Citation: | LIANG Changhao, YIN Dingran, LIU Meijun, YIN Guanxiang, LI Xun, WANG Yaqi, LIU Siqi, TONG Min, LIU Pengwei, SU Xiangfei, FEI Yutong. Exploring the Essential Factors of Applying the Consensus Methods in the Development of Traditional Chinese Medicine Guidelines: A Qualitative Interview[J]. Medical Journal of Peking Union Medical College Hospital, 2024, 15(4): 942-952. DOI: 10.12290/xhyxzz.2023-0320 |
This study delves into the pivotal factors influencing the consensus process within traditional Chinese medicine guideline development, with the objective of augmenting the quality of this process through methodological recommendations aimed at elevating standardization.
Semi-structured qualitative interviews were used to interview guideline leaders, working groups and consensus groups to explore the pertinent elements impacting the credibility of consensus and gather insights into the constitution and progression of the consensus methodology.
The study encompassed interviews with 26 participants, yielding 212 codes that were subsequently categorized into five domains: establishment of the consensus group, integration of patient participation, adeptness of the meeting moderator, preparation for consensus formulation, and overarching factors influencing consensus. The research distilled three fundamental phases for forming a consensus group and delineated 17 fundamental tenets for applying the consensus methodology.
In forthcoming guideline development endeavors, it is advisable to bolster methodological training ahead of the consensus process while ensuring comprehensive engagement of methodologists. Encouraging experts to navigate differences judiciously and prioritizing meticulous methodology and evidentiary groundwork are recommended. The process should involve openly disclosing the selection of consensus group members, heightening the involvement of patients, and effective management and disclosure of conflicts of interest. This collective approach helps curtail bias, enhance transparency, bolster reliability, and fortify the scientific rigor of consensus outcomes.
[1] |
中华中医药学会. 循证中医药临床实践指南制定的技术流程和规范: T/CACM 1032-2017[S]. 北京: 中华中医药学会, 2017: 1-7.
China Association of Chinese Medicine. Technical processes and specification for developing guidelines of evidence-based Chinese medicine clinical practice: T/CACM 1032-2017[S]. Beijing: China Association of Chinese Medicine, 2017: 1-7.
|
[2] |
中华中医药学会. 中医临床诊疗指南编制通则: ZYYXH/T 473-2015[S]. 北京: 中国中医药出版社, 2015: 1-9.
China Association of Chinese Medicine. General principles for the development of traditional Chinese medicine clinical guideline: ZYYXH/T 473-2015[S]. Beijing: China Press of Traditional Chinese Medicine, 2015: 1-9.
|
[3] |
中华人民共和国国家市场监督管理总局, 中国国家标准化管理委员会. 针灸临床实践指南制定及其评估规范: GB/T 40972-2021[S]. 北京: 中国标准出版社, 2021: 1-23.
State Administration for Market Regulation, Standardization Administration of the People's Republic of China. Specification of formulation and evaluation for the clinical practice guideline of acupuncture and moxibustion: GB/T 40972-2021[S]. Beijing: Standards Press of China, 2021: 1-23.
|
[4] |
陈耀龙, 杨克虎, 王小钦, 等. 中国制订/修订临床诊疗指南的指导原则(2022版)[J]. 中华医学杂志, 2022, 102(10): 697-703. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGUD202210051.htm
Chen Y L, Yang K H, Wang X Q, et al. Guiding principles for formulating/revising clinical diagnosis and treatment guidelines in China (2022 edition)[J]. Natl Med J China, 2022, 102(10): 697-703. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGUD202210051.htm
|
[5] |
中华医学会肝病学分会, 中华医学会感染病学分会. 关于临床实践指南制订的规范[J]. 中华肝脏病杂志, 2015, 23(12): 881-887. DOI: 10.3760/cma.j.issn.1007-3418.2015.12.001
Chinese Society of Hepatology, Chinese Medical Associa-tion, Chinese Society of Infectious Diseases, Chinese Medical Association. Chinese recommendations for clinical practice guideline development[J]. Chin J Hepatol, 2015, 23(12): 881-887. DOI: 10.3760/cma.j.issn.1007-3418.2015.12.001
|
[6] |
蒋朱明, 詹思延, 贾晓巍, 等. 制订/修订《临床诊疗指南》的基本方法及程序[J]. 中华医学杂志, 2016, 96(4): 250-253. DOI: 10.3760/cma.j.issn.0376-2491.2016.04.004
Jiang Z M, Zhan S Y, Jia X W, et al. Basic methods and procedures for formulating/revising Clinical Diagnosis and Treatment Guidelines[J]. Natl Med J China, 2016, 96(4): 250-253. DOI: 10.3760/cma.j.issn.0376-2491.2016.04.004
|
[7] |
赵楠琦, 袁静云, 郭丽花, 等. 国内针灸临床实践指南制定中存在问题的思考[J]. 中国针灸, 2021, 41(4): 445-448. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGZE202104030.htm
Zhao N Q, Yuan J Y, Guo L H, et al. Consideration on existing problems in development of clinical practice guidelines for acupuncture and moxibustion in China[J]. Chin Acupunct Moxibustion, 2021, 41(4): 445-448. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGZE202104030.htm
|
[8] |
王郁, 王丽颖, 韩学杰. 基于文献的中医临床实践指南共识法专家遴选指标研究[J]. 中医药学报, 2022, 50(5): 40-43. https://www.cnki.com.cn/Article/CJFDTOTAL-ZYXB202205009.htm
Wang Y, Wang L Y, Han X J. Research on expert selection index of consensus method in TCM clinical practice guidelines based on literature review[J]. Acta Chin Med Pharmacol, 2022, 50(5): 40-43. https://www.cnki.com.cn/Article/CJFDTOTAL-ZYXB202205009.htm
|
[9] |
李元, 韩学杰, 王丽颖. 中医临床实践指南共识专家遴选方法[J]. 北京中医药, 2021, 40(9): 1002-1004. https://www.cnki.com.cn/Article/CJFDTOTAL-BJZO202109013.htm
Li Y, Han X J, Wang L Y. Research on the expert selection in consensus method of TCM clinical practice guidelines[J]. Beijing J Tradit Chin Med, 2021, 40(9): 1002-1004. https://www.cnki.com.cn/Article/CJFDTOTAL-BJZO202109013.htm
|
[10] |
孙阳, 李彬, 王建茹, 等. 中国心力衰竭指南质量系统评价和思考[J]. 辽宁中医杂志, 2022, 49(11): 4-9. https://www.cnki.com.cn/Article/CJFDTOTAL-LNZY202211002.htm
Sun Y, Li B, Wang J R, et al. Systematic review of quality of heart failure guidelines in China[J]. Liaoning J Tradit Chin Med, 2022, 49(11): 4-9. https://www.cnki.com.cn/Article/CJFDTOTAL-LNZY202211002.htm
|
[11] |
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(1): 26-34. https://www.cnki.com.cn/Article/CJFDTOTAL-ZZYZ202201008.htm
Liang C H, Xia R Y, Huang Z W, 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]. J Tradit Chin Med, 2022, 63(1): 26-34. https://www.cnki.com.cn/Article/CJFDTOTAL-ZZYZ202201008.htm
|
[12] |
费宇彤, 刘建平, 于河, 等. 报告定性研究个体访谈和焦点组访谈统一标准的介绍[J]. 中西医结合学报, 2008, 6(2): 115-118. https://www.cnki.com.cn/Article/CJFDTOTAL-XBZX200802002.htm
Fei Y T, Liu J P, Yu H, et al. Introduction to the consolidated criteria for reporting qualitative research[J]. J Integr Med, 2008, 6(2): 115-118. https://www.cnki.com.cn/Article/CJFDTOTAL-XBZX200802002.htm
|
[13] |
丁楠, 武晓冬, 赵楠琦, 等. 对国内针灸临床实践指南制定中共识达成的分析与思考[J]. 中国针灸, 2022, 42(3): 337-342. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGZE202203024.htm
