask rationing in practice. Part 3 evaluated the adequacy of a number of legal models and argued the Australian position the does not sufficiently promote procedurally-fair decisions or distributive justice. Part 4 evaluated the policy environment and determined Australian policies on decisions about life-sustaining treatment are fragmented and provide inconsistent and insufficient guidance about futility, resource allocation and dispute resolution. Both Part 3 and Part 4 provided recommendations for how the regulatory system could promote more transparent and fair decisions. 188 The purpose of this final chapter is fivefold. First, it will reiterate the main objectives of the thesis. Second, it will discuss how the six papers address these specific objectives and, in doing so, achieve the overarching aim of the thesis. Third, the chapter will provide a synthesis of the thesis’ recommendations. Fourth the chapter will detail how the thesis provides significant and original contributions to knowledge in this field. Finally, the chapter provides some suggestions for future research. 9.2 CUMULATIVE EFFECT OF THE PUBLICATIONS The principal aim of this thesis was to determine whether the current regulatory mechanisms that govern, or purport to govern, decisions to forgo life-sustaining treatment in Australia adequately promote transparent and fair decision making, or whether a new or additional regulatory response is needed. Several research questions were identified to address this issue, which corresponded to a number of specific objectives. For ease of reference, these are set out again in this section. This is followed by setting out the main findings of each research question, with reference to the specific publications. As a whole this section of the chapter establishes the cumulative effect of the publications and the significant and original knowledge claim of the thesis. 9.2.1 Research questions and objectives Research Question 1. What is the nature of concerns that doctors’ decisions to withhold or withdraw potentially life-sustaining treatment are not sufficiently transparent or procedurally-fair? Review and critically analyse the literature on the concept of ‘futility’ as a basis for withholding or withdrawing life-sustaining treatment (Objective 1.1); Evaluate whether the term ‘futility’ is a useful construct in end-of-life decisions (Objective 1.2); and Identify ways that the current decision-making paradigm lacks transparency and fairness (Objective 1.3). Research Question 2. What ethical rationales do doctors rely on when they recommend withholding or withdrawing life-sustaining treatment from adult patients at the end of life, and how are they conceptualised? 189 Investigate doctors’ perceptions of the extent to which resource factors influence determinations about futility for adult patients (Objective 2.1); and Examine how doctors conceptualise the relationship between resource constraints and futility (Objective 2.2). Research Question 3. What are the current legal models that address decisions to withhold or withdraw life-sustaining treatment and to what extent do they promote transparent and procedurally-fair decisions? Identify the values that should anchor regulatory responses to decisions about life-sustaining treatment (Objective 3.1); Identify all current legal models that determine who has decision-making authority over whether potentially life-sustaining treatment is provided (Objective 3.2); Identify legal mechanisms for dispute resolution when there is a dispute about life-sustaining treatment (Objective 3.3); and Evaluate whether the current legal model of decision making and dispute resolution needs reform to align with the articulated values (Objective 3.4). Research Question 4. What professional guidance is available to doctors making decisions to withhold or withdraw life-sustaining treatment and to what extent does it promote transparent and procedurally-fair decisions? Identify all relevant publicly-available medical policies that address doctors’ decisions to withhold or withdraw life-sustaining treatment from adult patients (Objective 4.1); Analyse the policy guidance on decision making criteria (including the role of resources in decisions) (Objective 4.2); Analyse the policy guidance on the decision-making process and dispute resolution (Objective 4.3); and Critically evaluate whether the current policy approach is sufficiently transparent and procedurally fair (Objective 4.4) 190 9.2.2 The Basis of Concerns about Transparency and Procedural Fairness The first research question sought to identify concerns about transparency and procedural fairness in the theoretical and empirical literature on doctor-initiated decisions to withhold or withdraw life-sustaining treatment. This research question was principally addressed by Chapter 3, the Futile or Disputed Treatment Chapter, however these concerns were identified by aspects of each of the publications. The Futile or Disputed Treatment Chapter discerned two primary threats to transparent and procedurally-fair decisions. The objective ‘mask’ of futility is problematic because it: 1. Obscures the relevance of patient values to decisions; and, 2. Fosters a lack of frank engagement with distributive justice. The Futile or Disputed Treatment Chapter discussed each threat in more detail. First, the chapter set out how the concept of futility appears objective but often masks value-laden assessments about whether a treatment is worth pursuing. The way futility is applied is therefore problematic. Decisions about life-sustaining treatment require a fair process to more explicitly give patients or their substitute decision makers the opportunity to understand and challenge doctors’ assessments. Second, the chapter also examined how concerns about distributive justice are not sufficiently acknowledged in existing decision-making paradigms, which are centred on the patient. The influence of scarce resources is therefore not articulated or available for challenge. This creates a risk that some rationing decisions (when resources are the primary basis for the decision) are characterised as decisions about a lack of patient benefit. Chapter 6, the Critique of Legal Models Chapter, built on the concerns identified in the Futile or Disputed Treatment Chapter, primarily focusing on the first problem, the lack of recognition of the value-laden nature of decisions. The Critique of Legal Models Chapter explains how rather than focusing on terminology, a better approach in the face of a contested decision about futility is to ask: 1) who decides?; and 2) how should stakeholders reach consensus and resolve disputes? On the first question, the chapter argues a key threat to procedurally-fair decisions is the lack of involvement of the patient or their substitute decision maker. While doctors have expertise in making medical assessments, and knowledge about when a treatment is not likely to work, they are also poor prognosticators and (like all of us) 191 have implicit and explicit biases that influence decisions.1 This is not to minimise the importance of doctors’ involvement in these decisions, however. Although patients (or their substitute decision makers) are well-placed to give effect to the individual’s values, they might not appropriately comprehend or have adequate knowledge about medical aspects of the decision. Decision making for patients who lack capacity is further complicated because substitute decision makers may feel guilt or grief, or may not have knowledge of, or appropriately consider, the patient’s wishes.2 Given the different positions of doctors and patients or their substitute decision-makers, to promote more procedurally-fair decisions when decisions are based on a patient’s interests it is necessary to have a process that recognises the perspectives of relevant stakeholders. The Charlie Gard Paper also elaborated on the concerns identified by the Futile or Disputed Treatment Chapter and brought more attention to the second problem, the lack of frank engagement with distributive justice as a non-treatment rationale. The Charlie Gard case illustrates how when there is uncertainty or disagreement about what is in a patient’s best interests, distributive justice can be a clearer ethical rationale for limiting treatment. This is because it is not in society’s interests to expend copious resources on treatment that is extremely unlikely to work. However, the traditional medical and legal paradigm for life- sustaining treatment is focused solely on the patient. This creates a two-fold problem. First, resources typically are not a live consideration in legal actions, even when ethically they should be. Second, the lack of regulatory engagement with resource constraints means there is a tendency for rationing decisions to be subsumed or obscured by the objective ‘mask’ of futility. In summary, Chapter 2 of the thesis, in concert with several of the publications, comprehensively examined the literature and identified the main concerns with procedural fairness and transparency in doctor-initiated decisions to withhold or withdraw life-sustaining treatment. These are summarised in Table 4, below. These concerns, coupled with the qualitative analysis discussed in the next section, provide the foundation for the thesis’ regulatory critique. 1 Ben White et al, ‘Withholding and Withdrawing Potentially Life-Sustaining Treatment: Who Should Decide?’ in Ian Freckelton and Kerry Petersen (eds), Tensions and Traumas in Health Law (Federation Press, 2017) 454, 460-461 (‘Critique of Legal Models Chapter’). 2 White et al, Critique of Legal Models Chapter (n 1) 461. 192 Table 4. Concerns about transparency and procedural fairness in decisions to withhold or withdraw life- sustaining treatment Overarching concerns Concerns about transparency and procedural fairness synthesised from the literature 1) The objective ‘mask’ The subjective nature of most decisions is obscured by of futility apparently objective concepts and terminology. Patients and substitute decision makers do not have sufficient opportunities to have their values recognised in decision making and challenge medical assessments of ‘worth’. 2) The lack of frank Distributive justice is a valid rationale for limiting potentially engagement with life-sustaining treatment, however this is not articulated or distributive justice supported. Discussing the influence of resources on decisions about end- of-life care is taboo and not adequately confronted by court cases, medical policies, or doctors. 9.2.3 The Ethical Rationales That Doctors Rely on in Practice The second research question built on theoretical assertions in the literature that futility and rationing are confused in practice. This research question sought to empirically identify the rationales that doctors rely on in practice when they recommend withholding or withdrawing life-sustaining treatment from adult patients at the end of life, and how doctors conceive of them. The purpose of this investigation was to provide evidence of the ‘reality’ of medical practice. The thesis argues this empirical basis is needed because the regulatory system should appropriately respond to what occurs in practice. The qualitative research reported on in Chapter 4, the Doctors’ Perceptions of Practice Paper, showed that some doctors perceive decisions about withholding and withdrawing life- sustaining treatment can be influenced by distributive justice. While there was broad agreement that patient interests were paramount, doctors’ responses diverged in some key respects. Although some doctors maintained their decisions are focused solely on the patient, others acknowledged an awareness of resource constraints that influenced their practice. Significantly, the research empirically confirmed the longstanding theoretical assertion that the concept of futility could also obscure rationing decisions, decisions in which the primary justification for limiting life-sustaining treatment is because of resources. A cardiologist was reported in this paper describing how these decisions are obscured from patients or their substitute decision makers, stating, 193 You see there’s a lot of situations where you can be … pretty confident the treatment will work but you need to dress it up as a ‘will not work’ futility.3 It was striking that some doctors made this claim, while others maintained that resources did not influence their practice at all. It is possible this could reflect the diverse practice contexts of the doctors I interviewed, who worked in across 11 different hospital specialties. However, the paper argues it could also be because of doctors’ longstanding conscious or unconscious reluctance to acknowledge their role as gatekeepers of resources. This taboo is one barrier to more transparent recognition of the impact of resources on practice and must be combatted if rationing decisions are to be made in a more transparent and procedurally-fair way. Another barrier the Doctors’ Perceptions of Practice Paper identified is the lack of community or government engagement in determining reasonable cost-effectiveness limits on potentially life-sustaining treatment. The interviews showed that a number of doctors were significantly distressed by making resource-based decisions without appropriate institutional or administrative supports. Some also experienced distress from witnessing the provision of futile treatment and being acutely aware of how this impacts other patients and the health system. Those feelings of distress partly explain why some doctors felt aware of resource implications in discussions about life-sustaining treatment, even if patient interests took primacy. Doctors’ experiences of their practice demonstrate the need for more formal regulatory support for resource-based factors in decisions. To summarise, the Doctors’ Perceptions of Practice Paper added an empirical perspective to the theoretical discussion about the tension between futility and resources in practice. The findings reinforce previous empirical literature, introduced in the literature review in Chapter 2, which demonstrates doctors are not solely patient advocates, but engage in rationing treatment at the bedside. Even when not making rationing decisions (in other words, where resources are not the primary basis for the decision), the awareness of resource constraints can also influence the decision-making process. The thesis argues that the regulatory system should recognise these factors in how it approaches decisions about life- sustaining treatment. In particular, rationing is appropriate and morally justifiable, provided 3 Eliana Close et al, ‘Doctors’ Perceptions of How Resource Limitations Relate to Futility in End-of-Life Decision Making: A Qualitative Analysis’ (2019) 45 Journal of Medical Ethics 373, 376 (‘Doctors’ Perceptions of Practice Paper’). 194 there are transparent mechanisms to allow decisions to be disclosed and potentially challenged. However, the Doctors’ Perceptions of Practice Paper establishes that in the Australian context, a number of doctors across hospital specialties perceive these mechanisms are lacking. 9.2.4 The Extent to Which Current Legal Models Address Concerns About Transparency and Procedural Fairness Part 2 of the thesis set out concerns about transparency and procedural fairness in decisions about life-sustaining treatment and established that they have an empirical as well as theoretical basis. Part 3 then moved on to identify and examine the legal models for decision making about life sustaining treatment, evaluating the extent to which they address these concerns. Two publications evaluated the legal models for decision making: Chapter 5, the Charlie Gard Paper and Chapter 6, the Critique of Legal Models Chapter. As a starting point, both publications endorsed a set of values that Downie, White and Willmott argue should guide regulatory choices for decisions about life-sustaining treatment, including transparency (as an aspect of procedural fairness) and distributive justice.4 The Charlie Gard Paper divided these values into three domains: Values centred on the individual patient (life, autonomy, equality); Values promoting the integrity of the regulatory system (rule of law, procedural fairness, access to justice); and, Values recognising viewpoints external to the patient (distributive justice, conscience, humility). This thesis is focused on the value of procedural fairness (which encompasses transparency) and the value of distributive justice, but the entire list of values was considered in these publications to evaluate the legal system as an integrated whole. Ideally, the system should balance the values and sufficiently promote each domain. The analysis of the legal models in Part 4 is aligned to three key questions that are emphasised in the literature on futility: 1) who decides, 2) how should disputes be resolved, and 3) on what criteria? The focus of the thesis is predominantly on the first and second questions, but the third is briefly addressed as well. 4 Jocelyn Downie, Lindy Willmott and Benjamin P White, ‘Cutting the Gordian Knot of Futility: A Case for Law Reform on Unilateral Withholding and Withdrawal of Potentially Life-Sustaining Treatment’ (2014) 26(1) New Zealand Universities Law Review 24. 