<p>Informing the Process of Consent for Surgery: Identification of Key Constructs</p><p> and Quality Factors</p><p>Mr N Mark Bagnall1 – BMedSc(Hons), MBChB(Hons) MSc, MRCS – Clinical </p><p>Research Fellow</p><p>Mr Philip H Pucher1 MD PhD MRCS – Honorary Clinical Lecturer</p><p>Mr Maximilian J Johnston2 – MB BCh, PhD MRCS – Clinical Research Fellow</p><p>Miss Sonal Arora2 – MBBS, PhD, MRCS – Clinical Lecturer</p><p>Professor Thanos Athanasiou1 – MD, PhD, FETCS, FRCS – Professor of</p><p>Cardiovascular Sciences</p><p>Mr Omar Faiz1,3 – BSc(Hons), MBBS, FRCS, MS – Senior Lecturer in Surgery</p><p>Professor the Lord Ara Darzi1 – PC, KBE, HonFrEng, FMedSci – Professor of</p><p>Surgery</p><p>1. Department of Surgery & Cancer, Imperial College London, St Mary’s Hospital,</p><p>Paddington, London, W21NY, United Kingdom</p><p>2. Imperial Patient Safety Translational Research Centre, Department of Surgery & Cancer, </p><p>Imperial College London, St Mary’s Hospital, Paddington, London, W21NY, United Kingdom</p><p>3. St Marks Hospital & Academic Institute, Northwick Park NHS Trust, Watford Road, Harrow,</p><p>Middlesex, HA1 3UJ, United Kingdom</p><p>Correspondence to:</p><p>Mr Philip Pucher Department of Surgery and Cancer, Imperial College London, 10th Floor QEQM, St Mary’s Hospital, South Wharf Road, London W21NY (UK), Tel: +44 (0)2033127619, Fax: +44(0)233126309, Email: [email protected]</p><p>Word count: 2,293</p><p>Short title: Informed consent in surgery</p><p>The authors declare no conflicts of interest.</p><p>1 Contributions:</p><p>NMB designed the study, collected data, and performed analysis as well as drafted the manuscript. PHP performed additional analysis and drafted the manuscript. MJJ co-designed the study and aided in drafting of the manuscript as well as performing analysis and data collection. SA designed the study, aided in analysis, and proofed the manuscript. TA, OF, and AD aided in study design, drafting, and proofing of the final manuscript.</p><p>2 Abstract</p><p>Background: Informed consent is a fundamental requirement of any invasive procedure. Failure to obtain appropriate and informed consent may result in unwanted or unnecessary procedures, as well as financial penalty in case of litigation. The aim of this study was to identify key constructs of the consent process which might be used to determine the performance of clinicians taking informed consent in surgery.</p><p>Methods: A multi-modal methodology was used. A systematic review was conducted in accordance with PRISMA guidelines to identify evidence-based components of the consent process. Results were supplemented by semi-structured interviews with senior trainees and attending surgeons which were transcribed and subjected to emergent theme analysis with repeated sampling until thematic saturation was reached. </p><p>Results: 710 search results were returned, with 26 articles included in final qualitative synthesis of the systematic review. Significant variation existed between articles in the description of the consent procedure. 16 semi-structured interviews were conducted before saturation was reached. Key components of the consent process were identified with broad consensus for the most common elements. </p><p>Trainers felt that experiential learning and targeted skills training courses should be used to improve practice in this area.</p><p>Conclusion: Key components for obtaining informed consent in surgery have been identified. These should be used to influence curricular design, possible assessment methods, and focus points to improve clinical practice and patient experience in future.</p><p>3 Keywords: consent, validation, standardized patient, simulation.</p><p>4 Introduction</p><p>Informed consent is an ethical and legal obligation prior to performing any invasive procedure. Consent is a complex process; it is not simply the giving of information by a health professional, but a dialogue between the patient and the physician1. Consent requires sophisticated communication and interpersonal skills to engender trust, explore patients’ understanding and concerns, and deliver accurate information regarding the planned procedure2. Patients who have incurred harm or developed complications following surgery may feel that this possible outcome was not explained explicitly as a recognised risk of the procedure. These patients may elect to initiate complaints procedures and seek legal advice regarding compensation3.</p><p>Litigation resulting from consent errors and omissions places a significant financial burden on health service providers and individual surgeons4. Indeed, between 2008 and 2013, more than £1 billion was paid to patients by the National Health Service</p><p>Litigation Authority for surgical litigation claims in the United Kingdom alone. Despite this, the taking of consent by trainees rather than those with independent practice privileges remains frequent5. Furthermore, training and assessment of competency to enable informed consent is poorly described in the literature and widely variable. </p><p>The consent process is a vital component of high-quality patient care in surgery as it establishes a contract of trust between patient and doctor. The quality of patient care is a key priority for the healthcare industry and recent research has demonstrated the importance of placing patients at the forefront of their own care6, 7.