方法对比

	实用剂量-效应分析	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	1990s–2000s (formalized in pragmatic trial context)	1967
提出者	Rooted in pharmacoepidemiology and pragmatic trial methodology; PRECIS framework by Thorpe et al. (2009)	Daniel Schwartz & Joseph Lellouch
类型	Observational or experimental quantitative method	Interventional study design
开创性文献	Greenland, S., & Longnecker, M. P. (1992). Methods for trend estimation from summarized dose-response data, with applications to meta-analysis. American Journal of Epidemiology, 135(11), 1301–1309.	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.
别名	real-world dose-response analysis, pragmatic exposure-response study, dose-response in pragmatic trials, effectiveness dose-response analysis	pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial
相关	4	6
摘要	Pragmatic dose-response analysis quantifies how varying levels of an exposure or treatment relate to clinical outcomes under real-world conditions. By embedding dose-response questions within pragmatic study designs — broad eligibility criteria, routine care settings, and heterogeneous populations — it bridges the gap between controlled pharmacological dose-finding and the messy variability of everyday clinical practice. The approach is especially valued when the goal is to establish or refine optimal dosing guidance from evidence that reflects actual patient populations.	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.