Stakeholders' perspectives on patient involvement in systematic reviews - Results of a World Café in Germany.

INTRODUCTION: Patient involvement (PI) in systematic reviews (SRs) can help to improve the quality of SRs and enhance the credibility of the research process. At the same time, PI in SRs poses challenges such as the need for extra time. While several organizations and working groups from English-speaking countries provide recommendations for PI in SRs, there is a lack of current insights from stakeholders in Germany, including researchers and patients. Eliciting their perspectives is indicated, as PI in SRs in Germany might differ due to language barriers and organizational dissimilarities. For sharing and discussing stakeholders' experiences in Germany, a workshop was facilitated. This paper summarizes the results of the workshop to elucidate stakeholders' perspectives on key aspects of PI in SRs in Germany. METHODS: A World Café was conducted at the 2023 conference of the Network for Evidence-based Medicine. Participants at all levels of experience could take part without prior registration. The data obtained was summarized narratively in an iterative process, and a framework of the topics discussed was developed. RESULTS: 22 participants, predominantly researchers, took part. Participants formulated several general conditions for PI in SRs such as time and transparency. The majority of the tasks described referred to the application phase and the initial phase of a SR. The development of training and information materials in plain German language was deemed essential. The application phase of an externally funded SR and patient recruitment were considered as particularly challenging. DISCUSSION: Several of the formulated aspects such as time and transparency are consistent with earlier work. The project start of a SR, however, has so far not been explicitly described in the literature as being of particular importance. This phase might be even more crucial to SR projects in Germany since researchers are expected to develop information materials for patients. Both the application phase and patient recruitment could be considered particularly challenging due to a lower degree of organisation of PI in Germany. CONCLUSION: World Café participants described many aspects referring to the project start of a SR. This underlines that PI in SRs needs to be described as a process. A process model intertwining the phases of a SR with the respective phases of PI, ideally including best practices for each phase, could be of great value. With respect to the specific context in Germany, a greater degree of organization of PI, i.e. coordinated by an institution, could help to manage challenges such as patient recruitment.

Shared decision-making in the Netherlands: Progress is made, but not for all. Time to become inclusive to patients.

Dutch initiatives targeting shared decision-making (SDM) are still growing, supported by the government, the Federation of Patients' Organisations, professional bodies and healthcare insurers. The large majority of patients prefers the SDM model. The Dutch are working hard to realise improvement in the application of SDM in daily clinical practice, resulting in glimpses of success with objectified improvement on observed behavior. Nevertheless, the culture shift is still ongoing. Large-scale uptake of SDM behavior is still a challenge. We haven't yet fully reached the patients' needs, given disappointing research data on patients' experiences and professional behavior. In all Dutch implementation projects, early adopters, believers or higher-educated persons have been overrepresented, while patients with limited health literacy have been underrepresented. This is a huge problem as 25% of the Dutch adult population have limited health literacy. To further enhance SDM there are issues to be addressed: We need to make physicians conscious about their limited application of SDM in daily practice, especially regarding preference and decision talk. We need to reward clinicians for the extra work that comes with SDM. We need to be inclusive to patients with limited health literacy, who are less often actually involved in decision-making and at the same time more likely to regret their chosen treatment compared to patients with higher health literacy.

Where are we in shared decision-making in Italy? A brief updated review.

The aim of this paper is to provide an overview of the current state of the art concerning patient-centred care (PCC), shared decision-making (SDM), and patient involvement in health care in Italy, by updating the previous versions of the review. In the past 5 years some progress has been made towards a higher involvement of patients in their health care and patient-centredness into the national health care system. The updated scoping literature search focused on articles reporting primary data collected in Italy and showed a great increase in the number of publications. Nonetheless, the research efforts are still relatively sporadic compared to other countries especially as for evaluations of interventions and, most notably, they are not driven by a consistent effort to promote SDM and PCC in clinical practice.

Shared decision-making in Argentina in 2022.

