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多站点随机临床试验中行为干预数据收集完整性监测的原则和策略。

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

机构信息

University of Kentucky, 315 College of Nursing Building, 760 Rose Street, Lexington, KY 40536, USA.

出版信息

Res Nurs Health. 2011 Aug;34(4):362-71. doi: 10.1002/nur.20440. Epub 2011 May 12.

DOI:10.1002/nur.20440
PMID:21567433
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3272671/
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.

摘要

虽然已经很好地描述了用于增强行为干预完整性的治疗保真度策略,但关于监测数据收集完整性的内容却很少。本文介绍了为监测“青少年/年轻成人移植期间的故事和音乐恢复力”研究(R01NR008583、U10CA098543 和 U10CA095861)的数据收集完整性而制定的原则和策略,这是一项多中心儿童肿瘤学组的随机临床试验,研究的是针对接受干细胞移植的青少年和年轻成人的音乐治疗干预。本文中概述的原则和策略为行为干预数据收集完整性监测计划的制定和评估提供了一个模型,研究人员可以对此进行调整,并且可能对资助机构和资助申请评审人员评估提案有用。

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本文引用的文献

1
Development and use of a web-based data management system for a randomized clinical trial of adolescents and young adults.为一项针对青少年和青年成年人的随机临床试验开发并使用基于网络的数据管理系统。
Comput Inform Nurs. 2011 Jun;29(6):337-43. doi: 10.1097/NCN.0b013e3181fcbc95.
2
A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behavior research.一种用于评估治疗保真度的新工具以及对10年健康行为研究中治疗保真度的评估。
J Consult Clin Psychol. 2005 Oct;73(5):852-60. doi: 10.1037/0022-006X.73.5.852.
3
Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium.提高健康行为改变研究中的治疗保真度:美国国立卫生研究院行为改变联盟的最佳实践与建议
Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.
4
The Behavior Change Consortium: setting the stage for a new century of health behavior-change research.行为改变联盟:为健康行为改变研究的新世纪奠定基础。
Health Educ Res. 2002 Oct;17(5):500-11. doi: 10.1093/her/17.5.500.