Community consultation in the pediatric intensive care unit for an exception from informed consent Trial: A survey of patient caregivers

• Authors: Catherine E Ross, Boston Children’s Hospital and Harvard Medical School; Sonja Lehmann, Emory University; Margaret M Hayes, Beth Israel Deaconess Medical Center and Harvard Medical School; Jolin B Yamin, Beth Israel Deaconess Medical Center and Harvard Medical School; Robert A Berg, Children’s Hospital of Philadelphia; Monica E Kleinman, Boston Children’s Hospital and Harvard Medical School; Michael W Donnino, Beth Israel Deaconess Medical Center and Harvard Medical School; Amy M Sullivan, Beth Israel Deaconess Medical Center and Harvard Medical School
• Journal Title: Resuscitation Plus
• Volume: Volume 13
• Publisher: Elsevier | 2023-03-01
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1016/j.resplu.2022.100355
• Subjects: Health Sciences, Medicine and Surgery
• Keywords: Exception from informed consent; Pediatric ICU; Family perspectives; Peri-arrest bolus epinephrine

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). 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. 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. 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.