Based on the convergent parallel design of mixed methods research to construct the evaluation index factor pool of traditional Chinese medicine for 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 450000, 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 for 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 indicators 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 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 indicators of the therapeutic effect of IS in TCM is constructed to meet the needs, which provides the preliminary work basis for the construction of the core outcome set of IS in the next stage.

Citation： LI Chunxiao, YANG Yuqing, LING Xiao, XING Dongmei, LIU Xiangzhe. Based on the convergent parallel design of mixed methods research to construct the evaluation index factor pool of traditional Chinese medicine for the treatment of ischemic stroke. Chinese Journal of Evidence-Based Medicine, 2024, 24(12): 1384-1391. doi: 10.7507/1672-2531.202408042 Copy

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4.	王靖陽, 徐強. 中藥注射劑治療腦梗死臨床研究進展. 中國中醫藥現代遠程教育, 2024, 22(11): 166-169.
5.	朱冉冉, 王津翔, 潘蓓, 等. 腦卒中中西醫結合康復臨床循證實踐指南. 上海中醫藥雜志, 2024, 58(6): 1-11.
6.	代欣玥, 訾明杰, 孫明月, 等. 符合中醫藥特色的綜合療效評價體系構建思路及方法. 中國新藥雜志, 2024, 33(2): 105-109.
7.	邢冬梅, 劉志斌, 李春曉, 等. 中醫藥核心指標集報告質量評價. 中華中醫藥雜志, 2024, 39(1): 407-409.
8.	邱瑞瑾, 魏旭煦, 關之玥, 等. 中醫藥領域核心指標集研究現狀及展望. 中國循證醫學雜志, 2023, 23(2): 211-220.
9.	張明妍, 蔡慧姿, 牛柏寒, 等. 中醫藥核心指標集研究中指標池構建相關影響因素分析. 中國循證醫學雜志, 2021, 21(4): 464-468.
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12.	褚紅玲, 劉逸舒, 汪洋, 等. 全科醫學研究中混合方法研究的設計和實施要點及案例解析. 中國全科醫學, 2023, 26(1): 118-125.
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14.	張寧, 李靜, 史光琴, 等. 聚斂式設計混合方法研究在護理研究中的應用進展. 全科護理, 2024, 22(2): 299-303.
15.	Creswell JW. 混合方法研究導論. 上海: 上海人民出版社, 2015.
16.	李春曉, 楊玉晴, 凌霄, 等. 基于混合方法探討中藥注射劑臨床療效評價指標的篩選. 中醫雜志, 2023, 64(22): 2291-2294.
17.	田翠翠. 基于半結構訪談法對原發性高血壓患者針刺降壓接受度及感受度的定性研究. 天津: 天津中醫藥大學, 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.
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20.	李楠, 龐穩泰, 王虎城, 等. 中成藥治療腦梗死急性期臨床試驗結局指標分析. 天津中醫藥, 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.	張冬, 張俊華, 孫鳳, 等. 真實世界研究與中醫藥大數據. 世界中醫藥, 2019, 14(12): 3119-3122.
23.	李金根, 姜眾會, 高鑄燁, 等. 真實世界研究在中醫藥臨床研究中的應用. 世界科學技術-中醫藥現代化, 2017, 19(1): 78-82.
24.	龔杰, 石磊, 母東煜, 等. 循證初步構建老年肌少癥營養功能性食品臨床試驗指標池. 中華老年多器官疾病雜志, 2021, 20(10): 731-737.
25.	周子琪, 曾小慶, 龔杰, 等. 建立慢性腎病特殊醫學用途配方食品的效果評價指標池探討. 預防醫學情報雜志, 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.	張明妍, 張俊華, 杜亮, 等. 譯文: 核心指標集研制標準: COS-STAD推薦. 中國循證醫學雜志, 2018, 18(7): 753-757.
28.	張明妍, 張俊華, 杜亮, 等. 核心指標集研制規范(COS-STAD)介紹及其在中醫藥領域應用的思考. 中國循證醫學雜志, 2018, 18(4): 392-396.
29.	張翔宇. 中醫藥治療室性早搏核心指標集研究. 天津: 天津中醫藥大學, 2022.
30.	崔瑩. 基于GRADE分級工具系統評價針灸臨床證據質量及核心指標集構建: 原發性抑郁癥. 天津: 天津中醫藥大學, 2022.
31.	李凱. 中醫藥治療肺癌核心指標集研究. 天津: 天津中醫藥大學, 2021.
32.	張俊華, 王海南. 臨床評價核心指標集研究方法與實踐. 上海: 上海科學技術出版社, 2021.
33.	Creswell JW, Clark V. 混合方法研究: 設計與實施. 重慶: 重慶大學出版社, 2017.

