Patient & Public Involvement in Research: a collaborative Approach to Clinical Trials
Background and aim
Cognitive impairment is a prevalent symptom in person with multiple sclerosis (pwMS). However, there is a lack of consensus regarding neurorehabilitation strategies to address MS-related cognitive deficits, and a consequent lack of interventions in clinical practice. In the past years, Patient and Public involvement (PPI) has emerged in various aspects of research, from conception of a study to dissemination of results. The PPI aims to improve the quality and clinical impact of studies, integrating the valuable expertise of patients’ representatives on the disease.
Method
A PPI was included in our multicentric international clinical randomized control trial (RCT) that is currently in the preparatory phase. This study aims to evaluate the benefits of different innovative digital approaches integrating cognitive exercises, associated or not with physical exercises, for the rehabilitation of cognitive deficits among patients with MS. To include patient representatives at all stages of this project, we established three main phases for the PPI: conception of the Study Design (Phase I), Recruitment (Phase II) and Interpretation and Dissemination of the results (Phase III).
Phase I of the PPI, consisting of evaluations and discussions on study feasibility, is currently ongoing, and will be concluded in September 2024.
Discussion
The collaboration with patient representatives in the Phase I of the PPI will provide insights on the objectives, study endpoints, and experimental design of the protocol and conception of future studies. Phase II of the PPI will enhance intervention accessibility to patients and Phase III will ensure the quality and comprehension for knowledge dissemination.
Conclusion
This collaborative approach aims to provide an effective and evidence-based intervention for the rehabilitation of cognitive deficits in pwMS.