Psychosocial and pharmacological treatment of patients following deliberate self-harm: the methodological issues involved in evaluating effectiveness.

Development of effective treatments for patients following deliberate self-harm (self-poisoning or self-injury) is a very important element in suicide prevention. The randomized controlled trial (RCT) is the mainstay of evaluation of treatments. In a systematic review of the literature, the effectiveness of treatments based on RCTs was examined and the quality of the RCTs was assessed. Twenty trials were identified, and where possible, these were grouped on the basis of similarities among the types of treatment. In this paper, we examine the methodological aspects of the trials and consider what may be learned that will assist in the design of future studies in this field. The methodological quality of the trials was reasonable, but most trials included too few participants to detect clinically important differences in rates of repeated self-harm. In planning future trials, the following major issues should be addressed: investigators should perform power calculations to determine the number of subjects necessary to detect clinically important effects, provide information on method of randomization and interventions, use standard measures of outcome, and focus on homogeneous subgroups of patients. Improving the methodology of future studies in this field will be essential if sound evidence is to be obtained which can inform effective service provision for deliberate self-harm patients.