Argentina is an upper-middle income country located in South America with an estimated population of 46.2 million inhabitants. There is no unified research agenda or government initiatives encouraging the implementation and research of Shared Decision-Making (SDM). Our working group at the Family and Community Medicine Division of the Hospital Italiano de Buenos Aires is the leading centre for research and implementation of SDM in the country. The implementation strategy is articulated in undergraduate, postgraduate and continuous medical education. However, it is challenged by the professionals' perception that they are already doing it or lack time during consultations. We have advanced research to understand how to adapt tools to measure and implement SDM in our settings. Still, we face additional challenges related to funding, accessing diverse populations beyond the reach of our institution and incorporating patients in the co-production of research. While most of our efforts arise from the voluntary work of our healthcare professionals, we believe this is a strength since SDM research and implementation are then directly linked to patient care.

Shared decision-making in Poland: State of the art, challenges and opportunities.

The purpose of the present paper is to review the progress in recognition and implementation of shared decision-making (SDM) practice in the Polish health care system. In Poland, equal access to health care is a constitutional right. The foundations for SDM practice within the Polish health care system are laid in legislation regulating the professions of doctors and dentists, as well as patients' rights, which assert the duty of physicians to provide clear and patient-adjusted information on diagnostic and treatment options, health status and prognosis before obtaining consent. Over recent years, patient organizations have gained voice in the institutional setting. At the same time participatory decision-making at the individual patient level remains uneven, with a considerable variety between health care settings or even physicians. The challenges related to the implementation of SDM practices include low health care funding and staff shortages, which limit both the scope of available choices and consultation time. Fragmentation of care and inadequate standardization constitute additional barriers to the elaboration and sharing of good SDM practices.

Patientenpartizipation in der pädiatrischen Versorgungsforschung am Universitätsklinikum Freiburg: von der Projektbeteiligung zum Patientenbeirat.

Participation of patients and relatives in research means that those affected are involved in the research process in a partnership role. Despite the growing importance of participatory approaches and the large number of available concepts, many researchers and patients are faced with the question of how participatory research can be realized and organized in concrete terms. Here we report on our experiences with two different forms of patient participation in research in the context of pediatric health care research at a university hospital: (1) In a project for the development and evaluation of a case management for patients with spinal muscular atrophy, patient representatives have an consultative role. (2) In the patient advisory board, which is to accompany the research activities of the research group at the site continuously and systematically, i.e. in all phases, the participation currently corresponds to a contributory role (involvement) which, in the future, could be moved onto the collaborative stage. In both forms of participation, the essential questions include the selection of the participating patients, the type and extent of participation, and the evaluation of the effect of participation on the research that is carried out. In our experience, both forms of participation add value to research from the perspective of all participants. At the same time, they bring different opportunities and challenges. While in project-based participation the sphere of influence is already delineated by researchers, the context of the patient advisory board provides more room and openness to develop, for example, a research agenda and thus identify new research topics. In our experience, however, sufficient resources (in terms of time and money) are required from all participants, as well as good, trusting cooperation with jointly developed processes to realize both forms of participation.

Moving towards patient-centered care and shared decision-making in Germany.

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.

[Advanced training program seeking to strengthen nationwide self-help organizations: development of the ÖKUSS advanced training concept]. / Bundesweit tätige Selbsthilfeorganisationen durch Weiterbildung stärken: Die Entwicklung des ÖKUSS-Weiterbildungskonzepts.

