Development of a methodological framework for clinical researches in Chinese medicine under the mode of syndrome dominating disease using the operationalization of concept method_Chinese Journal of Evidence-Based Medicine

Authors：

HUANG Qian ¹ , XUAN Meiling ¹ , GUO Xiaohui ¹ , CAO Wencong ² , LIU Bingqing ² , QIU Xingying ² , ZHOU Li ¹ ,  WEN Zehuai ^1,2

1. Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, P. R. China;
2. Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou 510405, P. R. China;

Corresponding author：

WEN Zehuai, Email: wenzh@gzucm.edu.cn

Keywords：

Treating different diseases with the same treatment; Syndrome dominating disease; Clinical research; Operationalization of concept; Methodological framework

DOI：

10.7507/1672-2531.202401127

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective With reference to the method of operationalization of concept in the field of sociology, this study developed a methodological framework for intervention trials of Chinese medicine (CM) under the mode of syndrome dominating disease. Methods First, an operational definition of the syndrome dominating disease research model was clarified to provide the scope and direction of the methodological framework construction. Then a scoping review was conducted to identify the design features of clinical researches under the model to summarize the basic structure and content of the framework; furthermore, in-depth interviews were carried out to collect the views and suggestions of CM experts on this type of study, which added details to the framework. Finally, a survey was conducted to evaluate the rationality and feasibility of the methodological framework. Results A total of 74 studies were included and 12 CM experts were interviewed, and the results of the literature and interview study were synthesized to form a preliminary methodological framework. Thirty-two experts participated in the survey and most of them held a positive assessment of the rationality of the framework, then according to the experts’ suggestions, the final methodological framework which was a four-level structure with 25 items was established. Conclusion Following the internationally recognized methods and steps, this study develops a rational and feasible methodological framework for CM trials under the mode of syndrome dominating disease, which can provide references for future studies’ design, implementation and evaluation.

Citation： HUANG Qian, XUAN Meiling, GUO Xiaohui, CAO Wencong, LIU Bingqing, QIU Xingying, ZHOU Li, WEN Zehuai. Development of a methodological framework for clinical researches in Chinese medicine under the mode of syndrome dominating disease using the operationalization of concept method. Chinese Journal of Evidence-Based Medicine, 2024, 24(10): 1192-1197. doi: 10.7507/1672-2531.202401127 Copy

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1. 赵晨, 张晓雨, 胡嘉元, 等. 中医同证候系疾病临床研究母方案设计方法. 中医杂志, 2018, 59(2): 111-115.
2. 焦一鸣, 王放, 付小红. 论以证统病的研究. 中医文献杂志, 2011, 29(6): 5-6.
3. 王阶, 熊兴江, 张兰凤. 病证结合模式及临床运用探索. 中国中西医结合杂志, 2012, 32(3): 297-299.
4. 丁正香, 朱沛, 尹天雷, 等. 裸花紫珠片治疗热(瘀)毒证的证病结合临床研究. 世界中医药, 2017, 12(12): 3128-3132, 3137.
5. 孙艳君. 黄连解毒丸治疗实热火毒证的临床研究. 天津: 天津中医药大学, 2021.
6. 王少卿, 高颖. 从证病结合模式探讨证候类中药新药的临床研究方法. 环球中医药, 2014, 7(9): 724-726.
7. 尹天雷, 乔铁, 刘天舒, 等. 热炎宁颗粒治疗风热证148例临床观察及中医“以证统病”的临床科研思路探讨. 中国医药导报, 2009, 6(11): 20-22.
8. 李敏. 补肾促卵冲剂治疗排卵障碍性不孕症随机双盲对照多中心临床研究. 北京: 中国中医科学院, 2016.
9. 明浩. 痰瘀通胶囊治疗高脂血症合并非酒精性脂肪肝(痰瘀互阻证)的临床疗效研究. 武汉: 湖北中医药大学, 2014.
10. 韩芳, 范吉平, 郭盛楠, 等. 针对肝郁化热证的证候类中药新药临床评价研究. 世界中医药, 2018, 13(7): 1633-1636, 1640.
11. What is methodological framework. 2019.
12. McMeekin N, Wu O, Germeni E, et al. How methodological frameworks are being developed: evidence from a scoping review. BMC Med Res Methodol, 2020, 20(1): 173.
13. Squires H, Chilcott J, Akehurst R, et al. A framework for developing the structure of public health economic models. Value Health, 2016, 19(5): 588-601.
14. Kallio H, Pietilä AM, Johnson M, et al. Systematic methodological review: developing a framework for a qualitative semi-structured interview guide. J Adv Nurs, 2016, 72(12): 2954-2965.
15. 陕飞, 尹道馨, 李子禹, 等. 外科临床研究方法学指引—IDEAL框架及指南介绍与解读. 中国实用外科杂志, 2020, 40(1): 93-101.
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17. 卞薇, 陈慧, 宋国敏, 等. 概况性评价简介. 中国循证医学杂志, 2017, 17(4): 488-493.
18. 廖星. 运用定性研究方法探索中医师诊治疾病的过程. 北京: 北京中医药大学, 2011.
19. 倪胜楼. 基于半结构式访谈和多阶段随机问卷调研的中医临床方药量效关系研究. 北京: 北京中医药大学, 2014.
20. 李涵, 孙杨, 张晓雨, 等. 以证统病—中医临床思维的回归与创新. 世界中医药, 2019, 14(10): 2552-2556, 2562.
21. 国家药品监督管理局. 证候类中药新药临床研究技术指导原则. 2018.

Chinese Journal of Evidence-Based Medicine

Development of a methodological framework for clinical researches in Chinese medicine under the mode of syndrome dominating disease using the operationalization of concept method

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