中医药临床实践指南质量评价建议清单及解读

Quality evaluation recommendation list and interpretation of traditional Chinese medicine clinical practice guidelines

基于建立一个完善的适用于中医药领域的指南评价体系的构想,笔者认为一个完整的中医药临床实践指南评价体系应分为质量评价、临床适用性评价及临床应用性调查3部分。根据指南评价的不同目的、不同的评价人员、不同的评价方式及不同的评价时点,形成质量评价建议清单、临床适用性评价建议清单及临床应用性调查问卷。其中,质量评价的目的是评价指南制订过程中方法学质量,以衡量整个指南制订过程是否做到了科学严谨。评价人员必须是循证医学背景的方法学家。一个逻辑清晰、详细全面的指南质量评价清单将为中医药指南制订小组人员提供好的评价工具,对于指南的质量以及推广应用起到重要的促进作用。笔者主要参考国际上公认的评价工具的制订流程及方法,经过中医药领域权威的临床专家与方法学家的论证,结合了中医药领域自身的特点,对中医药领域临床实践指南的质量评价建议清单的内容提出建议。该文介绍了整个质量评价建议清单,并针对每个条目给予详细解读,希望为将来中医药临床实践指南制订过程的规范化提供借鉴和参考。

Based on the idea of establishing a complete guideline evaluation system applicable to the field of traditional Chinese medicine(TCM), the author believes that a complete guideline evaluation system of traditional Chinese medicine clinical practice should be divided into three parts: quality evaluation, clinical applicability evaluation and clinical application investigation. According to the different purposes, different evaluators, different evaluation methods and different evaluation time points in the guideline evaluation, the quality evaluation recommendation list, the clinical applicability evaluation recommendation list and the clinical application questionnaire were formed. Among them, the purpose of quality evaluation is to evaluate the methodological quality in the guideline development process, in order to measure whether the entire guideline development process is scientifically rigorous. The evaluators must be the methodologists with an evidence-based medicine background. Therefore, a logical, detailed and comprehensive guideline quality evaluation list will provide good evaluation tools for the TCM guideline formulation team and play an important role in promoting the quality and application of the guidelines. By referring to the internationally recognized development process and methods of evaluation tools, as well as the proof by authoritative TCM clinical experts and methodologists, the author worked out the quality evaluation list of clinical practice guidelines applicable to the field of TCM by considering the characteristics of TCM field. In this paper, the author introduces the whole list of quality evaluation recommendations, and interprets each item in details, hoping to provide reference for the standardization of TCM clinical practice guidelines in the future.