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美国疼痛与神经科学学会(ASPN)关于大流行或紧急情况下临床研究的最佳实践。

Best Practices from the American Society of Pain and Neuroscience (ASPN) for Clinical Research During a Pandemic or Emergency.

作者信息

Petersen Erika A, Deer Timothy R, Bojanic Stana, Sankary Lauren R, Strand Natalie H, Al Kaisy Adnan, Huygen Frank, Sayed Dawood, Steegers Monique, Verrills Paul, Schatman Michael E

机构信息

Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA.

Spine and Nerve Center of the Virginias, Charleston, WV, USA.

出版信息

J Pain Res. 2023 Feb 1;16:327-339. doi: 10.2147/JPR.S393539. eCollection 2023.

Abstract

The COVID-19 pandemic caught many areas of medicine in a state of unpreparedness for conducting research and completing ongoing projects during a global crisis, including the field of pain medicine. Waves of infection led to a disjointed ability to provide care and conduct clinical research. The American Society of Pain and Neuroscience (ASPN) Research Group has created guidance for pragmatic and ethical considerations for research during future emergency or disaster situations. This analysis uses governmental guidance, scientific best practices, and expert opinion to address procedure-based or device-based clinical trials during such times. Current literature offers limited recommendations on this important issue, and the findings of this group fill a void for protocols to improve patient safety and efficacy, especially as we anticipate the impact of future disasters and spreading global infectious diseases. We recommend local adaptations to best practices and innovations to enable continued research while respecting the stressors to the research subjects, investigator teams, health-care systems, and to local infrastructure.

摘要

新冠疫情使医学的许多领域在全球危机期间处于未做好开展研究和完成正在进行项目准备的状态,疼痛医学领域也不例外。感染浪潮导致提供护理和开展临床研究的能力脱节。美国疼痛与神经科学学会(ASPN)研究小组针对未来紧急或灾难情况下研究的务实和伦理考量制定了指南。本分析利用政府指导意见、科学最佳实践和专家意见,来解决此类时期基于程序或基于设备的临床试验问题。当前文献对此重要问题的建议有限,该小组的研究结果填补了关于改善患者安全性和疗效方案的空白,尤其是在我们预计未来灾难和全球传染病蔓延影响的情况下。我们建议根据当地情况调整最佳实践和创新方法,以便在尊重研究对象、研究团队、医疗保健系统及当地基础设施所面临压力的同时,能够继续开展研究。

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