Evaluating the Acceptability, Feasibility, and Outcomes of Two Methods Involving Patients With Disability in Developing Clinical Guidelines: Crossover Pilot Study

J Particip Med. 2021 Nov 23;13(3):e24319. doi: 10.2196/24319.


Background: Engaging patients and the public in clinical practice guideline (CPG) development is believed to contribute significantly to guideline quality, but the advantages of the various co-design strategies have not been empirically compared, making it difficult to choose one strategy over another.

Objective: This pilot study aims to document the acceptability, feasibility, and outcomes of 2 methods of involving patients in outlining CPG.

Methods: A single-blind crossover pragmatic study was performed with patients with traumatic brain injury. The patients experimented with 2 alternative methods of producing clinical practice recommendations (ie, a discussion group and a wiki). The participants rated the acceptability of the 2 methods, and feasibility was assessed using indicators, such as the number of participants who completed the 2 methods and the number of support interventions required. Experts, blinded to the method, independently rated the participants' outcome recommendations for clarity, accuracy, appropriateness, and usefulness.

Results: We recruited 20 participants, and 16 completed the study. The acceptability of the 2 methods showed little variation, with qualitative comments expressing a slight preference for the social nature of focus groups. Thus, both methods of involving patients in CPG development appeared feasible, and the experts' opinions of the adapted recommendations were both positive, although the recommendations produced through focus groups were deemed more relevant to support clinical practice.

Conclusions: Our results confirm the acceptability and feasibility of focus groups and wikis to allow patients with traumatic brain injury to participate in clinical practice guideline production. This study contributes to the scientific literature by suggesting that the 2 methods were acceptable, feasible, and produced positive outcomes.

Trial registration: ClinicalTrials.gov NCT02023138; https://clinicaltrials.gov/ct2/show/NCT02023138.

Keywords: brain injury; clinical practice; clinical practice guidelines; participation; patient; patient participation; traumatic; traumatic brain injuries.

Associated data

  • ClinicalTrials.gov/NCT02023138