Challenges Enrolling Children Into Traumatic Brain Injury Trials: An Observational Study
Challenges Enrolling Children Into Traumatic Brain Injury Trials: An Observational Study
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DOI：
10.1111/acem.13085
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发表时间：
2017-01-01
影响因子：
4.4
通讯作者：
Kuppermann, Nathan
中科院分区：
文献类型：
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作者：
Stanley, Rachel M.;Johnson, Michael D.;Kuppermann, Nathan
目的：为准备在急诊科（EDs）治疗中重度钝性颅脑损伤（tbi）儿童的临床试验，我们进行了这项可行性研究，以(1)确定符合条件的儿童的数量和临床特征，(2)确定患者和监护人到达急诊科的时间，(3)描述tbi在计算机断层扫描（CT）上的异质性。方法我们对16例18岁儿童进行了前瞻性观察研究，这些儿童表现为钝性头部创伤，格拉斯哥昏迷评分为3-12分。我们记录了潜在符合条件的患者数量、患者和监护人到达的时间、患者人口统计学和临床特征、损伤严重程度和颅脑CT表现。结果在连续6个月的时间里，我们在16个地点招募了295名符合条件的儿童。心脏骤停和无法存活的损伤是将患者排除在未来试验之外的最常见特征。大多数儿童在受伤后2小时内到达，但大多数监护人直到受伤后2-3小时才到达。脑外伤的类型有很大的范围，其中硬膜下出血是最常见的。将中重度TBI患儿纳入时间敏感型临床试验将需要大量的试验地点和细致的准备和协调，并且考虑到患者和监护人到达的时间，获得知情同意将具有挑战性。联邦紧急研究知情同意例外将是招收这些儿童的重要考虑因素。
ObjectivesIn preparation for a clinical trial of therapeutic agents for children with moderate-to-severe blunt traumatic brain injuries (TBIs) in emergency departments (EDs), we conducted this feasibility study to (1) determine the number and clinical characteristics of eligible children, (2) determine the timing of patient andguardian arrival to the ED, and (3) describe the heterogeneity of TBIs on computed tomography (CT) scans.MethodsWe conducted a prospective observational study at 16 EDs of children 18years of age presenting with blunt head trauma and Glasgow Coma Scale scores of 3-12. We documented the number of potentially eligible patients, timing of patient and guardian arrival, patient demographics and clinical characteristics, severity of injuries, and cranial CT findings.ResultsWe enrolled 295 eligible children at the 16 sites over 6 consecutive months. Cardiac arrest and nonsurvivable injuries were the most common characteristics that would exclude patients from a future trial. Most children arrived within 2hours of injury, but most guardians did not arrive until 2-3hours after the injury. There was a substantial range in types of TBIs, with subdural hemorrhages being the most common.ConclusionEnrolling children with moderate-to-severe TBI into time-sensitive clinical trials will require large numbers of sites and meticulous preparation and coordination and will prove challenging to obtain informed consent given the timing of patient and guardian arrival. The Federal Exception from Informed Consent for Emergency Research will be an important consideration for enrolling these children.