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Objectives Since 2018, four establishments in Quebec have been instrumental in implementing the PAROLE-Onco program, which introduced accompanying patients (APs) in healthcare teams to improve cancer patients’ experience. APs are patient advisors who have acquired specific experiential knowledge related to living with cancer, using services, and interacting with healthcare professionals. They are therefore in a unique and reliable position to be able to provide emotional, informational, cognitive and navigational support to patients dealing with cancer. We aimed to explore APs’ perspectives regarding the limiting and facilitating factors in terms of how they are integrated into the clinical oncology teams. Methods A qualitative study based on semi-structured interviews and focus groups was conducted with 20 APs at the beginning of their intervention (T1) and two years afterwards (T2). Limiting and facilitating factors of APs’ integration into clinical teams were analyzed in terms of governance, culture, resources and tools. Results The most significant limiting factors raised by APs to be integrated into clinical teams were: governance involvement, organizational boundaries, team members' availabilities, and confusion about the specific roles played by APs. Communication challenges were also raised, leading to inadequate promotion of the program to patients. The lack of time, space and compensation were also mentioned as limiting factors. Creating opportunities for team members to meet APs, building trust and teaching team members how APs’ activities are complementary to theirs were enhancing factors. Other facilitators include APs being involved in decision-making committees, being leaders in the PAROLE-Onco program promotion to patients and clinical team members and creating opportunities to communicate with team members to help enhance their work and provide feedback to improve patient services. Awareness of APs’ added value for the team and patients is also a key facilitator. Regarding tools, offering accompanying services by telephone allows both patients and APs to benefit from the flexibility they need. Conclusion Over time, APs were able to identify the best factors for successful implementation. Recommendations include APs and professionals working in co-construction on organization, leadership, resources, and status factors. This could help catalyze a change in culture within health establishments and allow people dealing with cancer to benefit from the experiential knowledge of other patients within their clinical team.

Evaluating rare disease interventions poses challenges for HTA agencies, including uncertainties and ethical issues and tensions. INESSS has recently adopted a Statement of Principles and Ethical Foundations which proposes a multidimensional approach to value appraisal as well as five principles to frame the evaluation process.Our aim was to identify and analyse HTA challenges for appraising interventions for rare diseases, using the Statement's approach to value appraisal as an analytical framework, and outline how the Statement's principles can help address these challenges. Challenges, covering a diversity of aspects, were identified by leveraging institutional experience in diverse domains of expertise and consolidated through narrative literature review. Challenges were categorized by value dimension (clinical, populational, economic, organisational, and sociocultural), which allowed to pinpoint how each challenge affects the ability to appraise the value of an intervention. Key ethical tensions across dimensions were also identified. Specific approaches to addressing these challenges - related to knowledge mobilization and integration, deliberation, and recommendation-making - were outlined on the basis of the principles promulgated in theA multidimensional approach can be fruitful for analysing challenges for appraising the value of rare disease interventions and help guide approaches to tackle them.

Background Moral questions are vital questions because they concern what is esteemed to be the best action, the best choice and, ultimately, the best life to live. Health ethics which aims to address these moral questions has contributed to moving ethics toward more experience-based and user-oriented ethics theory and methodology. Despite this, current approaches remain an incomplete lever for human development and flourishing. This context led us to imagine and develop the stance of a “living ethics”, a radically participatory and situated form of ethics which we describe in this inaugural collective and programmatic paper. Methods We followed a participatory discussion and writing process known as instrumentalist concept analysis. Initial informal local consultations were undertaken about pragmatic ethics, and from these conversations emerged the current project. An exploratory literature review was undertaken, and a diverse working group of 21 co-authors was assembled. The working group held a total of 8 workshop-like meetings supported by prior reading and iterative revision of a shared draft document accessible through an online platform. Meetings were video-recorded and transcribed to support this process. Four subgroups were created to further the working group’s reflections in specific domains of health ethics. Results In its first sense, a living ethics designates a form of ethics attentive to human experience and the role played by morality in human existence. In its second sense, a living ethics represents an ongoing effort to interrogate and scrutinize our moral experiences to promote the engagement of both individuals and communities in envisioning and enacting scenarios which correspond to their flourishing as authentic ethical agents. Living ethics bears specific theoretical, methodological, and practical implications in various areas of health ethics activity such as clinical and organizational ethics, health policy and public health, health ethics research, and learning and teaching health ethics. Conclusions Living ethics encourages meaningful participation of stakeholders and reflects a commitment to the existential nature of moral affairs. Looking forward, there is a need for ongoing dialogue about the nature of living ethics and the methodological practices coherent with this orientation. We hope to build on this idea to initiate collaborative projects locally and internationally.