195 Who decides? The Critique of Legal Models Chapter identified and evaluated a spectrum of legal models for determining who has authority to decide when there is a dispute about life- sustaining treatment. The chapter set out five existing legal models for decision-making, based on the extent to which doctors are empowered to unilaterally withhold or withdraw potentially life-sustaining treatment. These are listed in Table 5 (viewed best in colour), which summarises the extent to which each model promotes procedural fairness (which includes transparency) and distributive justice. Table 5. The extent to which existing legal models for decision-making about life-sustaining treatment promote procedural fairness and distributive justice5 Legal Model: Locus of decision- Example Promotes Promotes making authority procedural distributive fairness? justice? Model 1: Doctor may unilaterally Australian common withhold or withdraw potentially law ✘ ✔ life-sustaining treatment Not explicitly6 Model 2: Doctor may unilaterally R (on application of withhold or withdraw potentially Tracey) v Cambridge ✘ ✔ life-sustaining treatment but must University Hospital Not explicitly consult with the patient or NHS Trust 7 substitute decision-maker Model 3: Doctor may unilaterally Texas Advance withhold or withdraw potentially Directives Act8 ✘ ✔ life-sustaining treatment, but an Depends on Not explicitly internal review committee is the how review decision-maker if there is a is structured disagreement Model 4: Decision-making Not in any current authority is shared between the legal regimes, but ✔ ✘ doctor and patient or substitute embodied in policy decision-maker statements9 5 Darker-coloured sections indicate a stronger position. For example, for Model 2, the light orange section under procedural fairness indicates that the added requirement of consultation is an improvement on Model 1, but still poses problems for procedural fairness because the doctor is the ultimate decision maker. 6 By giving the doctor the final say, Model 1 (and 2 and 3) promote distributive justice by facilitating doctors to put a stop to treatment that is unable or unlikely to work. Unlike Model 6 in the Critique of Legal Models Chapter, these models do not explicitly incorporate resource-based rationales in their decision-making paradigm. 7 (2011) 80 NSWLR 354, [6]. 8 Advance Directives Act, 166 Texas Health and Safety Code (1999) (‘TADA’). 9 See, eg, NSW Department of Health, End-of-Life Care and Decision-Making – Guidelines (Guideline No GL2005_057, 22 March 2005) 196 Model 5: Patient or substitute Queensland decision-maker consent is guardianship ✔ ✘ required to withhold or withdraw legislation10 potentially life-sustaining treatment The Critique of Legal Models Chapter evaluated each model for decision making against the core values we identified and found that none adequately promoted all of the values. Both of the Australian legal positions were problematic, for different reasons. Model 1, the Australian common law position, was the least aligned with the values. Of particular relevance to this thesis, it does not promote procedural fairness because there is no requirement that the doctor consult with the patient or substitute decision maker prior to withholding or withdrawing potentially life-sustaining treatment.11 Consequently, a patient or substitute decision maker might not even be aware that the decision to limit life-sustaining treatment was made. In contrast, Model 5 (the Queensland legal position) promotes procedural fairness, since the patient or substitute decision maker has the authority to decide and therefore drives the decision-making process. However, it fails to respect distributive justice, since the patient or substitute decision-maker could demand treatment that is extremely unlikely to work and is not cost effective.12 Therefore, the Critique of Legal Models Chapter establishes that the current legal models for decision making need reform to better recognise procedural fairness and transparency. The chapter makes recommendations for this reform, which are set out in section 9.3.1, below. How should disputes be resolved? A corollary issue that this thesis briefly investigated was whether the courts have a role to play in conflicts about life-sustaining treatment at all. This is a live question because some jurisdictions have effectively precluded the courts from adjudicating these disputes.13 As outlined in the Charlie Gard Paper, some argue that courts are ill-suited to this role because their processes are too lengthy and adversarial and the opportunity to appeal unduly prolong End of Life for the Critically Ill (Edition 1.0, 2014) 197 conflict. Other dispute resolution forums have been suggested, including mediation, conciliation and resolution by hospital ethics committees. The Charlie Gard Paper acknowledges the importance of complementary forms of dispute resolution but defends the role of the legal system in disputes about life-sustaining treatment. It contends that a judicial or quasi-judicial process (such as the Australian mechanism of resolving disputes by a tribunal) best promotes the values articulated, including access to justice and the rule of law. In particular, a judicial or quasi-judicial process has both private and public functions. Both courts and tribunals provide publicly-available reasons and set precedents that promote better decisions in the future. These decisions are therefore more transparent than those made by ethics committees. From a process perspective, the Australian use of tribunals to resolve disputes is therefore defensible and to the extent that it used, promotes transparency and procedural fairness. It has the advantage of operating more quickly and flexibly than the court system. However, as I discuss in section 9.5, there is a need for more research in Australia on the number of conflicts and how they are resolved. This would inform recommendations for further reforms to dispute resolution processes. On what criteria? The other aspect the Charlie Gard Paper and the Critique of Legal Models Chapter very briefly touched on was whether the best interests test is the appropriate criterion for decisions about life-sustaining treatment for individuals who lack capacity. There is a body of literature about the utility of the best interests standard in disputes about life-sustaining treatment, and this thesis did not set out to critique it in detail.14 In the Charlie Gard Paper,15 we argued that the best interests tests is defensible, but that the courts should refine its application. To combat the concerns raised about the objective ‘mask’ of futility, the courts should consider best interests from the patient’s perspective and make it clear that these decisions are value-laden. Summary: Evaluation of legal models In summary, Part 3 of the thesis satisfied the aim of identifying and evaluating current legal models for decision making about potentially life-sustaining treatment to determine the 14 See, eg, Seema K Shah, Abby R Rosenberg, Douglas S Diekema, ‘Charlie Gard and the Limits of Best Interests’ (2017) 171(10) JAMA Pediatrics 937; Julian Savulescu, ‘Is it in Charlie Gard’s Best Interest to Die?’ (2017) 389 (10082) The Lancet 1868. 15 Close, Willmott and White, Charlie Gard Paper (n 13) 478. See also Thaddeus Mason Pope, ‘The Best Interest Standard: Both Guide and Limit to Medical Decision Making on Behalf of Incapacitated Patients’ (2011) 22(2) Journal of Clinical Ethics 134. 198 extent to which they address concerns about transparency and procedural fairness. An important finding of the thesis is that there is no one ‘default’ legal model for decisions to forgo life-sustaining treatment. There are a variety of models beyond the ‘doctor knows best’ model allowing unilateral decision making.16 Some clinicians argue that a legal position that removes unilateral decision making power erodes their clinical judgment and threatens their expertise.17 However, given the widespread bioethical support for the proposition that most futility determinations are moral judgments, this position is difficult to maintain. The legal model for decision making should be designed to balance a range of values and this thesis has demonstrated that legal reform is necessary to better promote procedural fairness, transparency and distributive justice. 9.2.5 The Extent to Which Professional Guidance Addresses Concerns about Transparency and Procedural Fairness The law on withholding and withdrawing life-sustaining futile treatment sets out a minimum standard for doctors to follow; however, it is not the only regulatory mechanism intended to guide behaviour. Medical policies also play a role in regulating doctors’ decisions and elevating the minimum standard set by law. The fourth research question therefore sought to identify and analyse the professional guidance available to doctors making decisions to withhold or withdraw life-sustaining treatment to determine the extent that it addresses concerns about transparency and procedural fairness. This was accomplished by Part 4 of the thesis, which investigated the policies targeted at doctors as another component of the regulatory system. Part 4 was comprised of two publications, Chapter 7, the Medical Futility Policy Analysis and Chapter 8, the Balancing Patient and Societal Interests Analysis Paper. Each of these publications was targeted towards one of the two concerns identified in Part 2 of the thesis (discussed in section 9.2.2). The Medical Futility Policy Analysis examined how policies address the value-laden nature of futility, while the Balancing Patient and Societal Interests Policy Analysis scrutinised how policies approach the role of distributive justice. Policy approaches to the objective ‘mask’ of futility The Medical Futility Policy Analysis, comprehensively identified and then analysed all freely-available Australian policies that purport to guide doctors about decisions to withhold 16 Ben White et al, Critique of Legal Models Chapter (n 1) 473. 17 See, eg, Sean Lawrence et al, ‘Autonomy Versus Futility? Barriers to Good Clinical Practice in End-of-Life Care: A Queensland Case’ (2012) 196(6) Medical Journal of Australia 404. 199 or withdraw life-sustaining treatment. The review located relevant policies issued by the Commonwealth government, by state and territory governments, and by professional organisations. Several of the professional organisations had issued an end-of-life policy for the first time in the last few years, indicating increasing attention to issues around withholding and withdrawing life-sustaining treatment. The policy review targeted two key areas to determine the extent to which the Australian policy environment promotes transparency and procedural fairness. First, it examined how the policies conceptualise futility and the terminology they use to refer to it. Second, the paper considered the extent to which the policies provided guidance about the decision-making process, including the scope of unilateral decision making and how to prevent and resolve disputes The qualitative document analysis in the Medical Futility Policy Analysis reached three key findings, all indicating the Australian policy environment requires reform. First, the analysis revealed that the policy environment in Australia is fragmented, with doctors being subject to different levels of guidance depending on the jurisdiction and medical specialty in which they practise. Second, policies adopt different terminology and conceptualisations of futility. Many of the policies followed a general trend in the literature towards alternate terms including ‘non-beneficial treatment’, but some still retained the language of futility. The paper argues that in most of the policies, even the alternative language does not sufficiently promote procedurally-fair decisions. This is because they do not sufficiently capture that decisions about futility are value-laden. Notably, there was a lack of recognition of the distinction between physiologically futile treatment (which doctors rightly should not provide) and treatment that is potentially inappropriate (which requires engagement with patients or substitute decision makers). Third, the Medical Futility Policy Analysis also found that the policies as a whole generally lacked a procedural approach to decision making. Except for a few documents, the New South Wales Conflict Resolution in End of Life Settings18 and the ANZICS Statement19 in particular, the policies contained very little, if any, guidance about how to resolve conflicts about life-sustaining treatment. Taken as a whole, the findings in the Medical Futility Analysis 18 NSW Department of Health, Conflict Resolution in End of Life Settings (CRELS) (Final CRELS Project Working Group Report Including Consultation Summary, 1 September 2010) 200 Paper demonstrate that Australian policies on life-sustaining treatment have scope to provide much more guidance about navigating the value-laden nature of futility in practice. Policy approaches to distributive justice The Balancing Patient and Societal Interests Policy Analysis investigated the same set of medical policies from a different perspective. This paper investigated the extent to which policies that provide guidance to doctors about withholding and withdrawing life-sustaining treatment also provide guidance about distributive justice. The paper determined only eight of the 21 policies in the initial review mentioned resource allocation, most only at a high level. These eight policies showed broad support for the existence of doctors’ ethical duties to promote distributive justice. However, most provided very little concrete guidance for practice, and did not reconcile the tensions between futility and scarce resources. Only two policies contained practical guidance about resource allocation, the Queensland Health Guidelines20 and the ANZICS Statement.21 The policies supported a transparent process for rationing decisions made by higher authorities but rejected rationing at the bedside except when there are extreme resource shortages. Therefore, the policies stopped short of supporting resource constraints as a transparent rationale for non-treatment. This was not surprising, given the lack of legal and community engagement with this issue. The Balancing Patient and Societal Interests Policy Analysis concluded that the policies need reform to better address the tension between futility and resource constraints and the practical reality that doctors ration at the bedside. However, to do this, more community engagement is needed. Summary: Evaluation of policies In summary, Part 4 of the thesis accomplished the aim of identifying and evaluating policies that address decisions to forgo life-sustaining treatment, to determine whether they address concerns about transparency and procedural fairness. The research uncovered the start of a policy shift, aimed to respond to the value-laden nature of futility. However, for the most part this shift relates to terminology and does not go far enough in recognising that a procedural approach is needed to better approach the subjectivity of decisions about life-sustaining treatment. The research also found that Australian medical policies do not provide sufficient 20 Queensland Health, End-of-Life Care: Guidelines for Decision-Making about Withholding and Withdrawing Life-Sustaining Measures from Adult Patients (2018) 201 guidance to doctors about distributive justice or rationing at the bedside. This latter finding was rooted in a lack of community and legal engagement with the resource implications of decisions about life-sustaining treatment. Overall, Part 4 of the thesis found that the Australian policy environment should be reformed to better promote more transparent and procedurally-fair decisions, and to provide more consistency across Australia. 9.3 SYNTHESIS OF RECOMMENDATIONS This thesis set out to answer the overarching research question: What, if any, reform is needed to promote increased transparency and procedural fairness in the regulatory regime that governs, or purports to govern, decisions to withhold or withdraw life-sustaining treatment for adult patients at the end of life? As discussed in section 9.2, the publications as a whole demonstrate that the current regulatory approach is in need of reform. An alternate approach is required to facilitate more transparent and procedurally fair decisions, to better balance the interests of patients, doctors and society. Each of the publications provided a number of high-level recommendations for reform to achieve this goal. The purpose of this section is to set out a unified account of these recommendations. The last part of the section also includes a summary of findings that point to other areas for reform, beyond the laws and policies that were the focus of this thesis. 