Based on the convergent parallel design of mixed methods research to construct the evaluation index factor pool of traditional Chinese medicine in the treatment of ischemic stroke_Chinese Journal of Evidence-Based Medicine

Authors：

 LI Chunxiao ^1,2,3 , YANG Yuqing ^1,2 , LING Xiao ^1,2 , Xing Dongmei ⁴ , Liu Xiangzhe ⁵

1. Department of Pharmacy, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, P. R. China;
2. Henan Province Engineering Research Center for Clinical Application, Evaluation and Transformation of Traditional Chinese Medicine/Henan Province Engineering Laboratory for Clinical Evaluation Technology of Chinese Medicine, Zhengzhou 450000, P. R. China;
3. Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan province & Education Ministry of P. R. China, Henan University of Chinese Medicine, Zhengzhou 450046, P. R. China;
4. Department of Cardiology, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, P. R. China;
5. Department of encephalopathy, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, P. R. China;

Corresponding author：

LI Chunxiao, Email: lichunxiao@126.com

Keywords：

Mixed method research; Index factor pool; Convergent parallel design; Traditional Chinese medicine; Ischemic stroke

DOI：

10.7507/1672-2531.202408042

Video：

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Objective The core indicator pool of ischemic stroke (IS) was constructed to provide a basis for the establishment of the core outcome set (COS), so as to improve the consistency of clinical research and evaluation results of traditional Chinese medicine (TCM) treatment of IS. Methods In this study, the mixed methods research (MMR) convergent parallel design was used to carry out qualitative research and quantitative research at the same time, and the two research results were integrated to reach a conclusion. Quantitative research comprehensively collected the multi-source efficacy evaluation indicators of TCM treatment of IS, and carried out descriptive statistical analysis based on frequency theory. Semi-structured interviews were used in the qualitative research, relevant interest groups were selected to understand the evaluation indicators of the IS efficacy of TCM treatment that they were concerned about, and NVivo software was used for in-depth analysis, coding, classification, and extraction of the efficacy indicators. Based on the principle of pillar integration, quantitative and qualitative research results were integrated to construct an element pool of evaluation indexes for the treatment of IS with traditional Chinese medicine. Results A total of 437 standard papers, 71 registered trial protocols, 100 real-world medical data cases and several guideline consensus policy documents were included in the quantitative study, and a total of 314 indicators in the acute phase of IS, 154 indicators in the recovery phase, and 104 indicators in the sequelae phase were extracted. In the qualitative research part, a total of 32 indicators in the acute stage of IS, 34 indicators in the recovery stage and 35 indicators in the sequelae stage were extracted through interviews. Through group discussion and the principle of pillar integration, an element pool of IS ischemic stroke indicators was formed, including 279 IS indicators in the acute stage, 142 indicators in the recovery stage and 91 indicators in the sequelae stage. Conclusion Based on the MMR convergent parallel design, the element pool of the characteristic indexes of the therapeutic effect of IS in TCM was constructed to meet the needs, which provided the preliminary work basis for the construction of the core outcome set of ischemic stroke in the next stage.