POINTS CLES Le public est de plus en plus sensible a l’importance de divulguer et de gerer les conflits d’interets (CI) lies a l’elaboration des guides de pratique clinique et des directives de sante publique, en raison de dossiers recents tres mediatises au Canada et a l’e

IntroductionReal-world evidence (RWE) can be of value to support comparative effectiveness of drugs and technologies by providing additional information about their use for a variety of patients in real contexts of care. However, the integration of RWE in appraisals can be challenging, and INESSS felt the need to reinforce and explicit the underlying methodological and theoretical foundations.MethodsA comprehensive literature review was carried out, followed by collaborative development work by members of the methodological and assessment teams.ResultsThe literature review led to a common understanding of RWE underlying principles and fed the subsequent phases of the project. Three factors were identified as driving the integration of RWE in reimbursement appraisals at INESSS. Specifically, (i) the design and conduct of the real-world studies are done in accordance with best practices, (ii) the results are presented transparently and include all relevant information to assess the quality of the study and the data, and (iii) the RWE submitted is appropriate and relevant for decision-making. This third component is further ascertained by considering the decisional context (what are the circumstances motivating the submission of RWE and how does it correlate or not with existing evidence?), the data (is the dataset fit for decision needs?) and the study methods (are study design and analytical methods robust enough?). Globally, INESSS considers the integration of RWE in appraisals and its weighting, in relation with the (more traditional) available evidence, to be a case-by-case exercise.ConclusionsThe characterization of the main factors driving the integration of RWE in reimbursement appraisals at INESSS serves as a basis for communicating the requirements for evaluation submissions by sponsors. It further reinforces INESSS capabilities in assessing innovations, which can imply an appraisal of value at various moments along the lifecycle and with a diversity of evidence types. Considering the rapidly evolving literature and international experience, this work is expected to evolve too, and will be updated as needed.

In recent years, recognizing patients’ experiential knowledge to improve the quality of care has resulted in the participation of patient advisors at various levels of healthcare systems. Some who are working at the clinical level are called accompanying patients (AP). A PRISMA-ScR exploratory scoping review of the literature was conducted on articles published from 2005 to 2021. Articles not in English or French and grey literature were excluded. The databases searched included Medline, PubMed, Scopus, and Google Scholar. The data were organized according to the similarities in the ethical foundations of the included papers. Out of 2095 identified papers, 8 met inclusion criteria. Terms used to describe APs included peer support, resource parent, and peer health mediator. The clinical settings included psychiatry/mental health and neonatology. APs, patients, healthcare professionals, managers and policy makers were included in the studies. Three personal ethical foundations describing the foundations of the AP role were found: resilience, listening skills and altruism. The ethical foundations of this role also addressed interpersonal and interprofessional relationships with other actors in the healthcare system. The literature on the ethical foundations of APs is sparse, with heterogeneous methodologies. Further studies mobilizing well-defined methodologies would further validate the current results and deepen our understanding of the ethical foundations of the AP role.

