Integrating lived experience into rehabilitation clinical trial design: A framework for success

Research Objectives: To propose an evidence-based, best-practice framework for lived experience and community engagement in clinical trials testing rehabilitation interventions.

Design: This project applied a mixed-method and iterative process. Commencing first with a scoping review of available policies and processes, we then undertook a consultation and development process with key stakeholders. Facilitated group discussion and triangulation of findings supported the development of a structured framework that included both principles of conduct as well as practical processes.

Setting: Trials will be conducted in both inpatient and ambulatory rehabilitation settings, and therefore the engagement framework was conceptually developed with people with lived experience (PWLE) across this continuum.

Participants: Key stakeholders were PWLE and carers, research academics and Consumer Health Forum (Australia’s leading advocate on consumer health care issues).

Interventions: Not applicable

Main Outcome Measures: To better understand the issues affecting meaningful engagement as well as implementation and strategies that can be applied, evidence was drawn from multiple sources. The method included content analysis of published policies, frameworks and guidelines specific to engaging PWLE, evidence-focused review of proposed elements using a focus group method, and consultative discussion. Methods were applied for data collection and analysis so as to ensure triangulation of results.

Results: Clinical trials were acknowledged to be a specialist design, and formal training in clinical trial methodology was seen to be critical, irrespective of the level of participation sought by PWLE. To ensure equality and effective involvement, engagement in trial design, governance, enrolment and data collection, dissemination and translation were acknowledged. Formal training, remuneration and compensation, and principles for ensuring accessible communication form key process recommendations. Pilot testing demonstrated the successful application of the framework to support active partnership of PWLE in rehabilitation trials.

Conclusions: This study produced an effective method for meaningful community stakeholder engagement to ensure clinical trial designs remain rigorous, research teams are able to maximise participant benefit while minimising participant burden, and trial results are readily translated so as to optimise adoption in clinical practice.

Author(s) Disclosures: The authors declare no conflicts of interest.