Patient and Citizen Participation in the Identification of Ethical Considerations Aiming to Address Uncertainty in the Evaluation of Promising Interventions in a Pandemic Context.

Since the beginning of the COVID-19 pandemic, numerous studies have been conducted to identify interventions that could contribute to alleviating the burden it has caused. The Institut national d'excellence en santé et en services sociaux (INESSS) has played a key role in informing the government of Québec regarding the evaluation of specific pandemic-related interventions. This process took place in a context characterized by a sense of urgency to assess and recommend potential interventions that could save lives and reduce the effects of the disease on populations and healthcare systems, which increased the pressure on the regulatory agencies leading these evaluations. While some of the interventions examined were considered promising, results from COVID-19 studies often led to uncertainty regarding their efficacy or safety. Regulatory agencies evaluating the value of promising interventions thus face challenges in deciding whether these should be made available to the population, particularly when assessing their benefit-risk balance. To shed light on these challenges, we identified underlying ethical considerations that can influence such an assessment. A rapid literature review was conducted in February 2021, to identify the main challenges associated with the benefit-risk balance assessment of promising interventions. To reinforce our understanding of the underlying ethical considerations, we initiated a discussion among various social actors involved in critical thinking surrounding the evaluation of promising interventions, including ethicists, clinicians and researchers involved in clinical or public health practice, as well as patients and citizens. This discussion allowed us to create a space for exchange and mutual understanding among these various actors who contributed equally to the identification of ethical considerations. The knowledge and perspectives stemming from the scientific literature and those consulted were integrated in a common reflection on these ethical considerations. This allowed patients and citizens, directly affected by the evaluation of pandemic-related interventions and the resulting social choices, to contribute to the identification of the relevant ethical considerations. It also allowed for reflection on the responsibilities of the various actors involved in the development, evaluation, and distribution of promising interventions in a setting of urgency and uncertainty, such as that brought about by the COVID-19 pandemic.

Developing recommendations for the diagnosis and treatment of Lyme disease: the role of the patient's perspective in a controversial environment.

CONTEXT: The 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. METHODOLOGY: All 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. RESULTS: Five 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. CONCLUSION: The combination of methods to collect and integrate patients' knowledge and patient associations' perspectives helped develop a comprehensive understanding of a controversial object of evaluation.