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Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An

Caleb E Ward1, Kathleen M Adelgais2, Maija Holsti3

  • 1George Washington University School of Medicine and Health Sciences, Children's National Hospital, Washington, DC, USA.

Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine
|March 7, 2024
PubMed

Insights

Most people support the Pediatric Dose Optimization for Seizures in EMS (PediDOSE) trial, including enrolling children without prior consent. However, support varied by race and healthcare profession.

Area of Science:

  • Emergency Medicine
  • Pediatric Care
  • Clinical Trials

Background:

  • Federal regulations permit exception from informed consent (EFIC) for emergency research when prospective consent is not feasible.
  • Public opinion on including children in EFIC studies is not well understood.
  • The PediDOSE trial investigates standardized midazolam dosing for pediatric seizures in emergency settings.

Purpose of the Study:

  • To determine public support for and concerns regarding the PediDOSE EFIC trial.
  • To assess demographic variations in public support for the PediDOSE trial.

Main Methods:

  • A mixed-methods study was conducted across 20 U.S. communities.
  • Participants reviewed study information before completing an online survey.
  • Logistic regression analysis identified factors associated with support, and qualitative analysis explored concerns.

Main Results:

  • 96% of 2450 respondents supported the PediDOSE trial, with 70% approving enrollment without prior consent.
  • Support was lower among non-Hispanic Black respondents compared to non-Hispanic White respondents (aOR 0.57).
  • Healthcare providers, particularly prehospital emergency medicine clinicians, showed higher support (aOR 5.82).

Conclusions:

  • The PediDOSE trial with EFIC has broad public support, including for enrolling children without prior consent.
  • Support varied significantly by race and healthcare profession.
  • Further research is needed to address concerns of specific racial and ethnic groups in EFIC trials.
Abstract

Keywords:
emergency medical services, pediatricsinformed consentresearch ethicsseizures

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