Abstract
Background: The Appraisal of Guidelines Research and Evaluation (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. Purpose: To adjust and expand AGREE II according to characteristics of TCM clinical practice guidelines. Methods: 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. Results: 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. Conclusion: 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.