诊断试验准确性研究的设计类型和选择  

Designs and appropriate choices for diagnostic test accuracy study

作　　者：刘晓龙 邬娜[1,2] 李亚斐[1,2] Liu Xiaolong;Wu Na;Li Yafei(Department of Epidemiology,College of Preventive Medicine,Army Medical University(Third Military Medical University),Chongqing 400038,China;Clinical Epidemiology and Evidence-Based Medicine Center,Army Medical University(Third Military Medical University),Chongqing 400038,China)

机构地区：[1]陆军军医大学(第三军医大学)军事预防医学系军队流行病学教研室,重庆400038 [2]陆军军医大学(第三军医大学)临床流行病学和循证医学中心,重庆400038

出　　处：《中华流行病学杂志》2024年第12期1705-1714,共10页Chinese Journal of Epidemiology

基　　金：国家自然科学基金(82073649,81871896)。

摘　　要：诊断试验是临床工作中不可或缺的工具,在将诊断试验引入临床实践之前,要经由科学设计的准确性研究进行严格评价,其准确性直接关系到诊断的正确性和治疗决策的合理性。本文介绍了诊断试验准确性研究的设计类型及其特点,包括单组设计、诊断性病例对照研究设计、单组配对设计以及平行组设计,并根据研究问题所处阶段、诊断试验在临床诊断路径中的作用和实际临床应用场景推荐合适的设计类型,为进一步规范当前临床诊断试验准确性研究设计提出建议。本文旨在帮助临床研究者更好地了解和选择合适的诊断试验准确性研究设计类型,以期提高诊断试验准确性研究的质量。Diagnostic tests are indispensable tools in clinical practice and are rigorously evaluated through scientifically designed accuracy studies before the clinical practice.The accuracy of these tests directly affects the correctness of the diagnosis and the rationality of treatment decisions.This article introduces the types of designs and their characteristics used in diagnostic test accuracy studies,including single-group studies,diagnostic case-control studies,single-group paired studies,and parallel-group studies.It recommends appropriate design types based on the research question stage,the diagnostic test's role in the clinical diagnostic pathway,and the actual clinical application scenario to provide suggestions for further standardizing the design of current clinical diagnostic test accuracy research.This article may help clinical researchers better understand and choose the appropriate type of diagnostic test accuracy study design to improve diagnostic test accuracy research quality.

关 键 词：诊断试验准确性 设计类型 单个诊断试验准确性研究 诊断试验准确性比较研究 

分 类 号：R-03[医药卫生]