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1. Zhang H, Jin B, You X, et al. Pharmacodynamic advantages and characteristics of traditional Chinese medicine in prevention and treatment of ischemic stroke. Chin Herb Med, 2023, 15(4): 496-508.
2. Roth GA, Mensah GA, Johnson CO, et al. Global burden of cardiovascular diseases and risk factors, 1990-2019: update from the GBD 2019 Study. J Am Coll Cardiol, 2020, 76(25): 2982-3021.
3. 杜杰, 王建民, 杨建彬. 血栓通注射液联合奥拉西坦对老年缺血性脑卒中的作用. 西北药学杂志, 2024, 39(3): 153-157.
4. 王靖阳, 徐强. 中药注射剂治疗脑梗死临床研究进展. 中国中医药现代远程教育, 2024, 22(11): 166-169.
5. 朱冉冉, 王津翔, 潘蓓, 等. 脑卒中中西医结合康复临床循证实践指南. 上海中医药杂志, 2024, 58(6): 1-11.
6. 代欣玥, 訾明杰, 孙明月, 等. 符合中医药特色的综合疗效评价体系构建思路及方法. 中国新药杂志, 2024, 33(2): 105-109.
7. 邢冬梅, 刘志斌, 李春晓, 等. 中医药核心指标集报告质量评价. 中华中医药杂志, 2024, 39(1): 407-409.
8. 邱瑞瑾, 魏旭煦, 关之玥, 等. 中医药领域核心指标集研究现状及展望. 中国循证医学杂志, 2023, 23(2): 211-220.
9. 张明妍, 蔡慧姿, 牛柏寒, 等. 中医药核心指标集研究中指标池构建相关影响因素分析. 中国循证医学杂志, 2021, 21(4): 464-468.
10. De Vincenzo C, Cena L, Trainini A, et al. Perinatal loss and parents' grief amidst the COVID-19 pandemic: a mixed-method research. Behav Sci (Basel), 2024, 14(4): 339.
11. Haenssgen MJ, Elliott EM, Phommachanh S, et al. Trust in healthcare: methodological and conceptual insights from mixed-method research in Lao People's Democratic Republic. BMJ Glob Health, 2024, 9(5): e014640.
12. 褚红玲, 刘逸舒, 汪洋, 等. 全科医学研究中混合方法研究的设计和实施要点及案例解析. 中国全科医学, 2023, 26(1): 118-125.
13. Östlund U, Kidd L, Wengström Y, et al. Combining qualitative and quantitative research within mixed method research designs: a methodological review. Int J Nurs Stud, 2011, 48(3): 369-383.
14. 张宁, 李静, 史光琴, 等. 聚敛式设计混合方法研究在护理研究中的应用进展. 全科护理, 2024, 22(2): 299-303.
15. Creswell JW. 混合方法研究导论. 上海: 上海人民出版社, 2015.
16. 李春晓, 杨玉晴, 凌霄, 等. 基于混合方法探讨中药注射剂临床疗效评价指标的筛选. 中医杂志, 2023, 64(22): 2291-2294.
17. 田翠翠. 基于半结构访谈法对原发性高血压患者针刺降压接受度及感受度的定性研究. 天津: 天津中医药大学, 2020.
18. Johnson RE, Grove A, Clarke A. Pillar integration process: a joint display technique to integrate data in mixedmethods research. J Mix Methods Res, 2019, 13(3): 301-320.
19. Gauly J, Ulahannan A, Grove A. The Extended Pillar Integration Process (ePIP): a data integration method allowing the systematic synthesis of findings from three different sources. J Mix Methods Res, 2022, 18: 31-47.
20. 李楠, 庞稳泰, 王虎城, 等. 中成药治疗脑梗死急性期临床试验结局指标分析. 天津中医药, 2020, 37(9): 1034-1038.
21. Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence - what is it and what can it tell us. N Engl J Med, 2016, 375(23): 2293-2297.
22. 张冬, 张俊华, 孙凤, 等. 真实世界研究与中医药大数据. 世界中医药, 2019, 14(12): 3119-3122.
23. 李金根, 姜众会, 高铸烨, 等. 真实世界研究在中医药临床研究中的应用. 世界科学技术-中医药现代化, 2017, 19(1): 78-82.
24. 龚杰, 石磊, 母东煜, 等. 循证初步构建老年肌少症营养功能性食品临床试验指标池. 中华老年多器官疾病杂志, 2021, 20(10): 731-737.
25. 周子琪, 曾小庆, 龚杰, 等. 建立慢性肾病特殊医学用途配方食品的效果评价指标池探讨. 预防医学情报杂志, 2021, 37(10): 1398-1404.
26. Kirkham JJ, Davis K, Altman DG, et al. Core Outcome Set-STAndards for Development: the COS-STAD recommendations. PLoS Med, 2017, 14(11): e1002447.
27. 张明妍, 张俊华, 杜亮, 等. 译文: 核心指标集研制标准: COS-STAD推荐. 中国循证医学杂志, 2018, 18(7): 753-757.
28. 张明妍, 张俊华, 杜亮, 等. 核心指标集研制规范(COS-STAD)介绍及其在中医药领域应用的思考. 中国循证医学杂志, 2018, 18(4): 392-396.
29. 张翔宇. 中医药治疗室性早搏核心指标集研究. 天津: 天津中医药大学, 2022.
30. 崔莹. 基于GRADE分级工具系统评价针灸临床证据质量及核心指标集构建: 原发性抑郁症. 天津: 天津中医药大学, 2022.
31. 李凯. 中医药治疗肺癌核心指标集研究. 天津: 天津中医药大学, 2021.
32. 张俊华, 王海南. 临床评价核心指标集研究方法与实践. 上海: 上海科学技术出版社, 2021.
33. Creswell JW, Clark V. 混合方法研究: 设计与实施. 重庆: 重庆大学出版社, 2017.

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Latest ArticlesBased on the convergent parallel design of mixed methods research to construct the evaluation index factor pool of traditional Chinese medicine in the treatment of ischemic stroke

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