title: Principles and strategies for monitoring data collection integrity in a multi-site randomized clinical trial of a behavioral intervention.
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.
authors.affiliation: University of Kentucky, 315 College of Nursing Building, 760 Rose Street, Lexington, KY 40536, USA.
authors.forename: Celeste R
authors.initials: CR
authors.lastname: Phillips-Salimi
authors.forename: Molly A
authors.initials: MA
authors.lastname: Donovan Stickler
authors.forename: Kristin
authors.initials: K
authors.lastname: Stegenga
authors.forename: Melissa
authors.initials: M
authors.lastname: Lee
authors.forename: Joan E
authors.initials: JE
authors.lastname: Haase
mesh_terms: D035841:Behavioral Research / Q000379:methods* / Q000458:organization & administration / Q000592:standards; D003142:Communication; D003625:Data Collection; D006801:Humans; D008370:Manuals as Topic / Q000592:standards; D015337:Multicenter Studies as Topic / Q000379:methods* / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards