Participant File

For this year’s HAS symposium, I wanted to focus on the contribution that patient and user perceptions can make to improving the quality of care and the health technology assessment (HTA).

As a public institution that plays an active role in ensuring the healthcare democracy, the HAS naturally incorporates patients and health system users in its research and methods. Our institution constantly seeks to innovate in this area. Examples of this include the cooperation framework introduced in 2008 giving expert status to association representatives taking part in our working groups and committees, the tracer patient method, the e-Satis tool to measure inpatient satisfaction and the brand new system being trialled getting patients involved in the HTA.

As far as I am concerned, it is essential that we further extend this approach. Patients - and all health system users more generally - are, in fact, the ultimate beneficiaries of the HAS’s commitment to care quality. Consequently, it is they who must be given priority in terms of guiding our strategies, products and methods. To move closer towards this goal, it is important to set aside time for forward-looking reflection and to consider the issue of their involvement from a scientific point of view, rather than a legal one. That is exactly what the “Patient dynamics: innovating and measuring” symposium sets out to do.

Which methods - either tried and tested or emerging - can we draw on to incorporate the perspective of patients and users? To what end? What is the impact of using patient experience on the quality of care, its relevance, medical decision making, and the assessment of medicines, medical devices and health strategies? More broadly, why, how, to what extent and how effectively can those who use the healthcare system every day serve as catalysts for its progress?

This scientific symposium aims to provide a collective platform for consideration of these issues, making the best possible use of French and international experience and research, from both the hospital and ambulatory sectors.

The sessions proposed are hinged around our main missions and challenges at the HAS.

Hence the first session presents various experiences of the involvement of users in healthcare structures, the aim being to improve quality of care on a collective level.

The second session seeks to identify how the analysis of individual patients’ expectations, perceptions and assessment of the outcome of their treatment constitute a lever for improving their care.

And finally, the third session explores how the contribution of patients and investigation of their preferences can play a useful role when assessing the benefits of a health product.

I would like to extend my warmest thanks to the speakers, some of whom have travelled from far afield. We are honoured that they accepted our invitation. There is no doubt that the research presented and the debate and discussions triggered will inspire innovative “user-centred” approaches and strategies, both within the Haute Autorité de Santé and on the part of the various health system players.

Prof. Agnès BuzynChair of the Board, Haute Autorité de Santé

For this year’s HAS symposium, I wanted to focus on the contribution that patient and user perceptions can make to improving the quality of care and the health technology assessment (HTA).

As a public institution that plays an active role in ensuring the healthcare democracy, the HAS naturally incorporates patients and health system users in its research and methods. Our institution constantly seeks to innovate in this area. Examples of this include the cooperation framework introduced in 2008 giving expert status to association representatives taking part in our working groups and committees, the tracer patient method, the e-Satis tool to measure inpatient satisfaction and the brand new system being trialled getting patients involved in the HTA.

As far as I am concerned, it is essential that we further extend this approach. Patients - and all health system users more generally - are, in fact, the ultimate beneficiaries of the HAS’s commitment to care quality. Consequently, it is they who must be given priority in terms of guiding our strategies, products and methods. To move closer towards this goal, it is important to set aside time for forward-looking reflection and to consider the issue of their involvement from a scientific point of view, rather than a legal one. That is exactly what the “Patient dynamics: innovating and measuring” symposium sets out to do.

Which methods - either tried and tested or emerging - can we draw on to incorporate the perspective of patients and users? To what end? What is the impact of using patient experience on the quality of care, its relevance, medical decision making, and the assessment of medicines, medical devices and health strategies? More broadly, why, how, to what extent and how effectively can those who use the healthcare system every day serve as catalysts for its progress?

This scientific symposium aims to provide a collective platform for consideration of these issues, making the best possible use of French and international experience and research, from both the hospital and ambulatory sectors.

The sessions proposed are hinged around our main missions and challenges at the HAS.

Hence the first session presents various experiences of the involvement of users in healthcare structures, the aim being to improve quality of care on a collective level.

The second session seeks to identify how the analysis of individual patients’ expectations, perceptions and assessment of the outcome of their treatment constitute a lever for improving their care.

And finally, the third session explores how the contribution of patients and investigation of their preferences can play a useful role when assessing the benefits of a health product.

I would like to extend my warmest thanks to the speakers, some of whom have travelled from far afield. We are honoured that they accepted our invitation. There is no doubt that the research presented and the debate and discussions triggered will inspire innovative “user-centred” approaches and strategies, both within the Haute Autorité de Santé and on the part of the various health system players.

Prof. Agnès BuzynChair of the Board, Haute Autorité de Santé

Editorial

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Scientific programme

8.15 – 9.00 a.m. Welcome

9.15 – 9.45 a.m. Opening addresses Agnès Buzyn, Chair of the Board, HAS Marisol Touraine, Minister for Social Affair and Health

9.45 – 11.15 a.m. Session 1 – The contribution of users in healthcare quality and safety improvement initiatives ModeratorMaud Guillaumin, JournalistGuest speakerAngela Coulter, Director of Global Initiatives, Informed Medical Decisions Foundation, USA

Involvement of users: force for progress in FranceVéronique Ghadi, Project Manager, Department for the Improvement of Healthcare Quality and Safety, HAS

American experiences of user and patient involvementArlene Bierman, Director, Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, USA

Patient leader approach to take on board the experience of careDavid Mc Nally, Deputy Director, Patient Experience, Directorate of Nursing Care, and Steve Sharples, Patient Leader, from the Patient Leaders Expert Advisory Group, NHS England

