手法を比較

	実用的な診断精度研究	実用的ランダム化比較試験 ― 実臨床における有効性
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	2000s–2010s (formalized alongside STARD reporting guidelines)	1967
提唱者	Evolved from STARD initiative (Bossuyt et al.) and pragmatic trial framework (Schwartz & Lellouch, 1967)	Daniel Schwartz & Joseph Lellouch
種類	Observational diagnostic study design	Interventional study 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.	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.
別名	real-world diagnostic accuracy study, pragmatic DAS, routine-care diagnostic study, pragmatic test evaluation	pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial
関連	6	6
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 pragmatic randomized clinical trial (pragmatic RCT) is an interventional study that tests whether a treatment works under routine clinical conditions, as opposed to the tightly controlled setting of an explanatory trial. It prioritizes broad eligibility, flexible delivery, and patient-relevant outcomes to answer the question 'Does this treatment work in everyday practice?' rather than 'Can this treatment work under ideal circumstances?' The distinction between pragmatic and explanatory trials was formally articulated by Schwartz and Lellouch in 1967 and operationalized by the PRECIS tool in 2009.