背景:患者和公众参与(PPI)是加强医疗保健研究和交付的基石,包括临床指南的制定。健康结果涉及可归因于干预的个人或人群的健康状况变化。相关健康结果的讨论会影响最终的临床实践指南。这项研究探讨了美国国家健康与护理卓越研究所(NICE)的PPI贡献者的投入如何整合到指南制定中。特别是在健康结果选择方面。
方法:本研究采用人种学方法。数据包括:委员会会议的观察,范围界定研讨会和培训课程,以及对PPI贡献者的深入采访,卫生专业人员和临床指南制定委员会的主席。数据进行了主题分析。
结果:PPI贡献者在指南制定过程中的输入通常范围有限,特别是在选择健康结果方面。他们输入的主要制约因素包括:准则的技术内容和语言,假设PPI贡献者和卫生专业人员之间与健康相关的优先事项存在差异,以及指导方针制定过程的线性时间表。然而,PPI贡献者可以影响临床指南的制定,包括相关健康结果的选择。这是通过几个因素实现的,突出了委员会主席的重要作用,培训和支持所有委员会成员的重要性,使用简单的语言和所有委员会成员参与的机会。
结论:在临床指南制定的结果选择阶段,可实现独立成员的输入,但是有挑战需要克服。研究结果确定了未来指南开发人员可以支持有意义的外行参与指南开发和健康结果选择的方式。
BACKGROUND: Patient and public involvement (PPI) is a cornerstone in enhancing healthcare research and delivery, including clinical
guideline development. Health outcomes concern changes in the health status of an individual or population that are attributable to an intervention. Discussion of relevant health outcomes impacts the resulting clinical
guidelines for practice. This study explores how the input of PPI contributors at the National Institute of Health and Care Excellence (NICE) is integrated into guideline development, particularly in relation to health outcome selection.
METHODS: The study used an ethnographic methodological approach. Data comprised: observations of committee meetings, scoping workshops and training sessions, and in-depth interviews with PPI contributors, health professionals and chairs from clinical guideline development committees. Data were analysed thematically.
RESULTS: PPI contributors\' input in the
guideline development process was often of limited scope, particularly in selecting health outcomes. Key constraints on their input included: the technical content and language of
guidelines, assumed differences in the health-related priorities between PPI contributors and health professionals, and the linear timeline of the guideline development process. However, PPI contributors can influence clinical guideline development including the selection of relevant health outcomes. This was achieved through several factors and highlights the important role of the committee chair, the importance of training and support for all committee members, the use of plain language and the opportunity for all committee members to engage.
CONCLUSIONS: Lay member input during the outcome selection phase of clinical guideline development is achievable, but there are challenges to overcome. Study findings identify ways that future guideline developers can support meaningful lay involvement in
guideline development and health outcome selection.