IntroductionThe Institut national d’excellence en santé et en services sociaux (INESSS) makes recommendations regarding introduction, coverage, optimal use or withdrawal of interventions in physical and mental health and social services to support fair and reasonable decisions. The objectives of this work were to develop a statement of principles and ethical foundations for a common appraisal framework across diverse interventions, to enhance legitimacy and coherence of evaluation practices, and develop reflective approaches throughout the institution to operationalize the principles.MethodsTo develop this statement, INESSS reviewed its practices across different units, surveyed the literature on innovative practices and the evolution of HTA, and undertook an extensive internal and external consultative process. The principles are used to develop reflective activities as part of a continuous improvement strategy.ResultsThe adopted approach to value appraisal considers the contributions of interventions to the Triple Aim of health and social services systems as well as their organizational and sociocultural feasibility and impacts (clinical, populational, economic, organizational, sociocultural dimensions). This approach is articulated around five principles including: (i) evaluating the most relevant objects and adapting evaluation modalities; (ii) mobilizing and integrating diverse types of knowledge; (iii) supporting multidimensional deliberation including diverse perspectives; (iv) developing fair and reasonable recommendations; (v) promoting value creation by supporting the implementation of recommendations and re-evaluation. Although all principles contribute to the legitimacy and credibility of the recommendations, which we aim to implement and consolidate through a set of activities, deliberation is an important part of the process that we are striving to improve. A first set of reflective activities are planned to support its operationalization, including: materials to promote a common understanding of the diverse aspects of the deliberation, reflective workshops on selected past projects, and sharing emerging reflections across INESSS units to further continuous improvement in operationalizing the principles.ConclusionsMoving forward, INESSS’s strategic intention is to mobilize its staff and collaborators to facilitate the rigorous, agile and coherent application of these principles.

Context The National Institute of Excellence in Health and Social Services (INESSS), which functions as the Québec health technology assessment (HTA) agency, tested a new way to engage patients along with health‐care professionals in the co‐construction of recommendations regarding implantable cardioverter‐defibrillator replacement. Objective The objective of this article was to describe the process of co‐construction of recommendations and to propose methods of building best practices for patient involvement (PI) in HTA. Design Throughout the process, documents were collected and participant observations were made. Individual interviews were conducted with patients, health‐care professionals and the INESSS scientific team, from January to March 2018. Results Three committees were established: an expert patient committee to reflect on patient experience literature; an expert health professional committee to reflect on medical literature; and a co‐construction committee through which both patients and health‐care professionals contributed to develop the recommendations. The expert patients validated and contextualized a literature review produced by the scientific team. This allowed the scientists to consider aspects related to the patient experience and to integrate the feedback from patients into HTA recommendations. The most important factor contributing to a positive PI experience was the structured methodology for selecting patient participants, and a key factor that inhibited the process was a lack of training in PI on the part of the scientific team. Conclusions This experience demonstrates that it is possible to co‐construct recommendations, even for technically complex HTA subjects, through a more democratic process than usual which led to more patient‐focused guidance.

Quebec is one of the Canadian provinces with the highest rates of cancer incidence and prevalence. A study by the Rossy Cancer Network (RCN) of McGill university assessed six aspects of the patient experience among cancer patients and found that emotional support is the aspect most lacking. To improve this support, trained patient advisors (PAs) can be included as full-fledged members of the healthcare team, given that PA can rely on their knowledge with experiencing the disease and from using health and social care services to accompany cancer patients, they could help to round out the health and social care services offer in oncology. However, the feasibility of integrating PAs in clinical oncology teams has not been studied. In this multisite study, we will explore how to integrate PAs in clinical oncology teams and, under what conditions this can be successfully done. We aim to better understand effects of this PA intervention on patients, on the PAs themselves, the health and social care team, the administrators, and on the organization of services and to identify associated ethical and legal issues. We will conduct six mixed methods longitudinal case studies. Qualitative data will be used to study the integration of the PAs into clinical oncology teams and to identify the factors that are facilitators and inhibitors of the process, the associated ethical and legal issues, and the challenges that the PAs experience. Quantitative data will be used to assess effects on patients, PAs and team members, if any, of the PA intervention. The results will be used to support oncology programs in the integration of PAs into their healthcare teams and to design a future randomized pragmatic trial to evaluate the impact of PAs as full-fledged members of clinical oncology teams on cancer patients’ experience of emotional support throughout their care trajectory. This study will be the first to integrate PAs as full-fledged members of the clinical oncology team and to assess possible clinical and organizational level effects. Given the unique role of PAs, this study will complement the body of research on peer support and patient navigation. An additional innovative aspect of this study will be consideration of the ethical and legal issues at stake and how to address them in the health care organizations.

