BACKGROUND AND PURPOSE Subject retention into clinical trials is vital, and prehospital enrollment may be associated with higher rates of subject withdrawal than more traditional methods of enrollment. We describe rates of subject retention in a prehospital trial of acute stroke therapy. METHODS All subjects were enrolled into the NIH Field Administration of Stroke Therapy-Magnesium (FAST-MAG) phase 3 clinical trial. Paramedics screened eligible subjects and contacted the physician-investigator using a dedicated in-ambulance cellular phone. Physician-investigators obtained explicit informed consent from the subject or on-scene legally authorized representative (LAR) who reviewed and signed a consent form. Exception from informed consent (EFIC) was utilized in later stages of the study. RESULTS There were 1,700 subjects enrolled; 1,017 provided consent (60%), 662 were enrolled via LAR (39%), and 21 were enrolled via EFIC (1%). Of the 1,700 patients, 1,413 (83%) completed the 90-day visit, 265 (16%) died prior to the 90-day visit, and 22 (1.3%) withdrew from the study before completion. There were no differences in rates of withdrawal by method of study enrolment, i.e., self-consent (n = 14), 1.4%; LAR (n = 8), 1.2%; EFIC (n = 0) 0%. CONCLUSION There was a high rate of retention when subjects were enrolled into prehospital stroke research using a phone-based method to obtain explicit consent.

中文翻译：

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使用基于电话的医师-研究者驱动的注册方法进行院前卒中研究中的受试者保留。

背景和目的将受试者保留在临床试验中至关重要，院前入院可能与较传统的入院方法相比，受试者退出率更高。我们描述了急性卒中治疗的院前试验中受试者保留率。方法所有受试者均被纳入NIH卒中治疗镁现场管理（FAST-MAG）3期临床试验。医护人员筛查了合格的受试者，并使用专用的救护车内手机与医师调查员联系。医师研究人员从受试者或现场合法授权代表（LAR）那里获得了明确的知情同意，该代表审阅并签署了同意书。研究的后期阶段使用了知情同意书中的例外（EFIC）。结果共有1700名受试者入选。1，征得同意的017人（占60％），通过LAR参加的有662人（占39％），通过EFIC参加的有21人（占1％）。在1,700名患者中，有1,413名（83％）完成了为期90天的访问，其中265名（16％）在完成90天访问之前死亡，有22名（1.3％）在完成之前退出了研究。通过研究入学的退出率没有差异，即自我同意（n = 14）为1.4％；LAR（n = 8），1.2％；EFIC（n = 0）0％。结论当使用基于电话的方法获得明确同意而将受试者纳入院前卒中研究时，保留率很高。通过研究入学的退出率没有差异，即自我同意（n = 14）为1.4％；LAR（n = 8），1.2％；EFIC（n = 0）0％。结论当使用基于电话的方法获得明确同意而将受试者纳入院前卒中研究时，保留率很高。通过研究入学的退出率没有差异，即自我同意（n = 14）为1.4％；LAR（n = 8），1.2％；EFIC（n = 0）0％。结论当使用基于电话的方法获得明确同意而将受试者纳入院前卒中研究时，保留率很高。