病例对照研究设计在医院感染相关临床研究中的应用及其结果报告规范

Application of case-control study design in clinical research on hospital-acquired infections and specifications for report of results

  • 摘要:
    目的 总结病例对照研究的设计要点及数据资料的分析和总结规范, 以期提高医院感染相关临床研究的研究质量。
    方法 基于医院感染数据时效性强、混杂因素多的特征, 系统梳理病例对照研究的设计类型, 通过典型案例解析研究设计、数据清理及统计分析方法, 并列举病例对照研究设计的常见类型和设计要点, 梳理基于医院感染临床问题的病例对照研究结果报告范式。
    结果 本文从病例对照研究的设计要点入手, 基于医院感染的相关临床研究特点, 构建包含三大核心要素的研究设计框架:明确暴露的时间逻辑, 制定混杂因素控制策略, 选择适配的统计模型。同时形成报告规范, 实现方法学透明化。
    结论 明确病例对照研究设计要点和结果报告规范, 可提高医院感染相关病例对照设计的临床研究的研究质量及其科学性和可行性。

     

    Abstract:
    OBJECTIVE To summarize the key points for design of case-control study, analyze the data and summarize the specifications so as to raise the quality of related clinical research on hospital-acquired infections.
    METHODS The types for design of the case-control study were systematically summarized based on the characteristics of hospital-acquired infection data with strong timeliness and various confounding factors. The design, data clearance and statistical analysis method were studied by analysis of typical cases, the common types for design of the case-control study and the key points of design were listed, and the specifications for report of the result of case-control study based on the clinical problems about hospital-acquired infections were summed up.
    RESULTS By starting from the key points for the design of the case-control study, the design framework of the study that contained three core elements was established based on the characteristics of related research on hospital-acquired infections, the three core elements were as follows: clarifying the temporal logic of exposure, developing strategies for the control of confounding factors, selecting appropriate statistical models. Meanwhile, the reporting specifications were formulated to achieve the methodological transparency.
    CONCLUSION Clarifying the key points for design of the case-control study and the specifications for report of results can improve the quality of clinical research on case-control design for hospital-acquired infection cases and boost the scientificity and feasibility.

     

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