BACKGROUND Randomised controlled trials (RCTs) are the most important method of evaluating new treatments and treatment policies. Despite this, there are relatively few large pragmatic RCTs in psychiatry.
AIMS To explore the main advantages of large pragmatic RCTs and the obstacles to performing them in psychiatry.
METHOD A narrative review of literature on pragmatic RCTs with examples drawn from psychiatry and other medical specialities.
RESULTS Obstacles to performing pragmatic RCTs in psychiatry include the complexity of psychiatric interventions, the complexity of outcomes used in psychiatry and the difficulties of blinding subjects and investigators to some psychiatric interventions.
CONCLUSIONS Researchers need to frame questions in a form that is relevant to clinicians and to convince clinicians to cooperate in simple large pragmatic trials.