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Community consultation in the pediatric intensive care unit for an exception from informed consent Trial: A survey of patient caregivers.
- Source :
-
Resuscitation plus [Resusc Plus] 2023 Jan 13; Vol. 13, pp. 100355. Date of Electronic Publication: 2023 Jan 13 (Print Publication: 2023). - Publication Year :
- 2023
-
Abstract
- Aim: 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).<br />Methods: 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.<br />Results: 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.<br />Conclusions: 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.<br /> (© 2023 The Authors.)
Details
- Language :
- English
- ISSN :
- 2666-5204
- Volume :
- 13
- Database :
- MEDLINE
- Journal :
- Resuscitation plus
- Publication Type :
- Academic Journal
- Accession number :
- 36686322
- Full Text :
- https://doi.org/10.1016/j.resplu.2022.100355