评价两种让残疾患者参与制定临床指南方法的可接受性、可行性和有效性：一项随机实用试点试验的研究方案。
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.
机构信息
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.
出版信息
Trials. 2014 Apr 10;15:118. doi: 10.1186/1745-6215-15-118.
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.
背景
尽管人们对患者和人群（IPP）参与制定和改编临床实践指南（CPG）的重要性及其面临的挑战越来越感兴趣，但对于最佳方法的了解仍存在不足。这在康复领域尤其成问题，因为残疾人士在参与指南制定和改编过程中可能面临许多障碍。本试点试验的目的是记录两种使残疾患者（颅脑损伤）参与 CPG 制定的方法的可接受性、可行性和有效性。
方法/设计：将对 20 名颅脑损伤（TBI）患者进行单盲、随机、交叉实用试验。他们将被随机分为两组，每组尝试两种不同的推荐方法；一个讨论组（对照干预）和一个 Wiki，这是一个可以由有权访问它的人修改的网页（实验性干预）。参与者将对两种方法的可接受性进行评分，而可行性将通过参与者访问和完成两种方法的数量以及所需的支持干预措施的数量等指标进行评估。20 名专家将对参与者提出的建议进行独立评分，不了解提出建议的方法，评估标准为清晰度、准确性、适当性和有用性。
讨论
我们的试验将允许在更大的 TBI 康复患者指南改编项目中使用最佳的 IPP 方法。最终，结果将为 CPG 制定的科学提供信息，并为康复环境中 IPP 的日益增长的知识做出贡献。
试验注册
临床试验 KT 加拿大 87776。
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