Montreal model, partnership between patients and health professionalsMarie-Pascale Pomey, Professor, Department of Health Administration, University of Montreal – Physician Advisor to the Institut national d’excellence en santé et services sociaux (National Insti-tute for Excellence in Healthcare and Social Services), Canada

Round tableArlene Bierman − Angela Coulter − Véronique Ghadi − David Mc Nally − Marie-Pascale Pomey − Steve Sharples

11.15 – 11.30 a.m. Break

11.30 a.m. – 1 p.m. Session 2 – From patient experience collecting to shared decision makingModeratorMaud GuillauminGuest speakerAngela Coulter

Listening to what the patient says: contribution of qualitative data collectionMartine Bungener, Economist, Sociologist, Emeritus Research Director, CNRS − CERMES3

Assessing patient experience of care: patient reported experience measures (PREMs) and patient reported outcome measures (PROMs)Arlene Bierman, Director, Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, USA

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Patient reported outcome measures (PROM’s), experience in allied health practicePhilip Van Der Wees, Senior Researcher, Scientific Institute for Quality of Healthcare (IQ healthcare), Radboud University Nijmegen Medical Centre, Netherlands

Shared decision making, experience of Massachusetts General HospitalKaren Sepucha, Assistant Professor of Medicine, Harvard Medical School, Massachusetts General Hospital, USA

Round tableArlene Bierman − Martine Bungener − Catherine Cerisey (Vice-Chair, Cancer Contribution Association − Administrator, Europa Donna – member of the patient information commission, HAS) − Angela Coulter − Catherine Grenier (Director for the Improvement of Healthcare Quality and Safety, HAS) − Karen Sepucha − Philip Van Der Wees

1 – 2.15 p.m. Lunch

2.15 – 3.45 p.m. Session 3 – The patient perspective in health technology assessmentModeratorMaud GuillauminGuest speaker Angela Coulter

Patient contributionsKaren Facey, International Health Policy Consultant

Example of an agency seeking to incorporate various forms of patient perspectiveLaura Weeks, Scientific Advisor, Canadian Agency for Drugs & Technologies in Health, Canada (video)

Pilot projects for the measurement of preferencesIrina Cleemput, Senior Health Economist, Belgian Health Care Knowledge Centre, KCE, Belgium Marion Danner, Research Associate, Institute for Health Economics and Clinical Epidemiology, Univer-sity Hospital of Cologne, Germany

Round tableAngela Coulter − Irina Cleemput − Marion Danner − Christophe Duguet (Public Affairs Manager, AFM-Téléthon – Member of the Economic Assessment and Public Health Commission, HAS) − Karen Facey − Catherine Rumeau-Pichon (Deputy Director of Medical, Economic and Public Health Assessment, HAS)

3.45 – 4.15 p.m. ConclusionAngela Coulter

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Guest speaker (Angela Coulter)

Session 1 – The contribution of users in healthcare quality and safety improvement initiatives

Involvement of users: force for progress in France (Véronique Ghadi)

American experiences of user and patient involvement (Arlene S. Bierman)

Patient leader approach to take on board the experience of care (David Mc Nally)

Montreal model, partnership between patients and health professionals (Marie-Pascale Pomey)

News from HAS: the patient tracer

Session 2 – From patient experience collecting to shared decision makingListening to what the patient says: contribution of qualitative data collection (Martine Bungener)

Assessing patient experience of care: patient reported experience measures (PREMs) and patient reported outcome measures (PROMs) (Arlene S. Bierman)

Patient reported outcome measures (PROMs), experience in allied health practice (Philip Van Der Wees)

Shared decision making, experience of Massachusetts General Hospital (Karen Sepucha)

News from HAS: e-Satis

Session 3 – The patient perspective in health technology assessmentPatient contributions (Karen Facey)

Example of an agency seeking to incorporate various forms of patient perspective (Laura Weeks)

Pilot projects for the measurement of preferences (Irina Cleemput)

Pilot projects for the measurement of preferences (Marion Danner)

News from HAS: taking into account the patients perspectives when assessing medicines and medical devices

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Summary

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Angela Coulter, Director of Global Initiatives, Informed Medical Decisions Foundation, USAAngela Coulter, PhD, Hon FRCGP is a UK-based health policy analyst and researcher, with special interests in patient and public involvement. A social scientist by training, she has higher degrees in health services research from the University of London and the University of Oxford. Now freelance and still involved in research, her previous roles include Chief Executive of Picker Institute Europe, Director of Policy and Development at the King’s Fund, Director of the Health Services Research Unit at the University of Oxford and Director of Global Initiatives at the Informed Medical Decisions Foundation. She is Adjunct Professor at the University of Southern Denmark and an Honorary Fellow of the Royal College of General Practitioners. Angela Coulter has published more than 300 research papers and reports and several books including The Autonomous Patient, The European Patient of the Future (winner of the 2004 Baxter Award), The Global Challenge of Healthcare Rationing, Hospital Referrals, Engaging Patients in Healthcare and Understanding and Using Health Experiences. She was the founding editor of Health Expectations, an international peer-reviewed journal on patient and public involvement in health care and health policy. She has won awards for her work from the Donabedian Foundation of Barcelona in 2012 and the International Shared Decision Making Conference in 2013.

Informed Medical Decisions FoundationIts mission is to help people make better health decisions.

