Evaluation of Treatment in Occupational Therapy: Part 2. Practical Issues in Conducting Clinical Trials

Clinically relevant and methodologically rigorous evaluation research in occupational therapy can be a challenge to implement. Attention must be given to: i) identification of a pool of study subjects, ii) strategies for recruitment of subjects, iii) monitoring the enrollment of study patients, iv) methods to maintain compliance with treatment protocols, and v) plans to deal with concurrent, non-study treatments offered to patients. This paper discusses how these practical issues affect the scientific merit of an evaluation study. Approaches to the resolution of these issues which have been found useful in conducting a multi-centre randomized control trial of upper extremity inhibitive casting and intensive neurodevelopmental therapy for children with cerebral palsy are discussed.