中医药临床指南/共识中推荐意见分级标准的制订

Development of Grading Criteria on Recommendations in Clinical Guidelines/Consensus for Traditional Chinese Medicine

目的制定中医药领域临床指南/共识中推荐意见分级标准,用于指导中医药临床指南和专家共识制订者形成科学规范的推荐意见。方法采用文献研究与专家共识研究相结合的方法。文献研究以33部《中医循证临床实践指南》及32部指南制定手册为对象,提取与推荐意见产生、分级、报告等相关内容。专家共识研究包括问卷调查与专家共识会议两部分。首先在文献研究的基础上制订初始条目,进行专家问卷调查;再召开专家共识会议,针对问卷调查结果进行进一步讨论、共识,最终形成标准。结果目前中医药指南及不同指南制定手册推荐使用的推荐意见分级标准不尽相同,不同指南制定机构会根据实际情况对国际统一标准进行改编。在指南推荐意见报告方面,纳入的中医药循证临床指南与国际指南制定手册要求尚有一定差距。选取不同领域36名专家对标准初始条目进行问卷调查,14名参加专家共识会议,形成《中医药临床指南/共识中推荐意见强度分级标准》,包括推荐意见形成方法报告原则、影响推荐意见的因素、推荐意见强度分级及表述、推荐意见内容报告4个部分。结论中医药制定指南和专家共识时应兼顾多方面因素,通过规范的专家共识法产生推荐意见及强度;推荐意见形成过程应规范,内容应进行清晰的报告。

Objective To develope grading criteria on recommendations in clinical guidelines/consensus for traditional Chinese medicine(TCM) in order to guide the framers of TCM clinical guidelines and expert consensus to form scientific and standard recommendations. Methods Combination of literature study and expert consensus study was applied. In the literature study, 33 versions of Evidence-based TCM Clinical Practice Guidelines and 32 guideline developing handbooks were taken as objects. Information about recommendation development, grading and reporting was extracted. The expert consensus study included questionnaire survey and an expert consensus meeting. Firstly, on the basis of the literature study, primary items were developed to conduct expert questionnaire survey. After that, the expert consensus meeting was held to further discuss the results of questionnaire survey, reaching a consensus and finally form the criteria. Results At present, the recommendation grading criteria in the TCM guidelines and guideline developing handbooks are different from each other. Different guideline developing groups usually adapted international unified standards according to their actual situation. Besides, there is still a certain gap between the included evidence-based TCM clinical guidelines and requirements in the developing handbooks of international guidelines in terms of guideline recommendation report. A total of 36 experts covering different fields were invited to conduct questionnaire survey on the primary items of the criteria, and 14 experts attended the consensus meeting to form Grading Criteria on Recommendation Strength in Clinical Guidelines/Consensus for TCM, including 4 parts: report principles on developing methods of recommendations, factors affecting recommendations, grading and expressing of recommendation strength, and content report of recommendations. Conclusion When developing guidelines and expert consensus in TCM, different factors should be taken into fully consideration. Recommendations and strength should be developed by a standard expert consensus method. Moreover, the process of recommendation development should be standard, and its content should also be reported specifically.