Useful reference> An overview of relevant studies can be found in Angela Coulter’s book, Engaging Patients

in Healthcare, Open University Press/ McGraw Hill, 2011 : https://www.amazon.co.uk/Engaging-patients-healthcare-Coulter/dp/0335242715/ref=sr_1_1?s=books&ie=UTF8&qid=1474295444&sr=1-1&keywords=engaging+patients+in+healthcare

Guest speaker

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Healthcare system users are interlocutors for healthcare professionals on issues of quality and safety of care. Their individual or collective experience allows them to provide a complementary point of view from health professionals and institutions, focused on use, and a patient’s perspective on living with illness and treatment.

To improve the quality of care, users are involved in various ways:> Drawing up written documents for patients in order to provide everyone with access

to information;> Participating in a project within the care unit aiming to improve the way patients

are received, their daily life, their pathway within a facility and the conditions for carrying out medical acts;

> Participating in facilities’ quality and risk management committee;> Participating in research projects and in training healthcare professionals.

This session is designed to highlight different experiences in France and abroad to show the impact that users’ involvement has had on quality of care.

Session 1The contribution of users in healthcare quality and safety improvement initiatives

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Session 1 - The contribution of users in healthcare quality and safety improvement initiatives - 11 -

Involvement of users: force for progress in France

Véronique Ghadi, Project Manager, Department for the Improvement of Healthcare Quality and Safety, HASVéronique Ghadi, a trained sociologist, has carried out many projects on the role of users from an individual and collective perspective in the healthcare system and on coordinating their point of view with that of professionals. Following her work on «ordinary abuse» in healthcare institutions, she joined the HAS to continue studies on involving users in improvement and quality initiatives and in certification.

Haute Autorité de Santé (HAS)The HAS aims to contribute to the regulation of the healthcare system by improving health-care quality and efficiency. Its work is twofold: evaluation and recommendation, and accre-ditation and certification. The HAS also designs tools, guides and methods which it provides to healthcare players to improve their care or the implementation of their projects.

Scientific works/projects presentedFounded on the conviction, substantiated by international works, that the involvement of users is a means of improving healthcare quality and security, the HAS supports and develops this issue as part of its work on certification: it encourages facilities to work in partnership with users, develops methods for collecting patients’ perspectives on the quality of treat-ment and care, and works with user representatives to produce tools, making them a player in certification.

A survey carried out in the spring of 2016 explored the involvements of user representatives in politics and healthcare establishments’ quality initiatives, from the point of view of both health professionals and expert-visitors as well as user representatives. The HAS attempted to compare the various perceptions and to reach a concrete understanding of the resources at the disposal of users’ representatives and the procedures for collaborating with healthcare professionals.

Useful reference> http://www.has-sante.fr/portail/jcms/c_2708167/fr/faire-valoir-le-point-de-vue-des-usa-

gers-dans-la-certification

Contact> E-mail: v.ghadi@has-sante.fr

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Session 1 - The contribution of users in healthcare quality and safety improvement initiatives - 13 -

American experiences of user and patient involvement

Arlene S. Bierman, Director, Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, USAArlene S. Bierman, MD, MS is director of AHRQ’s Center for Evidence and Practice Improvement which includes the Evidence-Based Practice Center Program; the U.S. Preventive Services Task Force Program; the Division of Health Information Technology, the Division of Practice Improvement and the National Center for Excellence in Primary Care Research. Dr. Bierman is a general internist, geriatrician, and health services researcher, whose work has focused on improving access, quality, and outcomes of health care for older adults with chronic illness.

Agency for Healthcare Research and Quality (AHRQ)AHRQ’s mission is to produce evidence to make health care safer, higher quality, more acces-sible, equitable, and affordable, and to work with HHS and other partners to make sure that the evidence is understood and used.

Scientific works/projects presentedResearch shows that when patients are engaged in their health care, it can lead to measurable improvements in safety and quality. In a time of major changes in health care delivery it is also important to include the community voice in health system transformation. AHRQ developed the widely adopted Guide to Patient and Family Engagement in Hospital Quality and Safety to help patients, families, and health professionals work together as partners to promote improvements in care. The Patient- and Family-Centered Care (PFCC) Learning Community comprised of eleven Florida-based hospitals was developed to support hospitals in adopting and implementing strategies from a “cluster” of innovations, selected from the AHRQ Health Care Innovations Exchange, to advance the practice of PFCC. AHRQ has supported research in public deliberation, a method for gaining stakeholder input into complex health system decisions that affect populations whose perspectives are often absent.

Useful references> http://www.ahrq.gov/professionals/systems/hospital/engagingfamilies/index.html

> http://www.ahrq.gov/professionals/systems/hospital/engagingfamilies/guide.html

> https://innovations.ahrq.gov/scale-up-and-spread/reports/advancing-practice-patient-and-family-centered-care-hospitals-learning

> https://www.ncbi.nlm.nih.gov/pubmed/25828260

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Session 1 - The contribution of users in healthcare quality and safety improvement initiatives - 15 -

Patient leader approach to take on board the experience of care

David McNally, Deputy Director, Patient Experience, Directorate of Nursing Care, NHS, EnglandDavid McNally, BA, MA (Econ) has been national Head of Patient Experience in National Health Service in England since 2013. He was lead author of an article on the impact of patient leadership on improving experience of care published in Patient Experience Journal in 2015. He has worked previously at Regional and Local level in the Health Service, in Adult Social Care and in the charitable sector.

Steve Sharples, Patient Leader, from the Patient Leaders Expert Advisory Group, NHS EnglandSteve Sharples, BA, MA, was a Manufacturing Consultant and Photographer He worked in a wide range of industries at all personnel levels to meet the required briefs. He is currently a Patient Leader with over 15 years experience of working at both primary and secondary care level to enhance patient experience. Currently he is working on a project to enrich the health and well being of elderly patients.

