Patient engagement as a collaborative process in a large Dutch COVID-19 vaccination study (RECOVAC) - insight into the contribution of patient engagement and learnings for the future.

ABSTRACT

BACKGROUND: The need for patient engagement in health research has been increasingly acknowledged and accepted in recent years. However, implementation is still limited due to lack of evidence on its value and lack of guidance on how to implement patient engagement. This study aims to provide insight into the contribution of patient engagement in the RECOVAC project, which studied COVID-19 vaccination in kidney patients, and formulate concrete practice-based action perspectives for patient engagement. METHODS: We used a qualitative participatory mixed methods approach, based on the Patient Engagement Monitoring and Evaluation (PEME) framework. Patient engagement and data collection were based on the Reflexive Monitoring in Action (RMA) approach. Data collection included participant observations, open ended questionnaires and interactive reflection sessions. Qualitative analysis was done via a thematic approach. RESULTS: We have described the process of patient engagement systematically, provided insight in its value and found that there is a need for clear aims, expectations and preparations from the start of the engagement process. We have shown that reflection throughout the process is of utmost importance and the same applies to clear communication between researchers and patient representatives. By being part of the consortium patient representatives had direct access to information, straight from the source, on for example the vaccination schedule and medication availability and had indirect influence on decisions made by the National Institute for Public Health and the Environment (RIVM) on preventive measures and treatment against COVID-19. Having experienced patient representatives is important, otherwise training needs to be provided. We also found that patient engagement had impact on conduct and outcomes of research activities itself and may have impact on future research and patient engagement activities in general. CONCLUSION: Patient engagement has changed the course of the project. Concrete practice-based action perspectives have been formulated, which are already being implemented by the Dutch Kidney Patients Association (NVN). Studying patient engagement in a high pace project with high public interest has resulted in lessons learned and will help prepare and implement patient involvement in future research projects. CLINICAL TRIAL REGISTRATION The RECOVAC studies in which the patient engagement took place are registered at clinicialtrial.gov (NCT04741386 registration date 2021-02-04, NCT04841785 registration date 2021-03-22 and NCT05030974 registration date 2021-08-20).

This article is about the extensive engagement of patients in a scientific research project and what that engagement adds to the project. Although researchers acknowledge the importance of engagement of patients in research projects, it is not happening very often, Because there is not enough scientific evidence on the value of patient engagement and not enough guidance for researcher on how to implement it in their research. We used the Patient Engagement Monitoring and Evaluation (PEME) framework and qualitative participatory mixed methods research to provide insight into patient involvement in the RECOVAC project, which studied COVID-19 vaccination in kidney patients. We also formulated practical guidance for researchers who want to engage patients in their research. We describe the process of patient engagement in the RECOVAC project; what went well and what could be improved. We found that it is important to prepare well, keep reflecting on the engagement process throughout the project with all stakeholders of the project, communicate clearly and have experienced patient representatives involved or have training available for them. Patient engagement had impact on the conduct and outcome of the research activities itself and on activities outside of the project (e.g., doctors changing their conversations with their patients). We can conclude that involving patients changed the project and its outcomes to better fit with the needs of patients. A guideline has been made and is already implemented by the Dutch Kidney Patients Association. The lessons learned from this project will help researchers involve patients in their future projects.