</p><p>Some subsets of patients may also require careful forethought regarding their capacity to give consent. Patients with altered mental status due to mental illness, intoxication or traumatic injury may not have the ability to understand, retain, weigh and make a decision on information that is provided to them8, 9. In order to make this</p><p>5 determination and guide the patient through the consent process, surgeons need to possess both technical knowledge of the procedure and, crucially, solid non-technical skills such as communication, judgment, teamwork and situational awareness10.</p><p>Communication and teamwork skills are already being measured in the operating theatre and on the surgical ward11-13. In order to objectively assess the consent process, it is first necessary to identify the key constructs and factors which determine the quality of informed consent. The assessment of medical students to take consent from simulated patients has been previously described by Kiehl et al but has involved the use of arbitrarily defined performance measures selected without the benefit of any evidence-based process14. In addition, this study was limited by the use of medical student participants rather than trained clinicians. There are no available reports of a robust and evidence-based development of an assessment framework to measure the quality of consent amongst practicing clinicians. This is important because before attempts are made to improve the consent process, it first needs to be measured.</p><p>The aim of this study was to identify key constructs of the consent process, which could in turn be used to determine the quality and competency of a surgeon obtaining informed consent from an adult patient for a routine surgical procedure.</p><p>6 Methods</p><p>A multi-modal methodology was adopted, incorporating both existing evidence via a systematic literature review and semi-structured interviews with practicing surgeons. </p><p>Systematic review</p><p>A systematic review of the literature was performed, following the PRISMA guidelines</p><p>(Figure 1) to identify the key components of the consent process and any studies that assessed a clinician’s competency in obtaining informed consent. Electronic databases (OVID Medline, Embase, PsycINFO) were searched using the following keywords and their combinations: (1) “consent” AND “surgery”, (2) “consent” AND</p><p>(“skill” OR “competenc*” OR “evaluation” OR “assessment”). Limits were set from</p><p>January 1980 to April 2015. Reference lists of retrieved articles were also hand- searched to augment the sensitivity of the primary search. Gray literature articles, including position statements published by The American College of Surgeons, The</p><p>Centers for Medicare & Medicaid Services and the United Kingdom General Medical</p><p>Council were also evaluated. </p><p>To be considered for inclusion in the review, articles needed to describe components of the consenting process relating to an interventional procedure. Due to the paucity of data, both clinical data and expert opinion pieces were considered. Conference abstracts, dissertation abstracts and extracts for book chapters were excluded. All articles evaluating patients aged under 18 years, patients with mental incapacity, surrogate consent, or patients not undergoing interventional procedures were also rejected. Studies evaluating consent for research purposes only or exclusively the quality of consent form documentation were also eliminated. Finally, any references</p><p>7 that did not describe components of the consent process, or only described the harms associated with a single procedure were also excluded. </p><p>Eligibility of articles was judged independently by two reviewers (NMB, SA) and disagreement resolved through discussion with a third reviewer (MJ). Data on first author, publication year, country, type of article, surgical specialty, components of consent were extracted and input into an Excel (Microsoft Corp, Redmond, WA) spreadsheet and qualitatively summarised. Owing to the low level of available evidence, with the majority consisting of reviews, narratives, and surveys, study quality was not explicitly assessed.</p><p>Interviews</p><p>Semi-structured interviews were conducted, with purposive sampling of senior trainees and attending surgeons with extensive experience of the consent process and use of it in clinical practice. In the absence of a formalised metric to select surgeons particularly skilled at taking consent, the purposive sample included interviewees who excelled in terms of their communication skills, based on both formalised feedback and anecdotal evidence. Sample size was determined by the point at which thematic saturation was reached. All interviews were audiotaped and transcribed verbatim. Two members of the research team with backgrounds in both surgery and education coded each interview independently using a clearly defined standardized framework based on findings from the review. Key components of informed consent were identified using emergent theme analysis of transcripts. To ensure rigor and reliability, the interviewers were fully trained, and interviews piloted.