方法对比

	单盲随机对照试验	实用性随机对照试验
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	1967
提出者	Bradford Hill and colleagues (MRC streptomycin trial, 1948); blinding conventions codified in CONSORT guidelines	Daniel Schwartz and Joseph Lellouch
类型	Experimental design — blinded randomized trial	Experimental design — pragmatic trial
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.	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.
别名	single-masked RCT, single-blind RCT, single-blind trial, SB-RCT	pRCT, pragmatic trial, practical clinical trial, real-world RCT
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 pragmatic randomized controlled trial (pRCT) tests whether an intervention works under ordinary, real-world conditions — broad eligibility, flexible delivery, and routine care settings. Participants are still randomly assigned to treatment or control, preserving causal inference, but the study is designed to reflect the diversity and variability of actual practice rather than the ideal conditions of an explanatory trial. The defining framework is the PRECIS-2 tool, which maps any RCT along nine pragmatic-to-explanatory dimensions.