Combining and analyzing data from heterogeneous randomized controlled trials of complex multiplecomponent intervention studies, or discussing them in a systematic review, is not straightforward. The present article describes certain issues to be considered when combining data across studies, based on discussions in an NIH-sponsored workshop on pooling issues across studies in consortia (see Belle et al. in Psychol Aging, 18(3):396-405, 2003). Several statistical methodologies are described and their advantages and limitations are explored. Whether weighting the different studies data differently, or via employing random effects, one must recognize that different pooling methodologies may yield different results. Pooling can be used for comprehensive exploratory analyses of data from RCTs and should not be viewed as replacing the standard analysis plan for each study. Pooling may help to identify intervention components that may be more effective especially for subsets of participants with certain behavioral characteristics. Pooling, when supported by statistical tests, can allow exploratory investigation of potential hypotheses and for the design of future interventions.
KeywordsStatistical pooling of studies, Random-effects metaanalysis, Study-level meta-regression, Multilevel meta-regression, Multilevel structural models INTRODUCTION Randomized controlled trials (RCTs) are considered the gold standard experimental study design for establishing the causal effect of an intervention on an outcome of interest. RCTs are usually designed to have high internal validity in addressing specific hypotheses but may have less external validity as their inclusion and exclusion criteria may be very restrictive. Often there are many similar trials addressing the same type of research hypotheses but with different target populations, settings, or outcome measures. Such trials may not evaluate exactly the same intervention, especially in trials of interventions that include combinations of multiple behavioral, social, pharmacological and/or environmental components.