Improving the delivery and organisation of mental health services: beyond the conventional randomised controlled trial

Background There is an ethical imperative to evaluate service and policy initiatives, such as those highlighted in the recent National Service Framework, just as there is to evaluate individual treatments. Aims To outline the best methods available for evaluating the delivery and organisation of mental health services. Method We present a narrative methodological overview, using salient examples from mental health services research. Results Cluster randomised studies involve the random allocation of groups of clinicians, clinical teams or hospitals rather than individual patients, and produce the least biased evaluation of mental health policy, organisation or service delivery, Where randomisation is impossible or impractical (often when services or policies are already implemented), then quasi-experimental designs can be used. Such designs have both strengths and many potential flaws. Conclusions The gold standard remains the randomised trial, but with due consideration to the unit of randomisation. Use of quasi-experimental designs can be justified in certain circumstances but should be attempted and interpreted with caution. Declaration of interest S.G. is supported by the Medical Research Council Health Services Research Fellowship Programme.