BACKGROUND: Self-help organizations act in a self-determined manner, but can be strengthened by conducive framework conditions such as advanced training programs. The Austrian Competence and Service Agency for Self-help ÖKUSS was created as part of the framework of the concept for public promotion of self-help. It developed an advanced training program for the systematic support of nationwide self-help organizations (NSHO). The article describes the conceptual development of an advanced training program and discusses how to deal with ambivalences arising in the process. METHOD: Three training tracks were derived from the objectives of the concept for the public promotion of self-help (promoting the visibility of self-help organizations, strengthening self-help organizations in their activities, and patient participation). To determine the contents, the advanced training needs of NSHO were identified on the basis of process-produced data (including feedback forms), relevant literature, and the results of workshops with self-help representatives. An Internet search was conducted to build on existing offerings. The ÖKUSS concept was developed in several workshops with representatives of self-help organizations and its contents and framework conditions were discussed. RESULTS: Training Track 1 "Strengthening self-help activities" aims to strengthen the self-image of NSHO as a self-help organization and to support the implementation of activities with introductory seminars and additional workshops. Training Track 2 "Promoting cooperation" supports the meeting and dialogue between NSHO representatives and experts with expert dialogues and annual projects. Training Track 3 "Strengthening collective patient participation" prepares NSHO representatives for participation in health policy decision-making processes in a modular course. DISCUSSION AND CONCLUSIONS: During the development process, ambivalences in a social, factual, time and space dimension were dealt with: On the social dimension, the aim was to take decisions regarding the objectives, form and content of the continuing education program as closely as possible to the participants and to offer low-threshold participation. On the factual level, the focus was on the competence of those affected and/or the transfer of competence for implementing activities. In terms of time, a balance had to be struck between the time resources available to the NSHO representatives and the time required to develop competence. In terms of space, on-site events were preferred to online events (before COVID-19). Finally, a different approach was chosen for each training track. For the further development of the advanced training program, a piloting and a participatory development with NSHO representatives is recommended.

[Patient and public involvement in health-related research: How is the selection of participants reported?] / Bürger- und Patientenbeteiligung in der gesundheitsbezogenen Forschung: Wie wird über die Auswahl von Teilnehmenden berichtet?

BACKGROUND AND OBJECTIVES: In recent years, the reporting on patient and public involvement (PPI) in health-related research has gained significantly in importance. However, little attention is being paid to the selection of target groups or participating citizens and patients. Individual contributions already point out that the selection is often described in a complex but ambiguous way; for example, individual groups are often not sufficiently differentiated from each other. The aim of our study is to provide an overview of the main topics, questions and challenges that are specific to the selection of participants in PPI by means of an explorative sample of different PPI documents (studies with PPI, studies on PPI, PPI guidelines, PPI websites, PPI journals). Based on this overview, we will make recommendations to help authors of studies and other relevant stakeholders in the planning, implementation and reporting of participant selection. METHODS: First, the explorative sample of the above-mentioned PPI documents was identified by conducting a systematic database and online search. A total of 46 documents were taken into account, including 11 studies with PPI, 12 studies on PPI, 12 guidelines, 6 websites and 5 journals. Relevant text passages were extracted from each of them and evaluated using deductively and inductively developed topic-specific categories. RESULTS: Overall, the selected PPI documents significantly vary a) in the use of terms, b) in the detailing of the individual aspects of participant selection, and c) in the description of the planning and implementation of participant selection. For the latter, there is usually a lack of systematic, comprehensive explanations, e. g., on how to weigh up a relevant number of participants, on objectives and methods in the selection process and on how to prepare participants. DISCUSSION: The various documents about and contributions to the topic of PPI should, in future, report more transparently and systematically on the selection of participants, especially to create practical added value for authors of studies. This includes, in particular, the description of the selection (studies with PPI), a complete overview of all relevant steps of the selection process (PPI guidelines), recommendations on how to deal with representativeness (studies on PPI), notes on reporting PPI (journals) as well as overviews of individual steps of the implementation process (PPI websites).

[Patient orientation and patient participation in research: Deficits, modes and expectations from a patient representative's point of view]. / Patientenorientierung und Patientenbeteiligung in der Forschung ­ Mängel, Formen und Erwartungen aus Sicht eines Patientenvertreters.

