Xie Xiuli, Wang Yangyang, Li Hui
Department of Standardization of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Department of Standardization of Chinese Medicine, Guangdong Provincial Academy of Chinese Medicine, Guangzhou, China.
Front Pharmacol. 2023 Jan 12;13:1057920. doi: 10.3389/fphar.2022.1057920. eCollection 2022.
The (AGREE) II instrument has been widely used in the methodological quality assessment of clinical practice guidelines (CPG). Chinese medicine CPGs have unique characteristics which distinguish them from those of Western medicine, e.g. syndrome differentiation, on which treatments are based. As such, certain domains and items in AGREE II are unsuitable for assessing TCM CPGs. Therefore, it is necessary to adjust and supplement the description and rating section of some items of the AGREE Ⅱinstrument. To adjust and expand AGREE II according to characteristics of TCM clinical practice guidelines. A research working group was established, consisting of a core working group and an expert consensus group, before a systematic literature search performed to screen for TCM guidelines. Two researchers evaluated the quality of the included guidelines using AGREE Ⅱ and later proposed adjustments to some items of AGREE Ⅱ and supplementary comments, which were applicable to TCM CPGs, and drafted an initial version of AGREE Ⅱ for TCM. Suggestions from literature on development and evaluation of TCM CPGs were solicited and integrated into the revised version, which 16 experts were then invited to advise on. When the experts reached a consensus, their comments to the draft were adopted by the core group into the final version. After evaluating the included TCM guidelines, the two researchers offered adjustments and supplementary comments for AGREE Ⅱ Items 1, 7, 10, 11, 12, 15, and 18, and drafted an initial version of AGREE Ⅱ for TCM. Combining suggestions from the literature on development and quality evaluation of TCM clinical guidelines, the core working group modified AGREE Ⅱ items 2, 4, 5, 8, 9, 13, 20, and 21, then proposed the revised version of AGREE Ⅱ for TCM, on which was advised by a group of experts, before consensus on improvements was reached. The results of the first round of expert surveys showed strong agreement, and experts' opinions were adopted into the final version of AGREE Ⅱ for TCM. Based on the characteristics of the TCM CPGs, we adjustment and expansion were made to create AGREE II for TCM. This version is suitable for the assessment of methodological quality of TCM CPGs, capable of providing content support for the standardization of procedures and methods of formulating TCM CPGs.
AGREE II工具已广泛应用于临床实践指南（CPG）的方法学质量评估。中医临床实践指南具有区别于西医临床实践指南的独特特征，例如其基于辨证论治。因此，AGREE II中的某些领域和条目不适用于评估中医临床实践指南。所以，有必要对AGREE II工具中一些条目的描述和评分部分进行调整和补充。为了根据中医临床实践指南的特点对AGREE II进行调整和扩展，成立了一个研究工作组，该工作组由一个核心工作组和一个专家共识组组成，之后进行了系统的文献检索以筛选中医指南。两名研究人员使用AGREE II评估纳入指南的质量，随后对AGREE II的一些条目提出适用于中医临床实践指南的调整建议和补充意见，并起草了中医AGREE II的初始版本。征求了有关中医临床实践指南制定和评估的文献中的建议并将其纳入修订版，然后邀请16位专家对此进行咨询。当专家们达成共识时，他们对草案的意见被核心小组采纳到最终版本中。在评估纳入的中医指南后，两名研究人员对AGREE II的第1、7、10、11、12、15和18项提出了调整和补充意见，并起草了中医AGREE II的初始版本。结合中医临床指南制定和质量评估文献中的建议，核心工作组对AGREE II的第2、4、5、8、9、13、20和21项进行了修改，随后提出了中医AGREE II的修订版，一组专家对此进行了咨询，之后才达成改进共识。第一轮专家调查结果显示出高度一致性，专家意见被纳入中医AGREE II的最终版本。基于中医临床实践指南的特点，我们进行了调整和扩展以创建中医AGREE II。此版本适用于中医临床实践指南的方法学质量评估，能够为中医临床实践指南制定程序和方法的标准化提供内容支持。
