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effect of non-compliance on estimates of cost-effectiveness considered. Of the remaining studies, one conducted an intention-to-treat analysis for the clinical outcome but appeared to omit non-compliers from the estimates of cost; one study calculated intention-to-treat estimates of effect on the clinical and the cost outcomes and an unbiased estimate of the clinical effect in compliers; and one study included non-compliers in their allocated groups for the main analysis but conducted a sensitivity analysis of cost-effectiveness with these people excluded. The fourth was a cluster-randomised trial, which presented costs and clinical effects per catchment area and costs per individual receiving the intervention. Conclusions Preliminary findings suggest that the majority of studies take an intention-to-treat approach to comparing costs between randomly allocated treatments. However, it is unclear whether the costs of allocated or of received treatment are contributing to these estimates. A minority of studies are conducting secondary per protocol analyses, with no study attempting an unbiased estimate of cost-effectiveness in compliers. How the costs of partial compliance, which may be associated with treatment success, can be incorporated into these estimates without causing bias is unclear.

Estimation of cost-effectiveness in randomised controlled trials when not all participants allocated to active intervention receive it