Ross Catherine E, Lehmann Sonja, Hayes Margaret M, Yamin Jolin B, Berg Robert A, Kleinman Monica E, Donnino Michael W, Sullivan Amy M
Division of Medicine Critical Care, Department of Pediatrics Boston Children's Hospital and Harvard Medical School, 333 Longwood Avenue, Boston, MA 02115, USA.
Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, 1 Deaconess Road, Boston, MA 02115, USA.
Resusc Plus. 2023 Jan 13;13:100355. doi: 10.1016/j.resplu.2022.100355. eCollection 2023 Mar.
To explore perspectives of families in the pediatric intensive care unit (PICU) about an emergency interventional trial on peri-arrest bolus epinephrine for acute hypotension using Exception From Informed Consent (EFIC).
We performed face-to-face interviews with families whose children were hospitalized in the PICU. A research team member provided an educational presentation about the planned trial and administered a survey with open- and closed-ended items. Analyses included descriptive statistics for quantitative data and thematic analysis for qualitative data.
Sixty-seven participants contributed to 60 survey responses (53 individuals and 7 families for whom 2 family members participated). Most participants answered favorably toward the planned trial: 55/58 (95%) reported that the trial seemed "somewhat" or "very important"; 52/57 (91%) felt the use of EFIC was "somewhat" or "completely acceptable"; and 43/58 (74%) said they would be "somewhat" or "very likely" to allow their child to participate. Five themes emerged supporting participation in the planned trial: 1) trust in the clinical team; 2) familiarity with the study intervention (epinephrine); 3) study protocol being similar to standard care; 4) informed consent during an emergency was not feasible; and 5) importance of research. Barriers to potential participation included requests for additional time to decide about participating and misconceptions about study elements, especially eligibility.
Families of PICU patients generally supported plans for an emergency interventional trial using EFIC. Future inpatient EFIC studies may benefit from highlighting the themes identified here in their educational materials.
探讨儿科重症监护病房（PICU）患儿家庭对于一项关于使用知情同意豁免（EFIC）进行的围心脏骤停大剂量肾上腺素治疗急性低血压的紧急干预试验的看法。
我们对孩子在PICU住院的家庭进行了面对面访谈。一名研究团队成员就计划中的试验进行了教育讲座，并进行了一项包含开放式和封闭式问题的调查。分析包括定量数据的描述性统计和定性数据的主题分析。
67名参与者提供了60份调查问卷回复（53名个体以及7个家庭，每个家庭有2名成员参与）。大多数参与者对计划中的试验给予肯定答复：55/58（95%）报告称该试验似乎“有点”或“非常重要”；52/57（91%）认为使用EFIC“有点”或“完全可以接受”；43/58（74%）表示他们“有点”或“非常有可能”允许自己的孩子参与。出现了五个支持参与计划试验的主题：1）对临床团队的信任；2）对研究干预措施（肾上腺素）的熟悉；3）研究方案与标准治疗相似；4）紧急情况下无法获得知情同意；5）研究的重要性。潜在参与的障碍包括需要更多时间来决定是否参与以及对研究内容存在误解，尤其是关于入选标准。
PICU患者的家庭普遍支持使用EFIC进行紧急干预试验的计划。未来针对住院患者的EFIC研究可能会从在其教育材料中突出此处确定的主题中受益。
