Manish I. Shah

Trauma is the leading cause of death among children in the United States, and many hemorrhage-related deaths occur within hours of injury (1,2). The 2023 Pediatric Trauma Hemorrhagic Shock Consensu...

INTRODUCTIONHemorrhagic shock remains a leading cause of early trauma-related mortality in children, accounting for nearly 8% of pediatric trauma-related deaths (1-4). Children with hemorrhagic sho...

Providing high quality, evidence-based clinical care in the prehospital setting and establishing efficient and highly reliable prehospital systems of care has been identified as a priority for elev...

INTRODUCTIONConducting impactful research on time-critical illnesses requires standard human subjects’ protection review and occasionally a waiver of informed consent. In 1996, the United States (U...

Background: Federal Exception from Informed Consent (EFIC) regulations allow emergency care research without a priori consent under limited conditions by integrating feedback from community consultation and notification of communities through public disclosure (CC/PD) activities (21 CFR 50.24). Our objectives were to evaluate community acceptance of a pediatric emergency care trial using a commercial survey tool and to determine the characteristics associated with supportive respondents. Methods: The Pediatric Prehospital Airway Resuscitation Trial (Pedi‐PART) is an EFIC trial designed to compare pediatric prehospital airway management strategies. Pedi‐PART conducted community consultation/public disclosure (CC/PD) activities in March–April 2024. The CC/PD process used a commercial marketing research platform (Qualtrics Inc.) to provide study information and solicit feedback via an 18‐question survey. Participants indicated support for the study through three specific questions and provided demographic characteristics. We determined the predictors of trial approval among survey respondents. Results: A total of 6753 individuals completed surveys. The median age was 42 (IQR: 30–59) years, 62% were female, 13% were Black, and 15% were Hispanic. Survey respondents indicated support for conducting Pedi‐PART in their community as follows: 90% of males, 91% of females, 89% of Blacks, 92% of Hispanics, 92% of Whites, 90% of other race/ethnicities, and 93% of parents of a child < 18 years. Among respondents with less than a high school education, 84% approved of the study compared to 93% in those with a post‐graduate degree. Among those with an annual household income < $20,000, 85% approved of the study compared to 94% of those with an > $100,000 annual household income. In multivariable analysis, higher education and being the parent/guardian of a minor child were associated with support of the trial. Conclusions: Survey respondents largely supported the Pedi‐PART trial. Respondents who were parents or who had higher education were more likely to support the trial.

Background: Seizures are one of the most common reasons for emergency medical services (EMS) activation for children, and current EMS practice results in underdosing and delayed delivery of anti-seizure medication. A prehospital evidence-based guideline recommends using intranasal or intramuscular midazolam as first-line treatment for pediatric seizures. Despite attempts to implement these guidelines, one-third of children having a paramedic-witnessed seizure have ongoing seizures on emergency department (ED) arrival; this may be due to inadequate or delayed midazolam dosing. Replacing the error-prone, sequential calculations with age-based midazolam dosing may be simpler, faster, and more effective without compromising safety. The objective of this manuscript is to describe the methodology of the Pediatric Dose Optimization for Seizures in EMS (PediDOSE) study, a clinical trial designed to compare the effectiveness and safety of an EMS protocol with four age-based categories for midazolam dosing relative to the current weight-based dosing. Methods: We are conducting a large EMS-based stepped wedge trial in the Pediatric Emergency Care Applied Research Network (PECARN) by implementing midazolam dosing based on four age categories in seizure protocols in EMS systems in 20 cities. We believe that this implementation will stop more seizures before ED arrival without increasing respiratory failure rates. The primary aim of this study is to compare the effectiveness of age-based EMS midazolam dosing compared to the current weight-based dosing on seizure cessation upon ED arrival. The secondary aim is to determine the frequency of respiratory failure in children after the implementation of EMS midazolam dosing based on these age categories. Conclusion: If this study demonstrates that an EMS patient care protocol with age-based midazolam dosing is safe and more effective than current practice, the potential impact of this study is a paradigm shift in the treatment of pediatric seizures that can be easily implemented in EMS systems across the country. Beyond seizures, the concept of age-based dosing may also be applicable to other commonly encountered pediatric prehospital conditions for which medication may be indicated.

Background: Community consultation (CC) is crucial for exception from informed consent (EFIC) trials. Digital marketing platforms offer a novel and efficient way to gather community input through surveys. This study aimed to determine if the demographics of digital CC survey respondents align with those of their targeted communities. Methods: We deployed an EFIC CC digital survey for Pedi‐PART, a multicenter study on paramedic airway management in critically ill children. A seven‐item survey, developed to gauge community perspectives on emergency care research and the trial, was disseminated through a digital marketing platform (Qualtrics Inc.). The survey targeted adults aged 18–65 residing within the geographic service areas of 10 participating EMS agencies. We determined community demographic data from the 2022 American Community Survey (ACS) for the dominant county in each service area. We compared survey respondent demographics (age, sex, race, ethnicity, household income, education) with those of the corresponding communities. Results: We received 6630 completed surveys (528 to 913 per community). The proportion of individuals over 35 years old was similar between survey and community populations (67.1% vs. 66.5%). Survey respondents were more likely to be female (60.0% vs. 50.9%) and report household incomes < $100,000 (77.5% vs. 60.2%). Survey respondents were less likely to be Black, American Indian, Pacific Islander, or other race (33.9% vs. 52.1%), Hispanic ethnicity (15.3% vs. 34.9%), or have at least a high school education (23.2% vs. 34.9%). Demographic differences between survey respondents and communities varied across the 10 communities. Conclusions: Demographic differences may exist between digital survey respondents and their targeted communities. Study teams should account for these factors when utilizing such platforms for EFIC CC.