Ding N, Wu X D, Zhao N Q, et al. Analysis and thought on reaching the consensus during the development of acupuncture and moxibustion clinical practice guidelines in China[J]. Chin Acupunct Moxibustion, 2022, 42(3): 337-342. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGZE202203024.htm
|
[14] |
Diamond I R, Grant R C, Feldman B M, et al. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies[J]. J Clin Epidemiol, 2014, 67(4): 401-409. DOI: 10.1016/j.jclinepi.2013.12.002
|
[15] |
JANDHYALA R. Delphi, non-RAND modified Delphi, RAND/UCLA appropriateness method and a novel group awareness and consensus methodology for consensus measurement: a systematic literature review[J]. Curr Med Res Opin, 2020, 36(11): 1873-1887. DOI: 10.1080/03007995.2020.1816946
|
[16] |
Humphrey-Murto S, Varpio L, Wood T J, et al. The use of the Delphi and other consensus group methods in medical education research: a review[J]. Acad Med, 2017, 92(10): 1491-1498. DOI: 10.1097/ACM.0000000000001812
|
[17] |
梁昌昊, 尹冠翔, 王雅琪, 等. 中医药临床实践指南制订和修订中德尔菲法应用的方法流程及建议[J]. 协和医学杂志, 2023, 14(5): 1084-1090. DOI: 10.12290/xhyxzz.2022-0649
Liang C H, Yin G X, Wang Y Q, et al. Application of Delphi method in the development and revision of clinical practice guidelines of traditional Chinese medicine: process and suggestions[J]. Med J PUMCH, 2023, 14(5): 1084-1090. DOI: 10.12290/xhyxzz.2022-0649
|
[18] |
廖星, 谢雁鸣, 张俊华, 等. 中医临床实践指南制修订中专家共识技术规范[J]. 中国中药杂志, 2019, 44(20): 4354-4359. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGZY201920034.htm
Liao X, Xie Y M, Zhang J H, et al. Technical specification of expert consensus statement in developing clinical practice guidelines of traditional Chinese medicine[J]. China J Chin Mater Med, 2019, 44(20): 4354-4359. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGZY201920034.htm
|
[19] |
周奇, 王琪, 俞阳, 等. 临床实践指南制定中的共识方法[J]. 药品评价, 2016, 13(16): 13-17. DOI: 10.3969/j.issn.1672-2809.2016.16.002
Zhou Q, Wang Q, Yu Y, et al. Consensus methods in the development of clinical practice guidelines[J]. Drug Eval, 2016, 13(16): 13-17. DOI: 10.3969/j.issn.1672-2809.2016.16.002
|
[20] |
王悦, 董兴鲁, 高胤桐, 等. 患者指南在中医药领域的发展策略及价值[J]. 中医杂志, 2022, 63(10): 923-926. https://www.cnki.com.cn/Article/CJFDTOTAL-ZZYZ202210006.htm
Wang Y, Dong X L, Gao Y T, et al. The development strategy and value of patient version of guidelines in traditional Chinese medicine[J]. J Tradit Chin Med, 2022, 63(10): 923-926. https://www.cnki.com.cn/Article/CJFDTOTAL-ZZYZ202210006.htm
|
[21] |
Liang C, Yin G, Lin Z, et al. How well did the consensus methods apply in the guideline development of traditional Chinese medicine: a web-based survey in China[J]. BMC Med Res Methodol, 2023, 23(1): 264. DOI: 10.1186/s12874-023-02087-0
|
[22] |
《中成药临床应用循证指南》制定/修订工作组. 制定/修订《中成药临床应用循证指南》的方法与程序[J]. 中国研究型医院, 2020, 7(3): 93-97. https://www.cnki.com.cn/Article/CJFDTOTAL-YJXU202003030.htm
Working Group for Formulation/Revision of Evidence Based Guidelines for Clinical Application of Traditional Chinese Patent Medicines and Simple Preparations. The methods and procedures of formulating and revising the Evidence-Based Guidelines for Clinical Use of Chinese Medicine[J]. J Chin Res Hosp, 2020, 7(3): 93-97. https://www.cnki.com.cn/Article/CJFDTOTAL-YJXU202003030.htm
|
[23] |
陈薇, 刘建平. 中西医结合临床实践指南制定原则和流程[J]. 中国中西医结合杂志, 2022, 42(12): 1413-1417. DOI: 10.7661/j.cjim.20221010.030
Chen W, Liu J P. Principles and procedures for development of clinical practice guidelines for integrated Chinese and western medicine[J]. Chin J Integr Tradit West Med, 2022, 42(12): 1413-1417. DOI: 10.7661/j.cjim.20221010.030
|
[24] |
Schünemann H J, Zhang Y Q, Oxman A D. Distinguishing opinion from evidence in guidelines[J]. BMJ, 2019, 366: l4606.
|