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领域流行病学临床研究
方法族Process / pipelineProcess / pipeline
起源年份2000s–2010s (adaptive designs codified for diagnostics ~2010s)2003-2015
提出者Adaptation of STARD framework (Bossuyt et al.) combined with adaptive design principles (Jennison & Turnbull; FDA guidance)Bossuyt, Reitsma, and STARD group (2003); clinical epidemiology pioneers
类型Adaptive observational/experimental study designResearch Design
开创性文献Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L., ... & Cohen, J. F. (2015). STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ, 351, h5527. DOI ↗Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., ... & de Vet, H. C. (2003). Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Annals of Internal Medicine, 138(1), 40–44. DOI ↗
别名adaptive DTA study, adaptive diagnostic test evaluation, adaptive test accuracy trial, adaptive STARD studydiagnostic accuracy study, test accuracy, STARD, diagnostic evaluation
相关62
摘要An adaptive diagnostic accuracy study evaluates how well an index test distinguishes between patients with and without a target condition, while incorporating pre-specified interim analyses that allow modifications — such as sample size re-estimation, threshold adjustment, or subgroup enrichment — based on accumulating data. This design improves efficiency and ethical conduct compared to fixed-sample diagnostic studies, particularly when prior prevalence or test performance data are uncertain.A diagnostic accuracy study evaluates how well a new diagnostic test (or biomarker, imaging modality, clinical assessment) detects the presence or absence of disease compared to a reference standard (gold standard). Standardized since 2003 by the STARD (Standards for Reporting of Diagnostic Accuracy Studies) initiative, diagnostic accuracy studies are fundamental to clinical medicine, determining whether and how new tests can improve patient diagnosis and treatment.
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ScholarGate方法对比: Adaptive Diagnostic Accuracy Study · Diagnostic Accuracy Study Design. 于 2026-06-17 检索自 https://scholargate.app/zh/compare