Individually randomized group treatment trials: a critical appraisal of frequently used design and analytic approaches.

OBJECTIVES: We reviewed published individually randomized group treatment (IRGT) trials to assess researchers' awareness of within-group correlation and determine whether appropriate design and analytic methods were used to test for treatment effectiveness. METHODS: We assessed sample size and analytic methods in IRGT trials published in 6 public health and behavioral health journals between 2002 and 2006. RESULTS: Our review included 34 articles; in 32 (94.1%) of these articles, inappropriate analytic methods were used. In only 1 article did the researchers claim that expected intraclass correlations (ICCs) were taken into account in sample size estimation; in most articles, sample size was not mentioned or ICCs were ignored in the reported calculations. CONCLUSIONS: Trials in which individuals are randomly assigned to study conditions and treatments administered in groups may induce within-group correlation, violating the assumption of independence underlying commonly used statistical methods. Methods that take expected ICCs into account should be used in reexamining past studies and planning future studies to ensure that interventions are not judged effective solely on the basis of statistical artifacts. We strongly encourage investigators to report ICCs from IRGT trials and describe study characteristics clearly to aid these efforts.