方法对比

	Pragmatic Kaplan-Meier Analysis	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	1958 (estimator); pragmatic application formalized 1967 onward	1967
提出者	Kaplan & Meier (estimator, 1958); Schwartz & Lellouch (pragmatic trial framework, 1967)	Daniel Schwartz & Joseph Lellouch
类型	Non-parametric survival estimator within pragmatic study design	Interventional study design
开创性文献	Kaplan, E. L., & Meier, P. (1958). Nonparametric estimation from incomplete observations. Journal of the American Statistical Association, 53(282), 457–481.	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.
别名	pragmatic KM analysis, real-world Kaplan-Meier, pragmatic survival curve estimation, KM analysis in pragmatic trials	pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial
相关	5	6
摘要	Pragmatic Kaplan-Meier analysis applies the non-parametric Kaplan-Meier product-limit estimator to time-to-event data collected under real-world or pragmatic conditions — diverse populations, routine clinical care, minimal exclusions, and standard-of-care comparators. Unlike explanatory trials designed to isolate a treatment effect under ideal conditions, pragmatic designs accept real-world heterogeneity, and the resulting survival curves reflect the effectiveness of an intervention as it actually performs in clinical practice.	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.