[Designs and appropriate choices for diagnostic test accuracy study]

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.