方法对比

	实用病例系列研究	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	Pragmatic framing formalized 1967; case series practice predates 20th century	1967
提出者	Pragmatic framework: Schwartz & Lellouch (1967); case series design: longstanding clinical tradition	Daniel Schwartz & Joseph Lellouch
类型	Observational descriptive study	Interventional study design
开创性文献	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.
别名	real-world case series, pragmatic observational case series, practice-based case series	pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial
相关	5	6
摘要	A pragmatic case series is an observational study that documents consecutive or purposively selected patients receiving a clinical intervention or presenting with a condition under routine, real-world practice conditions — without randomization, a control group, or the highly controlled eligibility criteria characteristic of explanatory trials. It is used to describe treatment patterns, outcomes, and adverse events as they occur in everyday clinical settings.	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.