医院感染的临床诊断试验设计要点与报告规范

Key points for design of clinical diagnostic test studies for health care-associated infections and reporting specifications

  • 摘要: 目的 系统梳理诊断试验的核心设计要点,并总结标准化的期刊论文报告规范。方法 依托国际诊断研究报告规范(STARD标准)及质量评估工具(QUADAS),结合医院感染临床场景,系统梳理诊断准确性研究的关键方法学要素。重点围绕研究诊断试验研究设计及诊断试验结果呈现的两个维度,归纳结构化的论文撰写路径。结果 构建了全流程的诊断试验方法学撰写标准; 针对研究中常见的受试者选取偏倚、金标准使用不当或滞后、盲法报告缺失及指标使用不规范等问题,提出了针对性的防范策略并深度融入设计环节; 同时提炼形成了基线特征及诊断效能(单一及多指标并/串联)的标准化图表呈现样范及建议。结论 严格遵循诊断试验的设计要点与报告规范,能有效控制各类研究偏倚,提升临床医学诊断研究的科学性、透明度与可重复性,从而为医院感染防控及医疗决策提供坚实的循证基础。

     

    Abstract: OBJECTIVE To systematically summarize the key points for design of diagnostic test and conclude standardized reporting specifications for journal articles. METHODS Drawing on the Standards for Reporting of Diagnostic Accuracy Study (STARD) and the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) tool, the key methodological components of diagnostic accuracy studies were systematically delineated within the context of health care-associated infection (HAI) in clinical settings. Focusing on two dimensions presented by the design of diagnostic test research and the result of diagnostic test, a structured pathway for manuscript preparation was summarized. RESULTS A comprehensive, standardized writing framework for diagnostic test was established. Addressing the prevalent challenges such as selection bias in participants, inappropriate or delayed application of golden standards, inadequate reporting of blinding, and non-standardized model fitting of multiple indicators for combined diagnosis, the targeted prevention strategies that were integrated into the design phase were proposed. Furthermore, the standardized templates for presenting baseline characteristics, diagnostic performance (including single and parallel/serial multi-indicator models) and stratified analysis of results were formulated. CONCLUSION Strict adherence to the design principles and reporting standards of diagnostic test can effectively mitigates various research biases and enhance the scientific rigor, transparency, and reproducibility of clinical diagnostic studies, which lays a robust evidence-based foundation for prevention and control of HAIs, formulation of clinical guideline and medical decision-making.

     

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