Development, refinement, and testing of occupational therapy interventions require a systematic approach. The authors explain the four phases for clinical trials used in pharmaceutical research and apply them to the development and testing of occupational therapy interventions. The challenges faced by occupational therapy researchers in designing clinical trials include difficulties in specifying the intervention, blinding subjects, therapists, and evaluators, and identifying objective but client-centered measures of primary outcomes. Examples are provided of researchers who have developed and tested occupational therapy interventions in phases.
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