Because of their multifaceted nature

31 Social Science Research Unit, Institute of Education, University of London, London WC1H ONR2 Public and Environmental Health Research Unit, London School of Hygiene and Tropical Medicine, London WC1E 7HT3 Centre for Sexual Health and HIV Research, London WC1E 6AUCorrespondence to: A OakleyAccepted 14 October 2005Most randomised controlled trials focus on outcomes, not on the processes involved in implementing an intervention. Using an example from school based health promotion, this paper argues that including a process evaluation would improve the science of many randomised controlled trials”Complex interventions” are health service interventions that are not drugs or surgical procedures, but have many potential “active ingredients.”1 A complex intervention combines different components in a whole that is more than the sum of its parts.2 Randomised controlled trials (RCTs) are the most rigorous way to evaluate the effectiveness of interventions, regardless of their complexity. Because of their multifaceted nature and dependence on social context, complex interventions pose methodological challenges, and require adaptations to the standard design of such trials.3 This paper outlines a framework for using process evaluation as an integral element of RCTs.

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