Quality Improvement QUALITY IMPROVEMENT

May 2020 A special supplement in partnership with The Health Foundation

Quality improvement QUALITY IMPROVEMENT

EDITOR’S CHOICE

1 A road map towards better quality improvement Raffaella Bosurgi

EDITORIALS

BMJ 2020 2 Prioritising quality improvement EDITORIAL OFFICES The Editor, The BMJ Joanna Bircher BMA House, Tavistock Square London, UK, WC1H 9JR Email: [email protected] Tel: + 44 (0) 20 7387 4410 3 Creating space for quality improvement Fax: + 44 (0) 20 7383 6418 Dominique Allwood, Rebecca Fisher, Will Warburton, Jennifer Dixon BMJ - Beijing A1203 Tian Yuan Gang Center East 3rd Ring North Road 5 Better healthcare must mean better for patients and carers Chaoyang District Beijing 100027 Anya de Iongh, Sibylle Erdmann China Telephone: +86 (10) 5722 7209 BMJ - Hoboken BMJ Publishing Inc ANALYSIS Two Hudson Place Hoboken, NJ 07030 Tel: 1- 855-458-0579 7 Improving together: collaboration needs to start with regulators email [email protected] BMJ - Mumbai Nicola Burgess, Graeme Currie, Bernard Crump, John Richmond, Mark Johnson 102, Navkar Chamber, A Wing Marol, Andheri - Kurla Road Andheri (East) Mumbai 400059 Tel: +91 22-40260312/13/14 10 Spreading and scaling up innovation and improvement Email: [email protected] Trisha Greenhalgh, Chrysanthi Papoutsi BMJ - Noida Mindmill Corporate Tower 6th Floor, 24 A, Film City Sector 16 A 16 Changing how we think about healthcare improvement Noida 201301 Telephone: + 91 120 4345733 - 38 Jeffrey Braithwaite Email: [email protected] BMJ - Singapore Suntec Tower Two 21 Understanding organisational culture for healthcare quality improvement 9 Temasek Boulevard, #29-01 Singapore 038989 Russell Mannion, Huw Davies Tel: +65 3157 1399 Email: [email protected] BMJ - Sydney 25 Can we import improvements from industry to healthcare? Australia Telephone: +61 (0)2 8041 7646 Carl Macrae, Kevin Stewart Email: [email protected] Twitter: Follow the editor, Fiona Godlee @fgodlee and The BMJ at twitter.com/bmj_latest 29 How organisations contribute to improving the quality of healthcare BMA Members’ Enquiries Email: [email protected],uk Naomi J Fulop, Angus I G Ramsay Tel: + 44 (0) 20 7383 6955 Advertising Email: [email protected] Tel: + 44 (0) 20 3655 5611 34 Adapting Lean methods to facilitate stakeholder engagement and Reprints co-design in healthcare Email: [email protected] Tel: + 44 (0) 7866 262 344 Iain Smith, Chris Hicks, Tom McGovern Subscriptions Email: [email protected] Tel: + 44 (0) 20 7111 1105 38 Revitalising audit and feedback to improve patient care Other resources Other contacts: http://www.bmj.com/about-bmj Robbie Foy, Mirek Skrypak, Sarah Alderson, Noah Michael Ivers, Bren McInerney, Jill Stoddart, Advice to authors: http://www.bmj.com/about-bmj/resources-authors Jane Ingham, Danny Keenan To submit an article: submit.bmj.com The BMJ is published by BMJ Publishing Group Ltd, a wholly owned subsidiary of the British Medical Association. The BMA grants editorial freedom to the Editor of The BMJ. The views ESSAYS expressed in the journal are those of the authors and may not necessarily comply with BMJ policy. The BMJ follows guidelines on editorial independence produced by the World Association of Medical Editors (www.wame. org/wamestmt.htm#independence) and the code on good 42 How to improve healthcare improvement publication practice produced by the Committee on Publication Ethics (www.publicationethics.org.uk/guidelines/). Mary Dixon-Woods The BMJ is intended for medical professionals and is provided without warranty, express or implied. Statements in the journal are the responsibility of their authors and advertisers and not authors’ 46 Getting more health from healthcare: quality improvement must acknowledge institutions, the BMJ Publishing Group, or The BMJ unless otherwise specifi ed or determined by law. Acceptance of advertising does not imply patient coproduction endorsement. To the fullest extent permitted by law, the BMJ Publishing Group shall not Paul Batalden be liable for any loss, injury, or damage resulting from the use of The BMJ or any information in it whether based on contract, tort, or otherwise. Readers are advised to verify any information they choose to rely on. 49 Why healthcare leadership should embrace quality improvement @BMJ Publishing Group Ltd 2020 All Rights Reserved. No part of this publication may be reproduced, stored John R Drew, Meghana Pandit in a retrieval system, or transmitted in any form or by any other means, electronic, mechanical, photocopying, recoding, or otherwise, without prior permission, in writing, of The BMJ. QUALITY IMPROVEMENT

EDUCATION

52 How to get started in quality improvement Bryan Jones, Emma Vaux, Anna Olsson-Brown

56 Using data for improvement Amar Shah

60 Evaluating the impact of healthcare interventions using routine data Geraldine M Clarke, Stefano Conti, Arne T Wolters, Adam Steventon

65 Quality improvement into practice Adam Backhouse, Fatai Ogunlayi

71 How to improve care across boundaries Charles Coughlan, Nishma Manek, Yasmin Razak, Robert E Klaber

Article provenance These articles are part of a series commissioned by The BMJ based on ideas generated by a joint editorial group with members from the Health Foundation and The BMJ, including a patient/carer. The BMJ retained full editorial control over external peer review, editing, and publication. Open access fees and The BMJ’s quality improvement editor post are funded by the Health Foundation.

Indexing The BMJ Please do not use the page numbers given in this edition when citing or linking to content in The BMJ. Please be aware that The BMJ is an online journal, and the online version of the journal and each article at thebmj.com is the complete version. Please note that only the online article locator is required when indexing or citing content from The BMJ. We recommend that you use the Digital Object Identifier (doi) available online at the top of every article and printed in each article in this edition for indexing. The citation format is given on each article. EDITOR'S CHOICE

A road map towards better quality improvement

he BMJ and the Health Foundation’s Promoting curiosity within organisations But can the implementation of series on quality improvement is might be key. Creation of cycles around improvement approaches such as audit and T exploring the adaptive system of the projects where every single team member feedback lead to a culture of continuous NHS and what is needed to deliver a better has a sense of purpose and can ask, “Why improvement? Robbie Foy and colleagues quality of care. This booklet contains some are we doing this?” could lead to a more discuss how embedding rigorous yet of the content published since June 2019. transformative approach. A culture shift in pragmatic evaluations of improvement We hope it will help healthcare professionals attitude in order to have a better dialogue is methods within national programmes to unlock some of the challenges healthcare only possible by changing the hierarchical can deliver cumulative gains while systems face today. relationships within an organisation. simultaneously producing generalisable Quality improvement is often defined as Nicola Burgess and colleagues (p 7) point knowledge (p 38). And as Adam Backhouse a group of systematic approaches that uses out how network governance is important and Ogunlayi Fatai argue (p 65), quality specific techniques to improve delivery of care in increasing collaboration. Developing improvement should represent a valuable and bring change. But is quality improvement relational authority is a key element. opportunity for individuals to deliver change different from quality management? In their We also need to be sure quality improvement and implement leadership. essay, John Drew and Meghana Pandit (p 49) actually improves the quality of health Quality improvement remains a practice seek to understand the differences between services. Mary Dixon-Woods (p 42) calls for delivered by expert people rather than a way management and quality improvement, more evidence based research and highlights of thinking within the healthcare system. The looking at where the two can coalesce for how by using research and bringing together series will help to understand how quality organisational success. They discuss how the practice and the study of improvement, improvement can be useful and powerful if leadership, quality management, and quality we can help to improve quality improvement. applied by all within the healthcare system improvement overlap. Charles Coughlan Quality improvement has its origins in in order to deliver better care, improve and colleagues (p 71) argue that dedicated process manufacturing such as the Lean system outcomes for patients, and transform complex leadership among patients, managers, and developed for Japan’s automotive industry, but healthcare systems. clinicians seems vital to improve quality these can be a poor fit with a patient centred Raffaella Bosurgi, quality improvement editor across organisational boundaries. But where health system. Iain Smith and colleagues (p The BMJ to start? As Joanna Bircher highlights in her 34) illustrate how Lean improvement strategies Correspondence to: [email protected] editorial (p 2), deciding what to prioritise and that take customers’ values into consideration Cite this as: BMJ 2020;368:m1102 where to begin can be challenging. could be applied in healthcare. http://dx.doi.org/10.1136/bmj.m1102

the bmj | BMJ 2020;368:m1102 | doi: 10.1136/bmj.m1102 1 EDITORIAL

Prioritising quality improvement QI is a team sport, best played by those making the improvements

n almost every part of our lives we are of change, particularly when changes are GP partner. Greater Manchester GP Excellence Programme inundated with information. The working designed and driven by the people delivering is a collaboration between the Royal College of General 7 Practitioners and Greater Manchester Health and Social Ilives of primary care doctors and their care, in full collaboration with patients. Care Partnership. managers are no different. In 1964 Bertram Quality improvement is a team sport and is Provenance and peer review: Commissioned; not Gross, professor of political science at Hunter played best when owned by those making externally peer reviewed. College in New York, defined the concept of the improvements. Projects work best when This article is one of a series commissioned by The BMJ information overload: priorities are set locally unless external based on ideas generated by a joint editorial group “Information overload occurs when the benchmarking data show problems with with members from the Health Foundation and The amount of input to a system exceeds its patient safety or quality of care or practice BMJ, including a patient/carer. The BMJ retained full processing capacity. Decision makers have viability is being affected by poor performance editorial control over external peer review, editing, and publication. Open access fees and The BMJ’s quality fairly limited cognitive processing capacity. in financially driven targets. improvement editor post are funded by the Health Consequently, when information overload Primary care doctors have an important Foundation. occurs, it is likely that a reduction in decision role in quality improvement. They need to be Joanna Bircher, clinical director 1 quality will occur.” aware of practice performance data and find Greater Manchester GP Excellence Programme, The quality of the care we provide is ways to present it to the practice team and Manchester, UK measured, benchmarked, and reported back patients in a meaningful way—for example, Correspondence to: J Bircher to us by a multitude of organisations. In by taking into account variations in practice [email protected] England, primary care doctors can compare demographics and list turnover. their patient experience scores with those The increase in primary care workload of the practice down the road through the without a matched increase in funding limits National GP Patient Survey.2 They can see the time available for practice development This is an Open Access article distributed in accordance how well they are achieving screening targets and improvement.8 Although there has been with the Creative Commons Attribution Non Commercial 3 (CC BY-NC 4.0) license, which permits others to on the public health websites and compare some attempt to rectify this, until the effects are distribute, remix, adapt, build upon this work non- their prescribing on openprescribing.net.4 felt at the frontline, practices must prioritise commercially, and license their derivative works on Commissioning organisations send improvements that focus on working more different terms, provided the original work is properly cited and the use is non-commercial. See: http:// practices data on referring behaviour, rates effectively and efficiently. This is in line with creativecommons.org/licenses/by-nc/4.0/. of unplanned admissions, or how much their the NHS sustainable improvement programme patients use the emergency department. Some Time for Care.9 Feedback from participants of aspects of performance can affect practice the programme indicates that it has improved 5 income through performance related pay, job satisfaction and teamwork and embedded 1 Gross BM. The managing of organizations: the including targets for treatment and follow-up basic quality improvement methods that administrative struggle. Free Press of Glencoe, 1964. of patients with long term conditions. practices can apply to other aspects of care 2 NHS England, NHS Improvement. National GP patient survey. https://www.gp-patient.co.uk/ Regulators use much of this information to such as patient outcomes and access. 3 Public Health England. National general practice guide judgments of services provided.6 Improvement won’t happen unless people profiles. https://fingertips.phe.org.uk/profile/general- practice take action. The importance of “starting 4 EBM DataLab. Open Prescribing. https:// Where to start? with why” has been recognised in many openprescribing.net With so many possible areas where workplace environments,10 and healthcare 5 NHS Digital. Quality and outcomes framework. https:// digital.nhs.uk/data-and-information/data-collections- improvements might be made, it can feel like delivery and improvement is no different. If and-data-sets/data-collections/quality-and-outcomes- an impossible task to choose which should people working in a practice have a strong framework-qof take priority. Improvement often needs several sense of purpose and know why they do 6 Care Quality Commission. How we monitor GP practices. https://www.cqc.org.uk/guidance-providers/gps/how- iterative cycles before solutions that work what they do, they will notice when current we-monitor-gp-practices emerge. Sustained improvement takes time performance isn’t delivering their aspirations. 7 Mannion R, Davies H. Understanding organisational and effort, and it is easy to get demoralised culture for healthcare quality improvement. This can generate improvement priorities BMJ 2018;363:k4907. doi:10.1136/bmj.k4907 if practices or individuals take on too many that resonate with the values, vision, and 8 Baird B, Charles A, Honeyman M, Maguire D, Das P. projects and can’t follow them through. It is purpose of the team and the organisation. Understanding pressures in general practice. Kings tempting to prioritise the areas that affect Fund, 2016. Using these priorities to create broad themes 9 NHS England. Releasing time for care. https://www. practice income or please regulators rather than over time creates a coherent and meaningful england.nhs.uk/gp/gpfv/redesign/gpdp/releasing-time/ projects that matter more to patients and staff. improvement plan that everyone understands 10 Sinek S. Start with why: how great leaders inspire everyone to take action. Penguin Random House, 2011. High quality care develops when an and can work towards. organisational culture promotes curiosity, Competing interests: I have read and understood BMJ Cite this as: BMJ 2019;367:l6594 experimentation, and continuous small cycles policy on declaration of interests and declare that I am a http://dx.doi.org/10.1136/bmj.l6594

2 doi: 10.1136/bmj.l6594 | BMJ 2019;367:l6594 | the bmj EDITORIAL

Creating space for quality improvement Clinicians already have the motivation; now they need time, skills, and support

ast year The BMJ and the Health services, including communicating and improve a service, committed doctors Foundation launched a joint negotiating better within and beyond may turn their energies elsewhere— series of papers exploring how their teams on the best way forward. to academic work, medical training, to improve the delivery of health- Like studying the science of medicine, committee work, private practice—in fact, care (https://www.bmj.com/ to make improvements doctors need to anywhere other than bettering everyday Lquality-improvement).1 2 The series aims to apply scientific principles to the practice clinical work. discuss the evidence for systematic quality of everyday work and to test changes, Yet there is plenty of evidence that improvement, provide knowledge and sup- analyse results, and adapt accordingly. systematic quality improvement makes port to clinicians, and ultimately to help This broad approach is loosely called a difference, not just for patients but for improve care for patients. quality improvement in healthcare. staff too.8 9 And despite everything many Stories of a disordered system abound The task ahead is not necessarily to doctors in the wider NHS are motivated in healthcare: the notes or test results that turn doctors into managers, but the first to reach beyond the boundaries of don’t arrive, the overbooked clinic, the frail step must be to equip doctors and other traditional medicine and improve care. patient who wastes hours travelling to and clinicians with formal skills to make The intrinsic motivation of healthcare from an appointment that the hospital had continuous improvements to the quality professionals to improve care for patients rescheduled but failed to communicate. At of the services they provide. This means could undoubtedly be put to more effective the front line the problems frustrate, waste new technical and relational skills and use with more knowledge, careful planned time, and add avoidable risk; at national behaviours. development of clinicians, and practical level, they add up to slow progress on Despite substantial debate, multiple support. Our aim is that this series will quality, wasted resource, and severely initiatives to equip clinicians with quality contribute to these important goals. dented staff enthusiasm and public trust in improvement skills, and advances in Competing interests: We have read and understood BMJ 4 the NHS. defining the role of a doctor, medical policy on declaration of interests and have no relevant Leaving aside the human cost of poorly training still does not help enough doctors interests to declare. managed care, the aggregate loss of to develop these skills. Audit (sometimes Provenance and peer review: Commissioned; not value each year is high. In today’s NHS, rebranded as quality improvement) externally peer reviewed. the pressure—from rising demand and a is increasingly mandated as part of This article is one of a series commissioned by The BMJ financial squeeze in the NHS and social postgraduate clinical training but doctors based on ideas generated by a joint editorial group with care—is intense, with staff working flat are largely unsupported to do it, which members from the Health Foundation and The BMJ, including a patient/carer. The BMJ retained full editorial out to do their best for patients, in many risks quality improvement being viewed as control over external peer review, editing, and publication. cases at great personal cost. Suggestions a tick box exercise needed to get through Open access fees and The BMJ’s quality improvement to those working at the front line that annual appraisal. editor post are funded by the Health Foundation. things could be done differently can be While some royal colleges in the UK Dominique Allwood, assistant director of improvement met with a chorus of: “But we have no are making progress in introducing Rebecca Fisher, policy fellow 5-7 time to think/no support/no power/no postgraduates to quality improvement, Will Warburton, director of improvement resources,” sometimes followed by “the many places of work either do not Jennifer Dixon, chief executive organisation or government must do recognise the need or offer no support. Health Foundation, London, UK something.” There is a widespread view, and implicit Correspondence to: J Dixon But some clinical teams do carve out the hope, that improvements to care occur [email protected] space to discover what needs to change, at the front line by a kind of osmosis then design and make improvements to or, worse still, only through new the services they are responsible for.3 technologies or “management,” without There is no substitute—only clinicians, careful ongoing systematic effort of This is an Open Access article distributed in accordance patients, and carers at the front line clinical staff. A good time to excite with the terms of the Creative Commons Attribution can see clearly every day what needs to doctors on this agenda should be early (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial change. in their career. But junior doctors are on use, provided the original work is properly cited. See: In making these improvements doctors short rotations, have limited time to do http://creativecommons.org/licenses/by/4.0/. have gone beyond their primary remit anything, and may feel they are transient of practising medicine. If disordered workers with no authority to improve care is to improve then we need more existing practices. clinicians to view their role as bigger No surprises then that juniors become 1 De Iongh A, Erdmann S. Better healthcare must than the traditional scope of medicine cynical, senior clinicians don’t know about mean better for patients and carers. BMJ taught at medical school. Just as doctors or are sceptical about quality improvement 2018;361:k1877. learn to assess, diagnose, and treat approaches, and both may run a mile from 2 Braithwaite J. Changing how we think about healthcare improvement. BMJ 2018;361:k2014. clinical conditions they also need to a management perceived to be focused 3 Health Foundation. Improvement projects, learn how to design improvements to on financial control. Rather than try to tools and resources.http://www.health.org.uk/ the bmj | BMJ 2018;361:k1924 | doi: 10.1136/bmj.k1924 3 EDITORIAL

collection/improvement-projects-tools-and- 6 Peden C, ed. Quality improvement in anaesthesia. infections in the ICU. N Engl J Med 2006;355:2725- resources 2012. https://www.rcoa.ac.uk/system/files/CSQ- 32. doi:10.1056/NEJMoa061115 4 GMC. Good medical practice. https://www.gmc-uk. ARB2012-QIA.pdf 9 Salford Royal NHS Foundation Trust. Quality org/-/media/documents/Good_medical_practice___ 7 Choudry MI, Stewart K, Woodhead T. The Royal College improvement strategy, 2015-2018. http://www.srft. English_1215.pdf_51527435.pdf of Physician’s quality improvement hub—how can nhs.uk/EasysiteWeb/getresource.axd?AssetID=39260 5 Royal College of General Practitioners. Quality it help physicians to improve patient care?Future &type=full&servicetype=Inline improvement project. https://www.rcgp.org.uk/ Hospital Journal 2016;3:21106. training-exams/mrcgp-workplace-based-assessment- 8 Pronovost P, Needham D, Berenholtz S, et al. An Cite this as: BMJ 2018;361:k1924 wpba/qip-guidance.aspx intervention to decrease catheter-related bloodstream http://dx.doi.org/10.1136/bmj.k1924

4 doi: 10.1136/bmj.k1924 | BMJ 2018;361:k1924 | the bmj EDITORIAL

Better healthcare must mean better for patients and carers Their perspectives are essential to all successful healthcare improvement

uality improvement in health- always better information, as criticism of process can give insight into what these care is a team effort1 and most the NHS friends and family test has recently unintended consequences might be and effective when it includes peo- explored.3 how to avoid them. Collaboration works ple using services and their Paying attention to the quality of language both ways. With a deeper connection and carers, families, and advocates. is the foundation for successful dialogue appreciation of the rationale for decisions QThese people bring direct expertise in mat- and everyday collaboration. Many patients and the constraints that we all operate ters of health from their personal experience and carers can describe the pain caused by under (organisational, clinical, personal) of illness as well as skills from lives beyond a single word they encountered while being we can learn together—and that is always the healthcare system. treated. Especially with new words and better. Some aspects of healthcare undeniably labels, it is important that we are respectful For people using services, better need to be improved, but the quality deficit towards their owners. For instance, only healthcare is personal, as we juggle self needs to be clearly described from every people with experience of dementia can managing an illness with the practicalities angle. We can do things better or we can verify which services are indeed dementia of daily life. Often, better actually means do better things, but both usually mean friendly. choosing the least worst of a limited menu acting differently. Patients, carers, and their In recent years, we have seen a qualitative of options. To judge what is better from a advocates are a vital source of different expansion of the boundaries of the patients’ point of view, we must remember perspectives in healthcare. traditional patient-doctor relationship.4 that the starting point is a profoundly The invitation to patients to get Patient advocates are becoming more disruptive life event. Living through illness involved needs to be both timely and confident when exchanging knowledge with gives individuals a unique insight of respectful. In a board meeting discussing clinicians and researchers about medical enormous value to quality improvement quality indicators, for example, it is conditions, bringing in their knowledge efforts. These efforts must recognise the demeaning to refer to the participating from outside the medical arena. But we still qualitative nature of patient experience and parent as “mummy.” Looking at someone have some way to go before all clinicians give it equal priority with the experience of through this lens blinds us to the other welcome every patient contribution, either healthcare professionals providing clinical life experiences they may have had in during consultations or in discussing service services. The two elements fit hand in glove, their professional career. We need to improvements. One example of better even if our language and systems don’t respectfully acknowledge all the attributes, healthcare might be that we no longer hear always reflect it. qualities, and skills that people bring to patients, carers, or healthcare professionals Competing interests: We have read and understood the table, whether gained through their say, “I was too afraid to ask or say…” BMJ policy on declaration of interests and declare SE is a founding member of Q, a healthcare improvement initiative patient experiences or other personal or Beyond these personal encounters, led by the Health Foundation and supported by NHS career experiences. patients also have a key role in Improvement. She is also a member of The BMJ’s patient In healthcare improvement we are organisational change to improve panel. asking patients to play a range of roles in healthcare. The delicate balance of Provenance and peer review: Commissioned; not an invisible script, from telling their story, sometimes competing drivers such as speed, externally peer reviewed. to being representative of a broader group, volume, integration, and specialisation This article is one of a series commissioned by The BMJ based on ideas generated by a joint editorial group with to partners in coproduction. It’s not always all directly affect people who use health members from the Health Foundation and The BMJ, clear which of these roles patients are asked services, so their perspectives need to including a patient/carer. The BMJ retained full editorial to play.2 Patients can find themselves stuck inform this bigger picture too. Models control over external peer review, editing, and publication. in limbo between two expected roles or already exist to involve people, their carers, Open access fees and The BMJ’s quality improvement editor post are funded by the Health Foundation. trying to second guess what is required. In families, and advocates in all aspects 1 this situation, doing better means improving of organisational improvement.5 The Anya de Iongh , patient editor 2 the relevance and practical impact of every common thread across these is timeliness— Sibylle Erdmann , chair of parent group 1 contribution. involvement early is always better. The BMJ, London, UK 2 The level of patient involvement will differ Any quality improvement effort can London Neonatal Network, London, UK according to the requirements of projects produce unintended collateral damage Correspondence to: A de Iongh [email protected] and the preferences of individuals. At all for patients if the “improvement” is one levels, quality of input trumps quantity. dimensional. The flaws of improvement Patients and carers already provide initiatives will be invisible until users miss solicited and unsolicited insights into their the refuge of a kitchen with a toaster in a experiences of services. “Feedback fatigue” children’s ward or the comfort of a biscuit This is an Open Access article distributed in accordance 6 with the terms of the Creative Commons Attribution can set in if the purpose of further feedback during regular intravenous treatments. (CC BY 4.0) license, which permits others to distribute, requests isn’t clear. New information isn’t Proper collaboration early in the change remix, adapt and build upon this work, for commercial

the bmj | BMJ 2018;361:k1877 | doi: 10.1136/bmj.k1877 5 EDITORIAL

use, provided the original work is properly cited. See: 2 Liabo K, Boddy K, Burchmore H, Cockcroft E, 5 NHS England. Patient participation resources. http://creativecommons.org/licenses/by/4.0/. Britten N. Clarifying the roles of patients in research. https://www.england.nhs.uk/participation/ BMJ 2018;361:k1463. https://www.bmj.com/ resources/ content/361/bmj.k1463. doi:10.1136/bmj.k1463 6 Giles C. Jeremy Hunt stole my biscuits. BMJ 3 Robert G, Cornwell J, Black N. Friends and family test Opinion, 31 Oct 2017. http://blogs.bmj.com/ should no longer be mandatory. BMJ 2018;360:k367. bmj/2017/10/31/ceinwen-giles-jeremy-hunt- 1 Miller R, Miller R, Gardner T, Warburton W. Briefing. doi:10.1136/bmj.k367 stole-my-biscuits/ Partnerships for improvement: ingredients for success. 4 Riggare S. E-patients hold key to the future of Health Foundation, 2017. https://health.org.uk/sites/ healthcare. BMJ 2018;360:k846. https://www.bmj. Cite this as: BMJ 2018;361:k1877 health/files/PartnershipsForImprovement.pdf com/content/360/bmj.k846. doi:10.1136/bmj.k846 http://dx.doi.org/10.1136/bmj.k1877

6 doi: 10.1136/bmj.k1877 | BMJ 2018;361:k1877 | the bmj ANALYSIS

Improving together: collaboration needs to start with regulators Nicola Burgess and colleagues argue for a move away from top-down regulation to a new approach that facilitates rather than hinders learning across organisations

he regulatory landscape in the characterised by trust and mutual respect autonomous organisations to work together, UK is changing again. From 1 and has to be earnt over time.4 To support learn together, and improve together.11 April 2019 NHS England and our argument we draw on our experience As with interorganisational learning, NHS Improvement became what analysing a major experiment in delivering networked governance is relational, is effectively a single organisation service transformation in five NHS hospital emerging from informal social systems Twith far reaching responsibility for the over- trusts in partnership with NHS Improvement characterised by solidarity among network sight of the system. The structural features and the Virginia Mason Institute in the US members, a shared goal, and frequent of this change, which will eventually require (box 1).3 knowledge exchange.7 11 12 Although NHS legislative reform, have been widely debated, policy enshrines the building blocks for more not least by those affected by plans for a col- Interorganisational learning collaborative approaches to improvement laborative approach to improvement in the Organisational learning describes the pro- through integrated care systems, pervasive NHS.1 2 But there has been less discussion cess of assimilation and embedding new top-down regulation may stymie action on about the style and approach to regulation knowledge in an organisation underpinned the ground. Policy emphasis on managing that might be best suited to drive improve- by social interactions between individuals performance can mean that staff focus on ment in the NHS as set out in the long term and groups. Cross-organisational networks meeting targets, reducing the energy for plan.3 We contend that a major change is are becoming more common and offer con- interorganisational learning.13 required in the way the system interacts with siderable potential for organisational learn- service providers if we are to be successful in ing. Like learning within organisations, How do we build a relational approach to developing a new service model for the 21st learning across organisations is facilitated governance? century. through frequent and structured dialogue Moving from top-down regulation to net- Currently the NHS relies on positional underpinned by high levels of trust and worked governance requires a radical change authority—a hierarchical system in which information sharing.5 6 Such reciprocity and from mechanisms that rely on positional regulators use their power and leverage to trust, however, requires long term commit- authority to mandate change, to mecha- drive change. Drawing on organisational ment from collaborating parties, with regu- nisms that employ relational authority. The theory we contend that structural change lar, meaningful face-to-face interactions.6-8 partnership between NHS Improvement in the regulatory landscape is insufficient Interorganisational learning is best and the Virginia Mason Institute shows how to drive interorganisational learning for supported by networked forms of a relational approach to governance can be improvement. Specifically, we argue that governance—that is, when governance is nurtured. The partnership is a five year col- regulation needs to shift towards a more shared between a group of autonomous laboration to transfer learning from a US hos- relational form of governance in which organisations—rather than by a hierarchical pital with an enviable reputation for patient informal social systems foster learning across approach. Where accountability is safety and quality to the English NHS (box organisations. This relational authority hierarchical, provider organisations 1). Part of this commitment was to establish emerges through interpersonal relationships are driven to ensure compliance9 10; by a transformation guidance board to enable contrast, networked governance motivates the five participating trusts to support one KEY MESSAGES • If collaboration between organisations Box 1: NHS-Virginia Mason Institute partnership is to drive improvement, regulators In 2015 a five year partnership was established between the NHS and US based Virginia Mason need to reconsider their approach to Institute, a non-profit organisation specialising in transforming healthcare. After a competitive the exercise of power and authority tendering process, five NHS trusts were selected to form the partnership and develop localised • Top-down governance forces organisa- versions of the Virginia Mason production system. tions to seek rapid short term solutions The production system is an adaptation of that used by the Japanese car manufacturer Toyota. that do not address complex problems Based on principles commonly known as Lean, the system makes patients central to all activity; • Effective collaboration requires invest- any activity that doesn’t add value to the patient is “waste” and should whenever possible, be ment in developing relationships eliminated. between organisations characterised Although the centrality of patients may seem obvious, many healthcare processes are designed by trust and reciprocity around the needs of the service provider rather than patients. The partnership seeks to build • A relational approach between the skills in quality improvement within and across the five NHS trusts so that they can redesign regulator and service providers can processes to ensure the highest quality of care while reducing the cost of delivering the service. foster interorganisational learning and Crucially, the partnership shares a goal to support development of a sustainable culture of governance continuous improvement. the bmj | BMJ 2019;367:l6392 | doi: 10.1136/bmj.l6392 7 ANALYSIS another, learn together, and foster ongoing Box 2: What does relational space and relational authority look like? dialogue among all partners. The transformational guidance board The most striking feature of the NHS-Virginia Mason partnership is the quality and quantity of time is an example of a goal directed, intero invested in face-to-face meetings. All five chief executives travel to London from various parts of rganisational network,7 where all network the UK to meet with the same senior executives of NHS Improvement and senior representatives members are working towards a shared goal. from Virginia Mason every month. The meeting lasts for six hours, during which there are no Its members comprise chief executives of the laptops open, no phone calls taken, and dialogue is fluent, reciprocal, and supportive. five NHS partner trusts, senior members of Spending six hours in a windowless room in London with senior representatives of the NHS Improvement, and senior improvement regulator may sound like punishment, but after more than three years these chief executives specialists from Virginia Mason. NHS told us it was “the best day of the month.” This is because discussions are frank, honest, and Improvement leads the administration of reciprocal and there is an air of friendship and friendly rivalry, with an overwhelming sense the network and is an active participant. that all organisational partners are learning together. Relational investments of this nature are The board provides two key mechanisms uncommon in the NHS; trusts typically compete against each other for business and reputation, that combine to foster relational authority—a and in-person interaction with the regulator is usually a sign a trust is in trouble. protected relational space and a “compact” One chief executive explains: (non-binding informal contract14) on “It’s quite remarkable really … Regulators are usually regulators; they’re usually telling you you’re expected behaviours and commitments. not doing something very well. But actually, this is different. It’s really important in terms of how These mechanisms allow interorganisational you are allowed to create the space to learn and develop, and even when things aren’t going so learning and network governance to emerge. well, there’s a dialogue to be had. So, it’s a different relationship.”

Protected relational space and honest discussion takes place about organisations and to the transformational A protected relational space is an area what the board should have done differently. guidance board is testament to network where people can work collaboratively governance. Chief executives rarely miss towards establishing new norms and roles Shifting attitudes a meeting or prepare inadequately. This that challenge institutional practices.15 All Dialogue is central to interorganisational is partly because of the value that they stakeholders are included but individuals learning.16 When relationships are hierar- associate with the meeting and partly must support the aim to change processes; it chical, interaction commonly veers towards because of the social norms firmly embedded does not include people motivated to defend “skilful discussion” designed to keep the across the group. The chief executives all the status quo. A protected relational space relationship with a more powerful actor at prepare reports of progress and challenges is crucial for fostering frank and honest arm’s length. A protected relational space to share at the meetings and they engage dialogue about how to lead change (box 2). allowed our stakeholders to come together in dialogue that supports one another All stakeholders must feel psychologically regularly, engage in honest reflection, and towards improvement goals. For example, safe to share the challenges they face as develop collective thinking towards a shared one trust showcased its “heat map” of well as their successes; this is particularly goal. To our surprise we regularly heard rep- training—a document that visually depicts important when relationships are character- resentatives from the regulator claiming they where trained individuals are located within ised by a legacy of power imbalance, as in were reflecting on their behaviours as a regu- the organisation. The document can be the case between a regulator and provider lator and how those behaviours inhibit the used to identify concentrations of trained organisation. improvement capability the network seeks individuals to inform future training plans to build. and improvement efforts. The heat map was Create a compact In tandem, the continued commitment of deemed an excellent idea and subsequently Moving from positional authority towards the trust chief executives both within their adopted by the other four trusts. relational authority requires a radical change in behaviour. In our example, the first step towards achieving relational authority Box 3: Compact between NHS Improvement and partner trusts for interorganisational learning occurred A compact was created to set down the reciprocal commitments of NHS Improvement and the through collective structuring and negotia- partner trusts in working collaboratively towards their shared vision. The compact states: tion of a compact— a process in which the “We aspire to fulfil these commitments and will be open to respectful communication from our expected behaviours and reciprocal com- partner(s) about how well we do in that regard. We accept that this is a developmental journey for mitments of the regulator and the chief all of us.” Some of the responsibilities included are listed below. executives are explicitly negotiated and for- malised. NHS Improvement responsibilities Members of the transformational gui • Behave in a positive, respectful, and consistent way at all levels of interaction with trusts and be dance board spent almost 12 months open and transparent developing the compact. Broad categories • Maintain integrity of positive partnership working even when under external pressure and show of partner responsibilities outlined in empathy with trust issues the compact include creating the right • Be candid in offering constructive criticism and receptive in receiving it—always assume good environment; fostering excellence; liste intent ning, communication, and influencing; Trust responsibilities focus on patients; focus on staff; and a focus • Act in a way that is respectful, open, and transparent with a commitment to early warning and no on leadership (box 3). In the event that the surprises compact is disrupted—for example, if a chief • When under pressure on wider delivery look to the method as part of the solution not a barrier executive wasn’t sufficiently supported in • Work with the wider system so everyone understands the methods, process, and what is line with the terms of the compact—a frank required to maximise benefits

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Can the approach be extended across the NHS? Competing interests: We have read and understood uk/news-and-comment/blogs/the-human-chemistry-of- The role of regulator is changing towards BMJ policy on declaration of interests and have no trust-relationships-and-shared-understandings 17 relevant interests to declare. 3 NHS. The NHS long term plan. 2019.https://www. a more facilitative improvement role. To longtermplan.nhs.uk/ date, attempts to transform the NHS have Provenance and peer review: Commissioned; 4 Uzzi B. Social structure and competition in interfirm mainly focused on structural change and externally peer reviewed. networks. Sci Q, 1997. doi:10.2307/2393808 5 Bate P. Changing the culture of a hospital: from tightening up regulatory processes that This article is one of a series commissioned by The BMJ hierarchy to networked community. Public Adm serve to reinforce the positional authority based on ideas generated by a joint editorial group 2000;78:485-731. doi:10.1111/1467-9299.00215 with members from the Health Foundation and The of the regulator. Our analysis suggests that 6 Lave J, Wenger E. Situated learning. Legitimate BMJ, including a patient/carer. The BMJ retained full peripheral participation. University of Cambridge Press, network governance can be more effective editorial control over external peer review, editing, and 1991. doi:10.1017/CBO9780511815355 at fostering collaboration for improvement, publication. Open access fees and The BMJ’s quality 7 Jones C, Hesterly WS, Borgatti SP. A general theory and that such governance occurs through improvement editor post are funded by the Health of network governance: Exchange conditions and Foundation. development of relational authority. We social mechanisms. Acad Manage Rev 1997;22. Nicola Burgess, associate professor of operations doi:10.5465/amr.1997.9711022109 acknowledge that the partnership represents management 8 Ostrom E. Collective action and the evolution of just one example of a networked governance Graeme Currie, professor of public management social norms. J Econ Perspect 2000;14:137-58. approach and this particular example is doi:10.1257/jep.14.3.137 Bernard Crump, professor of practice in healthcare and 9 Addicott R, McGivern G, Ferlie E. Networks, organizational limited to a collaboration with just five NHS leadership learning and knowledge management: NHS cancer provider organisations. The challenge will John Richmond, research fellow networks. Public Money Manag 2006;26:87-94. be how to replicate this approach across the Mark Johnson, associate professor of operations doi:10.1111/j.1467-9302.2006.00506.x broader system. management 10 Burgess N, Strauss K, Currie G, Wood G. Organizational ambidexterity and the hybrid middle manager: the To reiterate our earlier contention, University of Warwick, Warwick Business School, case of patient safety in UK hospitals. Hum Resour relational authority is earned over time. Coventry, UK Manage 2015;54(Suppl 1):s87-109. doi:10.1002/ We have identified a safe relational space Correspondence to: N Burgess hrm.21725 [email protected] 11 Romzek BS, LeRoux K, Blackmar JM. A preliminary and the process of creating a new compact theory of informal accountability among network as important conditions to bring about organizational actors. Public Adm Rev 2012;72:442- interorganisational learning and network 53. doi:10.1111/j.1540-6210.2011.02547.x 12 Provan KG, Kenis P. Modes of network governance: governance. A different approach to structure, management and effectiveness. J Public Adm governance is plausible, possible, and This is an Open Access article distributed in accordance Res Theory 2008;18:229-52. doi:10.1093/jopart/ with the Creative Commons Attribution Non Commercial desirable. mum015 (CC BY-NC 4.0) license, which permits others to 13 Burgess N, Strauss K, Currie G, Wood G. Organizational Contributors and sources: The authors are engaged in a distribute, remix, adapt, build upon this work non- ambidexterity and the hybrid middle manager: The formative and summative evaluation of the NHS-Virginia commercially, and license their derivative works on case of patient safety in UK hospitals. Hum Resour Mason partnership. The evaluation uses mixed methods, different terms, provided the original work is properly Manage 2015;54(S1):s87-109. but this article is based on the qualitative elements. cited and the use is non-commercial. See: http:// 14 Kornacki MJ, Silversin JB. A new compact: aligning The methods included over 50 hours of observation creativecommons.org/licenses/by-nc/4.0/. physician-organization expectations to transform generating over 600 pages of detailed notes and verbatim patient care. Health Administration Press, 2015. transcription; 14 semistructured interviews with members 15 Kellogg KC. Operating room: relational spaces of the board and analysis of the detailed minutes of all and microinstitutional change in surgery. board meetings since its inception in October 2015. NB AJS 2009;115:657-711. doi:10.1086/603535 was responsible for the planning, conduct, and reporting 1 Edwards N. Local lessons: what can we learn from 16 Beeby M, Booth C. Networks and inter-organizational of the work described and for writing the article. GC Tameside and Glossop? Nuffield Trust 2019. https:// learning: a critical review. Learn Organ 2000;7:75-88. and BC provided support in the planning, conduct, and www.nuffieldtrust.org.uk/news-item/local-lessons- doi:10.1108/09696470010316260 reporting of the work and the revision of the article. JR what-can-we-learn-from-tameside-and-glossop 17 Furnival J, Walshe K, Boaden R. Emerging hybridity: provided a supporting role in the conduct of the work, 2 Richard R, Horton T. The human chemistry of trust, comparing UK healthcare regulatory arrangements. J including interviews and observations, and MJ supported relationships and shared understandings. Health Health Organ Manag 2017;31:517-28. doi:10.1108/ the planning. NB is guarantor. Foundation blog 25 Jun 2019. https://www.health.org. JHOM-06-2016-0109

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Spreading and scaling up innovation and improvement Disseminating innovation across the healthcare system is challenging but potentially achievable through different logics: mechanistic, ecological, and social, say Trisha Greenhalgh and Chrysanthi Papoutsi

he general practitioner in the sur- scale in a complex system. A technology one or a few selected settings, followed by gery, the nurse manager on the or pathway that works smoothly in setting a systematic effort to replicate it in other ward, and the policy maker in the A will operate awkwardly (or not at all) in settings, partly by identifying and dealing boardroom would be forgiven for setting B. with barriers (which get in the way of the losing track of all the new tech- Given these realities, what insights does implementation effort) and facilitators Tnologies, care pathways, and service models the rapidly growing research literature on (which potentially support it). that could potentially improve the quality, spread and scale-up offer the busy clinician, Patient input can be harnessed very safety, or efficiency of care. Yet we know manager, commissioner, or policy maker? productively in this effort, though careful that innovations rarely achieve widespread How—if at all—does this literature speak to attention needs to be paid to power uptake even when there is robust evidence of the patient? dynamics, the kinds of data that are their benefits (and especially when such evi- “Spread” generally means replicating an collected, and how and by whom those data dence is absent or contested).1 The NHS Long initiative somewhere else and “scale-up” are analysed.15 Term Plan points out that every approach means tackling the infrastructural Although the sequence depicted in figure prioritised in the plan is already happening problems (across an organisation, locality, 1 is often promoted as the key to quality somewhere in the NHS but has not yet been or health system) that arise during full scale improvement, one systematic review widely adopted.2 implementation,3 though in practice the one showed that nearly half of all successful There are common sense reasons why blurs into the other. scale-up initiatives had not followed it.10 spreading an innovation across an entire In this rapid review (the methods of Implementation science approaches tend health system is hard. Achieving any change which are described in box 1) we found that to draw heavily on quality improvement takes work, and it usually also involves—in scholars of spread and scale-up had used methodology. Barker and colleagues various combinations—spending money, many different theoretical lenses. We have describe this methodology as an “engine” diverting staff from their daily work, shifting chosen to discuss three—implementation that uses rapid cycle change to drive spread deeply held cultural or professional norms, science, complexity science, and social of an innovation, with some potential to and taking risks. Simplistic metaphors science, each of which is based on a different adapt to different contexts.3 (“blueprint,” “pipeline,” “multiplier”) logic of change (mechanical, ecological, In recent years, implementation science aside, there is no simple or universally and social, respectively; table 1). Many has matured as a field in a way that has replicable way of implementing change at successful spread and scale-up programmes paralleled developments in the Medical draw predominantly on one of these lenses Research Council’s guidance for developing but include elements of the other two. and testing complex interventions.17 Both KEY MESSAGES have shifted from a highly structured and • Spread (replicating an intervention) Implementation science: spread and scale-up as narrowly experimental approach based and scale-up (building infrastructure structured improvement on mechanical logic (which emphasised to support full scale implementation) Implementation science, defined as “the standardisation and replicability) to a are difficult scientific study of methods to promote the more adaptive approach that recognises • Implementation science takes a struc- systematic uptake of research findings and the need to think flexibly, understand and tured and phased approach to devel- other evidence based practices into routine respond to local context, use qualitative 16 oping, replicating, and evaluating an practice” (page 2), developed from the evi- methods to explore processes and intervention in multiple sites dence based medicine movement in Europe mechanisms, and adapt the intervention and North America. It is perhaps best known to achieve best fit with different settings.18 • Complexity science encourages a flexible and adaptive approach to change for the sequential, structured (and somewhat This shift resonates with the complexity in a dynamic, self organising system top-down) method of spreading focused science approach described in the next improvement techniques.10 16 section. Social science approaches consider why • The first phase of this approach An example of spread using an people act in the way they do, espe - (after initial set-up and orientation) is implementation science logic is shown in cially the organisational and wider the development of a clearly defined box 2. social forces that shape and constrain intervention, the components of which people’s actions are optimised to reflect the evidence base Complexity science: spread and scale-up as • These approaches may be used in com- (especially relating to how to change adaptive change bination to tackle the challenges of individual behaviour) (fig 1). There is then A complex system is a set of things, people, spread and scale-up a small scale trial of this intervention in and processes that evolve dynamically and

