手法を比較

	実用的生存時間解析 ― 実世界におけるイベント発生までの時間解析	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	Conceptual framework: 1967; widespread application: 1990s–2000s	1967
提唱者	Schwartz & Lellouch (explanatory vs. pragmatic distinction, 1967); extended in survival analysis literature from the 1970s onward	Daniel Schwartz & Joseph Lellouch
種類	Observational / experimental hybrid — time-to-event analysis in real-world or pragmatic-trial settings	Interventional study design
原典	Ford, I., & Norrie, J. (2016). Pragmatic Trials. New England Journal of Medicine, 375(5), 454–463.	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.
別名	real-world survival analysis, pragmatic time-to-event analysis, effectiveness survival analysis, PSA	pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial
関連	5	6
概要	Pragmatic survival analysis applies time-to-event statistical methods within pragmatic or real-world settings, estimating how long patients survive, remain event-free, or retain treatment benefit under conditions of routine clinical practice. Unlike explanatory survival analyses conducted under tightly controlled trial conditions, the pragmatic variant embraces the heterogeneity, treatment switching, non-adherence, and competing events that characterise real-world patient populations, prioritising external validity over internal precision.	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.