方法对比

	实用诊断准确性研究	实用性随机临床试验
领域	流行病学	流行病学
方法族	Process / pipeline	Process / pipeline
起源年份	2000s–2010s (formalized alongside STARD reporting guidelines)	1967
提出者	Evolved from STARD initiative (Bossuyt et al.) and pragmatic trial framework (Schwartz & Lellouch, 1967)	Daniel Schwartz & Joseph Lellouch
类型	Observational diagnostic study design	Interventional study design
开创性文献	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.
别名	real-world diagnostic accuracy study, pragmatic DAS, routine-care diagnostic study, pragmatic test evaluation	pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial
相关	6	6
摘要	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.