KEY POINTS Public awareness regarding the importance of disclosing and managing conflicts of interest (COIs) during the development of clinical practice and public health guidelines is growing, owing to recent high-profile news stories within and outside Canada.[1][1]–[9][2] Despite the existence

ContextThe Ministry of Health in Québec requested the National Institute of Excellence in Health and Social Services to produce clinical and implementation recommendations for the prophylaxis, diagnosis, and treatment of Lyme disease.Objectives(i) Describe the process of trialing different modalities of patient engagement as a means to integrate a diversity of patient perspectives and (ii) Describe the learning process of INESSS regarding the integration of the patient perspective.MethodologyAll documents were analyzed, and a survey with all advisory committee members and semi-structured interviews with stakeholders were conducted. Each interview was transcribed verbatim and imported into QDA miner software for the purposes of analysis. Data analysis was carried out concurrently with data collection to allow for an iterative approach between data collection and analysis.ResultsFive methods to integrate the perspectives of patients were used: (i) interviews with patients, (ii) inclusion of patient partners within the advisory committee, (iii) literature review, (iv) focus groups with one patient association, and (v) feedback from patient associations on recommendations intended for decision makers and other targeted stakeholders. The patient partners influenced decisions by sharing their experiential knowledge. The patient interviews and the literature review added an in-depth perspective on the disease and experience with the healthcare system. The patient association members shared their perspectives and helped disseminate the recommendation to sustain a practice change.ConclusionThe combination of methods to collect and integrate patients’ knowledge and patient associations’ perspectives helped develop a comprehensive understanding of a controversial object of evaluation.

Objectives Increasing emphasis is given on involving patients in health technology assessment (HTA). While this is mainly done at the level of regional and national HTA agencies, this tendency is also emerging in local HTA units. In this study, we provide the results of a survey conducted in local HTA units in the province of Quebec, Canada. The aim of the survey was to provide an overview of local HTA unit practices to involve patients, users, caregivers, and citizens in their process, their interest in doing so, and their information needs for this. Methods The survey was conducted in 2017 with a response rate of eleven units over a possibility of twelve. Results Three units out of eleven (27.3 percent) never involved patients or members of the public in their processes and all indicated that they will involve them in the next few years. The three most important needs for support identified in the HTA units were in: recruiting and selecting patients; integrating experiential knowledge; and knowing and implementing the best methods and practices for partnership. Conclusion Patient involvement in local HTA units is quickly evolving and that is why they urgently need tools to involve more effectively patients and members of the public in their process.

Increasing emphasis is given on involving patients in health technology assessment (HTA). While this is mainly done at the level of regional and national HTA agencies, this tendency is also emerging in local HTA units. In this study we provide the results of a survey conducted in local HTA units in the province of Quebec, Canada. The aim of the survey was to provide a panorama of local HTA units practices to involve patients in their process, their interest in doing so, and their information needs for this. The survey was conducted in 2017 with a response rate of 11 units over a possibility of 12. Results indicate that only 3 units over 11 never involved patients or members of the public in their process and that all will involve them in the next few years. The three most important needs identified in the HTA units were: recruiting and selecting patients; integrating experiential knowledge; and knowing and implementing the winning conditions for partnership. To conclude, patient involvement in local HTA units is quickly evolving; that is why the latter urgently need tools to involve more effectively patients and members of the public in their process. Key messages There is a need to develop tools to involve patients in HTA process. Patient involvement in local HTA units is quickly evolving.

