Community consultation in the pediatric intensive care unit for an exception from informed consent Trial: A survey of patient caregivers.
Community consultation in the pediatric intensive care unit for an exception from informed consent Trial: A survey of patient caregivers.
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DOI：
10.1016/j.resplu.2022.100355
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发表时间：
2023-03
影响因子：
2.4
通讯作者：
Sullivan, Amy M.
中科院分区：
文献类型：
--
作者：
Ross, Catherine E.;Lehmann, Sonja;Hayes, Margaret M.;Yamin, Jolin B.;Berg, Robert A.;Kleinman, Monica E.;Donnino, Michael W.;Sullivan, Amy M.
探讨儿科重症监护病房（PICU）中家属对使用知情同意例外（EFIC）进行围术期推注肾上腺素治疗急性低血压的紧急干预试验的看法。我们对在PICU住院的孩子的家庭进行了面对面的采访。一名研究团队成员提供了有关计划试验的教育演示，并进行了开放式和封闭式项目的调查。分析包括定量数据的描述性统计和定性数据的专题分析。67名参与者提供了60份调查回复（53名个人和7个家庭，其中2名家庭成员参与）。大多数参与者对计划中的试验表示赞同：55/58（95%）报告说试验似乎“有点”或“非常重要”; 52/57（91%）认为EFIC的使用“有点”或“完全可以接受”; 43/58（74%）表示他们“有点”或“非常可能”允许他们的孩子参加。出现了五个支持参与计划试验的主题：1）信任临床团队; 2）熟悉研究干预（肾上腺素）; 3）研究方案与标准治疗相似; 4）紧急情况下的知情同意不可行; 5）研究的重要性。潜在参与的障碍包括要求额外的时间来决定参与和对研究要素的误解，特别是资格。PICU患者家属普遍支持使用EFIC进行紧急干预试验的计划。未来的住院EFIC研究可能会受益于强调这里确定的主题在他们的教育材料。
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.
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影响因子：
4.7
作者：
Kiger, Michelle E.;Varpio, Lara
通讯作者：
Varpio, Lara
影响因子：
6.5
作者：
Ross, Catherine E.;Asaro, Lisa A.;Kleinman, Monica E.
通讯作者：
Kleinman, Monica E.
影响因子：
2.4
作者：
Ross CE;Hayes MM;Kleinman ME;Donnino MW;Sullivan AM
通讯作者：
Sullivan AM
DOI：
10.1111/acem.14264
发表时间：
2021-10
期刊：
Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
影响因子：
--
作者：
Dickert NW;Metz K;Fetters MD;Haggins AN;Harney DK;Speight CD;Silbergleit R
通讯作者：
Silbergleit R
影响因子：
2.9
作者：
Woolfall, Kerry;Young, Bridget;Gamble, Carrol
通讯作者：
Gamble, Carrol