Technical specification for developing a clinical practice guideline for the integration of traditional Chinese medicine and Western medicine

Abstract

Developing a clinical practice guideline (CPG) for integrating traditional Chinese medicine (TCM) and Western medicine (WM) requires the accurate identification, collation, and integration of all available evidence on TCM and WM in a comprehensive, meaningful, and resource-efficient manner. This entails framing appropriate clinical questions, retrieving and synthesizing evidence from multiple resources, and providing concise and complete recommendations for specific diseases. However, some existing CPGs for integrating TCM and WM lack deep and organic integration. As the effective preparation of a CPG for integrating TCM and WM typically involves a complex set of principles, methodology, and steps, we believe that a cohesive, step-by-step guide on how to prepare a CPG for integrating TCM and WM is essential. To facilitate the design and development of a robust CPG, we present a clear and concise methodology, outlining relevant principles and procedures, supported by references for guidance. This technical specification aims to simplify the methodology for preparing a CPG for integrating TCM and WM; provide healthcare professionals and researchers with methodologically sound tools; and enhance the quality of CPGs for integrating TCM and WM. This technical specification may help elucidate this complex process, facilitate evaluation of the quality of published CPGs for integrating TCM and WM, and improve the understanding and application of recommendations for the combined and integrated use of TCM and WM in a new system.

Keywords

clinical practice guideline / integration / methodological procedure / traditional Chinese medicine / Western medicine

References

[1] ChenKJ. Evidence-based clinical Chinese medicine: novel exploration through global vision. Chin J Integr Med. 2019; 25:79–80.

[2] JinYH,WangYP, XieYL, et al. Research on the development methodology for clinical practice guidelines for organic integration of traditional Chinese and Western medicine. Mil Med Res. 2023; 10:45.

[3] ZhangJ,LiY, ZhangB, et al. Evidence-based traditional Chinese medicine research: Beijing Declaration. J Evid Based Med. 2020; 13:91–92.

[4] TianG,ZhaoC, ZhangX, et al. Evidence-based traditional Chinese medicine research: two decades of development, its impact, and breakthrough. J Evid Based Med. 2021; 14:65–74.

[5] RobinsonN. Integrated traditional Chinese medicine. Complement Ther Clin Pract. 2006; 12:132–140.

[6] ChenY,WangC, ShangH,Yang K,NorrisSL. Clinical practice guidelines in China. BMJ. 2018; 360:j5158.

[7] YaoS,WeiD, ChenYL, et al. Quality assessment of clinical practice guidelines for integrative medicine in China: a systematic review. Chin J Integr Med. 2017; 23:381–385.

[8] TangX,ShiX, ZhaoH, et al. Characteristics and quality of clinical practice guidelines addressing acupuncture interventions: a systematic survey of 133 guidelines and 433 acupuncture recommendations. BMJ Open. 2022; 12:e058834.

[9] ZhongLL,ZhengY, LauAY, et al. Would integrated Western and traditional Chinese medicine have more benefits for stroke rehabilitation? A systematic review and meta-analysis. Stroke Vasc Neurol. 2022; 7:77–85.

[10] WangWJ,ZhangT. Integration of traditional Chinese medicine and Western medicine in the era of precision medicine. J Integr Med. 2017; 15:1–7.

[11] YangN,LiuH, ZhaoW, et al. Development of the Scientific, Transparent and Applicable Rankings (STAR) tool for clinical practice guidelines. Chin Med J. 2023; 136:1430–1438.

[12] TianJ,ZhangB, GaoX, et al. Recommendations for the preparation of clinical application guidelines of the Chinese medicines for the treatment of common diseases. Chin J Integr Med. 2018; 38:7–11.

[13] ChenYL,ZhaoC, ZhangL, et al. Toward evidence-based Chinese medicine: status quo, opportunities and challenges. Chin J Integr Med. 2018; 24:163–170.

[14] WangY,ShiX, LiL,EfferthT, ShangD. The impact of artificial intelligence on Traditional Chinese Medicine. Am J Chin Med. 2021; 49:1297–1314.

[15] TangJL,LiuBY, MaKW. Traditional Chinese medicine. Lancet. 2008; 372:1938–1940.

[16] SchünemannHJ,Zhang Y,OxmanAD. Distinguishing opinion from evidence in guidelines. BMJ. 2019; 366:l4606.

[17] MustafaRA,GarciaCAC, BhattM, et al. GRADE notes: how to use GRADE when there is “no” evidence? A case study of the expert evidence approach. J Clin Epidemiol. 2021; 137:231–235.

[18] LiuSH,ChenPS, HuangCC, et al. Unlocking the mystery of the therapeutic effects of Chinese medicine on cancer. Front Pharmacol. 2021; 11:601785.

[19] PetersS,SukumarK, BlanchardS, et al. Trends in guideline implementation: an updated scoping review. Implement Sci. 2022; 17:50.

[20] ChenY,GuyattGH, MunnZ, et al. Clinical practice guidelines registry: toward reducing duplication, improving collaboration, and increasing transparency. Ann Intern Med. 2021; 174:705–707.

[21] XunY,LuoX, LvM, et al. Protocols for clinical practice guidelines. J Evid Based Med. 2023; 16:3–9.

[22] FandinoW. Formulating a good research question: pearls and pitfalls. Indian J Anaesth. 2019; 63:611–616.

[23] EvansL,RhodesA, AlhazzaniW, et al. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021; 47:1181–1247.

[24] CookeA,SmithD, BoothA. Beyond PICO: the SPIDER tool for qualitative evidence synthesis. Qual Health Res. 2012; 22:1435–1443.

[25] YangJ,RenX, LvX, et al. Key technologies and evidence evaluation elements for retrieval of ancient documents of “traditional Chinese medicine theory” under the triple-combination system of TCM theory, human-use experience, and clinical trials. Chinese Journal of New Drugs. 2023; 32:989–993.

[26] LiJ,LiB, ZhaoXK,Tu JY,LiY. A critical review to grading systems and recommendations of traditional Chinese medicine guidelines. Health Qual Life Outcomes. 2020; 18:174.

[27] Technical specifications for real-world study in TCM: evidence quality evaluation and reporting. J Tradit Chin Med. 2022; 63:293–300.

[28] LiuJP. GRADE Methods in traditional medicine. Integr Med Res. 2022; 11:100836.

[29] MercuriM,BaigrieB, UpshurREG. Going from evidence to recommendations: can GRADE get us there? J Eval Clin Pract. 2018; 24:1232–1239.

[30] MobergJ,OxmanAD, RosenbaumS, et al. The GRADE Evidence to Decision (EtD) framework for health system and public health decisions. Health Res Policy Syst. 2018; 16:45.

[31] XieR,XiaY, ChenY, et al. The RIGHT extension statement for Traditional Chinese Medicine: development, recommendations, and explanation. Pharmacol Res. 2020; 160:105178.

[32] JiangM,LuC, ZhangC, et al. Syndrome differentiation in modern research of traditional Chinese medicine. J Ethnopharmacol. 2012; 140:634–642.

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2024 The Author(s). Journal of Evidence-Based Medicine published by Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.