Designs and appropriate choices for diagnostic test accuracy study

VernacularTitle:诊断试验准确性研究的设计类型和选择
Author: Xiaolong LIU ¹ ; Na WU ; Yafei LI
Author Information

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
Keywords: Diagnostic test accuracy; Design types; Single diagnostic test accuracy study; Comparative diagnostic test accuracy study
From: Chinese Journal of Epidemiology 2024;45(12):1705-1714
CountryChina
Language:Chinese
Abstract: 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.