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U.S. Trends of ED Visits for Pediatric Traumatic Brain Injuries: Implications for Clinical Trials
Cheng Chen1,2, Junxin Shi3,4, Rachel M Stanley5,6,7
1Center for Pediatric Trauma Research, The Research Institute at Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH 43205, USA. Cheng.Chen@nationwidechildrens.org.
Insights
Pediatric traumatic brain injuries (TBI) treated in U.S. emergency departments increased by 34.1% from 2006-2013. Future clinical trials require careful feasibility assessments due to challenges in recruiting severe pediatric TBI cases.
Area of Science:
- Neurology
- Pediatrics
- Public Health
Background:
- Traumatic brain injuries (TBI) are a significant cause of morbidity and mortality in children.
- Understanding trends in pediatric TBI is crucial for developing effective prevention and treatment strategies.
- The Nationwide Emergency Department Sample (NEDS) database provides valuable insights into emergency department utilization for pediatric TBI.
Purpose of the Study:
- To describe trends in annual patient numbers, demographics, and hospital characteristics of pediatric traumatic brain injuries (TBI) treated in U.S. emergency departments (EDs) between 2006 and 2013.
- To estimate sample sizes for potential clinical trials involving pediatric TBI cases using the NEDS database.
- To identify hospital characteristics associated with higher pediatric TBI case volumes.
Main Methods:
- Utilized the 2006-2013 Nationwide Emergency Department Sample (NEDS) database.
- Calculated national estimates of patient demographics and hospital characteristics for pediatric TBI.
- Conducted simulation analyses to assess potential sample sizes for clinical trials under various scenarios.
Main Results:
- Between 2006 and 2013, an estimated 6,089,930 pediatric TBI cases were treated in U.S. EDs.
- Pediatric TBI-related ED visits increased by 34.1% during the study period.
- Hospitals with >1000 annual TBI visits, Level I/II Trauma Centers, pediatric hospitals, and teaching hospitals are likely to yield ample cases for studies, though severe TBI recruitment may be challenging.
Conclusions:
- Pediatric TBI-related emergency department visits in the U.S. saw a significant increase from 2006 to 2013.
- Including unspecified head injuries could alter national estimates and demographic patterns.
- Future pediatric TBI clinical trials necessitate thorough feasibility assessments and sample size estimations at selected sites.
Abstract:
Our goal in this paper was to use the 2006-2013 Nationwide Emergency Department Sample (NEDS) database to describe trends of annual patient number, patient demographics and hospital characteristics of pediatric traumatic brain injuries (TBI) treated in U.S. emergency departments (EDs); and to use the same database to estimate the available sample sizes for various clinical trials of pediatric TBI cases. National estimates of patient demographics and hospital characteristics were calculated for pediatric TBI. Simulation analyses assessed the potential number of pediatric TBI cases from randomly selected hospitals for inclusion in future clinical trials under different scenarios. Between 2006 and 2013, the NEDS database estimated that of the 215,204,932 children who visited the ED, 6,089,930 (2.83%) had a TBI diagnosis. During the study period in the US EDs, pediatric TBI patients increased by 34.1%. Simulation analyses suggest that hospital EDs with annual TBI ED visits >1000, Levels I and II Trauma Centers, pediatric hospitals, and teaching hospitals will likely provide ample cases for pediatric TBI studies. However, recruiting severe pediatric TBI cases for clinical trials from a limited number of hospital EDs will be challenging due to small sample sizes. Pediatric TBI-related ED visits in the U.S. increased by over 30% from 2006 to 2013. Including unspecified head injury cases with ICD-9-CM code 959.01 would significantly change the national estimates and demographic patterns of pediatric TBI cases. Future clinical trials of children with TBI should conduct a careful feasibility assessment to estimate their sample size and study power in selected study sites.