方法对比

	单盲随机对照试验	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	1948 (formalized); single-blind variant established in mid-20th century clinical trial methodology	1978–1980s
提出者	Bradford Hill and colleagues (MRC streptomycin trial, 1948); blinding conventions codified in CONSORT guidelines	Cornfield (1978); systematised by Donner and colleagues (1980s)
类型	Experimental design — blinded randomized trial	Experimental design
开创性文献	Schulz, K. F., Altman, D. G., Moher, D., & CONSORT Group. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMJ, 340, c332.	Donner, A., & Klar, N. (2000). Design and Analysis of Cluster Randomization Trials in Health Research. Arnold. ISBN: 978-0340652978
别名	single-masked RCT, single-blind RCT, single-blind trial, SB-RCT	cluster RCT, group-randomized trial, community randomized trial, cluster-randomized experiment
相关	5	4
摘要	A single-blind randomized controlled trial (SB-RCT) is a rigorous experimental design in which participants are randomly assigned to treatment or control conditions while remaining unaware of which condition they have received. Investigators, outcome assessors, and data analysts are not blinded. By masking participants, the design eliminates placebo and nocebo response biases on the participant side, while preserving investigator flexibility to administer and monitor the intervention.	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.