方法对比

	实用性对照组实验设计	整群随机对照试验
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)	1978–1980s
提出者	Schwartz & Lellouch (pragmatic vs explanatory distinction); extended by PRECIS framework (Thorpe et al.)	Cornfield (1978); systematised by Donner and colleagues (1980s)
类型	Experimental design (pragmatic variant)	Experimental 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.	Donner, A., & Klar, N. (2000). Design and Analysis of Cluster Randomization Trials in Health Research. Arnold. ISBN: 978-0340652978
别名	pragmatic controlled trial, effectiveness trial with control group, real-world control group design, pragmatic comparative design	cluster RCT, group-randomized trial, community randomized trial, cluster-randomized experiment
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 cluster randomized controlled trial (cluster RCT) is an experimental design in which intact social or organisational groups — such as schools, clinics, villages, or workplaces — are randomly assigned to treatment conditions rather than individual participants. Outcomes are still measured at the individual level, but the unit of randomization is the cluster. This design is essential when an intervention is delivered to whole groups, when there is a risk of contamination between participants in the same setting, or when individual randomization is logistically or ethically impractical.