NHS EnglandNHS England’s mission is to ensure “High quality care for all, now and for future generations”. To achieve this: the NHS has a single definition of high quality care; NHS strives to improve quality for everyone – from the least disadvantaged to the most, and from all backgrounds; NHS is committed to ensuring its resources to secure a sustainable NHS.

Scientific works/projects presentedCo-producing improved experience of care with patient leaders. The project was commis-sioned by NHS England in 2014 and was completed in 2015. We set out to answer three questions:

> Do patients and carers as leaders make a difference in the attention that experience of care gets alongside clinical effectiveness and safety?

> Can patient leaders influence NHS organisations to act on patient and carer feedback to improve experience of care?

> What do NHS organisations need to do to make this approach work?

What did we do?> Patient leaders & NHS managers co-produced the project from conception through an

Advisory Group that also discussed and agreed key learning points and conclusions.> There were three interlinked project phases:

- Tweetchat & workshop to identify initial themes- Gathering 18 case examples from 17 NHS organisations- Advisory Group selected 4 case examples that were visited for more detailed study- Thematic analysis identified overarching critical success factors and building blocks.

Useful references> https://www.england.nhs.uk/ourwork/pe/ipe-rep/ > http://pxjournal.org/journal/vol2/iss2/3/

Contacts> E-mail: davidmcnally@nhs.net> E-mail: stevesharples@mac.com

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Session 1 - The contribution of users in healthcare quality and safety improvement initiatives - 17 -

Montreal model, partnership between patients and health professionals

Marie-Pascale Pomey, Professor, Department of Health Administration, University of Montreal – Physician Advisor to the Institut national d’excellence en santé et services sociaux (National Institute for Excellence in Healthcare and Social Services), Quebec, CanadaMarie-Pascale Pomey is a professor at the School of Public Health at the University of Montreal and a researcher within the CHUM Research Centre. She directs the master’s degree in quality and safety in health care (QUÉOPS-i). This master’s degree provides quality and safety of care training to the managers. She is working on a research programme focusing on the evaluation of different models for involving patients and their loved ones at the various levels of governance of the healthcare system.

The University of MontrealThis university is internationally renowned for its leading role in patient involvement in the fields of teaching, research and training for future healthcare professionals.

Scientific works/projects presentedThis presentation will set out the theoretical basis for patient partnerships and will later critique this new model which may be rolled out at clinical, organizational and systemic levels and which factors may influence its success both from the perspective of patients and healthcare professionals. By making patients an essential partner for all decisions that concern them and giving them a role as treatment organisation experts, the Montreal model now offers pertinent perspectives for the management of chronic illnesses and disabilities but also for the reorganization of healthcare and care units. This presentation will focus on several examples of the model’s implementation in healthcare and social services establish-ments in Quebec, to demonstrate its impact on a clinical and organizational level.

Useful references> http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0122499 > http://www.cairn.info/resume.php?ID_ARTICLE=SPUB_150_0041 > http://pxjournal.org/journal/vol2/iss2/4/

Contact> E-mail: marie-pascale.pomey@umontreal.ca

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The patient tracer method is based on a retrospective analysis of a patient’s care via his/her experience and that of his/her family. It can be employed as part of a process to improve the practices of a healthcare facility or in the context of healthcare facility certification.

In a nutshellA patient with a profile determined in advance - generally a complex profile - is selected. His/her records are examined by a multidisciplinary team consisting of various different professions and his/her views are collected during an interview lasting around 30 minutes. The aim is to analyse the patient’s care via various aspects: his/her welcome/reception, consideration of his/her rights, his/her perception, pain management, management of medicines, preparation for discharge, organisation within the team, collaboration between professionals, etc.The HAS has made the patient tracer method a routine investigation method in the context of healthcare facilities certification (V2014). Surveyors first meet the team for a 2-hour meeting for an initial analysis of the case in question. After this initial meeting, a synopsis of areas for improvement and positive points is drawn up and validated with the team. The surveyors then meet the patient - who has previously been informed and given his/her consent. This interview therefore supplements and extends the surveyors observations.The method is also used by the various care providers (in healthcare facilities or in the community) as a method to improve practices or to prepare the quality report required for certification, with a few methodological adjustments. In this context, the HAS recommends that user representatives (UR) be involved, particularly for patient interviews. This is because user representatives may hear and interpret things differently from health professionals and it is the combination of these different perspectives that makes the approach interesting and useful.

What is the purpose?The tracer patient method makes it possible to:> incorporate the patient perspective, taking into account his/her experiences and those of

his/her family when assessing care in a healthcare facilities;> assess the patient care path, from prior to hospital admission to post discharge. The patient care

process from the time of admission, the interfaces between different sectors and collaboration between professions and disciplines throughout the care process, as well as collaboration with external parties, before and after hospitalisation, are studied more specifically.

For surveyors, this method enables them to more specifically assess the implementation of quality strategies in a real situation, as well as compliance with certification criteria.For care providers (particularly healthcare facilities), it offers the advantage of working as part of a multidisciplinary and multiprofessional team on the basis of a patient’s individual care. It makes it possible to include all the players involved in the patient’s care and user representatives within a genuinely team-based approach. Community professionals can also be involved (nurses, community pharmacists, physiotherapists, general practitioners, etc.). The team’s examination and analysis of its own practices reinforces the team dynamic and helps to develop a shared quality/safety culture. This patient-centred assessment approach is easy for care team professionals to adopt since it fits squarely with their core profession.

