ABSTRACT
APPROACH is an EU-wide research consortium with the goal to identify different subgroups of knee osteoarthritis to enable future differential diagnosis and treatment. During a 2-year clinical study images, biomarkers and clinical data are collected from people living with knee osteoarthritis and data are analyzed to confirm patterns that can indicate such different subgroups. A Patient Council (PC) has been set up at project initiation and consists of five people from Norway, The Netherlands and UK. Initially, this group of individuals had to learn how to effectively work with each other and with the researchers. Today, the PC is a strong team that is fully integrated in the consortium and acknowledged by researchers as an important sounding board. The article describes this journey looking at formal processes of involvement - organizational structure, budget, meetings - and more informal processes such as building relationships and changing researcher perceptions. It describes how the PC helped improve the experience and engagement of study participants by providing input to the clinical protocol and ensuring effective communication (e.g. through direct interactions with participants and newsletters). Furthermore, the PC is helping with dissemination of results and project advocacy, and overall provides the patient perspective to researchers. Additionally, the authors experienced and describe the intangible benefits such as a shift in researcher attitudes and a sense of community and purpose for PC members. Importantly, learnings reported in this article also include the challenges, such as effective integration of the PC with researchers' work in the early phase of the project. TRIAL REGISTRATION: US National Library of Medicine, NCT03883568 , retrospectively registered 21 March 2019.
This article describes the activities and lessons learned from the involvement of a Patient Council in APPROACH, a 5-year European clinical research project focusing on osteoarthritis, the most common form of joint disease. The Patient Council is a group of five people from different EU countries who live with osteoarthritis. They use their knowledge of life with the disease and their own past experience as participants in clinical studies to help improve the experience of people who participate in the APPROACH clinical study. In addition, they provide the overall patient perspective to the researchers within the project.When the project started, the Patient Council was a group of individuals who didn't know each other. They had to find a way to work together with each other as a team, and with the researchers to ensure their involvement was integrated effectively into the project. The authors (current members of the Patient Council and other selected project members) describe in this article what was needed to successfully work together, the process of becoming fully engaged and involved and describe the impact that their activities have made on the clinical study during the project and beyond. They share their lessons learned with the goal to help other research projects to integrate the patient perspective effectively, and to encourage people living with a medical condition to share their experience with researchers through patient involvement activities.
