Sample size calculations in pediatric clinical trials conducted in an ICU: a systematic review.

ABSTRACT: At the design stage of a clinical trial, several assumptions have to be made. These usually include guesses about parameters that are not of direct interest but must be accounted for in the analysis of the treatment effect and also in the sample size calculation (nuisance parameters, e.g. the standard deviation or the control group event rate). We conducted a systematic review to investigate the impact of misspecification of nuisance parameters in pediatric randomized controlled trials conducted in intensive care units. We searched MEDLINE through PubMed. We included all publications concerning two-arm RCTs where efficacy assessment was the main objective. We included trials with pharmacological interventions. Only trials with a dichotomous or a continuous outcome were included. This led t

SUBMITTER: Nikolakopoulos S 

PROVIDER: S-EPMC4107993 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature