方法对比

	Pragmatic Clinical Trial	簇随机试验
领域	临床研究	临床研究
方法族	Process / pipeline	Process / pipeline
起源年份	2009-2015	1999-2000
提出者	Thorpe et al. (2009); PRECIS framework developed by international consortia	Campbell, Grimshaw, Elbourne et al.
类型	Research Design	Research Design
开创性文献	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.	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.
别名	pragmatic trial, real-world trial, effectiveness trial, PRECIS-2	CRT, cluster RCT, cluster trial, group randomization
相关	4	3
摘要	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?'	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.