The patient tracer:

News from HAS

a method to assess the quality and safety of patient care

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In addition to collecting patient satisfaction, collecting patients’ experiences and health outcomes reported by patients helps create a joint reflection process between patients and healthcare staff to improve treatment on both a collective and individual level. Collecting patient feedback may be done in several ways, by contacting the patient themselves, their representatives or their carers. The qualitative data collected helps provide an in-depth analysis of the mechanisms at play from a patient perspective. The quantitative data is used to measure and compare experiences, over time or between hospitals, for cases where the patient is the main or sole source of information. Two implementation experiences where patient data was used in a clinical and outpatient context are presented, as well as their impact on the relationship between healthcare professionals and patients to ensure that the treatment given takes into account the patient’s objectives and preferences in particular through shared decision making.

Session 2From patient experience collecting to shared decision making

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Session 2 - From patient experience collecting to shared decision making - 23 -

Listening to what the patient says: contribution of qualitative data collection

Martine Bungener, Economist, Sociologist, Emeritus Research Director, CNRS − CERMES3Martine Bungener has been an economist and sociologist since 1978. She then became a research fellow and later research director at the CNRS. She was initially a member of LEGOS (Paris-Dauphine University), then in 1987 she became member of the CERMES - Centre for Medical, Scientific, Health and Social Research, (CNRS, Inserm EHESS), a laboratory which she later directed between 1997 and 2010. Member of Inserm’s orientation and strategic discussion committee, CORES, from 2001 to 2007, she has chaired Inserm’s patients’ organization focus group, GRAM, since 2008.

CERMES3The CERMES3 is a social science research unit created in 1986 (CERMES) by Claudine Herzlich, which works on medicine and health and is attached to the CNRS, the INSERM, the EHESS and the Paris-Descartes University.

Scientific works/projects presentedChair of Inserm’s patients’ organization focus group, GRAM, since 2008, Martine Bungener works on getting the voices of patients and their associations heard by researchers in the field of biomedical research. For the last 30 years, a large part of her work carried out at the CNRS has focused on patients and their families in the treatment process, using empirical research analysing the role of families with patients with chronic schizophrenia, together with the association for friends and family of patients with psychic disabilities (UNAFAM) as well as work on patients with HIV and, more recently, those with Alzheimers, and their loved ones who care for them at home. To achieve this she focusses on qualitative methods which enable direct opinions to be collected from those concerned, to observe how they act and to appreciate their reasons for how they act.

Useful references> http://www.inserm.fr/content/download/82699/623758/file/Association_malades.pdf> Trajectoires brisées, familles captives. La maladie mentale à domicile, Martine Bungener,

Editions de l’INSERM, 1995> Alzheimer, Préserver ce qui importe. Approche par les capabilités de l’accompagnement

à domicile, Le Galès, Catherine, Bungener, Martine et le groupe Capabilités. 2015. Presses Universitaires de Rennes.

Contact> E-mail: bungener@vjf.cnrs.fr

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Session 2 - From patient experience collecting to shared decision making - 25 -

Assessing patient experience of care: patient reported experience measures (PREMs) and patient reported outcome measures (PROMs)

Arlene S. Bierman, Director, Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, USAArlene S. Bierman, MD, MS is director of AHRQ’s Center for Evidence and Practice Improvement which includes the Evidence-Based Practice Center Program; the U.S. Preventive Services Task Force Program; the Division of Health Information Technology, the Division of Practice Improvement and the National Center for Excellence in Primary Care Research. Dr. Bierman is a general internist, geriatrician, and health services researcher, whose work has focused on improving access, quality, and outcomes of health care for older adults with chronic illness.

Agency for Healthcare Research and Quality (AHRQ)AHRQ’s mission is to produce evidence to make health care safer, higher quality, more acces-sible, equitable, and affordable, and to work with HHS and other partners to make sure that the evidence is understood and used.

Scientific works/projects presentedPatient-Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROMs) are complimentary approaches to engaging patients in improving health care quality. The CAHPS® family of surveys ask about patients’ experiences with their health care. CAHPS surveys are based what patients say is important to measure. The questions cover areas for which patients are the best or the only source of the information. CAHPS surveys provide information for quality improvement and are often used for public repor-ting. HCAHPS (or “Hospital CAHPS”) measures patients’ experiences in the inpatient setting. The US Centers for Medicare and Medicaid Services requires this survey for participating inpatient hospitals. PROMs foster the incorporation of patient goals and preferences into shared-decision making and care planning.

Useful references> http://www.ahrq.gov/cahps/index.html

> http://www.ahrq.gov/cahps/about-cahps/index.html

> http://www.ahrq.gov/cahps/news-and-events/podcasts/ginsberg-podcast.html

> https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/CAHPS/

> http://www.hcahpsonline.org/home.aspx

> http://content.healthaffairs.org/content/35/4/575.abstract

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Session 2 - From patient experience collecting to shared decision making - 27 -

Patient reported outcome measures (PROMs), experience in allied health practice

Philip Van Der Wees, Senior Researcher, Scientific Institute for Quality of Healthcare (IQ healthcare), Radboud University Nijmegen Medical Centre, NetherlandsPhilip Van Der Wees is physical therapist and senior researcher. His research projects are aimed at quality, implementation, and evaluation of healthcare. Central focus of his research is developing and implementing clinical guidelines; and assessing health care outcomes - specifically patient-reported outcomes. From 2010-2012 he was chair of the Guidelines International Network (G-I-N).

The Scientific Institute for Quality of Healthcare (IQ healthcare)This institute is a research department of Radboud university medical center in the Netherlands. IQ healthcare’s scientific approach is fundamentally focused on value-driven healthcare for patients, care professionals, insurers and government, leading to a reduction in unnecessary costs and an improvement of the sustainability of healthcare.

Scientific works/projects presentedPhilip Van Der Wees is project leader of the Dutch physical therapy outcomes registry in collaboration with the Royal Dutch Society for Physical Therapy. He also leads the expert center IQ PROM, which aims at the application and evaluation of patient-reported outcomes measures (PROMs). His research projects over the past years were aimed at development and implementation of clinical guidelines. Philip Van Der Wees is affiliated with the Celsus Academy of sustainable healthcare. Celsus is the center of excellence in the Netherlands for sustainable healthcare building a bridge between healthcare policy, science and practice. In 2011, Philip Van der Wees was selected by the Commonwealth Fund for the Harkness Fellowships in Health Care Policy and Practice and he has worked at Harvard Medical School in Boston from 2011-2013 to conduct his fellowship.

Useful references> http://www.iqhealthcare.nl/en/about-iq/our-staff/person/?person=1997

> https://www.ncbi.nlm.nih.gov/pubmed/?term=van+der+wees+p

> www.iqprom.nl

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Session 2 - From patient experience collecting to shared decision making - 29 -

Shared decision making, experience of Massachusetts General Hospital

Karen Sepucha, Assistant Professor of Medicine, Harvard Medical School, Massachusetts General Hospital, USAKaren Sepucha is the director of the Health Decision Sciences Center at Massachusetts General Hospital (MGH) and an assistant professor in Medicine at Harvard Medical School. Her research focuses on evaluating and implementing tools and measures to promote shared decision making across the hospital.

Massachusetts General Hospital (MGH)MGH is consistently one of the top ranked hospitals in the United States, and is the first and largest teaching hospital of Harvard Medical School. Some of the early leaders in the field of shared decision making are from MGH, and the hospital has been working to integrate shared decision making into clinical care for more than 10 years.

Scientific works/projects presentedMassachusetts General Hospital’s integration of shared decision making into practice has focused on the following three elements: developing a culture receptive to, and health care providers skilled in, shared decision making conversations; using patient decision aids to help inform and engage patients; and providing infrastructure and resources to support the implementation of shared decision making in practice. The hospital has eighteen adult primary care practices that are staffed by about 260 primary care clinicians and serve more than 200,000 patients at more than a million visits a year. In the last ten years, we have trained over 900 clinicians and staff and distributed more than 35,000 patient decision aids. We will highlight key lessons learned from this experience and describe the impact of strategies used to overcome barriers and increase use of shared decision making.

Useful references> http://content.healthaffairs.org/content/35/4/630.abstract

> http://www.massgeneral.org/decisionsciences/

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Collecting feedback relating to patient satisfaction is now essential when it comes to measuring and improving the quality of care in healthcare facilities. It is for this reason that – after several years of experimentation led by the Ministry for Health – the HAS launched its “e-Satis” national survey in September in order to provide a continuous, reliable and controlled method for measuring the experience and satisfaction of hospital patients.

In a nutshellToday, any patient admitted for a period of over 48 hours to one of the 1,493 hospitals or clinics carrying out activities in the field of medicine, surgery or obstetrics is concerned by the survey. Their email address is requested when they are admitted to the healthcare institution. Two weeks after their discharge from the hospital or clinic, they will receive an email containing a link to the secure, anonymous satisfaction survey.In fewer than 10 minutes and just a few clicks, they can provide their feedback concerning the various phases of the hospitalisation process:> their welcome/reception in the institution;> their care (information, waiting times, respect for privacy/confidentiality, pain management, etc.);> their room and meals;> the organisation of their discharge.

What is the purpose?All the patients’ answers are collected and compiled anonymously. Hospitals and clinics are sent the questionnaire results on an ongoing basis, enabling them to identify their strengths and weaknesses in order to improve the care offered to their patients. This satisfaction survey is an additional tool alongside other HAS indicators, which, for a number of years, have already allowed teams to monitor the processes in place in order to guarantee the quality and safety of healthcare (patient record management, anaesthesia management, management of strokes, post-partum bleeding, etc.).In parallel, an overall satisfaction score per institution will be published on the www.scopesante.fr website at the end of this year, enabling people to find out the level of patient satisfaction of the health institution of their choice.

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Collecting feedback relating to patient satisfaction is now essential when it comes to measuring and improving the quality of care in healthcare facilities. It is for this reason that – after several years of experimentation led by the Ministry for Health – the HAS launched its “e-Satis” national survey in September in order to provide a continuous, reliable and controlled method for measuring the experience and satisfaction of hospital patients.

In a nutshellToday, any patient admitted for a period of over 48 hours to one of the 1,493 hospitals or clinics carrying out activities in the field of medicine, surgery or obstetrics is concerned by the survey. Their email address is requested when they are admitted to the healthcare institution. Two weeks after their discharge from the hospital or clinic, they will receive an email containing a link to the secure, anonymous satisfaction survey.In fewer than 10 minutes and just a few clicks, they can provide their feedback concerning the various phases of the hospitalisation process:> their welcome/reception in the institution;> their care (information, waiting times, respect for privacy/confidentiality, pain management, etc.);> their room and meals;> the organisation of their discharge.

