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Am J Occup Ther. 2013 Mar-Apr;67(2):146-53. doi: 10.5014/ajot.2013.006213.

Protocol development, treatment fidelity, adherence to treatment, and quality control.

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Division of Occupational Therapy, School of Health and Rehabilitation Sciences, Ohio State University Medical Center, Columbus, OH 43210, USA.


Occupational therapy leaders have emphasized the importance of intervention effectiveness research. The CONSORT and TREND checklists have been suggested as useful tools for reporting the results of randomized and nonrandomized studies, respectively. Despite such recommendations, research protocols and reports continue to underutilize the available tools, a situation reflecting limited resources for and experience with the conduct of effectiveness research. To address this issue, and using the CONSORT statement to structure the analysis, this article discusses strategies for optimization of protocol development, treatment fidelity, adherence to treatment, and quality control. We recommend several approaches to increase the quality of research throughout these various processes. Examples of implementation from our laboratory provide evidence of the utility of these strategies.

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