The article addresses deficits in patient orientation and patient involvement in medical research from a patient's perspective and provides recommendations for their further development. Researchers often practice patient orientation as well as patient involvement in an unstructured and inconsistent manner. The decision if and how patient involvement takes place is, to a considerable extent, the researchers' responsibility. This decision should always be part of a patient-oriented alignment of the research project, which researchers pursue regardless of the existence, initiative and participation of a patient organization. Possible modes of involvement are assigned to different phases of the research process. In this article, patient orientation and the choice of the form of involvement is considered to constitute an obligation of researchers and decision makers early in the process. Involvement should take place on a fair basis. Decision makers should consider determining specific requirements for patient orientation, e. g. in their calls for proposals or selection/award criteria.

[Older patients' involvement in research (INVOLVE-Clin): a study protocol]. / Aktive Beteiligung von älteren Patient*innen an klinischer Forschung (INVOLVE-Clin): Ein Studienprotokoll.

INTRODUCTION: Patient involvement in health research is an integral part of health care in many countries. It promotes the relevance and quality of research and increases the meaningfulness of research results. Meanwhile, the value of patient involvement has also been recognised in Germany. The lack of a common understanding of patient involvement and appropriate methods make implementation difficult. In Germany, patients are still rarely involved in the planning and conduct of health research. Vulnerable patient groups such as the elderly and the very old are considered particularly challenging for researchers in active patient involvement due to their special needs, which is why they are often neglected. Especially nursing home residents suffer from a variety of health impairments which are accompanied by a high number of prescription drugs and adverse events and can therefore make patient involvement more difficult. The present project aims to test the method of patient advisory boards for the involvement of nursing home residents. Using the design of a clinical trial to optimise medication for nursing home residents as a case study, we will assess the feasibility of the method for this target group. We will also install a patient advocate as moderator of the advisory board. The study plan is described in the present study protocol. METHODS: Two patient advisory boards with nursing home residents will be established. With a patient advocate acting as moderator, the essential elements of a clinical trial to optimise medication will be discussed and passed on to the study planning team via the patient advocate. The overall topic of the clinical trial is the optimisation of medication in cardiovascular disease. The nursing home residents are informed about the contents and ideas of the study to be planned and the interests of the researchers, respectively, and will discuss the proposals of the study planning team. Nursing home residents', the patient advocate's and the researchers' expectations and experiences will be examined in individual interviews. DISCUSSION: The study will provide a potentially suitable method to involve nursing home residents in the research process. The jointly developed study design will be incorporated into a new project proposal. The results will be used to inform the development of a German handbook on active public and patient involvement.

[Patient involvement in clinical practice guidelines is poor after 12 years of German guideline standards: A review of guideline methodologies]. / Unzureichende Patientenbeteiligung an der Leitlinienentwicklung in Deutschland ­ eine Analyse der von der AWMF verbreiteten ärztlichen Empfehlungen.

BACKGROUND: As early as 1997, the German Guideline for Guidelines laid down patient participation in guideline development as the cornerstone of good, trustworthy medical guidelines. The German Guideline Assessment Tool (DELBI) published in 2005 requires patients or relatives to be involved in the development of medical guidelines. Ideally, this should be effected through membership in the author group. The Association of the Scientific Medical Societies in Germany (AWMF) recommends this approach for the so-called S3 guidelines (systematically developed guidelines) and S2k guidelines (consensus-based guidelines). The present study addresses the question of whether and to what extent German guideline publishers adhere to these principles of patient orientation. METHODS: For this purpose, a descriptive analysis of the guidelines valid at the beginning of November 2017 was carried out. All guidelines (n=520) of the AWMF member societies were assessed. We evaluated S3- and S2k guidelines only, as these are of particular importance for patient involvement due to the requirement of an interdisciplinary guideline group. Data were reported on the involvement of patients (as co-authors of medical guidelines) and on the existence of guidance documents addressing patients and the public (so-called patient information and patient guidelines). RESULTS: Regarding the 105 (165) S3 (S2k) guidelines, we found evidence on patient involvement in guideline development in 99 (134) cases (94 % of S3 / 81 % of S2k guidelines). In 61 (87) guidelines, authors had contributed to the authors group (58 % / 53 %) and 59 (80) guidelines with voting rights (56 % / 48 %). For 50 (15) S3 (S2k) guidelines (48 % / 9 %), the guideline report provided information on the existence or planned development of guidance documents for patients and the public (patient guidelines or patient information). Guidance-related patient information was available on the internet for only 37 (2) S3 (S2k) guidelines (35 % / 2 %). CONCLUSION: A substantial gap remains between patient / public involvement standards for guideline development and practice in Germany, even 12 years after the publication of national guideline standards. This is a missed opportunity since guidelines without adequate participation of those affected by the recommendations have a problem of legitimacy and transparency. Only guidelines where patients were involved in all voting processes during development build and strengthen trust between patients and the medical profession. And only those who present the rationale for medical recommendations in a generally understandable and comprehensible manner let affected individuals make individual decisions.