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Box 1: Search methods and summary of dataset process • Facilitate interdependencies—designers Through a keyword and snowball search, we identified recent systematic reviews, narrative should develop methods to assess the reviews, realist reviews, and theoretical syntheses on spread or scale-up (see supplementary nature and strength of interdependen- file). Each had a different focus, such as improvement science in high income4-6 and low 3 7 8 9 10 cies; implementation teams should attend and middle income countries, innovation in primary care or public health, complex to these relationships, reinforcing existing interventions,11 leadership for innovation,12 the social practice of innovation,13 and technology 14 15 ones where appropriate and facilitating adoption. new ones All these reviews emphasised the need to attend to the complex relationship between • Encourage sensemaking—designers intervention, people, organisation, and the wider context, but they used different conceptual should build focused experimentation frameworks and theoretical lenses. into their designs; implementation Prompted by a reviewer of an earlier draft of this paper, we searched the literature for reviews teams should encourage participants that had explicitly considered how patients might be involved in spread and scale-up efforts. We to ask questions, admit ignorance, found no such reviews so removed the “review” filter from our search and selected one relevant, 15 explore paradoxes, exchange different high quality, primary study. viewpoints, and reflect collectively. To this list, we would add: can be defined in terms of their relationships “blueprint” innovation in a standardised • Develop adaptive capability in staff— and interactions.4 18 Such systems are char- way across widely different settings. The individuals should be trained not acterised by uncertainty, unpredictability, plan-do-study-act engine depicted in figure merely to complete tasks as directed and emergence. They adapt through self 1 might work for small scale improvement but to tinker with technologies and pro- organisation (such as continuous adapta- initiatives, but spreading and scaling up cesses and make judgments when faced tions initiated by frontline staff to allow them major innovations across a health system with incomplete or ambiguous data to complete tasks given local contingencies requires attention to the underlying logic of • Attend to human relationships—embed- and availability of resources), attention to complex systems, which is ecological rather ding innovation requires people to work interdependencies (how the parts of the than mechanical.4 5 7 8 together to solve emergent problems system fit together), and sensemaking (the Lanham and colleagues, for example, using give-and-take and “muddling process by which people, individually and recommend the following principles when through” collectively, assign meaning to experience planning major change programmes in • Harness conflict productively—there is and link it to action).4 conditions of complexity4: rarely a single, right way of tackling a To study the ecological (that is, complex problem, so view conflicting emergent, interdependent, adaptive) • Acknowledge unpredictability—design- perspectives as the raw ingredients for properties of complex systems, researchers ers of interventions should contemplate multifaceted solutions. and evaluators use multiple methods, multiple plausible futures; implementa- particularly ethnographic observation, tion teams should tailor designs to local These principles underpin the concept in real world settings. Such studies are context and view surprises as opportu- of the learning health system, defined usually written up as richly described case nities as one “in which science, informatics, studies incorporating both quantitative • Recognise self organisation—designers incentives, and culture are aligned for and qualitative data and including a should expect their designs to be modi- continuous improvement and innovation, narrative of how and why things changed fied, perhaps extensively, as they are with best practices seamlessly embedded over time. taken up in different settings; imple- in the delivery process and new knowledge Complexity can be hard to square with mentation teams should actively cap- captured as an integral by-product of spread strategies that seek to replicate a ture data and feed it into the adaptation the delivery experience” (page 17).20 A

Table 1 | Different approaches to spread and scale-up in innovation and improvement Implementation science Complexity science Social science Main focus Evidence based interventions in practice The evolving and emergent Social study of individuals, groups, and properties of systems organisations Contribution Provides a concrete, planned approach to the Ecological view that emphasises the system’s Foregrounds patterns of social behaviour and delivery and study of spread and scale-up inherent unpredictability and need for adaptive interaction, professional beliefs and values, and change at multiple, interacting levels organisational routines and structures Key mechanisms of Uncertainty reduction, emphasis on fidelity and Emergent properties of an interacting system—self Social, professional, and organisational spread and scale-up contextual influences organisation, management of interdependencies, influences that shape (and are shaped by) and sense making individual and collective action Preferred methods for Use structured, programmatic approaches to Gain a rich understanding of the case in its Develop and apply theories of how individuals’ achieving spread and develop and replicate a complex intervention historical, sociopolitical, and organisational behaviour and actions are influenced by scale-up across multiple settings context. Use multiple methods flexibly and interpersonal, material, organisational, adaptively. Expect surprises and handle them professional, and other factors creatively. Develop individuals and organisations to be creative and resilient Preferred methods for Metrics for measuring improvement Case study approach using multiple qualitative Ethnography, interview based methods, and researching spread and (quantitatively) and systematic approach and quantitative methods. Narrative can be used case narratives to provide insights into social scale-up to exploring processes and mechanisms as a synthesising tool to capture complex chains interactions and contexts (qualitatively) of causation How success is Replication of a particular service model or Nuanced narrative about what changed and why, Theoretically informed and empirically justified measured approach in multiple contexts (“fidelity”) including (where relevant) how the intervention explanations about human and organisational was adapted or why it was abandoned behaviour the bmj | BMJ 2020;365:l2068 | doi: 10.1136/bmj.l2068 11 ANALYSIS

Social science approaches to scale and Specic spread generate theories about why and Ideas, explanations, improvement hunches, theories how programmes of change diverge from intervention initial plans over time: explanations that answer the question, “What did people do in this particular case and why did P Very small-scale test of change that have the effect it did?” A programme AD using plan-do-study-act cycle S theory is expressed at a very low level of generality (that is, it may apply only P Follow-up tests and to the case being analysed and closely AD iterative renement S comparable settings)—for example, “The nurses did not engage because of a staffing P crisis.” Social scientists also develop P ADP Small-scale tests of change more general (“substantive”) theories to ADS in multiple sites ADS explain why spread and scale-up did or S did not happen—for example, theories of behaviour change (individual level), absorptive capacity (organisational level), or interorganisational influence (supra- P Widespread P P implementation Changes that result in organisational level). Usually, a social ADDPAS with local improvement at scale ASD tailoring science explanation of a spread or scale-up effort requires both substantive theory (or theories) and a more specific programme 11 13 23 Fig 1 | Rapid cycle test of change model of spread used in implementation science. Drawing on theory. insights and a previous diagram in a review by Barker3 Shaw and colleagues synthesised various substantive theories (summarised in the supplementary file) that have learning health system is characterised by and adaptively rather than mechanically. been used to analyse the spread and participatory culture, distributed leadership, They experiment with innovations, develop scale-up effort as social practice.13 These engaged patients, shared and evidence feelings (positive or negative) about them, theories—which include normalisation based decision making, transparent worry about them, adapt them to particular process theory, actor-network theory, and assessment of outcomes, and use of tasks, “work around” them, and try to structuration theory—help researchers 1 information and technology for continuous redesign them. Efforts to standardise the and change agents to tap into (with a learning. Innovation, improvement, spread, replication of an intervention across multiple view to influencing) the organisational and scale-up will all occur more readily in settings therefore rarely go to plan. and societal influences that shape and such a system.20 There are numerous specific models of spread and scale-up that embrace (implicitly Box 2: An implementation science approach to spread and scale-up or explicitly) ecological logic and the learning health system; some are listed in McKay and colleagues followed the full sequence of efficacy, effectiveness, and implementation table 2. trials to develop, test, and scale up an intervention of physical activity and healthy eating 19 An example of a complexity science in elementary schools in British Colombia, Canada. In the first phase, the multifaceted approach to scale-up and spread is shown intervention (consisting of resources, training for teachers, school facilitators, and a regional in box 3. It shows that although the success support team) was developed through participatory research with schools, communities, of an initiative based on implementation and other stakeholders, taking account of contextual realities, behaviour change, and social- science can be measured by fidelity of ecological theories. its replication across a range of contexts, Efficacy was evaluated in a cluster randomised controlled trial in 10 schools, which measured success of a change effort in different parts four outcomes: school based opportunities for physical activity; actual physical activity of a complex system is better measured by a levels; students’ chronic disease risk factors (such as obesity) and academic performance; nuanced account of what changed and why.22 and students’ self reported consumption of vegetables and fruit. Process evaluation captured contextual and operational issues that led to refinement of the intervention, which was then Social science: spread and scale-up as social evaluated for effectiveness under real world conditions in a larger cluster randomised controlled action trial. Social science approaches seek to identify In the implementation and scale-up phase, a further 348 schools were supported to adopt and explain social mechanisms, such as and embed the intervention (with attention to fidelity of key components) and evaluate its what people believe and feel; why people effect locally. At the time of publication, 225 trained regional trainers had delivered over 4000 act as they do; how they interpret material workshops to train over 80 000 teachers, reaching approximately 500 000 students. The artefacts and other people’s actions; and programme, which took six years to develop and pilot, was sustained over 10 years. how they draw on programme resources to This is a rare example of a predominantly top-down (structured and programmatic) spread and achieve their goals (or why they refuse or are scale-up strategy that achieved widespread coverage and measurable improvements in some unable to do so). but not all outcome measures. Its success, however, is also likely to be attributable to the use As the previous section emphasised, staff of participatory research and social-ecological theories and to a positive policy context, strong in organisations implement change creatively professional buy-in, generous resourcing, and long timescale.

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Table 2 | Specific models for applying complexity science to spread and scale-up Name of model (author, year) Key components Comment Participatory adaptation In the context of international health, use of decentralised planning, Proposed as a flexible way of achieving standardisation, (Øvretveit, 2010)7 pragmatic modification, and improvement facilitators to adapt the replication, and accountability while also respecting emergence operational details of an intervention to local circumstances and adaptation at the local level Facilitated evolution Local sites are supported to develop the capacity to find, adapt, and develop More radical approach than participatory adaptation. In one (Øvretveit, 2010)7 practices and models of care that tackle the challenges they face, with no example, the goal of preventing HIV/AIDS in a low income African external expectation placed on how problems are framed or which solutions community was achieved through a community development are to be adopted. Draws on the concept of resilience (defined as a system’s initiative, which provided women with independent income capability to withstand and recover from internal tensions and external shocks) 3S scale-up infrastructure A combination of strategic leadership, innovation culture, high quality data These should not be viewed as mechanical tools to be applied (Øvretveit, 2011)5 capture systems, and adaptive facilitation deterministically to “solve” complexity (though formulaic versions Breakthrough Provision of resources, infrastructure, and impetus for inter-organisational of the breakthrough collaborative model exist). Rather, they are collaboratives exchange of resources, stories, and ideas oriented to achieving an broad approaches that might be used creatively and reflexively to (Øvretveit, 2011)5 improvement goal—typically through periodic collaborative workshops manage complexity Experience based In collaborative workshops and in preparatory and follow-up work, patients Not explicitly focused on complexity but follows many of the co-design (Bate and work together with staff to identify emotional “touch points” in the patient principles of effective change in complex systems—notably self Robert, 2006)21 journey and redesign the service in a way that centres on improving the patient organisation, collective sensemaking, and harnessing conflict experience productively constrain individuals’ actions. What Conclusion laps between them. These approaches can do patients expect? What do different We have presented three different logics inform the design and implementation professional groups define as the gold through which spread and scale-up can of spread and scale-up programmes from standard of excellence? What do different be approached: mechanistic (implementa- small quality improvement interventions to professionals on the team expect of each tion science), ecological (complexity sci- system-wide transformational change and other? What is thought to be legally ence), and social (social science). We have can offer insights to frontline teams about sanctioned (whether or not correct)? separated them for analytic purposes, but how and why particular change efforts are Many social scientists view the there are substantial synergies and over- effective (or not). Empirical studies of spread organisation as a “meso” level world that mediates between the individual (micro) and societal (macro). Individuals’ actions Box 3: A complexity science approach to spread and scale-up in organisations are seen as shaped not Eaton and colleagues used a combination of systematic review and national stakeholder only by practical and material realities interviews to build up an international case study of challenges to the spread of evidence based but also by what are known as scripts or mental health programmes in low and middle income countries.8 Although every country had its routines—that is, expected or required own unique problems, some inter-related challenges recurred: limited financial resources and patterns of behaviour defined by formal government commitment; overcentralisation of services in large psychiatric hospitals along with roles, regulations, and standard operating a weak, underfunded primary care sector; scarcity of trained mental health personnel; and low procedures as well as by informal customs, 24 public health expertise among mental health leaders. practices, and traditions. Organisational In the context of such widespread problems, the term scale-up was extended to refer to several routines, in turn, are strongly influenced linked goals: increase coverage (the number of people receiving mental health services); increase by external social forces including the range and appropriateness of services offered; increase the extent to which these services professional norms, public expectations, were evidence based (using service models that had been tested in comparable settings); and laws and policies, and commercial and strengthen the mental healthcare system through policy formulation, implementation planning, other vested interests. and financing. Also key to the spread and scale-up effort were mobilising political will and Organisational change can thus be reducing the stigma of mental health conditions among both lay people and health professionals. viewed as inherently transgressive, because Seen through a complexity lens, all these goals are interdependent and mutually reinforcing. doing things differently violates the norms, Numerous approaches were taken in different countries at national level (including attempts expectations, and rules that are inscribed to influence the prioritisation, planning, and resource allocation for mental health services; in organisational routines. Yet because challenging the tertiary care focus; developing and disseminating evidence based guidelines; routines are carried out by creative, thinking developing human resource policies and programmes) and local level (support for service individuals rather than automatons, they restructuring; training programmes for primary care staff in common mental disorders; contain the scope for adaptation and 24 engagement and education of patients, families, and communities; and strengthening systems change. Leaders—clinical, managerial, and for evaluation and monitoring). Many settings were found to have weak data systems. By perhaps most importantly hybrid leaders who improving the quality of routinely collected data, developing reliable metrics of success that bridge both these roles—have a crucial part in fed into system planning in a timely way, and developing links with academic researchers, the creating the preconditions in which staff will potential for system learning was greatly improved, though the spread and scale-up effort was feel confident to innovate and improve (for more successful in some settings than others. example, by setting a climate of risk taking In contrast with the example in box 1, a highly programmatic top-down approach emphasising and collaborative learning rather than one of 3 12 fidelity of an intervention would not have worked in this case. An adaptive approach, combining playing safe and covering one’s back). An national policy efforts with bottom-up strengthening of local services, was needed to take example of how social science has informed account of the precarious political and economic context in many low and middle income a study of spread and scale-up is shown in countries and the multiple interdependencies in the system. box 4.

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5 Øvretveit J, Garofalo L, Mittman B. Scaling up Box 4: A social science approach to spread and scale-up improvements more quickly and effectively. Int J Qual A good example of how researchers used social theory to explain both spread and non-spread Health Care 2017;29:1014-9. doi:10.1093/intqhc/ mzx147 of innovations are Dixon-Woods and colleagues’ studies of national efforts to reduce catheter 6 Leeman J, Birken SA, Powell BJ, Rohweder C, Shea 23 associated infections in intensive care units in the United States (highly successful) and United CM. Beyond “implementation strategies”: classifying Kingdom (less successful).25 the full range of strategies used in implementation The US investigators had initially concluded (using an implementation science lens) that a science and practice. Implement Sci 2017;12:125. doi:10.1186/s13012-017-0657-x technical checklist, introduced in over 100 intensive care units, had dramatically reduced rates 7 Øvretveit J. Widespread focused improvement: lessons of central venous catheter infection by making the care process more systematic, rational, from international health for spreading specific consistent, and evidence based. Dixon-Woods and her colleagues undertook post hoc interviews, improvements to health services in high-income countries. Int J Qual Health Care 2011;23:239-46. reanalysed the data, and came up with a new theory of spread that was predominantly social doi:10.1093/intqhc/mzr018 rather than technical. 8 Eaton J, McCay L, Semrau M, et al. Scale up of services They showed, for example, that the US programme came to be seen as something a “good” for mental health in low-income and middle-income countries. Lancet 2011;378:1592-603. doi:10.1016/ intensive care unit should be signing up to, perhaps because it was led by respected opinion S0140-6736(11)60891-X leaders from a university. Relations between participating units strengthened as a result of 9 Ben Charif A, Zomahoun HTV, LeBlanc A, et al. participation, resulting in extensive interorganisational networking and lateral support. As Effective strategies for scaling up evidence-based the initiative evolved, it took on the characteristics of a grassroots social movement in which practices in primary care: a systematic review. Implement Sci 2017;12:139. doi:10.1186/s13012- responsible clinicians and managers identified strongly with the programme and wanted to be 017-0672-y involved. 10 Indig D, Lee K, Grunseit A, Milat A, Bauman A. A later ethnographic study by the same team25 used a different programme theory to explain Pathways for scaling up public health interventions. BMC Public Health 2017;18:68. doi:10.1186/ why the same intervention largely failed to spread in UK intensive care units, despite a nearly s12889-017-4572-5 identical phased model of implementation. In the UK, the intervention was seen as top-down 11 Willis CD, Riley BL, Stockton L, et al. Scaling up complex and driven by government rather than professionally led and collaborative; the initiative was interventions: insights from a realist synthesis. Health introduced in parallel with other major infection control policies so had a less distinct identity; Res Policy Syst 2016;14:88. doi:10.1186/s12961- 016-0158-4 there was limited lateral support between participating units; and in low performing units there 12 Currie G, Spyridonides D. Sharing leadership for appeared to be a history of under-resourced improvement initiatives that had resulted in change diffusion of innovation in professionalized settings. fatigue. Hum Relat 2019; [forthcoming]. 13 Shaw J, Shaw S, Wherton J, Hughes G, Greenhalgh This case took a social science approach in the sense that a detailed programme theory was T. Studying scale-up and spread as social practice: developed to explain both high and low success in different contexts, though the original design theoretical introduction and empirical case study. had been a conventional (largely behavioural) implementation science intervention. J Med Internet Res 2017;19:e244. doi:10.2196/ jmir.7482 14 Greenhalgh T, Wherton J, Papoutsi C, et al. and scale-up can, and perhaps should, com- Trisha Greenhalgh, professor Beyond adoption: a new framework for theorizing bine more than one perspective. As a rule Chrysanthi Papoutsi, postdoctoral researcher and evaluating nonadoption, abandonment, and challenges to the scale-up, spread, and of thumb, the larger, more ambitious, and Primary Care Health Sciences, University of Oxford, sustainability of health and care technologies. more politically contested the spread chal- Oxford OX2 6GG, UK J Med Internet Res 2017;19:e367. doi:10.2196/ lenge, the more ecological and social prac- Correspondence to: T Greenhalgh jmir.8775 [email protected] 15 Renedo A, Marston CA, Spyridonidis D, et al. Patient tice perspectives will need to supplement (or and public involvement in healthcare quality replace) “mechanical” efforts to replicate an improvement: how organizations can help patients intervention. and professionals to collaborate. Public Manage Rev 2015;17:17-34. doi:10.1080/14719037.2014.8 For further reading on the interface 81535 between implementation science, This is an Open Access article distributed in accordance 16 Nilsen P. Making sense of implementation theories, complexity science, and social practice, we with the Creative Commons Attribution Non Commercial models and frameworks. Implement Sci 2015;10:53. (CC BY-NC 4.0) license, which permits others to doi:10.1186/s13012-015-0242-0 recommend Braithwaite and colleagues’ distribute, remix, adapt, build upon this work non- 26 17 Craig P, Dieppe P, Macintyre S, Michie S, Nazareth recent theoretical synthesis. commercially, and license their derivative works on I, Petticrew M, Medical Research Council Guidance. different terms, provided the original work is properly Competing interests: We have read and understood Developing and evaluating complex interventions: cited and the use is non-commercial. See: http:// BMJ policy on declaration of interests and declare the the new Medical Research Council guidance. creativecommons.org/licenses/by-nc/4.0/. following interests: none. BMJ 2008;337:a1655. doi:10.1136/bmj.a1655 18 Greenhalgh T, Papoutsi C. Studying complexity in Patient and public involvement: Patients and the health services research: desperately seeking an public were not involved directly in this review article. overdue paradigm shift. BMC Med 2018;16:95. The methodology included a specific search for studies doi:10.1186/s12916-018-1089-4 in which patients and the public were involved in 1 Greenhalgh T, Robert G, Macfarlane F, Bate 19 McKay HA, Macdonald HM, Nettlefold L, Masse LC, spread and scale-up projects. P, Kyriakidou O. Diffusion of innovations in Day M, Naylor PJ. Action Schools! BC implementation: service organizations: systematic review and from efficacy to effectiveness to scale-up. Br Funding: TG is funded by the National Institute for recommendations. Milbank Q 2004;82:581-629. J Sports Med 2015;49:210-8. doi:10.1136/ Health Research Biomedical Research Centre, Oxford; doi:10.1111/j.0887-378X.2004.00325.x bjsports-2013-093361 grant BRC-1215-20008 to the Oxford University 2 NHS England. NHS long term plan. NHS England, 20 Institute of Medicine Round Table on Value and Hospitals NHS Foundation Trust and the University of 2019. Science-Driven Healthcare. The learning health system Oxford. Funders had no say in the planning, execution, 3 Barker PM, Reid A, Schall MW. A framework for and its innovation collaboratives, page 13. http://www. or writing up of the paper. scaling up health interventions: lessons from large- nationalacademies.org/hmd/Activities/Quality/~/ This article is part of a series commissioned by The BMJ scale improvement initiatives in Africa. Implement media/Files/Activity%20Files/Quality/VSRT/Core%20 based on ideas generated by a joint editorial group Sci 2016;11:12. doi:10.1186/s13012-016-0374-x Documents/ForEDistrib.pdf. National Academy of with members from the Health Foundation and The 4 Lanham HJ, Leykum LK, Taylor BS, McCannon CJ, Medicine, 2011. BMJ, including a patient/carer. The BMJ retained full Lindberg C, Lester RT. How complexity science 21 Bate P, Robert G. Experience-based design: from editorial control over external peer review, editing, and can inform scale-up and spread in health care: redesigning the system around the patient to publication. Open access fees and The BMJ’s quality understanding the role of self-organization in variation co-designing services with the patient. Qual Saf improvement editor post are funded by the Health across local contexts. Soc Sci Med 2013;93:194-202. Health Care 2006;15:307-10. doi:10.1136/ Foundation doi:10.1016/j.socscimed.2012.05.040 qshc.2005.016527

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22 Greenhalgh T, Macfarlane F, Barton-Sweeney C, 24 Greenhalgh T. Role of routines in collaborative work systems change. BMC Med 2018;16:63. doi:10.1186/ Woodard F. “If we build it, will it stay?” A case study of in healthcare organisations. BMJ 2008;337:a2448. s12916-018-1057-z the sustainability of whole-system change in London. doi:10.1136/bmj.a2448 Milbank Q 2012;90:516-47. doi:10.1111/j.1468- 25 Dixon-Woods M, Leslie M, Tarrant C, Bion J. Explaining Supplementary file: Reviews and theo- 0009.2012.00673.x Matching Michigan: an ethnographic study of a 23 Dixon-Woods M, Bosk CL, Aveling EL, Goeschel CA, patient safety program. Implement Sci 2013;8:70. retical syntheses of spread and scale-up in Pronovost PJ. Explaining Michigan: developing an doi:10.1186/1748-5908-8-70 healthcare ex post theory of a quality improvement program. 26 Braithwaite J, Churruca K, Long JC, Ellis LA, Herkes Milbank Q 2011;89:167-205. doi:10.1111/j.1468- J. When complexity science meets implementation Cite this as: BMJ 2020;365:l2068 0009.2011.00625.x science: a theoretical and empirical analysis of http://dx.doi.org/10.1136/bmj.l2068

the bmj | BMJ 2020;365:l2068 | doi: 10.1136/bmj.l2068 15 Analysis

Changing how we think about healthcare improvement Complexity science offers ways to change our collective mindset about healthcare systems, enabling us to improve performance that is otherwise stagnant, argues Jeffrey Braithwaite

or all the talk about quality health- Why change is hard different ways to the same inputs (staff, care, systems performance has The overarching challenge lies in the nature funding, presenting patients, buildings, frozen in time. Only 50-60% of of health systems. Healthcare is a complex and equipment). In the language of care has been delivered in line adaptive system, meaning that the system’s complexity science, this is “non-linearity.” with level 1 evidence or consensus performance and behaviour changes over The sheer number of variables and the based guidelines for at least a decade and a time and cannot be completely understood unpredictability of their interactions F1-5 half ; around a third of medicine is waste, by simply knowing about the individual com- make it hard to impose order. And health with no measurable effects or justification ponents. No other system is more complex: systems are indeterministic—meaning for the considerable expenditure6-9; and the not banking, education, manufacturing, that the future cannot be predicted by rate of adverse events across healthcare has or the military. No other industry or sector extrapolating from the past. They are also remained at about one in 10 patients for 25 has the equivalent range and breadth— fractal and self similar, often looking alike years.10-13 Dealing with this stagnation has such intricate funding models, the multiple in, for example, organisational culture in proved remarkably difficult—so how do we moving parts, the complicated clients with different places and at different points tackle it in a new, effective way? diverse needs, and so many options and in time. We need to understand why system-wide interventions for any one person’s needs. How then is a system as complex progress has been so elusive and to identify Patient presentation is uncertain, and many and seemingly dynamic as healthcare the kinds of initiatives that have made clinical processes need to be individualised typically in a steady state, with entrenched positive contributions to date. Then we can to each patient. Healthcare has numerous behaviours, cultures, and politics? Because ask what new solutions are emerging that stakeholders, with different roles and inter- the total of the negotiations, trade-offs, and may make a difference in the future and ests, and uneven regulations that tightly con- positioning of stakeholders pulls strongly start to change our thinking about healthcare trol some matters and barely touch others. towards inertia.14 15 No one person or group systems. The various combinations of care, activities, is to blame; but a complex system clearly events, interactions, and outcomes are, for does not change merely because someone all intents and purposes, infinite. devises and then mandates a purpose KEY MESSAGES When advocates for improvement seek designed solution. Studies of concerted to implement change, health systems do improvement efforts, for example in North • The key measures of health system per- not react predictably; they respond in Carolina, USA,16 and in the NHS,17 show formance have frozen for decades—60% of care is based on evidence or guidelines; the system wastes about 30% of Box 1: Selected attractors and repellents of change all health expenditure; and some 10% Systems can change when: of patients experience an adverse event • Stimulated by medical progress—eg, new diagnostic tests and treatments, imaging tech- • Proponents of change too often use top nology, or surgical advances down tools such as issuing more policy, • Incontrovertible evidence shows public benefit—eg, immunising infants or reducing prescribing more regulation, restructur- smoking rates in developed countries ing, and introducing more stringent • New models of care emerge—eg, the shift to day only surgery or providing GP advice performance indicators remotely via apps, teleconferences, or telemedicine • We must move instead towards a learn- • Clinical practices alter by necessity or because of professional acceptance—eg, laparo- ing system that applies more nuanced scopic techniques systems thinking and provides stronger • Sources: Thimbleby, 201319; Farmanova et al, 201620; Westerlund et al, 201521; Watt feedback loops to nudge systems behav- et al, 201722 iour out of equilibrium, thereby building Systems can reject change when: momentum for change • The primary or sole strategy is to mandate solutions from the top down • Effective change will need to factor in • The change is not supported by parties with power to resist or reject, such as the medical knowledge about the system’s complex- profession or the media ity rather than perpetuate the current • The initiative encounters entrenched bureaucracy, particularly in organisations such improvement paradigm, which applies as public hospitals linear thinking in blunt ways • More policies and procedures are issued on top of a multiplicity of existing policies and • Yet we should recognise how truly hard procedures this is in the messy, real world of com- • Attempts to alter deep seated politics or cultures are superficial plex care • Sources: Coiera, 201115; Braithwaite et al, 201723; Khalifa, 201324

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Box 2: Initiatives to change the system’s hardware is successfully taken up and widely spread, its shelf life will be short—this is the sustain- • Restructuring organisations—The boxes on the NHS organisation chart have regularly ability problem. The pace at which new ideas been redrawn to little benefit. Although such reorganisations do produce structural are being generated, and previous ones dis- change, they do not greatly alter entrenched cultures, much less downstream clini- carded, is accelerating, particularly so over cal outcomes.25 Two studies assessing structural change showed that merging NHS 26 27 the past 20 years. trusts and restructuring Australian hospitals produced no measurable gains and So paradoxically, although nothing lasts, put things back by 18 months or more. genuine transformational improvement • Capital investments—New buildings and new equipment or technology are necessary remains frustratingly elusive. Adding to changes that can contribute to better, more modernised models of caring. Technology the challenge, as Contandriopoulos and supporting new diagnoses and treatments, tests, and clinical techniques can instigate colleagues remind us, knowledge (even important gains. These initiatives, however, are mostly left to research and develop- level 1 evidence) is unevenly distributed, ment departments, researchers, or clinicians, while politicians and managers focus poorly understood, and always contested.38 on organisational charts, opening new hospitals, and prescribing policy. Accepting this reality is uncomfortable for • Financial models and targets—Studies from the US Commonwealth Fund and inter- 28 those promoting improvement. “Agents of national experience indicate that no one financial model is better than any other, change” tend to prefer optimism or even the 29 and perverse outcomes and gaming often result from imposed targets and key 30 delusion that their new policies or initiatives performance indicators. are widely adopted.14 This dichotomy has been described as “work-as-imagined” by policy makers and managers and as “work- this. Instead, the system alters over time ing the organisation chart, upgrading the as-done” by the clinicians at the coalface.39 and to its own rhythm (idiosyncratically infrastructure, or changing financial models Policy makers and managers try to instigate and locally).18 or targets, for example (box 2). The NHS and change remotely; clinicians try to deliver care This raises further questions: what other systems have invested heavily in many proximally. This leads to much antagonism— circumstances can precipitate changes such efforts. But the gains have been modest, or merely ignorance of the other’s role. in complex health systems, and what and the extent to which such changes have circumstances frustrate progress? Box 1 contributed to better patient care is unclear. Understanding emergence and resilience summarises selected initiatives. Attractors The other approach is to change the “soft- How do we move forward? Whatever solu- enable or create sufficient change for the ware” of the system by tackling the culture tions we choose must reflect the complex- system to be nudged before it settles into a of clinical settings (and the quality of leader- ity of the system and respect its resilient new state. Resisters or repellents hold the ship offered by managers and policy makers) features.40 We must change our approach status quo or reject change. and using implementation and improvement to understanding health systems and their A key message from the examples in box 1 methods (box 3). intricacies.41 42 is that change is accepted when people are One way is to break with the NHS’s involved in the decisions and activities that Changing our collective mindset pattern of attempting systems improvement affect them, but they resist when change is Instead of using the metaphor of hardware from the top down. Complex adaptive imposed by others. Policy mandated change and software, we could change our thinking. systems have multiple interacting agents is never given the same weight as clinically We need to recognise three problems. Firstly, with degrees of discretion to repel, driven change. implementing and securing acceptance of ignore, modify, or selectively adopt top new solutions is difficult, even when armed down mandates. Clinicians behave how Systems hardware and software with level 1 or other persuasive evidence— they think they should, learning from Much has been written about the many this is the take-up problem. Secondly, dis- and influencing each other, rather than efforts to initiate change in health systems seminating knowledge of an intervention’s by responding to managers’ or policy around the world, most of which seems to benefits across the entire system is hard— makers’ admonitions. Frontline clinicians presuppose two familiar pathways. One is to this is the diffusion problem. Thirdly, even if in complex adaptive systems accept new alter the system’s “hardware” by restructur- a new model of care, technology, or practice ideas based on their own logic, not that of those in the upper echelons. Healthcare is governed far more by local organisational cultures and politics than by what the Box 3: Initiatives to change the system’s software secretary of state for health or a remote • Enhancing organisational and workplace culture—A systematic review found a con- policy maker or manager wants. sistent association in over 62 studies between organisational and workplace cultures Change, when it does occur, is always 31 and patient outcomes across multiple settings. Encouraging positive organisational emergent. This is when features of cultures to promote better patient outcomes seems time well spent. But these are local- the system, and behaviours, appear ised solutions. unexpectedly, arising from the interactions • Implementation science and improvement studies—Studies have tested models for cre- of smaller or simpler entities; thus, unique ating implementable interventions and for getting more research evidence into routine team behaviours emerge from individuals 32 33 34 clinical practice. Ideas have emerged—such as the PARiHS framework and models and their interactions. 32 that take a more system-wide view — that identify important ingredients in change such Those on the frontline of care (clinicians, as context, persuasiveness of the evidence, and active facilitation. But applying such staff, patients) navigate change through models to systems has shown the limits of progress. For any intervention, the effect size their small part of the system, adjusting to that can be secured when successful (and many interventions yield no or little benefit) their local circumstances, and responding to 35-37 is modest; perhaps around 16% on average. their own interests rather than to top down the bmj | BMJ 2018;361:k2014 | doi: 10.1136/bmj.k2014 17 Analysis

Table 1 | Twenty complexity oriented enablers and insights41 47-56 Enabler (what to do) Insight (why to do it) For policy makers: Take multiple evaluations of what’s going on Different stakeholders have distinguishable views on what’s happening in complex systems Use system tools to uncover the system’s features Causal loop diagrams, social network analyses, role plays, and simulation can provide insights into a system’s characteristics Customise change to local contexts Culture is unique to the context: tailoring change to the circumstances is crucial Work with, not against, trends Going against the currents of change is possible, but is fraught with frustration and risk—the trend is your friend Balance standardisation and variety There is constant tension between the push for uniformity and the need for local initiatives Use the informal system, not just the formal system Organisational chart thinking only gets people so far; use the informal system and its cultural and political attributes Take every opportunity to bolster communication, trust, and Care is delivered as a system of systems, with multiple interacting networks of people at its heart—communication, trust, and interpersonal relations relationships are key to any progress For managers and improvement teams: Model the system’s properties Systems diagrams and models, computer based or hand drawn, can illuminate the dynamics of the system Use multimethod research and improvement techniques Randomised controlled trials or single method data gathering approaches rarely expose sufficient dimensions of complex problems Appreciate less is more in interventions Resist aiming to control the system through improvement strategies, projects, and change initiatives: spend more time learning about the effects of interventions than obsessing about intricate designs Leverage complexity thinking Immerse local teams in complexity science and systems thinking Focus less on the individual and more on the system It’s much harder to change individuals—seek instead to nudge or perturb the system Develop and apply feedback to people involved at every Change and improvement is a set of feedback loops, not an event or a linear process opportunity Look for things going right as well as those going wrong This promotes a more balanced view of the system For frontline clinicians: Adopt a new problem solving focus based on systems thinking Search for interconnections rather than getting stuck on any one solution rather than obsessing with finding “a” way forward Look for behavioural patterns in the system and listen to the The rich behaviours and practices of others, and the signals and messages they convey, are full of beneficial cultural and language people use systems information Beware excessively causal logic Take care in attributing cause and effect—overgeneralising causation is a common error Trade-off between constant turmoil and implementing changes All systems sit not far from the edge of chaos: ride the boundary, and remember the old lesson that much in clinical practice and before they are ready systems is uncertain Understand that adaptation is almost always micro and granular Big picture transformational change is rare and is expressed differently in different settings when it does occur Appreciate that humans have a social brain Organisational participants are perennially tuned in to the behavioural repertoires of others: use this expertise, and be attentive to others’ needs and motivations instructions. Thus, healthcare is naturally if we also better appreciate how clinicians Fifthly, we could simply be more humble resilient, always buffering itself against handle dynamic situations throughout the in our aspirations. Putting the myth of change that does not make sense to those day, constantly adapting, and getting so inevitable progress aside, we should who are on the ground, delivering care. much right, we can begin to identify the recognise that big, at-scale interventions factors and conditions that underpin that sometimes have little or no effects and Towards a nuanced appreciation of change? success. that small initiatives can sometimes yield Here are six principles on which a new This leads to a fourth, related, point. A unanticipated outcomes.47 We must admit to approach to change might be built. Firstly, recent book45 looking at achievements in ourselves that we cannot know in advance we must pay much more attention to how healthcare delivery across 60 low, middle, which will occur. care is delivered at the coalface. Bureau- and high income countries showed us that Sixthly, and most importantly, we crats and managers, among others, will not every system can tell multiple success might adopt a new mental model that improve the system or make patients safer by stories. These range from organ donation appreciates the complexity of care systems issuing swathes more policy, regulating more and transplantation in Spain to early and understands that change is always avidly, introducing more clunky IT systems, warning systems for deteriorating patients in unpredictable, hard won, and takes time, 43 or striking off doctors. Australia and Qatar, implementing minimum it is often tortuous, and always needs to be Secondly, all meaningful improvement required standards in Afghanistan, making tailored to the setting. Table 1 shows 20 ways is local, centred on natural networks of improvements in information technology to exploit these principles. These enablers 44 clinicians and patients. One size fits in Taiwan, and embracing community and insights need practice but can be used all templates of change, represented by based health insurance in Rwanda. These by anyone, including patients. For ease of standardisation and generic strategies, too apparently disparate achievements have application, they have been separated into often fail. We must encourage ideas from four common factors: begin with small scale complexity approaches for policy makers, many sources; care processes and outcomes initiatives and build up; convert data and managers and improvement teams, and will vary whatever we do. information into intelligence and give this frontline clinicians. Thirdly, we must acknowledge that openly to the appropriate decision makers; clinicians doing complex everyday work remember the lone hero model does not Conclusion get things right far more than they get them work and that collaboration underpins all We need to turn healthcare into a learn- wrong. We focus on the 10% of adverse productive change; and always start with the ing system, with participants attuned to events while mostly overlooking the 90% patient at the centre of any reform measure.46 systems features and with strong feedback 40 of care that has no harm. Understanding Such inspiring ideas reflect complexity loops to try to build momentum for change. errors is critical, as is seeking to stop thinking and are not necessarily predicated If we construct a shared outlook and draw outmoded, wasteful, or excessive care. But, on reductionist, cause-effect logic. on new thinking paradigms, perhaps we

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Int J Qual Health 40 Hollnagel E, Braithwaite J, Wears R, eds. Resilient by/4.0/. Care 2016;28:830-7. Health Care. Ashgate, 2013. 21 Westerlund A, Garvare R, Höög E, et al. Facilitating 41 Braithwaite J, Churruca K, Ellis LA, et al. Complexity system-wide organizational change in health care. Int J science in healthcare – aspirations, approaches, Qual Serv Sci 2015;7: applications and accomplishments: a white paper. 72-8910.1108/IJQSS-01-2015-0004. Sydney, Australia: Australian Institute of Health 22 Watt N, Sigfrid L, Legido-Quigley H, et al. Health systems Innovation, Macquarie University; 2017. 1 Braithwaite J, Hibbert PD, Jaffe A, et al. Quality facilitators and barriers to the integration of HIV and 42 Braithwaite J, Wears RL, Hollnagel E. Resilient health of health care for children in Australia, 2012- chronic disease services: a systematic review. Health care: turning patient safety on its head. Int J Qual 2013. JAMA 2018;319:1113-24. doi:10.1001/ Policy Plan. 2017;32(suppl_4):iv13-iv26. Health Care 2015;27:418-20. doi:10.1093/intqhc/ jama.2018.0162 23 Braithwaite J, Westbrook J, Coiera E, et al. A systems mzv063 2 Mangione-Smith R, DeCristofaro AH, Setodji CM, et al. science perspective on the capacity for change in 43 Dyer C. Bawa-Garba case has left profession shaken The quality of ambulatory care delivered to children in public hospitals. Isr J Health Policy Res 2017;6:16. and stirred. BMJ 2018;360:k456. doi:10.1136/ the United States. N Engl J Med 2007;357:1515-23. doi:10.1186/s13584-017-0143-6 bmj.k456 doi:10.1056/NEJMsa064637 24 Khalifa M. Barriers to health information systems 44 Braithwaite J, Runciman WB, Merry AF. Towards 3 McGlynn EA, Asch SM, Adams J, et al. The quality of and electronic medical records implementation: safer, better healthcare: harnessing the natural health care delivered to adults in the United States. a field study of Saudi Arabian hospitals. 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The Oxford and management cost analysis. BMJ 2002;325:246. Accomplishing reform: successful case studies drawn Handbook of Health Care Management. Oxford doi:10.1136/bmj.325.7358.246 from the health systems of 60 countries. Int J Qual University Press, 2016: 325-51. 27 Braithwaite J, Westbrook MT, Hindle D, Iedema RA, Health Care 2017;29:880-6. doi:10.1093/intqhc/ 6 Berwick DM, Hackbarth AD. Eliminating waste in US Black DA. Does restructuring hospitals result in mzx122 health care. JAMA 2012;307:1513-6. doi:10.1001/ greater efficiency? An empirical test using diachronic 47 Rickles D, Hawe P, Shiell A. A simple guide to jama.2012.362 data. Health Serv Manage Res 2006;19:1-12. chaos and complexity. J Epidemiol Community 7 OECD. Tackling wasteful spending on health. OECD doi:10.1258/095148406775322016 Health 2007;61:933-7. doi:10.1136/ Publishing, 2017. 28 Ryan AM, Krinsky S, Kontopantelis E, Doran T. Long- jech.2006.054254 8 Saini V, Brownlee S, Elshaug AG, Glasziou P, Heath I. term evidence for the effect of pay-for-performance in 48 Plsek PE, Greenhalgh T. Complexity science: Addressing overuse and underuse around the world. primary care on mortality in the UK: a population study. The challenge of complexity in health Lancet 2017;390:105-7. doi:10.1016/S0140- Lancet 2016;388:268-74. doi:10.1016/S0140- care. BMJ 2001;323:625-8. doi:10.1136/ 6736(16)32573-9 6736(16)00276-2 bmj.323.7313.625 the bmj | BMJ 2018;361:k2014 | doi: 10.1136/bmj.k2014 19 Analysis

49 Plsek PE, Wilson T. Complexity, leadership, network theory. Soc Sci Med 2010;70:1285-94. 54 Bar-Yam Y. Improving the effectiveness of health care and management in healthcare organisations. doi:10.1016/j.socscimed.2009.12.034 and public health: a multiscale complex systems BMJ 2001;323:746-9. doi:10.1136/ 52 Greenhalgh T. Higher education governance as analysis. Am J Public Health 2006;96:459-66. bmj.323.7315.746 language games: a wittgensteinian case study of the doi:10.2105/AJPH.2005.064444 50 Leykum LK, Lanham HJ, Pugh JA, et al. Manifestations breakdown of governance at the London School of 55 May CR, Johnson M, Finch T. Implementation, context and implications of uncertainty for improving Economics 2004-2011. High Educ Q 2015;69:193- and complexity. Implement Sci 2016;11:141. healthcare systems: an analysis of observational and 21310.1111/hequ.12064. doi:10.1186/s13012-016-0506-3 interventional studies grounded in complexity science. 53 Greenhalgh T, Shaw S, Wherton J, et al. SCALS: a 56 Axelrod R, Cohen MD. Harnessing Complexity. Organizational Implications of a Scientific Implement Sci 2014;9:165. doi:10.1186/s13012- fourth-generation study of assisted living technologies Frontier. Basic Books, 2001. 014-0165-1 in their organisational, social, political and policy 51 Greenhalgh T, Stones R. Theorising big IT programmes context. BMJ Open 2016;6:e010208. doi:10.1136/ Cite this as: BMJ 2018;361:k2014 in healthcare: strong structuration theory meets actor- bmjopen-2015-010208 http://dx.doi.org/10.1136/bmj.k2014

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Understanding organisational culture for healthcare quality improvement Russell Mannion and Huw Davies explore how notions of culture relate to service performance, quality, safety, and improvement

f we believe the headlines, health Greater specificity around both culture obscured) layers (box 2). First, and most services are suffering epidemics of and performance enables us to understand visible, are the physical artefacts and cultural shortcomings. Extensive more precisely the possible relations arrangements, as well as the associated enquiries into failures and scandals between them: quality improvement work is behaviours that get things done. These in the NHS over several decades have ill served by broadbrush accounts of culture visible manifestations of culture are seen indicated aspects of hospital culture as lead- and service quality. We seek to move past the in how estate, equipment, and staff are I 1 2 ing to those failings.(box 1). The recent use of culture as simply a rhetorical tool used configured and used, and in the range of report into over 450 premature deaths at by politicians and in policy edicts. Instead, behaviours seen as normal and acceptable. Gosport War Memorial Hospital mentions we outline a more nuanced account of the These include the embedded and accepted culture 21 times.3 After such reports, wide- social dynamics of healthcare services. care pathways, clinical practices, and spread and fundamental cultural change is communication patterns, sometimes referred typically prescribed as the remedy (box 1).4 5 What is culture in this context? to as “the way things are done around here.” Ideas of culture are also central to Healthcare organisational culture (from The second level is the shared ways of quality improvement methods. From basic here, just culture) is a metaphor for some thinking that are used to justify the visible clinical audit to sustained improvement of the softer, less visible, aspects of health manifestations (box 2). This includes the “collaboratives,” business process service organisations and how these become beliefs, values, and arguments used to re-engineering, Lean Six Sigma, the need manifest in patterns of care. The study of sustain current patterns of clinical practice. for cultural reorientation is part of the organisational practices derives from social In this way, the local clinical culture is challenge.6 Yet although the language of anthropologists’ approaches to the study expressed not only through what is done, organisational culture—sometimes culprit, of indigenous people: both seek to unravel but also how it is talked about and justified. sometimes remedy, and always part of the the dynamics of unfamiliar “tribes.” The Deeper still, and thus much less overt underlying substrate at which change is view that culture can be managed to remedy and accessible, are the largely unspoken directed—has some immediate appeal, past deficits and produce desirable future and often unconscious expectations we should ask deeper questions. What outcomes is often smuggled in through and presuppositions that underpin both actually is culture in health services? How this re-application of the ideas of culture to dialogue and clinical practice (the shared does culture relate to healthcare quality, organisations. This view needs some critical assumptions; box 2). Such attitudes may be safety, and performance? And can changing scrutiny,5 one that explores a more nuanced formed early, go deep, and be less amenable culture lead to improvements in care and account of organisational culture in health- to modification. organisational performance? care. These three levels are linked, of course, In one common framing,7 the shared but not simply. Some of the deeper values aspects of organisational life—the culture— and assumptions are taught in early KEY MESSAGES are categorised as three (increasingly professional education (the so-called • Organisational culture represents the shared ways of thinking, feeling, and Box 1: Centrality of culture to healthcare scandals: from Kennedy to Francis behaving in healthcare organisations. From Ian Kennedy’s review of the failings in paediatric cardiac surgery in Bristol during the 1980s Healthcare organisations are best • and 90s2 to Robert Francis’s inquiry into the systemic failings at Mid Staffordshire Hospital Trust viewed as comprising multiple sub - over a decade later,1 culture has been implicated. cultures, which may be driving forces for change or may undermine quality Culture as culprit improvement initiatives “There was an insular ‘club’ culture [at Bristol], in which it was difficult for anyone to stand out, to press for change, or to raise questions and concerns” (p302)2 • A growing body of evidence links cultures and quality, but we need a more “Aspects of a negative culture have emerged at all levels of the NHS system. These include: a nuanced and sophisticated understand- lack of consideration of risks to patients, defensiveness, looking inwards not outwards, secrecy, ings of cultural dynamics misplaced assumptions of trust, acceptance of poor standards, and, above all, a failure to put the 1 • Although culture is often identified as patient first in everything done” (p2357) the primary culprit in healthcare scan- Culture as remedy dals, with cultural reform required to “The culture of healthcare, which so critically affects all other aspects of the service which patients remedy failings, such simplistic diag- receive, must develop and change” (p277)2 noses and prescriptions lack depth and “The extent of the failure of the system shown in this inquiry’s report suggests that a fundamental specificity culture change is needed” (p65)1 the bmj | BMJ 2018;363:k4907 | doi: 10.1136/bmj.k4907 21 ANALYSIS

Box 2: Three levels of organisational culture in healthcare7 8 view evidence through a positivist natural sciences lens. Managers may be more Visible manifestations of healthcare culture include the distribution of services and roles between concerned with patients as groups and service organisations (such as the long established divides between secondary and primary value a social science based experiential care and between health and social care), the physical layouts of facilities (receptionists behind perspective.10 These cultural divergences desks and doctors in consulting rooms), the established pathways through care (including the have important implications for ubiquitous outpatients appointment), demarcation between staff groups in activities performed collaborative work, especially for people in (and the tussles that challenge or reinforce these), staffing practices and reporting arrangements, hybrid roles who may either retain a cultural dress codes (such as different coloured scrubs for different staff groups in emergency allegiance to their base group or seek to departments), reward systems (pay and pensions, but also the less tangible rewards of autonomy adopt the cultural orientations of their new and respect), and the local rituals and ceremonies that support approved practices. Visible role. They also form an important target for manifestations of culture (sometimes called artefacts) also include the established ways (both purposeful cultural reform, which might formal and informal) of tackling quality improvement and patient safety, the management of risk, sometimes seek to strengthen current trends and the accepted ways of responding to staff concerns and patient feedback or complaints. or at other times to inhibit them. Shared ways of thinking include the values and beliefs used to justify and sustain the visible In sum, specific subcultures may be manifestations above and their associated behaviours, as well as the rationales put forward powerful catalysts for innovation and for doing things differently. This might include prevailing views on patient needs, autonomy, improvement or defenders of the status quo and dignity; ideas about evidence for action; and expectations about safety, quality, clinical (for good or ill); they can be useful safeguards performance, and service improvement. against risk or covert countercultures quietly Deeper shared assumptions are the (largely unconscious and unexamined) underpinnings of day- undermining necessary reforms. Making to-day practice. These might include ideas about appropriate professional roles and delineations; sense of this subcultural diversity should be expectations about patients’ and carers’ knowledge and dispositions; and assumptions about the an essential part of any cultural “diagnosis” relative power of healthcare professionals—collectively and individually—in the health system. in seeking quality improvement.

