手法を比較

	実用的な診断精度研究	診断精度の研究デザイン
分野	疫学	臨床研究
系統	Process / pipeline	Process / pipeline
提唱年	2000s–2010s (formalized alongside STARD reporting guidelines)	2003-2015
提唱者	Evolved from STARD initiative (Bossuyt et al.) and pragmatic trial framework (Schwartz & Lellouch, 1967)	Bossuyt, Reitsma, and STARD group (2003); clinical epidemiology pioneers
種類	Observational diagnostic study design	Research Design
原典	Bossuyt, P. M., et al. (2015). STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies. BMJ, 351, h5527.	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.
別名	real-world diagnostic accuracy study, pragmatic DAS, routine-care diagnostic study, pragmatic test evaluation	diagnostic accuracy study, test accuracy, STARD, diagnostic evaluation
関連	6	2
概要	A pragmatic diagnostic accuracy study evaluates how well a diagnostic test performs under real-world clinical conditions — not in idealized, tightly controlled settings. Conducted within routine care workflows, it measures sensitivity, specificity, predictive values, and likelihood ratios for an index test against a reference standard, yielding accuracy estimates directly applicable to clinical practice rather than laboratory benchmarks.	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.