Estimating psychological treatment effects froma randomised controlled trial with both non-compliance and loss to follow-up

Abstract

Background The Outcomes of Depression International Network (ODIN) trial evaluated the effect oftwo psychological interventions for the treatment of depression in primary care. Only about halfofthe patients in the treatment arm complied with the offer of treatment, prompting the question: 'What was the effect of treatment in those patients who actually received it?' Aims To illustrate the estimation ofthe effect of receipt of treatment in a randomised controlled trial subject to non-compliance and loss to follow-up. Method We estimated the complier average causal effect (CACE) of treatment. Results In the ODIN trial the effect of receipt of psychological intervention (an average of about 4 points on the Beck Depression Inventory) is abouttwicethat of offering it. Conclusions The statistical analysis of the results of a clinical trial subject to noncompliance to allocated treatment is now reasonably straightforward through estimation of a CACE and investigators should be encouraged to present the results of analyses of this type as a routine component of a trial report. Declaration of interest None. Funding detailed in Acknowledgements. Paper accepted when GW was Editor of the Journal.