Japanese Journal of Behavior Therapy
Online ISSN : 2424-2594
Print ISSN : 0910-6529
Improving Protocol Design of Clinical Trials of Nonpharmacological Treatments(<Special Issue>International Reporting Guidelines in Japanese in Journal of Behavior Therapy)
Yasuyuki OKUMURA
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2014 Volume 40 Issue 3 Pages 155-165

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Abstract

In articles on the Japanese Journal of Behavior Therapy, the reporting quality of research methods and results is often insufficient, even though researchers are responsible for the completeness and accuracy of their reports. This issue can be resolved through the use of reporting guidelines such as the CONSORT (Consolidated Standards of Reporting Trials) statement, which can also help researchers design study protocols better. The present paper attempts to enhance understanding of CONSORT recommendations, in order to improve the content of clinical trial protocols of nonpharmacological treatments. It focuses on 5 critical CONSORT requirements (i.e., trial registration, primary outcome, harms, precise details of interventions, and sample size calculations), and provide a detailed explanation as well as several examples from published papers for each.

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© 2014 Japanese Association of Behavioral and Cognitive Therapies
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