Moving towards shared decision making in the physician-patient encounter in France: State of the art and future prospects

Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) 123-124 (2017) 41–45

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Special Issue / Schwerpunkt

Moving towards shared decision making in the physician-patient encounter in France: State of the art and future prospects Auf dem Weg zu einer partizipativen Entscheidungsfindung im Arzt-Patient-Kontakt in Frankreich: Stand der Dinge und Zukunftsaussichten Nora Moumjid 1,2,3,∗ , Julien Carretier 2,3 , Giovanna Marsico 4 , Franc¸ois Blot 5 , Christine Durif-Bruckert 6,7 , Franck Chauvin 2,8 1

Lyon 1 University, Lyon, France HESPER EA 7425, Lyon, France 3 Léon Bérard Cancer Centre, Lyon, France 4 French Ministry of Health, Paris, France 5 Gustave Roussy Cancer Institute, Paris, France 6 Lyon 2 University, Lyon, France 7 GRePS EA 4163, Lyon, France 8 Saint Etienne University, Saint-Etienne, France 2

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Article History: Available online: 22 May 2017

Keywords: shared decision making France information healthcare consumers

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Artikel-Historie: Online gestellt: 22. Mai 2017

Schlüsselwörter: partizipative Entscheidungsfindung Frankreich Information Gesundheitswesen Nutzer

a b s t r a c t In this paper we present the evolution of shared decision making since the mid-nineties in terms of legislation, official statements and guidelines. We outline the goals and declarations of the French Ministry of Health and the French National Authority for Health, for whom informing patients and shared decision-making are central concerns. Finally, we discuss research projects and clinical initiatives in shared decision-making in France and provide a general overview of progress and barriers to progress.

z u s a m m e n f a s s u n g In diesem Beitrag stellen wir die Entwicklung der partizipativen Entscheidungsfindung (Shared Decision Making) seit Mitte der 1990er-Jahre in Bezug auf die französische Gesetzgebung sowie offizielle Erklärungen und Leitlinien vor. Wir präsentieren die Ziele und Erklärungen des französischen Gesundheitsministeriums und der französischen Nationalen Gesundheitsbehörde ,,Haute Autorité de Santé‘‘ (HAS). Für beide sind Patienteninformation und partizipative Entscheidungsfindung wichtige Anliegen. Schließlich diskutieren wir Forschungsprojekte und klinische Initiativen zur partizipativen Entscheidungsfindung in Frankreich und geben einen allgemeinen Überblick über die weiteren Entwicklungen und die dabei zu überwindenden Hürden.

∗ Corresponding author: Senior Lecturer Nora Moumjid, HESPER EA 7425, Lyon 1 University, 8 avenue Rockefeller, 69373 Lyon Cedex 08, France. E-mail: [email protected] (N. Moumjid). http://dx.doi.org/10.1016/j.zefq.2017.05.017 1865-9217/

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The French healthcare system The French healthcare system consists of basic public insurance coverage supplemented by private insurance. It relies on market mechanisms at the provider level; provides patients with a wide choice of providers; offers fairly large incentives to produce high volumes of services; and is contained by gate-keeping arrangements [1]. In 2015, health spending accounted for 11.1% of GDP in France, the fifth highest percentage after the United States, Switzerland, Japan, Germany and Sweden [2]. Direct out of pocket payments account for only 8% of total financing in 2016, the lowest rate in Europe. Life expectancy is 79.4 for males and 85.4 for females, ranking France as ninth in the world [3].