</p><p>25% of participants were contacted after thematic analysis was conducted to cross- check accuracy of content and transcription, to ensure valid findings had been extrapolated from the interviews.</p><p>8 Results</p><p>Systematic review</p><p>Twenty-six eligible articles were distilled from a systematic search (Figure 1): four practice guidelines15-18, two systematic reviews19, 20, two non-systematic literature reviews21, 22, four narrative reviews2, 23-25, five simulation-based cohort studies14, 26-29, three clinician questionnaire survey studies30-32, and six patient interview/questionnaire studies9, 33-37. Demographic details of these are described in appendix 1. </p><p>A total of 33 key components of the consent process were identified from the systematic review. There was a great deal of variation between what studies reported as essential components of the consent process (see appendix 1 for results in full). The most commonly named components of the consent process were that it must explain the diagnosis and procedure (92% of articles), explain general (92%) and procedure-specific (88%) risks, assess that the patient possessed the mental capacity to give consent (88%), and that alternative options including avoidance of treatment and the consequences thereof be clarified to the patient (81%). The least commonly identified components included disclosure of the operating surgeon’s clinical outcomes for the procedure, as well as disclosure of other surgeons’ outcomes for the same procedure – both of which were mentioned in only a single study (4% of articles)37.</p><p>Five studies14, 26-29 describing existing tools for the assessment of the consent process were considered (see table 1). All described locally developed assessment tools without a structured developmental framework. Only a single tool cited any peer-</p><p>9 reviewed evidence as playing a role in the development process28. Two of the tools described testing with medical student cohorts, whereas the remainder described use with small trainee groups (n= 8 - 31). Though three studies reported inter-rater reliability, none of the five tools described any psychometric testing or reported validity evidence to support the assessment tools’ ability to appropriately discriminate between differing levels of clinician performance in the consenting process. </p><p>Semi-structured interviews</p><p>Thematic saturation was achieved following recruitment of eight senior residents and eight attending general surgeons. Interviewees were asked to identify the most important components of the consent process, what information should be given to patients, what skills were required of clinicians, and how to improve the consent process. 72 different themes were identified through interviews (for full results see appendix 2), with the most common results presented in Table 2. Viewpoints expressed by senior trainees and attending surgeons were similar across all domains, with broad consensus between interviewees on the content of the consent process. All interview subjects agreed that this must include the details, risks, and benefits of the procedure, as well as describing alternative treatment options, in keeping with published literature and guidelines.</p><p>All subjects (100%) commented on the importance of communication and non-verbal skills in the consenting process, with the most common themes being the use of appropriate language and non-verbal skills such as body language and gesturing.</p><p>All subjects (100%) stated that improvement of the consent process was necessary.</p><p>Only one subject (attending surgeon) believed that the existing model of experiential learning was sufficient. Though most (69%) subjects believed that experience-based</p><p>10 learning played a role in improving performance, all but one subject (94%) believed adjunctive teaching methods were required, with the most common suggestions being generic communication training (56%), video-based feedback sessions or feedback from patients and relatives (both 38%), and formalised high-stakes examination of trainees’ ability to take informed consent (31%). The use of simulation and standardised patients for this was supported by all (100%) of subjects.</p><p>Discussion</p><p>Despite being the ubiquitous lynchpin of the surgeon-patient relationship, the consent process is a poorly understood process which has been sparsely subjected to empirical consideration to date. </p><p>The systematic review of the existing evidence presented here makes it apparent that the consent process has been previously subjected to only limited empirical examination. Previously published literature relies heavily on individual or sall groups of clinicians describing their own views on consent practice. The few studies which do attempt to measure performance during the consenting process do not do so in a psychometrically sound fashion, use tools developed in an ad-hoc fashion, and lack validity evidence. This study presents a first detailed assessment of the critical factors involved in ensuring and obtaining informed patient consent for surgery, combining a critical analysis of existing literature with expert opinions procured via recognised methodology (semi-structured interviews). </p><p>The significant variation in the described elements of the consenting process, reported here as part of the systematic review (appendix 1), further illustrates the lack of clear consensus on the issue. The semi-structured interview component of this study therefore sought to clarify this by seeking to identify, through repeated</p><p>11 interviews, both recurring themes of critical parts of the consent process, as well as ensuring the full breadth of items was considered, by selecting a sample size based on thematic saturation.