卢姝亚;赵思雅;吴守媛;罗旭飞;刘云兰;吕萌;杨楠;王晓辉;陈耀龙;
LU Shuya;ZHAO Siya;WU Shouyuan;LUO Xufei;LIU Yunlan;LYU Meng;YANG Nan;WANG Xiaohui;CHEN Yaolong;School of Public Health,Lanzhou University;Institute of Health Data Science,Lanzhou University;Research Unit of Evidence-Based Evaluation and Guidelines,Chinese Academy of Medical Sciences,School of Basic Medical Sciences,Lanzhou University;WHO Collaborating Center for Guideline Implementation and Knowledge Translation;Lanzhou University,an Affiliate of the Cochrane China Network;Lanzhou University GR

• 1:兰州大学公共卫生学院
• 2:兰州大学健康数据科学研究院
• 3:中国医学科学院循证评价与指南研究创新单元兰州大学基础医学院
• 4:世界卫生组织指南实施与知识转化合作中心

摘要(Abstract)：

目的调查2019年期刊公开发表的中国临床实践指南证据质量和/或推荐强度分级现状,以期为指南制订者合理应用证据质量和推荐强度分级方法提供参考。方法系统检索并筛选2019年期刊公开发表的中国临床实践指南,纳入对推荐意见进行证据质量和/或推荐强度分级的指南。提取证据质量和推荐强度的分级方法、分级描述和表述内容等信息。结果 2019年期刊公开发表的中国临床实践指南共226篇,其中106篇(46.9%)(中文87篇,英文19篇)纳入本研究。采用的分级方法共18种,其中推荐意见分级评价、制订与评估(Grading of Recommendations Assessment, Development and Evaluation, GRADE)分级系统应用最多(35.8%,38/106);采用的分级描述共6种,证据质量分级描述多采用字母(39.6%,42/106),推荐强度分级描述多采用文字(34.9%,37/106)。采用文字描述推荐强度的指南中,最常使用的词语是"可以"。38篇指南采用GRADE分级,仅15篇按照GRADE工作组要求规范呈现分级标准及内容,共包含250条分级明确的推荐意见,60.4%(151/250)为强推荐,44.8%(112/250)的推荐意见引用低或极低质量证据,38.4%(96/250)的推荐意见采用系统评价作为证据支持。结论 2019年期刊公开发表的中国指南分级系统使用率较低,且分级方法使用仍不完整、不统一、不规范。GRADE分级系统使用率低,仅极少数指南按照GRADE工作组要求规范呈现分级标准及内容。推荐使用GRADE分级系统,促进指南推荐意见的科学、透明与合理制订。
Objective To investigate the methodological issues related to the quality of evidence and strength of recommendations of 2019 Chinese clinical practice guidelines(hereafter referred to as “guidelines”) published in journals, so as to provide reference for standardization of recommendations.MethodsWe searched and analyzed information on Chinese guidelines published in 2019,evaluated the quality of evidence, and graded the strength of recommendations. Information on grading methods, grading descriptions, phrases for the quality of evidence, and the strength of recommendation was extracted. Results A total of 226 Chinese clinical practice guidelines were published in journals in 2019,of which 106 guidelines(87 Chinese guidelines, 19 English guidelines) were included in this study. There were 18 grading methods adopted, with the GRADE(Grading of Recommendations Assessment, Development and Evaluation) system being the most used(35.8%,38/106). A total of 6 grading descriptions were used; the most frequently used symbol for grading the quality of evidence was letters(39.6%,42/106); the most frequently used symbol for grading the strength of recommendations was text(34.9%,37/106). The most common word used in the guidelines to describe the recommended strength was “may”. Among the 38 guidelines that used the GRADE system, only 15 followed the presentation recommended by the GRADE working group. There were 250 clearly graded recommendations included, with 60.4%(151/250) being strong recommendations and 44.8%(112/250) citing low or very low-quality evidence. There were 96 recommendations(38.4%,96/250) that were supported by systematic reviews.Conclusions Chinese guidelines published in journals in 2019 that used the grading system accounts for a small proportion compared with those that did not use. And the quality of evidence and strength of recommendations used in guidelines remains incomplete, inconsistent and irregular. The GRADE system is underused. Very few guidelines present grading criteria and details in accordance with the requirements of the GRADE Working Group.We recommend the use of the GRADE system to promote the rigorous, transparent and rational development of guideline recommendations.

关键词(KeyWords)： 临床实践指南;证据质量;推荐强度;GRADE
clinical practice guidelines;quality of evidence;strength of recommendation;GRADE

Abstract:

Keywords:

基金项目(Foundation): 国家社会科学基金重大项目（19ZDA142）;; 国家重点研发计划（2018YFC1705500）;; 中央高校基本科研业务费专项资金资助（lzujbky-2021-ey13）~~

作者(Authors): 卢姝亚;赵思雅;吴守媛;罗旭飞;刘云兰;吕萌;杨楠;王晓辉;陈耀龙;
LU Shuya;ZHAO Siya;WU Shouyuan;LUO Xufei;LIU Yunlan;LYU Meng;YANG Nan;WANG Xiaohui;CHEN Yaolong;School of Public Health,Lanzhou University;Institute of Health Data Science,Lanzhou University;Research Unit of Evidence-Based Evaluation and Guidelines,Chinese Academy of Medical Sciences,School of Basic Medical Sciences,Lanzhou University;WHO Collaborating Center for Guideline Implementation and Knowledge Translation;Lanzhou University,an Affiliate of the Cochrane China Network;Lanzhou University GR

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