Legislative recognition Patient demand for more information and participation in medical decisions in France began to increase in the 1980s through AIDS associations [4,5]. In the 1990s, these claims were reinforced by the tainted blood scandal [6] and by demands from cancer patients [7]. Legislation began to acknowledge the patient’s right to information with the Huriet-Sérusclat Law of 20th December 1988 [8], which was about the protection of participants in medical research. This law stipulates that patients must receive precise information and that they can give or withdraw their consent at any time. A few years later, in 1995, the Medical Deontological Code (Article 35, first indent) [9] indicated that ‘‘the physician owes patients fair, clear and accurate information about their health status and the medical tests and care he proposes. Over the course of the disease, he takes into account patients’ expectations and makes sure that they readily understand the information delivered.’’ In the same year, the Charter on the Rights of Hospitalised Patients [10] required that ‘‘the physician give all patients simple, easily intelligible and accurate information’’ and stated that ‘‘patients deserve tactful, straightforward answers to their questions.’’ In 1997, the Hedreul judgment [11] marked a turning point in the acknowledgement of the physician’s duty to inform patients. Physicians were henceforth ‘‘not only required to inform their patients but also to prove that they had done so.’’ This overturned a 1951 decision (Civil court.1, 29 May 1951) [12] stating that the burden of proof of a physician’s failure to inform a patient lay with the patient him or herself. A second turning point was the 2002 Law Pertaining to Patients’ Rights and the Quality of the Healthcare System known as the ‘‘Law of March 4th 2002’’, giving birth to a new approach in France known as ‘‘democracy in healthcare’’ (démocratie sanitaire) [13]. This law went even further than the Hedreul judgement by stating that patients should be actors in their healthcare decisions and real partners in their relationship with healthcare professionals. It stipulates that ‘‘any individual has the right to be informed about his/her health status. This information covers the various tests, treatments or preventive actions suggested, their utility, possible emergencies and other consequences, associated risks, severe or frequent, other possible options and the possible consequences for the patient in case of refusal’’ (Public Health Code, Art. L.1111-2) [13]). It also states that ‘‘all patients are entitled to access to information on their own health and to make their own decisions with the help of and in agreement with their physician’’ (Public Health Code, Art. L.1111.4) [13]. In 2009, the Hospital, Patients, Health and Territories Law (Law n◦ 2009-879) [14] and in 2016, the Law to Modernise the Healthcare System (Law n◦ 2016-41) [15] reaffirmed the démocratie sanitaire approach by focusing on accurately informing the healthcare user (see Public Health Information service below). Thus French legislation has moved progressively towards recognizing patients’ right to information and even their right to participate in medical decision-making. These topics have become

central concerns for the French Ministry of Health and the French National Authority for Health. Patient information initiatives by government health authorities The French National Authority for Health (FNAH) is an independent public body with financial autonomy and wide-ranging powers including assessment of drugs, medical devices and procedures, publication of guidelines, accreditation of healthcare organisations and certification of doctors. Interestingly, one of its main current missions, defined by government decree, is to provide information to the public and generally improve the quality of medical information. To that aim, in 2005 it developed a methodological practical guide called ‘‘Development of information documents for patients and healthcare consumers’’ [16] to enable and even incite healthcare professionals to provide high quality information for their patients. The guide was also intended for professional organisations and learned societies aiming to provide patients/healthcare consumers with written information based on current practice guidelines. National professional recommendations that were developed in 2000 had stipulated that written information is a necessary adjunct to the oral information provided by doctors [17]. The new guide was based on international studies [18]. It included a detailed explanation of the methodological steps to be followed to provide healthcare consumers with intelligible evidence-based information. In addition, in 2009 the FNAH organised two multidisciplinary seminars on shared decision-making, attended by healthcare professionals, patient representatives and national and international social scientists. These seminars were summarised in a report given to the FNAH College in charge of strategy and mission, but unfortunately no action has been taken in the short term, either in terms of funding opportunities or other initiatives. In 2013, the FNAH published a report entitled ‘‘Patients and professionals deciding together – concept, patient decision aids and shared decisionmaking’’ [19]. This report drew on the state of the art in shared decision making, in terms of conceptual frameworks and studies published at the national and international level. The report is freely available on the FNAH website but is unfortunately poorly disseminated.. More recently, a real new milestone was reached by the FNAH in October 2015 with the creation of the new Patient Information Committee. This committee will develop documents (for instance methodological guides for creating decision aids) and tools aimed at healthcare consumers to promote shared decision-making in the physician-patient encounter. The Public Health Information Service (PHIS) While patients are increasingly interested in being involved in their own care, access to public health information is still limited and unequitable. Based on the National Health Strategy, the French Ministry of Health therefore declared in 2013 that it was the state’s responsibility to organize a public health information service. To meet this commitment and the expectations of the citizens, the Law of modernization of our healthcare system was adopted on January 26, 2016. Article 88 provided for the creation of ‘‘a public service, under the responsibility of the Minister for Health, with the task of disseminating information, free of charge and to the widest possible audience, on health and especially on treatment, care and support offered to the public. The information should be in simple language and adapted to people with disabilities’’ [15]. The PHIS emerged from the French government’s desire to inform and support citizens by promoting their participation in health choices.

