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. 趙晨, 張曉雨, 胡嘉元, 等. 中醫同證候系疾病臨床研究母方案設計方法. 中醫雜志, 2018, 59(2): 111-115.
2. 焦一鳴, 王放, 付小紅. 論以證統病的研究. 中醫文獻雜志, 2011, 29(6): 5-6.
3. 王階, 熊興江, 張蘭鳳. 病證結合模式及臨床運用探索. 中國中西醫結合雜志, 2012, 32(3): 297-299.
4. 丁正香, 朱沛, 尹天雷, 等. 裸花紫珠片治療熱(瘀)毒證的證病結合臨床研究. 世界中醫藥, 2017, 12(12): 3128-3132, 3137.
5. 孫艷君. 黃連解毒丸治療實熱火毒證的臨床研究. 天津: 天津中醫藥大學, 2021.
6. 王少卿, 高穎. 從證病結合模式探討證候類中藥新藥的臨床研究方法. 環球中醫藥, 2014, 7(9): 724-726.
7. 尹天雷, 喬鐵, 劉天舒, 等. 熱炎寧顆粒治療風熱證148例臨床觀察及中醫“以證統病”的臨床科研思路探討. 中國醫藥導報, 2009, 6(11): 20-22.
8. 李敏. 補腎促卵沖劑治療排卵障礙性不孕癥隨機雙盲對照多中心臨床研究. 北京: 中國中醫科學院, 2016.
9. 明浩. 痰瘀通膠囊治療高脂血癥合并非酒精性脂肪肝(痰瘀互阻證)的臨床療效研究. 武漢: 湖北中醫藥大學, 2014.
10. 韓芳, 范吉平, 郭盛楠, 等. 針對肝郁化熱證的證候類中藥新藥臨床評價研究. 世界中醫藥, 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, Pietil? 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. 陜飛, 尹道馨, 李子禹, 等. 外科臨床研究方法學指引—IDEAL框架及指南介紹與解讀. 中國實用外科雜志, 2020, 40(1): 93-101.
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18. 廖星. 運用定性研究方法探索中醫師診治疾病的過程. 北京: 北京中醫藥大學, 2011.
19. 倪勝樓. 基于半結構式訪談和多階段隨機問卷調研的中醫臨床方藥量效關系研究. 北京: 北京中醫藥大學, 2014.
20. 李涵, 孫楊, 張曉雨, 等. 以證統病—中醫臨床思維的回歸與創新. 世界中醫藥, 2019, 14(10): 2552-2556, 2562.
21. 國家藥品監督管理局. 證候類中藥新藥臨床研究技術指導原則. 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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