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Principles and strategies for monitoring data collection integrity in a multi-site randomized clinical trial of a behavioral intervention

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  • This study was supported by the National Institutes of Health, National Institute of Nursing Research R01NR008583, and the National Cancer Institute U10 CA098543 and U10 CA095861. Additional support was provided by the first author's Individual National Research Service Award from the National Institute of Nursing Research F31NR009733-01A1.

  • Part of this paper was presented at the American Psychosocial Oncology Society (APOS) 5th Annual Conference, Irvine, CA. February 2008.

Abstract

Although treatment fidelity strategies for enhancing the integrity of behavioral interventions have been well described, little has been written about monitoring data collection integrity. This article describes the principles and strategies developed to monitor data collection integrity of the “Stories and Music for Adolescent/Young Adult Resilience During Transplant” study (R01NR008583, U10CA098543, and U10CA095861)—a multi-site Children's Oncology Group randomized clinical trial of a music therapy intervention for adolescents and young adults undergoing stem cell transplant. The principles and strategies outlined in this article provide one model for development and evaluation of a data collection integrity monitoring plan for behavioral interventions that may be adapted by investigators and may be useful to funding agencies and grant application reviewers in evaluating proposals. © 2011 Wiley Periodicals, Inc. Res Nurs Health 34:362–371, 2011

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