Trials assessing parmacotherapeutic management of aggression in psychiatric patients: comparability with clinical practice.

INTRODUCTION In a previous review of randomized controlled trials (RCTs) on the pharmacotherapeutic management of aggression, it was shown that there is only weak evidence of effectiveness. In the present study we aim to determine comparability of patients included in these RCTs and patients of psychiatric long-stay wards. METHODS Exclusion criteria that were used in at least 20% of the RCTs were applied to a sample of aggressive inpatients from clinical practice, in order to find what proportion of these patients would be eligible to participate in the reviewed, high quality RCTs. RESULTS Only 30% of aggressive psychiatric patients as seen in clinical practice would be eligible to participate in a typical randomized controlled trial based on the most frequently applied exclusion criteria. DISCUSSION The low comparability of patients included in RCTs with those seen in clinical practice may decrease the generalizability of the findings form RCTs to clinical practice.