Enhancing adherence in randomized controlled clinical trials

This paper identifies individual and systematic primary, secondary, and ter tiary prevention approaches that can be used to enhance adherence in random ized controlled trials. Specifically, strategies such as these are discusse d: careful screening during enrollment, use of a run-in period, fully infor ming participants of the study burden, explaining randomization, determinin g the participant's prior history with treatment interventions, establishin g and using a tracking system, clearly specifying adherence measures, and s taff training in communication and negotiation. These strategies have been gathered over time from our experiences working in multiple randomized cont rolled trials. Research on factors that promote or detract from adherence s hould be a standard part of randomized controlled trials. Control Clin Tria ls 2000;21:226S-232S (C) Elsevier Science Inc. 2000.