首页|基于混合方法聚敛式平行设计构建中医药治疗缺血性脑卒中疗效评价指标要素池

基于混合方法聚敛式平行设计构建中医药治疗缺血性脑卒中疗效评价指标要素池

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目的 构建中医药治疗缺血性脑卒中(ischemic stroke,IS)的指标要素池,为IS核心指标集的建立提供基础,以提高中医药治疗IS临床研究和评价结果的一致性.方法 本研究采用混合方法研究聚敛式平行设计,同时开展定性研究和定量研究,整合两种研究结果得出结论.定量研究全面收集中医药治疗IS的多源疗效评价指标,并基于频率学进行描述性统计分析;定性研究采用半结构化访谈,选择相关利益群体了解其关注的中医药治疗IS疗效评价指标,采用NVivo软件进行数据分析、编码和归类,提取疗效指标.通过支柱整合原理,整合定量和定性研究结果,构建中医药治疗IS的疗效评价指标要素池.结果 定量研究部分共纳入437篇标准文献、71项登记注册试验方案、100份真实世界医疗数据病例以及若干指南共识政策性文件,共提取到IS急性期指标314个,恢复期指标154个,后遗症期指标104个;定性研究部分通过访谈共计提取到IS急性期指标32个、恢复期34个和后遗症期指标35个.通过课题组小组讨论,结合支柱整合原理,形成IS指标要素池,包括IS急性期指标279个,恢复期指标142个以及后遗症期指标91个.结论 基于混合方法研究聚敛式平行设计成功构建了一个满足需求的中医药治疗IS疗效评价指标要素池,为进一步构建IS核心指标集提供了坚实的前期基础.
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
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.

Mixed method researchIndex factor poolConvergent parallel designTraditional Chinese medicineIschemic stroke

李春晓、杨玉晴、凌霄、邢冬梅、刘向哲

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河南中医药大学第一附属医院药学部(郑州 450000)

河南省中药临床应用、评价与转化工程研究中心/河南省中药临床药学中医药重点实验室(郑州 450000)

河南中医药大学呼吸疾病中医药防治省部共建协同创新中心(郑州 450000)

河南中医药大学第一附属医院心内科(郑州 450000)

河南中医药大学第一附属医院脑病科(郑州 450000)

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混合方法研究 指标要素池 聚敛式平行设计 中医药 缺血性脑卒中

2024

中国循证医学杂志
四川大学

中国循证医学杂志

CSTPCD北大核心
影响因子:1.761
ISSN:1672-2531
年,卷(期):2024.24(12)