Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain
Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.
BMJ Open. 2021 Dec 2;11(12):e053587. doi: 10.1136/bmjopen-2021-053587.
This study aims to better understand the current practice of clinical guideline adaptation and identify challenges raised in this process, given that published adapted clinical guidelines are generally of low quality, poorly reported and not based on published frameworks.
A qualitative study based on semistructured interviews. We conducted a framework analysis for the adaptation process, and thematic analysis for participants' views and experiences about adaptation process.
Nine guideline development organisations from seven countries.
Guideline developers who have adapted clinical guidelines within the last 3 years. We identified potential participants through published adapted clinical guidelines, recommendations from experts, and a review of the Guideline International Network Conference attendees' list.
We conducted ten interviews and identified nine adaptation methodologies. The reasons for adapting clinical guidelines include developing clinical guidelines, implementing source clinical guidelines, and harmonising and updating existing clinical guidelines. We identified the following core steps of the adaptation process (1) selection of scope and source guideline(s), (2) assessment of source materials (guidelines, recommendations and evidence level), (3) decision-making process and (4) external review and follow-up process. Challenges on the adaptation of clinical guidelines include limitations from source clinical guidelines (poor quality or reporting), limitations from adaptation settings (lacking resources or skills), adaptation process intensity and complexity, and implementation barriers. We also described how participants address the complexities and implementation issues of the adaptation process.
Adaptation processes have been increasingly used to develop clinical guidelines, with the emergence of different purposes. The identification of core steps and assessment levels could help guideline adaptation developers streamline their processes. More methodological research is needed to develop rigorous international standards for adapting clinical guidelines.
本研究旨在更好地了解临床指南改编的当前实践，并确定在这个过程中提出的挑战，因为已发表的改编临床指南通常质量较低、报告较差，并且不是基于已发表的框架。
一项基于半结构化访谈的定性研究。我们对改编过程进行了框架分析，并对参与者对改编过程的看法和经验进行了主题分析。
来自七个国家的九个指南制定组织。
在过去 3 年内改编过临床指南的指南制定者。我们通过已发表的改编临床指南、专家建议以及对指南国际网络会议参会者名单的审查，确定了潜在的参与者。
我们进行了十次访谈，确定了九种改编方法。改编临床指南的原因包括制定临床指南、实施源临床指南以及协调和更新现有临床指南。我们确定了改编过程的以下核心步骤（1）选择范围和源指南，（2）评估源材料（指南、建议和证据水平），（3）决策过程，以及（4）外部审查和后续过程。改编临床指南的挑战包括源临床指南的局限性（质量或报告不佳）、改编设置的局限性（缺乏资源或技能）、改编过程的强度和复杂性以及实施障碍。我们还描述了参与者如何解决改编过程的复杂性和实施问题。
改编过程已越来越多地用于制定临床指南，出现了不同的目的。核心步骤和评估水平的确定可以帮助指南改编开发者简化其流程。需要进行更多的方法学研究，以制定改编临床指南的严格国际标准。
