Randomised controlled trials of group interventions with an individual level comparator: are appropriate statistical methods being used?
نویسندگان
چکیده
Results A total of 738 protocols were published in Trials in 2013/ 2014 and 37 (5%) were included in the review. Group interventions included psychological therapies, lifestyle interventions, parenting programmes and exercise interventions. Sample sizes ranged from 35 to 796, median 112 and all used a 1:1 allocation ratio. Eight trials (22%, 95% CI 9% to 38%) recognised the potential for differential clustering between treatment arms. Three trials inflated the sample size of the trial, three trials planned to account for the differential clustering between the groups in the primary analysis and three trials planned to explore the effect of differential clustering in a planned sensitivity analysis.
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