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The PHIS is built on a partnership approach aimed at bringing together all the public healthcare institutions (FNAH, INCA, CNSA, CNAMTS, INSERM1 , regional health agencies, etc.) and non-profit contributors into a single body that would adopt common editorial standards so that information is more intelligible to the general public. The PHIS aims to ensure the coherence and cohesion of public programs so that they focus on a common vision of health information, including the development of tools to encourage the involvement of healthcare consumers in the process of improving the service. To achieve these objectives, the PHIS is currently implementing a national health information strategy based on the following elements: a) An information standard for public and private non-profit organisations producing health content, based on rigorous criteria of quality, independence, readability and accessibility; b) Analysis of how its website, Santé.fr, is used, in order to identify areas for improvement; c) The development of collaborative spaces promoting interaction between citizens and public authorities. To ensure this program meets the expectations of citizens the Ministry of Health set up a multidisciplinary strategic advisory committee to prioritise themes to be addressed by the PHIS and its implementation modalities. The PHIS thus represents a democratic mechanism allowing citizens to interact with the public health authorities by participating in and co-constructing a platform for accessible health information relevant to their needs. Shared decision making research We summarise here the current state of research and clinical initiatives in shared decision-making in France and apologize for not mentioning projects that we are not aware of. Since the mid 1990s, several studies have been conducted on the role and behaviour of patients and/or physician in shared decisionmaking. To our knowledge, these studies at local, regional and national levels mainly focus on cancer. At the local level, studies have shown that patients wish to be informed [20,21], but that they distinguish between shared decision-making and participation in the management of their disease [22]. They also showed that subjecting patients to a single normative behavioural model of shared decision-making in an era of shifting paradigms of medical authority may undermine patients’ quest for what they believe to be a more important right, which is a guarantee of the best care available [22]. An ongoing study on a team of three breast cancer surgeons who began practising shared decision-making in their routine medical practice in the Léon Bérard cancer centre in 2007 will show how they adapted their practice to better fit with their patients’ preferences, with their own preferences, and with the type of relationship they wish to have with their patients [23]. To our knowledge, this is the only French medical team that has decided to adopt a shared decision-making approach in their everyday medical practice with surgeons, now retired, but who played a key role in the implementation of shared decision-making in France [24]. At the regional level, a study conducted in public and private hospitals and comprehensive cancer centres located in the southwest of France and in the Rhône-Alps region analysed the decision-making process about adjuvant chemotherapy in

1 INCA: National Cancer Care Institute. CNSA: National Solidarity Fund for Autonomy. CNAMTS: National Health Insurance Fund for Employees. INSERM: French Medical Research Institute.

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routine practice and physicians’ difficulties and needs with respect to the use of decision aids. The study aimed to promote the wider use of decision aids in routine clinical practice in France. The results showed the influence of the local context, of professional groups and of physicians’ individual sociocultural backgrounds [25]. Another study conducted in the Rhône-Alps region showed that most breast cancer surgeons reported adopting an approach of ‘‘some sharing’’, i.e. where the patient can ask all the questions he/she wants but the physician remains the sole decision maker, underlying how breast cancer surgeons are reluctant to engage in a real shared decision-making approach [26]. The same study, in a mirror analysis, showed that one patient out of three reported that they would have liked to participate more in the decision-making process about treatment. At the national level, three surveys (VICAN, VICAN 2, VICAN 3) have been conducted to date by the French National Cancer Institute in partnership with the INSERM on decision-making and the quality of life of cancer patients two and five years after diagnosis. In the first two surveys (outcomes of the third are currently being analysed), 57.8% of respondents declared they were involved in their treatment decision-making process and 74.2% were satisfied with their role in decision-making [27]. While 63.5% of respondents were satisfied with the information exchange with the medical team, only 28% of low-income patients were satisfied compared to 44.7% of high-income patients, and there were significant social disparities associated with different information-seeking behaviours [28]. These surveys also showed that women with low health literacy levels (131 women among 639, or 20%) reported worse communication with the healthcare team, were more likely to report that they did not participate in therapeutic choices, would have liked more involvement in decision-making [29]. These results suggest that better communication is needed to improve decision-making among breast cancer patients with low literacy levels. Lastly, at the national level, in 2015 the first randomised controlled trial using a decision aid was conducted in breast cancer screening among 16 000 women aged 50 to 74 years. The results showed that the rate of screening in the intervention group was 40.25% (3174/7885) compared with 42.13% (3353/7959) in the control group (p=0.002), demonstrating that the decision aid reduced participation in cancer screening. These outcomes show for the first time in France how important it is to promote informed patient choices [30]. Concerning shared decision-making measures, another study recently validated the French version of CollaboRATE [31]. This is the first French initiative in the area of measuring shared decisionmaking, opening the way to other similar initiatives in this field [32]. Shared decision-making studies are now also being undertaken in the context of cystic fibrosis, psychiatry, and in primary care. French GPs are increasingly interested in adopting a shared decision-making approach in their routine medical practice [33,34]. Moreover, studies are being conducted in what the French call ‘‘convenir ensemble’’ or therapeutic education, with projects being developed in collaboration with the French Therapeutic Education Association.

