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Open Access Study protocol

Evaluation of the acceptability, feasibility and effectiveness of two methods of involving patients with disability in developing clinical guidelines: study protocol of a randomized pragmatic pilot trial

Marie-Eve Lamontagne12*, Kadija Perreault2 and Marie-Pierre Gagnon34

Author Affiliations

1 Center for Interdisciplinary Research in Rehabilitation and Social Integration, Institut de réadaptation en déficience physique de Québec, 525, boulevard Wilfrid-Hamel, Québec G1M 2S8, QC, Canada

2 Département de réadaptation, Faculté de Médecine, Université Laval, 1050, avenue de la Médecine, Québec G1V 0A6, QC, Canada

3 Faculté des sciences infirmières, Université Laval, 1050, avenue de la Médecine, Québec G1V 0A6, QC, Canada

4 Centre hospitalier de Québec Research Center, 10, rue de l'Espinay, D7-722, Québec G1L 3 L5, QC, Canada

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Trials 2014, 15:118  doi:10.1186/1745-6215-15-118

Published: 10 April 2014

Abstract

Background

Despite growing interest in the importance of, and challenges associated with the involvement of patient and population (IPP) in the process of developing and adapting clinical practice guidelines (CPGs), there is a lack of knowledge about the best method to use. This is especially problematic in the field of rehabilitation, where individuals with disabilities might face many barriers to their involvement in the guideline development and adaptation process. The goal of this pilot trial is to document the acceptability, feasibility and effectiveness of two methods of involving patients with a disability (traumatic brain injury) in CPG development.

Methods/Design

A single-blind, randomized, crossover pragmatic trial will be performed with 20 patients with traumatic brain injury (TBI). They will be randomized into two groups, and each will try two alternative methods of producing recommendations; a discussion group (control intervention) and a Wiki, a webpage that can be modified by those who have access to it (experimental intervention). The participants will rate the acceptability of the two methods, and feasibility will be assessed using indicators such as the number of participants who accessed and completed the two methods, and the number of support interventions required. Twenty experts, blinded to the method of producing the recommendations, will independently rate the recommendations produced by the participants for clarity, accuracy, appropriateness and usefulness.

Discussion

Our trial will allow for the use of optimal IPP methods in a larger project of adapting guidelines for the rehabilitation of individuals with TBI. Ultimately the results will inform the science of CPG development and contribute to the growing knowledge about IPP in rehabilitation settings.

Trial registration

Clinical trial KT Canada 87776.

Keywords:
Clinical practice guideline; Brain injury; Patient and population participation; Adaptation; Disabilities