9.3.1 Recommendations for legal reform The thesis provided some recommendations for legal reform, to better promote transparency and procedurally-fair decisions, to better respond to the medico-ethical reality of practice identified in Part 2. The findings have established two overarching goals for legal reform to better address procedural fairness and distributive justice: 1. To legally-enshrine the position of patients and their substitute decision makers in decision making to advance procedurally-fair decisions that are driven by the patient’s values; and, 2. To better promote transparency about distributive justice as a rationale for or influence on non-treatment decisions. As described below, the thesis argues these two goals would be advanced through reform of the legal model for decision making. This section also discusses other legal reforms, which are 202 not as central to the thesis but flow from its findings: promoting access to justice and inviting the courts to engage in a clearer articulation of best interests. Reform the legal model for decision making As discussed in section 9.2.4, both Australian legal models for decision making do not adequately respect key values. In Chapter 2, the literature review set out the common law legal position in Australia that doctors do not need to provide life-sustaining treatment they regard as futile or against good medical practice. The most prevalent legal model in Australia therefore permits doctors to unilaterally withhold or withdraw life-sustaining treatment (Model 1 in the Critique of Legal Models Chapter, as discussed in section 9.2.4). As discussed, there is no legal requirement to disclose the decision or consult with the patient or substitute decision maker, which poses a threat to procedural fairness.22 While in practice, doctors might still engage patients or their substitute decision makers in shared decision making, there is no legal requirement that this must occur. The ability of patients or substitute decision makers to participate in decision-making about potentially futile treatment is therefore not protected by law. In contrast, the Queensland guardianship legislation creates an exception to the common law position for patients who lack capacity. It requires doctors to obtain consent to withhold or withdraw life-sustaining treatment, even if the doctor believes the treatment is against good medical practice.23 This represents the other end of the spectrum of decision-making models (Model 5), promoting procedurally-fair decisions but with arguably too much weight given to substitute decision makers. As noted in section 9.2.4, this model does not adequately respect distributive justice since patients or substitute decision makers can compel treatment that physiologically will not work. The thesis argues that the legal model of decision making should be reformed to better support procedural fairness, transparency, and distributive justice. Given that both Australian models (the common law and the Queensland guardianship legislation) do not sufficiently promote key values, the Charlie Gard Paper and the Critique of Legal Models Chapter provide 22 Cf Cameron Stewart, ‘A Defence of the Requirement to Seek Consent to Withhold and Withdraw Futile Treatments’ (2012) 196(6) Medical Journal of Australia 406. Stewart argues that the common law encourages doctors to seek consent or consensus from substitute decision makers as evidence of an assessment of the patient’s best interests. As argued in the Critique of Legal Models Chapter, while the law would not permit doctors to make arbitrary decisions, and therefore might require information from the patient or substitute decision maker, the ultimate decision is solely the doctor’s responsibility. 23 GAA, s 79; Sch 2, s 5(2). 203 an alternative approach. This model is situated between Model 4 and 5 in the spectrum of decision making. To promote procedural fairness, the model situates presumptive decision- making authority with the patient or substitute decision maker. This recognises that decisions about potentially inappropriate treatment are typically value-laden assessments of whether a treatment is ‘worth it’. However, to better accommodate distributive justice and conscience, the model places important limits on the patient’s or substitute decision maker’s authority. The first limit is that doctors are not compelled provide treatment that is physiologically futile; in other words, treatment that will not work. The second limit is that doctors do not have to provide treatment when they have a lawful excuse. Lawful excuses include when the patient or substitute decision maker consents to withholding or withdrawing life-sustaining treatment; compliance with a valid resource allocation policy; when it is physically impossible to provide the treatment; or when the patient is transferred to another doctor who is agrees to provide the treatment. This model better respects both procedural fairness and distributive justice, and promotes other values including patient autonomy. Procedural fairness is promoted because patients or substitute decision makers have authority over decisions about treatment that involve an assessment of whether it is worth it. Decisions about treatment that will not work are rightly in the doctor’s domain. Distributive justice is promoted because this structure encourages the development of resource allocation policies that delineate when treatments have very little value. This would enable doctors or hospitals to articulate non-treatment rationales based on distributive justice as well as on patient interests, which could then be adjudicated on by the court. Reform processes to promote better access to justice As a corollary to reform of the legal model, the thesis also briefly suggests other legal reforms designed to better promote access to justice in disputes. Like procedural fairness, this is another aspect of the values that promote the integrity of the legal system. There is a body of literature criticising court processes as being too slow, backed up by commentary on recent high-profile cases. The thesis argues the Australian tribunal system provides the speed and flexibility that is needed for decisions about life-sustaining treatment (although more research is needed to better understand the efficacy of these systems in practice). The thesis briefly notes two possible reforms which would improve access to justice. First, the Charlie Gard Paper suggests one option is to amend court procedures as necessary to streamline disputes. For 204 example, judges could be permitted to narrow the issues or determine the nature of evidence received (for example, to avoid a ‘battle of the experts’). The second possible reform is to design an ethics-committee model that is fairer and more independent of the medical perspective than in other jurisdictions where this is used, such as Texas.24 The point the thesis emphasises is some kind of external process is needed, and ethics committee models have often been criticised for lacking fairness. Promote better articulation of values in court cases Finally, it is worth noting again, as discussed in section 9.2.4, given the legal process is centred on best interests as the criterion for assessing whether life-sustaining treatment is ‘worth it’ it is critical that the courts adopt an approach which recognises the value-laden nature of this inquiry. These comments about best interests are not so much suggestions for reform but rather directed towards improving on the application of the current well-entrenched test for making decisions for those who lack capacity. One way to better clarify best interests is the ‘balance sheet approach’ used in the United Kingdom.25 It is important that the courts clarify the underlying cause of the dispute, as this has implications for resolution. Is the disagreement driven by the family’s misunderstanding of prognosis or have the doctors reached a premature conclusion?26 Or, for example, does the family value keeping their relative alive on a ventilator, despite catastrophic brain damage. If the dispute is about a clash of values rather than a misunderstanding of fact, adjudicators should recognise this and be less deferential to the medical position. The court’s reasoning should recognise that the appropriate use of life-sustaining technologies is an inherently normative question. 9.3.2 Recommendations for policy reform Part 4 of the thesis identified the 21 publicly-available policies that address withholding or withdrawing life-sustaining treatment in Australia and found that they did not adequately promote transparency and procedural fairness in several key ways. The Medical Futility Policy Analysis and the Balancing Patient and Societal Interests Policy Analysis both provided recommendations for policy reform. This thesis argues that policy reform should be directed to both concerns about the objective ‘mask’ of futility: (1) the lack of recognition that it is 24 TADA (n 8). 25 Close, Willmott and White, Charlie Gard Paper (n 13) 478. 26 White et al, Critique of Legal Models Chapter (n 1) 462-463. 205 value-laden; and (2) the lack of engagement with distributive justice. From a pragmatic perspective, the former area should be more straightforward to achieve, while the latter will require more community engagement with the resource implications of decisions about life- sustaining treatment. Improved policy frameworks and more precise terminology The central policy reform this thesis recommends is to develop a multi-society consensus statement that addresses decision making and conflict resolution for disputes about life- sustaining treatment in critical care. This is essential whether or not there is legal reform. The aim of this policy reform should be to develop a consistent approach to decisions about life- sustaining treatment across the country. This could then be adopted and refined for different medical specialties and contexts as needed. Importantly, this thesis argues any policy reform should occur through a consensus process, involving a broad range of experts and stakeholders including health professionals, patients, families, substitute decision makers, hospital administrators, lawyers, bioethicists, and relevant representatives from governments and professional organisations. Such a process would ensure that the resulting policy has legitimacy and is suited to the Australian context. The policy itself should aim to develop consistent terminology for decisions to withhold or withdraw life-sustaining treatment, which limits the word ‘futile’ to the rare categories of cases of treatment that will not work.27 The policy could adopt the Multi-Society Statement’s language of labelling all situations where there is a value judgment ‘potentially inappropriate treatment’. Alternatively, some other terminology may be more appropriate. The Futile or Disputed Treatment Chapter argues that the term ‘disputed treatment’ should be used as a neutral term to describe the sought-after treatment in cases of intractable conflict. Any overarching policy should also focus on setting out a process for navigating disputes. The thesis argues that the focus on initial discussions should be on establishing goals of care between the patient or substitute decision maker and health professionals. Indeed, several states 27 See, eg, Gabriel T Bosslet et al, ‘An Official ATS/AACN/ACCP/ESICM/SCCM Policy Statement: Responding to Requests for Potentially Inappropriate Treatments in Intensive Care Units' (2015) 191(11) American Journal of Respiratory and Critical Care Medicine 1318 (‘Multi-Society Statement’). At various points the thesis has endorsed the Multi-Society Statement as a model that promotes better ethical decision making. An important feature of the Multi-Society Statement is that limits the word ‘futile’ to treatment that physiologically will not work. It therefore draws a terminological and procedural distinction between treatment that is futile (which doctors can refuse to provide) and treatment that is ‘potentially inappropriate’ (which requires engagement with patients or their substitute decision makers). 206 have shifted to promoting a goals of care framework for end-of-life discussions. While this is an important starting point, any policy reform must combat the striking lack of guidance about dispute resolution in policies on withholding and withdrawing life-sustaining treatment. This would go much further towards recognising a ‘procedural approach’ to decisions, which is advocated by a significant part of the literature. Thus far Australian policies have preferred to adopt a consensus model of decision making, rather than the ethics committee models that are more common in the United States. However, the results of this research showed that the policies (with a few exceptions) ignore the possibility of disputes altogether. Moreover, ethics committee involvement likely occurs at an institutional level, but in an ad hoc way. Developing a consistent approach to futility disputes would promote more consistent decision making, which could then be adapted as needed to institutional contexts. Policy engagement with distributive justice The Australian policy environment is also unsatisfactory in its treatment of doctors’ duties to consider distributive justice. However, the thesis found that this is in part driven by a lack of community and legal engagement with bedside rationing. The Balancing Patient and Societal Interests Policy Analysis provides several suggestions for possible reforms. First, any policies that address futility (or a like concept) should also clarify that decisions about resources are distinct. Second, the consensus statement discussed above should also address the impact of resources on decisions and how to approach this with patients and substitute decision makers. Third, policies could advocate specific boundaries of clinical decision making where public input is needed, for example, in relation to the process or factors that should drive ICU bed allocation. 9.3.3 Other areas for reform Although beyond the scope of this thesis, which focused on law and policy, its findings also point to other reforms that could address the issues identified in this thesis. One theme that emerged from the Doctors’ Perceptions of Practice Paper and the policy analyses was the need for more public education about the realities of life-sustaining medical treatment. This should focus not on vague notions of the ‘reasonable limits of medicine’ but rather more specifically on likely outcomes, choices, and societal impacts, including the financial implications of life- sustaining treatment. Participants in the Doctors’ Perceptions of Practice Paper emphasised that the community needs to find a way to have a sensible dialogue about the impacts of life- 207 sustaining technologies (both societal and individual), that is not mired in the taboo of rationing. Processes for dispute resolution should also be sensitive to the traumas that give rise to them. Not all disputes are about value clashes– some arise because the family or substitute decision maker are mistaken about key facts. Any dispute resolution mechanisms must recognise the role of trust-building in these interactions,28 and institutional structures should aim to provide supports to foster the time and space needed to establish and maintain this trust. 9.4 SIGNIFICANCE OF FINDINGS Decisions to withhold or withdraw potentially life-sustaining treatment are a regular part of clinical practice, especially in the ICU. Although most disputes about life-sustaining treatment do not reach the courts, it is important to evaluate how the regulatory system treats decision making and approaches conflicts when they occur. The regulatory response should foster transparent and procedurally-fair decisions, to promote the integrity of the justice system and to enable patients or their substitute decision makers to challenge and rigorously test assumptions. Dispute resolution mechanisms must also be sufficiently agile and responsive to the clinical, emotional, and social context of these difficult situations. This thesis casts doubt on the traditional insistence that decisions about life-sustaining treatment are always focused solely on the patient. The thesis’ analysis of futility demonstrates it is a flawed concept as a basis for withholding and withdrawing life-sustaining treatment, although it is one that is recognised by doctors in practice. Australia’s approach to futility is in need of reform. The way it is currently operationalised in law, policy and practice does not sufficiently address the value-laden nature of decisions or promote transparency about distributive justice as a non-treatment rationale. This thesis is also significant as it establishes an empirical foundation for the argument that the regulatory system must better address distributive justice as a non-treatment rationale. The empirical research showed that an awareness of resource constraints can impact clinical practice subtly, as a background factor, or more forcefully as the underlying reason for limiting treatment. This is problematic because the true basis for decisions is obscured and doctors experience distress from acting as covert gatekeepers of treatment. The regulatory system must 28 Brian D Leland et al, ‘Futility Disputes: A Review of the Literature and Proposed Model for Dispute Navigation Through Trust Building’ (2017) 32(9) Journal of Intensive Care Medicine 532. 