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

Catherine E Ross; Sonja Lehmann; Margaret M Hayes; Jolin B Yamin; Robert A Berg; Monica E Kleinman; Michael W Donnino; Amy M Sullivan

doi:10.1016/j.resplu.2022.100355

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

Resusc Plus. 2023 Jan 13:13:100355. doi: 10.1016/j.resplu.2022.100355. eCollection 2023 Mar.

Authors

Catherine E Ross^{1

2}, Sonja Lehmann³, Margaret M Hayes⁴, Jolin B Yamin², Robert A Berg⁵, Monica E Kleinman⁶, Michael W Donnino^{2

4}, Amy M Sullivan⁷

Affiliations

¹ Division of Medicine Critical Care, Department of Pediatrics Boston Children's Hospital and Harvard Medical School, 333 Longwood Avenue, Boston, MA 02115, USA.
² Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, 1 Deaconess Road, Boston, MA 02115, USA.
³ Emory University School of Medicine, 2015 Uppergate Dr, Atlanta, GA 30307, USA.
⁴ Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, 330 Brookline Avenue, Boston, MA 02115, USA.
⁵ Division of Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, 3401 Civic Center Boulevard, Philadelphia, PA, 19104, USA.
⁶ Division of Critical Care Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital and Harvard Medical School, 300 Longwood Avenue, Boston, MA 02115, USA.
⁷ Department of Medicine and Carl J. Shapiro Institute for Research and Education, Beth Israel Deaconess Medical Center and Harvard Medical School, 330 Brookline Avenue, Boston, MA 02115, USA.

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.

Keywords: CC, community consultation; EFIC, exception from informed consent; EPI Dose, Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial; Exception from informed consent; FDA, Food and Drug Administration; Family perspectives; PICU, pediatric intensive care unit; Pediatric ICU; Peri-arrest bolus epinephrine.

Abstract

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