[Kick-off article: Patients first in health care: Status quo]. / Impulsbeitrag: Patient First in der Gesundheitsversorgung: Status quo.

"Putting patients first in health care" seems to be a rhetorical statement. But is it really the case that patients always come first? And where exactly do we stand with patient involvement and patient orientation in Germany? What participation options are currently available? Is the patient involvement and patient orientation we have so far achieved sufficient? What needs to be done? These questions will be addressed in the following discussion. Patient self-help organizations, patient interest groups, patient representatives as well as the industrial and political decision-making bodies agree that the patient perspective should be more strongly integrated into health care and health care delivery decisions. The relevant information and sources of evidence, however, are yet insufficiently provided and used. Patients are experts for their own cause. There is consensus that patient participation is and must be an integral part of all levels of health care. Patient representation has made enormous progress in the last decade. This article outlines the current state of affairs of patient representation, patient involvement, their legal legitimacy and possible future scenarios. The transformation from of a paternalistically oriented health care system towards a patient-oriented system is far advanced, but much remains to be done. (As supplied by guesteditors).

Shared decision making in Iran: Current and future trends.

This paper describes the current situation of shared decision making (SDM) in the Iranian healthcare system, discusses barriers to implementation and gives future directions. What about policy regarding SDM? Although the Ministry of Health and Medical Education has enacted some legislation on informed consent and patients' rights, there is no policy specifically regarding SDM in Iran. What about decision support tools for patients? Although some Iranian researchers and clinicians have highlighted patients' desire to be informed and involved in decisions related to their health, there is no program to develop or evaluate decision support tools such as patient decision aids in Iran. What about professional interest and implementation? In spite of interest among some health professionals in SDM and increasing attention to patient involvement in decisions, very little has been done to train Iranian health professionals in SDM. There is also no clear strategy or policy to support SDM implementation within the national health system, and initiatives to promote SDM are in their infancy. What does the future look like? SDM's future in Iran seems promising. However, implementation of SDM will depend on strengthening collaborations among patients, health professionals, academics and policy makers, along with the Iranian government investing in promoting SDM.

Shared decision making, a buzz-word in the Netherlands, the pace quickens towards nationwide implementation .

Currently, shared decision making (SDM) is on the agenda among target patient representative groups, policy makers and professional bodies. Although the International Conference for Shared Decision Making (ISDM) 2011 generated a positive boost, hesitation was also felt among Dutch clinicians, who are challenged by many new tasks. No hesitation is seen among the majority of patients, opting mostly for the SDM model. We haven't reached these patients' needs fully yet, given disappointing research data on patients' experiences and professional behaviour. There is plenty of room for improvement in daily practice, for which many best practices are being designed and increasingly implemented, such as national campaigns to empower patients, central governance of patient decision aids that are developed along clinical practice guidelines, postgraduate training, collaborative learning and system changes, and merging goal setting and SDM in complex care. This is explicitly supported by the Dutch government, the Ministry of Health, patient groups, professional bodies and health insurers. The culture shift in the minds and hearts of patients and clinicians has started but is still ongoing. Enthusiasm for this way of working could be undermined if SDM is defined and implemented in a simplistic, dogmatic manner leading to irresponsible transferring of the professionals' uncertainty, responsibility, and decisional stress to patients.

