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.
Highlights
Traumatic brain injury (TBI) is the leading cause of death and disability in trauma patients [1].In the United States in 2000 alone, an estimated 50,658 traumatic brain injuries (TBI)-associated hospitalizations occurred in children ≤17 years [2]
Our results provided the potential number of TBI cases available for clinical trials under different circumstances
Department Sample (NEDS) found pediatric TBI related emergency departments (EDs) visits in the US increased by about 30% over the past decade
Summary
The 2006–2013 Nationwide Emergency Department Sample (NEDS) is part of the Healthcare Cost and Utilization Project (HCUP) developed by the Agency for Healthcare Research and Quality (AHRQ). The NEDS is the largest all-payer ED database that is publicly available in the U.S Based on a stratified probability sample of hospital-based EDs from community, non-rehabilitation hospitals, the NEDS contains about 30 million ED visits from more than 900 hospitals that approximate a 20-percent stratified sample of U.S hospital-based EDs in 2013. The NEDS provides more than 100 clinical and non-clinical variables for each ED visit, which includes up to 15 ICD-9-CM codes. The NEDS uses a stratified and random sampling scheme. The universe of the NEDS is defined as (1) community, non-rehabilitation hospital-based EDs in the U.S that were included in American
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