手法を比較

	実用的なネストされた症例対照研究	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	1977 (nested case-control); pragmatic variant emerged in real-world evidence research from 1990s onwards	1967
提唱者	Duncan Thomas (nested case-control); pragmatic design concept from Schwartz & Lellouch (1967)	Daniel Schwartz & Joseph Lellouch
種類	Observational epidemiological study design	Interventional study design
原典	Thomas, D. C. (1977). Addendum to: Methods of cohort analysis: Appraisal by application to asbestos mining. Journal of the Royal Statistical Society, Series A, 140(4), 469–491.	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.
別名	real-world nested case-control, pragmatic NCC, nested case-control in routine data, real-world evidence nested case-control	pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial
関連	5	6
概要	A pragmatic nested case-control study embeds a case-control analysis within a pre-existing real-world cohort — typically drawn from electronic health records, administrative claims, or disease registries — to examine associations between exposures and outcomes under routine clinical conditions. Controls are sampled from the risk set (those still at risk at the time each case occurs), preserving temporal sequence while dramatically reducing data-collection costs compared with a full cohort analysis.	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.