Can culture be assessed and managed? hidden curriculum), reinforced through services, with important implications for There are two distinctive views of culture. ongoing professional interactions, and patient experience and service delivery. The first is optimistic about the potential then made visible as accepted practices. for purposive cultural management, see- Other cultural manifestations are created One culture or many subcultures? ing culture as something that an organisa- or shaped externally, perhaps by the macro Healthcare organisations are notoriously tion has— an attribute that can be assessed policy environment (for example, service varied, fractured by specialty, occupational and manipulated to improve care. By con- configurations or reward systems), but groupings, professional hierarchies, and trast, the second view is more concerned over time these can influence shared ways service lines. Some cultural attributes might with securing insights about organisational of thinking and even deeper assumptions be widespread and stable, whereas others dynamics, without focusing on whether they (about who or what is valued, for example). may be shared only in subgroups or held can be manipulated. It sees organisational As healthcare becomes more global, with only tentatively. Important subcultures are culture as something the organisation simply regular movement of care staff across delineated most obviously, as professional is—an account of local dynamics not readily national borders, major shapers of the groups, and the faultlines are most obvi- separable from the organisational here-and- cultural aspects of care may also include ous as these groups compete for resources now. national, ethnic, or religious cultures. and status.9 Other subcultures can emerge These two perspectives take us down Organisational culture, then, covers how over time. Some staff groupings may excel different routes of assessing and managing things are arranged and accomplished, at articulating and enacting desirable val- local healthcare cultures. The first as well as how they are talked about and ues and practices, which may be helpful to emphasises the use of metrics to assess the justified—that is, the stories and narratives organisational goals; for example, special- prevalent organisational culture around about what is done and why, and the ist teams or centres of excellence. Less help- a performance domain, such as patient presuppositions that underpin these. Taken fully perhaps, other subgroups may actively safety. This approach assumes that a strong together these can reflect a shared and work to undermine changes promoted from “safety culture” is associated with better commonly understood view of hospital life external sources (often construed as coun- outcomes for patients. Such measures may manifested in patterns of care, safety, and tercultures). Whether such countercultures identify targets for managed change, and risk. Although we focus on the hospital reflect unwarranted resistance to change or a repeated measurement may be used to environment here, these arrangements more appropriate defence of enduring values gauge progress against cultural objectives, and narratives are found (albeit in different may be hard to discern and depends on both with the hope that improvements in care forms) across all healthcare organisations perspective and context. will follow (for example, the Safety Attitude from general practices to community trusts. Hospitals, then, are a dynamic cultural Questionnaire; box 3). Many such tools Those wishing and situated to improve mosaic made up of multiple, complex, exist to assess different aspects of culture, services need a sophisticated understanding and overlapping subgroups with variably although the science behind them is often of the social dynamics and shared mental shared assumptions, values, beliefs, and weak11 and their reliability and validity are schema that underpin and reinforce existing behaviours. Two of the major professional questionable.12 practices and inform their readiness to groupings concerned with quality The second view seeks to explore local change. improvement—doctors and managers— cultural dynamics, often working through An important additional layer of may differ in several important ways, for dialogue and perhaps using images and complexity is that shared mental schema example. Doctors may focus on patients narratives rather than measurement may be confined to subgroups within care as individuals rather than groups and instruments. This view is more modest about

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the potential for manager-led purposeful Box 3: Two examples of culture assessment tools directed at patient safety change but may still see cultural assessment as part of an overall influencing strategy The Safety Attitude Questionnaire (SAQ) is a major (quantitative) assessment tool developed in (for example, the Manchester Patient Safety the United States and widely used in the NHS to help organisations assess their safety culture and Framework; box 3). track changes over time. The SAQ is a reworking and refinement of a similar tool widely used in Although both perspectives draw on the aviation industry. There are various versions of the SAQ, but these typically comprise some 60 assessment tools, they do so for different survey items, designed in the form of five point Likert scales, in six safety related domains: safety reasons: the first emphasising quantitative climate; team work; stress recognition; perceptions of management; working conditions; and job measurement to identify targets for satisfaction. Completed by individuals, scores are then aggregated to give an indication of the change and to track progress (a summative overall strength of the organisation’s extant safety culture. approach); the second using qualitative The Manchester Patient Safety Framework is a facilitative (qualitative) educational tool. It aims insights more discursively to prompt to provide insight into safety culture and how it can be improved among teams and organisations. reflection, learning, and shared actions (a The tool explores nine dimensions of patient safety and describes what an organisation would more formative strategy). In practice, many look like at different levels of patient safety. Assessment is carried out in facilitator-led workshops, researchers, organisational leaders, and and the assessments can be used to prompt reflections, stimulate discussions, and understand quality improvement specialists will seek strengths and weaknesses. insights from across these approaches, despite the (at times uncomfortable) accommodations needed between their they talk about and manage performance culture is a complex construct can allow divergent assumptions. and improvement. more judicious application of the concept. Paying greater attention to the multilayered Does culture matter? Conclusions and multifaceted complexity underlying the It seems obvious that the shared, cultural Too often the term culture is used as a term—and recognising that many and var- aspects of organisational life must have metaphor for something the organisation ied cultural subgroups make up our health- some bearing on organisational outcomes. is thought to have. But acknowledging that care organisations—opens new avenues for Yet because of the complexity of healthcare cultures and the ambiguity around health service “success,” establishing such links Box 4: Insights from empirical study of the links between culture and care through research is not easy.13 Nonetheless, The importance of leadership the most recent systematic review of work A recent intervention study (Leadership Saves Lives) focused on leadership actions to promote in this area found a “consistently positive positive changes in organisational culture in 10 hospitals in the US. It found that changes in culture association . . . between culture and out- over a two year period varied substantially between hospitals.15 16 In the hospitals that experienced comes across multiple studies, settings, and substantial and positive cultural shifts, changes were most prominent in specific domains, such countries.”14 So, culture does seem to matter. as perceptions of the learning environment, senior management support, and psychological Individual studies can also offer important safety. Hospitals with marked positive shifts in culture also experienced significant decreases in actionable insights, such as on the impor- risk-standardised mortality rates (in this case for treatment of acute myocardial infarction). These tance of leadership, the need for balanced findings from the US show which elements of culture need attention from hospital leaders—in cultures, and on the contingent nature of particular, fostering a learning environment, offering sustained and visible senior management the relationships between culture and per- support to clinical teams, and ensuring that staff across the organisation feel “psychologically formance (box 4). safe” and able to speak up when things are felt to be going wrong. Clearly, the relations between culture and The need for balanced cultures quality, safety, or efficiency are unlikely Research has shown that, in addition to cultural types, the balance between different cultures is to be straightforward. Culture, although important. Shortell, for example, found that, in a sample of chronic illness management teams, important, offers no “magic bullet”—the balance among team members relating to the cultural values of participation, achievement, challenge becomes one of understanding openness to innovation, and adherence to rules and accountability was positively associated with which components of culture might both the number and depth of changes aimed at improving the quality of care.17 influence which aspects of performance. The appearance of contingent relationships Moreover, any relations between culture The research indicates that there is no single “best” culture that always leads to success across and health service outcomes are likely to the full range of performance domains. Instead, the aspects of performance valued in a given be mutual and recursive: that is, perceived culture are enhanced in organisations with strong congruence with that culture. Early studies in performance is as likely to shape local Canadian, UK, and US hospitals found, for example, that hospitals with inwardly oriented cultures healthcare cultures as culture is to shape that emphasised managing through informal interpersonal relationships performed significantly local healthcare performance. Virtuous above average on measures of employee loyalty and commitment than those with outward looking circles of high performance leading to cultures.18 Conversely, hospitals with outward looking cultures and procedural management reinforcing cultures of high expectations performed better on measures of external stakeholder satisfaction. More recently, large scale may be seen, as can spirals into decline longitudinal research in English NHS hospital trusts19 replicated some of these findings. where perceived performance failings lead to demoralisation and resignation to those poor The influence of the wider organisational environment standards.20 In these arguments, we can see A qualitative case study of six NHS hospitals found clear differences in the cultural profile of how narrative practices about performance “high” and “low” performing hospitals in terms of: leadership style and management orientation; can have important effects on local cultures accountability and information systems; human resource policies; and relations with other 20 and that this has implications for clinician organisations in the local health economy. Each of these provides potentially important targets leaders, managers, and policy makers in how for purposeful cultural change aimed at performance improvement. the bmj | BMJ 2018;363:k4907 | doi: 10.1136/bmj.k4907 23 ANALYSIS understanding the deeply social and discur- Competing interests: None declared. 7 Schein E. Organizational culture and leadership. Jossey sive nature of complex organisations. Bass, 1985. Provenance and peer review: Commissioned; 8 Mannion R. Davies, H Cultures in Healthcare. In: How these insights are used in quality externally peer reviewed. Ferlie E, Montgomery K, Reff Pedersen A, eds. Oxford improvement depends on both other This article is one of a series commissioned by The BMJ Handbook of Health Care Management. Oxford conceptual framings of the healthcare based on ideas generated by a joint editorial group University Press, 2016. 9 Powell AE, Davies HTO. The struggle to improve setting, the aspect of service quality or with members from the Health Foundation and The BMJ, including a patient/carer. The BMJ retained full patient care in the face of professional boundaries. performance to be improved, and on the editorial control over external peer review, editing, and Soc Sci Med 2012;75:807-14. doi:10.1016/j. precise nature of the quality improvement publication. Open access fees and The BMJ’s quality socscimed.2012.03.049 methods to be used.6 For some framings improvement editor post are funded by the Health 10 Davies HT, Nutley SM, Mannion R. Organisational Foundation. culture and quality of health care. Qual Health and improvement methods, culture is Care 2000;9:111-9. doi:10.1136/qhc.9.2.111 Russell Mannion, professor1 key; for others, cultural aspects are in the 11 Jung T, Scott T, Davies H, Bower P, Mannion R. Huw Davies, professor2 background. Our view is that the cultural Instruments for the exploration of organizational 1Health Services Management Centre, University of culture. Public Adm Rev 2009;69:1987-1096. dimensions of organisations are an Birmingham, Birmingham, UK doi:10.1111/j.1540-6210.2009.02066.x . important substrate on which improvement 2School of Management, University of St Andrews, 12 Jung T, Scott T, Davies H, Bower P, Mannion R. focused change is being sought and that, St Andrews, UK Instruments for the exploration of organizational culture. Public Adm Rev 2009;69:1987-96. although never fully manageable, cultures Correspondence to: R Mannion doi:10.1111/j.1540-6210.2009.02066.x. can be better understood and must be [email protected] 13 Scott T, Mannion R, Marshall M, Davies H. purposefully shaped. Does organisational culture influence health Finally, the cultural framing of healthcare care performance? A review of the evidence. J Health Serv Res Policy 2003;8:105-17. organisations draws attention to specific doi:10.1258/135581903321466085 aspects of organisational life: the shared This is an Open Access article distributed in accordance 14 Braithwaite J, Herkes J, Ludlow K, Testa L, Lamprell G. patterns of feeling, thinking, talking, and with the Creative Commons Attribution Non Commercial Association between organisational and workplace (CC BY-NC 4.0) license, which permits others to cultures, and patient outcomes: systematic review. accomplishing that underpin local practice. distribute, remix, adapt, build upon this work non- BMJ Open 2017;7:e017708. . doi:10.1136/ In doing so, other equally important aspects commercially, and license their derivative works on bmjopen-2017-017708 of organisational life may be marginalised different terms, provided the original work is properly 15 Curry LA, Brault MA, Linnander EL, et al. Influencing cited and the use is non-commercial. See: http:// organisational culture to improve hospital performance in or neglected, such as individual skill, creativecommons.org/licenses/by-nc/4.0/. care of patients with acute myocardial infarction: a mixed- attitude, and responsibility; governance and methods intervention study. BMJ Qual Saf 2018;27:207- performance management arrangements; 17. doi:10.1136/bmjqs-2017-006989 the macro structural arrangements within 16 Bradley EH, Brewster AL, McNatt Z, et al. How guiding coalitions promote positive culture change in which local service lines are embedded; 1 Francis R. The Mid Staffordshire NHS Foundation Trust hospitals: a longitudinal mixed methods interventional the incentives spread across the system; public inquiry. 2013. https://www.gov.uk/government/ study. BMJ Qual Saf 2018;27:218-25. doi:10.1136/ and the availability of material resources, publications/report-of-the-mid-staffordshire-nhs- bmjqs-2017-006574 foundation-trust-public-inquiry 17 Shortell SM, Marsteller JA, Lin M, et al. The role human capital, and knowledge. Each 2 Kennedy I. The Report of the Public Inquiry into children’s of perceived team effectiveness in improving of these aspects interacts with and can heart surgery at the Bristol Royal Infirmary 1984-1995. chronic illness care. Med Care 2004;42:1040-8. sometimes overwhelm cultural features, Learning from Bristol. 2001. https://psnet.ahrq.gov/ doi:10.1097/00005650-200411000-00002 with a resultant effect on the ability to resources/resource/5187/learning-from-bristol-the- 18 Gerowitz MB, Lemieux-Charles L, Heginbothan C, report-of-the-public-inquiry-into-childrens-heart-surgery- Johnson B. Top management culture and shape and improve culture and services. at-the-bristol-royal-infirmary-1984-1995 performance in Canadian, UK and US hospitals. The choice to focus improvement efforts on 3 Gosport Independent Panel. Gosport War Memorial Health Serv Manage Res 1996;9:69-78. healthcare culture to the exclusion of, say, Hospital: the report of the Gosport independent panel. doi:10.1177/095148489600900201 2018. https://www.gosportpanel.independent.gov.uk/ 19 Jacobs R, Mannion R, Davies HTO, Harrison S, Konteh F, policy frameworks or resource constraints, 4 Dixon-Woods M, Baker R, Charles K, et al. Culture and Walshe K. The relationship between organizational inevitably has political ramifications, and behaviour in the English National Health Service: culture and performance in acute hospitals. these should be dealt with rather than overview of lessons from a large multimethod study. Soc Sci Med 2013;76:115-25. doi:10.1016/j. BMJ Qual Saf 2014;23:106-15. doi:10.1136/ socscimed.2012.10.014 ignored. Cultural reform in healthcare is bmjqs-2013-001947 20 Mannion R, Davies HT, Marshall MN. Cultural no substitute for adequate resourcing. That 5 Davies HT, Mannion R. Will prescriptions for cultural characteristics of “high” and “low” performing said, the cultural perspective outlined here change improve the NHS? BMJ 2013;346:f1305. hospitals. J Health Organ Manag 2005;19:431-9. provides an insightful way of thinking and a doi:10.1136/bmj.f1305 doi:10.1108/14777260510629689 6 Powell AE, Rushmer RK, Davies HTO. A systematic practical set of tools to support wider quality narrative review of quality improvement models in Cite this as: BMJ 2018;363:k4907 improvement work in healthcare. health care. NHS Quality Improvement Scotland, 2009. http://dx.doi.org/10.1136/bmj.k4907

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Can we import improvements from industry to healthcare? Healthcare has more to learn from other industries, including aviation—but it’s more complex than we think argue Carl Macrae and Kevin Stewart

xhortations to learn from other tools, methods, strategies, and techniques Healthcare is better understood as perhaps industries have been common in to improve quality and safety: why not just 20 different industries, many of which need the world of healthcare improve- apply these in healthcare? to seamlessly interact at critical junctures ment since the inception of the Of course, it is not that simple. Translating throughout a patient’s journey.13 What works discipline.1 These are not always and adapting improvement techniques in one part of healthcare may not work in Ehelpful. Recounting oversimplified improve- to healthcare is hard and has had varied another. It is therefore unsurprising that ment examples from other industries (often results. Some interventions, such as those what works in an entirely different industry, aviation) can provoke considerable frus- aimed at reducing infections related to such as car manufacturing, may not easily tration and scepticism among clinicians central venous catheters, have proved and directly transfer to all healthcare exposed to the unique challenges and eve- popular and successful6; others, such as settings. The diversity of healthcare means ryday complexities of trying to improve incident reporting systems, have met with that it is almost meaningless to compare it healthcare. Patients are not aeroplanes, and frustration and failure.7 Initial enthusiasm with nuclear power or aviation. hospitals are not production lines. Nonethe- for oversimplified, large scale attempts Another rarely recognised consideration is less, many successful efforts to improve the to apply a new improvement technique that work in other industries is also diverse. quality and safety of healthcare have taken often quickly gives way to confusion, In the healthcare literature, for example, inspiration from other industries. Here we complication, and criticism.8 9 “aviation” is often translated as “pilots re-examine some familiar exemplars from Despite these difficulties and frustrations, flying aeroplanes”14—which overlooks the aviation industry to show what is (still) looking to other industries for ideas and the considerable differences between to be learnt, even in areas that have made inspiration still has value, just as other the operational work of flight crew, the substantial improvements. industries are increasingly looking to learn diagnostic work of engineers, the physical from healthcare.10 But to do this well requires repair work of maintenance technicians, No simple solution a more sophisticated approach centred on the design work of system analysts, and the From simulation training2 to patient hando- three principles. myriad other activities that constitute any ver3 to structured communication4 to qual- Firstly, efforts to translate improvement complex industry. ity improvement itself,5 many healthcare strategies from one setting to another need When attempting to transfer improvement improvement interventions have been to be based on a sophisticated understanding lessons, it is important to understand the adapted from industrial settings as diverse of the contextual, practical, and structural precise nature of the work in different as civil aviation, nuclear power, and car differences (and similarities) between those healthcare settings as well as in other manufacturing. Initially, learning from other settings.11 Secondly, translational efforts industries. For instance, it might be useful industries seems to offer a simple shortcut to need to pay close attention to the cultural and to draw parallels between the technical, anyone trying to improve healthcare. Other organisational arrangements that support process oriented, monitoring activities of industries have spent decades developing the particular improvement intervention. anaesthesia and similar types of activities Thirdly, any translational effort needs to be in the control rooms of nuclear power based on a process of careful adaptation and plants.10 Likewise, the complex diagnostic KEY MESSAGES intelligent reinvention, not simply importing tasks, multiple handovers, and relatively • Many of the improvement strategies, and applying a readymade tool. isolated working patterns of maintenance tools, and techniques in healthcare engineering may be a useful analogue for have been drawn from other industries Lost in translation some elements of primary care. • When transferring improvement meth- Why is learning from other industries so In addition, successful translation from ods key elements are often missed, hard? One of the main reasons is obvious: other industries into healthcare typically mistranslated, or inappropriate to caring for patients is radically different from depends on considerable adaptation and healthcare making cars or flying aeroplanes. Healthcare reinvention of the original improvement • It is important to understand the work is unique in the intimacy, complexity, and techniques. This can be seen in three areas context and organisational systems that sensitivity of the services it provides as well of healthcare improvement that have drawn underpin a method’s success as the trust, compassion, and empathy that heavily on techniques pioneered in other underpin it.12 Healthcare is also enormously industries. • Better understanding of healthcare systems is also vital for successful transla- varied: elective surgery, community mental Incident investigation and analysis tion health, emergency medicine, and palliative care are very different in terms of the work, Analysing and investigating adverse inci- Other industries allocate considerable • knowledge, and activities involved— and the dents has been a cornerstone of improving resources and dedicated staff to systems ways they need to be organised and man- patient safety for many years. The pioneering analysis and quality improvement aged. reports that established the discipline drew the bmj | BMJ 2019;364:l1039 | doi: 10.1136/bmj.l1039 25 ANALYSIS directly on the experience of other industries, safety checklists25 and other cognitive aids establishing standard protocols for reliable primarily aviation,15 16 and incident reporting such as emergency manuals.26 Checklists communication,3 26 rather than aiming to systems have subsequently become one of provide a set of structured and practical create effective teams through the use of a the most widely implemented improvement instructions that either prompt, or serve to checklist.9 strategies across modern healthcare. The verify, a series of actions at key stages of a In other industries, checklists are English National Reporting and Learning healthcare process—such as the sign-in just one element of a carefully designed System currently collects data on over two process before surgery9 or during an anaes- sociotechnical system built to support million incident reports each year17 and root thetic emergency.26 Checklists draw directly processes for high reliability and effective cause analysis techniques have been widely on those used in other industries—aviation human performance. Some areas of adopted.8 in particular—and the approach has been healthcare, such as maternity care, have However, the translation of these widely popularised. emulated this successfully.27 But in many approaches into healthcare has often missed However, in the process of being healthcare settings the checklist may be or misconstrued some of the most important imported into healthcare, checklists the only element of an entire process that elements seen in other industries. Incident have taken on several functions beyond has been actively designed with reliability investigations in industries such as nuclear those in other industries. For example, in and safety in mind.9 This brings both risks power18 are typically conducted by dedicated healthcare checklists are often intended and opportunities. One risk is that an in-house teams of professionally trained to prompt communication and facilitate over-reliance on checklists, coupled with investigators; routinely incorporate rigorous team functioning. In other industries, the unrealistic expectations regarding their human factors and systems analysis; are collective use of checklists depends on application, leads to well meaning people separated entirely from any management the prior creation of cohesive and well with limited expertise developing cognitive processes that seek to allocate blame; and functioning teams through building stable aids that are poorly designed or ineffective typically produce actions that focus on cultural norms and expectations, routinely and therefore distract more than they strong, systemic safety improvements such training for simulated emergencies, and support. as redesigning equipment. In contrast, the fundamental organisational systems and structures Box 1: System-wide, learning focused, safety investigation needed to effectively learn from What? incident investigations remain relatively In April 2017 England became the first country to establish a dedicated, system-wide safety underdeveloped in many healthcare settings. investigation organisation for healthcare: the Healthcare Safety Investigation Branch. Norway is Investigations can get tangled up with launching a similar organisation in 2019 (the National Investigation Board for the Health and Care political processes of blame, there is limited 22 Services), and other countries are exploring the idea. expertise, and resulting improvement 8 actions are not always robust. There has Why? also been a heavy focus on collecting and The objectives of these new organisations are translated directly from other industries, recording large quantities of incidents. including railways, shipping, and aviation: to undertake rigorous, non-punitive, and systematic Reporting incidents has almost become an investigations into serious patient safety risks that span the healthcare system to develop system- end in itself, whereas in other industries wide recommendations for learning and improvement.21 incidents are used merely as a starting point to investigate and improve work systems.19 How? Growing frustration7 has recently led Uniquely, the organisations are independent of all other parts of the healthcare system. They can to a reappraisal of the focus on reporting, therefore investigate and issue recommendations to all parts of the healthcare system—from with attention increasingly shifting back frontline practice, to the design of equipment, to the regulation of services. Importantly, the to the practical work of investigating and investigation processes are focused solely on learning and are entirely separate from systems that improving healthcare.20 21 Notably, several seek to allocate blame, liability, or punishment. Information collected for the purposes of safety national healthcare systems are developing investigation will be used only for safety improvement and cannot be used by other organisations the capacity for routine, system-wide safety for punitive purposes. Ensuring this independence requires strong legislative protections to investigations (box 1). prevent safety information from being used inappropriately.23 Many healthcare organisations still have a long way to go before they can reliably What’s different in healthcare? transform incidents into improvements. The principles of investigation are common across all industries, but the practical specifics will Revisiting the organisational and cultural need to be reinvented to deal with the unique challenges of healthcare. In particular: principles that support this in other • Healthcare practices draw on cutting edge and ever changing medical science and so industries still offers salient lessons, investigations will need to engage with scientific evidence and will probably need to regularly primarily the need for well resourced recommend further scientific inquiry safety teams led by experts that allow • Health systems are much more complex than any transport industry and encompass a wide range systematic examination of practical work of highly specialised professional groups, skilled activities, and advanced technologies and the development of robust system level • Healthcare investigations must sensitively engage patients and families throughout the process; improvements in contexts removed from fear they are often the only people who see the entire trajectory of care and blame.24 • Healthcare organisations routinely capture few data relevant to safety—there are no “black box” flight data recorders as in aviation—and the data that are collected may be difficult to collate and Checklists and cognitive aids are often qualitative One of the highest profile improvement inter- • Healthcare processes are less specified and less standardised than in other industries, meaning ventions adopted from other industries are there may be few benchmarks against which to identify deviation

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Healthcare could learn further from the Box 2: Integrating systems analysis, decision making, and cognitive aids strategic use of cognitive aids and checklists as part of more integrated approaches What? to designing processes and improving The routine operational decisions that are made in airlines that determine whether a commercial reliability. For instance, considerable airliner is airworthy and safe to fly are governed by a minimum equipment list (MEL). effort goes into supporting in-the-moment Why? professional decision making by mapping At any point in time, any aircraft is likely to have some equipment that is faulty or inoperable. The out the complex conditions under which it MEL can be more than 400 pages, mapping out the conditions and contingencies under which an is safe for an aircraft to depart and when it aircraft is safe to fly and providing the basis for sophisticated professional judgments by engineers is not (box 2). and flight crews regarding whether an aircraft is safe to operate or not. Essentially, the MEL maps out for most conceivable scenarios that “If this is broken then it is safe to fly if A and B are Quality improvement and systems design operational and you don’t do C.” Healthcare quality improvement owes its existence to other industries. Process re- How? engineering and systems improvement tools The core requirements are determined by aviation regulators, documented by aircraft such as lean production,29 plan-do-study-act manufacturers, incorporated into airline operators’ procedures, and implemented by engineers cycles,5 statistical process control,30 and fail- and flight crew. MELs are highly systematised decision support tools that capture a deep body ure modes and effects analysis31 have been of technical knowledge and present it in a way that supports expert judgment and professional imported into healthcare almost wholesale. accountability. These sophisticated cognitive aids aim to support cautious and balanced decisions Many of these methods may seem simple5 about risks: ensuring that airworthiness and safety are maintained at all times and core regulatory but are actually highly sophisticated requirements are met, while avoiding unduly inconveniencing passengers or affecting airline and challenging techniques that require revenues by removing serviceable aircraft from operation. considerable expertise to implement well. Reviews suggest that they are not always What’s different in healthcare? consistently or effectively applied in The need to balance safety and productivity pressures, and to structure shared decision making, healthcare.5 31 This might be partly because are common to many healthcare settings, but the specifics of how such an approach might be individuals and teams are not appropriately incorporated into healthcare would need detailed analysis: trained or experienced in the particular • In which healthcare contexts might it be useful to develop more extensive, systems oriented method.5 But more fundamentally, it points cognitive aids equivalent to a MEL, and when might such tightly structured decision making be to the importance of having appropriate inappropriate or overly constraining? organisational systems, resources, and • How might a healthcare equivalent of a MEL be designed and implemented in surgical settings 28 culture in place to support the systematic given that around 20% of surgical procedures start with missing equipment, and what application of improvement methods. adaptations might be required for different types of surgical procedure? One of the hidden assumptions that • To what extend might the principle of deep standardisation that underpins MELs conflict underpins many process improvement with new efforts to standardise healthcare processes, such as the National Safety Standard methods is that there are stable processes for Invasive Procedures in England, which encourages considerable variation in the local in place to improve. However, as the development and implementation of procedures and checklists? reliability of systems such as those for inpatient prescribing and theatre equipment coordinating with all the component and fundamental lessons for healthcare is availability has been found to be about 80%,28 manufacturers (from engines to flight the extent to which other industries allocate this can be a bold assumption. Activities in computers), designing the maintenance considerable resources and dedicated staff to many areas of healthcare have often grown processes, and defining the procedures for systems analysis and quality improvement.24 up organically over many years, so the operating and maintaining the aircraft— most fundamental step in many healthcare even down to specifying that on certain From translation to exploration improvement projects is often simply to types of twin engine aircraft on certain types Learning from other industries is neither design a process to begin with. of operations, the same engineer may not simple nor straightforward but it remains To date, the improvement approach in conduct the same maintenance task on both an important part of improving the quality healthcare has largely focused on initiating engines, in case the same error is made. and safety of healthcare. Adapting quality large numbers of locally led improvement Healthcare has much to learn from other improvement tools from elsewhere requires projects. This approach can work to optimise industries about integrating complex a deep understanding of the mechanisms processes that already exist but is less suited technical, operational, and organisational and systems that underpin an improvement to tackling the large, complex problems systems. Recent examples include the technique in one industry; closely examining of system design.32 Again, insights from systems engineering work undertaken the context, practices, and challenges inher- other industries are still highly relevant to integrate technologies, processes, and ent in a particular setting in healthcare; and to healthcare, such as the importance of systems in intensive care units33 34 and efforts then carefully adapting and reinventing the systems engineering. to apply safety case techniques from the improvement technique to work in health- One of the defining features of many nuclear and chemical process industries to care. At the core, the process of learning from industries is the importance of “systems analyse, map, and improve the reliability other industries is really a process of learn- integrators,” who oversee and coordinate of health systems.35 There are likely be ing more about our own. the design of complex systems. In aviation, new lessons to learn from developments for example, major manufacturers—such in user-led design36 and the organisation Contributors and sources: CM has researched and 27 designed safety systems in healthcare, aviation, and as Boeing or Airbus—fulfil this function of resilient organisational systems. But other industries, including the work underpinning by designing the core of the aircraft, above all, perhaps one of the most striking England’s new Healthcare Safety Investigation Branch. the bmj | BMJ 2019;364:l1039 | doi: 10.1136/bmj.l1039 27 ANALYSIS

KS has longstanding experience in system-wide quality it make a difference? BMJ Qual Saf 2012;21:84-8. 22 Wiig S, Macrae C. Introducing national healthcare improvement initiatives and national improvement doi:10.1136/bmjqs-2011-000297 safety investigation bodies. Br J Surg 2018;105:1710- programmes. This article arose from discussions at an 5 Reed JE, Card AJ. The problem with plan-do-study-act 2. doi:10.1002/bjs.11033 international quality conference. CM drafted the article cycles. BMJ Qual Saf 2016;25:147-52. doi:10.1136/ 23 House of Lords and House of Commons Joint and KS reviewed and helped revise it. CM is guarantor. bmjqs-2015-005076 Committee on Draft Health Service Safety 6 Dixon-Woods M, Bosk CL, Aveling EL, Goeschel CA, Investigations Bill. A new capability for investigating Competing interests: We have read and understood Pronovost PJ. Explaining Michigan: developing an patient safety incidents. House of Commons, 2018. BMJ policy on declaration of interests and declare that ex post theory of a quality improvement program. 24 Macrae C. Close calls: managing risk and resilience CM has previously been employed as a researcher-in- Milbank Q 2011;89:167-205. doi:10.1111/j.1468- in airline flight safety management. Palgrave, 2014. residence at the Healthcare Safety Investigation Branch. 0009.2011.00625.x doi:10.1057/9781137376121 Provenance and peer review: Commissioned; 7 Shojania KG. The frustrating case of incident-reporting 25 Bosk CL, Dixon-Woods M, Goeschel CA, Pronovost PJ. externally peer reviewed. systems. Qual Saf Health Care 2008;17:400-2. Reality check for checklists. Lancet 2009;374:444-5. doi:10.1136/qshc.2008.029496 doi:10.1016/S0140-6736(09)61440-9 This article is one of a series commissioned by The BMJ 8 Peerally MF, Carr S, Waring J, Dixon-Woods M. 26 Goldhaber-Fiebert SN, Macrae C. Emergency manuals: based on ideas generated by a joint editorial group The problem with root cause analysis. BMJ Qual how quality improvement and implementation with members from the Health Foundation and The Saf 2017;26:417-22. science can enable better perioperative management BMJ, including a patient/carer. The BMJ retained full 9 Catchpole K, Russ S. The problem with checklists. during crises. Anesthesiol Clin 2018;36:45-62. editorial control over external peer review, editing, and BMJ Qual Saf 2015;24:545-9. doi:10.1136/ doi:10.1016/j.anclin.2017.10.003 publication. Open access fees and The BMJ’s quality bmjqs-2015-004431 27 Macrae C, Draycott T. Delivering high reliability in improvement editor post are funded by the Health 10 Weinger MB, Hallbert BP, Logan MK. Risk and reliability maternity care: in situ simulation as a source of Foundation. in healthcare and nuclear power: learning from each organisational resilience. Saf Sci 2016. doi:10.1016/j. Carl Macrae,professor of organisational behaviour and other. AAMI, 2013. ssci.2016.10.019 psychology1 11 Grote G. Safety management in different high-risk 28 Burnett S, Franklin BD, Moorthy K, Cooke MW, 2 domains—all the same? Saf Sci 2012;50:1983-92. Vincent C. How reliable are clinical systems in Kevin Stewart, medical director doi:10.1016/j.ssci.2011.07.017 the UK NHS? A study of seven NHS organisations. 1University of Nottingham, Nottingham University 12 Dixon-Woods M, Yeung K, Bosk CL. Why is UK BMJ Qual Saf 2012;21:466-72. doi:10.1136/ Business School, Centre for Health Innovation, medicine no longer a self-regulating profession? bmjqs-2011-000442 Leadership and Learning, Nottingham, UK The role of scandals involving “bad apple” doctors. 29 Radnor ZJ, Holweg M, Waring J. Lean in healthcare: 2Healthcare Safety Investigation Branch, Farnborough, UK Soc Sci Med 2011;73:1452-9. doi:10.1016/j. the unfilled promise? Soc Sci Med 2012;74:364-71. socscimed.2011.08.031 doi:10.1016/j.socscimed.2011.02.011 Correspondence to: C Macrae 13 Vincent C, Amalberti R. Safer healthcare: strategies for 30 Langley GJ, Moen RD, Nolan KM, Nolan TW, Norman CL, [email protected] the real world. Springer, 201610.1007/978-3-319- Provost LP. The improvement guide: a practical 25559-0. approach to enhancing organizational performance. 14 Kapur N, Parand A, Soukup T, Reader T, John Wiley, 2009. Sevdalis N. Aviation and healthcare: a 31 Liberati EG, Peerally MF, Dixon-Woods M. Learning comparative review with implications for from high risk industries may not be straightforward: This is an Open Access article distributed in accordance patient safety. JRSM Open 2016;7:1-10. a qualitative study of the hierarchy of risk controls with the Creative Commons Attribution Non Commercial doi:10.1177/2054270415616548 approach in healthcare. Int J Qual Health Care (CC BY-NC 4.0) license, which permits others to 15 Kohn LT, Corrigan JM, Donaldson MS. To err is 2018;30:39-43. doi:10.1093/intqhc/mzx163 distribute, remix, adapt, build upon this work non- human. Institute of Medicine, 1999. 32 Dixon-Woods M, McNicol S, Martin G. Ten challenges commercially, and license their derivative works on 16 Department of Health. An organisation with a memory: in improving quality in healthcare: lessons from the different terms, provided the original work is properly report of an expert group on learning from adverse Health Foundation’s programme evaluations and cited and the use is non-commercial. See: http:// events in the NHS chaired by the chief medical relevant literature. BMJ Qual Saf 2012;21:876-84. creativecommons.org/licenses/by-nc/4.0/. officer. Department of Health, 2000. doi:10.1136/bmjqs-2011-000760 17 National Reporting and Learning System. NRLS 33 Nitkin K. Tomorrow’s ICU. Hopkins Medicine 2017 quarterly data workbook. 2018. https://improvement. Winter.https://www.hopkinsmedicine.org/news/ nhs.uk/documents/2563/NaPSIR_quarterly_data_ publications/hopkins_medicine_magazine/features/ 1 Berwick DM. Continuous improvement as an ideal summary_Jul_-_Sep_17.zip winter-2017/tomorrows-icu in health care. N Engl J Med 1989;320:53-6. 18 Carrol JS. Organizational learning activities in high- 34 Pronovost PJ, Mathews SC, Chute CG, Rosen A. Creating doi:10.1056/NEJM198901053200110 hazard industries: the logics underlying self-analysis. J a purpose-driven learning and improving health 2 Gaba DM, Howard SK, Fish KJ, Smith BE, Sowb YA. Manage Stud 1998;35:699-717. doi:10.1111/1467- system: The Johns Hopkins Medicine quality and safety simulation-based training in anesthesia crisis 6486.00116 experience. Learning Health Systems 2016;1:e10018- resource management (ACRM): a decade of 19 Macrae C. The problem with incident reporting. 7. doi:10.1002/lrh2.10018 experience. Simul Gaming 2001;32:175-93. BMJ Qual Saf 2016;25:71-5. doi:10.1136/ 35 Sujan MA, Habli I, Kelly TP, Pozzi S, Johnson CW. Should doi:10.1177/104687810103200206 bmjqs-2015-004732 healthcare providers do safety cases? Lessons from 3 Catchpole K, Sellers R, Goldman A, McCulloch P, 20 National Patient Safety Foundation. RCA2: improving a cross-industry review of safety case practices. Saf Hignett S. Patient handovers within the hospital: root cause analyses and actions to prevent Sci 2016;84:181-9. doi:10.1016/j.ssci.2015.12.021 translating knowledge from motor racing to healthcare. harm. National Patient Safety Foundation, 2015. 36 Von Hippel E. Democratising innovation. MIT Press, Qual Saf Health Care 2010;19:318-22. doi:10.1136/ 21 Macrae C, Vincent C. Learning from failure: the 2006. qshc.2009.026542 need for independent safety investigation in 4 Lee P, Allen K, Daly M. A communication and patient healthcare. J R Soc Med 2014;107:439-43. Cite this as: BMJ 2019;364:l1039 safety training programme for all healthcare staff: can doi:10.1177/0141076814555939 http://dx.doi.org/10.1136/bmj.l1039

