手法を比較

	実用的対照群実験計画	クラスターランダム化比較試験
分野	実験計画法	実験計画法
系統	Process / pipeline	Process / pipeline
提唱年	1967 (seminal distinction); 2009 (PRECIS operationalization)	1978–1980s
提唱者	Schwartz & Lellouch (pragmatic vs explanatory distinction); extended by PRECIS framework (Thorpe et al.)	Cornfield (1978); systematised by Donner and colleagues (1980s)
種類	Experimental design (pragmatic variant)	Experimental design
原典	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
別名	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
関連	6	4
概要	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.