Zhang Rong, Yan Si-Yu, Wang Yun-Yun, Huang Qiao, Ren Xiang-Ying, Tan Ran, Deng Yu-Qing, Su Lin-Xia, Wang Yong-Bo, Zhao Zheng-Rong, Jin Ying-Hui
Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.
Department of Neurotumor Disease Diagnosis and Treatment Center, Taihe Hospital, Hubei University of Medicine, Shiyan, China.
Front Med (Lausanne). 2021 Nov 2;8:758617. doi: 10.3389/fmed.2021.758617. eCollection 2021.
This study aimed to systematically review the status and trends of Chinese clinical practice guidelines (CPGs) during the time period 2010-2020 and explore their methodological characteristics. Then, based on the strengths and weaknesses in development, offer several recommendations for the quality improvement which will serve as a reference for the users and developers of CPG. With the development of evidence-based medicine (EBM), the CPGs play an increasingly important role in healthcare decision-making both in China and worldwide. The CPGs that have been used to help the health professionals in the healthcare decision-making were included. The China National Knowledge Infrastructure (CNKI) and WanFang databases were searched from 2010 to 2020 for the studies describing the general and methodological characteristics of Chinese CPGs. Comparisons of the methodological characteristics between the groups were conducted using the chi-square test or Fisher's exact test. The M-K test was adopted to identify the monotonically increasing or decreasing trends of methodological characteristics over the timespan. A total of 2,654 CPGs fulfilled the inclusion criteria. The quantity and quality of the guidelines developed in China have improved over the time span. From 2010 to 2020,the guidelines had differing characteristics and covered a wide range of subjects. In total, 2,318(87.34%) guidelines focused on Western Medicine. Eight (0.30%) had been developed for patient versions of guidelines, 10(0.38%) were tentative guidelines, and 16(0.60%) were rapid advice guidelines. Medical specialty societies (including their branches) (71.1%) were the main guideline makers. The most addressed diseases were neoplasms (14.43%). The target population is mainly adults (84.97%). The methodological quality of consensus-based (CB)-CPGs was obviously lower than evidence-based (EB)-CPGs. Except for the item, "recommendations were based on evidence of systematic reviews," there were statistical differences in all other methodological items between the EB-CPGS and CB-CPGS ( < 0.01). Higher methodological quality has been observed in EB-CPGs. All the data relating to the methodological characteristics indicated that higher methodological quality was present in the guidelines using GRADE ( < 0.01). The quantity and quality of the guidelines developed in China have improved between 2010 and 2020. CB-CPGs have also paid attention to the methodology quality, but obviously, this is lower than that in the EB-CPGs.
本研究旨在系统回顾2010 - 2020年期间中国临床实践指南（CPG）的现状和趋势，并探讨其方法学特征。然后，基于发展中的优势和不足，提出若干质量改进建议，为CPG的使用者和制定者提供参考。随着循证医学（EBM）的发展，CPG在中国和全球的医疗决策中发挥着越来越重要的作用。本研究纳入了用于帮助卫生专业人员进行医疗决策的CPG。检索了中国知网（CNKI）和万方数据库2010年至2020年期间描述中国CPG一般特征和方法学特征的研究。使用卡方检验或Fisher精确检验对各组之间的方法学特征进行比较。采用M - K检验来确定方法学特征在时间跨度上的单调递增或递减趋势。共有2654篇CPG符合纳入标准。在该时间段内，中国制定的指南数量和质量均有所提高。2010年至2020年期间，指南具有不同的特征，涵盖广泛的主题。总计2318篇（87.34%）指南聚焦于西医。8篇（0.30%）为患者版指南，10篇（0.38%）为试行指南，16篇（0.60%）为快速建议指南。医学专业学会（包括其分会）（71.1%）是主要的指南制定者。提及最多的疾病是肿瘤（14.43%）。目标人群主要是成年人（84.97%）。基于共识（CB）的CPG的方法学质量明显低于基于证据（EB）的CPG。除了“推荐基于系统评价的证据”这一项外，EB - CPG和CB - CPG在所有其他方法学项目上均存在统计学差异（<0.01）。在EB - CPG中观察到更高的方法学质量。所有与方法学特征相关的数据表明，使用GRADE的指南具有更高的方法学质量（<0.01）。2010年至2020年期间，中国制定的指南数量和质量均有所提高。CB - CPG也关注方法学质量，但显然低于EB - CPG。