208 respond to distributive justice in practice to promote more transparent decision making and to support doctors in their practice. The thesis also reveals that current legal models for decision making about life-sustaining treatment do not adequately promote both procedural fairness and transparency about distributive justice. It is important to have regulatory mechanisms that encourage a thorough examination and deliberation about life-sustaining treatment, which is challengeable and legitimate. The medical profession’s insistence on the unilateral model of decision making about life-sustaining treatment does not sufficiently acknowledge that these decisions are inherently value-laden. The thesis demonstrates that none of the existing legal models of decision making adequately recognises both patient interests and distributive justice. Therefore, this thesis endorses a model for legal reform that better promotes both patient values and concerns about scarce resources. Finally, the thesis provides significant insight into current Australian medical policies on withholding and withdrawing life-sustaining treatment, an area that was previously subject to next to no research. The research depicts a fragmented and inconsistent Australian policy environment, which is in need of reform. There is an opportunity to create an overarching policy which sets out a consistent terminology and procedural approach to decisions to forgo life-sustaining treatment across Australian medical practice. Such a policy should use distinct terminology to distinguish between treatment that is physiologically futile and treatment that involves an assessment of the patient’s values. It should also provide comprehensive guidance for navigating disputes, involving neutral arbiters if needed. Finally, the most challenging part of policy reform is that Australian policies must engage more deeply with the question of rationing at the bedside. This inevitably will require broader community discussions about the value of ongoing life-sustaining treatment in the critically ill. 9.5 DIRECTIONS FOR FUTURE RESEARCH The publications in this thesis suggest some areas for future research, including interviewing doctors who work in private settings to gain a broader understanding of how resource factors might shape their practice. Beyond these recommendations, this section provides ideas for further areas of research that arise from the thesis as a whole. 209 Frequently-cited suggestions for combatting disputes about life-sustaining treatment include promoting advance care planning and improving communication,29 and educating patients, families and the public about palliative care and what various life-sustaining treatments can reasonably accomplish.30 This section is focused on going beyond these suggestions to target other specific, actionable areas that flow from the findings of this thesis. 9.5.1 Research on institutional policies This study scrutinised publicly-available policies on withholding and withdrawing life- sustaining treatment. Another area for research is to examine institutional regulatory mechanisms, in particular policies about withholding and withdrawing life-sustaining treatment. There are a number of broad factors that regulate potentially life-sustaining treatment, and it is important to understand the institutional forces that may shape doctors’ behaviour. Some research has already occurred in Australia in this area,31 but there is scope for more empirical research (both quantitative and qualitative). 9.5.2 Research on other stakeholders This thesis was centred on doctors’ perceptions of their practice. Further research with other stakeholders involved in disputes about life-sustaining treatment would provide insight into their experiences of the dispute resolution process. Qualitative research has occurred in Ontario, Canada on substitute decision makers’ and lawyers experiences.32 Similar research would be useful to gain the Australian perspective on how decisions are made and disputes are navigated. Another group to engage could be judges or tribunal members who preside over these disputes. 29 See, eg, James Downar et al, ‘Nonbeneficial Treatment Canada: Definitions, Causes, and Potential Solutions from the Perspective of Healthcare Practitioners’ (2015) 43 Critical Care Medicine 270; C Adrian Austin et al, ‘Tools to Promote Shared Decision Making in Serious Illness: A Systematic Review’ (2015) 175(7) JAMA Internal Medicine 1213. 30 See, eg, Ralf J Jox et al, ‘Medical Futility at the End of Life: The Perspectives of Intensive Care and Palliative Care Clinicians’ (2012) 38(9) Journal of Medical Ethics 540; Claire E Johnson et al, ‘Goals of Patient Care System Change with Video-Based Education Increases Rates of Advance Cardiopulmonary Resuscitation Decision-Making and Discussions in Hospitalised Rehabilitation Patients’ (2017) 47(7) Internal Medicine Journal 798. 31 See, eg, M Levinson et al, ‘Comparison of Not For Resuscitation (NFR) Forms Across Five Victorian Health Services’ (2014) 44(7) Internal Medicine Journal 671. 32 James Downar et al, Balancing the Interests of Patients, Substitute Decision-Makers, Family and Health Care Providers in Decision-Making Over the Withdrawal and Withholding of Life-Sustaining Treatment (Law Commission of Ontario, 2017) 210 Such research should also include patient and substitute decision makers’ views about resourcing as an element in decisions, to test the status quo of routine nondisclosure of rationing decisions. Young et al note an argument in favour of keeping resource pressures out of the clinical interaction is: … to protect patients or their surrogates from the frustration, anxiety, and feelings of abandonment that may arise if they sense that their welfare is not being promoted.33 However, transparent disclosure of parallel resource pressures, if handled sensitively, can increase trust and foster stronger doctor-patient relationships more generally.34 Research from the United Kingdom suggests that the majority of patients and health professionals support more explicit rationing.35 Such research in Australia would challenge the assumption that confronting resource implications in a forthright way is problematic and could help design processes that help support clinicians and administrators make these decisions openly. 9.5.3 The prevalence and nature of disputes about life-sustaining treatment Most decisions about life-sustaining treatment do not end up in the courts or publicised by the media, but rather are resolved in the hospital setting. There is a significant lack of data about the rates of medical end-of-life decisions in Australia, including decisions to withhold or withdraw life-sustaining treatment. This data is needed to provide more understanding about the types of medical decisions that are made. This concrete data would inform better policy choices and provide a picture of end-of-life decision making as a whole. More data is also needed about the nature of conflicts and how disputes are currently resolved by legal and non-legal mechanisms, including hospital ethics committees. A comprehensive review of the effectiveness of dispute-resolution processes would also inform regulatory reform. 9.6 CONCLUDING COMMENTS This thesis is an original multi-disciplinary examination of doctor-initiated decisions to withhold or withdraw life-sustaining treatment. It combines an analysis of law and policy with 33 Michael J Young et al, ‘Rationing in the Intensive Care Unit: To Disclose Or Disguise?' (2012) 40(1) Critical Care Medicine 261, 261. 34 Ibid. 35 Amanda Owen-Smith, Joanna Coast and Jenny Donovan, ‘The Desirability of Being Open about Health Care Rationing Decisions: Findings from a Qualitative Study of Patients and Clinical Professionals’ (2010) 15(1) Journal of Health Services Research and Policy 14. 211 an empirical investigation of doctors’ perceptions of practice. This is the first study to examine the tensions between the concept of futility and distributive justice in practice and to examine how Australian laws and policies respond to these tensions. More work is needed to break down the taboos about discussing resource allocation and rationing in end-of-life care. As the population ages and the rates of decisions to withhold or withdraw life-sustaining treatment increase, it is likely that the community will need to face the resource implications of being able to keep people alive in increasingly poor states of health. This thesis found that doctors are bearing the brunt of the government and community’s lack of engagement with distributive justice. This was poignantly articulated by an emergency consultant in this study who said: What distresses me is that this discussion is not being had in the public domain because I think it’s all very well for the politicians to expect doctors to make these decisions, but the public’s expectations are going up and up and their belief in medicine being able to fix absolutely everything is going up and up … we have real problem between the reality and cost, the resources and the expectations.36 Current forms of Australian regulation have failed to effectively respond to the tensions between patient interests and distributive justice in practice. The conclusions in this thesis support the need for changes to the regulatory framework that better promote the development of transparent resource allocation policies. Ultimately, this is a process that must be led by the community and the medical profession. Setting out a more patient-focused process around futility is the first step towards more transparency in decision making about life-sustaining treatment as a whole. 36 Eliana Close et al, Doctors’ Perceptions of Practice Paper (n 3) 377. 212 Appendix A – Statements of Contribution Statements of Contribution of Co-Authors are included for: Chapter 3 – Futile or Disputed Treatment Chapter Chapter 4 – Doctors’ Perceptions of Practice Paper Chapter 5 – Charlie Gard Paper Chapter 6 – Critique of Legal Models Chapter Chapter 7 – Medical Futility Policy Analysis Chapter 8 – Balancing Patient and Societal Interests Policy Analysis 213 Statement of Contribution of Co-Authors for Thesis by Published Papers The authors listed below have certified that: 1. they meet the criteria for authorship in that they have participated in the conception, execution, or interpretation, of at least that part of the publication in their field of expertise; 2. they take public responsibility for their part of the publication, except for the responsible author who accepts overall responsibility for the publication; 3. there are no other authors of the publication according to these criteria; 4. potential conflicts of interest have been disclosed to (a) granting bodies, (b) the editor or publisher of journals or other publications, and (c) the head of the responsible academic unit, and 5. they agree to the use of the publication in the student’s thesis and its publication on the QUT’s ePrints site consistent with any limitations set by publisher requirements. In the case of Chapter 3: Ben White, Lindy Willmott and Eliana Close, ‘Futile, Non-beneficial, Potentially Inappropriate or “Disputed” Treatment’ in Nathan Emmerich et al (eds), Contemporary European Perspectives on the Ethics in End of Life Care (Springer, 2020) Contributor Statement of contribution Eliana Close Eliana Close formulated the conceptual direction of the chapter, with the other authors, and wrote the first draft of part of the QUT Verified Signature manuscript. She critically revised multiple drafts of the manuscript 7 August 2019 and approved the final version. Ben White Ben White formulated the conceptual direction of the chapter, with QUT Verified Signature the other authors, and wrote the first draft of part of the manuscript. He critically revised multiple drafts of the manuscript and approved the final version. Lindy Willmott Lindy Willmott formulated the conceptual direction of the chapter, with the other authors, and wrote the first draft of part of the QUT Verified Signature manuscript. She critically revised multiple drafts of the manuscript and approved the final version. Principal Supervisor Confirmation I have sighted email or other correspondence from all co-authors confirming their certifying authorship. Professor Lindy Willmott QUT Verified Signature 9 December 2019 214 Statement of Contribution of Co-Authors for Thesis by Published Papers The authors listed below have certified that: 1. they meet the criteria for authorship in that they have participated in the conception, execution, or interpretation, of at least that part of the publication in their field of expertise; 2. they take public responsibility for their part of the publication, except for the responsible author who accepts overall responsibility for the publication; 3. there are no other authors of the publication according to these criteria; 4. potential conflicts of interest have been disclosed to (a) granting bodies, (b) the editor or publisher of journals or other publications, and (c) the head of the responsible academic unit, and 5. they agree to the use of the publication in the student’s thesis and its publication on the QUT’s ePrints site consistent with any limitations set by publisher requirements. In the case of Chapter 4: Eliana Close, Ben White, Lindy Willmott, Cindy Gallois, Malcolm Parker, Nicholas Graves and Sarah Winch, ‘Doctors’ Perceptions of how Resource Limitations Relate to Futility in End-of-Life Decision Making: A Qualitative Analysis’ (2019) 45 Journal of Medical Ethics 373 Contributor Statement of contribution Eliana Close Eliana Close conceptualised the article, drafted the outline and substantially wrote the manuscript. She conducted the qualitative QUT Verified Signature interviews, developed the data analysis approach for this article and analysed the data. She also contributed to the design of the 23 April 2019 qualitative data collection method for the broader project. Ben White refined the article outline, reviewed select interview Ben White transcripts, contributed to the data analysis, and critically revised QUT Verified Signature the manuscript, approving the final version. He also contributed to the design of the qualitative data collection method for the broader project. Lindy Willmott Lindy Willmott refined the article outline, reviewed select interview transcripts, contributed to the data analysis, and QUT Verified Signature critically revised the manuscript, approving the final version. She also contributed to the design of the qualitative data collection method for the broader project. 215 Cindy Gallois discussed the concept of the article, helped develop the data analysis approach, and critically revised the manuscript, Cindy Gallois approving the final version. She also contributed to the design of the qualitative data collection method for the broader project. Malcolm Parker discussed the concept of the article and critically revised the manuscript, approving the final version. He also Malcolm Parker contributed to the design of the qualitative data collection method for the broader project. Nicholas Graves discussed the concept of the article and critically revised the manuscript, approving the final version. He also Nicholas Graves contributed to the design of the qualitative data collection method for the broader project. Sarah Winch discussed the concept of the article and critically revised the manuscript, approving the final version. She also Sarah Winch contributed to the design of the qualitative data collection method for the broader project. Principal Supervisor Confirmation I have sighted email or other correspondence from all co-authors confirming their certifying authorship. Professor Lindy Willmott QUT Verified Signature 9 December 2019 216 Statement of Contribution of Co-Authors for Thesis by Published Papers The authors listed below have certified that: 1. they meet the criteria for authorship in that they have participated in the conception, execution, or interpretation, of at least that part of the publication in their field of expertise; 2. they take public responsibility for their part of the publication, except for the responsible author who accepts overall responsibility for the publication; 3. there are no other authors of the publication according to these criteria; 4. potential conflicts of interest have been disclosed to (a) granting bodies, (b) the editor or publisher of journals or other publications, and (c) the head of the responsible academic unit, and 5. they agree to the use of the publication in the student’s thesis and its publication on the QUT’s ePrints site consistent with any limitations set by publisher requirements. In the case of Chapter 5: Eliana Close, Lindy Willmott and Benjamin P White, ‘Charlie Gard: In Defence of the Law’ (2018) 44(7) Journal of Medical Ethics 476 Contributor Statement of contribution Eliana Close Eliana Close formulated the conceptual direction of the paper and wrote a detailed outline, based on discussions with the other QUT Verified Signature authors. She substantially wrote the manuscript and approved the 7 August 2019 final version. Lindy Willmott Lindy Willmott contributed to the conceptual direction of the QUT Verified Signature paper, and refined the outline. She critically revised multiple drafts of the manuscript, and approved the final version. Ben White Ben White contributed to the conceptual direction of the paper and refined the outline. He critically revised multiple drafts of the QUT Verified Signature manuscript, and approved the final version. Principal Supervisor Confirmation I have sighted email or other correspondence from all co-authors confirming their certifying authorship. Professor Lindy Willmott QUT Verified Signature 9 December 2019 217 Statement of Contribution of Co-Authors for Thesis by Published Papers The authors listed below have certified that: 1. they meet the criteria for authorship in that they have participated in the conception, execution, or interpretation, of at least that part of the publication in their field of expertise; 2. they take public responsibility for their part of the publication, except for the responsible author who accepts overall responsibility for the publication; 3. there are no other authors of the publication according to these criteria; 4. potential conflicts of interest have been disclosed to (a) granting bodies, (b) the editor or publisher of journals or other publications, and (c) the head of the responsible academic unit, and 5. they agree to the use of the publication in the student’s thesis and its publication on the QUT’s ePrints site consistent with any limitations set by publisher requirements. In the case of Chapter 6: Ben White, Lindy Willmott, Eliana Close and Jocelyn Downie, ‘Withholding and Withdrawing Potentially Life-Sustaining Treatment: Who Should Decide?” in Ian Freckelton and Kerry Petersen (eds), Tensions and Traumas in Health Law (Federation Press, 2017) 454 Contributor Statement of contribution Eliana Close Eliana Close formulated the conceptual direction of the chapter, in discussion with the other authors. She refined the QUT Verified Signature outline and wrote the section ‘Tensions and traumas around treatment disputes’. She critically revised multiple drafts of the 11 July 2019 manuscript and approved the final version. Ben White formulated the conceptual direction of the chapter, Ben White in discussion with the other authors. He developed the outline and wrote the introduction to the manuscript. He critically QUT Verified Signature revised multiple drafts of the manuscript and approved the final version. Lindy Willmott Lindy Willmott formulated the conceptual direction of the chapter, in discussion with the other authors. She refined the outline and contributed to drafting the section ‘Possible legal QUT Verified Signature models for decision-making’. She critically revised multiple drafts of the manuscript and approved the final version. Jocelyn Downie formulated the conceptual direction of the chapter, in discussion with the other authors. She refined the chapter outline and contributed to writing the section ‘How Jocelyn Downie should we regulate decision-making about potentially life- sustaining treatment’. She critically revised multiple drafts of the manuscript and approved the final version. 