</p><p>The need to define the key tenets of obtaining written, informed consent, which might in future enable assessment of the quality of the consent as a discrete process within medical or surgical training, is clear. The days in which clinicians acted as sole arbiters in the determination of patient care decisions are rightfully, in the past. It is now universally recognised that patients must be given the means to understand proposed procedures and their inherent risks and consequences in order to make informed decisions about their care. Failure to do so may result in uninformed decisions and avoidable complications, and in some cases legal action. Medical litigation has been estimated to cost upward of $55 billion USD annually in the United</p><p>States alone.38 A significant proportion of claims relate specifically to patient dissatisfaction with the consent process39, 40, whereas greater numbers still may be attributed to complications which constitute accepted risks (such as postoperative infection) but were not fully appreciated by the patient during the consent process. </p><p>Whether cases of litigation result from failures of the critical factors identified in this study or not remains unclear, potentially in part due to the fact that this area has been previously underexplored. Existing studies have described “dissatisfaction with the consent process”40 as the underlying cause for litigation without defining in greater detail. The taxonomy of factors involved in the consent process identified in this study may in future help the more detailed analyses of such cases, just as it may enable better training and assessment to avoid litigation in the first place.</p><p>To improve the consent process, a multi-pronged approach may be required. The findings of this study suggest additional training and examination of obtaining consent should be integrated into medical and surgical curricula. Both generic</p><p>12 communication / non-technical training, as well as consent-specific modules backed by standardised patient simulation and assessment should be considered.</p><p>Additionally, patient education adjuncts such as enhanced written, web- or video- based information packages may be of use to help patients better comprehend the implications of consenting to surgery. The significant potential to improve patient understanding and recall in this manner is illustrated by Shukla and colleagues, who assessed information retention in a cohort of patients undergoing ophthalmic surgery and through a series of interventions were able to improve information recall by nearly 50% when compared to a standardised consent procedure.41</p><p>The appropriateness of use of generic or templated consent forms should be considered for each individual case. The written consent form, the findings of this study highlight, forms only one component of the consent process. The legal process makes clear that a patient’s signature alone is no guarantor against litigation.</p><p>A generic form which appropriately documents risks involved for a given procedure may still be valid as long as used as part of the “holistic” approach for consent, in which patient education, informed consent, and doctor-patient relationship are key.</p><p>Discussions which take place outside of the printed consent form should be documented in medical records, and the patient’s consent should be reviewed by the operating surgeon in cases where the written consent is taken by other members of the clinical team.</p><p>The results of this study must be considered in the context of several limitations. As interviews were conducted with surgical experts within the UK, the generalizability of the resulting findings to other countries and regions is not assured and may require further assessment. However, the systematic review included all literature regardless of country of origin, the vast majority of which stemmed from authors based outside of the UK. Additionally, an interview-based strategy was pursued in order to allow for maximally inclusive reporting of results, rather than a consensus-</p><p>13 based approach which might have resulted in a framework tailored more to a specific country, surgical specialty, or patient group. </p><p>If the consent process is to be viewed as a formal clinical skill, it must be subject to both training and assessment. Future research must aim to build on the work on this study to develop and validate an assessment framework based on the constructs identified here. Such a metric should ideally involve both a “checklist” component of the individual elements which achieved broad consensus (> 80%{Singh, 2014</p><p>#2776}) such as identification of the patient, site, and procedure, as well as a global assessment of practice, as has been successfully implemented in numerous other valid and widely used assessment tools. Elements which reached a lesser degree</p><p>(i.e. > 50%) of agreement should be further investigation as to their validity for inclusion, whereas those with poor agreement (< 50%) should be disregarded, or may require redefining and reconsideration. In addition to the development of a measurement tool, addressing these measures via formalised integration into training curricula, one might expect this to result in a better surgical experience for patients and clinicians alike.