手法を比較

	実用的症例対照研究	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	1950s–1960s (classical); pragmatic framing 1967–2000s	1967
提唱者	Evolved from classical case-control methodology (Dorn, 1954; Cornfield, 1956); pragmatic framing formalized by Schwartz & Lellouch (1967)	Daniel Schwartz & Joseph Lellouch
種類	Observational epidemiological study design	Interventional study design
原典	Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.
別名	real-world case-control study, pragmatic case-control design, effectiveness case-control study, PCCS	pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial
関連	6	6
概要	A pragmatic case-control study is an observational design that compares individuals who have developed a disease or outcome (cases) with those who have not (controls), using data collected under routine real-world conditions rather than strictly controlled experimental settings. Exposure histories are reconstructed from clinical records, registries, or administrative databases. The design is chosen when a conventional explanatory case-control study would be impractical, unethical, or too narrow to inform actual clinical or public-health decisions.	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.