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How organisations contribute to improving the quality of healthcare Naomi Fulop and Angus Ramsay argue that we should focus more on how organisations and organisational leaders can contribute to improving the quality of healthcare

mproving the quality of healthcare is and embedding systems for education and through its leadership and processes—can complex.1 2 Frontline staff are often training.10 11 Subsequent reviews of quality bridge these levels to influence the quality of seen as the key to improving quality— inspections12 and reviews of evidence on care delivered at the front line.14-16 for instance, by identifying where it factors influencing quality improvement,9 A key macro influence on organisations can be improved and developing and board contributions13 indicate that performing their role in improving Icreative solutions.3 4 However, research organisational leadership is crucial in quality is the way the healthcare system and reviews of major healthcare scandals delivering high quality care. is governed and regulated. Regulation acknowledge the contributions of other We discuss how organisational processes provides accountability to the wider stakeholders in improving quality, including such as development of a strategy and use system and therefore has a potentially regulators, policy makers, service users, and of data can be used to drive improvement, strong influence on how healthcare organisations providing healthcare.5 6 the characteristics of organisations that are organisations approach improvement. For Policies on the role of organisations in good at improvement, and what to consider example, multiple regulators in healthcare improving quality have tended to focus when thinking about how organisations systems, as is the case in England, can on how they might be better structured or can help improve quality of healthcare and lead to “regulatory overload,”17 making regulated. However, greater consideration patient outcomes. it hard for organisations to focus on is required of how organisations and their We present evidence on the role of quality improvement rather than quality leaders can contribute to improving quality: organisations in improvement drawn from assurance18 because of the need to respond organisations vary in both how they act to acute hospital settings in the UK and other to different (and potentially conflicting) support improvement7 8 and the degree to countries. Although contexts may vary—for regulatory approaches, priorities, which they provide high quality healthcare.9 example, in whether health policy is made incentives, and sanctions.17 19 20 Some earlier studies suggest that at regional or national level, or in the form high performing organisations share and function of healthcare organisations— How can organisations contribute to improving several features reflecting organisational the lessons have potential relevance to all quality? commitment to improving quality. These settings. Organisations can use various levers and include creating a supportive culture, processes to translate external inputs (such building an appropriate infrastructure, Placing healthcare organisations in their context as policy and regulatory incentives) and Health systems operate at three inter-related internal inputs (such as local assurance KEY MESSAGES levels: macro, meso, and micro (box 1). systems providing data on performance Research suggests that an organisation— and capacity) to support quality improve- • The contribution of healthcare organi- ment.7 18 21 Organisations can facilitate sations to improving quality is not fully improvement by developing and implement- understood or considered sufficiently Box 1: Macro, meso, and micro ing an organisation-wide quality improve- Organisations can facilitate improve- 9 22 3 • contributions to the quality of healthcare14 ment strategy that includes the following ment by developing and implement- actions: ing an organisation-wide strategy for Macro (national health systems) improving quality • Regulatory system • Using appropriate data to measure and monitor performance20 21 22 • Organisational leaders need to sup - • Finance • National priorities and policies • Linking incentives (both carrot and port system-wide staff engagement in 16 22 improvement activity and, where nec- • Accreditation stick) with performance on quality • Recruiting, developing, maintaining, essary, challenge professional interests Meso (hospitals) and supporting a quality proficient and resistance • Strategies workforce21 Leaders need to be outward facing, to • Systems • • Ensuring sufficient technical resources learn from others, and to manage exter- • Processes and building a culture that supports nal influences. Strong clinical represen- • Cultures improvement.9 16 tation and challenge from independent • Practices voices are key components of effective • Structures Many of the key organisational activities leadership for improving quality Micro (departments, teams) important to improving quality, such as • Regulators can facilitate healthcare • Relational issues setting strategy and agreeing performance organisations’ contribution by minimis- • Communication measures, are defined at organisational level 13 ing regulatory overload and contradic- • Professional work by the board. Bottom-up, clinician-led tory demands • Competence improvement is often seen as the answer to the bmj | BMJ 2019;365:l1773 | doi: 10.1136/bmj.l1773 29 ANALYSIS

32 33 Leadership across multiple hospitals in a given area. Combine bottom-up clinical leadership with top-down regional authority Evidence suggests that how such changes Bottom up + Top down are led and implemented influences the impact of the changes, including on patient outcomes (fig 1). Clinicians led development of Ensured all stakeholders, such as meaningful clinical standards: provider and payer organisations, “what good looks like” were involved throughout process What do organisations that do well in improving quality look like? Research suggests that organisations that Ensured clinical commitment and system-wide ownership of changes deliver high quality care show high com- Enabled leaders to challenge local professional and managerial resistance to change mitment to improving quality, reflected for instance in how organisations are led (eg, senior management involvement) and managed (eg, use of data and standards). As an Leadership and implementation approaches interlinked illustration, fig 3 contrasts the approaches taken by US organisations with high patient mortality from acute myocardial infarction Implementation with those that have low mortality. Contributions of launch, standards, and facilitation Some recent research has developed Launch Standards Facilitation the concept of maturity in relation to how boards of organisations govern for quality Single launch date System wide use of Operational support improvement and what organisational gave clarity on when quality standards from local networks processes accomplish and sustain it.18 system went online linked to nancial vital in facilitating incentives supported timely implementation More mature boards tend to use data consistent delivery to drive improvements in quality rather of care than merely for external assurance,18 20 and they combine hard quantitative data on performance with soft data on Combined eﬀect: personal experiences to make the case for Higher proportion of patients treated in specialist unit 22 Higher likelihood of receiving evidence based care improvement. They also engage with Signi cant reductions in patient mortality (eg, 96 additional lives saved relevant stakeholders (including patients18 a year in London) and length of hospital stay and the public), translate this into strategic 9-11 Fig 1 | Leading and implementing system-wide change across organisations: centralising acute priorities, and have processes for stroke services in London and Greater Manchester25 27 28 managing and communicating information with stakeholders.8 9 18 They value learning 4 7 22 34 the quality challenge, and it is an important as discussed elsewhere in this series.20 29 30 and development —for example, part of successful quality improvement.3 Although the relation between culture and drawing on external examples of good 24 However, relying solely on frontline quality is complex, organisations can use practice to achieve initial improvement then staff to lead improvement is risky because formal and informal managerial processes focusing on local, creative problem solving 34 professional self interest can shape or limit to influence culture and thus improve quality for continued improvement. Finally, the focus of improvement activity.22 25 26 of care.30 these organisations are outward facing, Furthermore, lack of system-wide or engaging with and managing their wider organisation-wide agreement on objectives What helps organisations contribute to quality? environment, including payers and other 7 13 29 34 might result in variations at system level, As set out in box 1, the relationship between provider organisations. reflecting localised priorities rather than a healthcare organisation and its exter- By contrast, organisations with lower what is likely to provide the best care for nal environment (especially regulators) is levels of such capabilities (such as lack patients. As well as empowering staff and important in that organisation’s contribu- of coherent mission, high turnover of 18 23 supporting system-wide staff engagement tion to quality. A qualitative study of leadership, and poor external relationships) 18 35 36 in activity around improving quality4 20 hospitals and their external environments in appear to slow or limit improvement. organisational leaders must challenge five European countries showed how some Some interventions have been identified localised professional interests, tribalism, were better able to align multiple financial to help organisations struggling to 7 35 and resistance to change.18 22 and quality demands. Figure 2 shows con- improve quality. Furthermore, research The reorganisation of acute stroke services trasting organisational responses to external on organisational turnaround provides in the UK (fig 1) shows how leadership demands and the features of both the exter- evidence of organisational leaders can play a pivotal role in managing nal demands and the organisations that con- harnessing crises, such as major safety professional and organisational resistance tributed to these different responses. issues or financial difficulties, to drive 36 37 to changes that aim to improve quality of Organisations can also contribute to radical change and improvement. Key care. Importantly in this case, leaders cited improving quality through participation changes to turn round organisations have external organisations’ priorities and public in (or leading) major system change, included refocused accountability systems consultation responses when holding the working beyond their own catchment areas (eg, making quality a key performance line against local resistance to change.25 across their local system—for example, indicator, devolving accountability to 31 11 38 The culture of organisations is commonly integrating health and social care services clinical teams ), introducing processes considered important in improving quality, or centralising specialist acute services to facilitate improvement (eg, dedicated

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Response to external demands Characteristics Underlying features Management prioritises nancial targets over quality (unless quality targets Less Immediate cost were linked to nancial incentives) likely saving measures Lower investment in quality - training cuts, cancelling study leave, and vacancies frozen, resulting in no time for staﬀ to focus on improvement

Medium term strategies Organisations struggled to prioritise between multiple quality demands where quality and Staﬀ became overloaded in trying to meet these demands Coherence of reducing costs not aligned Proposals for redesign were met with resistance (perceived as cost cutting) external demands Management capability to align Medium term strategies Staﬀ associated service redesign with increases in quality; demands where quality and organisations worked with external bodies to negotiate meaningful Leadership stability nancial goals aligned objectives balancing nance and improving quality

Focus on embedding quality and nancial objectives in day to day activity Longer term (at least Organisations invested in developing a capable quality workforce three years) strategy Ongoing dialogue with external bodies to ensure quality and nance More objectives aligned likely

Fig 2 | How hospitals respond to external finance and quality demands7 improvement roles,36 38 increased training clinicians.39 Active discussion of strategy engage with and manage both their exter- opportunities, and sharing timely data on is enhanced by independent challenge nal context and local professional inter- quality and cost with clinical teams11 36 38), by non-executives who are well versed in ests), and underlying features (including supporting culture change (eg, increasing quality issues; this is likely to enhance coherence of external demands and lead- collaboration between clinicians and focus on quality at board level, ensuring ership stability). Box 2 summarises these management11 36 38 with clinicians leading it is at the heart of an organisation’s themes. However, the balance of priorities on quality and management supporting vision and strategy.13 As noted elsewhere, among these is unclear: organisations will them), and learning from the experience of focus is growing on service users guiding want to analyse how they can maximise other organisations.11 36 38 However, for such improvement.40 However, it has been their contribution to improving quality interventions to have a chance of success, challenging to involve service users taking account of their particular context. organisations need both sufficient space meaningfully at senior leadership level.41 Regulators and policy makers also need to think and the people to make change to consider how they can better facilitate happen.23 What can we conclude? healthcare organisations’ role in improving The composition of senior leadership Although organisations are central to quality. Organisations are more likely to seems to influence how well organisations improving quality, there is much variation deliver quality improvement effectively deliver on quality. Having clinicians on in how they contribute, both locally and if externally set objectives are clear and the board has been associated with better at system level. We have described ways manageable, and there is time and resources organisational performance,23 39 through in which organisations can contribute to with which to meet these. Regulators enhanced decision making, increased improvement in terms of their processes should seek to avoid generating regulatory credibility with local clinicians (facilitating (such as how they develop strategy and overload and contradictory demands; and frontline uptake of policy), and making use data to drive improvements in qual- they should strengthen organisational organisations more likely to attract talented ity), their leadership (such as how leaders leadership’s hand by giving them headspace

TOP 5% HOSPITALS BOTTOM 5% HOSPITALS risk standardised risk standardised mortality rate: 11.4 to 14.0 FEATURE mortality rate: 17.9 to 20.9

Common vision: improving quality “the glue” - Organisational Meeting targets, focus on aligning quality and nancial objectives values and goals “checking boxes”

High commitment; use of quality data to Senior High senior turnover; insuﬃcient resources; guide strategy and accountability; suitable management intermittent use of data; feedback not nancial and other resources for quality involvement reliably used to plan improving quality

High qualication standards; physician Staﬀ Weak physician presence in quality; champions; empowered nursing staﬀ; presence/ nurses not valued reliably; pharmicists had pharmacists integrated into care process expertise limited involvement in decision making

Staff with shared commitment to Communication Constrained information ow (irregular communication and seamless transitions and coordination meetings, inefficient IT); inadequate in care; recognised interdependencies between groups transparency; staff felt isolated

Adverse events used to learn and improve; Problem Innovation not encouraged; data incorporated into organisation; solving and challenging to get buy-in; inadequate non-punitive culture; outward focused learning focus on learning from elsewhere

No association Protocols and processes No association with high or low for acute myocardial with high or low performance infarction care performance

Fig 3 | Contrasting organisational approaches in US healthcare organisations with the top and bottom 5% risk standardised mortality for acute myocardial infarction in 20178 the bmj | BMJ 2019;365:l1773 | doi: 10.1136/bmj.l1773 31 ANALYSIS

15 Ramsay A, Magnusson C, Fulop N. The relationship Box 2: What helps organisations contribute to quality? between external and local governance systems: the case of health care associated infections and Organisational process medication errors in one NHS trust. Qual Saf Health • An organisation-wide quality strategy to shift from external assurance to prioritising Care 2010;19:e45. doi:10.1136/qshc.2009.037473 improvement 16 Fulop N, Robert G. Context for successful quality • Combine hard and soft data to drive quality improvement. Health Foundation, 2015. 17 Davies C, Anand P, Artigas L, et al. Links between • Engage and communicate with stakeholders, including patients and carers, staff, and external governance, incentives and outcomes: a review of partners the literature. Report for the National Co-ordinating Centre for NHS Service Delivery and Organisation R & D • Build culture of trust, supporting innovation and problem solving (NCCSDO). NCCSDO, 2005. Organisational leadership 18 Jones L, Pomeroy L, Robert G, Burnett S, Anderson JE, Fulop NJ. How do hospital boards govern for • Support system-wide staff engagement in improving quality quality improvement? A mixed methods study of 15 • Be outward facing, to learn from and manage external context organisations in England. BMJ Qual Saf 2017;26:978- • Challenge local professional interests where necessary 86. doi:10.1136/bmjqs-2016-006433 19 Walshe K. The rise of regulation in the NHS. • Feature a strong clinical voice and independent challenge, especially on the board BMJ 2002;324:967-70. doi:10.1136/ bmj.324.7343.967 Underlying features 20 Dixon-Woods M, Baker R, Charles K, et al. Culture and • Space to think about improving quality behaviour in the English National Health Service: • Resources to implement improvements overview of lessons from a large multimethod study. • Coherent external requirements: avoid regulatory overload and contradictory demands BMJ Qual Saf 2014;23:106-15. doi:10.1136/ bmjqs-2013-001947 • Stability of leadership 21 Gandhi TK, Kaplan GS, Leape L, et al. Transforming concepts in patient safety: a progress report. BMJ Qual Saf 2018;27:1019-26. doi:10.1136/ bmjqs-2017-007756 to look beyond compliance and prioritise 1 Committee on Quality of Health Care in America, 22 Dixon-Woods M, McNicol S, Martin G. Ten challenges improving quality. Institute of Medicine. Crossing the quality chasm: in improving quality in healthcare: lessons from the a new health system for the 21st century. National Health Foundation’s programme evaluations and Competing interests: We have read and understood Academy Press, 2001. relevant literature. BMJ Qual Saf 2012;21:876-84. BMJ policy on declaration of interests and declare 2 Department of Health. An organisation with a doi:10.1136/bmjqs-2011-000760 that NJF is an NIHR senior investigator and was in part memory. Department of Health, 2000. 23 Jones L, Pomeroy L, Robert G, et al. Explaining supported by the NIHR Collaboration for Leadership 3 Allwood D, Fisher R, Warburton W, Dixon J. Creating organisational responses to a board-level quality in Applied Health Research and Care (CLAHRC) North space for quality improvement. BMJ 2018;361:k1924. improvement intervention: findings from an evaluation Thames at Barts Health NHS Trust. The views expressed doi:10.1136/bmj.k1924 in six providers in the English National Health Service. are those of the authors and not necessarily those of 4 Braithwaite J. Changing how we think about healthcare BMJ Qual Saf 2019;28:198-204. doi:10.1136/ the NHS, the NIHR, or the Department of Health and improvement. BMJ 2018;361:k2014. doi:10.1136/ bmjqs-2018-008291 Social Care. bmj.k2014 24 Black N. New era for health services will focus on 5 Francis R. Report of the Mid Staffordshire NHS systems and creativity. BMJ 2018;362:k2605. Contributors and sources: Both authors made Foundation Trust public inquiry. Stationery Office, doi:10.1136/bmj.k2605 substantial contributions to the conception and 2013. 25 Turner S, Ramsay A, Perry C, et al. Lessons for design of the work; to the acquisition, analysis, and 6 The Bristol Royal Infirmary Inquiry. The Report of the major system change: centralization of stroke interpretation of data; and to drafting the work and public inquiry into children’s heart surgery at the services in two metropolitan areas of England. revising it critically for important intellectual content. Bristol Royal Infirmary 1984-1995: learning from J Health Serv Res Policy 2016;21:156-65. NJF is the guarantor. Bristol. HM Stationery Office, 2001. doi:10.1177/1355819615626189 7 Burnett S, Mendel P, Nunes F, et al. Using institutional This article is part of a series commissioned by The BMJ 26 Turner S, Ramsay A, Fulop N. The role of professional theory to analyse hospital responses to external based on ideas generated by a joint editorial group communities in governing patient safety. J Health demands for finance and quality in five European with members from the Health Foundation and The Organ Manag 2013;27:527-43. doi:10.1108/JHOM- countries. J Health Serv Res Policy 2016;21:109-17. BMJ, including a patient/carer. The BMJ retained full 07-2012-0138 doi:10.1177/1355819615622655 editorial control over external peer review, editing, and 27 Fulop NJ, Ramsay AIG, Hunter RM, et al. Evaluation of 8 Curry LA, Spatz E, Cherlin E, et al. What distinguishes publication. Open access fees and The BMJ’s quality reconfigurations of acute stroke services in different top-performing hospitals in acute myocardial infarction improvement editor post are funded by the Health regions of England and lessons for implementation: mortality rates? A qualitative study. Ann Intern Foundation a mixed-methods study. Health Services and Delivery Med 2011;154:384-90. doi:10.7326/0003-4819- Research 2019;7. doi:10.3310/hsdr07070 Naomi J Fulop, professor of healthcare organisation 154-6-201103150-00003 and management 28 Fulop NJ, Ramsay AI, Perry C, et al. Explaining 9 Care Quality Commission. Quality improvement in outcomes in major system change: a qualitative study Angus I G Ramsay, NIHR knowledge mobilisation hospital trusts: sharing learning from trusts on a of implementing centralised acute stroke services in research fellow journey of QI. Care Quality Commission, 2018. two large metropolitan regions in England. Implement UCL Department of Applied Health Research, London, UK 10 Baker GR, MacIntosh-Murray A, Porcellato C, Dionne Sci 2016;11:80. doi:10.1186/s13012-016-0445-z L, Stelmacovich K, Born K. High performing healthcare 29 Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander Correspondence to: N J Fulop systems: delivering quality by design. Longwoods [email protected] JA, Lowery JC. Fostering implementation of health services Publishing, 2008. research findings into practice: a consolidated framework 11 Bate P, Mendel P, Robert G. Organizing for quality: the for advancing implementation science. Implement improvement journeys of leading hospitals in Europe Sci 2009;4:50. doi:10.1186/1748-5908-4-50 and the United States. Radcliffe Publishing Ltd, 2007. 30 Mannion R, Davies H. Understanding organisational doi:10.1201/b20730 culture for healthcare quality improvement. 12 NHS Improvement. Developmental reviews of BMJ 2018;363:k4907. doi:10.1136/bmj.k4907 This is an Open Access article distributed in accordance leadership and governance using the well-led with the Creative Commons Attribution Non Commercial 31 Exworthy M, Powell M, Glasby J. The governance of framework: guidance for NHS trusts and NHS integrated health and social care in England since (CC BY-NC 4.0) license, which permits others to foundation trusts. NHS Improvement, 2017. distribute, remix, adapt, build upon this work non- 2010: great expectations not met once again?Health 13 Ramsay A, Fulop N, Fresko A, Rubenstein S. The Healthy Policy 2017;121:1124-30. doi:10.1016/j. commercially, and license their derivative works on NHS Board 2013: Review of guidance and research different terms, provided the original work is properly healthpol.2017.07.009 evidence. NHS Leadership Academy, 2013. 32 Moran CG, Lecky F, Bouamra O, et al. Changing the cited and the use is non-commercial. See: http:// 14 Robert GB, Anderson JE, Burnett SJ, et al, QUASER creativecommons.org/licenses/by-nc/4.0/. system-major trauma patients and their outcomes team. A longitudinal, multi-level comparative study of in the NHS (England) 2008-17. EClinicalMedicine quality and safety in European hospitals: the QUASER 2018;4. doi:10.1016/j.eclinm.2018.11.001 study protocol. BMC Health Serv Res 2011;11:285. 33 Morris S, Hunter RM, Ramsay AIG, et al. Impact doi:10.1186/1472-6963-11-285 of centralising acute stroke services in English

32 doi: 10.1136/bmj.l1773 | BMJ 2019;365:l1773 | the bmj ANALYSIS

metropolitan areas on mortality and length of 36 Harvey G, Jas P, Walshe K. Analysing organisational Health Serv Res 2016;16(Suppl 2):169. doi:10.1186/ hospital stay: difference-in-differences analysis. context: case studies on the contribution of s12913-016-1395-5 BMJ 2014;349:g4757. doi:10.1136/bmj.g4757 absorptive capacity theory to understanding inter- 40 Dalton J, Chambers D, Harden M, Street A, Parker 34 Nembhard IM, Cherian P, Bradley EH. Deliberate organisational variation in performance improvement. G, Eastwood A. Service user engagement in health learning in health care: the effect of importing BMJ Qual Saf 2015;24:48-55. doi:10.1136/ service reconfiguration: a rapid evidence synthesis. best practices and creative problem solving bmjqs-2014-002928 J Health Serv Res Policy 2016;21:195-205. on hospital performance improvement. 37 Harvey G, Hyde P, Fulop N, Edwards N, Filochowski J, doi:10.1177/1355819615623305 Med Care Res Rev 2014;71:450-71. Walshe K. Recognising, understanding and addressing 41 McKevitt C, Ramsay AIG, Perry C, et al. Patient, carer doi:10.1177/1077558714536619 performance problems in healthcare organisations and public involvement in major system change in 35 Vaughn VM, Saint S, Krein SL, et al. Characteristics providing care to NHS patients. Crown, 2006. acute stroke services: the construction of value. Health of healthcare organisations struggling to improve 38 Jabbal J, Lewis M. Approaches to better value in the Expect 2018;21:685-92. doi:10.1111/hex.12668 quality: results from a systematic review of qualitative NHS: Improving quality and cost. King’s Fund, 2018. studies. BMJ Qual Saf 2019;28:74-84. doi:10.1136/ 39 Sarto F, Veronesi G. Clinical leadership and hospital Cite this as: BMJ 2019;365:l1773 bmjqs-2017-007573 performance: assessing the evidence base. BMC http://dx.doi.org/10.1136/bmj.l1773

the bmj | BMJ 2019;365:l1773 | doi: 10.1136/bmj.l1773 33 ANALYSIS

Adapting Lean methods to facilitate stakeholder engagement and co-design in healthcare Quality improvement approaches drawn from industry can go beyond traditional concepts of value and deliver improvements in healthcare services, argue Iain Smith and colleagues

ealthcare systems internation- can be used to engage stakeholders in both healthcare using a Lean approach requires ally face quality and productiv- defining value and designing systems and understanding of how Lean views customer ity challenges and calls have processes to deliver value. value, how this concept should be translated been made for them to focus to the healthcare context, and practical on delivering better value.1-3 What is Lean? methods for engaging stakeholders in HHowever, in healthcare, value is a debated Lean is derived from the practices of Japan’s defining and delivering value. concept. Value is often viewed in terms of automotive industry, specifically the Toy- health outcomes per spend for a given popu- ota production system.13 It is a systematic Translating Lean value principle to healthcare lation4 or in terms of clinical efficacy, focus- improvement approach that conceptualises Lean value definitions typically empha- ing on interventions with a robust evidence work as processes that can be continuously sise a commercial, production perspective. base and reducing the use of interventions of improved by emphasising customer value Customer value is related to manufacturing low benefit.2 But it can also be considered at and eliminating waste.6 13 Although it was processes that convert raw materials into the level of the microsystem, and systematic developed for industry, it has been used finished products, such as a car, ready for quality improvement (QI) approaches can successfully to improve quality and safety sale.24 Customers will not pay for defective help provide better value through action on in acute, primary, and mental healthcare vehicles, so to deliver value these processes quality, safety, and productivity.1 contexts (box 1). must be performed correctly first time.7 Pro- The Lean method is one approach that is The goal of Lean is to improve customer duction activities that are not adding value being increasingly used to enhance value value.13 20 Defining value in customer terms is are deemed to be waste and targeted for in healthcare.5-7 In the UK, for example, the first step. The Lean ideal is then to design elimination.13 NHS Improvement (which regulates systems and processes that deliver customer US advocates applying Lean to healthcare NHS care providers) has embarked on a value without waste, delay, or errors. This is have tended towards definitions of value programme to embed Lean in English NHS achieved through iterative application of the in terms of the customer’s willingness to trusts—some with support from the Virginia Lean principles (box 2), which set out the pay20 and its corollary that “anything in Mason Institute, a US based healthcare steps for continuous improvement towards the process that the customer would be consultancy,8 and others with support from the ideal.13 22 unwilling to pay for is waste.”25 Although an NHS Improvement consulting team.9 Contextual and cultural differences must this logic may be appropriate for the US Lean has drawn criticism for assuming that be taken into account when importing system of hybrid payment healthcare, it is production efficiency techniques can apply improvement approaches from other less relevant in national health insurance directly to healthcare10 11 and for lacking industries.23 Differences must be well systems like the NHS.26-28 methods to integrate clinical knowledge understood to adapt the approach to Unlike manufacturing, healthcare and expertise with patients’ preferences and the specific requirements of the new services are generally intangible and are needs in defining value.12 We examine how it context.23 Therefore, delivering value for characterised by simultaneous production

KEY MESSAGES Box 1: Examples of Lean in healthcare • Quality improvement approaches used • Western Sussex Hospitals NHS Foundation Trust has developed its patient first improvement in industry, such as Lean, consider system based on Lean principles. The system has been credited as contributing to the trust value from a customer perspective, being rated outstanding by the Care Quality Commission.14 15 It is also credited with improving focusing on productivity timeliness of patient observations, fall rates, response rates for friends and family tests, and • Healthcare requires a more holistic, theatre start times, as well as many more small improvements that make a difference to the multistakeholder view of value to tar- everyday experience of patients or staff.16 17 get improvement that benefits patients • NHS England’s General Practice Development Programme has saved thousands of hours of as well as clinicians and management clinical time by applying Lean principles through its “time for care” and “productive general • Lean also has methods that enable practice” programmes. This involved identifying and implementing high impact changes to healthcare stakeholders (including reduce waiting times and increase available GP time. Examples include redirecting patients not staff and patients) to engage in the requiring a GP appointment to see other healthcare professionals such as nurse prescribers.18 definition of value and the design of • A cross-organisational collaborative in North East England used Lean methods to improve processes dementia care and nurse-led liaison mental health services for older adults. This included rapid • Early involvement of all stakeholders improvement events that resulted in changes that reduced wait times, readmission rates, and through these methods can optimise length of hospital stay and made qualitative improvements such as increased confidence of the outcomes staff and calmer ward environments.19

34 doi: 10.1136/bmj.m35 | BMJ 2020;368:m35 | the bmj ANALYSIS

21 perception that patients are unable to Box 2: Five core principles of Lean in healthcare contribute because of a lack of knowledge • Value—Understanding value from the customer’s perspective (usually the patient) or ability). • Value streams—Identifying all the steps (both helpful and unhelpful) in the pathways of care The 3P method engaged stakeholders to that patients experience as they move through the system articulate and share their value perspectives. • Flow—Working along care pathways to align healthcare processes to facilitate the smooth flow Most importantly, this included service of patients and information users, who shared their experiences and • Pull—Creating processes that direct value towards the patient such that every step in the patient views on how these could be improved. journey pulls people, skills, materials, and information towards it, as needed Their experience was combined with staff • Perfection—an ideal to be pursued through the ongoing continuous improvement of processes experience to design care pathways (value streams) to deliver the desired user value. and consumption.29 Value is not created stream analysis, which focuses on end- Staff contributed clinical experience and through transformative production steps to-end pathways at high level to define professional knowledge to ensure this in a remote factory. Rather, the value of the strategic improvement plans,37 and the could be done safely and effectively. The service is co-created with the customer (or production preparation process (3P), which treatment rooms and other facilities were end user)29-31; patients are not customers at focuses on developing new products and located to ensure steps in the pathway lined the end of a production process but right in production facilities.25 These Lean workshop up with the physical layout to facilitate the middle of it throughout their pathways formats differ in emphasis but all offer the good flow. The service user, carer, and staff of care. Some believe that the principles of opportunity to involve patients and service flows were mapped and simulated at each Lean have therefore been misunderstood and users in identifying value adding activities cycle of the design process. Information on a more service oriented view is required that and eliminating waste.35 The question is how pathways would work was discussed assumes value in healthcare is co-produced how can people leading health service by stakeholders, which helped facilitate with patients.26 30 improvement use these methods in practice? improvement. Although it may seem obvious that the Box 3 presents an example from the NHS To improve the overall experiences of patient should be considered the customer in North East England, which adopted care, participants applied a service oriented and value defined from their perspective,32 Lean using knowledge from Virginia approach in which “every step in the patient there are other customers and stakeholders Mason.45 The Lean 3P method was used journey [pulls] people, skills, materials in healthcare whose needs and value to involve stakeholders in simultaneously and information towards it, one at a time, perspectives must also be considered.32 33 designing healthcare facilities and service when needed.”21 This helped stakeholders Young and McClean33 proposed a framework systems.38 43 44 46 The example illustrates design more innovative models of care to help do this by defining three critical challenges to participation that may be that could respond flexibly to changing dimensions to healthcare value—clinical, generally applicable (specifically the circumstances. Services could then be operational, and experiential. The clinical dimension of value relates to delivering effective care that achieves the best clinical Box 3: Using Lean 3P in healthcare: the design of space project 33 34 outcome. The operational dimension The design of space project used the Lean 3P method to help NHS stakeholders such as relates to the effectiveness of care relative patients, clinicians, and architects design two endoscopy units, a maternity unit, and a 2 4 33 to the cost of care. The experiential paediatrics unit in North East England.38 dimension relates to how patients Previous reports of applying Lean 3P to design healthcare facilities have limited patient experience the care they receive and can involvement to consultative walkthroughs39 or not included them.40 Furthermore, earlier be related to their interactions with staff research into stakeholder participation in the design of healthcare facilities identified 2 20 33 as well as the care environment. The scepticism from professional designers about the ability of patients to contribute.41 42 Negative various healthcare stakeholders (such as beliefs about users’ ability included feelings that they are “meddling” in areas they know patients and carers, clinical and non-clinical nothing about41; practical barriers in interpreting drawings and perceiving them spatially in staff, managers, and regulators) may place three dimensions41; and concerns regarding understanding of professional issues such as different emphasis on these dimensions of construction costs and material options.42 value.33 The project showed that Lean 3P design workshops can provide an effective process for engaging a wide range of stakeholders43 and a structured approach for corporate and clinical Lean QI methods to engage healthcare staff to work together with patient representatives.44 The Lean concept of end-user value stakeholders contributed to the design process by drawing out the perspectives (clinical, operational, and Arguably, most applications of Lean to experiential) of multiple stakeholders in terms of what mattered most to them. Stakeholders healthcare have been limited by a largely were engaged in activities that stimulated discussion and debate and encouraged sharing of operational view of value, where the focus their requirements and preferences. In particular, the process gave patient and service user has been on reducing costs rather than a voices greater influence in designing the pathways and how delivery would be facilitated more holistic, multistakeholder view.11 33 by the layout of the physical environment—for example, the location, layout, and size of However, through various workshop for- treatment rooms. They were also able to contribute to the design of facilities for partners, mats, Lean does have methods that enable family members, and carers; creation of family friendly environments; and an emphasis on definition of value and enhance customer sound privacy. participation.35 Lean rapid improvement events are Simple Lean tools, such as spaghetti charts, were used to engage stakeholders in mapping already commonly used in healthcare to out the pathway (value stream) and flows that patients and staff would follow. Flows were also make incremental changes to processes.6 36 designed to minimise the burden on patients (in terms of movement and anxiety) and direct Other Lean workshops include value staff and equipment towards the patient to deliver care. the bmj | BMJ 2020;368:m35 | doi: 10.1136/bmj.m35 35 ANALYSIS

“pulled” towards patients as required (for fulfil their potential to deliver greater value for improvement. BMJ Open 2016;6:e012256. example, by bringing a clinician to a patient in healthcare. doi:10.1136/bmjopen-2016-012256 7 Kim CS, Spahlinger DA, Billi JE. Creating value in in a treatment room rather than moving We thank Cat Chatfield for helpful comments on earlier health care: the case for lean thinking. J Clin Outcomes the patient to the clinician in a different drafts. Manag 2009;16:557-62. location, reducing patient movement). 8 NHS Improvement. NHS partnership with Virginia Contributors and sources: This article is based partly Mason Institute. 2016. https://improvement.nhs.uk/ Through multiple cycles of design, the on research carried out by IS towards a PhD with resources/virginia-mason-institute/. Lean 3P method helped participants move Newcastle University Business School. The methods 9 NHS Improvement. Seven trusts take part in our towards an optimised service model and included participant observation in Lean 3P workshops; lean programme. 2018. https://www.england.nhs. design.44 46 interviews with workshop participants; and analysis of uk/2018/04/seven-trusts-take-part-in-our-lean- 3P workshop documentation and physical artefacts. programme/. IS was responsible for the planning, conduct, and 10 Hartzband P, Groopman J. Medical taylorism. N Engl J Effective collaboration reporting of the work described and for writing the Med 2016;374:106-8. doi:10.1056/NEJMp1512402 The example shows that QI approaches such article. CH and TM have extensive experience of the 11 Schonberger RJ. Reconstituting lean in healthcare: from implementation of Lean tools and philosophies in the waste elimination toward ‘queue-less’ patient-focused as Lean can be adapted to include important manufacturing, service, and healthcare sectors. They care. Bus Horiz 2018;61:13-22. doi:10.1016/j. dimensions of service led value and quality, provided support in the design, planning, conduct, and bushor.2017.09.001 such as patient experience and satisfaction. reporting of the work and the revision of the article. 12 Poksinska BB, Fialkowska-Filipek M, Engström J. Does Lean healthcare improve patient satisfaction? In translating such methods to healthcare, Competing interests: We have read and understood A mixed-method investigation into primary care. it is important to identify both the primary BMJ policy on declaration of interests and declare the BMJ Qual Saf 2017;26:95-103. doi:10.1136/ customer and other service stakeholders following interests: IS works as a quality improvement bmjqs-2015-004290 professional in the NHS. No payments were received in 13 Womack JP, Jones DT. Lean thinking: banish waste and to define value and target improvement. connection with this paper. create wealth in your corporation. Simon & Schuster, The 3P method facilitated conversations 1996. across multiple stakeholder groups (includ- Provenance and peer review: Commissioned; 14 Jones B, Horton T, Warburton W. The improvement externally peer reviewed. ing patients, clinicians, and managers) journey: why organisation-wide improvement in This article is one of a series commissioned by The health care matters, and how to get started. Health that considered value in a more holistic BMJ based on ideas generated by a joint editorial group Foundation, 2018. way. For example, the clinical dimension with members from the Health Foundation and The 15 Care Quality Commission. Quality improvement in of value involved stakeholders considering BMJ, including a patient/carer. The BMJ retained full hospital trusts. Sharing learning from trusts on a journey of QI. 2018. https://www.cqc.org.uk/sites/ the effectiveness of treatments; the opera- editorial control over external peer review, editing, and publication. Open access fees and The BMJ’s quality default/files/20180911_QI_hospitals_FINAL.pdf tional dimension involved stakeholders improvement editor post are funded by the Health 16 Care Quality Commission. Western Sussex NHS considering the efficiency and productiv- Foundation. Foundation Trust quality report 2016/17:34. http:// www.westernsussexhospitals.nhs.uk/wp-content/ ity of service delivery; and the experiential Iain Smith, visiting researcher uploads/2014/08/WSHFT-Quality-Report-2016-2017. dimension involved stakeholders consider- Chris Hicks, professor of operations management pdf ing patients’ preferences and needs. Stake- Tom McGovern, professor of business history and 17 Western Sussex NHS Foundation Trust. The patient holders, including patients, articulated and management first. Trust annual review 2017-18. https://www. westernsussexhospitals.nhs.uk/wp-content/ shared their value perspectives, tested their Newcastle University Business School, University of Newcastle upon Tyne, Newcastle upon Tyne, NE1 4SE, uploads/2018/07/WSHT-Annual-Review-2018-Lo-res. ideas, and co-designed healthcare facilities UK pdf and systems to deliver users’ requirements. 18 NHS England. General practice development Correspondence to: I Smith programme. 2015. https://www.england.nhs.uk/gp/ Stakeholder conversations about the differ- [email protected] gpfv/redesign/gpdp/. ent dimensions of value could also be facili- 19 Atkinson P, Mukaetova-Ladinska EB. Nurse-led tated in other workshop formats such as liaison mental health service for older adults: service rapid improvement events and value stream development using lean thinking methodology. 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Comparing Lean and quality consequences of overlooking experiential creativecommons.org/licenses/by-nc/4.0/. improvement. IHI white paper. Institute for Healthcare details that matter to patients. To achieve Improvement, 2014. this, the qualitative nature of patient 23 Macrae C, Stewart K. Can we import improvements experience must be recognised and from industry to healthcare?BMJ 2019;364:l1039. doi:10.1136/bmj.l1039 1 Ham C, Berwick D, Dixon J. Improving quality in the given equal priority to that of healthcare 24 Ohno T. Toyota production system: beyond 47 English NHS: A strategy for action. King’s Fund, 2016. professionals. It is therefore important to large-scale production. Productivity Press, 1988. 2 Gray M. Designing healthcare for a different doi:10.4324/9780429273018 involve patients, clinicians, and managers future. J R Soc Med 2016;109:453-8. 25 Plsek P. Accelerating health care transformation doi:10.1177/0141076816679781 early in the improvement initiative and with Lean and innovation: the Virginia Mason 3 NHS England. Five Year Forward View. NHS England, select methods that allow them to work Experience. CRC Press, 2014. 2014. 26 Radnor Z, Osborne SP. Lean: a failed theory for public together on improvement. This includes 4 Porter ME. What is value in health care?N Engl services?Public Manage Rev 2013;15:265-87. doi:10. facilitating conversations between J Med 2010;363:2477-81. doi:10.1056/ 1080/14719037.2012.748820 NEJMp1011024 stakeholders about what matters to them 27 Radnor ZJ, Holweg M, Waring J. Lean in healthcare: 5 Andersen H, Røvik KA, Ingebrigtsen T. Lean thinking and creating opportunities for practical the unfilled promise?Soc Sci Med 2012;74:364-71. in hospitals: is there a cure for the absence doi:10.1016/j.socscimed.2011.02.011 and tangible improvement activities such of evidence? A systematic review of reviews. 28 Osborne SP, Radnor Z, Kinder T, Vidal I. BMJ Open 2014;4:e003873. doi:10.1136/ as small scale tests of change, working The SERVICE Framework: a public-service- bmjopen-2013-003873 through the plan-do-study-act cycle, or dominant approach to sustainable public 6 Mazzocato P, Stenfors-Hayes T, von Thiele Schwarz U, services. Br J Manage 2015;26:424-38. creating prototypes together. In this way, Hasson H, Nyström ME. Kaizen practice in healthcare: a doi:10.1111/1467-8551.12094 QI approaches such as Lean will begin to qualitative analysis of hospital employees’ suggestions

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29 Osborne SP, Strokosch K. It takes two to tango? 36 Mazzocato P, Savage C, Brommels M, Aronsson H, method to improve design. Architectural Engineering Understanding the co-production of public services Thor J. Lean thinking in healthcare: a realist review of and Design Management 2013;9:95-109. doi:10.108 by integrating the services management and the literature. Qual Saf Health Care 2010;19:376-82. 0/17452007.2012.738040 public administration perspectives. Br J Manage doi:10.1136/qshc.2009.037986 43 Hicks C, McGovern T, Prior G, Smith I. Applying lean 2013;24:S31-47. doi:10.1111/1467-8551.12010 37 Martin AJ, Hogg P, Mackay S. A mixed model principles to the design of healthcare facilities. Int 30 Batalden P. Getting more health from healthcare: study evaluating lean in the transformation of J Prod Econ 2015;170:677-86. doi:10.1016/j. quality improvement must acknowledge patient an Orthopaedic Radiology service. Radiography ijpe.2015.05.029 coproduction. BMJ 2018;362:k3617. doi:10.1136/ 2013;19:2-6. doi:10.1016/j.radi.2012.09.005 44 Smith I. The participative design of an endoscopy bmj.k3617 38 Prior G, Smith IM. Developing a ‘design of space’ facility using Lean 3P. BMJ Qual Improv Rep 2016;5:1- 31 Osborne SP, Radnor Z, Strokosch K. Co-production intervention using lean thinking: final report for the 6. doi:10.1136/bmjquality.u208920.w3611 and the co-creation of value in public services: a Health Foundation shared purpose programme. North 45 Hunter DJ, Erskine J, Hicks C, et al. A mixed-methods suitable case for treatment?Public Manage Rev East Transformation System, 2016:1-31. evaluation of transformational 2016;18:639-53. doi:10.1080/14719037.2015.11 39 Pelly N, Zeallear B, Reed M, Martin L. Utilizing change in NHS North East. Health Services and 11927 integrated facility design to improve the quality Delivery Research 2014;2:1-185. doi:10.3310/ 32 Blackmore CC, Kaplan GS. Lean and the perfect of a pediatric ambulatory surgery center. Paediatr hsdr02470 patient experience. BMJ Qual Saf 2017;26:85-6. Anaesth 2013;23:634-8. doi:10.1111/pan.12195 46 Smith I. Operationalising the Lean principles in doi:10.1136/bmjqs-2016-005273 40 Nicholas J. An integrated lean-methods approach to maternity service design using 3P methodology. 33 Young TP, McClean SI. A critical look at Lean thinking hospital facilities redesign. Hosp Top 2012;90:47-55. BMJ Qual Improv Rep 2016;5:1-9. doi:10.1136/ in healthcare. Qual Saf Health Care 2008;17:382-6. doi:10.1080/00185868.2012.679911 bmjquality.u208920.w5761 doi:10.1136/qshc.2006.020131 41 Hignett S, Lu J. An investigation of the use of health 47 de Iongh A, Erdmann S. Better healthcare must mean 34 Darzi A. High quality care for all: NHS next stage review building notes by UK healthcare building designers. better for patients and carers. BMJ 2018;361:k1877. final report. Stationery Office, 2008. Appl Ergon 2009;40:608-16. doi:10.1016/j. doi:10.1136/bmj.k1877 35 Radnor Z, Walley P. Learning to walk before we try to apergo.2008.04.018 run: adapting Lean for the public sector. Public Money 42 Caixeta MCBF. A conceptual model for the design Cite this as: BMJ 2020;368:m35 Manag 2008;28:13-20. process of interventions in healthcare buildings: a http://dx.doi.org/10.1136/bmj.m35

the bmj | BMJ 2020;368:m35 | doi: 10.1136/bmj.m35 37 ANALYSIS

Revitalising audit and feedback to improve patient care Audit and feedback are widely used in quality improvement. Robbie Foy and colleagues argue that their full potential to improve patient care could be realised through a more evidence based and imaginative approach

ealthcare systems face chal- and improvement. Unsurprisingly, the full than once, delivered in both verbal and lenges in tackling variations in potential of audit and feedback has not been written formats, and includes both explicit patient care and outcomes.1 2 realised. targets for change and action plans.3 A Audit and feedback aim to Clinical, patient, and academic synthesis of expert interviews and systematic improve patient care by review- communities might need to have more reviews identified 15 “state of the science,” ing clinical performance against explicit sophisticated conversations about audit theory informed suggestions for effective H 8 standards and directing action towards and feedback to achieve substantial, data feedback (box 1). These are practical ways areas not meeting those standards.3 It is a driven, continuous improvement. They can to maximise the impact and value of existing widely used foundational component of also act now. There are ways to maximise audit programmes. quality improvement, included in around returns from the considerable resources, 60 national clinical audit programmes in including clinician time, invested in audit Pay attention to the whole cycle the United Kingdom. programmes. These include applying what The audit and feedback process comprises Ironically, there is currently a gap between is already known, paying attention to the one or more cycles of establishing best what audit and feedback can achieve and whole audit cycle, getting the right message practice criteria, measuring current prac- what they actually deliver, whether led to the right recipients, making more out of tice, feeding back findings, implement- locally or nationally. Several national audits less data, embedding research to improve ing changes, and further monitoring. This have been successful in driving improvement impact, and harnessing public and patient chain is only as strong as its weakest link. and reducing variations in care, such as for involvement. Feedback effects can be weakened by infor- stroke and lung cancer, but progress is also mation-intention gaps (feedback fails to con- slower than hoped for in other aspects of Apply what is already known vince recipients that change is necessary), care (table 1).4 5 Audit and feedback have Audit and feedback generally work. A intention-behaviour gaps (intentions are not a chequered past.6 Clinicians might feel Cochrane review of 140 randomised trials translated into action), or behaviour-impact threatened rather than supported by top- found that they produced a median 4.3% gaps (actions do not yield the desired effect 9 down feedback and rightly question whether absolute improvement (interquartile range on patient care). The success of national rewards outweigh efforts invested in poorly 0.5% to 16%) in healthcare professionals’ audit programmes depends on local arrange- designed audit. Healthcare organisations compliance with desired practice, such as ments that promote action as well as meas- recommended investigations or prescrib- urement.10 have limited resources to support and 3 act on audit and feedback. Dysfunctional ing. This is a modest effect, but cumulative A synthesis of 65 qualitative evaluations clinical and managerial relationships incremental gains through repeated audit proposed ways of designing audit undermine effective responses to feedback, cycles can deliver transformative change. programmes to better align with local Audit and feedback also influence reach and capacity, identity, and culture and to particularly when it is not clearly part of an population through scaled up national pro- promote greater changes in clinical integrated approach to quality assurance grammes, which other quality improvement behaviour.11 Healthcare organisations have approaches (such as financial incentives finite capacity, so audit programmes should KEY MESSAGES or educational outreach visits) might not be designed so that they require less work, achieve with similar resources; for example, make best use of limited local resources, and • Clinical audit and feedback entail reviewing clinical performance against social norm feedback (presenting informa- clearly state why any investment is justified. explicit standards and delivering feed- tion to show that individuals are outliers Clinician beliefs about what constitutes best back to enable data driven improve - in their behaviour) from a high profile mes- practice can influence how they respond to ment senger can reduce antibiotic prescribing in feedback, so audit programmes need to primary care at low cost and at national scale consider these while also challenging the The impact of audit could be max - • (table 1).7 status quo. All aspects of audit programmes imised by applying implementation The interquartile range in the Cochrane should be designed with a focus on the science, considering the needs of cli- review indicates that a quarter of audit and desired changes in behaviour by recipients nicians and patients, and emphasising feedback interventions had a relatively to achieve better outcomes; for example, action over measurement large, positive effect of up to 16% on patient feedback tackling unnecessary blood Embedding research on how to improve • care, whereas a quarter had a negative or transfusions could include suggested audit and feedback in large scale pro- null effect. The effects of feedback can be alternative approaches to minimise blood grammes can further enhance their 12 amplified by ensuring that it is given by loss during surgery. Because the purpose effectiveness and efficiency a supervisor or colleague, provided more of an audit programme is not measurement

