Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial.
Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial.
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DOI：
10.1161/strokeaha.115.011687
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发表时间：
2016-01
期刊：
影响因子：
8.3
通讯作者：
Field Administration of Stroke Therapy–Magnesium (FAST-MAG) Trial Nurse-Coordinators and Investigators
中科院分区：
文献类型：
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作者：
Kim DH;Saver JL;Starkman S;Liebeskind DS;Ali LK;Restrepo L;Kim-Tenser M;Valdes-Sueiras M;Eckstein M;Pratt F;Stratton S;Hamilton S;Conwit R;Sanossian N;Field Administration of Stroke Therapy–Magnesium (FAST-MAG) Trial Nurse-Coordinators and Investigators
院前卒中试验的入选率和筛选失败的原因尚未得到很好的描述。卒中治疗现场管理-镁（FAST-MAG）试验使用两阶段筛选过程确定了入组患者-护理人员亲自参加，然后通过手机进行医生调查。前瞻性记录从护理人员到入组医生-研究者的连续筛查电话的结果。从2005年到2012年，护理人员给医生调查人员打了4,458个电话，平均每辆车每135.7天打一个电话。共有1 700个（38.1%）电话导致登记。拟卒中患者的入组率为3.9%。在未入组的2，758名患者中，记录了3，140个筛选失败的原因。未入组的最常见原因是：距离最后一次已知健康超过2小时（17.2%），存在导致残疾的卒中前疾病（16.1%），以及缺乏知情同意提供者（9.5%）。针对院前环境的电话知情同意的新障碍并不常见，但包括：手机连接困难（3.2%）、患者听力困难（1.4%）、完成知情同意的时间不足（1.3%）或严重构音障碍（1.3%）。在这个大型的多中心院前试验中，从现场到医生研究者的每一个电话中，有近40%导致了试验入组。未入组的最常见原因是末次已知良好时间超出窗口、卒中前混杂医学状况和缺乏知情同意提供者。http://www.clinicaltrials.gov唯一标识符：NCT 00059332。完成院前电话知情同意的障碍
The enrollment yield and reasons for screen failure in prehospital stroke trials have not been well delineated. The Field Administration of Stroke Therapy – Magnesium (FAST-MAG) trial identified patients for enrollment using a two stage screening process - paramedics in person followed by physician-investigators by cellphone. Outcomes of consecutive screening calls from paramedics to enrolling physician-investigators were prospectively recorded. From 2005 to 2012, 4,458 phone calls were made by paramedics to physician-investigators, an average of one call per vehicle every 135.7 days. A total of 1,700 (38.1%) calls resulted in enrollments. The rate of enrollment of stroke mimics was 3.9%. Among the 2,758 patients not enrolled, 3,140 reasons for screen failure were documented. The most common reasons for non-enrollment were: more than 2 hours from last known well (17.2%), having a prestroke condition causing disability (16.1%), and absence of a consent provider (9.5%). Novel barriers for phone informed consent specific to the prehospital setting were infrequent, but included: cellphone connection difficulties (3.2%), patient being hard of hearing (1.4%), insufficient time to complete consent (1.3%) or severely dysarthric (1.3%). In this large, multicenter prehospital trial, nearly 40% of every calls from the field to physician-investigators resulted in trial enrollments. The most common reasons for non-enrollment were out of window last known well time, prestroke confounding medical condition, and absence of a consent provider. http://www.clinicaltrials.gov. Unique identifier: NCT00059332. Barrier to completion of prehospital phone informed consent