What is the purpose?All the patients’ answers are collected and compiled anonymously. Hospitals and clinics are sent the questionnaire results on an ongoing basis, enabling them to identify their strengths and weaknesses in order to improve the care offered to their patients. This satisfaction survey is an additional tool alongside other HAS indicators, which, for a number of years, have already allowed teams to monitor the processes in place in order to guarantee the quality and safety of healthcare (patient record management, anaesthesia management, management of strokes, post-partum bleeding, etc.).In parallel, an overall satisfaction score per institution will be published on the www.scopesante.fr website at the end of this year, enabling people to find out the level of patient satisfaction of the health institution of their choice.

e-Satis:

News from HAS

the HAS tool for assessing levels of hospital patient satisfaction

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It is necessary to involve patients and citizens in Health Technology Assessment (HTA) for at least two reasons. Firstly, from an ethical perspective, they are the first persons concerned by the results and consequences of assessments, and secondly, their views and experiences are unique in the assessment process.

Such involvement may take many forms including writing comments on non-finalised versions of documents, submitting written information in a questionnaire format, providing personal perspectives and knowledge in a deliberation process. Quantitative and qualitative methodologies may also be used with the objective of measuring preferences, experiences and patient needs.

This session presents patients’ contributions, their interest and their different types. The remarkable example of the Canadian agency, CADTH, helps understand how it is possible to implement different means to integrate patients’ perspectives and the impact of some such perspectives. Finally, we present pilot projects for the measurement of preferences.

Session 3The patient perspective in health technology assessment

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Session 3 - The patient perspective in health technology assessment - 35 -

Patient contributions

Karen Facey, International Health Policy ConsultantKaren Facey is a statistician and has worked in the pharmaceutical industry and medicines regulation. She was founding Chief Executive of the national HTA Agency in Scotland and now works as a consultant on HTA and patient involvement. She established the HTAi Interest Group on patient/citizen involvement and is co-editing a book on Patient Involvement in HTA.

Health Technology Assessment International (HTAi)HTAi is the global scientific and professional society for all those who produce, use, or encounter HTA. HTAi has members from over 65 countries and embraces all stakeholders, including researchers, agencies, policy makers, industry, academia, health service providers, and patients/users. It is a neutral forum for collaboration to promote and develop HTA.

Scientific works/projects presentedThe HTAi Interest Group for Patient/Citizen Involvement in HTA has developed a wide range of materials to support patient involvement in HTA for

> Patient organisations:glossary on HTA, a Guide to HTA, training webinar, online training in HTA, exercise to develop a patient group submission to HTA

> HTA bodies: template for patient group submissions, Values and Quality Standards for Patient Involvement in HTA, literature searching strategies for qualitative research, published papers in the International Journal for Technology Assessment in Health Care and The Patient.

It also has a regular monthly bulletin with news from across the globe about patient involvement in HTA and runs workshops and panels at the annual HTAi 2017 meeting.

Useful reference> http://www.htai.org/interest-groups/patient-and-citizen-involvement.html

Contact> Email: k.facey@btinternet.com

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Session 3 - The patient perspective in health technology assessment - 37 -

Example of an agency seeking to incorporate various forms of patient perspective

Laura Weeks, Scientific Advisor, Canadian Agency for Drugs & Technologies in Health, Canada (video)Laura Weeks provides methodological guidance throughout the HTA process, to help ensure quality, relevance and timeliness of CADTH products. Over the past two years, she has been combining her expertise with systematic review and qualitative research methods to incorporate patient perspectives within HTA.

Canadian Agency for Drugs & Technologies in Health (CADTH)CADTH is an independent, not-for-profit organization responsible for providing health care decision-makers with objective evidence to help make informed decisions about the optimal use of health technologies, including drugs, diagnostic tests, medical, dental, and surgical devices and procedures.

Scientific works/projects presentedAt CADTH, patient perspectives are integrated into HTA in different ways, depending on the HTA program. Since 2010, CADTH has invited patient groups to provide input into their Common Drug Review through the completion of a standardized patient input template. For medical devices, diagnostics and procedures, CADTH conducts a systematic review of the published qualitative literature related to patient and caregiver perspectives. Individual interviews are conducted with patients and their caregivers for CADTH’s Scientific Advice program, which has the mandate to provide early advice to pharmaceutical companies about clinical trial design.

In 2014, CADTH analyzed a series of patient group input submissions received as part of the Common Drug Review. Through this analysis, CADTH explored whether and how insights offered by patient groups are integrated into assessment reports and related expert committee recommendations. The analysis demonstrated that most often patient input is used by CADTH reviewers to frame their assessment, and by expert committee members to help interpret clinical evidence.

Useful references> https://researchinvolvement.biomedcentral.com/articles/10.1186/s40900-016-0036-9

> https://www.cadth.ca/sites/default/files/symp-2016/presentations/april11-2016/Concurrent-Session-B5-Laura-Weeks.pdf

Contacts> Email: Ken Bond: kenb@cadth.ca> Email: Laura Weeks: lauraw@cadth.ca

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Session 3 - The patient perspective in health technology assessment - 39 -

Pilot projects for the measurement of preferences

Irina Cleemput, Senior Health Economist, Belgian Health Care Knowledge Centre, KCE, BelgiumIrina Cleemput is senior health economist at the Belgian Health Care Knowledge Centre (KCE). Her areas of expertise are HTA, Health Services Research and Health Policy Research. Irina’s work focuses on the development of methods and tools to improve decision making, that are both feasible and applicable in real life.

Belgian Health Care Knowledge Centre (KCE)KCE is a publicly financed independent research agency, producing evidence-based research reports to support health care policy. Since 2004 KCE is investigating ways to improve the accountability for reasonableness of reimbursement decision making processes. It has produced several reports on this topic.