Collaborative efforts Fruitful collaborations are evolving with the purpose of furthering the progress of shared decision-making, such as a research partnership between French speaking members of the European Association in Healthcare and French researchers working in the shared decision-making field [35]. Another is an international multi-disciplinary study group that began in June 2014, when nine researchers and health professionals from France, Switzerland

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and Quebec created the Francophone Reflection-Action Group on Shared Decision Making (FREeDOM) [36]. They wished to address a) the slow evolution of shared decision making in France compared to in the US, the UK, the Netherlands, Germany, Spain, Italy and Australia as well as to Canada and Switzerland; b) a growing demand for information and participation in decisions about their care among users of the French healthcare system; and c) limited dissemination of shared decision-making approaches, projects and practices to health professionals and healthcare consumers in France and other francophone countries. This group now includes more than 90 patients and patient representatives organisations, healthcare professionals, social science researchers and healthcare officials. The group decided to a) focus on chronic diseases at every stage of the care pathway, i.e. prevention, diagnosis, therapeutic decisions, monitoring and adherence; b) develop shared decisionmaking training programs for medical and continuing education, focusing on training in medical and pharmacy faculties and nursing schools; c) act as a catalyst for potential collaborators on research projects on shared decision-making concepts, interventions and implementations by creating networks of those interested in participating; d) develop strategies to communicate shared decision-making to patients and the general public through citizen seminars and conferences, articles and media interventions. The group is currently building a website in French and English, a tool for communication between members and also for promoting and raising awareness of shared decision-making nationally and internationally.

Main conclusion and future prospects The shared decision-making approach meets society’s demand for more patient and healthcare user information and greater participation in the medical decision-making process. It also aims to satisfy an ethical obligation to respect patient autonomy, as emphasized by the France’s Law of March 4th 2002 [15]. The French legal context, increasing research and key initiatives developed by the national health agencies now more clearly incite healthcare professionals to respond to healthcare consumers’ demands by providing them with high quality information and allowing them to participate in decisions regarding their own health if they wish to do so. French healthcare professionals are less and less reluctant to adopt shared decision-making in their practice, recognizing patients’ preferences as a key issue in their healthcare management process. As for healthcare consumers, encouraged by active patients’ associations and their leaders, more and more of them support shared decision-making. They also increasingly recognise that physicians have limits, including scientific uncertainty, budget constraints, and organisational limitations, to mention only a few. In the coming years, this change in attitude among both patients and physicians may modify the French healthcare system, which still ranks poorly in terms of patient-centred care especially in physician-patient communication [37]. These encouraging signs, however, must not obscure the fact that much research on shared decision-making and clinical initiatives are still confined to the efforts of a few individuals who have difficulty with implementation and dissemination, even if they manage to obtain public and private funding to support their work. No structured approach to shared decision making exists on a national scale, in spite of France being one of the few countries to have legislation on the subject. This paradoxical situation is surprising and disappointing, given what is at stake in terms of ethics, health, social values and the fact that the approach emerged in response to societal demand. We believe that three areas hold promise for the future:

a) Educating health professionals in the patient-physician relationship and in shared-decision making. Medical education in France devotes little time to teaching about the physician-patient relationship or to shared decision-making and its associated skills [38]. However, there are some ambitious and encouraging projects underway, such as PACTEM (Patients ACTeurs de l’Education Médicale, or patient-actors in medical education) [39] and Étincelle du Soin [40]. The goal of PACTEM is to conceptualise, analyse and evaluate the contribution of patients to the training of physicians and other healthcare professionals by adopting a research-action approach. L’Etincelle du soin is a group of healthcare professionals, actors and trainers who wish to improve the patient-carer relationship through training healthcare professionals. b) Healthcare professionals’ desire to recognise patients as partners in decision-making through recognition of the expertise conferred by experience. c) Healthcare consumers’ views of medical authority: health professionals have limited technical know-how, uncertainty is part of their daily practice, and they need to be able to communicate, share and discuss this uncertainty with the patient if the patient wishes to be informed of it. Thus France appears to be moving slowly but steadily towards taking patients’ preferences into account in healthcare decisions that concern them, replacing vain declarations of intention with facilitating transmission of information and communication between patient and healthcare consumers – these are the signs of humanity in a relationship that risks becoming more mechanistic with every passing day.

Conflict of Interest None declared.

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