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Evaluation of Treatment in Occupational Therapy. Part 1. Methodology Issues in Conducting Clinical Trials

The purpose of this paper is to discuss important methodological issues that must be considered in planning and implementing clinical evaluation research in occupational therapy. The experiences of the authors in conducting a multi-centre intervention trial are used to illustrate issues and decisions which can both enhance the scientific integrity of clinical research while maint a ining its feasibility. Methodological issues include choice of research design, identification of significant confounding variables, subject selection and enrollment, incidence-prevalence bias, selection of appropriate and responsive outcome measures, maintenance of treatment consistency and compliance, and “masked” evaluation of outcomes. Attention to these issues will increase the methodological quality of occupational therapy evaluation research and improve the credibility of its results.