Sommaire Le Quebec s'est dote d'un Commissaire a la sante et au bien-etre pour apporter un eclairage pertinent au debat public et a la prise de decision gouvernementale dans le but de contribuer a l'amelioration de l'etat de sante et de bien-etre des citoyens. Au fil des annees, le Commissaire a developpe une expertise dans le domaine de l'evaluation de la performance fondee sur le croisement de differentes connaissances et sources d'information, et qui integre l'ethique et la participation citoyenne. Dans cet article, nous presentons la methode du Commissaire, ses resultats, ainsi que les enjeux et les defis qui y sont associes. Abstract Quebec established a Health and Welfare Commissioner to shed a relevant light on the public debate and government decision-making process to help improve citizens' health and welfare. Over the years, the Commissioner has developed an expertise in the performance measurement field based on the cross-section of various knowledge and information sources, and that integrates ethics and citizen engagement. In this article, we present the Commissioner's approach, its results, and related issues and challenges.

Introduction:Decisions about which health and social services to include in the publicly funded services basket are complex. Several criteria need to be taken into account in decision-making (DM), as well as ethical, economic and organizational issues. Nowadays a global consensus supports the view that citizens’ values and preferences must guide DM. To elicit these values and concerns regarding publicly funded services, the Quebec Health and Welfare Commissioner recently conducted a vast public consultation on the population viewpoints. Parts of this consultation targeted criteria for DM, approaches to assess new or current services and perspectives on appropriateness of care.Methods:Various consultation methods were used in complementary steps: a representative population survey (n=1850), six regional focus groups (n=62), a call for briefs (n=52) for groups that wished to share their views, consultation meetings (n=35) with diverse stakeholders and a call for personal accounts (n=2633). It also held five deliberation sessions (18 citizens and 9 experts) over the course of the project on major related issues.Results:The need to ensure the appropriateness of covered services was one of the strongest themes emerging from the consultation. Citizens want that the appropriateness evaluation be carried out under certain conditions: transparently, in explicit DM processes, using criteria that are clear and adaptable according to the disease or problem. The whole evaluation process needs to be well documented, showing clearly the data used and rejected, so that they can understand the decision and see on what basis it is supported. Among the usual criteria for DM, those related to cost are less valued whereas others are considered incomplete.Conclusions:Citizens have clear viewpoints and expectations regarding DM criteria and processes for resource allocation. Decision-makers must take them into account to ensure that the basket of insured services is representative of social values and preferences.

IntroductionIn a context of rapidly evolving technologies and growing evaluative challenges, the National Institute of Excellence in Health and Social Services (INESSS) is developing an institutional ethical framework making explicit and transparent the guiding principles and new modalities of process for health technology assessment for public coverage.MethodsThis framework is co-built by the INESSS experts - drugs, social services, technology and health services and cross-cutting methodologies - through literature and practice reviews as well as a consultative process on key topics with external collaborators.ResultsThe development process aims to: (i) identify the principles applicable to all the objects evaluated, (ii) define the evaluation strategies used to appropriately address evaluation challenges in the clinical, organizational, economic and societal dimensions, (iii) equip the scientific teams to successfully integrate diversified knowledge from the literature, stakeholders participation and medico-administrative data banks, and (iv) facilitate deliberation leading to evidence-informed recommendations. It is envisioned as a fully integrated process rooted in a reflexive multi-criteria approach supporting fair and reasonable decision. The presentation will focus on one of the key aspects of this framework, i.e., the development of principles for stakeholder participation based on a recent INESSS methodological forum on the topic, and the agile deployment of innovative processes and tools in various projects, including the patient partnership developed with a pioneering academic centre.ConclusionsThis framework provides explicit, transparent and cross-cutting processes and a framework for continuous improvement. The goal is to promote stakeholder engagement and enable increasingly complex arbitration aimed at equity and social justice, in a context of rising costs and uncertainty, and focused on the creation of value for our fellow citizens.

