[Development of a Ranking Tool for Scientificity, Transparency and Applicability of Clinical Practice Guidelines]

Zhonghua Yi Xue Za Zhi. 2022 May 31:102:1-10. doi: 10.3760/cma.j.cn112137-20220219-00340. Online ahead of print.
[Article in Chinese]

Abstract

Objective: To address the limitations of existing methods and tools for evaluating clinical practice guidelines, we aimed to develop a comprehensive instrument focusing on the three main dimensions of guideline development: scientificity, transparency, applicability. We will use it to rank the guidelines according to the scores. We abbreviated it as STAR, and its reliability, validity and usability were also tested. Methods: A multidisciplinary expert working group was set up, including methodologists, statisticians, journal editors, medical professionals, and others. Scoping review, Delphi methods and hierarchical analysis were used to determine the final checklist of STAR. Results: The new instrument contained 11 domains and 39 items. Intrinsic reliability of each domain was indicated by Cronbach's α coefficient, with a average value of 0.646. The Cohen's kappa coefficients for methodological evaluators and clinical evaluators were 0.783 and 0.618. The overall content validity index was 0.905. The R2 for the criterion validity analysis was 0.76. The average score for usability of the items was 4.6, and the mean time spent to evaluate each guideline was 20 minutes. Conclusion: The instrument has good reliability, validity and evaluating efficiency, and can be used for evaluating and ranking guidelines more comprehensively.

目的: 针对现有临床实践指南评价方法和工具的不足,研发针对临床实践指南科学性(Scientificity)、透明性(Transparency)和适用性(Applicability)的评级(Rankings)工具,缩写为STAR,并对其信效度进行验证和对易用性进行评估。 方法: 成立包含指南方法学家、统计学家、期刊编辑、医务人员等多学科的专家工作组,基于概况性评价、德尔菲法和层次分析法确定评级领域条目和相应分值,通过共识会议确定最终工具清单,并对工具进行信度、效度和易用性验证。 结果: 形成11个领域39个条目和相应分值的综合性评价工具。工具内在信度分析显示各领域平均Cronbach′s α系数值0.646;方法学评级人员和临床评级人员之间的信度Cohen′s kappa系数分别为0.783和0.618;条目整体内容效度指数0.905;效标效度分析决定系数R2为0.76;条目的易用性平均得分4.6,评价1部指南中位用时20分钟。 结论: STAR具有良好的信效度和评级效率,可针对中国指南的科学性、透明性和适用性进行综合评级。.

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