ArticleAcademic emergency medicine : official journal of the Society for Academic Emergency Medicine2024
Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An exception from informed consent (EFIC) trial.
Article in Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05121324 (Pediatric Dose Optimization for Seizures in EMS), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pediatric Dose Optimization for Seizures in EMS (PediDOSE)
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Views on consent approaches used in emergency and critical care research: a rapid, systematic review.Trials · 2026Pooled it
- Digital Technologies for Community Consultation and Public Disclosure in Exception From Informed Consent Trials.Journal of the American College of Emergency Physicians open · 2026Article
- Pediatric clinical trials in emergency or intensive care settings using exception from informed consent and waiver of informed consent regulations.World journal of emergency medicine · 2026Article
- Community consultation and public disclosure for the Randomized Trial of Sedative Choice for Intubation.Trials · 2026Article
- Effective Community Consultation for Prehospital EFIC Research: Lessons from a 20-Site Pediatric Trial.Prehospital emergency care · 2026Article
- Community Acceptance of a Pediatric Prehospital Exception From Informed Consent Trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2026Article
- Methodology for the Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study.Trials · 2025Article
- Article
- Community Consultation and Public Disclosure for the Randomized Trial of Sedative Choice for Intubation.medRxiv : the preprint server for health sciences · 2025Article
- The California Resuscitation Outcomes Consortium (CAL-ROC): A novel collaboration to facilitate the implementation of randomized clinical trials in the prehospital setting.Resuscitation plus · 2025Article
- Measuring the efficacy of community consultation in a pediatric exception from informed consent trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2025Article
- Application of digital engagement tools for exception from informed consent community consultation and public disclosure in the pediatric prehospital airway resuscitation trial.Resuscitation plus · 2025Article
- Analyzing patient perspectives with large language models: a cross-sectional study of sentiment and thematic classification on exception from informed consent.Scientific reports · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundFederal regulations allow exception from informed consent (EFIC) to study emergent conditions when obtaining prospective consent is not feasible. Little is known about public views on including children in EFIC studies. The Pediatric Dose Optimization for Seizures in EMS (PediDOSE) trial implements age-based, standardized midazolam dosing for pediatric seizures. The primary objective of this study was to determine public support for and concerns about the PediDOSE EFIC trial. The secondary objective was to assess how support for PediDOSE varied by demographics.
methodsWe conducted a mixed-methods study in 20 U.S. communities. Participants reviewed information about PediDOSE before completing an online survey. Descriptive data were generated. Univariable and multivariable logistic regression analysis identified factors associated with support for PediDOSE. Reviewers identified themes from free-text response data regarding participant concerns.
resultsOf 2450 respondents, 79% were parents/guardians, and 20% had a child with previous seizures. A total of 96% of respondents supported PediDOSE being conducted, and 70% approved of children being enrolled without prior consent. Non-Hispanic Black respondents were less likely than non-Hispanic White respondents to support PediDOSE with an adjusted odds ratio (aOR) of 0.57 (95% CI 0.42-0.75). Health care providers were more likely to support PediDOSE, with strongest support among prehospital emergency medicine clinicians (aOR 5.82, 95% CI 3.19-10.62). Age, gender, parental status, and level of education were not associated with support of PediDOSE. Common concerns about PediDOSE included adverse effects, legal and ethical concerns about enrolling without consent, and potential racial bias.
conclusionsIn communities where this study will occur, most respondents supported PediDOSE being conducted with EFIC and most approved of children being enrolled without prior consent. Support was lowest among non-Hispanic Black respondents and highest among health care providers. Further research is needed to determine optimal ways to address the concerns of specific racial and ethnic groups when conducting EFIC trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.