制定国家创伤研究行动计划：监管挑战德尔菲调查结果
Developing a National Trauma Research Action Plan: Results from the regulatory challenges Delphi survey.
作者信息
Price Michelle A, Villarreal Cynthia L, Moreno Ashley N, Flayter Rochelle, Herrera-Escobar Juan P, Sims Carrie A, Bulger Eileen M
机构信息
From the Coalition for National Trauma Research (M.A.P., C.L.V., A.N.M., NTRAP Regulatory Challenges Panel), San Antonio, Texas; Department of Emergency Services and Infusion Therapy (R.F.), Centura Health-St. Anthony Hospital, Lakewood, Colorado; Center for Surgery and Public Health (J.P.H.-E.), Brigham and Women's Hospital, Boston, Massachusetts; Division of Trauma, Critical Care, and Burn (C.A.S.), The Ohio State University, Columbus, Ohio; and Department of Surgery (E.M.B.), University of Washington, Seattle, Washington.
出版信息
J Trauma Acute Care Surg. 2024 Apr 1;96(4):658-665. doi: 10.1097/TA.0000000000004185. Epub 2023 Nov 30.
BACKGROUND
In 2016, the National Academies of Sciences, Engineering, and Medicine issued a report calling for a National Trauma Research Action Plan (NTRAP) requiring a resourced, coordinated, joint approach to trauma care research. The National Academies of Sciences, Engineering, and Medicine report recommended the identification of regulatory barriers to trauma research. The NTRAP Regulatory Challenges Panel of trauma researchers and regulatory professionals was convened to identify the most challenging aspects of regulatory processes involved in conducting research.
METHODS
Trauma researchers and regulatory experts were recruited to identify and rate challenging regulatory issues in 2021 to 2022. Challenge statements were developed from a comprehensive scoping review. Panelists rated the challenge level for each statement on a 9-point Likert scale. The Delphi survey was conducted over three online rounds. Consensus was defined a priori as ≥60% agreement. Results of the Delphi survey were presented to the panel during a webinar. Panel participants then participated in breakout sessions to strategize solutions, share lessons learned, and identify where more regulatory guidance is needed.
RESULTS
Thirty-eight subject matter experts rated 175 regulatory challenges, of which 141 (81%) reached the consensus threshold. Of the consensus-reaching challenge statements, 42 had a challenge rating of 6 or higher. Among the highest-rated challenges were issues pertaining to conducting prehospital research, exception from informed consent, mistrust of research among various racial and ethnic groups, and issues specific to conducting pediatric trauma research.
CONCLUSION
This Delphi survey rated challenges culled from a regulatory literature scoping review. The panel identified the most challenging aspects of human subjects protection while conducting trauma research and recommended strategies and best practices to address them. The findings from this study were used to develop the NTRAP Investigator Toolkit, which is available on the internet as a resource for trauma researchers.
LEVEL OF EVIDENCE
Prognostic and Epidemiological; Level IV.
背景
2016年，美国国家科学院、工程院和医学院发布了一份报告，呼吁制定一项国家创伤研究行动计划（NTRAP），要求采用资源充足、协调一致的联合方法开展创伤护理研究。美国国家科学院、工程院和医学院的报告建议确定创伤研究的监管障碍。为此召集了由创伤研究人员和监管专业人员组成的NTRAP监管挑战小组，以确定开展研究过程中监管程序最具挑战性的方面。
方法
招募创伤研究人员和监管专家，以识别并评估2021年至2022年期间具有挑战性的监管问题。挑战陈述是通过全面的范围审查制定的。小组成员根据9点李克特量表对每条陈述的挑战程度进行评分。德尔菲调查分三轮在线进行。事先将共识定义为达成≥60%的一致意见。德尔菲调查结果在一次网络研讨会上提交给了小组。小组参与者随后参加了分组会议，以制定解决方案策略、分享经验教训，并确定哪些方面需要更多的监管指导。
结果
38名主题专家对175项监管挑战进行了评分，其中141项（81%）达到了共识阈值。在达成共识的挑战陈述中，42项的挑战评分为6或更高。评分最高的挑战包括与院前研究相关的问题、知情同意的例外情况、不同种族和族裔群体对研究的不信任，以及开展儿科创伤研究的特定问题。
结论
这项德尔菲调查对从监管文献范围审查中挑选出的挑战进行了评分。该小组确定了开展创伤研究时在保护人类受试者方面最具挑战性的方面，并推荐了应对这些挑战的策略和最佳实践。本研究结果被用于开发NTRAP研究者工具包，该工具包可在互联网上获取，作为创伤研究人员的资源。
证据水平
预后和流行病学；四级。
Zotero 插件