Shared decision making in Italy: An updated revision of the current situation.

The aim of this paper is to update the previous review on the state of patient and public participation in healthcare in Italy. Policymakers consider patient involvement an important aspect in health care decisions and encourage patients to actively participate in the clinical interaction. Nevertheless, the term shared decision making (SDM) is still not clearly defined. Patient associations promote patient participation in health care decisions. Several experts attended the latest consensus conference about patient engagement to reach a consensus on the definition of SDM. Research regarding SDM in Italy continues to increase with 17 articles published between 2012 and 2017. Researchers have assessed the variables associated with patient involvement and explored the use of the SDM approach in different medical settings. Despite the dedicated SDM initiative, researchers in Italy recognize room for improvement. Work is needed to reach a common language regarding SDM and its mechanisms to implement this approach at the clinical level.

Shared decision making in Brazil: Concrete efforts to empower the patients' voice.

Patient involvement in healthcare decisions has grown in Brazil at three different levels: 1) the macro level, which includes the patient actively influencing legislation and regulation of medical care as well as political changes in the process of care itself; 2) the meso level, which includes institutions that aim to improve information, empowerment and counseling to patients, and 3) the micro level, which focuses on the actual decision-making process that takes place within patient-physician encounter. In Brazil, the macro and meso levels are stronger than the micro one. In this paper, the practical efforts to engage patients in the center of their own care are presented. In order to do that, an overview on the National Humanization Policy and the Brazilian patient's movement is provided.

Shared decision making in Argentina in 2017.

Argentina is a high-middle income country located in Southern South America with an estimated population of 44 million inhabitants. The epidemiological profile of the population is characterised by an increase of non-communicable diseases. The health system is heterogeneous, fragmented and loosely integrated. There are no unified research agenda or government initiatives encouraging the implementation of and research on shared decision making (SDM). Progress has been made lately to respect patient autonomy through the enactment of the 'Patients' Rights Act', which expressly enshrines the right of patients to get information as a key element of decision-making. To our knowledge, the team at the Department of Family and Community Medicine of the Hospital Italiano de Buenos Aires is the only one working on shared decision making in Argentina. This department carries out research, medical undergraduate and graduate training, and clinical practice implementation activities through strategies aimed at professionals and patients alike. We face some challenges regarding SDM, such as: 1) the fragmentation and the heterogeneity of the local health system; 2) we are a small group of people working on this topic who, simultaneously, have care, management, teaching and research responsibilities; 3) we have no government support and project funding is scarce; 4) due to the geographic location of the country, we must make a great effort in order to attend events on the state of the art in SDM. Given the current state of our health system, we believe the government is not likely to encourage, implement or research on SDM in the short term. Our group will continue to work on the local initiative and also to instil it in other interested groups.

Status report from Norway: Implementation of patient involvement in Norwegian health care.

Norway has traditionally high standards regarding civil rights particularly emphasizing equal access to societal resources including health care. This background and the health care system's centralized national organization make it perfectly suited for implementation of shared decision making (SDM). In recent years, great efforts have been made by policy- makers, regional health authorities and not least the patients to facilitate a process of change in health communication culture. SDM is currently even given highest priority in health care strategies on all system levels. SDM has been structurally implemented, e.g. by including corresponding guidance in the standard patient pathways. Moreover, SDM is established as an element of service on the national health portal hosting a constantly increasing number of decision aids. Essentially the Norwegian Knowledge Center for Health Services contributes by searching and providing information for use in decision aids. Implementation is now being rolled out unit by unit for a list of medical problems as a series production of SDM using decision aids and health professional training. Importantly, production of SDM begins and succeeds as a soundly structured communication with both clinical environments and patients. However, as communication training has not been implemented before now, there are no data demonstrating sufficient realization of SDM in current health care. Beyond making reasonable use of scientific achievements, the Norwegian movement's secret of success is the simultaneous commitment of all actors of the health system to a common idea.