Developing a protocol for a randomised controlled trial: factors to consider

Randomised controlled trial (RCT) research designs are generally considered to be the most rigorous way of determining whether a cause and effect relationship exists between an intervention/treatment and outcome, and for assessing the effectiveness, including cost- effectiveness, of an intervention or treatment ( 1 ). Studies employing such designs play an important role in nursing, as in all aspects of healthcare, because of the need to establish the evidence base for practice and to be able to predict the likely consequences of certain events and interventions under given conditions. This is important not only with respect to patient care but also to inform policy, planning and allocation of resources( 2 ).