方法对比

	簇随机试验	Pragmatic Clinical Trial
领域	临床研究	临床研究
方法族	Process / pipeline	Process / pipeline
起源年份	1999-2000	2009-2015
提出者	Campbell, Grimshaw, Elbourne et al.	Thorpe et al. (2009); PRECIS framework developed by international consortia
类型	Research Design	Research Design
开创性文献	Campbell, M. K., Grimshaw, J. M., & Elbourne, D. R. (2000). Intracluster correlation coefficients in cluster randomized trials: empirical insights into how should they be reported. BMC Medical Research Methodology, 4, 30.	Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Tugwell, P. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ, 180(10), E47–E57.
别名	CRT, cluster RCT, cluster trial, group randomization	pragmatic trial, real-world trial, effectiveness trial, PRECIS-2
相关	3	4
摘要	A cluster randomized trial (CRT) randomizes intact groups—schools, clinics, villages, or hospital wards—rather than individuals. Developed by Campbell, Grimshaw, and colleagues in the late 1990s to address real-world settings where intervention delivery or contamination occurs at the group level, CRTs are now standard for evaluating population-level, community-based, and policy interventions.	A pragmatic trial is designed to evaluate the real-world effectiveness of an intervention in typical clinical settings with diverse, representative patients, minimal exclusion criteria, and clinically relevant outcomes. Developed by Thorpe and colleagues (2009) and formalized via the PRECIS-2 framework (2015), pragmatic trials bridge the gap between explanatory efficacy trials (conducted in controlled research settings) and implementation science, answering the question 'Does this work in actual clinical practice?' rather than 'Can this work under ideal conditions?'