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Table 1 | Examples of national clinical audit programmes and randomised trials evaluating audit and feedback Objective Methods Illustrative findings National clinical audit programmes To measure and improve the structure, The National Clinical Audit for Stroke operates a prospective, continuous Stroke unit performance in key aspects of care improved processes, and outcomes of stroke care audit of the processes and outcomes of NHS funded stroke care and over five years; eg, the proportion of patients assessed rehabilitation in acute and post-acute settings in England and Wales. It by a stroke specialist consultant physician within 24 also reviews care at six months and beyond to assess how longer term hours rose from 74% to 83%, whereas the proportion of needs are met applicable patients screened for nutrition and seen by a dietitian by discharge rose from 66% to 81%.4 However, significant gaps in provision remain; eg, fewer than one in three patients receive a six month review To measure and improve care and For the National Lung Cancer Audit, secondary and tertiary care NHS The proportion of patients alive at least one year after outcomes for lung cancer hospitals in England and Wales submit data via the National Cancer diagnosis rose from 31% in 2010 to 37% in 2017.5 Registration and Analysis Service as part of the Cancer Outcomes and However, almost a third of patients still lack access to the Services Dataset. The data are linked to Hospital Episode Statistics, benefits of specialist nursing support the National Radiotherapy Dataset, the Systemic Anti-Cancer Dataset, pathology reports, and death certificate data Randomised trials of audit and feedback To assess the effect of adding an action 21 Dutch intensive care units were randomly assigned to receive Over six months, the proportion of patient shifts with implementation toolbox to electronic usual electronic feedback only or to feedback with an implementation adequate pain management increased by 14.8% audit and feedback targeting quality of toolbox suggesting practical actions staff could take to improve pain compared with 4.8% in the feedback only group pain management in intensive care units16 management To assess the effects of feedback 1581 English general practices whose prescribing rate for antibiotics Over six months, the rate of antibiotic items dispensed per including “social norm” persuasive was in the top 20% for their locality were randomly assigned to 1000 population was 127 in the feedback intervention messaging and patient focused receive feedback including a letter from England’s chief medical group and 131 in the control group, representing an information on antibiotic prescribing in officer highlighting the higher rate of antibioticprescribing or to no estimated 73 406 fewer antibiotic items dispensed. The higher prescribing general practices7 26 communication. They were then randomly assigned to receive patient patient focused intervention did not significantly affect focused information promoting reduced use of antibiotics or to no prescribing communication alone but using data to inform quality delegated projects conducted in isolation Get the right message to the right recipients improvement, we need to understand from mainstream pursuits and if any learning Feedback comparing performance among existing barriers to desired change and have is dissipated in collective amnesia. Clinical different healthcare organisations and clini- a plan for how feedback helps to tackle those and managerial leaders should ask questions cians can leverage competitive instincts. This barriers. about their organisational performance might not always work as intended. Nobody Without functioning local networks in response to feedback (box 2)13 and likes being told they are getting it wrong, and systems, national audit programmes set clear goals, mobilise resources, and repeatedly. Yet this is how clinicians and can become echo chambers, where good promote continuous improvement.14 Audit organisations often experience feedback sug- intentions and blame for limited progress and feedback by themselves cannot solve gesting suboptimal performance. Low base- reverberate. Audit and feedback will flounder ingrained deficiencies but can emphasise line performance is associated with greater if local quality improvement is based on priorities for change, inform focused actions, improvement after feedback3 but can elicit repeated, unconnected, and inappropriately and evaluate progress. defensive reactions (“I don’t believe these data”), especially if feedback does not align with recipient perceptions (”My patients are Box 1: Questions for audit programmes and healthcare organisations to consider in different”). Such responses are not uncom- designing, implementing, and responding to audit and feedback8 mon given that clinicians tend to overesti- mate their own performance.15 Continued Nature of the desired action negative feedback perceived as punitive can • Can you recommend actions that are consistent with established goals and priorities? also be demotivating and risk creating burn- • Can you recommend actions that can improve and are under the recipient’s control? out (“What else can I do?”). • Can you recommend specific actions? Giving feedback to professionals who Nature of the data available for feedback take pride in their work requires careful • Can you provide multiple instances of feedback? thought. Consider, for example, providing • Can you provide feedback as soon as possible and data frequency informed by the number of feedback to high performers—will positive new patient cases? feedback lead to reduced effort or increase • Can you provide individual rather than general data? • Can you choose comparators that reinforce desired behaviour change? Box 2: Questions that healthcare Feedback display organisations can ask themselves about • Can you closely link the visual display and summary message? performance13 • Can you provide feedback in more than one way? • Do we know how good we are? • Have you minimised extraneous cognitive load for feedback recipients? • Do we know where we stand relative to the Delivering feedback best? • Have you addressed barriers to feedback use? • Do we know where and understand why • Can you provide short, actionable messages followed by optional detail? variation exists in our organisation? • Have you addressed credibility of the information? • Over time, where are the gaps in our • Can you prevent defensive reactions to feedback? practice that indicate a need for change? • Can you construct feedback through social interaction? • In our efforts to improve, what’s working? the bmj | BMJ 2020;368:m213 | doi: 10.1136/bmj.m213 39 ANALYSIS motivation? Should audit programmes feedback programmes. Such approaches programme provides a robust empirical switch attention to new topics where offer greater population coverage, which driver for change. Modifications identified performance is poorer, at risk of inducing can overcome risks of biased sampling as more effective than the current standard fatigue in higher performers? Given the law associated with manual review, such as become the new standard; those that are not of diminishing returns, attempts to improve the loss of records of patients with poorer are discarded. already high levels of performance might outcomes. Routine data can also be collected be less fruitful than switching attention to and analysed in real time, thereby enabling Harness public and patient involvement other priorities. Many clinical actions have faster, continuous feedback and countering Healthcare providers and researchers are a “ceiling” beyond which improvement is objections voiced by clinicians (“These data still learning how to work meaningfully restricted because healthcare organisations are out of date”). with patients and the public, and there are or clinicians are functioning at or near their Data quality is only as good as coding opportunities in audit programmes. This maximum capabilities. at the point of care. Validity checks and means moving beyond current models of A range of approaches can help tailor quality control of the data might compound involvement—typically advisory group roles feedback to recipients’ needs. First, the burden on clinical teams. Data linkage to ensure accountability and contribute to feedback can include comparators that and extraction across different information strategy—towards active participation in show like for like (such as similar types requires compliance with data protection feedback and service improvement. of organisations with similar case mixes) and information governance requirements. Patients and the public are often and set realistic goals for change relative Even with all this in place, we must surprised by the extent of unwarranted to performance levels (such as lower acknowledge Einstein’s advice that not variations in healthcare delivery, which is but more achievable targets for poorer everything that counts can be counted, and the core business of audit programmes.25 performers). Second, feedback can be not everything that can be counted counts. They express frustration at the difficulties delivered alongside a range of tangible in routinely measuring less technical action plans to support improvement; Embed research to improve impact aspects of care, such as consultation for example, an implementation toolbox Poor research design, conduct, and dissem- skills and patient centredness. Involving improved pain management in intensive ination contribute to “research waste.”20 patients and the public, including seldom care units.16 17 Third, new audit criteria need Implementation science aims to translate heard communities, early in the process to be convincing, based on robust evidence research evidence into routine practice and of developing indicators is important. and with scope for patient and population policy but is also affected by research waste. Audit programmes can be at the forefront benefit. A cumulative meta-analysis of the Cochrane of innovating and evaluating different review of audit and feedback indicated that approaches to involvement, asking questions Make more out of less data the effect size stabilised in 2003 after 30 tri- such as, does incorporating the patient voice Healthcare organisations and clinicians als.21 By 2011, 47 more trials of audit and in feedback lead to greater improvement? need to juggle competing priorities and feedback versus control were published that Can feedback reports be better designed therefore struggle to act on all feedback did not substantially advance knowledge, to improve understanding for both lay and from national and local audit programmes. many omitting feedback features likely to professional board members of healthcare A 2012 snapshot identified 107 National enhance effectiveness. This indicated a organisations? Patients and the public Institute for Health and Care Excellence growing literature but “stagnant science.” represent an underexplored and untapped clinical guidelines relevant to primary care, Implementation laboratories offer a force for change, which audit programmes resulting in 2365 recommendations.18 Audit means of enhancing the impact of audit can learn to harness. programmes can help to identify which rec- and feedback while also producing ommendations have the greatest potential to generalisable knowledge about how Conclusion benefit patients and populations. to optimise effectiveness.22 A “radical Audit and feedback are widely used, some- One of the highest costs associated with incrementalist” approach entails making times abused, and often under-realised in audit programmes is the time and effort serial, small changes, supported by tightly healthcare. More imaginative design and involved in data collection, particularly focused evaluations to cumulatively improve responses are overdue; these require evi- the manual review of patient records. outcomes.23 It is already used in public dence informed conversations between clini- The burden of this data collection can be policy and in business. Amazon and eBay cians, patients, and academic communities. compounded by temptations to add in randomly assign potential customers to see It is time to fully leverage national audits to more variables for analyses that marginally different presentations of their products accelerate data guided improvement and improve precision.19 The resulting feedback online to understand what drives purchases. reduce unwarranted variations in health- might reinforce the credibility of data and It is also applicable to healthcare24 and care. The status quo is no longer ethical. enable recipients to explore associations can help answer many questions about Contributors and sources: RF, SA, and NMI in the data. Providing larger amounts of how best to organise and deliver feedback are general practitioners and implementation complex data, however, risks cognitive (such as, does feedback on performance researchers with international experience of designing overload and distracting recipients from indicating an organisation’s position and evaluating large scale audit and feedback programmes. MS, JS, JI, and DK work for the Healthcare key messages. The diminishing returns against top performing peers stimulate Quality Improvement Partnership, a charity led by the of continuing efforts to perfect data come more improvement than showing its position Academy of Medical Royal Colleges, the Royal College at the expense of focusing energy on against average performance? What is the of Nursing, and National Voices. MS has experience 19 in local, regional, and national delivery of quality improvement. effect of shorter versus longer feedback improvement programmes, including commissioning The increasing availability of electronic reports? Does adding additional persuasive of national clinical audits. BM is a service user patient record systems and routinely messages have any effect?). Embedding with involvement, activation, and empowerment expertise in quality improvement and health equality collected data on quality of care offer sequential head-to-head trials testing programmes. JS has operational expertise and opportunities for large scale, efficient different feedback methods in an audit leadership in the design of national clinical audit

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programmes in the UK and abroad and is a non- commercially, and license their derivative works on 13 Lloyd R. Quality health care. a guide to developing and executive director at the Mid Essex Hospital Trust. JI different terms, provided the original work is properly using indicators. Jones and Bartlett Publishers, Inc, has leadership and strategic management expertise cited and the use is non-commercial. See: http:// 2017. of healthcare providers and charities in quality creativecommons.org/licenses/by-nc/4.0/. 14 Dixon-Woods M, Martin GP. Does quality improvement improvement, including clinical audit. DK has expertise improve quality?Future Hosp J 2016;3:191-4. in leading clinical, regulatory, executive participation doi:10.7861/futurehosp.3-3-191 in national clinical audit and patient outcome 15 Eccles M, Ford GA, Duggan S, Steen N. Are programmes driving local quality improvement in postal questionnaire surveys of reported activity acute hospitals in the UK. RF and MS drafted the 1 Majeed A, Allwood D, Foley K, Bindman A. valid? An exploration using general practitioner initial manuscript. All authors contributed to and Healthcare outcomes and quality in the NHS: management of hypertension in older people. Br J Gen commented on subsequent drafts and approved the how do we compare and how might the NHS Pract 1999;49:35-8. final manuscript. RF is the guarantor. improve?BMJ 2018;362:k3036. doi:10.1136/bmj. 16 Roos-Blom MJ, Gude WT, de Jonge E, et al. NMI is supported by the Department of Family and k3036 Impact of audit and feedback with action Community Medicine at the University of Toronto and by 2 Levine DM, Linder JA, Landon BE. The quality of implementation toolbox on improving ICU pain a Canada Research Chair in Implementation of Evidence outpatient care delivered to adults in the United States, management: cluster-randomised controlled trial. Based Practice. 2002 to 2013. JAMA Intern Med 2016;176:1778-90. BMJ Qual Saf 2019;28:1007-15. doi:10.1136/ doi:10.1001/jamainternmed.2016.6217 bmjqs-2019-009588 Patient involvement: BM coauthored the manuscript 3 Ivers N, Jamtvedt G, Flottorp S, et al. Audit and 17 Gude WT, Roos-Blom MJ, van der Veer SN, et al. and emphasised the need to focus on tackling feedback: effects on professional practice and Facilitating action planning within audit and feedback unwarranted variations in healthcare delivery and healthcare outcomes. Cochrane Database Syst interventions: a mixed-methods process evaluation of involve a diverse range of patients and members of the Rev 2012;6:CD000259. doi:10.1002/14651858. an action implementation toolbox in intensive care. public in improving national audit programmes. CD000259.pub3 Implement Sci 2019;14:90. doi:10.1186/s13012- 019-0937-8 This article is one of a series commissioned by The BMJ 4 Sentinel Stroke National Audit Programme. Annual 18 Rushforth B, Stokes T, Andrews E, et al. Developing based on ideas generated by a joint editorial group public report April 2013-March 2018. 2019. https:// ‘high impact’ guideline-based quality indicators for UK with members from the Health Foundation and The www.hqip.org.uk/resource/sentinel-stroke-national- primary care: a multi-stage consensus process. BMC BMJ, including a patient/carer. The BMJ retained full audit-programme-annual-report-2019 Fam Pract 2015;16:156. doi:10.1186/s12875-015- editorial control over external peer review, editing, and 5 Royal College of Physicians. National Lung Cancer Audit 0350-6 publication. Open access fees and The BMJ’s quality annual report 2018. 2019. https://www.rcplondon. 19 Dixon-Woods M. How to improve healthcare improvement editor post are funded by the Health ac.uk/projects/outputs/national-lung-cancer-audit- improvement-an essay by Mary Dixon-Woods. Foundation. nlca-annual-report-2018 6 Johnston G, Crombie IK, Davies HTO, Alder EM, Millard BMJ 2019;367:l5514. doi:10.1136/bmj.l5514 Competing interests: We have read and understood A. Reviewing audit: barriers and facilitating factors for 20 Chalmers I, Glasziou P. Avoidable waste in the BMJ policy on declaration of interests and have the effective clinical audit. Qual Health Care 2000;9:23- production and reporting of research evidence. following interests to declare: JI, JS, DK, and MS declare 36. doi:10.1136/qhc.9.1.23 Lancet 2009;374:86-9. doi:10.1016/S0140- that they commission the NCAPOP on behalf of NHS 7 Hallsworth M, Chadborn T, Sallis A, et al. Provision of 6736(09)60329-9 England and Welsh government. The other authors social norm feedback to high prescribers of antibiotics 21 Ivers NM, Grimshaw JM, Jamtvedt G, et al. Growing declare no competing interests. in general practice: a pragmatic national randomised literature, stagnant science? Systematic review, meta-regression and cumulative analysis of audit and Robbie Foy, professor of primary care1 controlled trial. Lancet 2016;387:1743-52. doi:10.1016/S0140-6736(16)00215-4 feedback interventions in health care. J Gen Intern Mirek Skrypak, associate director for quality and Med 2014;29:1534-41. doi:10.1007/s11606-014- 2 8 Brehaut JC, Colquhoun HL, Eva KW, et al. Practice development feedback interventions: 15 suggestions for optimizing 2913-y Sarah Alderson, clinical lecturer in primary care and effectiveness. Ann Intern Med 2016;164:435-41. 22 Grimshaw JM, Ivers N, Linklater S, et al, Audit and Wellcome ISSF fellow3 doi:10.7326/M15-2248 Feedback MetaLab. Reinvigorating stagnant science: implementation laboratories and a meta-laboratory to 3 9 Gude WT, van Engen-Verheul MM, van der Veer SN, Noah Michael Ivers, clinician scientist efficiently advance the science of audit and feedback. 4 de Keizer NF, Peek N. How does audit and feedback Bren McInerney, community volunteer influence intentions of health professionals to improve BMJ Qual Saf 2019;28:416-23. doi:10.1136/ Jill Stoddart, director of operations2 practice? A laboratory experiment and field study in bmjqs-2018-008355 2 cardiac rehabilitation. BMJ Qual Saf 2017;26:279-87. 23 Halpern D, Mason D. Radical incrementalism. Evaluation Jane Ingham, chief executive officer 2015;21:143-9. doi:10.1177/1356389015578895 2 doi:10.1136/bmjqs-2015-004795 Danny Keenan, medical director 10 Wagner DJ, Durbin J, Barnsley J, Ivers NM. 24 Horwitz LI, Kuznetsova M, Jones SA. Creating a learning 1Leeds Institute of Health Sciences, Leeds, UK Measurement without management: qualitative health system through rapid-cycle, randomized testing. 2 evaluation of a voluntary audit & feedback N Engl J Med 2019;381:1175-9. doi:10.1056/ Healthcare Quality Improvement Partnership, London, NEJMsb1900856 UK intervention for primary care teams. BMC Health Serv Res 2019;19:419. doi:10.1186/s12913-019- 25 Ivers NM, Maybee A, Ontario Healthcare 3Women’s College Hospital, Toronto, ON, Canada 4226-7 Implementation Laboratory team. Engaging patients to 4 Gloucerstershire, UK 11 Brown B, Gude WT, Blakeman T, et al. Clinical select measures for a primary care audit and feedback initiative. CMAJ 2018;190(Suppl):S42-3. doi:10.1503/ Correspondence to: M Skrypak Performance Feedback Intervention Theory (CP-FIT): cmaj.180334 [email protected] a new theory for designing, implementing, and evaluating feedback in health care based on a 26 Elouafkaoui P, Young L, Newlands R, et al, Translation systematic review and meta-synthesis of qualitative Research in a Dental Setting (TRiaDS) Research research. Implement Sci 2019;14:40. doi:10.1186/ Methodology Group. An audit and feedback s13012-019-0883-5 intervention for reducing antibiotic prescribing in 12 National Blood Transfusion Committee. Patient blood general dental practice: the RAPiD cluster randomised controlled trial. PLoS Med 2016;13:e1002115. This is an Open Access article distributed in accordance management: An evidence-based approach to patient doi:10.1371/journal.pmed.1002115 with the Creative Commons Attribution Non Commercial care. 2014. https://www.transfusionguidelines.org/uk- (CC BY-NC 4.0) license, which permits others to transfusion-committees/national-blood-transfusion- Cite this as: BMJ 2020;368:m213 distribute, remix, adapt, build upon this work non- committee/patient-blood-management http://dx.doi.org/10.1136/bmj.m213

the bmj | BMJ 2020;368:m213 | doi: 10.1136/bmj.m213 41 ESSAY

How to improve healthcare improvement As improvement practice and research begin to come of age, Mary Dixon-Woods considers the key areas that need attention if we are to reap their benefits

n the NHS, as in health systems QI has been advocated in healthcare for and control organisations.25 26 Specific worldwide, patients are exposed to risks over 30 years13; policies emphasise the need interventions may, similarly, not survive the of avoidable harm 1 and unwarranted for QI and QI practice is mandated for many rigours of systematic testing. An example is variations in quality.2-4 But too often, healthcare professionals (including junior a programme to reduce hospital admissions problems in the quality and safety doctors). Yet the question, “Does quality from nursing homes that showed promise ofI healthcare are merely described, even improvement actually improve quality?” in a small study in the US,27 but a later “admired,”5 rather than fixed; the effort remains surprisingly difficult to answer.14 randomised implementation trial found no invested in collecting information (which is The evidence fo`r the benefits of QI is mixed14 effect on admissions or emergency department essential) is not matched by effort in making and generally of poor quality. It is important attendances.28 improvement. The National Confidential to resolve this unsatisfactory situation. That Some interventions are probably just Enquiry into Patient Outcome and Death, will require doing more to bring together not worth the effort and opportunity cost: for example, has raised many of the same the practice and the study of improvement, having nurses wear “do not disturb” tabards concerns in report after report.6 Catastrophic using research to improve improvement, during drug rounds, is one example.29 And degradations of organisations and units have and thinking beyond effectiveness when some QI efforts, perversely, may cause recurred throughout the history of the NHS, considering the study and practice of harm—as happened when a multicomponent with depressingly similar features each time.7-9 improvement. intervention was found to be associated with More resources are clearly necessary an increase rather than a decrease in surgical to tackle many of these problems. There Uniting practice and study site infections.30 is no dispute about the preconditions for The practice and study of improvement need Producing sound evidence for the high quality, safe care: funding, staff, closer integration. Though QI programmes and effectiveness of improvement interventions training, buildings, equipment, and other interventions may be just as consequential and programmes is likely to require a infrastructure. But quality health services for patient wellbeing as drugs, devices, and multipronged approach. More large scale trials depend not just on structures but on other biomedical interventions, research and other rigorous studies, with embedded processes.10 Optimising the use of available about improvement has often been seen as qualitative inquiry, should be a priority for resources requires continuous improvement unnecessary or discretionary,15 16 particularly research funders. of healthcare processes and systems.5 by some of its more ardent advocates. This is Not every study of improvement needs The NHS has seen many attempts to partly because the challenges faced are urgent, to be a randomised trial. One valuable but stimulate organisations to improve using and the solutions seem obvious, so just getting underused strategy involves wrapping incentive schemes, ranging from pay for on with it seems the right thing to do. evaluation around initiatives that are performance (the Quality and Outcomes But, as in many other areas of human happening anyway, especially when it Framework in primary care, for example) activity, QI is pervaded by optimism bias. It is possible to take advantage of natural to public reporting (such as annual quality is particularly affected by the “lovely baby” experiments or design roll-outs.31 Evaluation accounts). They have had mixed results, and syndrome, which happens when formal of the reorganisation of stroke care in London many have had unintended consequences.11 12 evaluation is eschewed because something and Manchester32 and the study of the Wanting to improve is not the same as looks so good that it is assumed it must work. Matching Michigan programme to reduce knowing how to do it. Five systematic reviews (published 2010-16) central line infections are good examples.33 34 In response, attention has increasingly reporting on evaluations of Lean and Six It would be impossible to externally turned to a set of approaches known Sigma did not identify a single randomised evaluate every QI project. Critically important as quality improvement (QI). Though a controlled trial.17-21 A systematic review of therefore will be increasing the rigour with definition of exactly what counts as a QI redesigning care processes identified no which QI efforts evaluate themselves, as approach has escaped consensus, QI is often randomised trials.22 A systematic review shown by a recent study of an attempt to identified with a set of techniques adapted of the application of plan-do-study-act in improve care of frail older people using a from industrial settings. They include the healthcare identified no randomised trials.23 “hospital at home” approach in southwest US Institute for Healthcare Improvement’s A systematic review of several QI methods England.35 This ingeniously designed study Model for Improvement, which, among other in surgery identified just one randomised found no effect on outcomes and also showed things, combines measurement with tests trial.56 that context matters. of small change (plan-do-study-act cycles).8 The sobering reality is that some well Despite the potential value of high quality Other popular approaches include Lean intentioned, initially plausible improvement evaluation, QI reports are often weak,18 with, and Six Sigma. QI can also involve specific efforts fail when subjected to more for example, interventions so poorly reported interventions intended to improve processes rigorous evaluation.24 For instance, a that reproducibility is frustrated.36 Recent and systems, ranging from checklists and controlled study of a large, well resourced reporting guidelines may help,37 but some “care bundles” of interventions (a set of programme that supported a group of NHS problems are not straightforward to resolve. In evidence based practices intended to be hospitals to implement the IHI’s Model for particular, current structures for governance done consistently) through to medicines Improvement found no differences in the and publishing research are not always well reconciliation and clinical pathways. rate of improvement between participating suited to QI, including situations where

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researchers study programmes they have not unit in Bristol, indicate that although How QI is organised institutionally also themselves initiated. Systematic learning from continuous improvement is key to their demands attention. It is often conducted as QI needs to improve, which may require fresh success, a specific branded improvement a highly local, almost artisan activity, with thinking about how best to align the goals of method is not necessary.45 This and other each organisation painstakingly working practice and study, and to reconcile the needs work shows that not all improvement needs out its own solution for each problem. of different stakeholders.38 to involve a well defined QI intervention, and Much improvement work is conducted by not everything requires a discrete project with professionals in training, often in the form Using research to improve improvement formal plan-do-study-act cycles. of small, time limited projects conducted Research can help to support the practice More broadly, research has shown that QI for accreditation. But working in this of improvement in many ways other than is just one contributor to improving quality isolated way means a lack of critical mass evaluation of its effectiveness. One important and safety. Organisations in many industries to support the right kinds of expertise, such role lies in creating assets that can be used to display similar variations to healthcare as the technical skill in human factors or improve practice, such as ways to visualise organisations, including large and persistent ergonomics necessary to engineer a process or data, analytical methods, and validated differences in performance and productivity devise a safety solution. Having hundreds of measures that assess the aspects of care that between seemingly similar enterprises.46 organisations all trying to do their own thing most matter to patients and staff. This kind of Important work, some of it experimental, also means much waste, and the absence work could, for example, help to reduce the is beginning to show that it is the quality of of harmonisation across basic processes current vast number of quality measures— their management practices that distinguishes introduces inefficiencies and risks.14 there are more than 1200 indicators of them.47 These practices include continuous A better approach to the interorganisational structure and process in perioperative care quality improvement as well as skills nature of health service provision requires alone.39 training, human resources, and operational solving the “problem of many hands.”53 We The study of improvement can also identify management, for example. QI without the need ways to agree which kinds of sector- how improvement practice can get better. For right contextual support is likely to have wide challenges need standardisation and instance, it has become clear that fidelity to the limited impact. interoperability; which solutions can be left basic principles of improvement methods is a to local customisation at implementation; major problem: plan-do-study-act cycles are Beyond effectiveness and which should be developed entirely crucial to many improvement approaches, yet Important as they are, evaluations of the locally.14 Better development of solutions only 20% of the projects that report using the approaches and interventions in individual and interventions is likely to require technique have done so properly.23 Research improvement programmes cannot answer more use of prototyping, modelling and has also identified problems in measurement— every pertinent question about improvement.48 simulation, and testing in different scenarios teams trying to do improvement may struggle Other key questions concern the values and and under different conditions,14 ideally with definitions, data collection, and inter assumptions intrinsic to QI. through coordinated, large scale efforts that pretation40—indicating that this too requires Consider the “product dominant” logic in incorporate high quality evaluation. more investment. many healthcare improvement efforts, which Finally, an approach that goes beyond Improvement research is particularly assumes that one party makes a product and effectiveness can also help in recognising important to help cumulate, synthesise, and conveys it to a consumer.49 Paul Batalden, the essential role of the professions in scale learning so that practice can move one of the early pioneers of QI in healthcare, healthcare improvement. The past half forward without reinventing solutions that proposes that we need instead a “service century has seen a dramatic redefining of the already exist or reintroducing things that dominant” logic, which assumes that health role and status of the healthcare professions do not work. Such theorising can be highly is co-produced with patients.49 in health systems54: unprecedented external practical,41 helping to clarify the mechanisms More broadly, we must interrogate how accountability, oversight, and surveillance through which interventions are likely to problems of quality and safety are identified, are now the norm. But policy makers would work, supporting the optimisation of those defined, and selected for attention by whom, do well to recognise how much more can be interventions, and identifying their most through which power structures, and with achieved through professional coalitions of appropriate targets.42 what consequences. Why, for instance, the willing than through too many imposed, Research can systematise learning from is so much attention given to individual compliance focused diktats. Research is now “positive deviance,” approaches that examine professional behaviour when systems are showing how the professions can be hugely individuals, teams, or organisations that show likely to be a more productive focus?50 Why important institutional forces for good.54 55 exceptionally good performance.43 Positive have quality and safety in mental illness and In particular, the professions have a unique deviance can be used to identify successful learning disability received less attention in and invaluable role in working as advocates designs for clinical processes that other practice, policy, and research51 despite high for improvement, creating alliances with organisations can apply.44 morbidity and mortality and evidence of both patients, providing training and education, Crucially, positive deviance can also help to serious harm and failures of organisational contributing expertise and wisdom, characterise the features of high performing learning? The concern extends to why the coordinating improvement efforts, and giving contexts and ensure that the right lessons are topic of social inequities in healthcare political voice for problems that need to be learnt. For example, a distinguishing feature improvement has remained so muted52 and to solved at system level (such as, for example, of many high performing organisations, the choice of subjects for study. Why is it, for equipment design). including many currently rated as outstanding example, that interventions like education and by the Care Quality Commission, is that they training, which have important roles in quality Conclusion use structured methods of continuous quality and safety and are undertaken at vast scale, Improvement efforts are critical to securing the improvement. But studies of high performing are often treated as undeserving of evaluation future of the NHS. But they need an evidence settings, such as the Southmead maternity or research? base. Without sound evaluation, patients may the bmj | BMJ 2019;366:l5514 | doi: 10.1136/bmj.l5514 43 ESSAY

be deprived of benefit, resources and energy how do we compare and how might the NHS 25 Benning A, Dixon-Woods M, Nwulu U, et al. Multiple may be wasted on ineffective QI interventions improve?BMJ 2018;362:k3036. doi:10.1136/bmj. component patient safety intervention in English k3036 hospitals: controlled evaluation of second phase. or on interventions that distribute risks 5 Sunstein CR. The real world of cost-benefit analysis: BMJ 2011;342:d199. doi:10.1136/bmj.d199 unfairly, and organisations are left unable to thirty-six questions (and almost as many answers). 26 Benning A, Ghaleb M, Suokas A, et al. Large scale make good decisions about trade-offs given Columbia Law Rev 2014;114:167-211. organisational intervention to improve patient safety 6 Healthcare Quality Improvement Partnership. NCEPOD in four UK hospitals: mixed method evaluation. their many competing priorities. The study common themes and recommendations. HQIP, 2018. BMJ 2011;342:d195. doi:10.1136/bmj.d195 of improvement has an important role in 7 Walshe K, Shortell SM. When things go wrong: how 27 Ouslander JG, Lamb G, Tappen R, et al. Interventions developing an evidence-base and in exploring health care organizations deal with major failures. to reduce hospitalizations from nursing homes: Health Aff (Millwood) 2004;23:103-11. doi:10.1377/ evaluation of the INTERACT II collaborative quality questions beyond effectiveness alone, and hlthaff.23.3.103 improvement project. J Am Geriatr Soc 2011;59:745- in particular showing the need to establish 8 Martin GP, Dixon-Woods M. After Mid Staffordshire: 53. doi:10.1111/j.1532-5415.2011.03333.x improvement as a collective endeavour that from acknowledgement, through learning, to 28 Kane RL, Huckfeldt P, Tappen R, et al. Effects of can benefit from professional leadership. improvement. BMJ Qual Saf 2014;23:706-8. an intervention to reduce hospitalizations from doi:10.1136/bmjqs-2014-003359 nursing homes: a randomized implementation Mary Dixon-Woods is the Health Foundation professor 9 Walshe K. Gosport deaths: lethal failures in care will trial of the INTERACT program. JAMA Intern of healthcare improvement studies and director of The happen again. BMJ 2018;362:k2931. doi:10.1136/ Med 2017;177:1257-64. doi:10.1001/ Healthcare Improvement Studies (THIS) Institute at the bmj.k2931 jamainternmed.2017.2657 University of Cambridge, funded by the Health Founda- 10 Donabedian A. The quality of care. How can it be 29 Westbrook JI, Li L, Hooper TD, Raban MZ, Middleton tion. Co-editor-in-chief of BMJ Quality and Safety, she is assessed?JAMA 1988;260:1743-8. doi:10.1001/ S, Lehnbom EC. Effectiveness of a ‘Do not interrupt’ an honorary fellow of the Royal College of General Prac- jama.1988.03410120089033 bundled intervention to reduce interruptions during titioners and the Royal College of Physicians. This article 11 Himmelstein DU, Ariely D, Woolhandler S. Pay-for- medication administration: a cluster randomised is based largely on the Harveian oration she gave at the performance: toxic to quality? Insights from behavioral controlled feasibility study.BMJ Qual Saf 2017;26:734- RCP on 18 October 2019, in the year of the college’s economics. Int J Health Serv 2014;44:203-14. 42. doi:10.1136/bmjqs-2016-006123 500th anniversary. The oration is available here: http:// doi:10.2190/HS.44.2.a 30 Anthony T, Murray BW, Sum-Ping JT, et al. www.clinmed.rcpjournal.org/content/19/1/47 and 12 Woolhandler S, Ariely D, Himmelstein DU. Why pay Evaluating an evidence-based bundle for the video version here: https://www.rcplondon.ac.uk/ for performance may be incompatible with quality preventing surgical site infection: a randomized events/harveian-oration-and-dinner-2018 improvement. BMJ 2012;345:e5015. doi:10.1136/ trial. Arch Surg 2011;146:263-9. doi:10.1001/ bmj.e5015 archsurg.2010.249 This article is one of a series commissioned by The BMJ 13 Berwick DM. Continuous improvement as an ideal 31 Portela MC, Pronovost PJ, Woodcock T, Carter based on ideas generated by a joint editorial group in health care. N Engl J Med 1989;320:53-6. P, Dixon-Woods M. How to study improvement with members from the Health Foundation and The doi:10.1056/NEJM198901053200110 interventions: a brief overview of possible study BMJ, including a patient/carer. The BMJ retained full 14 Dixon-Woods M, Martin GP. Does quality improvement types. BMJ Qual Saf 2015;24:325-36. doi:10.1136/ editorial control over external peer review, editing, and improve quality?Future Hosp J 2016;3:191-4. bmjqs-2014-003620 publication. Open access fees and The BMJ’s quality doi:10.7861/futurehosp.3-3-191 32 Ramsay AIG, Morris S, Hoffman A, et al. Effects improvement editor post are funded by the Health 15 Ioannidis JPA, Prasad V. Evaluating health system of centralizing acute stroke services on stroke Foundation. processes with randomized controlled trials. JAMA care provision in two large metropolitan areas in Intern Med 2013;173:1279-80. doi:10.1001/ England. Stroke 2015;46:2244-51. doi:10.1161/ Competing interests: I have read and understood jamainternmed.2013.1044 STROKEAHA.115.009723 BMJ policy on declaration of interests and a statement 16 Marshall M, Pronovost P, Dixon-Woods M. Promotion of 33 Bion J, Richardson A, Hibbert P, et al, Matching is available here: https://www.bmj.com/about-bmj/ improvement as a science. Lancet 2013;381:419-21. Michigan Collaboration & Writing Committee. advisory-panels/editorial-advisory-board/mary- doi:10.1016/S0140-6736(12)61850-9 ‘Matching Michigan’: a 2-year stepped interventional dixonwoods 17 Glasgow JM, Scott-Caziewell JR, Kaboli PJ. Guiding programme to minimise central venous catheter-blood Provenance and peer review: Commissioned; not inpatient quality improvement: a systematic review stream infections in intensive care units in England. externally peer reviewed. of Lean and Six Sigma. Jt Comm J Qual Patient BMJ Qual Saf 2013;22:110-23. doi:10.1136/ Saf 2010;36:533-40. doi:10.1016/S1553- bmjqs-2012-001325 Mary Dixon-Woods, director 7250(10)36081-8 34 Dixon-Woods M, Leslie M, Tarrant C, Bion J. Explaining THIS Institute, Cambridge, UK 18 Mason SE, Nicolay CR, Darzi A. The use of Lean and Matching Michigan: an ethnographic study of a Correspondence to: [email protected] Six Sigma methodologies in surgery: a systematic patient safety program. Implement Sci 2013;8:70. review. Surgeon 2015;13:91-100. doi:10.1016/j. doi:10.1186/1748-5908-8-70 surge.2014.08.002 35 Pearson M, Hemsley A, Blackwell R, Pegg L, Custerson 19 Deblois S, Lepanto L. Lean and Six Sigma in acute L. Improving Hospital at Home for frail older people: care: a systematic review of reviews. Int J Health insights from a quality improvement project to achieve change across regional health and social care sectors. This is an Open Access article distributed in accordance Care Qual Assur 2016;29:192-208. doi:10.1108/ BMC Health Serv Res 2017;17:387. doi:10.1186/ with the Creative Commons Attribution Non Commercial IJHCQA-05-2014-0058 s12913-017-2334-9 (CC BY-NC 4.0) license, which permits others to 20 Moraros J, Lemstra M, Nwankwo C. Lean interventions 36 Jones EL, Lees N, Martin G, Dixon-Woods M. How well distribute, remix, adapt, build upon this work non- in healthcare: do they actually work? A systematic is quality improvement described in the perioperative commercially, and license their derivative works on literature review. Int J Qual Health Care 2016;28:150- care literature? A systematic review. Jt Comm J Qual different terms, provided the original work is properly 65. doi:10.1093/intqhc/mzv123 Patient Saf 2016;42:196-206. doi:10.1016/S1553- cited and the use is non-commercial. See: http:// 21 Amaratunga T, Dobranowski J. Systematic review 7250(16)42025-8 creativecommons.org/licenses/by-nc/4.0/. of the application of lean and six sigma quality improvement methodologies in radiology. J Am Coll 37 Ogrinc G, Davies L, Goodman D, et al. SQUIRE 2.0 Radiol 2016;13:1088-1095.e7. doi:10.1016/j. (Standards for QUality Improvement Reporting jacr.2016.02.033 Excellence): revised publication guidelines from 22 van Leijen-Zeelenberg JE, Elissen AMJ, Grube K, a detailed consensus process. BMJ Qual Saf 1 Hogan H, Zipfel R, Neuburger J, Hutchings A, Darzi A, et al. The impact of redesigning care processes 2016;25:986-92. doi:10.1136/bmjqs-2015-004411 Black N. Avoidability of hospital deaths and association on quality of care: a systematic review. BMC Health 38 Watson SI, Dixon-Woods M, Taylor CA, et al. Revising with hospital-wide mortality ratios: retrospective Serv Res 2015;16:19. doi:10.1186/s12913-016- ethical guidance for the evaluation of programmes case record review and regression analysis. 1266-0 and interventions not initiated by researchers. J Med BMJ 2015;351:h3239. doi:10.1136/bmj.h3239 23 Taylor MJ, McNicholas C, Nicolay C, Darzi A, Bell Ethics 2019:medethics-2018-105263. doi:10.1136/ 2 Stewart K, Bray B, Buckingham R. Improving quality D, Reed JE. Systematic review of the application of medethics-2018-105263 of care through national clinical audit. Future Hosp the plan-do-study-act method to improve quality 39 Chazapis M, Gilhooly D, Smith AF, et al. Perioperative J 2016;3:203-6. doi:10.7861/futurehosp.3-3-203 in healthcare. BMJ Qual Saf 2014;23:290-8. structure and process quality and safety indicators: 3 Castelli A, Street A, Verzulli R, Ward P. Examining doi:10.1136/bmjqs-2013-001862 a systematic review. Br J Anaesth 2018;120:51-66. variations in hospital productivity in the English NHS. 24 Morgan DJ, Diekema DJ, Sepkowitz K, Perencevich doi:10.1016/j.bja.2017.10.001 Eur J Health Econ 2015;16:243-54. doi:10.1007/ EN. Adverse outcomes associated with Contact 40 Woodcock T, Liberati EG, Dixon-Woods M. A mixed- s10198-014-0569-5 Precautions: a review of the literature. Am J methods study of challenges experienced by clinical teams 4 Majeed A, Allwood D, Foley K, Bindman A. Infect Control 2009;37:85-93. doi:10.1016/j. in measuring improvement. BMJ Qual Saf 2019 [Epub Healthcare outcomes and quality in the NHS: ajic.2008.04.257 ahead of print]. doi:10.1136/bmjqs-2018-009048