</p><p>With the surgical profession increasingly under scrutiny, processes such as obtaining informed consent represent particularly critical interfaces between clinicians and patients, as they often take place at a vulnerable stage (e.g. when the patient has just been told they require an operation, or is about to undergo one). Suboptimal consenting practices may have unintended consequences for patient choice, impact upon the patient-doctor relationship, and lead to legal action. Disastrous physiological, psychological, and financial penalties may result. Despite this, appropriate tools to measure and assess performance in consent have been lacking in evidence-based development, validity testing, and clinical implementation. The factors identified in this study may allow the development of more robust tools in future with which to improve the patient consenting process. </p><p>14 15 References</p><p>16 Figure 1: Systematic literature search using PRISMA guidelines.</p><p>Records identified through Additional records identified</p><p> database searching (OVID through other sources Identification Medline EMBASE PsychINFO Guidelines/position statements 1980-2013) n=706 n=4</p><p>Records excluded (n = 586) Conference abstracts, Records after duplicates removed dissertation abstracts, book n=644 chapter extracts n=124 Paediatric studies n=64</p><p>Mental state impaired or Screening surrogate consent n=143 Non interventional n=147 Research consent only n=29 Abstracts screened Studies assessing a patient’s competency to consent n=25 n=644 Consent elements not described n=37 Specific procedural risks only described n=5 Studies assessing quality of</p><p> written consent form only n=12 Eligibility Full-text articles assessed for eligibility Full-text articles excluded (n=32) n=58 Non surgical studies n=2 (internal medicine & HIV) Research consent only n=5 Consent elements not described n=14 Ethical/legal/ergonomic</p><p> principles n=11 Included Articles included in qualitative synthesis n=26</p><p>17 Table 1. Previously described assessment tools for obtaining informed consent for invasive procedures</p><p>Author, Tool name, development Validity year, origin Subjects Setting method Reliability evidence Kiehl et al, Medical Appendicectomy, n/r IRR: Cronbach's n/r 2014, students cholecystectomy, alpha 0.57-0.61 Germany14 (n=155) hernia repair Shah, 2011, Endoscopy Colonoscopy n/r (adapted from tool IRR: Cronbach's n/r USA29 fellows (n=15) previously used at NYUSM*) alpha 0.60-0.75 for individual components Black, Vascular Carotid n/r IRR: Cronbach’s n/r 2009, UK27 trainees and endarterectomy alpha = 0.832 surgeons (n=31) Leeper- General Appendicectomy, Brown University n/r n/r Majors, surgery cholecystectomy, Interpersonal Skill 2003, residents bowel resection, Evaluation, development USA26 (n=8) breast cancer method n/r resection Roberts, Medical Cardiac Based on literature (part of n/r n/r 1999, students catheterisation Student Progress Assssment) USA28 (n=71)</p><p> n/r: none reported. IRR: inter-rater reliability. *NYUSM: New York University School of Medicine.</p><p>18 Table 2. Top five replies for each semi-structured interview domain Trainees Staff Total (%) (%) (%) What do you think are the important components of the consent process? Details of procedure 100 100 100 Generic risks 100 100 100 Alternative treatment options 100 100 100 Address patient concerns / expectations / misconceptions 87.5 87.5 87.5 Specific risks of surgery 62.5 100 81.3</p><p>What information should be given as part of the consent process? Risks of procedure 100 100 100 Benefits of procedure 100 100 100 Alternative treatment options 100 100 100 Information suitable for patient (layperson) understanding 62.5 100 81.3 Appropriate indications for surgery 75 75 75</p><p>What are the communication skills required to obtain informed consent? Language appropriate to patient (cultural, educational, level of detail) 87.5 87.5 87.5 Non-verbal skills (body language, gesturing) 62.5 62.5 62.5 Clear and unambiguous information transfer 37.5 62.5 50 Check understanding and recall 37.5 62.5 50 Empathy with patient 62.5 25 43.8</p><p>How can we improve consent process / train to do it better? Gain with experience 75 62.5 68.8 Communication skills training / courses 50 62.5 56.3 Video-based education sessions 50 25 37.5 Seek feedback from patients and relatives 37.5 37.5 37.5 OSCE-style formalised assessment 37.5 25 31.3</p><p>19</p>