在常规临床实践中患者报告的结果措施:机构审查委员会实践指南
Justin M Bachmann1, Molly A Shiflet2, Julia R Palacios3
1Assistant professor of medicine and biomedical informatics and medical director for patient-reported outcomes measurement at Vanderbilt University Medical Center. He is also a staff physician and research scientist at the Veterans Affairs Tennessee Valley Healthcare System.
Ethics & human research
|June 30, 2024
概括
患者报告的结果措施 (PROMs) 有助于临床护理,研究和质量改善. 这一框架有助于机构审查委员会 (IRB) 区分PROM的使用,确定对患者数据的必要监督.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 临床信息学 临床信息学
- 生物伦理学生物伦理学
背景情况:
- 患者报告的结果测量 (PROM) 越来越多地成为常规临床实践的组成部分.
- PROMs量化患者的症状和健康状况,使医疗保健与以患者为中心的结果保持一致.
- PROM数据的各种应用包括临床护理,研究和质量改进计划.
研究的目的:
- 为分类PROM用例提供一个框架:临床护理,人类受试者研究和质量改进.
- 为机构审查委员会 (IRB) 确定不同PROM应用程序的适当监督水平提供指导.
- 澄清PROM使用何时构成临床护理与人类受试者研究.
主要方法:
- 开发用于PROM数据使用的分类框架.
- 对临床护理PROM区分特征的分析 (数据平台,调查位置,长度,接口).
- 讨论IRB对临床收集的PROM数据的二次使用的监督.
主要成果:
- 区分PROMs的初级临床护理使用与人类受试者的研究对于IRB审查至关重要.
- 特定的PROM实施特征可以表明初级临床护理使用.
- 提出了一个框架,以指导IRB对PROM数据的决定,包括次要用途.
结论:
- 拟议的框架为IRB工作人员和使用PROM的临床医生提供了实际指导.
- 清晰的PROM用例分类简化了IRB监管,并促进了适当的数据使用.
- 了解PROM应用环境是导航监管要求和道德考虑的关键.
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