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41 Davidoff F, Dixon-Woods M, Leviton L, Michie S. 46 Syverson C. What determines productivity?J Econ 52 Boozary AS, Shojania KG. Pathology of poverty: the Demystifying theory and its use in improvement. Lit 2011;49:326-65. doi:10.1257/jel.49.2.326 need for quality improvement efforts to address social BMJ Qual Saf 2015;24:228-38. doi:10.1136/ 47 Bloom N, Eifert B, Mahajan A, et al. Does management determinants of health. BMJ Qual Saf 2018;27:421-4. bmjqs-2014-003627 matter? Evidence from India. Q J Econ 2013;128:1-51. doi:10.1136/bmjqs-2017-007552 42 Michie S, Johnston M, Abraham C, Lawton R, Parker doi:10.1093/qje/qjs044 53 Dixon-Woods M, Pronovost PJ. Patient safety and the D, Walker A“Psychological Theory” Group. Making 48 Cribb A. Improvement science meets improvement problem of many hands. BMJ Qual Saf 2016;25:485- psychological theory useful for implementing scholarship: reframing research for better healthcare. 8. doi:10.1136/bmjqs-2016-005232 evidence based practice: a consensus approach. Health Care Anal 2018;26:109-23. doi:10.1007/ 54 Martin GP, Armstrong N, Aveling EL, Herbert G, Qual Saf Health Care 2005;14:26-33. doi:10.1136/ s10728-017-0354-6 Dixon-Woods M. Professionalism redundant, qshc.2004.011155 49 Batalden P. Getting more health from healthcare: reshaped, or reinvigorated? realizing the 43 Lawton R, Taylor N, Clay-Williams R, Braithwaite J. quality improvement must acknowledge patient “third logic” in contemporary health care. Positive deviance: a different approach to achieving coproduction. BMJ 2018;362:k3617. doi:10.1136/ J Health Soc Behav 2015;56:378-97. patient safety. BMJ Qual Saf 2014;23:880-3. bmj.k3617 doi:10.1177/0022146515596353 doi:10.1136/bmjqs-2014-003115 50 Aveling EL, Parker M, Dixon-Woods M. What is 55 Freidson E. Professionalism, the third logic: on the practice 44 Bradley EH, Curry LA, Spatz ES, et al. Hospital strategies the role of individual accountability in patient of knowledge. University of Chicago Press, 2001. for reducing risk-standardized mortality rates in acute safety? A multi-site ethnographic study. Sociol 56 Nicolay CR, Purkayastha S, Greenhalgh A, et myocardial infarction. Ann Intern Med 2012;156:618- Health Illn 2016;38:216-32. doi:10.1111/1467- al. Systematic review of the application of 26. doi:10.7326/0003-4819-156-9-201205010- 9566.12370 quality improvement methodologies from the 00003 51 D’Lima D, Archer S, Thibaut BI, Ramtale SC, Dewa manufacturing industry to surgical healthcare. Br J 45 Liberati EG, Tarrant C, Willars J, et al. How to be a LH, Darzi A. A systematic review of patient safety Surg 2012;99:324-35. doi:10.1002/bjs.7803 very safe maternity unIT: An ethnographic study. in mental health: a protocol based on the inpatient Soc Sci Med 2019;223:64-72. doi:10.1016/j. setting. Syst Rev 2016;5:203. doi:10.1186/s13643- Cite this as: BMJ 2019;366:l5514 socscimed.2019.01.035 016-0365-7 http://dx.doi.org/10.1136/bmj.l5514

the bmj | BMJ 2019;366:l5514 | doi: 10.1136/bmj.l5514 45 ESSAY

Getting more health from healthcare: quality improvement must acknowledge patient coproduction Modelling healthcare as either a product or a service neglects essential aspects of coproduction between doctors and patients. Paul Batalden shares his learning from 10 years of studying change

ll clinicians experience from electronics to cars. This had led us Over time, as we saw thousands of teams moments when the healthcare to assume that “making a product” and improving system performance, we noticed system in which they work “making a service” were similar—they were how often ways of product dominant makes it difficult for them both systems for “making”—and that we thinking framed how healthcare was to deliver good care for their could think in either way as we developed perceived. Professionals were increasingly Apatients.1 Healthcare increasingly seems to and tested changes to improve healthcare. seen as “making” healthcare actions using include frustrating processes and unman- Product dominant thinking sometimes resources of time and materials, such as ageable administrative burdens that reduce fits well with healthcare: consider an older requesting investigations or generating the time available for patient care, with neg- patient with pain and limited mobility prescriptions. Productivity was measured ative effects on health outcomes. because of hip osteoarthritis who receives as the number of actions produced in each Clinicians are also increasingly called the product of a new hip. Through this unit of time—such as the number of patients on to improve the quality of the systems of improvement approach we could understand seen a day in an outpatient clinic—and the care that they deliver. Many participate in the elective surgery process, improving how amounts of other resources consumed. improvement efforts, from experiencing quickly patients progressed and achieved a Furthermore, what had been introduced as large scale, top-down organisational change pain-free outcome. “improvements”—such as shorter waits and to making small changes that improve the Sometimes, however, the fit was awkward delays, better documentation, altered work ways their team works and cares for patients. and it was necessary to include a service processes, and measured outputs—were Some will have taken courses on audit, the model as well as a product model—for instead increasingly seen as inimical to the Model for Improvement,2 Lean,3 and more. example, a patient supplied a need (a painful joy and mastery of real professional work. For many clinicians, however, the hip); service processes transformed the need Professionals and patients were increasingly underlying question, “What is quality into an output (analgesia); and patients frustrated. improvement, and how can it transform received a benefit that could be measured healthcare?” remains unanswered.4 Full as outcomes (reduced pain and increased Making services differs from making products appreciation of what it means to get more mobility). In his groundbreaking book, The Service health from healthcare demands as full an Using this language, we could consider the Economy, the health economist Victor understanding as possible of the systems clinician-patient relationship as a “supplier Fuchs noted that making a service in retail to be improved. Fortunately, the past and customer partnership.” Yet this also or banking was different from making a decade has afforded many opportunities didn’t seem quite right: patients are both product. Unlike for a product, two parties to fundamentally challenge thinking about suppliers and customers. Patients with heart are always involved in making a service.7 how healthcare actually works and how it disease, for example, consume healthcare The economists Elinor and Vincent Ostrom contributes to health. in the form of drugs and check-ups but they later suggested that public services were also are potential suppliers of activities that “coproduced.”8 More recently, management Healthcare as a product: an oversimplified improve their health, such as exercise and researchers have observed that people mak- model eating a healthy diet. ing public services (social work, healthcare, In 2007, a colleague and I described a Thinking about “supplier-customer education, police services, and others) have frame for thinking and working to improve partnerships” taught us new aspects of often been encouraged to adopt a “product and transform healthcare.5 This involved the transactions involved in professional dominant” logic.9 a substantial shift in the way we thought activities, such as the exchange of a symptom In product making, one party makes about healthcare; the shift became widely (less mobility and pain) for a treatment and and then conveys that product to a second used as one definition of quality improve- an outcome (more mobility and less pain). party, the consumer. For example, a car ment. Through asking the question, “How It’s important to remember, however, that manufacturer makes a vehicle and sells it to a might system-wide improvement strategies this focus on transactions also potentially customer. If we adopt that “product” logic for and efforts usefully improve healthcare?” diminished the nature of the human making a healthcare service, the professional we began to think in terms of systems and relationships between a patient and a health “makes” the service and then sells it to a processes, considering how to integrate professional, and their contribution to health. consumer-patient. But by confusing the logic improvement efforts with daily clinical These ways of thinking failed to encompass of product making with service making we operations and professional development. the “swampy lowlands” of healthcare, risk distorting our understanding of some of Our models were taken from such as physical pain as an expression of the elements of health services that actually manufacturing, with products ranging loneliness or psychological anguish.6 contribute to health. If we look at quality

46 doi: 10.1136/bmj.k1877 | BMJ 2018;361:k1877 | the bmj ESSAY improvement solely through a product limiting the burdens of illness and treatment a “professional,” learning for patients or dominant lens we will focus on processes, and optimising health. users is important as well. actions, and outputs, which risks neglecting • Patient participation—Coproduced relationships, outcomes that are less easy to How has our understanding changed the way we healthcare services always include measure, and, most importantly, individual think about healthcare systems? patient participation in some way. patient preferences. Rethinking healthcare Eleven years after our first publication, it is Active participation makes it possible to as a coproduced service adds depth to our clear that generating sustainable improve- understand the assets and social support understanding of how we might better ment in a coproduced system entails several that patients contribute to the service and design and make services, improve them, elements absent from our initial taxonomy: their health. Patient participation is built and ultimately increase their contribution • Health—The aim of these elements and on trust and relationships. to better health. their interaction is the improvement of • Professional development—Health To help us shift to a “service dominant” health. Our earlier emphasis on better professionals capable of service mindset we created a model of healthcare outcomes becomes more specific: coproduction understand and use several service coproduction10 based on the work better health. Health “belongs” to the analytical frames: science informed of Wagner11 and Coulter.12 Coproduction individual whose health it is. It is their practice, the experiences of individuals, of health describes the interdependent responsibility and difficult to “outsource,” and knowledge that integrates good work of users and professionals who are even to a professional. In the context of design principles and daily practice. These creating, designing, producing, delivering, daily healthcare services, health usually professionals also bring their knowledge, assessing, and evaluating the relationships includes minimising the burdens of illness skill, and habits to the interdependent and actions that contribute to the health and treatment. work of service coproduction. Their of individuals and populations. At its • Network or system—The operating way of work can contribute to a sense core are the interactions of patients and organising structure is more than a of trustworthiness. Coproducing professionals in different roles and degrees building, and its performance must be professionals further recognise that of shared work. characterised by quality, safety, and when they work as whole people they On an individual level, according to good benefit for money spent to deliver may become vulnerable as they work to this model, a healthcare service is usually value. Earlier we separated better system create a trusting, effective, interpersonal composed of a relationship and an action. performance from learning. Today we relationship. Joy and reflection on their When a trusted health professional explores acknowledge the benefit of integrating own lives helps sustain these professions a patient’s need, a relationship is formed. system performance with learning into a in the never ending confrontation with This relationship is key to agreement and network that reflects active learning and some of life’s boundaries. to shared actions that might follow, such as never ending change for improvement. • Assessment and measurement— procedures or drugs. Patient and professional It includes the development and use Measuring the process and results of a are held together by knowledge, skill, habit, of knowledge to offer standardised coproduced service invites attention to and a willingness to be vulnerable. responses to common needs, customised how the patient’s goals were elicited, Trustworthiness, respect, and trust make responses to particular needs, and flexible how they were addressed, and whether this relationship possible. Both parties responses to emergent needs. Although they were attained. It also must assess bring their knowledge, skill, and habits to some commentators have described the effectiveness of the professionals’ the service making task. A willingness to be continuous learning as the hallmark of interventions and practice. Good vulnerable arises from being fully present and able to fully engage another person. This idealised model does not always exist Example characteristics of knowledge elements in practice, but conceptualising it helps us to • Patient aim—Reason for seeking help, grounded in the reality of the patient’s life. The focus on those elements of the relationship circumstances surrounding that aim matter: a “well” patient may have different requirements for that typically require improvement; they a coproduced service than a “sick” one grant professionals important permission • Generalisable, science informed practice—Observations and evidence from others and other 13 to be vulnerable and to value more fully contexts. This usually reflects empirical study of specific individuals in defined settings. Benefit the knowledge and skills patients bring to for a particular person may be difficult to predict given the ways in which the generalisable making health services. information was constructed In some interactions, the focus may be • Particular context—The dynamic interactions among people and groups reflect the enormous 14 more on the action than the relationship, complexity of human environments. These physical, social, and cultural realities are expressed such as properly immobilising a fractured in the processes, systems, and dispositions of the local setting. This knowledge is constructed limb. Even within these apparently product from the current state, its processes and systems, the “coproduction” of knowledge, skills, dominant interactions, however, practising dispositions of the parties involved, the relationships of the parties, and their assets and social within a contextualising “service making” supports frame allows professionals to pay attention • Measurable improvement—Assessment of the degree to which the patient’s aim was understood to the patient’s lived reality, assets, social and achieved as well as the effect of the scientifically informed intervention. It usually includes a support, and aims. These might include balanced set of measures to reflect performance over time a patient’s caring responsibilities for an • Connecting patient aim and science informed practice in design of intervention—Working from elderly parent, or the role of their stress the patient’s aim, scientifically informed interventions are sought, explored, and matched relieving weekend basketball game. • Contextualising the planned change—Matching the possible interventions with the enabling and Attending to such experiences is not simply limiting features of the local setting as it changes a matter of courtesy but recognising what • Testing the change—Mobilisation of the strategic, operational, and human resource realities that is necessary to do the real, shared work of contribute to making changes happen the bmj | BMJ 2018;361:k1877 | doi: 10.1136/bmj.k1877 47 ESSAY

Dartmouth Institute for Health Policy and Clinical measurement becomes a means to Biography create new knowledge about service Practice, Geisel Medical School, Dartmouth College, Lebanon, New Hampshire 03756, USA development. Paul Batalden is a senior fellow of the Institute for Healthcare Improvement and an Correspondence to: [email protected] What knowledge do we need to improve active faculty member at Dartmouth and the healthcare systems? Jönköping University. He previously developed Previously we recognised the multiple the Institute for Healthcare Improvement, knowledge systems involved in designing the US Veteran Administration National This is an Open Access article distributed in accordance Quality Scholars programme, the General with the terms of the Creative Commons Attribution (CC and testing a change for improvement: BY 4.0) license, which permits others to distribute, remix, Competencies of the Accreditation Council adapt and build upon this work, for commercial use, Generalisable scientific knowledge + for Graduate Medical Education (ACGME), the provided the original work is properly cited. See: http:// Particular context → Measurable perfor- Dartmouth leadership preventive medicine creativecommons.org/licenses/by/4.0/. mance improvement residency, the annual health professional Today, in addition, we make explicit the educator’s summer symposium, the SQUIRE contributions of patients and professionals, publication guidelines, the improvement science fellowship programme of the who each bring different expertise, 1 Allwood D, Fisher R, Warburton W, Dixon J. Creating knowledge, and experience to their shared UK Health Foundation, and the Vinnvård space for quality improvement. BMJ 2018;361:k1924. Improvement Science fellowships in Sweden. doi:10.1136/bmj.k1924 interactions in the coproduction of a service: 2 Langley GJ, Moen RD, Nolan KM, et al. The improvement guide. 2nd ed. Jossey-Bass, 2009. (Patient aim + Generalisable, science produce health means undertaking 3 Bicheno J, Holweg M. The Lean toolbox. 5th ed. PICSIE informed practice) × Particular context professional development that goes Books, 2016. → Measurable improvement beyond generalisable, science informed 4 Batalden PB, Davidoff F. What is “quality improvement” and how can it transform healthcare?Qual Saf Health practice or improvement tools. Clinicians This modified improvement formula Care 2007;16:2-3. doi:10.1136/qshc.2006.022046 need to learn in ways that encompass all seeks to describe the coproduced world of 5 Batalden PB, Davidoff F. What is “quality improvement” of the forms of knowledge described here, and how can it transform healthcare?Qual Saf Health healthcare service. Each element is driven including eliciting a patient’s immediate Care 2007;16:2-3. doi:10.1136/qshc.2006.022046 by a different knowledge system (box). 6 Schön DA. The reflective practitioner. Basic Books, and long term aims. On an individual level, 1983. What do we need to do next? this can be described as shared decision 7 Fuchs V. The service economy. National Bureau of The different knowledge systems invited making. On a system level, this way of Economic Research, 1968. by these perspectives require scientific and 8 Ostrom V, Ostrom E. Public goods and public choices. thinking and practising may enable us to In: Savas ES, ed. Alternatives for delivering public experiential learning. We have learnt a great transform healthcare to improve health for services: toward improved performance. Westview deal in a decade of studying the improve- our patients and populations. Press, 1977: 7-44. ment process and building the science of 9 Osborne SP, Radnor Z, Nasi G. A new theory for public I thank my colleagues Frank Davidoff, David Leach, service management? Toward a (public) service- improvement. Now, explicitly extending this Gene Nelson, Cat Chatfield, and my family for the many dominant approach. Am Rev Public Adm 2012;43:135- scholarly approach to understand health- opportunities I have had to reflect on and discuss the 58. doi:10.1177/0275074012466935 care service coproduction and its limits is development of these ideas. 10 Batalden M, Batalden P, Margolis P, et al. Coproduction likely to help us to maximise the health we Competing interests: I have read and understood BMJ of healthcare service. BMJ Qual Saf 2016;25:509-17. doi:10.1136/bmjqs-2015-004315 get from healthcare still further. policy on declaration of interests and have no relevant interests to declare. 11 Wagner EH. Chronic disease management: what will Readers should note the service dominant it take to improve care for chronic illness?Eff Clin or product dominant thinking in their Provenance and peer review: Commissioned; not Pract 1998;1:2-4. externally peer reviewed. 12 Coulter A, Roberts S, Dixon A. Delivering better services organisation, assessment, improvement of for people with long-term conditions: building the services and in professional education. Acts This article is one of a series commissioned by The house of care. King’s Fund, 2013. BMJ based on ideas generated by a joint editorial group 13 Greenhalgh T. How to implement evidence-based of noticing can be important reminders to with members from the Health Foundation and The consider all knowledge elements, including healthcare. Wiley Blackwell, 2018. BMJ, including a patient/carer. The BMJ retained full 14 Braithwaite J, Churruca K, Ellis LA, et al. Complexity the important domain of patient aim. editorial control over external peer review, editing, and science in healthcare: aspirations, approaches, publication. Open access fees and The BMJ’s quality Whether clinicians are working in a applications and accomplishments . Australian Institute improvement editor post are funded by the Health of Health Innovation, 2017. coproduced healthcare service or designing Foundation. and improving health services, thinking Paul Batalden, professor emeritus, paediatrics, Cite this as: BMJ 2018;362:k3617 in this new way about the elements that community, and family medicine http://dx.doi.org/10.1136/bmj.l189

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Why healthcare leadership should embrace quality improvement Making quality improvement a core tenet of how healthcare organisations are run is essential to ensuring safe, high quality, and responsive services for patients, write John R Drew and Meghana Pandit

ealthcare staff often have a contributors to this gap: a lack of “headspace” take culture and people management more positive experience of quality and feeling like a cog in a machine.4 seriously and put it on a level footing with improvement (QI) compared Rising demand for healthcare and an financial and operational performance, with the daily experience of estimated 8% vacancy rate5 in the clinical we’d see a huge improvement in culture and how their organisations are workforce make it difficult to find time for QI. outcomes for patients as well.”9 1 Hled and managed. This indicates that some of Some leaders have committed to protecting The profound shifts in leadership and the conditions and assumptions required for time for QI because it generates a return management needed for QI to thrive QI are at odds with prevailing management in improved quality and productivity.6 But sometimes run contrary to traditional practices. For QI to become pervasive in this is still rare. Without long term strategic approaches for optimising short term healthcare, we need to change leadership and commitment, expecting people to find time performance. The recent average tenure of an management. for their second job is unrealistic. There NHS chief executive is 2-3 years, undermining At a QI event, we listened to an experienced is growing recognition that this needs to the sustainable culture change needed for QI.10 nurse explaining a QI project to improve change.7 8 Burgess and colleagues describe a different patient flow. The most striking thing was not Increased demand has been compounded type of governance that fosters learning, citing her description of the project or what she by a rise in transparency and regulation, the partnership of NHS Improvement and five had learnt or the benefits for patients, but especially in publicly funded health systems, trusts with the Virginia Mason Institute in instead how it had made her feel “valued and placing managers and leaders under the United States.11 Creating a compact with respected.” greater pressure. Regulators often require regulators enables a change in attitudes and A manager’s job is to achieve organisational improvement plans to be developed quickly, allows organisations to grow and learn, they goals. In the NHS, this includes meeting making meaningful staff engagement say. This promotes board longevity, which is emergency and elective targets, such as difficult. Recent changes in contracts, such a requirement for continuous improvement.6 the referral to treatment target, cancer and as job planning, and pension tax rules in the diagnostic standards, and the emergency UK have led many doctors to think that their When do QI and good management coalesce? department standard. Clinicians often perceive employment has become more transactional. The most senior leaders might have the managerial interactions as authoritarian This, combined with top-down target greatest challenge; their roles would shift and lacking patient centredness and see QI setting and a narrative of “grip and control,” from being responsible for all performance to 2 as inclusive, bottom-up engagement. Staff might explain why staff increasingly feel a devolved model of collective, inclusive, and appreciate non-hierarchical approaches. insignificant. compassionate leadership. Embedding QI can QI can be defined as “a systematic challenge senior leaders’ fundamental beliefs approach that uses specific techniques to QI as the basis of management and management practices. Safe healthcare 2 improve quality.” It requires infrastructure— QI depends on engaging and empowering the depends on defining and following standards, systematic and disciplined ways to eliminate teams delivering care and equipping them but an emphasis on engaging frontline staff to waste from processes, improve outcomes with the tools and skills they need to improve develop, apply, and improve those standards and experiences for patients, and eradicate care pathways. Ultimately, it means trusting is often lacking. Instead, standards are mistakes. It requires organisational patience professionals’ knowledge and judgment of implemented rapidly in a top-down, non- and a culture that empowers staff to achieve what patients need and allowing them to negotiable fashion.12 positive change. Organisations that foster make decisions, including the allocation of The language of QI often reflects nature, continuous improvement might say that resources, with appropriate accountability. describing organisations as ecosystems to all staff have two jobs: first, to do their job; This requires a shift in managerial and cultivate or living systems to keep healthy second, to improve it. leadership thinking (box 1). rather than machines to optimise. Human The nurse we spoke to said that the main QI needs to become the basis of how factors (such as relationships, trust, and difference when working on the QI project organisations are led and managed, replacing healthy multidisciplinary teams), talent was having the time and the “permission” to traditional, hierarchical structures and management, succession planning, and make improvements in her own work. Staff incentives. Regulators already recognise assurance are central to this way of working. engagement scores indicate that many NHS this; the Care Quality Commission’s report on Senior leaders must be role models. clinicians increasingly feel trapped in a flawed quality improvement in hospital trusts, for Their behaviour is amplified throughout system with little prospect of changing it.3 example, says that when leaders and frontline the organisations they lead, whether they Understanding why there is a gap between staff work together it creates a powerful sense recognise it or not. Staff will judge what is the predominant management practices and of shared purpose.6 This is often present in the important by where and how leaders spend culture of the NHS and the “microclimate” NHS trusts that it rates “outstanding,” it says. their time rather than by what they say. associated with local QI activities, and how to Dido Harding, chair of NHS Improvement, has The Virginia Mason Institute partnership close that gap, is vital. Staff often report two said, “If all of the boards in the NHS chose to was enabled in 2015 by the secretary of state the bmj | BMJ 2020;368:m872 | doi: 10.1136/bmj.m872 49 ESSAY

Box 1: Cycles of continuous improvement Learning good management in healthcare All QI activities need to start small and then scale up. The transition to full implementation requires includes not only learning to see opportunities constant plan-do-study-act cycles with user involvement and feedback. One QI activity that changed to improve healthcare processes but also organisational culture received the HSJ National Patient Safety Team Award in 2018. noticing the experience of frontline staff, and The process began with the team members asking themselves, if they were a patient, what would consequently leading in ways that engage they like to happen after a clinical harm incident in a hospital. The team then defined the current and empower them to “mobilise every ounce state and future vision. Eight frontline staff participated in a five day workshop to define the key of intelligence.” steps that would help achieve the desired outputs. They tested the approach over the next few This article is one of a series commissioned by The BMJ weeks and agreed metrics that were reported to executives at 30, 60, and 90 days. The workshop based on ideas generated by a joint editorial group included patient representatives. Several changes resulted in increased incident reporting and user with members from the Health Foundation and The feedback, introduction of safety huddles, and the creation of an innovative patient safety response BMJ, including a patient/carer. The BMJ retained full editorial control over external peer review, editing, and team. publication. Open access fees and The BMJ’s quality Making such changes stick requires constant and consistent messaging and leading by example. improvement editor post are funded by the Health Appreciating the efforts of frontline workers, and saying “thank you,” is vital. Foundation. Competing interests: We have read and understood for health and social care to adopt “lean One could argue that QI requires more BMJ policy on declaration of interests and declare the following interests: none. thinking” (a method developed by Toyota people to behave like leaders and fewer to John R Drew, improvement and culture consultant to deliver more benefits to society while behave like managers. In the most radical Meghana Pandit, chief medical officer eliminating waste) in the NHS. The trusts’ forms of QI (such as those described in 14 Oxford University NHS Foundation Trust, John Radcliffe progress is being evaluated, but some trusts Reinventing Organisations ), many of the Hospital, Headley Way, Oxford OX3 9DU, UK already report having developed a “golden roles and responsibilities of management Correspondence to: J R Drew thread” of QI that is visible to all, leading become shared among well functioning, [email protected] to improvements in CQC ratings and staff trusted frontline teams. The sense of “them engagement. and us” between frontline workforce and Translating QI endeavours into management vanishes. operational and financial success takes The chairman of the Japanese electronics This is an Open Access article distributed in accordance time, and caregivers, providers, and company Matsushita famously issued a with the Creative Commons Attribution Non Commercial regulators need to hold their nerve to see challenge: “The essence of management is (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non- lasting performance improvement. Other getting ideas out of the heads of the bosses and commercially, and license their derivative works on healthcare providers have embraced QI into the heads of labour . . . Business, we know, different terms, provided the original work is properly methods without formal partnerships is now so complex and difficult, the survival cited and the use is non-commercial. See: http:// creativecommons.org/licenses/by-nc/4.0/. with international organisations and have of firms so hazardous in an environment delivered strong long term results. A key increasingly unpredictable, competitive, and feature in most of these cases has been fraught with danger, that their continued coaching for the most senior leaders and existence depends on the day-to-day 1 King’s Fund. Making the case for quality improvement: 15 managers (for example, with a “lean” mobilisation of every ounce of intelligence.” lessons for NHS boards and leaders. 11 Oct 2017. coach, usually people with experience https://www.kingsfund.org.uk/publications/making- How can we help leaders get on this path? case-quality-improvement from other industries who have moved 2 The Health Foundation. Quality improvement made into healthcare or consultants) so that they Embedding QI in any organisation requires simple: what everyone should know about health care understand the changes they need to make a new narrative from regulators and boards, quality improvement. https://www.health.org.uk/sites/ in their own behaviours and practices. This strategic intent, investment in training default/files/QualityImprovementMadeSimple.pdf 13 3 NHS Improvement. Developing people, improving care. has been described in the motor industry. leaders and staff, a more distributed https://improvement.nhs.uk/resources/developing- leadership model that empowers frontline people-improving-care/ So is QI just good management? teams, and a meaningful role for patients so 4 Batalden PB, Davidoff F. What is “quality improvement” and how can it transform healthcare? Management, leadership, and QI are distinct that improvement activity is aligned to what Qual Saf Health Care 2007;16:2-3. doi:10.1136/ 6 16 but overlapping. Some leaders are not they most need and value. qshc.2006.022046 managers, and vice versa. Some, but not all, It also requires courage and patience from 5 Rolewicz L, Palmer B. The NHS workforce in numbers. leaders and managers will undertake QI, the most senior leaders as they commit to Nuffield Trust. 8 May 2019. https://www.nuffieldtrust. org.uk/resource/the-nhs-workforce-in-numbers which can be performed in isolation from new management practices. Their incentives 6 Care Quality Commission. Quality improvement in leadership and management. But integrating must depend not only on delivery of top- hospital trusts: sharing learning from trusts on a all three is likely to optimise outcomes. down targets but also on building a culture journey of QI. Sep 2018. https://www.cqc.org.uk/ publications/evaluation/quality-improvement-hospital- Broadly, management is controlling a group conducive to long term quality improvement, trusts-sharing-learning-trusts-journey-qi or team to accomplish a goal. Leadership which could be personally uncomfortable for 7 NHS Improvement. NHS interim people plan. Jun 2019. is influencing others to contribute towards them.17 https://www.longtermplan.nhs.uk/publication/interim- success. Management requires “grip” Quality management systems have an nhs-people-plan/ 18 8 West M. If it’s about NHS culture, it’s about leadership. (staying on top of details, intervening important role. Taichi Ohno, architect of King’s Fund Blog. 20 Jan 2016. https://improvement. quickly, and giving orders or instructions the Toyota Production System (popularised nhs.uk/resources/culture-leadership/ if performance is below expectations), and as “lean”), would instruct managers to spend 9 Lintern S. Boards should take culture as seriously as finance. Health Service Journal 3 Jun 2019. QI often requires a deliberate loosening of hours “watching” from within a chalk circle on https://www.hsj.co.uk/workforce/exclusive-dido- that grip. This could create conflict unless the factory floor. He wanted managers to learn harding-boards-should-take-culture-as-seriously-as- management has QI as a fundamental to see waste and opportunities to improve finance/7025202.article 10 Timmins N. The chief executive’s tale, views from the principle. quality and flow. frontline of the NHS. King’s Fund. May 2016. https://

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www.kingsfund.org.uk/sites/default/files/field/ 13 Spear S. Learning to lead at Toyota. Harvard Business 17 Lees P. The kicking has to stop. Faculty of Medical field_publication_file/The-chief-executive-tale-Kings- Review. May 2004. https://hbr.org/2004/05/learning- Leadership and Management. 25 Oct 2015. https:// Fund-May-2016.pdf to-lead-at-toyota www.fmlm.ac.uk/news-opinion/the-kicking-has-to-stop 11 Burgess N, Currie G, Crump B, Richmond J, Johnson M. 14 Laloux F. Reinventing organisations. Nelson Parker, 18 Kaplan HC, Brady PW, Dritz MC, et al. The influence Improving together: collaboration needs to start with 2014. of context on quality improvement success in regulators. BMJ 2019;367:l6392. doi:10.1136/bmj. 15 Pascale R. Managing on the edge: how health care: a systematic review of the literature. l6392 successful companies use conflict for competitive Milbank Q 2010;88:500-59. doi:10.1111/j.1468- 12 Anandaciva S, Ward D, Randhawa M, Edge R. advantage. Simon and Schuster, 1990. 0009.2010.00611.x Leadership in today’s NHS: delivering the impossible. 16 Drew J, McCallum B, Roggenhofer S. 18 Jul 2018. https://www.kingsfund.org.uk/ Journey to lean. Palgrave Macmillan, 2004. Cite this as: BMJ 2020;368:m872 publications/leadership-todays-nhs doi:10.1057/9781403948410. http://dx.doi.org/10.1136/bmj.m872

the bmj | BMJ 2020;368:m872 | doi: 10.1136/bmj.m872 51 EDUCATION

How to get started in quality improvement Bryan Jones,1 Emma Vaux,2 Ann Olsson-Brown3

1The Health Foundation, London, UK This article describes the skills, knowledge, and support needed to 2Royal Berkshire NHS Foundation Trust. Reading, UK get started in quality improvement and deliver effective interventions. 3Department of Molecular and Clinical Pharmacology, The Institute of Translational Medicine, University of Liverpool, Liverpool, UK What skills do you need? Correspondence to: B Jones Enthusiasm, optimism, curiosity, and perseverance are critical in [email protected] getting started and then in helping you to deal with the challenges you will inevitably face on your improvement journey. Quality improvement (box 1) is a core component of many under- Relational skills are also vital. At its best quality improvement graduate and postgraduate curriculums.1-5 Numerous healthcare is a team activity. The ability to collaborate with different people, organisations,6 professional regulators,7 and policy makers8 recog- including patients, is vital for a project to be successful.17 18 You need nise the benefits of training clinicians in quality improvement. to be willing to reach out to groups of people that you may not have Engaging in quality improvement enables clinicians to acquire, worked with before, and to value their ideas.19 No one person has assimilate, and apply important professional capabilities7 the skills or knowledge to come up with the solution to a problem such as managing complexity and training in human factors.1 on their own. For clinical trainees, it is a chance to improve care9; develop Learning how systems work and how to manage complexity is leadership, presentation, and time management skills to another core skill.20 An ability to translate quality improvement help their career development10; and build relationships with approaches and methods into practice (box 2), coupled with good colleagues in organisations that they have recently joined.11 project and time management skills, will help you design and For more experienced clinicians, it is an opportunity to address implement a robust project plan.27 longstanding concerns about the way in which care processes Equally important is an understanding of the measurement for and systems are delivered, and to strengthen their leadership for improvement model, which involves the gradual refinement of improvement skills.12 your intervention based on repeated tests of change. The aim is The benefits to patients, clinicians, and healthcare providers of to discover how to make your intervention work in your setting, engaging in quality improvement are considerable, but there are rather than to prove it works, so useful data, not perfect data, many challenges involved in designing, delivering, and sustaining an are needed.28 29 Some experience of data collection and analysis improvement intervention. These range from persuading colleagues methods (including statistical analysis tools such as run charts and that there is a problem that needs to be tackled, through to keeping statistical process control) is useful, but these will develop with them engaged once the intervention is up and running as other increasing experience.30 31 clinical priorities compete for their attention.13 You are also likely Most importantly, you need to enjoy the experience. It is rare to have competing priorities and will need support to make time that a clinician can institute real, tangible change, but with quality for quality improvement. The organisational culture, such as the improvement this is a real possibility, which is both empowering and extent to which clinicians are able to question existing practice and satisfying. Finally, don’t worry about what you don’t know. You will try new ideas,14-16 also has an important bearing on the success of learn by doing. Many skills needed to implement successful quality the intervention. improvement will be developed as you go; this is a fundamental feature of quality improvement. Box 1: Defining quality improvement1 • Quality improvement aims to make a difference to patients by How do you get started? improving safety, effectiveness, and experience of care by: The first step is to recruit your improvement team. Start with col- 32 • Using understanding of our complex healthcare environment leagues and patients, but also try to bring in people from other • Applying a systematic approach professions, including non-clinical staff. You need a blend of skills • Designing, testing, and implementing changes using real time and perspectives in your team. Find a colleague experienced in qual- measurement for improvement ity improvement who is willing to mentor or supervise you. Next, identify a problem collaboratively with your team. Use data to help with this (eg, clinical audits, registries of data on WHAT YOU NEED TO KNOW Box 2: Quality improvement approaches Participation in quality improvement can help clinicians and • Healthcare organisations use a range of improvement methods,21 22 trainees improve care together and develop important profes- such as the Model for Improvement, where changes are tested in small sional skills cycles that involve planning, doing, studying, and acting (PDSA),23 and • Effective quality improvement relies on collaborative work- Lean, which focuses on continually improving processes by removing ing with colleagues and patients and the use of a structured waste, duplication, and non-value adding steps.24 To be effective, such method methods need to be applied consistently and rigorously, with due regard • Enthusiasm, perseverance, good project management skills, to the context.25 In using PDSA cycles, for example, it is vital that teams and a willingness to explain your project to others and seek build in sufficient time for planning and reflection, and do not focus their support are key skills primarily on the “doing.”26

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Box 3: Clinical audit and quality improvement Next, develop your aim using the SMART framework: Specific (S), Measurable (M), Achievable (A), Realistic (R), and Timely (T).38 This Quality improvement is an umbrella term under which many 33 allows you to assess the scale of the intervention and to pare it down approaches sit, clinical audit being one. Clinical audit is commonly if your original idea is too ambitious. Aligning your improvement aim used by trainees to assess clinical effectiveness. Confusion of audit with the priorities of the organisation where you work will help you as both a term for assurance and improvement has perhaps limited to get management and executive support.39 its potential, with many audits ending at the data collection stage Having done this, map those stakeholders who might be affected and failing to lead to improvement interventions. Learning from big by your intervention and work out which ones you need to approach, datasets such as the National Clinical Audits in the UK is beginning and how to sell it to them.40 Take the time to talk to them. It will be to shift the focus to a quality improvement approach that focuses on appreciated and increases the likelihood of buy in, without which identifying and understanding unwanted variation in the local context; your quality improvement project is likely to fail irrespective of how developing and testing possible solutions, and moving from one-off 34 good your idea is. You need to be clear in your own mind about the change to multiple cycles of change. reasons you think it is important. Developing an “elevator pitch” based on your aims is a useful technique to persuade others,38 patients’ experiences and outcomes, and learning from incidents remembering different people are hooked in for different reasons. and complaints) (box 3). Take time to understand what might be The intervention will not be perfect first time. Expect a series of causing the problem. There are different techniques to help you iterative changes in response to false starts and obstacles. Measuring (process mapping, five whys, appreciative inquiry).35-37 Think about the impact of your intervention will enable you to refine it.28 Time the contextual factors that are contributing to the problem (eg, invested in all these aspects will improve your chances of success. the structure, culture, politics, capabilities and resources of your Right from the start, think about how improvement will be organisation). embedded. Attention to sustainability will mean that when you move

Quality improvement in action: three doctors and a medical student talk about the challenges and practicalities of quality improvement This box contains four interviews by Laura Nunez-Mulder with people who have experience in quality improvement. Alex Thompson, medical student at the University of Cambridge, is in the early stages of his first quality improvement project We are aiming to improve identification and early diagnosis of aortic dissections in our hospital. Our supervising consultant suspects that the threshold for organising computed tomography angiography for a suspected aortic dissection is too high, so to start with, my student colleague and I are finding out what proportion of CT angiograms result in a diagnosis of aortic dissection. I fit the project around my studies by working on it in small chunks here and there. You have to be very self motivated to see a project through to the end. Anna Olsson-Brown, research fellow at the University of Liverpool, engaged in quality improvement in her F1 year, and has since supported junior doctors to do the same. This extract is adapted from her BMJ Opinion piece (https://blogs.bmj.com/bmj/) Working in the emergency department after my F1 job in oncology, I noticed that the guidelines on neutropenic sepsis antibiotics were relatively unknown and even less frequently implemented. A colleague and I devised a neutropenic sepsis pathway for oncology patients in the emergency department including an alert label for blood tests. The pathway ran for six months and there was some initial improvement, but the benefit was not sustained after we left the department. As an ST3, I mentored a junior doctor whose quality improvement project led to the introduction of a syringe driver prescription sticker that continues to be used to this day. My top tips for those supporting trainees in quality improvement: • Make sure the project is sufficiently narrow to enable timely delivery • Ensure regular evaluation to assess impact • Support trainees to implement sustainable pathways that do not require their ongoing input. Amar Puttanna, consultant in diabetes and endocrinology at Good Hope Hospital, describes a project he carried out as a chief registrar of the Royal College of Physicians The project of which I am proudest is a referral service we launched to review medication for patients with diabetes and dementia. We worked with practitioners on the older adult care ward, the acute medical unit, the frailty service, and the IT teams, and we promoted the project in newsletters at the trust and the Royal College of Physicians. The success of the project depended on continuous promotion to raise awareness of the service because junior doctors move on frequently. Activity in our project reduced after I left the trust, though it is still ongoing and won a Quality in Care Award in November 2018. Though this project was a success, not everything works. But even the projects that fail contain valuable lessons. Mark Taubert, consultant in palliative medicine and honorary senior lecturer for Cardiff University School of Medicine, launched the TalkCPR project Speaking to people with expertise in quality improvement helped me to narrow my focus to one question: “Can videos be used to inform both staff and patients/carers about cardiopulmonary resuscitation and its risks in palliative illness?” With my team I created and evaluated TalkCPR, an online resource that has gone on to win awards (talkcpr.wales). The most challenging aspect was figuring out which tools might get the right information from any data I collected. I enrolled on a Silver Improving Quality Together course and joined the Welsh Bevan Commission, where I learned useful techniques such as multiple PDSA (plan, do, study, act) cycles, driver diagrams, and fishbone diagrams. the bmj | BMJ 2019;364:k5437 | doi: 10.1136/bmj.k5437 53 EDUCATION

Education into practice management, team working, and clinical governance. Done well, quality improvement is a highly beneficial, positive process which In designing your next quality improvement project: enables clinicians to deliver true change for the benefit of themselves, • What will you do to ensure that you understand the problem you are their organisations, and their patients. trying to solve? • How will you involve your colleagues and patients in your project and Competing interests: The BMJ has judged that there are no disqualifying financial ties to commercial companies. gain the support of managers and senior staff? • What steps will you take right from the start to ensure that any The authors declare the following other interests: none. improvements made are sustained? Further details of The BMJ policy on financial interests is here: https://www. bmj.com/about-bmj/resources-authors/forms-policies-and-checklists/declaration- competing-interests to your next job your improvement efforts, and those of others, and .41 42 Contributors: BJ produced the initial outline after discussions with EV and AOB. AO-B the impact you have collectively achieved will not be lost produced a first complete draft, which EV reworked and expanded. BJ then edited and finalised the text, which was approved by EV and AO-B. The revisions in the What support is needed? resubmitted version were drafted by BJ and edited and approved by EV and AO-B. BJ is You need support from both your organisation and experienced col- responsible for the overall content as guarantor. leagues to translate your skills into practice. Here are some steps you Provenance and peer review: This article is part of a series commissioned by The can take to help you make the most of your skills: BMJ based on ideas generated by a joint editorial group with members from the Health Foundation and The BMJ, including a patient/carer. The BMJ retained full • Find the mentor or supervisor who will help identify and support editorial control over external peer review, editing, and publication. Open access fees opportunities for you. Signposting and introduction to those in and The BMJ’s quality improvement editor post are funded by the Health Foundation. an organisation who will help influence (and may hinder) your quality improvement project is invaluable • Use planning and reporting tools to help manage your project, such as those in NHS Improvement’s project management 27 This is an Open Access article distributed in accordance with the terms of the Creative framework Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, • Identify if your local quality improvement or clinical audit team adapt and build upon this work, for commercial use, provided the original work is may be a source of support and useful development resource for properly cited. See: http://creativecommons.org/licenses/by/4.0/. you rather than just a place to register a project. Most want to support you. • Determine how you might access (or develop your own) local peer to peer support networks, coaching, and wider improvement 1 Academy of Medical Royal Colleges (AoMRC). Quality improvement: training for networks (eg, NHS networks; Q network43 44) better outcomes. March 2016. http://www.aomrc.org.uk/reports-guidance/quality- • Use quality improvement e-learning platforms such as those improvement-training-better-outcomes/ 2 Vaux E, Went S, Norris M, Ingham J. Learning to make a difference: introducing quality provided by Health Education England or NHS Education for improvement methods to core medical trainees. Clin Med (Lond) 2012;12:520-5. Scotland to build your knowledge45 46 doi:10.7861/clinmedicine.12-6-520 • Learn through feedback and assessment of your project (eg, via 3 Bethune R, Soo E, Woodhead P, Van Hamel C, Watson J. Engaging all doctors in 47 48 49 continuous quality improvement: a structured, supported programme for first- the QIPAT tool or a multi-source feedback tool. year doctors across a training deanery in England. BMJ Qual Saf 2013;22:613-7. doi:10.1136/bmjqs-2013-001926 Quality improvement approaches are still relatively new in the 4 Teigland CL, Blasiak RC, Wilson LA, Hines RE, Meyerhoff KL, Viera AJ. Patient safety education of healthcare professionals. Quality improvement can and quality improvement education: a cross-sectional study of medical students’ give clinicians a more productive, empowering, and educational preferences and attitudes. BMC Med Educ 2013;13:16. doi:10.1186/1472-6920- 13-16 experience. Quality improvement projects allow clinicians, 5 Nair P, Barai I, Prasad S, Gadhvi K. Quality improvement teaching at medical school: a working within a team, to identify an issue and implement student perspective. Adv Med Educ Pract 2016;7:171-2. doi:10.2147/AMEP.S101395 interventions that can result in true improvements in quality. 6 Jones B, Woodhead T. Building the foundations for improvement—how five UK Projects can be undertaken in fields that interest clinicians and trusts built quality improvement capability at scale within their organisations. The Health Foundation. February 2015. https://www.health.org.uk/publication/building- give them transferable skills in communication, leadership, project foundations-improvement 7 General Medical Council (GMC). Generic professional capabilities framework. May How patients were involved in the creation of this article 2017. https://www.gmc-uk.org/-/media/documents/generic-professional-capabilities- framework-0817_pdf-70417127.pdf The authors have drawn on their experience both in partnering with 8 NHS improvement (NHSI). Developing people—improving care A national framework for action on improvement and leadership development in NHS-funded services. patients in the design and delivery of multiple quality improvement December 2016. https://improvement.nhs.uk/resources/developing-people- activities and in participating in the Academy of Medical Royal Colleges improving-care/ Training for Better Outcomes Task and Finish Group1 in which patients 9 The Health Foundation. Involving junior doctors in quality improvement: evidence scan. were involved at every step. Patients were not directly involved in writing September 2011. https://www.health.org.uk/publication/involving-junior-doctors- quality-improvement this article. 10 Zarkali A, Acquaah F, Donaghy G, et al. Trainees leading quality improvement. A trainee doctor’s perspective on incorporating quality improvement in postgraduate medical training. Faculty of Medical Leadership and Management. March 2016. https://www. Sources and selection material fmlm.ac.uk/sites/default/files/content/resources/attachments/FMLM%20TSG%20 Think%20Tank%20Trainees%20leading%20quality%20improvement.pdf Evidence for this article was based on references drawn from authors’ 11 Hillman T, Roueche A. Quality improvement. BMJ 2011;342. 10.1136/bmj.d2060. academic experience in this area, guidance from organisations involved 12 Bohmer R. The instrumental value of medical leadership: Engaging doctors in improving services. The King’s Fund. 2012. https://www.kingsfund.org.uk/sites/ in supporting quality improvement work in practice such as NHS default/files/instrumental-value-medical-leadership-richard-bohmer-leadership- Improvement, The Health Foundation, and the Institute for Healthcare review2012-paper.pdf Improvement, and authors’ experience of working to support clinical 13 Dixon-Woods M, McNicol S, Martin G. Ten challenges in improving quality in healthcare: trainees to undertake quality improvement. lessons from the Health Foundation’s programme evaluations and relevant literature. BMJ Qual Saf 2012;1e9. doi:10.1136/bmjqs-2011-000760

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14 Curry LA, Brault MA, Linnander EL, et al. Influencing organisational culture to 31 Improvement NHS. (NHSI) Quality, Service Improvement and Redesign Tools. Statistical improve hospital performance in care of patients with acute myocardial infarction: a process control tool. May 2018. https://improvement.nhs.uk/resources/statistical- mixed-methods intervention study. BMJ Qual Saf 2018;27:207-17. doi:10.1136/ process-control-tool/ bmjqs-2017-006989.https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve& 32 Robert G, Cornwell J, Locock L, Purushotham A, Sturmey G, Gager M. Patients and staff db=PubMed&list_uids=29101292&dopt=Abstract as codesigners of healthcare services. BMJ 2015;350:g7714. doi:10.1136/bmj.g7714 15 Carroll JS, Edmondson AC. Leading organisational learning in health care. Qual Saf 33 Burgess R, Moorhead J. New principles of best practice in clinical audit. 2nd ed. Health Care 2002;11:51-6. 10.1136/qhc.11.1.51.https://www.ncbi.nlm.nih.gov/ Radcliffe publishing, 2011. entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12078370&dopt=Abstract 34 Royal College of Physicians. Unlocking the potential. Supporting doctors to use national 16 Mannion R, Davies H. Understanding organisational culture for healthcare quality clinical audit to drive improvement. April 2018. https://www.rcplondon.ac.uk/projects/ improvement. BMJ 2018;363:k4907. doi:10.1136/bmj.k4907 outputs/unlocking-potential-supporting-doctors-use-national-clinical-audit-drive 17 Richter A, Dawson J, West M. The effectiveness of teams in organisations: a meta- 35 Improvement NHS. (NHSI) Quality, Service Improvement and Redesign Tools: analysis. Int J Hum Resour Manage 2011;22:2749-69. doi:10.1080/09585192.2011 conventional process mapping. January 2018. https://improvement.nhs.uk/resources/ .573971. process-mapping-conventional-model/ 18 McPherson K, Headrick L, Moss F. Working and learning together: good quality care 36 Institute for Healthcare Improvement (IHI) 5 Whys: Finding the root cause. IHI tool. depends on it, but how can we achieve it?Qual Health Care 2001;10(Suppl 2):ii46-53. 2018. http://www.ihi.org/resources/Pages/Tools/5-Whys-Finding-the-Root-Cause.aspx 19 Lucas B, Nacer H. The habits of an improver. Thinking about learning for improvement 37 Scottish Social Services Council (SSSC) Appreciative Inquiry Resource Pack. 2016. in health care. The Health Foundation. October 2015. https://www.health.org.uk/sites/ http://learningzone.workforcesolutions.sssc.uk.com/course/view.php?id=67 health/files/TheHabitsOfAnImprover.pdf 38 Improvement NHS. (NHSI) Quality, Service Improvement and Redesign Tools: 20 Plsek PE, Greenhalgh T. Complexity science: The challenge of complexity in health care. Developing your aims statement. January 2018. https://improvement.nhs.uk/ BMJ 2001;323:625-8. doi:10.1136/bmj.323.7313.625 resources/aims-statement-development/ 21 The Health Foundation. Quality Improvement made simple: what everyone should 39 Pannick S, Sevdalis N, Athanasiou T. Beyond clinical engagement: a pragmatic model know about quality improvement. The Health Foundation. 2013. https://www.health. for quality improvement interventions, aligning clinical and managerial priorities. BMJ org.uk/publication/quality-improvement-made-simple Qual Saf 2016;25:716-25. doi:10.1136/bmjqs-2015-004453 22 Boaden R, Harvey G, Moxham C, Proudlove N. Quality improvement: theory and 40 Improvement NHS. (NHSI) Quality, Service Improvement and Redesign Tools: practice in healthcare. NHS Institute for Innovation and Improvement. 2008. https:// Stakeholder Analysis. January 2018. https://improvement.nhs.uk/documents/2169/ www.england.nhs.uk/improvement-hub/publication/quality-improvement-theory- stakeholder-analysis.pdf practice-in-healthcare/ 41 Royal College of Physicians. Unlocking the potential. Supporting doctors to use national 23 Institute for Healthcare Improvement (IHI). IHI resources: How to improve. IHI. 2018 clinical audit to drive improvement. April 2018. https://www.rcplondon.ac.uk/projects/ http://www.ihi.org/resources/Pages/HowtoImprove/default.aspx outputs/unlocking-potential-supporting-doctors-use-national-clinical-audit-drive 24 Lean Enterprise Institute. What is lean? Lean Enterprise Institute. 2018. https://www.lean. 42 Maher L, Gustafson D, Evans A. Sustainability model and guide. NHS Institute for org/WhatsLean/ Innovation and Improvement. February 2010. http://webarchive.nationalarchives.gov. 25 Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M. Perspectives on context. A uk/20160805122935/http:/www.nhsiq.nhs.uk/media/2757778/nhs_sustainability_ selection of essays considering the role of context in successful quality improvement. model_-_february_2010_1_.pdf The Health Foundation. 2014. https://www.health.org.uk/sites/health/files/ 43 Networks NHS. https://www.networks.nhs.uk/ PerspectivesOnContext_fullversion.pdf 44 Community Q. The Health Foundation. 2018. https://q.health.org.uk/ 26 Reed JE, Card AJ. The problem with Plan-Do-Study-Act cycles. BMJ Qual 45 Health Education England. e-learning for healthcare. https://www.e-lfh.org.uk/ Saf 2016;25:147-52.https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d programmes/research-audit-and-quality-improvement/ b=PubMed&list_uids=26700542&dopt=Abstract doi:10.1136/bmjqs-2015-005076 46 Scotland Quality Improvement Hub NHS. QI e-learning. http://www.qihub.scot.nhs.uk/ 27 Improvement NHS. (NHSI) Quality, Service Improvement and Redesign Tools. Project education-and-learning-xx/qi-e-learning.aspx management an overview. September 2017. https://improvement.nhs.uk/resources/ 47 Joint Royal Colleges of Physicians Training Board. Quality Improvement Assessment project-management-overview/ Tool (QIPAT). 2017. https://www.jrcptb.org.uk/documents/may-2012-quality- 28 Clarke J, Davidge M, James L. The how-to guide for measurement for improvement. improvement-assessment-tool-qipat NHS Institute for Innovation and Improvement 2009. https://www.england.nhs. 48 Joint Royal Colleges of Physicians Training Board. Quality improvement assessment uk/improvement-hub/wp-content/uploads/sites/44/2017/11/How-to-Guide-for- tool. May 2017. https://www.jrcptb.org.uk/documents/may-2012-quality- Measurement-for-Improvement.pdf improvement-assessment-tool-qipat 29 Nelson EC, Splaine ME, Batalden PB, Plume SK. Building measurement and data 49 Joint Royal Colleges of Physicians Training Board. Multi-source feedback. August 2014. collection into medical practice. Ann Intern Med 1998;128:460-6. doi:10.7326/0003- https://www.jrcptb.org.uk/documents/multi-source-feedback-august-2014. 4819-128-6-199803150-00007 30 Improvement NHS. (NHSI) Quality, Service Improvement and Redesign Tools. Run Cite this as: BMJ 2019;364:k5437 charts. January 2018. https://improvement.nhs.uk/resources/run-charts/ http://dx.doi.org/10.1136/bmj.k5437

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Using data for improvement Amar Shah

East London NHS Foundation Trust, London, E1 8DE, UK Box 1: Defining quality improvement2 Correspondence to: [email protected] @DrAmarShah Quality improvement aims to make a difference to patients by improving safety, effectiveness, and experience of care by: We all need a way to understand the quality of care we are provid- 1. Using understanding of our complex healthcare environment ing, or receiving, and how our service is performing. We use a range 2. Applying a systematic approach of data in order to fulfil this need, both quantitative and qualitative. 3. Designing, testing, and implementing changes using real-time Data are defined as “information, especially facts and numbers, col- measurement for improvement lected to be examined and considered and used to help decision- 1 making.” Data are used to make judgements, to answer questions, outcomes.4 He described the importance of focusing on structures and to monitor and support improvement in healthcare (box 1). The and processes in order to improve outcomes.5 When trying to same data can be used in different ways, depending on what we want understand quality within a complex system, we need to look at a to know or learn. mix of outcomes (what matters to patients), processes (the way we do Within healthcare, we use a range of data at different levels of the our work), and structures (resources, equipment, governance, etc). system: Therefore, when we are trying to improve something, we need a • Patient level—such as blood sugar, temperature, blood test results, small number of measures (ideally 5-8) to help us monitor whether or expressed wishes for care) we are moving towards our goal. Any improvement effort should • Service level—such as waiting times, outcomes, complaint themes, include one or two outcome measures linked explicitly to the aim of or collated feedback of patient experience the work, a small number of process measures that show how we are • Organisation level—such as staff experience or financial doing with the things we are actually working on to help us achieve performance our aim, and one or two balancing measures (box 2). Balancing • Population level—such as mortality, quality of life, employment, measures help us spot unintended consequences of the changes we and air quality. are making. As complex systems are unpredictable, our new changes This article outlines the data we need to understand the quality of care may result in an unexpected adverse effect. Balancing measures we are providing, what we need to capture to see if care is improving, help us stay alert to these, and ought to be things that are already how to interpret the data, and some tips for doing this more effectively. collected, so that we do not waste extra resource on collecting these.

What data do we need? How should we look at the data? Healthcare is a complex system, with multiple interdependencies and This depends on the question we are trying to answer. If we ask an array of factors influencing outcomes. Complex systems are open, whether an intervention was efficacious, as we might in a research 3 unpredictable, and continually adapting to their environment. No study, we would need to be able to compare data before and after single source of data can help us understand how a complex system the intervention and remove all potential confounders and bias. behaves, so we need several data sources to see how a complex sys- For example, to understand whether a new treatment is better than tem in healthcare is performing. the status quo, we might design a research study to compare the Avedis Donabedian, a doctor born in Lebanon in 1919, studied effect of the two interventions and ensure that all other character- quality in healthcare and contributed to our understanding of using istics are kept constant across both groups. This study might take several months, or possibly years, to complete, and would compare Sources and selection criteria the average of both groups to identify whether there is a statistically This article is based on my experience of using data for improvement at significant difference. East London NHS Foundation Trust, which is seen as one of the world This approach is unlikely to be possible in most contexts where we leaders in healthcare quality improvement. Our use of data, from trust are trying to improve quality. Most of the time when we are improving board to clinical team, has transformed over the past six years in line a service, we are making multiple changes and assessing impact in with the learning shared in this article. This article is also based on my real-time, without being able to remove all confounding factors and experience of teaching with the Institute for Healthcare Improvement, potential bias. When we ask whether an outcome has improved, as which guides and supports quality improvement efforts across the globe. we do when trying to improve something, we need to be able to look at data over time to see how the system changes as we intervene, with multiple tests of change over a period. For example, if we were WHAT YOU NEED TO KNOW trying to improve the time from a patient presenting in the emergency • Both qualitative and quantitative data are critical for evaluat- department to being admitted to a ward, we would likely be testing ing and guiding improvement several different changes at different places in the pathway. We would • A family of measures, incorporating outcome, process, and bal- want to be able to look at the outcome measure of total time from ancing measures, should be used to track improvement work presentation to admission on the ward, over time, on a daily basis, to be able to see whether the changes made lead to a reduction in • Time series analysis, using small amounts of data collected and displayed frequently, is the gold standard for using data the overall outcome. So, when looking at a quality issue from an for improvement improvement perspective, we view smaller amounts of data but more frequently to see if we are improving over time.2

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Box 2: Different types of measures of quality of care Outcome measures (linked explicitly to the aim of the project) • Aim—To reduce waiting times from referral to appointment in a clinic • Outcome measure—Length of time from referral being made to being seen in clinic ––Data collection—Date when each referral was made, and date when each referral was seen in clinic, in order to calculate the time in days from referral to being seen Process measures (linked to the things you are going to work on to achieve the aim) • Change idea—Use of a new referral form (to reduce numbers of inappropriate referrals and re-work in obtaining necessary information) • Process measure—Percentage of referrals received that are inappropriate or require further information Fig 1 | A typical run chart ––Data collection—Number of referrals received that are inappropriate or require further information each week divided by total number of referrals received each week LCL) defining the boundaries within which you would predict the • Change idea—Text messaging patients two days before the data to be.6 Shewhart charts use the terms “common cause variation” appointment (to reduce non-attendance and wasted appointment and “special cause variation,” with a different set of rules to identify slots) special causes. • Process measure—Percentage of patients receiving a text message two days before appointment Is it just about numbers? ––Data collection—Number of patients each week receiving a text We need to incorporate both qualitative and quantitative data to help message two days before their appointment divided by the total us learn about how the system is performing and to see if we improve number of patients seen each week over time. Quantitative data express quantity, amount, or range and • Process measure—Percentage of patients attending their appointment can be measured numerically—such as waiting times, mortality, ––Data collection—Number of patients attending their appointment haemoglobin level, cash flow. Quantitative data are often visualised each week divided by the total number of patients booked in each over time as time series analyses (run charts or control charts) to see week whether we are improving. Balancing measures (to spot unintended consequences) However, we should also be capturing, analysing, and learning from • Measure—Percentage of referrers who are satisfied or very satisfied qualitative data throughout our improvement work. Qualitative data with the referral process (to spot whether all these changes are having are virtually any type of information that can be observed and recorded a detrimental effect on the experience of those referring to us) that is not numerical in nature. Qualitative data are particularly useful ––Data collection—A monthly survey to referrers to assess their in helping us to gain deeper insight into an issue, and to understand satisfaction with the referral process meaning, opinion, and feelings. This is vital in supporting us to develop • Measure—Percentage of staff who are satisfied or very satisfied at theories about what to focus on and what might make a difference.7 work (to spot whether the changes are increasing burden on staff and Examples of qualitative data include waiting room observation, reducing their satisfaction at work) feedback about experience of care, free-text responses to a survey. ––Data collection—A monthly survey for staff to assess their Using qualitative data for improvement satisfaction at work One key point in an improvement journey when qualitative data are critical is at the start, when trying to identify “What matters most?” What is best practice in using data to support improvement? and what the team’s biggest opportunity for improvement is. The Best practice would be for each team to have a small number of meas- other key time to use qualitative data is during “Plan, Do, Study, Act” ures that are collectively agreed with patients and service users as being the most important ways of understanding the quality of the service being provided. These measures would be displayed transparently so that all staff, service users, and patients and families or carers can access them and understand how the service is performing. The data would be shown as time series analysis, to provide a visual display of whether the service is improving over time. The data should be available as close to real-time as possible, ideally on a daily or weekly basis. The data should prompt discussion and action, with the team reviewing the data regularly, identifying any signals that suggest something unusual in the data, and taking action as necessary. The main tools used for this purpose are the run chart and the Shewhart (or control) chart. The run chart (fig 1) is a graphical display of data in time order, with a median value, and uses probability-based rules to help identify whether the variation seen is random or non-random.2 The Shewhart (control) chart (fig 2) also displays data in time order, but with a mean as the centre line instead of a median, and upper and lower control limits (UCL and Fig 2 | A typical Shewhart (or control) chart the bmj | BMJ 2019;364:k5437 | doi: 10.1136/bmj.k5437 57 EDUCATION

Table 1 | Different ways to collect qualitative data for improvement Data collection method Advantages Disadvantages Using the data Free-text question in a Quick and easy to create, on paper or Questions are pre-determined so cannot adapt At the start of a project to capture opinions, ideas, survey electronic based on answers and feedback from service users and staff Beware of survey fatigue Interviews Can be individual or group Time intensive To help us understand the issue we want to work on Can be structured, semi-structured, or Need to facilitate the interview and take notes or in more detail with multiple perspectives unstructured record the discussion To help us appreciate a deeper meaning behind Can explore deeper meaning Analysing large amounts of narrative requires skill people’s views and theories Observations Able to see behaviour and impact of Time intensive Useful to understand the system from another human factors in real-world setting Obtrusive, so risk of Hawthorne (observer) effect— perspective Can be useful in understanding knowing you are being observed affects how you Can be particularly helpful in monitoring whether robustness of implementation behave implementation has been successful Review of documents Large amounts of documentation are Can be time intensive At start of project to identify opportunities for usually available, and may yield useful May need a defined search and sampling improvement through analysing service user information (such as complaints, incident strategy—you could ask your informatics or feedback, incidents. or complaints forms, clinical documentation) business intelligence team for help

(PDSA) cycles. Most PDSA cycles, when done well, rely on qualitative Tips to overcome common challenges in using data for improvement? data as well as quantitative data to help learn about how the test One of the key challenges faced by healthcare teams across the globe fared compared with our original theory and prediction. is being able to access data that is routinely collected, in order to use Table 1 shows four different ways to collect qualitative data, with it for improvement. Large volumes of data are collected in healthcare, advantages and disadvantages of each, and how we might use them but often little is available to staff or service users in a timescale or in within our improvement work. a form that allows it to be useful for improvement. One way to work

Fig 3 | Example of a safety cross in use

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Education into practice How patients were involved in the creation of this article • What are the key measures for the service that you work in? Service users are deeply involved in all quality improvement work at East • Are these measures available, transparently displayed, and viewed London NHS Foundation Trust, including within the training programmes over time? we deliver. Shared learning over many years has contributed to • What qualitative data do you use in helping guide your our understanding of how best to use all types of data to support improvement efforts? improvement. No patients have had input specifically into this article. around this is to have a simple form of measurement on the unit, clinic, or ward that the team own and update. This could be in the form of a safety cross8 or tally chart. A safety cross (fig 3) is a simple visual monthly calendar on the wall which allows teams to identify This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, when a safety event (such as a fall) occurred on the ward. The team remix, adapt, build upon this work non-commercially, and license their derivative works simply colours in each day green when no fall occurred, or colours on different terms, provided the original work is properly cited and the use is non- in red the days when a fall occurred. It allows the team to own the commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. data related to a safety event that they care about and easily see how many events are occurring over a month. Being able to see such data transparently on a ward allows teams to update data in real time and 1 Cambridge University Press. Cambridge online dictionary, 2008. https://dictionary. be able to respond to it effectively. cambridge.org/. A common challenge in using qualitative data is being able 2 Perla RJ, Provost LP, Murray SK. The run chart: a simple analytical tool for learning to analyse large quantities of written word. There are formal from variation in healthcare processes. BMJ Qual Saf 2011;20:46-51. doi:10.1136/ bmjqs.2009.037895 approaches to qualitative data analyses, but most healthcare staff 3 Braithwaite J. Changing how we think about healthcare improvement. are not trained in these methods. Key tips in avoiding this difficulty BMJ 2018;361:k2014. doi:10.1136/bmj.k2014 are (a) to be intentional with your search and sampling strategy 4 Best M, Neuhauser D. Avedis Donabedian: father of quality assurance and poet. Qual Saf Health Care 2004;13:472-3. doi:10.1136/qshc.2004.012591 so that you collect only the minimum amount of data that is likely 5 Donabedian A. The quality of care. How can it be assessed?JAMA 1988;260:1743-8. to be useful for learning and (b) to use simple ways to read and doi:10.1001/jama.1988.03410120089033 theme the data in order to extract useful information to guide 6 Mohammed MA. Using statistical process control to improve the quality of health care. your improvement work.9 If you want to try this, see if you can Qual Saf Health Care 2004;13:243-5. doi:10.1136/qshc.2004.011650 7 Davidoff F, Dixon-Woods M, Leviton L, Michie S. Demystifying theory and its use in find someone in your organisation with qualitative data analysis improvement. BMJ Qual Saf 2015;24:228-38. doi:10.1136/bmjqs-2014-003627 skills, such as clinical psychologists or the patient experience or 8 Flynn M. Quality & Safety—The safety cross system: simple and effective. https://www. informatics teams. inmo.ie/MagazineArticle/PrintArticle/11155. 9 Lloyd R. Quality health care: a guide to developing ad using indicators. 2nd ed. Jones & Competing interests: I have read and understood the BMJ Group policy on Bartlett Learning, declaration of interests and have no relevant interests to declare. Cite this as: BMJ 2019;364:l189 Provenance and peer review: Commissioned; externally peer reviewed. http://dx.doi.org/10.1136/bmj.l189

the bmj | BMJ 2019;364:k5437 | doi: 10.1136/bmj.k5437 59 EDUCATION Evaluating the impact of healthcare interventions using routine data Geraldine M Clarke,1 Stefano Conti,2 Arne T Wolters,1 Adam Steventon1

1The Health Foundation, London, UK as other interventions, socioeconomic trends, and political or 2NHS England and NHS Improvement, London, UK environmental conditions. Evaluations can be categorised as Correspondence to: G Clarke formative or summative (table 1). [email protected] Approaches such as the Plan, Do, Study, Act cycle11, which is part of the Model for Improvement, a commonly used tool to test Interventions to transform the delivery of health and social care are and understand small changes in quality improvement work12 may being implemented widely, such as those linked to Accountable Care be used to undertake formative evaluation. 1 Organizations in the United States, or to integrated care systems With either type of evaluation, it is important to be realistic about 2 in the UK. Assessing the impact of these health interventions how long it will take to see the intended effects. Assessment that enables healthcare teams to learn and to improve services, and can takes place too soon risks incorrectly concluding that there was no 3 inform future policy. However, some healthcare interventions are impact. This might lead stakeholders to question the value of the implemented without high quality evaluation, in ways that require intervention, when later assessment might have shown a different 4 onerous data collection, or may not be evaluated at all. picture. For example, in a small case study of cost savings from A range of routinely collected administrative and clinically proactively managing high risk patients, the costs of healthcare for generated healthcare data could be used to evaluate the impact of the eligible intervention population initially increased compared interventions to improve care. However, there is a lack of guidance with the comparison population, but after six months were as to where relevant routine data can be found or accessed and how consistently lower.14 they can be linked to other data. A diverse array of methodological This article focuses on impact evaluation, but this can only ever literature can also make it hard to understand which methods to address a fraction of questions.15 Much more can be accomplished apply to analyse the data. This article provides an introduction to if it is supplemented with other qualitative and quantitative help clinicians, commissioners, and other healthcare professionals methods, including process evaluation. This provides context, wishing to commission, interpret, or perform an impact evaluation assesses how the intervention was implemented, identifies of a health intervention. We highlight what to consider and discuss any emerging unintended pathways, and is important for key concepts relating to design, analysis, implementation, and understanding what happened in practice and for identifying interpretation. areas for improvement.16 The economic evaluation of healthcare interventions is also important for healthcare decision making, What are interventions, impacts, and impact evaluations? especially with ongoing financial pressures on health services.17 A health intervention is a combination of activities or strategies designed to assess, improve, maintain, promote, or modify What are the right evaluation questions? health among individuals or an entire population. Interventions An effective impact evaluation begins with the formulation of one can include educational or care programmes, policy changes, or more clear questions driven by the purpose of the evaluation and environmental improvements, or health promotion campaigns. what you and your stakeholders want to learn. For example, “What Interventions that include multiple independent or interacting is the impact of case management on patients’ experience of care?” 5 components are referred to as complex. The impact of any Formulate your evaluation questions using your understanding of intervention is likely to be shaped as much by the context (eg, the idea behind your intervention, the implementation challenges, communities, work places, homes, schools, or hospitals) in which and your knowledge of what data are available to measure outcomes. 6789 it is delivered, as the details of the intervention itself. Review your theory of change or logic model2122 to understand An impact is a positive or negative, direct or indirect, intended what inputs and activities were planned, and what outcomes were or unintended change produced by an intervention. An impact expected and when. Once you have understood the intended causal evaluation is a systematic and empirical investigation of the pathway, consider the practical aspects of implementation, which effects of an intervention; it assesses to what extent the outcomes include the barriers to change, unexpected changes by recipients experienced by affected individuals were caused by the intervention or providers, and other influences not previously accounted for. in question, and what can be attributed to other factors such Patient and public involvement (PPI) in setting the right question is strongly recommended for additional insights and meaningful WHAT YOU NEED TO KNOW results. For example, if evaluating the impact of case management, you could engage patients to understand what outcomes matter • What interventions have you designed or experienced most to them. Healthcare leaders may emphasise metrics such as aimed at transforming your service? Have they been emergency admissions, but other aspects such as the experience of evaluated? 523 care might matter more to patients. • What types of routine data are collected about the care you deliver? Do you know how to access them and use What methods can be used to perform an impact evaluation? them to evaluate care delivery? Randomised control designs, where individuals are randomly • What resources are available to you to support impact selected to receive either an intervention or a control treatment, are evaluations for interventions? often referred to as the “gold standard” of causal impact evaluation.24

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Table 1 | Impact evaluations Formative Summative Examples Conducted during the Conducted after the A formative evaluation of the Whole Systems Integrated Care (WSIC) programme, aimed at integrating development or implementation intervention’s completion, or at health and social care in London, found that difficulties in establishing data sharing and information of an intervention the end of a programme cycle governance, and differences in professional culture were hampering efforts to implement change10 Aims to fine tune or Aims to render judgment, or A summative impact evaluation of an NHS new care model vanguard initiative found that care home reorient the intervention make decisions about the future residents in Nottinghamshire who received enhanced support had substantially fewer attendances at of the intervention emergency departments and fewer emergency admissions than a matched control group.13 This evidence supported the decision by the NHS to roll out the Enhanced Health in Care Homes Model across the country.2

In large enough samples, the process of randomisation ensures Assessing similarity is only possible in relation to observed a balance in observed and unobserved characteristics between characteristics, and matching can result in biased estimates if the treatment and control groups. However, while often suitable for groups differ in relation to unobserved variables that are predictive assessing, for example, the safety and efficacy of medicines, these of the outcome (confounders). It is rarely possible to eliminate this designs may be impractical, unethical, or irrelevant when assessing possibility of bias when conducting observational studies, meaning the impact of complex changes to health service delivery. that the interpretation of the findings must always be sensitive to the Observational studies are an alternative approach to estimate possibility that the differences in outcomes were caused by a factor causal effects. They use the natural, or unplanned, variation in other than the intervention. Methods that can help when selection a population in relation to the exposure to an intervention, or is on unobserved characteristics include difference-in-difference,30 the factors that affect its outcomes, to remove the consequences regression discontinuity,31 instrumental variables,18 or synthetic of a non-randomised selection process.25 The idea is to mimic a controls.32Table 2 gives a summary of selected observational study randomised control design by ensuring treated and control groups designs. are equivalent—at least in terms of observed characteristics. This Observational studies are often referred to as natural (for natural can be achieved using a variety of well documented methods, or unplanned interventions), or quasi (for planned or intentional including regression control and matching,26 eg, propensity interventions) experiments. Natural experiments are discussed to scoring27 or genetic matching.28 If the matching is successful evaluate population health interventions.41 at producing such groups, and there are also no differences in unobserved characteristics, then it can be assumed that the What’s wrong with a simple before-and-after study? control group outcomes are representative of those that the Before-and-after studies compare changes in outcomes for the treated group would have experienced if nothing had changed, same group of patients at a single time point before and after ie, the counterfactual. For example, an evaluation of alternative receiving an intervention without reference to a control group. elective surgical interventions for primary total hip replacement on These differ from interrupted time series studies, which compare osteoarthritis patients in England and Wales used genetic matching changes in outcomes for successive groups of patients before and to compare patients across three different prosthesis groups, and after receiving an intervention (the interruption). reported that the most prevalent type of hip replacement was the Before-and-after studies are useful when it is not possible to least cost effective.29 include an unexposed control group, or for hypothesis generation.

Table 2 | Observational study designs for quantitative impact evaluation Method Strengths and limitations Matching33 Aims to find a subset of control group units (eg, individuals or hospitals) with similar Can be combined with other methods, eg, difference-in-differences and characteristics to the intervention group units in the pre-intervention period. For example, regression. Enables straightforward comparison between intervention and impact of enhanced support in care homes in Rushcliffe, Nottinghamshire13 control groups. Methods include propensity score matching and genetic matching Regression control34 Refers to use of regression techniques to estimate association between Can be beneficial to pre-process the data using matching in addition to an intervention and an outcome while holding the value of the other variables constant, thus regression control. This reduces the dependence of the estimated treatment adjusting for these variables effect on how the regression models are specified35 Difference-in-differences (DiD)30 Compares outcomes before and after an intervention in Simple to implement and intuitive to interpret. Depends on the assumption intervention and control group units. Controls for the effects of unobserved confounders that do that there are no unobserved differences between the intervention and not vary over time, eg, impact of hospital pay for performance on mortality in England36 control groups that vary over time, also referred to as the “parallel trends” assumption Synthetic controls32 Typically used when an intervention affects a whole population (eg, Allows for unobserved differences between the intervention and control region or hospital) for whom a well matched control group comprising whole control units is not groups to vary over time. The uncertainty of effect estimates is hard to available. Builds a “synthetic” control from a weighted average of the control group units, eg, quantify. Produces biased estimates over short pre-intervention periods impact of redesigning urgent and emergency care in Northumberland37 Regression discontinuity design31 Uses quasi-random variations in intervention exposure, There is usually a strong basis for assuming that patients close to either side eg, when patients are assigned to comparator groups depending on a threshold. Outcomes of of the threshold are similar. Because the method only uses data for patients patients just below the threshold are compared with those just above, eg, impact of statins on near the threshold, the results might not be generalisable cholesterol by exploiting differences in statin prescribing38 Interrupted time-series39 Compares outcomes at multiple time points before and after an Ensures limited impact of selection bias and confounding as a result of intervention (interruption) is implemented to determine whether the intervention has an effect population differences but does not generally control for confounding as that is statistically significantly greater than the underlying trend, eg, to examine the trends in a result of other interventions or events occurring at the same time as the diagnosis for people with dementia in the UK40 intervention Instrumental variables18 An instrumental variable is a variable that affects the outcome solely Explicitly addresses unmeasured confounding but conceptually difficult and through the effect on whether the patient receives the treatment. An instrumental variable can easily misused. Identification of instrumental variables is not straightforward. be used to counteract issues of measurement error and unobserved confounders, eg, used to Estimates are imprecise (large standard error), biased when sample size is assess delivery of premature babies in dedicated v hospital intensive care units19 small, and can be biased in large samples if assumptions are even slightly violated20 the bmj | BMJ 2020;365:l2239 | doi: 10.1136/bmj.l2239 61 EDUCATION

Table 3 | Commonly used routine datasets available in the NHS in England Dataset Dissemination and alternatives Hospital episode statistics (HES).46 HES is a database containing details of all HES is available through the Data Access Request Service (DARS),47 a service admissions, accident and emergency attendances, and outpatient appointments at NHS provided by NHS Digital. Commissioners, providers in the NHS, and analytics teams England hospitals and NHS England funded treatment centres. Information captured working on their behalf, can also access hospital data directly via the Secondary Use includes clinical information about diagnoses and operations, patient demographics, Service (SUS).48 These data are very similar to HES, processed by NHS Digital, and are geographical information, and administrative information such as the data and available for non-clinical uses, including research and planning health services method of admissions and discharge Primary care data is collected by general practices. Although there is no national Commissioners, and analytics teams working on their behalf, can work with an standard on how primary care data should be collected and/or reported, there are a intermediary service called Data Service for Commissioning Regional Office to request limited number of commonly used software providers to record these data. Information access to anonymised patient level general practice data (possibly linked to SUS, captured includes clinical information about diagnoses, treatment, and prescriptions, described above) for the purpose of risk stratification, invoice validation, and to patient demographics, geographical information, and administrative information on support commissioning. Anonymised UK primary care records for a representative booking and attendance of appointments, and whether appointments relate to a sample of the population are available for public health research through, for telephone consultation, an in-practice appointment, or a home visit instance, the Clinical Practice Research Datalink.49 Mortality data50 The Office for National Statistics (ONS) maintains a dataset of all ONS mortality data are routinely processed by NHS Digital, and can be linked to HES registered deaths in England. These data can be linked to routine health data to record data. These data can be requested through the DARS service. deaths that occur outside of hospital When deaths occur in hospital this is typically recorded as part of discharge information The Mental Health Services Data Set (MHSDS)51 contains record level data about the Like HES, MHSDS is available through the DARS service. Mental health data from care of children, young people, and adults who are in contact with mental health, learning before April 2016 have been recorded in the Mental Health Minimum Dataset also disabilities, or autism spectrum disorder services. These data cover data from April 2016 disseminated through NHS Digital

However, they are inherently susceptible to bias since changes provided the right information governance arrangements are in observed may simply reflect regression to the mean (any changes place. Pseudonymised records, where any identifying information in outcomes that might occur naturally in the absence of the is removed or replaced by an artificial identifier, are often used to intervention), or influences or secular trends unrelated to the support evaluation while maintaining patient confidentiality. See intervention, eg, changes in the economic or political environment, table 3 for commonly used routine datasets available in England. or a heightened public awareness of issues. Healthcare records can often be linked across different sources For example, a before-and-after study of the impact of a as a single patient identifier is commonly used across a healthcare care coordination service for older people tracked the hospital system, eg, the use of an NHS number in the UK. Using a common utilisation of the same patients before and after they were accepted pseudonym across different data sources can support linkage of into the service. They found that the service resulted in savings in pseudonymised records. Linking into publicly available sources hospital bed days and attendances at the emergency department.42 of administrative data and surveys can further enrich healthcare Reduced hospital utilisation could have reflected regression to the records. Commonly used administrative data available for UK mean here rather than the effects of the intervention; for example, populations include measures of GP practice quality and outcomes a patient could have had a specific health crisis before being invited from the Quality and Outcomes Framework (QOF),52 deprivation, to join the service and then reverted back to their previous state of rurality, and demographics from the 2011 Census,53 and patient health and hospital utilisation for reasons unconnected with the experience from the GP Patient Survey.54 care coordination service. Various tools are available to evaluate the risk of bias in non- Are there any additional considerations? randomised designs due to confounding and other potential It is essential to consider threats to validity when designing and biases.4344 evaluating an impact evaluation; validity relates to whether an evaluation is measuring what it is claiming to measure. See Where can I find suitable routine data? Rothman et al55 for further discussion. Healthcare systems generate vast amounts of data as part of their Internal validity refers to whether the effects observed are due to routine operation. These datasets are often designed to support the intervention and not some other confounding factor. Selection direct care, and for administrative purposes, rather than for bias, which results from the way in which subjects are recruited, research, and use of routinely collected data for evaluating changes or from differing rates of participation due, for example, to age, in health service delivery is not without pitfalls. For example, any gender, cultural or socioeconomic factors, is often a problem in variation observed between geographical regions, providers, and non-randomised designs. Care must be taken to account for such sometimes individual clinicians may reflect real and important biases when interpreting the results of an impact evaluation. variations in the actual healthcare quality provided, but can also Sensitivity analyses should be performed to provide reassurance result from differences in measurement.45 However, routine data regarding the plausibility of causal inferences. can be a rich source of information on a large group of patients with External validity refers to the extent to which the results of a different conditions across different geographical regions. Often, study can be generalised to other settings. Understanding the data have been collected for many years, enabling construction societal, economic, health system, and environmental context in of individual patient histories describing healthcare utilisation, which an intervention is delivered, and which makes its impact diagnoses, comorbidities, prescription of medication, and other unique, is critical when interpreting the results of evaluations, and treatments. considering whether they apply to your setting.56 Descriptions of Some of these data are collected centrally, across a wider system, context should be as rich as possible. and routinely shared for research and evaluation purposes, eg, Often, the impact of an intervention is likely to vary depending secondary care data in England (Hospital Episode Statistics), or on the characteristics of patients. These can be usefully explored in Medicare Claims data in the United States. Other sources, such as subgroup analyses.57 primary care data, are often collected at a more local level, but can Clear and transparent reporting using established guidelines be accessed through, or on behalf of, healthcare commissioners, (eg, STROBE58 or TREND59)to describe the intervention, study

62 doi: 10.1136/bmj.l2239 | BMJ 2020;365:l2239 | the bmj EDUCATION population, assignment of treatment, and control groups, and 9 Pawson R, Tilley N. Realistic evaluation. Sage, 1997. 10 Smith J, Wistow G. (Nuffield Trust comment) Learning from an intrepid pioneer: integrated methods used to estimate impact should be followed. Limitations care in North West London. https://www.nuffieldtrust.org.uk/news-item/learning-from- arising as a result of inherent biases, or validity, should be clearly an-intrepid-pioneer-integrated-care-in-north-west-london acknowledged. 11 Improvement NHS. Plan, Do, Study, Act (PDSA) cycles and the model for improvement. Handb Qual Serv Improv Tools, 2010. Around the world, many interventions designed to improve 12 Academy of Medical Royal Colleges. Quality Improvement—training for better outcomes. health and healthcare are under way. An evaluation is an essential 2016. https://www.aomrc.org.uk/wp-content/uploads/2016/06/Quality_improvement_ part of understanding what impact these changes are having, for key_findings_140316-2.pdf 13 Lloyd T, Wolters A, Steventon A. The impact of providing enhanced support for care whom and in what circumstances, and help inform future decisions home residents in Rushcliffe. 2017. http://www.health.org.uk/sites/health/files/ about improvement and further roll out. There is no standard, ‘‘one IAURushcliffe.pdf 14 Ferris TG, Weil E, Meyer GS, Neagle M, Heffernan JL, Torchiana DF. Cost savings from size fits all’’ recipe for a good evaluation: it must be tailored to the managing high-risk patients. In: Yong PL, Saunders RS, Olsen LA, editors. The healthcare project at hand. Understanding the overarching principles and imperative: lowering costs and improving outcomes: workshop series summary.Nat Acad standards is the first step towards a good evaluation. 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Briefing: The impact of redesigning urgent and doi:10.1200/JOP.2013.001364 emergency care in Northumberland 2017. https://www.health.org.uk/sites/health/files/ 4 Bickerdike L, Booth A, Wilson PM, et al. Social prescribing: less rhetoric and more reality. IAUNorthumberland.pdf A systematic review of the evidence. BMJ Open 2017;7:e013384. 38 Geneletti S, O’Keeffe AG, Sharples LD, Richardson S, Baio G. Bayesian regression 5 Campbell M, Fitzpatrick R, Haines A, et al. Framework for design and evaluation of discontinuity designs: incorporating clinical knowledge in the causal analysis of primary complex interventions to improve health. BMJ 2000;321:694-6. doi:10.1136/ care data. Stat Med 2015;34:2334-52. doi:10.1002/sim.6486 bmj.321.7262.694 39 Bernal JL, Cummins S, Gasparrini A. Interrupted time series regression for the evaluation 6 Rickles D. Causality in complex interventions. Med Health Care Philos 2009;12:77-90. of public health interventions: a tutorial.Int J Epidemiol 2016, 46:348-55. doi:10.1007/s11019-008-9140-4 40 Donegan K, Fox N, Black N, Livingston G, Banerjee S, Burns A. Trends in diagnosis 7 Hawe P. Lessons from complex interventions to improve health. Annu Rev Public and treatment for people with dementia in the UK from 2005 to 2015: a longitudinal Health 2015;36:307-23. doi:10.1146/annurev-publhealth-031912-114421 retrospective cohort study. Lancet Public Health 2017;2667:1-8. 8 Greenhalgh T, Papoutsi C. Studying complexity in health services research: desperately 41 Craig P, Cooper C, Gunnell D, et al. Using natural experiments to evaluate population seeking an overdue paradigm shift. BMC Med 2018;16:95. doi:10.1186/s12916-018- health interventions: new Medical Research Council guidance. J Epidemiol Community 1089-4 Health 2012;66:1182-6. doi:10.1136/jech-2011-200375 the bmj | BMJ 2020;365:l2239 | doi: 10.1136/bmj.l2239 63 EDUCATION

42 Mayhew L. On the effectiveness of care co-ordination services aimed at preventing 52 NHS Digital. Quality Outcomes Framework (QOF) https://digital.nhs.uk/data-and- hospital admissions and emergency attendances. Health Care Manag Sci 2009;12:269- information/data-tools-and-services/data-services/general-practice-data-hub/quality- 84. doi:10.1007/s10729-008-9092-5 outcomes-framework-qof 43 Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non- 53 Office for National Statistics. 2011 Census. https://www.ons.gov.uk/census/2011census randomised studies of interventions. BMJ 2016;355:i4919. doi:10.1136/bmj.i4919 54 NHS England. GP Patient Survey (GPPS). https://www.gp-patient.co.uk/ 44 Chen YF, Hemming K, Stevens AJ, Lilford RJ. Secular trends and evaluation of 55 Rothman KJ, Greenland S, Lash T. Modern Epidemiology. Lippincott Williams & Williams, complex interventions: the rising tide phenomenon. BMJ Qual Saf 2016;25:303-10. 2005. doi:10.1136/bmjqs-2015-004372 56 Minary L, Alla F, Cambon L, Kivits J, Potvin L. Addressing complexity in population health 45 Powell AE, Davies HT, Thomson RG. Using routine comparative data to assess the intervention research: the context/intervention interface. J Epidemiol Community Health quality of health care: understanding and avoiding common pitfalls. Qual Saf Health 2018;72:319-23. Care 2003;12:122-8. doi:10.1136/qhc.12.2.122 57 Sun X, Briel M, Walter SD, Guyatt GH. Is a subgroup effect believable? Updating criteria to 46 NHS Digital. Hospital Episode Statistics. https://digital.nhs.uk/data-and-information/ evaluate the credibility of subgroup analyses. BMJ 2010;340:c117. data-tools-and-services/data-services/hospital-episode-statistics 58 von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The 47 NHS Digital. Data Access Request Service (DARS) https://digital.nhs.uk/services/data- strengthening the reporting of observational studies in epidemiology (STROBE) statement: access-request-service-dars guidelines for reporting observational studies. Ann Intern Med 2007;147:573-7. 48 NHS Digital. Secondary Uses Service (SUS) https://digital.nhs.uk/services/secondary- 59 Des Jarlais DC, Lyles C, Crepaz N. the TREND. Improving the reporting quality of uses-service-sus nonrandomized evaluations: the TREND statement. Am J Public Health 2004;94:361-6. 49 Medicines and Healthcare Regulatory Agency and National Institute for Health Research 60 The Health Foundation. Evaluation: what to consider. 2015. https://www.health.org.uk/ (NIHR). Clinical Practice Research Datalink(CPRD). https://www.cprd.com publications/evaluation-what-to-consider 50 Office for National Statistics. Deaths. https://www.ons.gov.uk/ peoplepopulationandcommunity/birthsdeathsandmarriages/deaths 51 NHS Digital. Mental Health Services Data Set. https://digital.nhs.uk/data-and- Cite this as: BMJ 2020;365:l2239 information/data-collections-and-data-sets/data-sets/mental-health-services-data-set http://dx.doi.org/10.1136/bmj.l2239

64 doi: 10.1136/bmj.l2239 | BMJ 2020;365:l2239 | the bmj EDUCATION Quality improvement into practice Adam Backhouse,1 Fatai Ogunlayi2

1North London Partners in Health and Care, Islington CCG, London N1 1TH, UK How this article was made 2Institute of Applied Health Research, Public Health, University of Birmingham, B15 2TT, UK AB and FO are both specialist quality improvement practitioners and have developed their expertise working in QI roles for a variety of UK The benefits to front line clinicians of participating in quality healthcare organisations. The analysis presented here arose from AB improvement (QI) activity are promoted in many health systems. QI and FO’s observations of the challenges faced when introducing QI, can represent a valuable opportunity for individuals to be involved with healthcare providers often unable to distinguish between QI and in leading and delivering change, from improving individual other change approaches, making it difficult to understand what QI can patient care to transforming services across complex health and do for them. care systems.1 However, it is not clear that this promotion of QI has created be a useful reference to consider how particular methods or tools greater understanding of QI or widespread adoption. QI largely could be used as part of a QI approach. remains an activity undertaken by experts and early adopters, often in isolation from their peers.2 There is a danger of a widening gap What other approaches to improving healthcare are there? between this group and the majority of healthcare professionals. Taking considered action to change healthcare for the better is This article will make it easier for those new to QI to understand not new, but QI as a distinct approach to improving healthcare is what it is, where it fits with other approaches to improving care a relatively recent development. There are many well established (such as audit or research), when best to use a QI approach, approaches to evaluating and making changes to healthcare making it easier to understand the relevance and usefulness of QI services in use, and QI will only be adopted more widely if it offers in delivering better outcomes for patients. a new perspective or an advantage over other approaches in certain situations. How is quality improvement defined? A non-systematic literature scan identified the following other There are many definitions of QI (box 1). The BMJ’s Quality approaches for making change in healthcare: research, clinical Improvement series uses the Academy of Medical Royal Colleges audit, service evaluation, and clinical transformation. We also definition.6 Rather than viewing QI as a single method or set of identified innovation as an important catalyst for change, but tools, it can be more helpful to think of QI as based on a set of we did not consider it an approach to evaluating and changing principles common to many of these definitions: a systematic healthcare services so much as a catch-all term for describing the continuous approach that aims to solve problems in healthcare, development and introduction of new ideas into the system. A improve service provision, and ultimately provide better outcomes summary of the different approaches and their definition is shown for patients. in box 3. Many have elements in common with QI, but there are In this article we discuss QI as an approach to improving important difference in both intent and application. To be useful healthcare that follows the principles outlined in box 2; this may to clinicians and managers, QI must find a role within healthcare that complements research, audit, service evaluation, and clinical P transformation while retaining the core principles that differentiate How patients were involved in the creation of this article it from these approaches. This article was conceived and developed in response to conversations with clinicians and patients working together on co-produced quality Why do we need to make this distinction for QI to succeed? 22 improvement and research projects in a large UK hospital. The first Improvement in healthcare is 20% technical and 80% human. iteration of the article was reviewed by an expert patient, and, in Essential to that 80% is clear communication, clarity of approach, response to their feedback, we have sought to make clearer the link and a common language. Without this shared understanding of QI between understanding the issues raised and better patient care. as a distinct approach to change, QI work risks straying from the core principles outlined above, making it less likely to succeed.