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, 楊建彬. 血栓通注射液聯合奧拉西坦對老年缺血性腦卒中的作用. 西北藥學雜志, 2024, 39(3): 153-157.
4. 王靖陽, 徐強. 中藥注射劑治療腦梗死臨床研究進展. 中國中醫藥現代遠程教育, 2024, 22(11): 166-169.
5. 朱冉冉, 王津翔, 潘蓓, 等. 腦卒中中西醫結合康復臨床循證實踐指南. 上海中醫藥雜志, 2024, 58(6): 1-11.
6. 代欣玥, 訾明杰, 孫明月, 等. 符合中醫藥特色的綜合療效評價體系構建思路及方法. 中國新藥雜志, 2024, 33(2): 105-109.
7. 邢冬梅, 劉志斌, 李春曉, 等. 中醫藥核心指標集報告質量評價. 中華中醫藥雜志, 2024, 39(1): 407-409.
8. 邱瑞瑾, 魏旭煦, 關之玥, 等. 中醫藥領域核心指標集研究現狀及展望. 中國循證醫學雜志, 2023, 23(2): 211-220.
9. 張明妍, 蔡慧姿, 牛柏寒, 等. 中醫藥核心指標集研究中指標池構建相關影響因素分析. 中國循證醫學雜志, 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. 褚紅玲, 劉逸舒, 汪洋, 等. 全科醫學研究中混合方法研究的設計和實施要點及案例解析. 中國全科醫學, 2023, 26(1): 118-125.
13. ?stlund U, Kidd L, Wengstr?m 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. 張寧, 李靜, 史光琴, 等. 聚斂式設計混合方法研究在護理研究中的應用進展. 全科護理, 2024, 22(2): 299-303.
15. Creswell JW. 混合方法研究導論. 上海: 上海人民出版社, 2015.
16. 李春曉, 楊玉晴, 凌霄, 等. 基于混合方法探討中藥注射劑臨床療效評價指標的篩選. 中醫雜志, 2023, 64(22): 2291-2294.
17. 田翠翠. 基于半結構訪談法對原發性高血壓患者針刺降壓接受度及感受度的定性研究. 天津: 天津中醫藥大學, 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, 龐穩泰, 王虎城, 等. 中成藥治療腦梗死急性期臨床試驗結局指標分析. 天津中醫藥, 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. 張冬, 張俊華, 孫鳳, 等. 真實世界研究與中醫藥大數據. 世界中醫藥, 2019, 14(12): 3119-3122.
23. 李金根, 姜眾會, 高鑄燁, 等. 真實世界研究在中醫藥臨床研究中的應用. 世界科學技術-中醫藥現代化, 2017, 19(1): 78-82.
24. 龔杰, 石磊, 母東煜, 等. 循證初步構建老年肌少癥營養功能性食品臨床試驗指標池. 中華老年多器官疾病雜志, 2021, 20(10): 731-737.
25. 周子琪, 曾小慶, 龔杰, 等. 建立慢性腎病特殊醫學用途配方食品的效果評價指標池探討. 預防醫學情報雜志, 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. 張明妍, 張俊華, 杜亮, 等. 譯文: 核心指標集研制標準: COS-STAD推薦. 中國循證醫學雜志, 2018, 18(7): 753-757.
28. 張明妍, 張俊華, 杜亮, 等. 核心指標集研制規范(COS-STAD)介紹及其在中醫藥領域應用的思考. 中國循證醫學雜志, 2018, 18(4): 392-396.
29. 張翔宇. 中醫藥治療室性早搏核心指標集研究. 天津: 天津中醫藥大學, 2022.
30. 崔瑩. 基于GRADE分級工具系統評價針灸臨床證據質量及核心指標集構建: 原發性抑郁癥. 天津: 天津中醫藥大學, 2022.
31. 李凱. 中醫藥治療肺癌核心指標集研究. 天津: 天津中醫藥大學, 2021.
32. 張俊華, 王海南. 臨床評價核心指標集研究方法與實踐. 上海: 上海科學技術出版社, 2021.
33. Creswell JW, Clark V. 混合方法研究: 設計與實施. 重慶: 重慶大學出版社, 2017.

Chinese Journal of Evidence-Based Medicine

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

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