Rosell Bryant J, Shkirkova Kristina, Saver Jeffrey L, Liebeskind David S, Starkman Sidney, Kim-Tenser May, Eckstein Marc, Sharma Latisha, Conwit Robin, Hamilton Scott, Sanossian Nerses
Keck School of Medicine, Department of Neurology, University of Southern California, Los Angeles, California, USA.
Keck School of Medicine, Department of Neurology, University of Southern California, Los Angeles, California, USA,
Cerebrovasc Dis Extra. 2019;9(2):72-76. doi: 10.1159/000500851. Epub 2019 Jul 25.
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.
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.
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%.
There was a high rate of retention when subjects were enrolled into prehospital stroke research using a phone-based method to obtain explicit consent.
受试者参与临床试验的留存率至关重要，与更传统的入组方法相比，院前入组可能与更高的受试者退出率相关。我们描述了急性卒中治疗院前试验中受试者的留存率。
所有受试者均纳入美国国立卫生研究院卒中治疗镁剂现场应用（FAST-MAG）3期临床试验。护理人员筛选符合条件的受试者，并使用专用的救护车内移动电话联系医师研究者。医师研究者从受试者或现场法定授权代表（LAR）处获得明确的知情同意，后者需对同意书进行审核并签字。在研究的后期阶段采用了免知情同意（EFIC）。
共纳入1700名受试者；1017名提供了同意（60%），662名通过LAR入组（39%），21名通过EFIC入组（1%）。在这1700名患者中，1413名（83%）完成了90天随访，265名（16%）在90天随访前死亡，22名（1.3%）在研究完成前退出。按研究入组方法划分的退出率无差异，即自行同意（n = 14），1.4%；LAR（n = 8），1.2%；EFIC（n = 0），0%。
当采用基于电话的方法获得明确同意，将受试者纳入院前卒中研究时，留存率较高。