IntroductionHealth technology assessment (HTA) and the development of clinical practice guidelines (CPGs) support important health policy and clinical decisions. Conflicts of interest (COI) and conflicts of commitment (COC) can undermine the credibility and integrity of these processes, that of the actors involved, and, more alarmingly, the health of the population. Thus, management of COI and COC is critical. Although COI among experts participating in HTA and CPG development are increasingly discussed and managed, little is said about COCs and the possible COI and COC associated with patient participation. The aim of our study, which is part of the Institut national d'excellence en santé et services sociaux (INESSS) continuing improvement process for COI and COC management, was to identify best practices in this matter.MethodsWe examined the COI and COC management policies of ten HTA and CPG organizations and performed a review of the relevant academic literature.ResultsThree HTA and CPG organizations had norms regarding the management of patients’ COI and COC, whether they were representatives of patient associations or not. These norms addressed situations such as: when a patient represents a patients’ association; when a patients’ association or an individual patient has important (financial) ties with the pharmaceutical industry; or when an expert or one of his/her family members suffers from the disease related to the HTA or CPG. The declaration of a COI or COC should not necessarily lead to the individual's exclusion from the entire HTA or CPG development process, but it must lead to some evaluation and management. Patients appointed to share their perspectives are not considered to have COI or COC if their mandate is explicit.ConclusionsThe COI and COC of all participants in HTA and CPG development should be managed fairly and transparently. Therefore, the management of COI and COC among patients participating in HTA or CPG development should be based on the same principles as those applied to clinical experts.

Introduction:Decision-making about replacement or modification of an implantable cardioverter defibrillator (ICD) must be patient-centered and clinically appropriate. We engaged both patients and health care professionals in a multi-method approach in order to recommend structures and processes that facilitate informed and shared decision-making.Methods:A systematic literature review (2000 to 2017) was performed focusing on the patient's perspective and the optimal organization of structures and processes for decision-making. A province-wide field evaluation based on medical chart review was carried out to provide ‘real world’ evidence in Québec's six ICD implanting centers (1 July to 31 December, 2016; N = 418). Patients and health care professionals reviewed the findings of the review and field evaluation, and deliberated recommendations in an anonymous manner by electronic mail. A joint meeting focused on proposed recommendations concerning shared decision-making.Results:The patients provided feedback on the literature review based on their ICD experience, and highlighted the need for better and more interactive decision aids, clinical information and time, and a private space for sensitive discussions. The field evaluation underlined the variability of treatment choices at the time of replacement and that more than one in ten patients had undergone ICD deactivation. Proposed recommendations focus on multi-disciplinary, integrated follow-up of patients and outline best practice for incorporating patient wishes and life objectives when discussing treatment options. The multi-round consultation process allowed both patients and professionals to co-construct recommendations with our evaluation team.Conclusions:This multi-method approach enriched our interpretation of literature and ‘real world’ data and facilitated identification and prioritization of important themes. Partnership with both patients and clinicians added a new and energizing dynamic to our evaluation and recommendation processes. We acknowledge the contribution of the members of the patient committee and the clinical experts committee.

According to advocates and authors from different disciplines interested in biomedicine, biomedical research in genetics and genomics has the potential to transform medicine, the economy, society, and humanity as a whole. Believing in this potential, biomedical scientists produce knowledge and participate in the decisions concerning the orientation of this research and its applications. Through a qualitative analysis of scientists' practice-related discourse, we identified three main sources of complexity in their involvement in the "commercial revolution" of science. First, scientists insist on the existence of different types of university-industry relationships. Second, they urge that the multiple realities of genetic and genomic research be acknowledged. Third, they present themselves as individuals in a diverse scientific community, each with a unique position in this commercial revolution. This paper draws attention to these complexities because they must be considered when engaging in a study of genetics and genomics advances from a research ethics perspective.