Harnessing the power of patient engagement in evaluating a novel brace for knee osteoarthritis: a co-produced commentary

Abstract

Introduction: Patient oriented research (POR) invites patients to partner with researchers, clinicians, and other stakeholders, incorporating diverse perspectives to generate scientific evidence meaningful to all parties involved. We adopted a POR approach for this study evaluating the feasibility of conducting a randomized control trial of a novel tri-compartment offloader brace for knee osteoarthritis. We involved patients as partners to enhance study design, implementation and interpretation of key outcomes.

Approach: Patient involvement consisted of two patient leaders and five patient advisors. Patients participated in 2 virtual focus groups to discuss study outcomes, protocol, results and knowledge translation. Patients were involved in all aspects of the research cycle.

Outcomes: Patient feedback resulted in changes to study design, documentation, participant recruitment, data collection, results interpretation and knowledge dissemination, improving the participant experience and aligning study outcomes with patient priorities. Study participants showed a high level of protocol adherence and follow-up rates were excellent. We experienced several unexpected benefits including genuine friendships, a deeper understanding of the patient experience, a more pragmatic approach to clinical research, and leadership opportunities for patients.

Recommendations: We agreed on POR "non-negotiables" to ensure a positive experience for everyone, including creating a safe and comfortable environment, being genuinely receptive to patient feedback, and providing appropriate supports for patients. We strongly recommend that researchers (1) involve patients as early as possible, (2) provide ample and equal opportunities for all patients to be involved, and (3) address system hierarchy by involving patients as equals and fully considering all patient ideas from the beginning of the project.

Conclusions: While POR is a learning process that is often more challenging than the traditional clinical research approach, the benefits are well worth the additional time and effort required to do it well. Over time, our team experienced a cultural shift and evolution from a top-down research approach to a more inclusive approach considering patient voices as equal to those of researchers. Patient involvement in all aspects of the research process, from question development to results interpretation and dissemination is integral to clinical research advancing equitably.

Keywords: Clinical research; Feasibility study; Knee brace; Knee osteoarthritis; Patient partners; Patient-oriented research.

Fig. 1

Summary of patient involvement throughout the research cycle. * indicates exclusive involvement of Patient Leaders. Image description: This figure describes how we incorporated “Patient Oriented Research” into the design and implementation of the research study. The figure comprises of 5 boxes in a loop labeled: Planning and Preparation, Study Design, Study Implementation, Data Analysis, and Dissemination. During the Planning and Preparation stage, 7 patients were recruited: 2 were patient leaders and 5 were Patient advisors. The Patient leaders were involved throughout the planning, design and implementation phases of the research. The Patient advisors participated in a panel discussion and data collection survey testing to help support the research

Fig. 2

Results from the final PPEET survey completed by all patients (n = 7) at the completion of the feasibility study