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

Abstract

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.

How to mobilise users' experiential knowledge in the evaluation of advanced technologies and practices in Quebec? The example of the permanent users' and relatives' panel

“…As such, all panel members were interviewed first, followed by scientific professionals-from those closely working with them to those leading various institutional units, and finally with the institutional vice-president. The topics that were discussed during the interviews were related to: (1) the process of setting up the URP; (2) the perception of the URP's contribution; (3) the challenges faced; and (4) the perspectives and prospects for improvement in the following years (see Appendix S1).…”

“…Agencies for Health Technology Assessment and Assessment of Social Services (AHTAASS) are increasingly called upon to integrate the experiential knowledge of patients, users, relatives and citizens into their work. 1 In this context, Quebec's agency, the Institut national d'excellence en santé et services sociaux (INESSS), 2 is no exception, 3 especially as in Québec, in 2018, a framework for the partnership approach between users, their families and health and social service provider 4 encourages all healthcare organisations to develop initiatives that mobilise patients' experiential knowledge. In this context, INESSS is developing a policy that integrates the points of view of citizens, patients and caregivers 5,6 and has set up an Office of Methodologies and ethics to support the participation of citizens, users, patients and their families in its various activities.…”