218 Principal Supervisor Confirmation I have sighted email or other correspondence from all co-authors confirming their certifying authorship. Professor Lindy Willmott QUT Verified Signature 10 December 2019 219 Statement of Contribution of Co-Authors for Thesis by Published Papers The authors listed below have certified that: 1. they meet the criteria for authorship in that they have participated in the conception, execution, or interpretation, of at least that part of the publication in their field of expertise; 2. they take public responsibility for their part of the publication, except for the responsible author who accepts overall responsibility for the publication; 3. there are no other authors of the publication according to these criteria; 4. potential conflicts of interest have been disclosed to (a) granting bodies, (b) the editor or publisher of journals or other publications, and (c) the head of the responsible academic unit, and 5. they agree to the use of the publication in the student’s thesis and its publication on the QUT’s ePrints site consistent with any limitations set by publisher requirements. In the case of Chapter 7: Eliana Close, Malcolm Parker, Lindy Willmott, Ben White and Andrew Crowden, ‘Australian Policies on “Futile” or “Non-Beneficial” Treatment at the End of Life: A Qualitative Content Analysis’ (2019) 27(2) Journal of Law and Medicine 415 Contributor Statement of contribution Eliana Close Eliana Close contributed to the conceptual direction of the paper, drafted an outline and wrote the manuscript. She collected the QUT Verified Signature policies, and developed and executed the analytic approach, with 11 November 2019 input from the other co-authors. Malcolm Parker contributed to the conceptual direction of the Malcolm Parker paper and provided feedback on the outline. He contributed to the QUT Verified Signature data analysis, critically revised multiple drafts of the manuscript and approved the final version. Lindy Willmott Lindy Willmott contributed to the conceptual direction of the QUT Verified Signature paper and provided feedback on the outline. She critically revised multiple drafts of the manuscript and approved the final version. Ben White Ben White contributed to the conceptual direction of the paper and provided feedback on the outline. He critically revised QUT Verified Signature multiple drafts of the manuscript and approved the final version. 220 Andrew Crowden contributed to the conceptual direction of the paper and provided feedback on the outline of the paper. He Andrew Crowden contributed to the data collection and analysis, critically revised multiple drafts of the manuscript and approved the final version. Principal Supervisor Confirmation I have sighted email or other correspondence from all co-authors confirming their certifying authorship. Professor Lindy Willmott QUT Verified Signature 9 December 2019 221 Statement of Contribution of Co-Authors for Thesis by Published Papers The authors listed below have certified that: 1. they meet the criteria for authorship in that they have participated in the conception, execution, or interpretation, of at least that part of the publication in their field of expertise; 2. they take public responsibility for their part of the publication, except for the responsible author who accepts overall responsibility for the publication; 3. there are no other authors of the publication according to these criteria; 4. potential conflicts of interest have been disclosed to (a) granting bodies, (b) the editor or publisher of journals or other publications, and (c) the head of the responsible academic unit, and 5. they agree to the use of the publication in the student’s thesis and its publication on the QUT’s ePrints site consistent with any limitations set by publisher requirements. In the case of Chapter 8: Eliana Close, Ben P White and Lindy Willmott, ‘Balancing Patient and Societal Interests in Decisions About Potentially Life-Sustaining Treatment’ (submitted to the Journal Bioethical Inquiry) Contributor Statement of contribution Eliana Close Eliana Close conceptualised the article and drafted the outline, wrote the first draft of the manuscript, and conducted the QUT Verified Signature qualitative data analysis. She critically revised multiple drafts of 22 November 2019 the manuscript, with input from the other co-authors. Ben White Ben White refined the article outline and methodology and contributed to the data analysis by reviewing documents. He QUT Verified Signature critically revised multiple drafts of the manuscript and approved the final version. Lindy Willmott Lindy Willmott refined the article outline and methodology and iteratively discussed the interpretation of the data. She critically revised multiple drafts of the manuscript and approved the final QUT Verified Signature version. Principal Supervisor Confirmation I have sighted email or other correspondence from all co-authors confirming their certifying authorship. Professor Lindy Willmott QUT Verified Signature 9 December 2019 222 Bibliography A Articles/Books/Reports Abbott, BA et al, ‘Families Looking Back: One Year After Discussion of Withdrawal or Withholding of Life-Sustaining Support’ (2001) 29(1) Critical Care Medicine 197 Allingham, Michael, Distributive Justice (Routledge, 1st ed, 2014) Altheide, David et al, ‘Emergent Qualitative Document Analysis’ in Sharlene Nagy Hesse- Biber and Patricia Leavy (eds), Handbook of Emergent Methods (Guildford Press, 2010) 127 Altheide, David L and Christopher J Schneider, Qualitative Media Analysis (SAGE Publications, 2nd ed, 2013) Angell, Marcia, ‘The Doctor as Double Agent’ (1993) 3(3) Kennedy Institute of Ethics Journal 279 Anstey, Matthew H, John L Adams and Elizabeth A McGlynn, ‘Perceptions of the Appropriateness of Care in California Adult Intensive Care Units’ (2015) 19 Critical Care Medicine 51 Asch, David A and Peter Ubel, ‘Rationing by Any Other Name’ (1997) 336(23) New England Journal of Medicine 1668 Austin, C Adrian et al, ‘Tools to Promote Shared Decision Making in Serious Illness: A Systematic Review’ (2015) 175(7) JAMA Internal Medicine 1213 Azoulay, Elie, Marine Chaize and Nancy Kentish-Barnes, ‘Involvement of ICU Families in Decisions: Fine-Tuning the Partnership’ (2014) 4(1) Annals of Intensive Care 1 Azoulay, Elie et al, ‘Risk of Post-Traumatic Stress Symptoms in Family Members of Intensive Care Unit Patients’ (2005) 171(9) American Journal of Respiratory and Critical Care Medicine 987 Azoulay, Elie et al, ‘Prevalence and Factors of Intensive Care Unit Conflicts: The Conflicus Study’ (2009) 180(9) American Journal of Respiratory and Critical Care Medicine 853 Bagheri, Alireza, ‘Regulating Medical Futility: Neither Excessive Patient’s Autonomy Nor Physician’s Paternalism’ (2008) 15(1) European Journal of Health Law 45 Bagheri, Alireza (ed), Medical Futility: A Cross-National Study (Imperial College Press, 2013) Baily, Mary Ann, ‘Futility, Autonomy, and Cost in End-of-Life Care’ (2011) 39 Journal of Law, Medicine and Ethics 172 223 Ball, Chad G et al, ‘The Impact of Country and Culture on End-of-Life Care for Injured Patients: Results From an International Survey’ (2010) 69(6) The Journal of Trauma: Injury, Infection, and Critical Care 1323 Baylis, Françoise ‘Expert Testimony by Persons Trained in Ethical Reasoning: The Case of Andrew Sawatzky’ (2000) 28(3) Journal of Law, Medicine and Ethics 224 Bernat, James L, ‘Medical Futility: Definition, Determination and Disputes in Critical Care’ (2005) 2(2) Neurocritical Care 198 Beauchamp, Tom L and James F Childress, Principles of Medical Ethics (Oxford University Press, 7th ed, 2013) Bhatia, Neera and James Tibballs, ‘Deficiencies and Missed Opportunities to Formulate Clinical Guidelines in Australia for Withholding or Withdrawing Life-Sustaining Treatment in Severely Disabled and Impaired Infants” (2015) 12(3) Journal of Bioethical Inquiry 449 Birchley, Giles, ‘Harm is All You Need? Best Interests and Disputes about Parental Decision-Making’ (2016) 42(2) Journal of Medical Ethics 111 Bloomer, Melissa J, Alison M Hutchinson and Mari Botti, ‘End-of-Life Care in Hospital: An Audit of Care Against Australian National Guidelines’ (2019) 43(5) Australian Health Review 578 Black, Julia, ‘Critical Reflections on Regulation’ (2002) 27 Australian Journal of Legal Philosophy 1 Bosslet, Gabriel T, Mary Baker and Thaddeus M Pope, ‘Reason-Giving and Medical Futility: Contrasting Legal and Social Discourse in the United States with the United Kingdom and Ontario, Canada’ (2016) 150(3) CHEST 714 Bosslet, Gabriel T, Bernard Lo and Douglas B White, ‘Resolving Family-Clinician Disputes in the Context of Contested Definitions of Futility’ (2018) 60(3) Perspectives in Biology and Medicine 314 Bosslet, Gabriel T et al, ‘An Official ATS/AACN/ACCP/ESICM/SCCM Policy Statement: Responding to Requests for Potentially Inappropriate Treatments in Intensive Care Units' (2015) 191(11) American Journal of Respiratory and Critical Care Medicine 1318 Bowen, Timothy, ‘Using Mediation in Situations of Withholding or Withdrawing Life- Sustaining Treatment: A New South Wales Perspective' (2009) 17(1) Journal of Law and Medicine 74 Boyd, K et al, ‘The Relationship Between Age and the Use of DNR Orders in Critical Care Patients: Evidence for Age Discrimination’ (1996) 156(16) Archives of Internal Medicine 1821 Braun, Virginia and Victoria Clarke, ‘Using Thematic Analysis in Psychology’ (2006) 3(2) Qualitative Research in Psychology 77 224 Breen, Catherine M et al, ‘Conflict Associated with Decisions to Limit Life-Sustaining Treatment in Intensive Care Units’ (2001) 16(5) Journal of General Internal Medicine 283 Brett, Allan S and Laurence B McCullough, ‘Getting Past Words: Futility and the Professional Ethics of Life-Sustaining Treatment’ (2018) 60(3) Perspectives in Biology and Medicine 319 Brick, Claudia et al, ‘Worth Living or Worth Dying? The Views of the General Public about Allowing Disabled Children to Die’ (2019) Journal of Medical Ethics ePub ahead of print, October 15 Brierley, Joe, Jim Linthicum and Andy Petros, ‘Should Religious Beliefs be Allowed to Stonewall a Secular Approach to Withdrawing and Withholding Treatment in Children?’ (2013) 39 Journal of Medical Ethics 573 Brieva, Jorge L, Prashanth Cooray and Martin Rowley, ‘Withholding and Withdrawal of Life-sustaining Therapies in Intensive Care: An Australian Experience’ (2009) 11(4) Critical Care and Resuscitation 266 Broad, Joanna B et al, ‘Where Do People Die? An International Comparison of the Percentage of Deaths Occurring in Hospital and Residential Aged Care Settings in 45 Populations, Using Published and Available Statistics’ (2013) 58(2) International Journal of Public Health 257 Brody, Howard, ‘The Physician’s Role in Determining Futility’ (1994) 42 Journal of the American Geriatric Society 875 Brody, Howard, ‘From an Ethics of Rationing to an Ethics of Waste Avoidance’ (2012) 366(21) New England Journal of Medicine 1949 Brody, Baruch A and Amir Halevy, ‘Is Futility a Futile Concept?’ (1995) 20(2) The Journal of Medicine and Philosophy 123 Brooks, Laura Anne, Elizabeth Manias and Patricia Nicholson, ‘Barriers, Enablers and Challenges to Initiating End-of-Life Care in an Australian Intensive Care Unit Context’ (2017) 30(3) Australian Critical Care 161 Brush, David R et al, ‘Recommendations to Limit Life Support: A National Survey of Critical Care Physicians’ (2012) 186(7) American Journal of Respiratory and Critical Care Medicine 633 Burns, Jeffrey P and Robert D Truog, ‘Futility: A Concept in Evolution’ (2007) 132(6) Chest 1987 Cardona-Morrell, Magnolia et al, ‘Non-Beneficial Treatments in Hospital at the End of Life: a Systematic Review on Extent of the Problem’ (2016) 28(4) International Journal for Quality in Health Care 456 225 Caplan, Arthur L, ‘Little Hope for Medical Futility’ (2012) 87(11) Mayo Clinic Proceedings 1040 Carney, Terry and David Tait. The Adult Guardianship Experiment: Tribunals & Popular Justice (Federation Press, 1997) Carter, Hannah E et al, ‘Incidence, Duration and Cost of Futile Treatment in End-of-Life Hospital Admissions to Three Australian Public-Sector Tertiary Hospitals: A Retrospective Multicentre Cohort Study’ (2017) 7(10) BMJ Open e017661 Cassel, Christine K and Jon C Tilburt, ‘Why the Ethics of Parsimonious Medicine is not the Ethics of Rationing’ (2013) 309(8) JAMA 773 Charles, Cathy, Amiram Gafni and Tim Whelan, ‘Decision-Making in the Physician–Patient Encounter: Revisiting the Shared Treatment Decision-Making Model’ (1999) 49(5) Social Science & Medicine 651 Chidwick, Paula, Robert Sibbald and Laura Hawryluck, ‘Best Interests at End of Life: An Updated Review of Decisions made by the Consent and Capacity Board of Ontario’ (2013) 28 Journal of Critical Care 22 Close, Eliana et al, ‘Doctors’ Perceptions of How Resource Limitations Relate to Futility in End-of-Life Decision Making: A Qualitative Analysis’ (2019) 45 Journal of Medical Ethics 373 Close, Eliana, Lindy Willmott and Benjamin P White, ‘Charlie Gard: In Defence of the Law’ (2018) 44(7) Journal of Medical Ethics 476 Coast, Joanna ‘The Rationing Debate: Rationing within the NHS Should be Explicit - The Case Against’ (1997) 314(7087) BMJ 1118 Cockburn, Tina and Des Butler, ‘Negligence’ in Ben White, Fiona McDonald and Lindy Willmott (eds), Health Law in Australia (Thomson Reuters, 3rd ed, 2018) 271 Cohen, Alan B, ‘The Debate Over Health Care Rationing: Déjà Vu All Over Again?’ (2012) 49(2) Inquiry 90 Cookson, Richard ‘Can the NICE “End-of-Life” Premium Be Given a Coherent Ethical Justification?’ (2013) 38(6) Journal of Health Politics, Policy and Law 1129. Cooper, Andrew B et al, ‘Scarcity: The Context of Rationing in an Ontario ICU’ (2013) 41(6) Critical Care Medicine 1476 Couët, Nicolas et al, ‘Assessments of the Extent to which Health-Care Providers Involve Patients in Decision Making: A Systematic Review of Studies Using the OPTION Instrument’ (2015) 18(4) Health Expectations 542 226 Courtwright, Andrew M et al, ‘Experience With a Hospital Policy on Not Offering Cardiopulmonary Resuscitation When Believed More Harmful Than Beneficial’ (2015) 30(1) Journal of Critical Care 173 Creyke, Robin et al, Control of Government Action: Text, Cases & Commentary (LexisNexis Butterworths, 5th ed, 2019) Curnow, Kate, ‘End-of-Life Decision-Making in a Health Services Setting: An Access to Justice Lens’ (2016) 23(4) Journal of Law and Medicine 886 Curnow, Kate and Lisa Toohey, ‘A Focus On Process: Procedures To Address Disputes about End of Life Decisions’ (2013) 24 Australasian Dispute Resolution Journal 45 Curtis, J Randall and Robert A Burt, ‘Why are Critical Care Clinicians so Powerfully Distressed by Family Demands for Futile Care?' (2003) 18(1) Journal of Critical Care 22 Daniels, Norman, ‘Accountability for Reasonableness’ (2000) 321(7272) BMJ 1300 Danjoux Meth, Nathalie, Bernard Lawless and Laura Hawryluck, ‘Conflicts in the ICU: Perspectives of administrators and clinicians’ (2009) 35(12) Intensive Care Medicine 2068 Deliens, Luc et al, ‘End-of-Life Decisions In Medical Practice In Flanders, Belgium: A Nationwide Survey’ (2000) 356(9244) The Lancet 1806 Davidson, Gavin et al, ‘An International Comparison of Legal Frameworks for Supported and Substitute Decision-Making in Mental Health Services’ (2016) 44 International Journal of Law and Psychiatry 30 deBronkart, Dave, ‘From Patient Centred to People Powered: Autonomy on the Rise’ (2015) 350 BMJ h148 Degner, Lesley F and Jeffrey A Sloan, ‘Decision Making During Serious Illness: What Role do Patients Really Want to Play?’ (1992) 45(9) Journal of Clinical Epidemiology 941. Deliens, Luc et al, ‘End-of-Life Decisions in Medical Practice in Flanders, Belgium: A Nationwide Survey’ (2000) 356(9244) The Lancet 1806 Detering, Karen M et al, ‘The Impact of Advance Care Planning on End of Life Care in Elderly Patients: Randomised Controlled Trial’ (2010) 340(7751) BMJ c1345 Dick, Robert, Convergent Interviewing (Interchange, 1990) Donley, Greer and Marion Danis, ‘Making the Case for Talking to Patients About the Costs of End-Of-Life Care’ (2011) 39 Journal of Law, Medicine and Ethics 183 Doukas, David J and Laurence B McCullough, ‘A Preventive Ethics Approach to Counseling Patients about Clinical Futility in the Primary Care Setting’ (1996) 5(10) Archives of Family Medicine 589 227 Downar, James et al, ‘Withholding and Withdrawing Treatment in Canada: Implications of the Supreme Court of Canada’s Decision in the Rasouli Case’ (2014) 186(16) CMAJ E622 Downar, James et al, ‘Nonbeneficial Treatment Canada: Definitions, Causes, and Potential Solutions from the Perspective of Healthcare Practitioners’ (2015) 43 Critical Care Medicine 270 Downar, James, Eliana Close and Robert Sibbald, ‘Do Physicians Require Consent to Withhold CPR that they Determine to be Nonbeneficial?’ (2019) 191(147) CMAJ E1289 Downie, Jocelyn and Jennifer Llewellyn, ‘Relational Theory & Health Law and Policy’ [2008] Health Law Journal 193 Downie, Jocelyn and Karen McEwen, ‘The Manitoba College of Physicians and Surgeons Position Statement on Withholding and Withdrawal of Life-Sustaining Treatment (2008): Three Problems and a Solution’ (2009) 17 Health Law Journal 115 Downie, Jocelyn, Lindy Willmott and Benjamin P White, ‘Cutting the Gordian Knot of Futility: A Case for Law Reform on Unilateral Withholding and Withdrawal of Potentially Life-Sustaining Treatment’ (2014) 26(1) New Zealand Universities Law Review 24 Downie Jocelyn, Lindy Willmott and Benjamin White, ‘Next Up: A Proposal for Values- Based Law Reform on Unilateral Withholding and Withdrawal of Potentially Life-Sustaining Treatment’ (2017) 54 Alberta Law Review 803 Driedger, S Michelle et al, ‘Finding Common Ground in Team-Based Qualitative Research Using the Convergent Interviewing Method’ (2006) 16(8) Qualitative Health Research 1145 Dzeng, Elizabeth et al, ‘Moral Distress Amongst American Physician Trainees Regarding Futile Treatments at the End Of Life: A Qualitative Study’ (2016) 31(1) Journal of General Internal Medicine 93 Engelhardt, H Tristram and George Khushf, ‘Futile Care for the Critically Ill Patient’ (1995) 1(4) Current Opinion in Critical Care 329 Esbati, Anahita, et al, ‘Legislation, Policies and Guidelines Related to Breastfeeding and the Baby Friendly Health Initiative in Australia: A Document Analysis’ (2018) 42(1) Australian Health Review 72 Escher, Monica et al, ‘Doctors' Decisions When Faced with Contradictory Patient Advance Directives and Health Care Proxy Opinion: A Randomized Vignette-Based Study’ (2015) 49(3) Journal of Pain and Symptom Management 637 Fassier, Thomas and Elie Azoulay, ‘Conflicts and Communication Gaps in the Intensive Care Unit’ (2010) 16 Current Opinion in Critical Care 654 Fassier, Thomas et al, ‘Who Am I to Decide Whether This Person Is to Die Today? Physicians’ Life-or-Death Decisions for Elderly Critically Ill Patients at the Emergency Department–ICU Interface: A Qualitative Study’ 68(1) Annals of Emergency Medicine 28 228 Faunce, Thomas A and Cameron Stewart, ‘The Messiha and Schiavo Cases: Third-Party Ethical Interventions in Futile Care Disputes’ (2005) 183(5) Medical Journal of Australia 261 Fleck, Leonard M, ‘Choosing Wisely is Parsimonious Care Just Rationing?’ (2016) 25(3) Cambridge Quarterly of Healthcare Ethics 366 Flessas, Tatiana and Emily Jackson, ‘Too Expensive to Treat? Non-Treatment Decisions at the Margins of Viability’ (2019) 27(3) Medical Law Review 461 Forbat Liz and Sarah Barclay, ‘Reducing Healthcare Conflict: Outcomes From Using The Conflict Management Framework’ (2019) 104(4) Archives of Disease in Childhood 328 Foreman, Linda M et al, ‘Factors Predictive of Preferred Place of Death in the General Population of South Australia’ (2006) 20(4) Palliative Medicine 447 Forte, Daniel et al, ‘Association Between Education in EOL Care and Variability in EOL Practice: A Survey of ICU Physicians’ (2012) 38(3) Intensive Care Medicine 404 Frank, Rosanna Kay, ‘Shared Decision Making and its Role in End of Life Care’ (2009) 18(10) British Journal of Nursing 612 Freckelton, Ian, ‘Futility of Treatment for Dying Children: Lessons from the Charlie Gard Case’ (2017) 25 Journal of Law and Medicine 7. Freckelton, Ian, ‘Responding Better to Desperate Parents: Warnings from the Alfie Evans Saga’ (2018) 25(4) Journal of Law and Medicine 918 Frick, Sonia, Dominik E Uehlinger and Regula M Zuercher Zenklusen, ‘Medical Futility: Predicting Outcome in Intensive Care Unit Patients by Nurses and Doctors – A Prospective Comparative Study’ (2003) 31(2) Critical Care Medicine 456 Fried, Terri R et al, ‘Understanding the Treatment Preferences of Seriously Ill Patients’ (2002) 346(14) The New England Journal of Medicine 1061 Friedman, Alex, ‘Beyond Accountability for Reasonableness’ (2008) 22(2) Bioethics 101 Frost, David W et al, ‘Patient and Healthcare Professional Factors Influencing End-of-Life Decision-Making During Critical Illness: A Systematic Review’ (2011) 39(5) Critical Care Medicine 1174 Gabbay, Ezra et al, ‘The Empirical Basis for Determinations of Medical Futility’ (2010) 25 Journal of General Internal Medicine 1083 Garros, Daniel, Rhonda J Rosychuk and Peter N Cox, ‘Circumstances Surrounding End of Life in a Pediatric Intensive Care Unit” (2003) 112(5) Pediatrics E371 229 Giannini, A and D Consonni, ‘Physicians’ Perceptions and Attitudes Regarding Inappropriate Admissions and Resource Allocation in the Intensive Care Setting’ (2006) 96(1) British Journal of Anaesthesia 57 Gibson, Jennifer L, Douglas K Martin and Peter A Singer, ‘Priority Setting in Hospitals: Fairness, Inclusiveness, and the Problem of Institutional Power Differences’ (2005) 61(1) Social Science & Medicine 2355 Goodridge, Donna, ‘End of Life Care Policies: Do They Make A Difference in Practice?’ (2010) 70(8) Social Science and Medicine 1166 Goold, Susan Door, Brent Williams and Robert M Arnold, ‘Conflicts Regarding Decisions to Limit Treatment: A Differential Diagnosis’ (2000) 283(7) Journal of the American Medical Association 909 Grace, Robert F, ‘The Case for Legislation: Explicit Rather Than Implicit Rationing (Who Gets into the ICU and Who Doesn’t)’ (2016) 18(1) Critical Care and Resuscitation 62 Hack, Thomas F et al, 'Do Patients Benefit from Participating in Medical Decision Making? Longitudinal Follow‐Up of Women with Breast Cancer' (2006) 15(1) Psycho‐Oncology 9 Halvorsen, Kristin, Reidun Førde and Per Nortvedt, ‘The Principle of Justice in Patient Priorities in the Intensive Care Unit: The Role of Significant Others’ (2009) 35(8) Journal of Medical Ethics 483 Hawryluck, Laura, ‘Ethics Review: Position Papers and Policies: Are They Really Helpful to Front-Line ICU Teams?’ (2006) 10(6) Critical Care 242 Hawryluck, Laura et al, ‘The Future of Decision-Making in Critical Care after Cuthbertson v Rasouli’ (2014) 61(10) Canadian Journal of Anaesthesiology 951 Heimer, Carol A, ‘The Unstable Alliance of Law and Morality’ in Steven Hitlin and Stephen Vaisey (eds), Handbook of the Sociology of Morality (Springer, 2010) 179al Helft, Paul R, Mark Siegler and John Lantos, ‘The Rise and Fall of the Futility Movement’ (2000) 343 New England Journal of Medicine 293 Henrich, Natalie J et al, ‘Causes of Moral Distress in the Intensive Care Unit: A Qualitative Study’ (2016) 35 Journal of Critical Care 57 Heyland, Daren K et al, ‘Understanding Cardiopulmonary Resuscitation Decision Making: Perspectives of Seriously Ill Hospitalized Patients and Family Members’ (2006) 130(2) CHEST 419 Higginson, Irene J et al, ‘Dying at Home - Is It Better? A Narrative Appraisal of the State of the Science’ (2013) 27(10) Palliative Medicine 918 230 Hill, Terry E, ‘How Clinicians Make (or Avoid) Moral Judgments of Patients: Implications of the Evidence for Relationships and Research’ (2010) 5 Philosophy, Ethics, and Humanities in Medicine 11 Hinkka, H et al, 'Factors Affecting Physicians’ Decisions to Forgo Life-Sustaining Treatments in Terminal Care’ (2002) 28 Journal of Medical Ethics 109 Hope, Tony, John McMillan and Elaine Hill, ‘Intensive Care Triage: Priority Should Be Independent of Whether Patients are Already Receiving Intensive Care’ (2012) 26(5) Bioethics 259 Hope, Tony, David Sprigings and Roger Crisp, ‘“Not Clinically Indicated”: Patients’ Interests or Resource Allocation?’ (1993) 306(6874) BMJ 379 Hurley, Richard, ‘How a fight for Charlie Gard became a fight against the state’ (2017) 358 BMJ j3675 Hurst, Samia A et al, ‘Prevalence and Determinants of Physician Bedside Rationing: Data From Europe’ (2006) 21(11) Journal of General Internal Medicine 1138 Huynh, Thanh N et al, ‘The Opportunity Cost of Futile Treatment in the ICU’ (2014) 42(9) Critical Care Medicine 1977 Huynh, Thanh N et al, ‘The Frequency and Cost of Treatment Perceived to be Futile in Critical Care’ (2013) 173(20) JAMA Internal Medicine 1887 Jackson, Emily, ‘The Relationship Between Medical Law and Good Medical Ethics’ (2015) 41 Journal of Medical Ethics 95 Jackson, Emily, Medical Law: Text, Cases, and Materials (Oxford University Press, 4th ed, 2016) Jecker, Nancy S, Schneiderman Lawrence J, ‘Futility and Rationing’ (1992) 92(2) The American Journal of Medicine 189 Johnson, Sara K et al, ‘An Empirical Study of Surrogates’ Preferred Level of Control Over Value-Laden Life Support Decisions in Intensive Care Units’ (2011) 183(7) American Journal of Respiratory and Critical Care Medicine 915. Jox, Ralf J et al, ‘Medical Futility at the End of Life: The Perspectives of Intensive Care and Palliative Care Clinicians’ (2012) 38(9) Journal of Medical Ethics 540 Kaposy, Chris et al, ‘The Distinction Between Withholding and Withdrawing Treatment in Rasouli: Providing a Solution to an Ethical Problem’ (2014) 21 Health Law Journal 29 Kardamanidis, K et al, ‘Hospital Costs of Older People in New South Wales in the Last Year of Life’ (2007) 187(7) Medical Journal of Australia 383 231 Kerridge, Ian, Michael Lowe and Cameron Stewart, Ethics and Law for the Health Professions (Federation Press, 4th ed, 2013) Kirby, Jeffrey, ‘Balancing Legitimate Critical-Care Interests: Setting Defensible Care Limits Through Policy Development’ (2016) 16(1) American Journal of Bioethics 38 Knaus, William A et al, ‘The APACHE III Prognostic System: Risk Prediction of Hospital Mortality for Critically III Hospitalized Adults’ (1991) 100(6) CHEST 1619 Kon, Alexander A, ‘Defining Futile and Potentially Inappropriate Interventions: A Policy Statement from the Society of Critical Care Medicine Ethics Committee’ (2016) 44(9) Critical Care Medicine 1769 Krakauer, Eric L, Christopher Crenner and Ken Fox, ‘Barriers to Optimum End-of-Life Care for Minority Patients’ (2002) 50(1) Journal of the American Geriatrics Society 182 Kuhse, Helga et al, ‘End-of-Life Decisions in Australian Medical Practice’ (1997) 166(4) Medical Journal of Australia 191 Langton, Julia M et al, ‘Retrospective Studies of End-of-Life Resource Utilization and Costs In Cancer Care Using Health Administrative Data: A Systematic Review' (2014) 13(1) Palliative Medicine 1167 Langton, Julia M et al, ‘Resource Use, Costs and Quality of End-of-Life Care: Observations in a Cohort of Elderly Australian Cancer Decedents’ (2015) 10(1) Implementation Science 25 Lantos, John, ‘Intractable Disagreements about Futility’ (2018) 60(3) Perspectives in Biology and Medicine 390 Lantos, John D et al, ‘The Illusion of Futility in Medical Practice’ (1989) 87 American Journal of Medicine 81 Lantos, John D and William L Meadow, ‘Should the “Slow Code” Be Resuscitated?’ (2011) 11(11) American Journal of Bioethics 8 Larcher, Vic, et al, ‘Making Decisions to Limit Treatment in Life-Limiting and Life- Threatening Conditions in Children: A Framework for Practice’ (2015) 100(Suppl 2) Archives of Disease in Childhood S1 Larochelle, MR et al, ‘Hospital Staff Attributions of the Causes of Physician Variation in End-of-Life Treatment Intensity’ (2009) 23 Palliative Medicine 460 Lawrence, Sean et al, ‘Autonomy Versus Futility? Barriers to Good Clinical Practice in End- of-Life Care: A Queensland Case’ (2012) 196(6) Medical Journal of Australia 404 Leland, Brian D et al, ‘Futility Disputes: A Review of the Literature and Proposed Model for Dispute Navigation Through Trust Building’ (2017) 32(9) Journal of Intensive Care Medicine 532 232 Le Conte, Philippe et al, ‘Death in Emergency Departments: A Multicenter Cross-Sectional Survey with Analysis of Withholding and Withdrawing Life Support’ (2010) 36(5) Intensive Care Medicine 765 Le Gall, Jean-Roger, Stanley Lemeshow and Fabienne Saulnier, ‘A new Simplified Acute Physiology Score (SAPS II) Based on a European/North American Multicenter Study’ (1993) 270(24) JAMA 2957 Lemiengre, Joke et al, ‘Institutional Ethics Policies on Medical End-of-Life Decisions: A Literature Review’ (2007) 83(2) Health Policy 131 Levinsky, Norman G, ‘The Doctor’s Master’ (1984) 311(24) New England Journal of Medicine 1573 Levinson, M et al, ‘Comparison of Not For Resuscitation (NFR) Forms Across Five Victorian Health Services’ (2014) 44(7) Internal Medicine Journal 671 Linney, Mike et al, ‘Achieving Consensus Advice for Paediatricians and Other Health Professionals on Prevention, Recognition and Management of Conflict in Paediatric Practice’ (2019) 104(5) Archives of Disease in Childhood 413 Locock, Louise ‘The Changing Nature of Rationing in the UK National Health Service’ (2000) 78(1) Public Administration 91 Löfmark, Rurik et al, ‘Physicians’ Experiences with End-of-Life Decision-Making: Survey in 6 European Countries and Australia’ (2008) 6(1) BMC Medicine 4 Long, Ann C and Randall J Curtis, ‘The Epidemic of Physician-Family Conflict in the ICU and What We Should Do About It’ (2014) 42(2) Critical Care Medicine 461 Luce, JM, ‘The Uncommon Case of Jahi McMath’ (2015) 147(4) CHEST 1144 Luce, John M and Douglas B White, ‘The Pressure to Withhold or Withdraw Life-sustaining Therapy from Critically Ill Patients in the United States’ (2007) 175(11) American Journal of Respiratory and Critical Care Medicine 1104 Madrigal, Vanessa N et al, ‘Parental Decision-Making Preferences in the Pediatric Intensive Care Unit’ (2012) 40(10) Critical Care Medicine 2876 Malloy, DC et al, ‘Ethical Decision-Making about Older Adults and Moral Intensity: An International Study of Physicians’ (2008) 34(4) Journal of Medical Ethics 285 Manning, Joanna, ‘Withdrawal of Life-Sustaining Treatment from a Patient in a Minimally Conscious State’ (2012) 19(3) Journal of Law and Medicine 430 Manning, Joanna, ‘Q: Can a Court or Patient Demand Treatment? A: Yeah but No’ (2018) 25 Journal of Law and Medicine 626 233 Manning, Joanna and Ron Paterson, ‘“Prioritization”: Rationing Health Care in New Zealand’ (2005) 33(4) The Journal of Law, Medicine & Ethics 681 Martin, Dominique, ‘Medical futility in Australia’ in Alireza Bagheri (ed), Medical Futility: A Cross-National Study (Imperial College Press, 2013) 119 Maxwell, Joseph A, A Realist Approach for Qualitative Research (SAGE Publications, 2012) McDonald, Fiona, ‘The Legal System and the Legitimacy of Clinical Guidelines’ (2017) 24 Journal of Law and Medicine 821 McDonald, Fiona and Deanna Sedgwick Fincher, ‘The Legal Framework of the Australian Health System’ in Ben White, Fiona McDonald and Lindy Willmott (eds), Health Law in Australia (Thomson Reuters, 3rd ed, 2018) McDougall, Rosalind J and Lauren Notini, ‘Overriding Parents’ Medical Decisions for their Children: A Systematic Review of Normative Literature’ (2014) 40(7) Journal of Meidcal Ethics 448. McDougall, Rosalind, Lauren Notini and Jessica Phillips, ‘Conflicts Between Parents and Health Professionals about a Child’s Medical Treatment: Using Clinical Ethics Records to Find Gaps in the Bioethics Literature’ (2015) 12(3) Journal of Bioethical Inquiry 429 McGee, Andrew and Dale Gardiner ‘Differences in the Definition of Brain Death and Their Legal Impact on Intensive Care Practice’ (2019) 74(5) Anaesthesia 569 McMillan, John, ‘Clinical Ethics and the Duty of Care’ (2019) 45 Journal of Medical Ethics 355. Meadow, William et al, ‘Power and Limitations of Daily Prognostications of Death in the Medical Intensive Care Unit’ (2011) 39(3) Critical Care Medicine 474 Miles, Matthew B, A Michael Huberman and Johnny Saldaña, Qualitative Data Analysis: A Methods Sourcebook (SAGE Publications, 3rd ed, 2014) Miles, Steven H, ‘Informed Demand for Non-Beneficial Medical Treatment’ (1991) 325(7) New England Journal