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研究在现场医疗护理:克服成功的障碍。

Research in Prehospital Care: Overcoming the Barriers to Success.

出版信息

Prehosp Emerg Care. 2016 Jul-Aug;20(4):448-53. doi: 10.3109/10903127.2014.980480. Epub 2015 May 18.

Abstract

OBJECTIVE

The objective of this project was to determine how investigators conduct clinical trials in the prehospital setting and to suggest how emergency medical services (EMS) systems can develop the capacity to conduct prehospital clinical research.

METHODS

A representative sample of U.S.-based study sites was selected from all studies registered on clinicaltrials.gov since the year 2000, where prehospital care providers conducted study-related activities in the prehospital setting. The site principal investigator and the research coordinator or EMS liaison were invited to participate in a structured discussion. A single interviewer conducted each discussion following a structured guide that generically asked for barriers and enablers to the sites' research success and then reviewed commonly identified prehospital research barriers. Notes were taken during each discussion and reviewed for common themes. Themes were reviewed by the project team and sent for comment to all participants.

RESULTS

Discussions were held with 25 principal investigators, 9 coordinators, and 7 EMS liaisons. A total of 27 communities were represented in the discussions from 22 different states. The communities had a range of research experience from one prehospital trial to multiple trials. Key barriers were funding, ethics approval, data collection, protocol training and compliance, randomizing and blinding interventions, obtaining patient outcomes, adequate study staffing, and partnering with EMS agencies.

CONCLUSION

This project identified many challenges to EMS research, but they were not insurmountable. Not every community can conduct every prehospital study. Communities should engage in studies that align with their values and resources. Investigators need to develop honest relationships where issues can be openly discussed and the community can collaborate on prehospital research. Learning from those who have overcome challenges may be a key to expanding the quality and quantity of EMS research.

摘要

目的

本项目旨在确定研究人员如何在院前环境中开展临床试验,并提出急救医疗服务(EMS)系统如何发展能力以开展院前临床研究。

方法

从 2000 年以来在 clinicaltrials.gov 上注册的所有研究中,选择了一个具有代表性的美国研究地点样本,其中院前护理提供者在院前环境中开展与研究相关的活动。邀请现场主要调查员和研究协调员或 EMS 联络人参加结构化讨论。一位访谈员按照通用的问题进行每次讨论,这些问题询问了站点研究成功的障碍和促进因素,然后审查了常见的院前研究障碍。每次讨论都记录了笔记,并审查了常见的主题。主题由项目团队审查,并发送给所有参与者征求意见。

结果

与 25 名主要调查员、9 名协调员和 7 名 EMS 联络人进行了讨论。来自 22 个不同州的 27 个社区参加了讨论。这些社区的研究经验从一项院前试验到多项试验不等。关键障碍是资金、伦理批准、数据收集、方案培训和合规性、随机和盲法干预、获得患者结果、足够的研究人员配备以及与 EMS 机构合作。

结论

本项目确定了 EMS 研究面临的许多挑战,但并非不可逾越。并非每个社区都可以进行每一项院前研究。社区应参与与其价值观和资源相一致的研究。研究人员需要建立坦诚的关系,在这种关系中可以公开讨论问题,社区可以合作开展院前研究。从克服挑战的人那里学习可能是扩大 EMS 研究质量和数量的关键。

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