Zhou Xu, Xu Sheng, Ren Qing, Chen Jianrong
Evidence-Based Medicine Research Center, Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi, China.
Department of Orthopedics and Traumatology, The University of Hong Kong, Pokfulam, Hong Kong, China.
Evid Based Complement Alternat Med. 2020 Sep 26;2020:9254503. doi: 10.1155/2020/9254503. eCollection 2020.
This study aimed to investigate the methodological quality of clinical guidelines (CGs) for integrated Chinese and Western medicine (ICWM) to inform clinical practice and guideline development.
We searched PubMed, EMBASE, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang Data, VIP, five guideline databases, and four online book malls to identify ICWM CGs published up to January 11, 2019. Four independent appraisers assessed the quality of CGs using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument and evaluated six specific concerns for ICWM. The standardized scores were calculated for the individual AGREE II domains.
Sixty-two ICWM CGs were included. The median standardized scores in the six domains of AGREE II were 65% in scope and purpose, 46% in clarity of presentation, 26% in applicability, 24% in stakeholder involvement, 15% in rigor of development, and 0% in editorial independence. The quality of ICWM CGs was significantly associated with the publication year (higher quality for CGs published after 2014) and the development method (higher quality for evidence-based CGs). Only one ICWM CG obtained a direct recommendation for use, and 14 could be recommended for use after modifications. The intra-appraiser consistency of the AGREE II appraisal was good (mean intraclass correlation coefficient range, 0.813-0.998). ICWM CGs also lacked a systematic search of ancient traditional Chinese medicine (TCM) classics (40.3%), conversion of TCM recommendations from ancient Chinese to the vernacular (14.5%), a discussion of interactions between TCM and Western medicine (27.4%), and rankings of different ICWM choices (0%).
Although an improvement after 2014 occurred, the current 64 ICWM CGs are generally of poor methodological quality. Only 15 ICWM CGs can be recommended for use directly or with modifications. As the key distinctions from Western/Chinese medicine CGs, the ICWM-specific recommendations are also insufficient for the ICWM CGs, especially for interactions between TCM and Western medicine and rankings of different ICWM choices. . This study has been registered at PROSPERO (no. CRD42018095767).
本研究旨在调查中西医结合临床指南(CGs)的方法学质量,以为临床实践和指南制定提供参考。
我们检索了PubMed、EMBASE、中国生物医学文献数据库、中国知网、万方数据、维普资讯、五个指南数据库和四个在线书店,以识别截至2019年1月11日发布的中西医结合临床指南。四名独立评估者使用《研究与评价指南II》(AGREE II)工具评估临床指南的质量,并评估了中西医结合的六个具体问题。计算了AGREE II各个领域的标准化分数。
纳入了62篇中西医结合临床指南。AGREE II六个领域的标准化分数中位数分别为:范围和目的65%,呈现清晰度46%,适用性26%,利益相关者参与度24%,制定严谨性15%,编辑独立性0%。中西医结合临床指南的质量与出版年份(2014年后出版的临床指南质量更高)和制定方法(循证临床指南质量更高)显著相关。只有一篇中西医结合临床指南获得直接使用推荐,14篇经修改后可推荐使用。AGREE II评估的评估者内一致性良好(组内相关系数均值范围为0.813 - 0.998)。中西医结合临床指南还缺乏对中医古籍的系统检索(40.3%)、中医推荐从古代汉语到白话文的转换(14.5%)、中西医相互作用的讨论(27.4%)以及不同中西医结合选择的排名(0%)。
尽管2014年后有所改进,但目前64篇中西医结合临床指南的方法学质量总体较差。只有15篇中西医结合临床指南可直接或经修改后推荐使用。作为与西医/中医临床指南的关键区别,中西医结合临床指南中针对中西医结合的特定推荐也不足,尤其是在中西医相互作用和不同中西医结合选择的排名方面。本研究已在国际前瞻性系统评价注册库(PROSPERO)注册(编号CRD42018095767)。