Scientific works/projects presentedAccountability for reasonableness presumes transparency of the decision making process, relevance of decision criteria, revisability of decisions and enforcement of the previous three conditions. In 2010 KCE published a framework for accountability for reasonableness in drug reimbursement decision making. Following up on this, three research projects were set up: one to elicit preferences from the general public regarding reimbursement decision criteria, one to assess the feasibility and acceptability of patient and public involvement in decision making processes in healthcare and one to develop and test a multi-criteria decision methodology for health technology appraisals. A pilot test was performed for the appraisal of unmet needs in 2016.

Useful references> https://kce.fgov.be/publication/report/drug-reimbursement-systems-international-

comparison-and-policy-recommendations-0#.V-DnS_waYjw

> https://kce.fgov.be/publication/report/incorporating-societal-preferences-in-reimbursement-decisions-%E2%80%93-relative-importan#.V-DnCfwaYjw

> https://kce.fgov.be/publication/report/multi-criteria-decision-analysis-for-the-appraisal-of-medical-needs-a-pilot-study

Contact> E-mail: irina.cleemput@kce.fgov.be

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Session 3 - The patient perspective in health technology assessment - 41 -

Pilot projects for the measurement of preferences

Marion Danner, Research Associate, Institute for Health Economics and Clinical Epidemiology, University Hospital of Cologne, GermanyMarion Danner has a background in economics and health economics, public health and epidemiology. She worked for the pharmaceutical and health insurance industry for about 10 years as well as for the German Institute for Quality and Efficiency in health care for more than 5 years. Marion is now at University of Cologne at the IGKE. Her research priorities are in preference research and health economic modelling.

Institute for Health Economics & Clinical Epidemiology (IGKE)IGKE has a research focus on patient-centered health care, methods for patient preference elicitation and health economics. Currently ongoing in the field is a preference project with the IQWiG in periodontal diseases and projects with pharmaceutical industry (e.g. age-related macular degeneration, diabetes).

Scientific works/projects presented> IQWiG: elicitation of preferences in patients suffering from major depression. Objective :

Feasability of Analytic Hierarchy Process (AHP) in patient population of interest, elicitation of preferences for endpoints assessed in IQWiG benefit assessment; performed in a group setting, physician preferences were also elicited for same treatment characteristics and opposed to patient preferences

> IQWiG pilot project in hepatitis C using a Discrete Choice Experiment (DCE) – only mentioned

> Reference to additional projects: preference elicitation in elderly patients suffering from age-related macular degeneration comparing AHP and DCE, preference project in perio-dontal disease

Useful references> https://www.iqwig.de/download/IQWiG_General_Methods_Version_%204-2.pdf

> https://www.iqwig.de/download/Executive-summary-of-working-paper_Analytic-Hierarchy-Process-pilot-project.pdf

> https://www.iqwig.de/download/GA10-03_Executive-summary-of-working-paper-1.1_Conjoint-Analysis.pdf

> https://www.iqwig.de/en/projects-results/projects/non-drug-interventions/ga15-01-measurement-of-preference-in-parodontopathy.6535.html#overview

Contact> E-mail: marion.danner@uk-koeln.de

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In France, the HAS is the body responsible for assessing medicines and medical devices with a view to their reimbursement and post marketing price-setting. This assessment is based on a rigorous analysis of clinical or real-life data, medico-economic data for some assessments and the scientific expertise of professionals. However, the patients concerned by these health products can provide an additional view based on their own personal experience and perspective. To take into account this patient expertise and after having studied various approaches implemented outside France (United Kingdom, Scotland and Canada, research conducted by the Health Technology Assessment international learned society), the HAS is introducing new tools that it is trialling from November 2016.

In a nutshellThe HAS always implemented processes designed to incorporate the patient perspective in its “health technology” assessments: consultation of patient associations prior to launching its studies, presence of patients in its working groups, inclusion of user representatives in its various commissions, etc. Today, it wants to reinforce this aspect and encourage the involvement of the patients concerned by the products it assesses (rapid HTA, a process which lasts only three months at HAS). Now, when an assessment of a medicine or a medical device is planned at the HAS, this information is published on its website and voluntary patient associations have 30 days to submit their contributions to the HAS.These contributions will be based on a standard questionnaire available on the HAS site. Hence patients (via their associations) will be able to provide their perspective in a formalised and collective manner. The contributions will be passed onto the expert members of the various commissions that assess health products: the Transparency Committee, CT; the Medical Device and Health Technology Evaluation Committee, CNEDiMTS; the Economic and Public Health Evaluation Committee, CEESP.An initial review on the ways in which this involvement took shape will be carried out after 6 months in operation.

What is the purpose?Formalising this new type of patient contribution to the assessment of health products should provide the commissions’ experts with a broader view concerning:> the impact of the disease or the state of health of the patients concerned, their perceptions,

their quality of life (or that of their families),> the experience of patients treated with therapies other than those assessed,> the experience of patients with the product assessed (provided that the patients have experience

using the products or the association knows the results of clinical trials relative to the product).The commissions (CT and CNEDiMTS, or even the CEESP) may also have access to all the information that the associations may deem useful for their assessment: ethical, societal or social problems, for example.

Taking into account the patients perspectives when assessing medicines and medical devices:

News from HAS

the HAS has introduced some new tools

The speakers’ presentations and debate videos are available on the HAS website, on the Colloque HAS page

www.has-sante.fr