of Medicine 512 Mills AC et al, ‘Testing a New Form to Document “Goals‐Of‐Care” Discussions Regarding Plans for End‐Of‐Life Care for Patients in an Australian Emergency Department’ (2018) 30(6) Emergency Medicine Australasia 777 Misak Cheryl J, Douglas B White and Roberd D Truog, ‘Medical Futility: A New Look at an Old Problem’ (2014) 146(6) CHEST 1667 Mobley, Melinda J et al, ‘The Relationship Between Moral Distress and Perception of Futile Care in the Critical Care Unit’ (2007) 23 Intensive and Critical Care Nursing 256 234 Montello, Martha, ‘Introduction to the Special Issue’ (2018) 60(3) Perspectives in Biology and Medicine 293 Moratti, S, ‘The Development of “Medical Futility”: Towards a Procedural Approach Based on the Role of the Medical Profession’ (2009) 35(6) Journal of Medical Ethics 369 Morgan, Bronwen and Karen Yeung, An Introduction to Law and Regulation (Cambridge University Press, 2007) Mueller, Paul S and C Christopher Hook, ‘Technological and Treatment Imperatives, Life- Sustaining Technologies, and Associated Ethical and Social Challenges’ (2013) 88 Mayo Clinic Proceedings 641 Murphy, Donald J et al, ‘The Influence of the Probability of Survival on Patients' Preferences Regarding Cardiopulmonary Resuscitation’ (1994) 330(8) The New England Journal of Medicine 545 Nair-Collins, Michael, ‘Laying Futility to Rest’ (2015) 5 Journal of Medicine and Philosophy 554 Nates, Joseph L et al, ‘ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research’ (2016) 44(8) Critical Care Medicine 1553 Neville, Thanh H et al, ‘Understanding Factors Contributing to Inappropriate Critical Care: A Mixed-Methods Analysis of Medical Record Documentation’ (2017) 20(11) Journal of Palliative Medicine 1260 Neville, Thanh H et al, ‘Differences Between Attendings’ And Fellows’ Perceptions Of Futile Treatment In The Intensive Care Unit At One Academic Health Center: Implications For Training’ (2015) 90(3) Academic Medicine 324 Newdick Christopher, Who Should We Treat? Rights and Rationing in the NHS (Oxford University Press, 2nd ed, 2005) Newson, Ainsley J, ‘The Value of Clinical Ethics Support in Australian Health Care’ (2015) 202(11) Medical Journal of Australia 568 Oerlemans, Anke JM et al, ‘Rationing in the Intensive Care Unit in Case of Full Bed Occupancy: A Survey Among Intensive Care Unit Physicians’ (2016) 16(1) BMC Anesthesiology 25 Orentlicher, David, Matters of Life and Death: Making Moral Theory Work in Medical Ethics and the Law (Princeton University Press, 2001) Owen-Smith, Amanda, Joanna Coast and Jenny Donovan, ‘The Desirability of Being Open about Health Care Rationing Decisions: Findings from a Qualitative Study of Patients and Clinical Professionals’ (2010) 15(1) Journal of Health Services Research and Policy 14 235 Palda, Valerie A et al, ‘“Futile” Care: Do We Provide It? Why? A Semistructured, Canada- Wide Survey of Intensive Care Unit Doctors and Nurses’ (2005) 20(3) Journal of Critical Care 207 Paris, JJ et al, ‘The Charlie Gard Case: British and American Approaches to Court Resolution of Disputes Over Medical Decisions’ (2017) 37(12) Journal of Perinatology 1268 Parker, Christine and John Braithwaite, ‘Regulation’ in Mark Tushnet and Peter Cane (eds) The Oxford Handbook of Legal Studies (Oxford University Press, 2005) 119 Parker, Malcolm, ‘Getting the Balance Right: Conceptual Considerations Concerning Legal Capacity and Supported Decision-Making’ (2016) 13 Bioethical Inquiry 381 Parker, Malcolm H, Colleen M Cartwright and Gail M Williams, ‘Impact of Specialty on Attitudes of Australian Medical Practitioners to End-of-Life Decisions' (2008) 188(8) Medical Journal of Australia 450 Persad, Govind, ‘Transparency Trade-offs: Priority Setting, Scarcity, and Health Fairness’ in Holly Fernandez Lynch et al (eds), Transparency in Health and Health Care in the United States (Cambridge University Press, 2019) Persad, Govind, Alan Wertheimer and Ezekiel J Emanuel, ‘Principles for Allocation of Scarce Medical Interventions’ (2009) 373(9661) The Lancet 423 Petrinec, Amy B et al, ‘Coping Strategies and Posttraumatic Stress Symptoms in Post-ICU Family Decision Makers’ (2015) 43(6) Critical Care Medicine 1205 Pieterse, Arwen H, Anne M Stiggelbout and Victor M Montori, ‘Shared Decision Making and the Importance of Time’ (2019) 322(1) JAMA 25 Piers, Ruth D et al, ‘Perceptions of Appropriateness of Care Among European and Israeli Intensive Care Unit Nurses and Physicians’ (2011) 306 Journal of the American Medical Association 2964 Ponterotto, Joseph G, ‘Brief Note on the Origins, Evolution and Meaning of the Qualitative Research Concept “Thick Description”’ (2006) 11(3) The Qualitative Report 538 Pope, Thaddeus Mason, ‘The Case of Samuel Golubchuk: The Dangers of Judicial Deference and Medical Self-Regulation’ (2010) 10(3) American Journal of Bioethics 59. Pope, Thaddeus Mason, ‘The Best Interest Standard: Both Guide and Limit to Medical Decision Making on Behalf of Incapacitated Patients’ (2011) 22(2) Journal of Clinical Ethics 134 Pope, Thaddeus Mason, ‘The Growing Power of Healthcare Ethics Committees Heightens Due Process Concerns’ (2013) 15 Cardozo Journal of Conflict Resolution 425 Pope, Thaddeus Mason, ‘The Texas Advanced Directives Act: Must a Death Panel be a Star Chamber?’ (2015) 15(8) The American Journal of Bioethics 41 236 Pope, Thaddeus Mason, ‘Dispute Resolution Mechanisms for Intractable Medical Futility Disputes’ (2016) 58 New York Law School Law Review 347 Pope, Thaddeus Mason, ‘Texas Advance Directives Act: Nearly a Model Dispute Resolution Mechanism for Intractable Medical Futility Conflicts’ (2016) 16 QUT Law Review 22 Pope, Thaddeus Mason, ‘Medical Futility and Potentially Inappropriate Treatment: Better Ethics with More Precise Definitions and Language’ (2018) 60(3) Perspectives in Biology and Medicine 423 Pope, Thaddeus M and Kristin Kemmerling, ‘Legal Briefing: Stopping Nonbeneficial Life- Sustaining Treatment without Consent’ (2016) 27(3) Journal of Clinical Ethics 254 Quill, Caroline M et al, ‘Variation in Decisions to Forgo Life-Sustaining Therapies in US ICUs’ (2014) 146(3) CHEST 573 Rivera, Seth et al, ‘Motivating Factors in Futile Clinical Interventions’ (2001) 119(6) CHEST 1944 Rivin, Arthur U, ‘Futile Care Policy - Lessons Learned From Three Years’ Experience in a Community Hospital’ (1997) 166(6) Western Journal of Medicine 389 Robert, René et al, ‘Influence of ICU-Bed Availability on ICU Admission Decisions’ (2015) 5(1) Annals of Intensive Care 1 Rosenwax, Lorna K et al, ‘Hospital and Emergency Department Use in the Last Year of Life: A Baseline for Future Modifications to End‐of‐Life Care’ (2011) 194(11) Medical Journal of Australia 570 Rubin, Michael A and Robert D Truog, ‘What to Do When There Aren’t Enough Beds in the PICU’ (2017) 19(2) AMA Journal of Ethics 157 Rubin, Susan B, ‘If We Think It’s Futile, Can’t We Just Say No?’ (2007) 19(1) HEC Forum 45 Savulescu, Julian, ‘Just Dying: The Futility Of Futility’ (2013) 39(9) Journal of Medical Ethics 583 Savulescu, Julian, ‘Is it in Charlie Gard’s Best Interest to Die?’ (2017) 389 (10082) The Lancet 1868 Seale, Clive ‘The Role of Doctors’ Religious Faith and Ethnicity in Taking Ethically Controversial Decisions During End-of-Life Care’ (2010) 36 Journal of Medical Ethics 677 Scheunemann, Leslie P and Douglas B White, ‘The Ethics and Reality of Rationing in Medicine’ (2011) 140(6) CHEST 1625 237 Scheunemann, Leslie P and Douglas B White, ‘The Physician as Rationer: Uncertainty about the Physician’s Role Obligations’ (2012) 33(4) Seminars in Respiratory and Critical Care Medicine 421 Scheunemann LP et al, ‘Clinician-Family Communication About Patients’ Values and Preferences in Intensive Care Units’ (2019) 179(5) JAMA 676 Schneiderman, Lawrence J, ‘Defining Medical Futility and Improving Medical Care’ (2011) 8 Journal of Bioethical Inquiry 123 Schneiderman, Lawrence J and Nancy S Jecker, Wrong Medicine: Doctors, Patients, and Futile Treatment (Johns Hopkins University Press, 2nd ed, 2011) Schneiderman, Lawrence J, Nancy S Jecker and Albert R Jonsen, ‘Medical Futility: Its Meaning and Ethical Implications’ (1990) 112 Annals of Internal Medicine 949 Schuster, Rachel A et al, ‘Investigating Conflict in ICUs - Is the Clinicians’ Perspective Enough?’ (2014) 42(2) Critical Care Medicine 328 Sen, Amartya, Inequality Reexamined (Russell Sage, 1995) Seale, Clive, ‘Changing Patterns of Death and Dying’ (2000) 51 Social Science Medicine 917 Shah, Seema K, Abby R Rosenberg, Douglas S Diekema, ‘Charlie Gard and the Limits of Best Interests’ (2017) 171(10) JAMA Pediatrics 937 Sibbald, Robert, James Downar and Laura Hawryluck, ‘Perceptions of “Futile Care” Among Caregivers in Intensive Care Units’ (2007) 177(10) CMAJ 1201 Singer, Peter A et al, ‘Hospital Policy on Appropriate Use of Life-Sustaining Treatment’ (2001) 29(1) Critical Care Medicine 187 Singal, Rohit K et al, ‘A Prospective Determination of the Incidence of Perceived Inappropriate Care in Critically Ill Patients’ (2014) 21 Canadian Respiratory Journal 165 Sinuff, Tasnim et al, ‘Rationing Critical Care Beds: A Systematic Review' (2004) 32(7) Critical Care Medicine 1588 Skene, Loane, ‘The Schiavo and Korp Cases: Conceptualising End-of-Life Decision-Making’ (2005) 13 Journal of Law and Medicine 223 Smith, Martin L, ‘Medical Inappropriateness Review: Appropriately Performed by a Medical Committee’ (2008) 18(2) Health Matrix 234 Solomon, Mildred Z, ‘How Physicians Talk About Futility: Making Words Mean Too Many Things’ (1993) 21(2) The Journal of Law, Medicine & Ethics 231 Sprung, Charles L et al, ‘End-of-Life Practices in European Intensive Care Units: The Ethicus Study’ (2003) 290(6) JAMA 790 238 Stewart, Cameron, ‘Futility Determination as a Process: Problems with Medical Sovereignty, Legal Issues and the Strengths and Weakness of the Procedural Approach’ (2011) 8(2) Journal of Bioethical Inquiry 155 Stewart, Cameron L, ‘A Defence of the Requirement to Seek Consent to Withhold and Withdraw Futile Treatments’ (2012) 196(6) Medical Journal of Australia 406 Stienstra, Deborah and Harvey Max Chochinov, ‘Vulnerability, Disability, and Palliative End-of-Life Care’ (2006) 22(3) Journal of Palliative Care 166 Strech, Daniel, Matthis Synofzik and Georg Marckmann, ‘How Physicians Allocate Scarce Resources at the Bedside: A Systematic Review of Qualitative Studies’ (2008) 33(1) Journal of Medicine and Philosophy 80 Strech, Daniel et al, ‘Are Physicians Willing to Ration Health Care? Conflicting Findings in A Systematic Review of Survey Research’ (2009) 90 Health Policy 113 Street, Jackie et al, ‘The Use of Citizens’ Juries in Health Policy Decision-Making: A Systematic Review’ (2014) 109 Social Science and Medicine 1 Swerissen, Hal and Stephen Duckett, Dying Well (Grattan Institute, September 2014) Syrett, Keith, Law, Legitimacy and the Rationing of Health Care: A Contextual and Comparative Perspective (Cambridge University Press, 2007) Then, Shih-Ning, ‘Evolution and Innovation in Guardianship Laws: Assisted Decision- making’ (2013) 35 Sydney Law Review 133 Then, Shih-Ning, Children As Tissue Donors: Regulatory Protection, Medical Ethics and Practice (Springer, 2018) Thomas, Robyn L et al, ‘Goals of Care: A Clinical Framework for Limitation of Medical Treatment’ (2014) 201(8) Medical Journal of Australia 452 Tilburt, Jon C, ‘Addressing Dual Agency: Getting Specific about the Expectations of Professionalism’ (2014) 14(9) American Journal of Bioethics 29 Trankle, Steven A ‘Is a Good Death Possible in Australian Critical and Acute Settings?: Physician Experiences with End-of-Life Care’ (2014) 13 BMC Palliative Care 41 Truog, Robert D, ‘Counterpoint: The Texas Advance Directives Act is Ethically Flawed: Medical Futility Disputes Must be Resolved by a Fair Process’ (2009) 136(4) CHEST 968 Truog, Robert D, ‘The United Kingdom Sets Limits on Experimental Treatments: The Case of Charlie Gard’ (2017) 318(11) JAMA 1001 239 Truog, Robert D, ‘Is It Always Wrong to Perform Futile CPR?’ (2010) 362(6) New England Journal of Medicine 477 Truog, Robert D, Allan S Brett and Joel Frader, ‘The Problem with Futility’ (1992) 326 New England Journal of Medicine 1560 Truog, Robert D et al, ‘Rationing in the Intensive Care Unit’ (2006) 34(4) Critical Care Medicine 958 Truog, Robert D, Thaddeus Mason Pope and David S Jones, ‘The 50-Year Legacy of the Harvard Report on Brain Death’ (2018) 320(4) JAMA 335 Tweet, Marysia S et al, ‘Emergency Cardiac Support with Extracorporeal Membrane Oxygenation for Cardiac Arrest’ (2013) 88 Mayo Clinic Proceedings 761 Ubel, Peter A, Pricing Life: Why It’s Time for Health Care Rationing (MIT Press, 2000) Ubel, Peter A, ‘Why It’s Not Time for Health Care Rationing’ (2015) 45(2) Hastings Center Report 15 Ubel, Peter A and Susan Goold, ‘Recognizing Bedside Rationing: Clear Cases and Tough Calls’ (1997) 126(1) Annals of Internal Medicine 74 Ulrich Connie M, Ann B Hamric and Christine Grady, ‘Moral Distress: A Growing Problem in the Health Professions?’ (2010) 40 The Hastings Centre Report 20 van der Heide, Agnes et al, ‘End-of-Life Decision-Making in Six European Countries: Descriptive Study’ (2003) 362(9381) The Lancet 345 van Ryn, Michelle and Steven S Fu, ‘Paved With Good Intentions: Do Public Health and Human Service Providers Contribute to Racial/Ethnic Disparities in Health?’ (2003) 93(2) American Journal of Public Health 248 van Ryn, Michelle et al, ‘Physicians’ Perceptions of Patients’ Social and Behavioral Characteristics and Race Disparities in Treatment Recommendations for Men With Coronary Artery Disease’ (2006) 96(2) American Journal of Public Health 351 Veatch, RM, ‘Why Physicians Cannot Determine if Care is Futile’ (1994) 42 Journal of the American Geriatric Association 871 Veatch, Robert M ‘Terri Schiavo, Son Hudson, and “Nonbeneficial” Medical Treatments’ (2005) 24(4) Health Affairs 976 Visser, Mieke, Luc Deliens and Dirk Houttekier, ‘Physician-Related Barriers to Communication and Patient- and Family-Centred Decision-Making towards the End of Life in Intensive Care: A Systematic Review’ (2014) 18 Critical Care 604 240 Walker, Rebekah J and Leonard E Egede, ‘Rationing of Care: Conceptual Ambiguity and Transparency in Data Collection and Synthesis’ (2016) 31(12) Journal of General Internal Medicine 1415 Wall Sarah, Wendy J Austin and Daniel Garros, ‘Organizational Influences on Health Professionals’ Experiences of Moral Distress in PICUs’ (2016) 28(1) HEC Forum 53 Walt, Gill et al, ‘“Doing” Health Policy Analysis: Methodological and Conceptual Reflections and Challenges’ (2008) 23(5) Health Policy Plan 308 Ward, Nicholas S et al, ‘Perceptions of Cost Constraints, Resource Limitations, and Rationing in United States Intensive Care Units: Results of a National Survey’ (2008) 36(2) Critical Care Medicine 471 Way, Jenny, Anthony L Back and J Randall Curtis, ‘Withdrawing Life Support and Resolution of Conflict With Families’ (2002) 325(7376) British Medical Journal 1342 Wear, S and G Logue, ‘The Problem of Medically Futile Treatment: Falling Back on a Preventive Ethics Approach’ (1995) 6(2) The Journal of Clinical Ethics 138 Welch, Lisa C, Joan M Teno and Vincent Mor, ‘End-of-Life Care in Black and White: Race Matters for Medical Care of Dying Patients and their Families’ (2005) 53(7) Journal of the American Geriatrics Society 1145 Weijer, Charles and Carl Elliott, ‘Pulling the Plug on Futility: Futility is not the Ethical Trump Card That Some Would Like It to Be’ (1995) 310(6981) BMJ 683 White, Ben and Lindy Willmott, Rethinking Life-Sustaining Measures: Questions for Queensland (QUT Printing Services, 2005) White, Ben, Lindy Willmott and John Allen, ‘Withholding and Withdrawing Life-Sustaining Treatment: Criminal Responsibility for Established Medical Practice?’ (2010) 17 Journal of Law and Medicine 849 White, Ben, et al, ‘What Does “Futility” Mean? An Empirical Study of Doctors’ Perceptions’ (2016) 204(8) Medical Journal of Australia 318.e1 White, Ben, Lindy Willmott and Eliana Close, ‘Futile, Non-Beneficial, Potentially Inappropriate or “Disputed” Treatment’ in Nathan Emmerich et al (eds), Contemporary European Perspectives on the Ethics of End of Life Care (Springer, 2020) White, Ben et al, ‘Withholding and Withdrawing Potentially Life-Sustaining Treatment: Who Should Decide?’ in Ian Freckelton and Kerry Petersen (eds), Tensions and Traumas in Health Law (Federation Press, 2017) 454 White, Ben et al, ‘The Role of Law in Decisions to Withhold and Withdraw Life-Sustaining Treatment from Adults Who Lack Capacity: A Cross-Sectional Study’ (2016) 43(5) Journal of Medical Ethics 327 241 White, Ben et al, ‘Prevalence and Predictors of Advance Directives in Australia’ (2014) 44 Internal Medicine Journal 975 White, Ben P et al, ‘Prevalence of Advance Care Directives in the Community: A Telephone Survey of Three Australian States’ (2019) 49 Internal Medicine Journal 1261. White, Douglas B et al, ‘Towards Shared Decision Making at the End of Life in Intensive Care Units’ (2007) 167 Archives of Internal Medicine 461 White, Douglas B and Thaddeus M Pope, ‘The Courts, Futility, and the Ends of Medicine’ (2012) 307(2) JAMA 151 White, Douglas and Thaddeus Pope, ‘Medical Futility and Potentially Inappropriate Treatment’ in Stuart J Younger and Robert M Arnold, The Oxford Handbook of Ethics at the End of Life (Oxford University Press, 2018) Wilkinson, Dominic, ‘Beyond Resources: Denying Parental Requests for Futile Treatment’ (2017) 389(10082) The Lancet 1866 Wilkinson, Dominic, ‘Conscientious Non-Objection in Intensive Care’ (2017) 26(1) Cambridge Quarterly of Healthcare Ethics 132 Wilkinson, Dominic, ‘Restoring Balance to “Best Interests” Disputes in Children’ (2017) 358 BMJ j3666 Wilkinson, Dominic and Tara Nair, ‘Harm Isn’t All You Need: Parental Discretion and Medical Decisions for a Child’ (2016) 42(2) Journal of Medical Ethics 116 Wilkinson, Dominic, Stavros Petrou and Julian Savulescu, ‘Expensive Care? Resource-Based Thresholds for Potentially Inappropriate Treatment in Intensive Care’ (2018) 35(1) Monash Bioethics Review 2 Wilkinson, Dominic, Stavros Petrou and Julian Savulescu, ‘Rationing Potentially Inappropriate Treatment in Newborn Intensive Care in Developed Countries’ (2018) 23(1) Seminars in Fetal and Neonatal Medicine 52 Wilkinson, DJC and J Savulescu, ‘Knowing When to Stop: Futility in the ICU’ (2011) 24(2) Current Opinion in Anaesthesiology 160 Wilkinson, Dominic and Julian Savulescu, ‘Hard Lessons: Learning from the Charlie Gard Case’ (2017) 44 Journal of Medical Ethics 438 Wilkinson, Dominic and Julian Savulescu, ‘After Charlie Gard: Ethically Ensuring Access to Innovative Treatment’ (2017) 390(10094) The Lancet 540 Wilkinson, Dominic and Julian Savulescu, ‘Alfie Evans and Charlie Gard—Should the Law Change?’ (2018) 361 BMJ k1891 Wilkinson, Dominic and Julian Savulescu, ‘Current Controversies and Irresolvable 242 Disagreement: The Case of Vincent Lambert and the Role of “Dissensus”’ (2019) 45(10) Journal of Medical Ethics 631 Wilkinson, Dominic JC and Robert D Truog, ‘The Luck of the Draw: Physician-Related Variability in End-Of-Life Decision-Making in Intensive Care’ (2013) 39(6) Intensive Care Medicine 1128 Wilkinson, Dominic, Robert Truog and Julian Savulescu, ‘In Favour of Medical Dissensus: Why We Should Agree to Disagree about End-of-Life Decisions: In Favour of Medical Dissensus’ (2016) 30(2) Bioethics 109 Williams, Alan, ‘Intergenerational Equity: An Exploration of the ‘Fair Innings’ Argument’ (1997) 6 Health Economics 117 Willmott, Lindy et al, ‘Futility and the Law: Knowledge, Practice and Attitudes of Doctors in End of Life Care’ (2016) 16(1) QUT Law Review 54 Willmott, Lindy, Benjamin P White and Jocelyn Downie, ‘Withholding and Withdrawal of “Futile” Life-Sustaining Treatment: Unilateral Medical Decision-Making in Australia and New Zealand' (2013) 20(4) Journal of Law and Medicine 907 Willmott, Lindy et al, ‘Reasons Doctors Provide Futile Treatment At The End Of Life: A Qualitative Study’ (2016) 42(8) Journal of Medical Ethics 496 Willmott, Lindy, Ben White and Malcolm K Smith, ‘“Best Interests” and Withholding and Withdrawing Life-Sustaining Treatment from an Adult Who Lacks Capacity in the Parens Patriae Jurisdiction’ (2014) 21(4) Journal of Law and Medicine 920 Willmott, Lindy et al, ‘Withholding and Withdrawing Life-Sustaining Treatment in a Patient’s Best Interests: Australian Judicial Deliberations’ (2014) 201(9) Medical Journal of Australia 545 Willmott, Lindy et al, ‘(Failed) Voluntary Euthanasia Law Reform in Australia: Two Decades of Trends, Models and Politics’ (2016) 39 University of New South Wales Law Journal 1 Willmott, Lindy, Ben White and Shih-Ning Then, ‘Withholding and Withdrawing Life- Sustaining Medical Treatment’ in Ben White, Fiona McDonald and Lindy Willmott (eds), Health Law in Australia (Thomson Reuters, 2nd ed, 2014) Willmott, Lindy, Ben White and Shih-Ning Then, ‘Withholding and Withdrawing Life- Sustaining Medical Treatment’ in Ben White, Fiona McDonald and Lindy Willmott (eds), Health Law in Australia (Thomson Reuters, 3rd ed, 2018) 571 Willmott, Lindy et al, ‘Is there a Role for Law in Medical Practice When Withholding and Withdrawing Life-Sustaining Medical Treatment? Empirical Findings on Attitudes of Doctors’ (2016) 24 Journal of Law and Medicine 342 243 Winzelberg, Gary S, Laura C Hanson and James A Tulsk, ‘Beyond Autonomy: Diversifying End-of-Life Decision-Making Approaches to Serve Patients and Families’ (2005) 53 Journal of the American Geriatrics Society 1046 You, JJ et al, ‘Barriers to Goals of Care Discussions with Seriously Ill Hospitalized Patients and their Families: A Multicenter Survey of Clinicians' (2015) 175(4) JAMA Internal Medicine 549 Young, Michael J et al, ‘Rationing in the Intensive Care Unit: To Disclose or Disguise?’ (2012) 40(1) Critical Care Medicine 261 Youngner, Stuart J, ‘Who Defines Futility?’ (1988) 260(14) JAMA 2094 Yourman, Lindsey C et al, ‘Prognostic Indices for Older Adults: A Systematic Review’ (2012) 307(2) JAMA 182 Zhang, Baohui et al, ‘Health Care Costs in the Last Week of Life: Associations With End-of- Life Conversations’ (2009) 169(5) Archives of Internal Medicine 480 Zier, Lucas S et al, ‘Surrogate Decision Makers’ Responses to Physicians’ Predictions of Medical Futility’ (2009) 136(1) CHEST 110 B Cases Aintree University Hospitals NHS Foundation Trust v James [2013] UKSC 67 Airedale NHS Trust v Bland [1993] AC 789 Alder Hey Children’s NHS Foundation Trust v Evans [2018] 2 FLR 1223; [2018] EWHC 308 (Fam) Application of Justice Health; Re a Patient [2011] NSWSC 432 Auckland Area Health Board v Attorney General [1993] 1 NZLR 235 Australian Capital Territory v JT [2009] ACTSC 105 Betancourt v Trinitas Hospital, 1 A 3d 823 (NJ Super Ct App Div, 2010) Brightwater Care Group v Rossiter (2009) 40 WAR 84 Briggs v Briggs [2016] EWCOP 53 Burke, R (on the application of) v General Medical Council [2005] EWCA Civ 1003 Cairns and Hinterland Hospital and Health Service v JT [2015] 2 Qd R 348 Cuthbertson v Rasouli [2013] 3 SCR 341 244 EGJW v MGC, 2014 CanLII 49888 (ON HPARB) Evans v Alder Hey Children’s NHS Foundation Trust [2018] EWCA Civ 984 Gard v the United Kingdom (App no 39793/17) [2017] ECHR 605 Glass v the United Kingdom (App no 61827/00) [2003] ECHR 719 Golubchuk v Salvation Army Grace General Hospital 2008 MBQB 49 Great Ormond Street Hospital v Yates [2017] EWHC 972 (Fam) Great Ormond Street Hospital v Yates [2017] EWHC 1909 (Fam) Hunter Area Health Service v Marchlewski (2000) 51 NSWLR 268 (NSWCA) Hunter and New England Area Health Service v A [2009] NSWSC 761 Re B (Adult: Refusal of Medical Treatment) [2002] 2 All ER 449 Re C (Adult: Refusal of Medical Treatment) [1994] 1 WLR 290 Re F (Mental Patient: Sterilisation) [1990] 2 AC 1 Re Herrington; Re King [2007] VSC 151 Re Charlie Gard (Unreported decision of Supreme Court of the United Kingdom, 19 June 2017, Lady Hale, Lord Kerr and Lord Wilson) Re Helga Wanglie, (Hennepin Cty, Minn. 1991) Re Lambert, Cour de cassation [French Court of Cassation], E1917330, 28 June 2019 Inquest into the death of Fay Cramb [2010] QCC (COR 2965/08(9), 7 May 2010) Inquest into the Death of June Woo [2009] QCC (COR 2713/02, 1 June 2009) Inquest into the death of Jaxon McGrorey-Smith [2018] NSWCC (2011/388722, 14 November 2018) Lane v Northern NSW Local Health District (No 3) [2014] NSWCA 233 McMath v State of California, No. 3: 15-cv-06042 HSG (N.D. Cal. Dec 12, 2016) Medical Board of Australia v Siow [2016] SAHPT 1 Melo v Superintendent of Royal Darwin Hospital (2007) 21 NTLR 197 Messiha v South East Health [2004] NSWSC 1061 245 Northridge v Central Sydney Area Health Service [2000] NSWSC 1241 Queensland v Astill (unreported, Supreme Court of Queensland, Muir J, 18 January 2006) R (Burke) v General Medical Council [2005] EWCA 1003 R (Tracey) v Cambridge University Hospital NHS Trust [2014] EWCA Civ 822 R v Cambridge Health Authority, ex parte B [1995] EWCA 49 (Civ) R v Clarke [1959] VR 645 R v Russell [1933] VLR 59 (VSC) R v Taktak (1988) 14 NSWLR 226 (NSWSC) Re A (medical treatment: male sterilisation) [2000] 1 FLR 549 (CA) Re A (a child) [2016] EWCA Civ 759 Re F (Mental Patient: Sterilisation) [1990] 2 AC 1 Re Herrington [2007] VSC 151 Re HG [2006] QGAAT 26 Re J (a minor) (wardship: medical treatment) [1990] 3 All ER 930 (CA) Re RWG [2000] QGAAT 2 Re HG [2006] QGAAT 26 Re SAJ [2007] QGAAT 62 Rogers v Whitaker (1992) 175 CLR 479 Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust v TG [2019] EWCOP 21 Slaveski v Austin Health [2010] VSC 493 Shortland v Northland Area Health Service [1998] 1 NZLR 433 (CA) TS & DS v Sydney Children’s Hospitals Network (Mohammed’s case), [2012] NSWSC 1207 W v M [2011] EWHC 2443 Wawrzyniak v Livingstone, 2019 ONSC 4900 246 Winspear v City Hospitals Sunderland NHS Foundation Trust [2015] EWHC 3250 Wyatt v Portsmouth NHS Trust [2005] EWHC 117 (Fam) Yates v Great Ormond Street Hospital [2017] EWCA Civ 410 C Legislation Advance Care Directives Act 2013 (SA) Advance Directives Act, 166 Texas Health and Safety Code (1999) Charter of Human Rights and Responsibilities Act 2006 (Vic) Children Act 1989 (UK) c 41 Colorado End of Life Options Act, Colo Rev Stat (2016) §§ 25-48-101 – 25-48-123 Consent to Medical Treatment and Palliative Care Act 1995 (SA) Criminal Code Act 1899 (Qld) Criminal Code Act 1924 (Tas) Criminal Code Act 1983 (NT) Criminal Code (WA) Criminal Code, RSC 1985, c C-46 Death with Dignity Act of 2016, DC Law (2017) Death with Dignity Bill 2016 (SA) End of Life Options Act, Cal Health and Safety Code, §§ 443-443.22 ABX2-15 (2015) (California) Guardianship and Administration Act 2000 (Qld) Guardianship and Administration Act 1990 (WA) Health Care Consent Act, SO 1996, c 2 Health Practitioner Regulation National Law Act 2009 (Cth) Human Rights Act 2004 (ACT) Human Rights Act 2019 (Qld) 247 Medical Treatment Planning and Decisions Act 2016 (Vic) Powers of Attorney Act 1998 (Qld) Victorian Medical Treatment Planning and Decisions Bill 2016 D Other Australian Bureau of Statistics, ‘Does Size Matter? - Population Projection 20 and 50 years from 2013’ (2014) Australian Bureau of Statistics, ‘3302.0: Deaths, Australia, 2018’ (2019) Australian Bureau of Statistics, ‘3303.0: Causes of Death Australia, 2018’ (2019) Australian Bureau of Statistics, ‘3222.0: Population Projections, Australia, 2017’ (2018) Australasian College for Emergency Medicine, Policy on End of Life and Palliative Care in the Emergency Department (ACEM, July 2016) Australian College of Rural and Remote Medicine, Position Statement - Rural End of Life Care and Advance Care Planning (ACRRM, 2015) https://www.acrrm.org.au/the-college-at- work/position-statements/policy/2015/12/20/college-position-statement-on-rural-end-of-life- care-and-advance-care-planning Australian Commission on Safety and Quality in Health Care, National Consensus Statement: Essential Elements for Safe and High-Quality End-of-Life Care (ACSQHC, 2015) https://www.safetyandquality.gov.au/wp-content/uploads/2015/05/National-Consensus- Statement-Essential-Elements-forsafe-high-quality-end-of-life-care.pdf Australian Institute for Health and Welfare, Health Expenditure Australia 2017-18 (AIHW, 25 September 2019) Australian Institute for Health and Welfare, Older Australia at a Glance (Web Report, 10 September 2018) Australian and New Zealand Intensive Care Society, ANZICS Statement on Care and Decision-Making at the End of Life for the Critically Ill (Edition 1.0, 2014) 248 Australian Medical Association, Code of Ethics (AMA, 2006) Australian Medical Association, “Of Death and Dying ̶ The Discussion We Must Have (16 September 2014) Australian Medical Association, Position Statement on End of Life Care and Advance Care Planning (5 September 2014) Australian Medical Association, AMA Position Statement: The Doctor's Role in Stewardship of Health Care Resources (18 July 2016) Australian Medical Association, AMA Code of Ethics 2004. Editorially revised 2006. Revised 2016. (17 March 2017) Australian Resuscitation Council and New Zealand Resuscitation Council, Guideline 10.5 – Legal and Ethical Issues Related to Resuscitation (ANZCOR, 2015), https://resus.org.au/guidelines/ Blackwell, Tom, ‘Family overjoyed as top court rules doctors must seek consent before taking a patient off life support’, Canada National Post (online), 18 October 2013 Bilefsky, Dan and Sewell Chan, ‘Dispute Over British Baby's Fate Draws In President and Pope’ New York Times, 4 July 2017, Bolzen, Stefanie, ‘Britisches Baby Charlie gestorben’ Die Welt, 28 July 2017 British Medical Association Ethics Committee, Withholding and Withdrawing Life- prolonging Medical Treatment: Guidance for Decision Making (BMA, 3rd ed, 2007) Caldwell, Felicity ‘Voluntary Euthanasia: Calls for Queensland Parliamentary Inquiry’, Brisbane Times, 17 October 2016 Choosing Wisely Australia, The Royal Australian College of General Practitioners: Tests, Treatments and Procedures Clinicians and Consumers Should Question (NPS MedicineWise, 2015-2016) 249 College of Intensive Care Medicine of Australia and New Zealand, Statement on Withholding and Withdrawing Treatment (2003, last reviewed in 2013) College of Physicians and Surgeons of Ontario, Planning for and Providing Quality End-of- life Care (CPSO, 2015) Doctors Offer to Treat Dying Winnipeg Man After Colleagues Refuse’, CBC News (online, 18 June 2008) Downar, James et al, Balancing the Interests of Patients, Substitute Decision-Makers, Family and Health Care Providers in Decision-Making Over the Withdrawal and Withholding of Life-Sustaining Treatment (Law Commission of Ontario, 2017) Government of Queensland, Advance Care Planning (Queensland Health, 3 August 2016) Hune-Brown, Nicholas, ‘A Life Interrupted: Hassan Rasouli’s Journey from an Earache to a High-Stakes Battle Over End-of-Life Decisions’ Toronto Life (online) 27 November 2012 ‘Winnipeg Man at Centre of End-of-Life Controversy Dies’, CBC News (online) 25 June 2008 Medical Board of Australia, Good Medical Practice: A Code of Conduct for Doctors in Australia (2014) https://www.medicalboard.gov.au/Codes-Guidelines-Policies/Code-of- conduct.aspx Ministry of Health, New South Wales Government, Advance Planning for Quality Care at End of Life, Action Plan 2013-2018 (11 July 2013), Health - NSW Government National Health and Medical Research Council, Ethical Guidelines for the Care of People in Post-Coma Unresponsiveness (Vegetative State) or a Minimally Responsive State (Australian Government, 2008) National Health and Medical Research Council, Ethical Guidelines for Organ Transplantation From Deceased Donors (NHMRC, 2016) 250 National Institute for Health and Care Excellence, Social Value Judgments: Principles for the Development of NICE Guidance (NICE, 2nd ed) NSW Department of Health, Conflict Resolution in End of Life Settings (CRELS) (Final CRELS Project Working Group Report Including Consultation Summary, 1 September 2010) NSW Department of Health, End-of-Life Care and Decision-Making – Guidelines (Guideline No GL2005_057, 22 March 2005) New South Wales Government, Department of Health, Using Resuscitation Plans in End of Life Decisions (PD2014_030) (NSW Health, 2014), https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2014_030.pdf Palliative Care Australia, National Palliative Care Standards (5th ed, PCA, 2018), Queensland Health, End-of-Life Care: Guidelines for Decision-Making about Withholding and Withdrawing Life-Sustaining Measures from Adult Patients (2018) British Medical Association, the Resuscitation Council (UK) and the Royal College of Nursing, Decisions Relating to Cardiopulmonary Resuscitation (3rd edition, 2016) Royal Australasian College of Physicians, Improving Care at the End of Life: Our Roles and Responsibilities (RACP, 2016), https://www.racp.edu.au/docs/default-source/advocacy- library/pa-pos-end-of-life-position-statement.pdf Royal Australasian College of Surgeons, Position Paper: End of Life Care (RACS, 2016), https://umbraco.surgeons.org/media/1642/2017-07-28_pos_fes-pst-057_end_of_life_care.pdf Schafer, Arthur, ‘Right‑To‑Die Ruling: Win for Families, Loss for Common Decency’, The Globe and Mail (online) 18 October 2013 South Australia Government, Department of Health, Providing Medical Assessment and/or Treatment Where Patient Consent Cannot be Obtained Policy Directive (SA Health, 2014), South Australia Government, Department of Health, Consent to Medical Treatment and Health Care Policy Guideline (SA Health, 2014), 251 l+resources/clinical+topics/end+of+life+for+health+professionals/consent+to+medical+treat ment+for+health+professionals> South Australia Government, Department of Health, Resuscitation Planning – 7 Step Pathway (SA Health, 2016), Smyth, Chris, ‘No 10 refuses to intervene in case of Charlie Gard’ The Times, 6 July 2017 Tasmanian Government, Department of Health, Medical Goals of Care Plan (undated), The Clinical, Technical and Ethical Principal Committee of the Australian Health Ministers’ Advisory Council, A National Framework for Advance Care Directives (Australian Health Ministers Advisory Council, 2011), The Transplantation Society of Australia and New Zealand, Clinical Guidelines for Organ Transplantation from Deceased Donors (TSANZ, 2019) Victorian Government, Department of Health and Human Services, A Guide to the Medical Treatment Planning and Decisions Act 2016: For health practitioners (Victoria DHHS, 2nd ed, 2019), Victoria State Government, Advance Care Planning Initiatives Wallace, Natasha, Ruth Pollard and Kristy Needham, Hospital Removes Life Support After Court Bid Fails, Sydney Morning Herald Western Australia Government, Department of Health, The End-of-Life Framework: A Statewide Model for the Provision of Comprehensive, Coordinated Care at End-of-Life in Western Australia (WA Health, 2016), https://ww2.health.wa.gov.au/~/media/Files/Corporate/general%20documents/End%20of%20 Life/PDF/The-End-of-Life-Framework.pdf 252