1.北京中医药大学循证医学中心,北京市朝阳区北三环东路 11 号,100029
2.北京中医药大学中医学院
3.中日友好医院
yutong_fei@163.com
收稿:2021-06-29,
修回:2021-09-23,
纸质出版:2022-01-02
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梁昌昊,夏如玉,黄子玮等.共识法在中医临床实践指南及专家共识中的应用及方法学报告特征分析[J].中医杂志,2022,63(01):26-34.
LIANG Changhao,XIA Ruyu,HUANG Ziwei,et al.How Consensus methods are Used in the Clinical Practice Guidelines and Experts Consensus Statements of Traditional Chinese Medicine: Analysis of the Current Status and the Methodological Features[J].Journal of Traditional Chinese Medicine,2022,63(01):26-34.
梁昌昊,夏如玉,黄子玮等.共识法在中医临床实践指南及专家共识中的应用及方法学报告特征分析[J].中医杂志,2022,63(01):26-34. DOI: 10.13288/j.11-2166/r.2022.01.007.
LIANG Changhao,XIA Ruyu,HUANG Ziwei,et al.How Consensus methods are Used in the Clinical Practice Guidelines and Experts Consensus Statements of Traditional Chinese Medicine: Analysis of the Current Status and the Methodological Features[J].Journal of Traditional Chinese Medicine,2022,63(01):26-34. DOI: 10.13288/j.11-2166/r.2022.01.007.
目的
2
调查中国发布的中医药临床实践指南(CPG)及专家共识中共识法的应用及方法学报告情况,为我国CPG的制订与修订提供参考。
方法
2
检索中国知网、万方数据、维普网、中国生物医学文献数据库、PubMed、Embase和Cochrane数据库以及各相关学会官网,纳入2016年1月1日至2020年12月31日发布的、符合标准的中医药领域CPG及专家共识。制定资料提取表,提取纳入文献基本特征、参与人员构成情况以及采用的共识方法和应用过程中的相关数据进行描述性统计分析。
结果
2
共纳入文献267篇,其中CPG 121篇(45.32%),专家共识146篇(54.68%)。文献类型以全文版文献最多,共158篇(59.18%);文献主题以“单纯围绕疾病”最多,共185篇(69.29%);制定组织以中医药领域专业学术机构牵头制定最多,共184篇(68.91%)。明确报告采用了共识方法的文献共97篇,使用最多的共识方法是德尔菲法(41篇),其次为共识会议法(10篇)、改良德尔菲法(9篇)、名义群组法(5篇),另有170篇未明确报告使用的共识方法。20.60%(55篇)的文献报告了形成推荐意见时的共识人数,10~93人,平均(31±11)人;50.18%(134篇)的文献共识组人员体现了多角色合作,但只有10篇提到患者参与,19篇提到方法学专家参与;16.48%(44篇)的文献报告了共识小组专家的遴选原则;26.59%(71篇)的文献明确报告达成共识的阈值;27.34%(73篇)的文献报告了利益冲突情况,其中2篇提到接受了资助,而其他71篇均报告无利益冲突情况。
结论
2
中医药CPG及专家共识在形成推荐意见时采用最多的共识方法为德尔菲法,但相关指南及专家共识对共识小组构成情况及人数、共识方法的过程报告均有不足。建议未来制订、修订CPG及专家共识时应详细报告制定过程中的共识方法,以提高制定过程的透明化和严谨性。
Objective
2
To
i
nvestigate the current status and the methodological features of consensus methods used in the traditional Chinese medicine (TCM) clinical practice guidelines (CPGs) and experts consensus statements (ECSs), thereby providing references for the development /revision of CPGs and ECSs.
Methods
2
We searched seven databases (CNKI, Wanfang, VIP, SinoMed, PubMed, Embase and Cochrane) and six official websites of relevant societies to collect CPGs and ECSs in TCM published between January 1st, 2016 and December 31st, 2020. We used the predefined table to extract the general characteristics of the included studies, the involved experts, the consensus methods and the application data for descriptive analyses.
Results
2
A total of 267 CPGs/ECSs were included, of which 121 were CPGs (45.32%) and 146 were ECSs (54.68%); the type of the CPGs/ECSs was mostly in full-text version (158, 59.18%); the theme of most CPGs/ECSs (185, 69.29%) was simply around disease; 184 (68.91%) CPGs/ECSs were developed by professional academic institutions in TCM. Consensus methods were clearly reported in 97 CPGs/ECSs, among which the Delphi method (41), consensus conference method (10), modified Delphi (9) and nominal group method (5) were mostly used; the other 170 (63.67%) CPGs/ECSs did not mention whether there was use of the consensus methods. In addition, 55 (20.60%) CPGs/ECSs reported the numbers of experts in the panel when developing recommendations, which ranged from 10 to 93 with an average of 31±11; the composition of the panel was multidisciplinary in 134 (50.18%) CPGs/ECSs, but patients were only involved in 10 CPGs/ECSs and methodological experts were introduced in 19 CPGs/ECSs; 44 (16.48%) CPGs/ECSs reported the selection principle of panel members and 71 (26.59%) reported the agreement standard. Seventy-three CPGs/ECSs (27.34%) stated the conflict of interest, of which two reported to be funded while the other 71 reported no conflict of interest.
Conclusion
2
Delphi consensus method is most commonly used when developing recommendations in TCM CPGs and ECSs. The essential details of the consensus process including the composition and the experts number of the panel are not sufficiently reported in current TCM CPGs and ECSs. In the future, we recommend reporting the consensus methods in detail, thereby improving the transparency and rigor in developing and revising TCM CPGs and ECSs.
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