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Published on: August 16, 2019
US estimates of hospitalized children with severe traumatic brain injury: implications for clinical trials
Rachel M Stanley1, Bema K Bonsu, Weiyan Zhao
1Department of Emergency Medicine, University of Michigan, Ann Arbor MI 48105, USA. stanleyr@umich.edu
Insights
Severe traumatic brain injury (TBI) in children is rare at individual hospitals. High-volume pediatric TBI centers are crucial for efficient clinical trial enrollment and effective therapy development.
Area of Science:
- Pediatric critical care medicine
- Neurology
- Clinical trial design
Background:
- Severe traumatic brain injury (TBI) in children presents unique challenges for clinical research.
- Estimating available patient populations is vital for designing effective clinical trials.
Purpose of the Study:
- To determine the sample size of pediatric severe TBI cases available for clinical trials.
- To describe patient demographics and hospital characteristics for severe TBI hospitalizations in the US.
Main Methods:
- Analysis of the 2006 Kids' Inpatient Database.
- Definition of severe TBI as requiring mechanical ventilation or intubation.
- Categorization of high-volume TBI hospitals and simulation analyses for trial recruitment.
Main Results:
- Most severe TBI cases were treated in children's units within general hospitals or non-children's hospitals.
- Less than 5% of hospitals were high-volume TBI centers, managing over 78% of cases.
- Simulation indicated diminishing returns from adding more recruitment sites beyond a certain point.
Conclusions:
- Children with severe TBI are infrequently seen at most US hospitals.
- Few hospitals manage a high volume of pediatric severe TBI cases.
- Strategic selection of high-volume centers is essential for maximizing enrollment efficiency in clinical trials for severe TBI therapies.
Objectives:
To estimate sample sizes available for clinical trials of severe traumatic brain injury (TBI) in children, we described the patient demographics and hospital characteristics associated with children hospitalized with severe TBI in the United States.
Methods:
We analyzed the 2006 Kids' Inpatient Database. Severe TBI hospitalizations were defined as children discharged with TBI who required mechanical ventilation or intubation. Types of high-volume severe TBI hospitals were categorized based on the numbers of discharged patients with severe TBI in 2006. National estimates of demographics and hospital characteristics were calculated for pediatric severe TBI. Simulation analyses were performed to assess the potential number of severe TBI cases from randomly selected hospitals for inclusion in future clinical trials.
Results:
The majority of children with severe TBI were discharged from either a children's unit in general hospitals (41%) or a nonchildren's hospital (34%). Less than 5% of all hospitals were high-volume TBI hospitals, which discharged >78% of severe TBI cases and were more likely to be a children's unit in a general hospital or a children's hospital. Simulation analyses indicate that there is a saturation point after which the benefit of adding additional recruitment sites decreases significantly.
Conclusions:
Children with severe TBI are infrequent at any one hospital in the United States, and few hospitals treat large numbers of children with severe TBI. To effectively plan trials of therapies for severe TBI, much attention has to be paid to selecting the right types of centers to maximize enrollment efficiency.
