Extending acute trials to remote populations: a pilot study during interhospital helicopter transfer.
Extending acute trials to remote populations: a pilot study during interhospital helicopter transfer.
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将急性试验扩展到偏远人群：院间直升机转运期间的试点研究。
DOI：
10.1161/strokeaha.108.530204
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发表时间：
2009
期刊：
影响因子：
8.3
通讯作者：
AIRDOCstudyInvestigators
中科院分区：
文献类型：
--
作者：
Leira,EnriqueC;Ahmed,Azeemuddin;Lamb,DianeL;Olalde,HeenaM;Callison,RCharles;Torner,JamesC;AdamsJr,HaroldP;AIRDOCstudyInvestigators
背景和目的-需要增加急性卒中试验招募的方法。本研究的目的是评估安全性和可接受性的早期直升机疏散期间启动急性中风试验，并测试干预措施，以促进知情consent.Methods-A随机，对照试验与急性中风患者谁是由直升机转移到大学的爱荷华州医院和诊所从2007年2月至2008年1月。待评价的干预措施是在直升机到达外部急诊室之前使用传真和电话联系患者/代理人。其目的是提高一项潜在有益的低风险医疗干预（雷尼替丁）预防吸入性肺炎的试点试验的后续同意率（主要结局）。符合条件的患者在飞往爱荷华州大学医院和诊所的途中接受了输注。干预组的同意率为54%，对照组为50%（P=0.69）。然而，当合作研究者和潜在受试者之间的到达前沟通成功时，同意率更高（69%）（P=0.04）。这种方法导致平均增益为59分钟相比，开始招聘抵达爱荷华州医院和Clinics. Conclusions入组中风干预试验是可行的，在直升机运输从社区医院急诊科三级中风中心。这一未充分利用的资源可能会提高试验效率，使目前被排除在研究之外的偏远人口能够参与并加快参与。同意率可能会进一步提高沟通策略，更成功地达到病人在急诊科外。
Background and Purpose—Methods to increase recruitment into acute stroke trials are needed. The purposes of this study were to evaluate the safety and acceptability of initiating acute stroke trials during early helicopter evacuation and to test an intervention to facilitate informed consent.Methods—A randomized, controlled trial was done with patients with acute stroke who were transferred by helicopter to the University of Iowa Hospitals and Clinics from February 2007 to January 2008. The intervention to be evaluated was the use of fax and a telephone call to the patient/surrogate ahead of helicopter arrival at the outside emergency department. The aim was to improve the rate of subsequent consent (primary outcome) for a pilot trial of a potentially beneficial, low-risk medical intervention (ranitidine) to prevent aspiration pneumonitis. Consenting eligible patients received the infusion during the flight to University of Iowa Hospitals and Clinics.Results—One hundred patients were enrolled. Consent rate was 54% in the intervention group and 50% in the control group (P=0.69). However, the consent rate was higher (69%) when prearrival communications between the coinvestigator and potential subjects were successful (P=0.04). This approach resulted in an average gain of 59 minutes as compared with initiating recruitment on arrival to University of Iowa Hospitals and Clinics.Conclusions—Enrollment into stroke intervention trials is feasible during helicopter transportation from a community hospital emergency department to a tertiary stroke center. This underused resource may improve trial efficiency by enabling and expediting participation of remote populations currently excluded from research. Consent rates might be further improved by communication strategies that are more successful in reaching patients at outside emergency departments.