What you need to know Box 1: Definitions of quality improvement • Thinking of quality improvement (QI) as a principle-based • Improvement in patient outcomes, system performance, approach to change provides greater clarity about (a) the and professional development that results from a combined, contribution QI offers to staff and patients, (b) how to multidisciplinary approach in how change is delivered.3 differentiate it from other approaches, (c) the benefits of • The delivery of healthcare with improved outcomes and lower cost using QI together with other change approaches through continuous redesigning of work processes and systems.4 • QI is not a silver bullet for all changes required in • Using a systematic change method and strategies to improve patient healthcare: it has great potential to be used together with experience and outcome.5 other change approaches, either concurrently (using audit • To make a difference to patients by improving safety, effectiveness, to inform iterative tests of change) or consecutively (using and experience of care by using understanding of our complex QI to adapt published research to local context) healthcare environment, applying a systematic approach, and • As QI becomes established, opportunities for these designing, testing, and implementing changes using real time collaborations will grow, to the benefit of patients. measurement for improvement.6 the bmj | BMJ 2020;368:m865 | doi: 10.1136/bmj.m865 65 EDUCATION

Box 2: Principles of QI • Primary intent—To bring about measurable improvement to a specific aspect of healthcare delivery, often with evidence or theory of what might work but requiring local iterative testing to find the best solution.7 • Employing an iterative process of testing change ideas—Adopting a theory of change which emphasises a continuous process of planning and testing changes, studying and learning from comparing the results to a predicted outcome, and adapting hypotheses in response to results of previous tests.8 9 • Consistent use of an agreed methodology—Many different QI methodologies are available; commonly cited methodologies include the Model for Improvement, Lean, Six Sigma, and Experience-based Co-design.4 Systematic review shows that the choice of tools or methodologies has little impact on the success of QI provided that the chosen methodology is followed consistently.10 Though there is no formal agreement on what constitutes a QI tool, it would include activities such as process mapping that can be used within a range of QI methodological approaches. NHS Scotland’s Quality Improvement Hub has a glossary of commonly used tools in QI.11 • Empowerment of front line staff and service users—QI work should engage staff and patients by providing them with the opportunity and skills to contribute to improvement work. Recognition of this need often manifests in drives from senior leadership or management to build QI capability in healthcare organisations, but it also requires that frontline staff and service users feel able to make use of these skills and take ownership of improvement work.12 • Using data to drive improvement—To drive decision making by measuring the impact of tests of change over time and understanding variation in processes and outcomes. Measurement for improvement typically prioritises this narrative approach over concerns around exactness and completeness of data.13 14 • Scale-up and spread, with adaptation to context—As interventions tested using a QI approach are scaled up and the degree of belief in their efficacy increases, it is desirable that they spread outward and be adopted by others. Key to successful diffusion of improvement is the adaption of interventions to new environments, patient and staff groups, available resources, and even personal preferences of healthcare providers in surrounding areas, again using an iterative testing approach.15 16

If practitioners cannot communicate clearly with their colleagues each other may mean missed opportunities for multi-pronged about the key principles and differences of a QI approach, there will approaches to improving care. be mismatched expectations about what QI is and how it is used, lowering the chance that QI work will be effective in improving What is the relationship between QI and other approaches such as audit? outcomes for patients.23 Academic journals, healthcare providers, and “arms-length There is also a risk that the language of QI is adopted to describe bodies” have made various attempts to distinguish between the change efforts regardless of their fidelity to a QI approach, either different approaches to improving healthcare.19 26-28 However, due to a lack of understanding of QI or a lack of intention to carry most comparisons do not include QI or compare QI to only one or it out consistently.9 Poor fidelity to the core principles of QI reduces two of the other approaches.7 29-31 To make it easier for people to its effectiveness and makes its desired outcome less likely, leading use QI approaches effectively and appropriately, we summarise to wasted effort by participants and decreasing its credibility.2 8 24 the similarities, differences, and crossover between QI and other This in turn further widens the gap between advocates of QI and approaches to tackling healthcare challenges (fig 1). those inclined to scepticism, and may lead to missed opportunities to use QI more widely, consequently leading to variation in the QI and research quality of patient care. Overview Without articulating the differences between QI and other Research aims to generate new generalisable knowledge, while approaches, there is a risk of not being able to identify where a QI QI typically involves a combination of generating new knowledge approach can best add value. Conversely, we might be tempted to or implementing existing knowledge within a specific setting.32 see QI as a “silver bullet” for every healthcare challenge when a Unlike research, including pragmatic research designed to test different approach may be more effective. In reality it is not clear effectiveness of interventions in real life, QI does not aim to provide that QI will be fit for purpose in tackling all of the wicked problems generalisable knowledge. In common with QI, research requires a of healthcare delivery and we must be able to identify the right tool consistent methodology. This method is typically used, however, for the job in each situation.25 Finally, while different approaches to prove or disprove a fixed hypothesis rather than the adaptive will be better suited to different types of challenge, not having a hypotheses developed through the iterative testing of ideas typical clear understanding of how approaches differ and complement of QI. Both research and QI are interested in the environment where

Box 3: Alternatives to QI Research—The attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.17 Clinical audit—A way to find out if healthcare is being provided in line with standards and to let care providers and patients know where their service is doing well, and where there could be improvements.18 Service evaluation—A process of investigating the effectiveness or efficiency of a service with the purpose of generating information for local decision making about the service.19 Clinical transformation—An umbrella term for more radical approaches to change; a deliberate, planned process to make dramatic and irreversible changes to how care is delivered.20 Innovation—To develop and deliver new or improved health policies, systems, products and technologies, and services and delivery methods that improve people’s health. Health innovation responds to unmet needs by employing new ways of thinking and working.21

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Clinical audit Research

“A way to find out if healthcare is being “The attempt to derive generalisable new provided in line with standards and let care knowledge by addressing clearly defined providers and patients know where their questions with systematic and rigorous service is doing well, and where there could methods” (Department of Health 2005) be improvements” (NHS England 2018) It starts from a hypothesis which is tested and Audit is a useful QI work may raise measured using a rigorous scientific approach Provides assurance that we are adhering to measurement tool questions about best practice, identifies shortfalls in practice, within a QI project, best practice which Research requires careful planning and often and suggests corrective actions to set a baseline help to identify funding and ethical approval to proceed or to study the research Use audit to provide assurance or improve the impact of a change opportunities Use research to derive generalisable new extent to which best practice is being followed knowledge to drive clinical care forward

Clinical audit may identify Quality improvement (QI) areas of non-compliance Using QI can help to test whether with best practice that would an intervention proven elsewhere A principle-based approach to continuously beneﬁt from a QI approach can also work here and support improving aspects of healthcare with a focus adaptation to local context on iterative change, learning, and adaptation

QI seeks to engage staﬀ and patients to change culture as well as processes and systems

Change using QI can be adapted and spread Service evaluation can be used to identify across teams and organisations shortfalls in services that would beneﬁt from QI allows the small scale testing a QI approach. It can also assess a service’s Use Quality Improvement to make small or piloting of ideas before they readiness for change or identify risks changes that will have a big impact are implemented in full as part associated with change of a transformation project

Service evaluation Upskilling staff in QI as part of a Clinical transformation “A process of investigating the effectiveness transformation project provides or efficiency of a service with the purpose of them with the skills to problem “A deliberate, planned process that sets out a generating information for local decision solve or tweak things after a large high aspiration to make dramatic and making about the service” (Healthcare Quality change has been completed irreversible changes to how care is delivered” Improvement Partnership 2011) (Health Foundation 2015)

ProvidesService evaluation assurance is that broad we and are adheringmay consider to It may be driven by clinical need, the need to bestfinancial practice, sustainability identifies and shortfalls workforce in practice, planning modernise, or by external demands. May andin addition suggests to qualitycorrective of service actions provided involve consultation with staff and partners

Use auditservice to evaluation provide assurance to take a or snapshot improve the Use a transformation approach when large extentof how toa service which best is performing practice is being followed scale change is required

Fig 1 | How quality improvement interacts with other approaches to improving healthcare work is conducted, though with different intentions: research aims local context of individual healthcare providers, generating new to eliminate or at least reduce the impact of many variables to knowledge in the process. Areas with little existing knowledge create generalisable knowledge, whereas QI seeks to understand requiring further research may be identified during improvement what works best in a given context. The rigour of data collection activities, which in turn can form research questions for further and analysis required for research is much higher; in QI a criterion study. QI and research also intersect in the field of improvement of “good enough” is often applied. science, the academic study of QI methods which seeks to ensure QI is carried out as effectively as possible.34 Relationship with QI Though the goal of clinical research is to develop new knowledge QI and clinical audit that will lead to changes in practice, much has been written on the Overview lag time between publication of research evidence and system- Clinical audit is closely related to QI: it is often used with the wide adoption, leading to delays in patients benefitting from new intention of iteratively improving the standard of healthcare, albeit treatments or interventions.33 QI offers a way to iteratively test the in relation to a pre-determined standard of best practice.35 When conditions required to adapt published research findings to the used iteratively, interspersed with improvement action, the clinical the bmj | BMJ 2020;368:m865 | doi: 10.1136/bmj.m865 67 EDUCATION audit cycle adheres to many of the principles of QI. However, in that there are inconsistencies in the methodology for carrying practice clinical audit is often used by healthcare organisations as it out. While the primary intent for QI is to make change that an assurance function, making it less likely to be carried out with will drive improvement, the primary intent for evaluation is a focus on empowering staff and service users to make changes to to assess the performance of current patient care.38 Service practice.36 Furthermore, academic reviews of audit programmes evaluation may be carried out proactively to assess a service have shown audit to be an ineffective approach to improving against its stated aims or to review the quality of patient care, quality due to a focus on data collection and analysis without a or may be commissioned in response to serious patient harm well developed approach to the action section of the audit cycle.37 or red flags about service performance. The purpose of service Clinical audits, such as the National Clinical Audit Programme evaluation is to help local decision makers determine whether in the UK (NCAPOP), often focus on the management of specific a service is fit for purpose and, if necessary, identify areas for clinical conditions. QI can focus on any part of service delivery and improvement. can take a more cross-cutting view which may identify issues and solutions that benefit multiple patient groups and pathways.30 Relationship with QI Service evaluation may be used to initiate QI activity by identifying Relationship with QI opportunities for change that would benefit from a QI approach. Audit is often the first step in a QI process and is used to identify It may also evaluate the impact of changes made using QI, either improvement opportunities, particularly where compliance during the work or after completion to assess sustainability of with known standards for high quality patient care needs to be improvements made. Though likely planned as separate activities, improved. Audit can be used to establish a baseline and to analyse service evaluation and QI may overlap and inform each other as the impact of tests of change against the baseline. Also, once an they both develop. Service evaluation may also make a judgment improvement project is under way, audit may form part of rapid about a service’s readiness for change and identify any barriers to, cycle evaluation, during the iterative testing phase, to understand or prerequisites for, carrying out QI. the impact of the idea being tested. Regular clinical audit may be a useful assurance tool to help track whether improvements have QI and clinical transformation been sustained over time. Overview Clinical transformation involves radical, dramatic, and irreversible QI and service evaluation change—the sort of change that cannot be achieved through Overview continuous improvement alone. As with service evaluation, there In practice, service evaluation is not subject to the same rigorous is no consensus on what clinical transformation entails, and it may definition or governance as research or clinical audit, meaning be best thought of as an umbrella term for the large scale reform or redesign of clinical services and the non-clinical services that support them.20 39 While it is possible to carry out transformation Scenario: QI for translational research activity that uses elements of QI approach, such as effective Newly published research shows that a particular physiotherapy engagement of the staff and patients involved, QI which rests on intervention is more clinically effective when delivered in short, iterative test of change cannot have a transformational approach— twice-daily bursts rather than longer, less frequent sessions. A team that is, one-off, irreversible change. of hospital physiotherapists wish to implement the change but are unclear how they will manage the shift in workload and how they should Relationship with QI introduce this potentially disruptive change to staff and to patients. There is opportunity to use QI to identify and test ideas before full scale clinical transformation is implemented. This • Before continuing reading think about your own practice—How would you approach this situation, and how would you use the QI principles described in this article? Scenario: Audit and QI Adopting a QI approach, the team realise that, although the change A foundation year 2 (FY2) doctor is asked to complete an audit of they want to make is already determined, the way in which it is a pre-surgical pathway by looking retrospectively through patient introduced and adapted to their wards is for them to decide. They documentation. She concludes that adherence to best practice is take time to explain the benefits of the change to colleagues and their mixed and recommends: “Remind the team of the importance of being current patients, and ask patients how they would best like to receive thorough in this respect and re-audit in 6 months.” The results are their extra physiotherapy sessions. presented at an audit meeting, but a re-audit a year later by a new FY2 doctor shows similar results. The change is planned and tested for two weeks with one physiotherapist working with a small number of patients. Data are • Before continuing reading think about your own practice—How would collected each day, including reasons why sessions were missed or you approach this situation, and how would you use the QI principles refused. The team review the data each day and make iterative changes described in this paper? to the physiotherapist’s schedule, and to the times of day the sessions Contrast the above with a team-led, rapid cycle audit in which everyone are offered to patients. Once an improvement is seen, this new way of contributes to collecting and reviewing data from the previous week, working is scaled up to all of the patients on the ward. discussed at a regular team meeting. Though surgical patients are The findings of the work are fed into a service evaluation of often transient, their experience of care and ideas for improvement are physiotherapy provision across the hospital, which uses the findings captured during discharge conversations. The team identify and test of the QI work to make recommendations about how physiotherapy several iterative changes to care processes. They document and test provision should be structured in the future. People feel more positive these changes between audits, leading to sustainable change. Some of about the change because they know colleagues who have already the surgeons involved work across multiple hospitals, and spread some made it work in practice. of the improvements, with the audit tool, as they go.

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Contributors: This work was initially conceived by AB. AB and FO were responsible for Scenario: QI and clinical transformation the research and drafting of the article. AB is the guarantor of the article. An NHS trust’s human resources (HR) team is struggling to manage its Competing interests: We have read and understood BMJ policy on declaration of junior doctor placements, rotas, and on-call duties, which is causing interests and have no relevant interests to declare. tension and has led to concern about medical cover and patient safety Provenance and peer review: This article is part of a series commissioned by The BMJ based on ideas generated by a joint editorial group with members from the Health out of hours. A neighbouring trust has launched a smartphone app that Foundation and The BMJ, including a patient/carer. The BMJ retained full editorial control supports clinicians and HR colleagues to manage these processes with over external peer review, editing, and publication. Open access fees and The BMJ’s the great success. quality improvement editor post are funded by the Health Foundation. This is an Open Access article distributed in accordance with the Creative Commons This problem feels ripe for a transformation approach—to launch the Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, app across the trust, confident that it will solve the trust’s problems. remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non- • Before continuing reading think about your own organisation—What commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. do you think will happen, and how would you use the QI principles described in this article for this situation? 1 Jones B, Vaux E, Olsson-Brown A. How to get started in quality improvement. BMJ 2019;364:k5408. doi:10.1136/bmj.k5437 Outcome without QI 2 Dixon-Woods M, Martin GP. Does quality improvement improve quality?Future Hosp Unfortunately, the HR team haven’t taken the time to understand the J 2016;3:191-4. doi:10.7861/futurehosp.3-3-191 3 Batalden PB, Davidoff F. What is “quality improvement” and how can it transform underlying problems with their current system, which revolve around healthcare?Qual Saf Health Care 2007;16:2-3. doi:10.1136/qshc.2006.022046 poor communication and clarity from the HR team, based on not 4 Ham C, Berwick D, Dixon J. Improving quality in the English NHS: A strategy for knowing who to contact and being unable to answer questions. HR action. King’s Fund, 2016. 5 Øvretveit J. Does improving quality save money? Health Foundation, 2009. assume that because the app has been a success elsewhere, it will work 6 Academy of Medical Royal Colleges. Quality improvement - Training for better here as well. outcomes. AMRoC, 2016. 7 Ogrinc G, Nelson WA, Adams SM, O’Hara AE. An instrument to differentiate between People get excited about the new app and the benefits it will bring, but clinical research and quality improvement. IRB 2013;35:1-8. no consideration is given to the processes and relationships that need 8 Reed JE, Card AJ. The problem with Plan-Do-Study-Act cycles. BMJ Qual Saf 2016;25:147- 52. doi:10.1136/bmjqs-2015-005076 to be in place to make it work. The app is launched with a high profile 9 McNicholas C, Lennox L, Woodcock T, Bell D, Reed JE. Evolving quality improvement campaign and adoption is high, but the same issues continue. The HR support strategies to improve Plan-Do-Study-Act cycle fidelity: a retrospective mixed- team are confused as to why things didn’t work. methods study. BMJ Qual Saf 2019;28:356-65. doi:10.1136/bmjqs-2017-007605 10 Alderwick H, et al. Making the case for quality improvement: lessons for NHS boards and Outcome with QI leaders. King’s Fund, 2017. 11 NHS Scotland Quality Improvement Hub. Quality improvement glossary of terms. http:// Although the app has worked elsewhere, rolling it out without adapting www.qihub.scot.nhs.uk/qi-basics/quality-improvement-glossary-of-terms.aspx. it to local context is a risk – one which application of QI principles can 12 Dixon-Woods M, McNicol S, Martin G. Ten challenges in improving quality in healthcare: lessons from the Health Foundation’s programme evaluations and relevant literature. mitigate. BMJ Qual Saf 2012;21:876-84. doi:10.1136/bmjqs-2011-000760 HR pilot the app in a volunteer speciality after spending time speaking 13 Solberg LI, Mosser G, McDonald S. The three faces of performance measurement: improvement, accountability, and research. Jt Comm J Qual Improv 1997;23:135-47. to clinicians to better understand their needs. They carry out several doi:10.1016/S1070-3241(16)30305-4 tests of change, ironing out issues with the process as they go, using 14 Shah A. Using data for improvement. BMJ 2019;364:l189. doi:10.1136/bmj.l189 issues logged and clinician feedback as a source of data. When they are 15 Massoud MR, Barry D, Murphy A, Albrecht Y, Sax S, Parchman M. How do we learn about improving health care: a call for a new epistemological paradigm. Int J Qual Health confident the app works for them, they expand out to a directorate, a Care 2016;28:420-4. doi:10.1093/intqhc/mzw039 division, and finally the transformational step of an organisation-wide 16 Horton T, Illingworth J, Warbuton W. The spread challenge - How to support the successful uptake of innovations and improvements in health care. Health Foundation, 2018. rollout can be taken. 17 Department of Health. Research governance framework for health and social care. 2nd ed. DoH, 2005. 18 NHS England. Clinical audit. https://www.england.nhs.uk/clinaudit/. 19 Healthcare Quality Improvement Partnership. A guide for clinical audit, research and has the benefit of engaging staff and patients in the clinical service review — An educational toolkit designed to help staff differentiate between transformation process and increasing the degree of belief clinical audit, research and service review activities. HQIP, 2011. 20 McKinsey Hospital Institute. Transformational change in NHS providers. Health that clinical transformation will be effective or beneficial. Foundation, 2015. Transformation activity, once completed, could be followed 21 World Health Organization. WHO Health Innovation Group. 2019. https://www.who.int/ up with QI activity to drive continuous improvement of the life-course/about/who-health-innovation-group/en/. 22 Sheffield Microsystem Coaching Academy. Final Report Sheffield Microsystem Coaching new process or allow adaption of new ways of working. As Academy. 2016. interventions made using QI are scaled up and spread, the line 23 Davidoff F, Dixon-Woods M, Leviton L, Michie S. Demystifying theory and its use in improvement. BMJ Qual Saf 2015;24:228-38. doi:10.1136/bmjqs-2014-003627 between QI and transformation may seem to blur. The shift from 24 Taylor MJ, McNicholas C, Nicolay C, Darzi A, Bell D, Reed JE. Systematic review of the QI to transformation occurs when the intention of the work shifts application of the plan-do-study-act method to improve quality in healthcare. BMJ Qual away from continuous testing and adaptation into the wholesale Saf 2014;23:290-8. doi:10.1136/bmjqs-2013-001862 25 Dixon-Woods M, Martin G, Tarrant C, et al. Safer Clinical Systems: evaluation findings. implementation of an agreed solution. Learning from the independent evaluation of the second phase of the Safer Clinical Systems programme. Health Foundation, 2014. 26 Twycross A, Shorten A. Service evaluation, audit and research: what is the difference?Evid Based Nurs 2014;17:65-6. doi:10.1136/eb-2014-101871 Education into practice 27 University Hospitals Bristol NHS Foundation Trust. Is your study research, audit or service evaluation. http://www.uhbristol.nhs.uk/research-innovation/for-researchers/is-it- Next time when faced with what looks like a quality improvement (QI) research,-audit-or-service-evaluation/. opportunity, consider asking: 28 University of Sheffield. Differentiating audit, service evaluation and research. 2006. https://www.sheffield.ac.uk/polopoly_fs/1.158539!/file/AuditorResearch.pdf. • How do you know that QI is the best approach to this situation? What 29 Royal College of Radiologists. Audit and quality improvement. https://www.rcr.ac.uk/ else might be appropriate? clinical-radiology/audit-and-quality-improvement. • Have you considered how to ensure you implement QI according to 30 Limb C, Fowler A, Gundogan B, Koshy K, Agha R. How to conduct a clinical audit and quality improvement project. Int J Surg Oncol (N Y) 2017;2:e24. doi:10.1097/ the principles described above? IJ9.0000000000000024 • Is there opportunity to use other approaches in tandem with QI for a 31 Hill SL, Small N. Differentiating between research, audit and quality improvement: governance implications. Clin Gov 2006;11:98-107. more effective result? doi:10.1108/14777270610660475 the bmj | BMJ 2020;368:m865 | doi: 10.1136/bmj.m865 69 EDUCATION

32 Finkelstein JA, Brickman AL, Capron A, et al. Oversight on the borderline: 37 Hillman T, Roueche A.Quality improvement. BMJ Careers 2011;342:d2060. Quality improvement and pragmatic research. Clin Trials 2015;12:457-66. doi:10.1136/bmj.d2060 doi:10.1177/1740774515597682 38 NHS Health Research Authority. Defining research. 2013. https://www.clahrc-eoe.nihr. 33 Collins B. Adoption and spread of innovation in the NHS. King’s Fund, 2018. ac.uk/wp-content/uploads/2014/04/defining-research.pdf. 34 Health Foundation. Evidence scan: improvement science. Health Foundation, 2011. 39 Randhawa M. Is transformation in the NHS really transformational? King’s Fund, 2018. 35 Healthcare Quality Improvement Partnership. Best practice in clinical audit. HQIP, 2016. 36 Johnston G, Crombie IK, Davies HT, Alder EM, Millard A. Reviewing audit: barriers and facilitating factors for effective clinical audit. Qual Health Care 2000;9:23-36. Cite this as: BMJ 2020;368:m865 doi:10.1136/qhc.9.1.23 http://dx.doi.org/10.1136/bmj.m865

70 doi: 10.1136/bmj.m865 | BMJ 2020;368:m865 | the bmj EDUCATION How to improve care across boundaries Charles Coughlan,1 Nishma Manek,2 Yasmin Razak,3 Robert E Klaber1

1Imperial College Healthcare NHS Trust, London, UK moves beyond reductive and compartmentalised approaches 2Cambridge, UK towards cross-boundary, coordinated, and person-centred care. 3Golborne Medical Centre, London, UK In the UK, many primary and secondary care organisations are Correspondence to: C Coughlan working at maximum capacity. Finding new ways of working that [email protected] bridge traditional divides can improve patient experience without overburdening professionals. Clinicians can learn new skills from Integrated care is a healthcare approach focused around the their colleagues, and, by engaging in genuine co-production, patient perspective, which aims to promote better coordination and discover what really matters to patients and carers. This is especially 1 continuity of care across organisational boundaries. Integrated pertinent to patients living with long term conditions, who require 2 3 care can improve patient experience and reduce duplication. regular contact with healthcare services. However, structural and cultural differences between physical and mental health services and across the primary and secondary What is the evidence for integrated care? care divide can impede its delivery. Perverse financial incentives Most integrated care evaluations have been performed in Western and outdated expectations of doctor and patient roles are further European and North American settings.5 4 Several thousand studies barriers to improving care across boundaries. Changes in service have been conducted worldwide, and the volume of literature commissioning and organisational culture may promote integrated has expanded threefold since 2007.6 Integrated care models care, but its delivery ultimately depends on the skills, behaviour, have largely focused on adults with long term conditions, though and engagement of healthcare workers. specialty-specific models have been described.7 Interventions are This article will explore the rationale and evidence base often complex and multifaceted. They include the introduction of for integrated care and highlight salient examples of quality joint clinics, multidisciplinary team meetings, staff education, and improvement (QI) across organisational boundaries in the UK new financial models. Outcomes of interest include patient and and beyond. We aim to provide clinicians with a practical guide staff satisfaction, health and social care resource utilisation and to implementing locally relevant, sustainable, and patient-centred cost.5 change across boundaries. High quality systematic reviews suggest that integrated care can deliver improvements in patient experience and access to Why is it important to improve care across boundaries? healthcare.5 8 Evidence for economic benefits and improvements in The consequences of ill health extend beyond physical symptoms. staff satisfaction is more equivocal.9 Disease can affect an individual’s mental health, independence Most integrated care studies are small and descriptive and fail to and family life. Patients want to receive responsive and holistic care account for the effects of local contextual factors on outcomes.10 from a trusted professional, in the right place and at the right time. The absence of well matched control groups in many interventional Siloed and fragmented health systems encourage professionals studies has frustrated efforts to ascertain precisely what caused an to treat clinical problems in isolation; patients’ wider health and intervention to succeed or fail, limiting generalisability and spread social and spiritual needs may remain unmet. Integrated care of best practice.11 Successful implementation of change across P boundaries seems to be context-dependent. Emerging evidence How patients were involved in the creation of this article has identified organisational culture, motivation of front line professionals, and funding12 as key factors influencing the delivery When planning this article, we asked a parent volunteer with of integrated care. experience of leading community based quality improvement (QI) work in North West London for her views on this topic. She said that What are the challenges and impediments to improving quality across sustained support from clinical staff was crucial in driving patient- whole systems? led improvement efforts; her involvement in QI also allowed her to Quality improvement (QI) across boundaries may form part of see the difference she could make to her local community. A second a wider strategy supporting integration of care at local, regional patient provided a written account summarising the benefits he had or national levels, or stem from grassroots initiatives conducted experienced as a result of improved coordination of care for his long by small clinician and patient networks. These “top-down” and term conditions. He also read through and commented on the final “bottom-up” approaches illustrate that there is no “one size fits all” draft of this article. method to achieve integrated care. None the less, several factors consistently promote (box 1) and impede improvement work. What you need to know Improving quality across organisational boundaries requires dedicated leadership from clinicians, managers, commissioners, • Integrated care aims to improve coordination and and patients and carers. NHS Improvement estimates that 5% of continuity of care for patients across organisational an organisation’s workforce must receive formal training in QI boundaries methodology to foster a culture of continuous improvement,13 • There are many different approaches to improving care but providing time and space for QI is challenging in the current across boundaries climate.14 • Improving care calls for effective and accountable Working across boundaries calls for cultivation of a shared leadership, agreement on a shared vision of improvement, vision between groups with potentially competing interests. and sustained patient involvement Stakeholders must invest time and effort in building relationships, the bmj | BMJ 2020;369:m1045 | doi: 10.1136/bmj.m1045 71 EDUCATION and larger organisations must convince smaller providers that understanding of patient problems—are therefore invaluable. integrated care will provide mutual benefits rather than one-sided Professionals must show leadership to build networks and give financial returns.15 Top-down approaches may necessitate changes patients a voice; these skills can be honed through participation in in commissioning practices to provide financial incentives for QI forums and formal training programmes. collaboration.1 As those most affected by changes to health systems, patients Separate computer systems in primary and secondary care should be placed at the centre of service redesign. Co-production frustrate clinicians’ efforts to form a holistic impression of a allows professionals to see and learn from the patient’s perspective, patient’s health needs and institute optimal treatment. Robust but patient involvement will be meaningful and sustainable only if information governance frameworks and data sharing agreements patients are involved from the outset, clear on their responsibilities, are needed to promote confidence in using electronic shared and receive support from senior clinicians and managers. Careful records and other tools. thought should be given to involving vulnerable patients or their The patient perspective is central to all integrated care advocates to avoid exacerbating existing health inequalities. programmes. Where possible, patients should be involved in In our experience, building relationships, maintaining patient planning, conducting, and evaluating improvement work, with involvement, and developing clinical leadership are essential sufficient support to avoid tokenistic engagement.16 Efforts must (fig 1).20 The following examples highlight approaches that clinical be made to reach vulnerable and disadvantaged patient groups teams have taken to address these challenges in the UK and to avoid the unintended consequence of building inequality into beyond. Table 1 shows a worked example of a QI project across integrated care models.17 organisational boundaries.

How to do it well Building relationships Clinicians, commissioners, and policymakers working across Connecting Care for Adults (CC4A), a team of hospital specialists the health system need to understand which behaviour changes based at Imperial College Healthcare NHS Trust, has developed promote integrated care and how best to implement them. They are a model that up-skills GPs caring for adults with long term currently limited by a lack of high quality evidence. conditions. This grassroots initiative was embedded within an Current evidence suggests that there is no universal method overarching programme that seeks to deliver integrated care across to improve care across boundaries. Strategic and grassroots North West London through service commissioning.18 Specialists approaches are not mutually exclusive and can be synergistic in and GPs conducted joint virtual registry reviews for patients living driving change. Commissioning for improvement can remove with chronic illnesses such as heart failure. Clinicians used a digital financial barriers to collaboration, but commissioning alone may be shared care record integrating primary, secondary, and social care insufficient to generate sustainable change.18 Patient populations data from eight London boroughs to create personalised care plans. exhibit different behaviours and health beliefs, so we must GPs felt more confident in supporting their patients; specialists canvass professionals and patients to identify locally relevant and received detailed feedback on their correspondence with primary tractable change ideas. The perspectives of general practitioners care; and patients had their care optimised by a specialist physician (GPs)—a group with substantial social capital19 and a rounded without attending in person.21 The sustained success of this approach rests on the strength of the relationships built between GPs and specialists, rational use of digital tools, and inter-professional feedback and education. Box 2 Box 1: General principles supporting improvement across whole contains a patient’s account of the impact of this intervention on systems his experience of living with long term conditions. Stakeholder engagement • Identify and engage stakeholders affected by changes—patients and Patient involvement staff As those most affected by QI and clinical transformation projects, • Identify and engage people who are central to the success of the patients can and should play a role in their design. Several project—senior clinicians, managers, and commissioners prominent examples of patient involvement in QI come from the Agree coordinated strategy Swedish region of Jönköping, which boasts a dedicated centre • Develop shared objectives for innovation and improvement known as the Qulturum. This • Clearly assign professional responsibility for clinical and provides patients and healthcare professionals with training to administrative tasks enhance the patient voice and incorporate it into QI. Patients are • Establish provisional timeframe for interventions, analysis, and invited to explore their experiences with clinicians at informal feedback coffee mornings and contribute to simulations that seek to redesign 22 Effective and accountable leadership clinical pathways around the patient experience. • Flatten hierarchies to encourage staff feedback during periods of For example, one group of patients has worked with specialist change nurses to develop a new method of dialysis that maximises patient • Advocate for patient involvement autonomy and increases system capacity in an area with rising demand. Dialysis-dependent patients attending the county’s Maintain staff and patient involvement and momentum Ryhov Hospital are trained to use and maintain dialysis equipment • Inter-professional and patient education independently. In the words of Goran Henriks, chief executive of • Building relationships within and between clinical teams the Qulturum: “[Patients] no longer think of themselves as sick • Training and up-skilling healthcare professionals people, but as healthy people with a need for dialysis.”23 Meaningful patient engagement • Involve patients in all stages of QI from design to dissemination Leadership • Measure outcomes that matter to patients Several organisations now seek to provide clinicians with formal • Assign clear roles and responsibilities and manage expectations training in leadership and improvement science, while others

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Identify Clinical problem Core team Patient population Patient representatives Key stakeholders

Planning Determine Shared vision and objectives Mutual guidelines Project leader Interventions Measures and outcomes

Implementation

Serial PDSA (plan-do-study-act) cycles

Review Review Real-time measurement Up-scale or change strategy

Sharing Feedback to patients and stakeholders Sharing Conferences and publications Disseminate in community

Fig 1 | Stepwise approach to delivering improved care across boundaries. Adapted with permission from Kvamme et al.20 promote collaboration between QI leaders to hasten the spread of The team behind the UK’s first Big Room has now established a ideas and best practice. national Flow Coaching Academy in Sheffield. Frontline staff from The adoption of “Big Rooms” across the UK represents a across the UK undertake a 12 month programme that trains them paradigm shift in the field of QI. These QI forums, which bring to coach Big Rooms in their workplace. Big Rooms have already frontline staff together in structured weekly meetings, provide an produced impressive results, such as a reduction in time to surgery environment in which QI can thrive. Trained “flow coaches” work in patients with acute cholecystitis and a reduction in sepsis related with colleagues to develop a systematic plan for improvement mortality among hospital inpatients.25 The success of this model of a patient pathway using QI techniques and tools including stems from multidisciplinary team working, strong leadership from stakeholder engagement, logic models, and process mapping. coaches and clinicians, and sustained engagement of frontline Staff use plan-do-study-act (PDSA) cycles to evaluate small tests staff, who can suggest and test locally relevant change ideas. of change, and clinical data are displayed in statistical process In primary care, emerging leadership initiatives such as control charts to monitor progress.24 “Next Generation GP” aim to provide trainees with the skills

Table 1 | Worked example of a project to improve the recognition and management of diabetic peripheral neuropathy in adult patients Key stage Specific example Clinical problem Management of diabetic peripheral neuropathy Patient population Patients >40 years of age living with type 1 or 2 diabetes and under the care of a single primary care network Patient representatives Invite 4-5 patients to participate—ideally from different GP practices and backgrounds and with different disease severity Key stakeholders Patients, carers, podiatrists, general practitioners, district nurses, specialist nurses, endocrinologists, orthopaedic and vascular surgeons Shared vision or objective Improved recognition, management, and prevention of diabetic peripheral neuropathy in primary and secondary care Shared guidelines Mutually acceptable guidelines for referral to secondary care Nominate project leader Diabetic specialist nurse, podiatrist, or general practitioner Plan interventions Multidisciplinary team meetings to facilitate personalised care planning. Joint clinics with specialist nurses or podiatrists in primary care. Peer mentoring sessions led by patients Measures that matter to Outcome measures—Number of days per month when activity limited by symptoms; hospitalisation; number of amputations patients and clinicians Process measures—Attendance at peer mentoring sessions the bmj | BMJ 2020;369:m1045 | doi: 10.1136/bmj.m1045 73 EDUCATION

Box 2: Patient perspective on remote registry reviews for chronic Conclusion disease Integrated care aims to improve patient experience by providing more holistic, coordinated, and person-centred care. Improving I am fortunate to be under the care of a clinic which has the benefit of quality across whole systems requires stakeholder engagement, virtual specialist support; many of my conditions are long term and agreement on a shared vision, clinical leadership, and patient require a high level of monitoring and care. My team at the clinic are involvement. Policy levers, commissioning, and organisational [now] able to coordinate this so much better…leaving me to lead a culture can promote integrated care, but the different health beliefs healthier life with fewer outpatient appointments. I much prefer this to and behaviours of patient populations dictate that there is no the standard approach in either the NHS or my private appointments, universal effective approach. Ultimately, the delivery of integrated where it can take many months to find solutions and clearly my health care depends on skilled and motivated frontline professionals would be at risk of deterioration. with adequate time, space, and support for innovation and A particular benefit is that I get specialist opinions about my improvement. conditions and treatment not only from the specialist consultants, whom I sometimes see privately, but also from the clinic’s NHS consultants who see the results of my pathology and other tests and Education into practice can discuss them with my team at the clinic. I would say that it has • Does your trust or general practice offer training in quality improved my relationship with my primary care team, and this can only improvement (QI) methodology to staff? be a good thing—the patient experience is much improved. • How can you empower your patient population to become involved in QI? • What would you like to learn from your colleagues in primary or needed to shape the system around them. Trainees participate secondary care? in regular workshops that empower them to enact change and provide a forum to share leaders’ personal stories. This helps them to understand the opportunities and challenges faced by Contributors: CC conceived the article and wrote the first draft. NM and YR highlighted 26 examples of quality improvement in primary care. NM, YR, and REK critically revised the leaders in primary, secondary, and social care. For those with manuscript for intellectual content. All authors revised subsequent drafts and approved more experience, the Health Foundation has established the Q the final version of the manuscript for publication. Community, which aims to connect over 3000 QI leaders across Competing interests: We have read and understood BMJ policy on declaration of the UK. This initiative allows clinicians to pool resources and interests and and declare the following interests: NM is co-founder of Next Generation GP. expertise and promotes collaboration to extend the scope and .27 Provenance and peer review: This article is part of a series commissioned by The reach of improvement work BMJ based on ideas generated by a joint editorial group with members from the Health Foundation and The BMJ, including a patient/carer. The BMJ retained full editorial control over external peer review, editing, and publication. Open access fees and The BMJ’s quality improvement editor post are funded by the Health Foundation. Additional education resources Patient consent: Patient consent obtained. • NHS Improvement. Improvement Fundamentals. https://www. Transparency: REK is guarantor for the manuscript and affirms that it offers an honest england.nhs.uk/sustainableimprovement/improvement- and accurate account of recent examples of quality improvement initiatives across the primary and secondary care divide and that no important aspects of this field have been fundamentals/ knowingly omitted. ○○Free online platform offering self directed mini-courses on quality This is an Open Access article distributed in accordance with the Creative Commons improvement (QI) for health and social care professionals. Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, Registration required remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non- • NHS Leadership Academy. Edward Jenner programme. https:// commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. www.leadershipacademy.nhs.uk/programmes/the-edward-jenner- programme/ 1 Shaw S, Rosen R, Rumbold B. What is integrated care? Nuffield Trust, 2011. https://www. nuffieldtrust.org.uk/files/2017-01/what-is-integrated-care-report-web-final.pdf. ○○Free online courses targeted at early career professionals. 2 Mastellos N, Gunn L, Harris M, Majeed A, Car J, Pappas Y. Assessing patients’ experience Completion of Launch and Foundations modules leads to an NHS of integrated care: a survey of patient views in the North West London Integrated Care Leadership Academy Award in Leadership Foundations. Registration Pilot. Int J Integr Care 2014;14:e015. doi:10.5334/ijic.1453 3 Care Quality Commission. Building bridges, breaking barriers. 2016. https://www.cqc. required org.uk/sites/default/files/20160712b_buildingbridges_report.pdf. • Harvard University. 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Int J Integr uk/ Care 2018;18:11. doi:10.5334/ijic.3975 7 Montgomery-Taylor S, Watson M, Klaber B. Child health—leading the way in integrated ○○Independent organisation that supports development of QI. Free care. J R Soc Med 2015;108:346-50. doi:10.1177/0141076815588315 resources include guides to promoting involvement of patients and 8 Powell Davies G, Williams AM, Larsen K, Perkins D, Roland M, Harris MF. Coordinating junior doctors in clinical audit and improvement work primary health care: an analysis of the outcomes of a systematic review. Med J Aust 2008;188(S8):S65-8. doi:10.5694/j.1326-5377.2008.tb01748.x Information source for patients 9 Nolte E, Pitchforth E. What is the evidence on the economic impacts of integrated care? • The Health Foundation. Quality improvement made simple. https:// Technical Report. World Health Organisation, 2014. https://researchonline.lshtm.ac.uk/ id/eprint/2530944. www.health.org.uk/publications/quality-improvement-made-simple 10 Ashton T. Implementing integrated models of care: the importance of the macro-level ○○This accessible guide from the Health Foundation provides an context. Int J Integr Care 2015;15:e019. doi:10.5334/ijic.2247 11 Goddard M, Mason AR. Integrated Care: A pill for all ills?Int J Health Policy overview of the importance of QI in the NHS and overseas Manag 2017;6:1-3. doi:10.15171/ijhpm.2016.111

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