方法对比

	实用性对照组实验设计	实用性随机对照试验
领域	实验设计	实验设计
方法族	Process / pipeline	Process / pipeline
起源年份	1967 (seminal distinction); 2009 (PRECIS operationalization)	1967
提出者	Schwartz & Lellouch (pragmatic vs explanatory distinction); extended by PRECIS framework (Thorpe et al.)	Daniel Schwartz and Joseph Lellouch
类型	Experimental design (pragmatic variant)	Experimental design — pragmatic trial
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	pragmatic controlled trial, effectiveness trial with control group, real-world control group design, pragmatic comparative design	pRCT, pragmatic trial, practical clinical trial, real-world RCT
相关	6	4
摘要	A pragmatic control group experimental design tests whether an intervention works under routine, real-world conditions by comparing it against a control condition — typically usual care or an active comparator — rather than a tightly controlled placebo. It prioritises external validity and applicability over the internal purity of an explanatory efficacy trial, asking whether an intervention makes a meaningful difference to people as they are actually treated in practice.	A pragmatic randomized controlled trial (pRCT) tests whether an intervention works under ordinary, real-world conditions — broad eligibility, flexible delivery, and routine care settings. Participants are still randomly assigned to treatment or control, preserving causal inference, but the study is designed to reflect the diversity and variability of actual practice rather than the ideal conditions of an explanatory trial. The defining framework is the PRECIS-2 tool, which maps any RCT along nine pragmatic-to-explanatory dimensions.