TY - JOUR
T1 - Validation of Prediction Rules for Computed Tomography Use in Children With Blunt Abdominal or Blunt Head Trauma
T2 - Protocol for a Prospective Multicenter Observational Cohort Study
AU - Ugalde, Irma T.
AU - Chaudhari, Pradip P.
AU - Badawy, Mohamed
AU - Ishimine, Paul
AU - McCarten-Gibbs, Kevan A.
AU - Yen, Kenneth
AU - Atigapramoj, Nisa S.
AU - Sage, Allyson
AU - Nielsen, Donovan
AU - Adelson, David
AU - Upperman, Jeffrey
AU - Tancredi, Daniel
AU - Kuppermann, Nathan
AU - Holmes, James F.
N1 - Funding Information:
The project was funded in 2016. Patient enrollment began on December 28, 2016, and was completed on September 1, 2021. Patient enrollment was extended due to the COVID-19 pandemic. The COVID-19 pandemic resulted in an initial halt to all non–COVID-19 research activities at participating study sites, after which study enrollment resumed until completion. As of September 1, 2021, over 7500 patients were enrolled in the IAI cohort, over 20,000 patients were enrolled in the TBI cohort, and over 4700 patients were enrolled in both. Additionally, over 450 clinicians were enrolled in the clinician survey. Data clean-up and analyses are projected to be completed by December 2022, and the results are expected to be submitted for peer-reviewed publication in 2023.
Publisher Copyright:
©Irma T Ugalde, Pradip P Chaudhari, Mohamed Badawy, Paul Ishimine, Kevan A McCarten-Gibbs, Kenneth Yen, Nisa S Atigapramoj, Allyson Sage, Donovan Nielsen, P David Adelson, Jeffrey Upperman, Daniel Tancredi, Nathan Kuppermann, James F Holmes.
PY - 2022/11
Y1 - 2022/11
N2 - Background: Traumatic brain injuries (TBIs) and intra-abdominal injuries (IAIs) are 2 leading causes of traumatic death and disability in children. To avoid missed or delayed diagnoses leading to increased morbidity, computed tomography (CT) is used liberally. However, the overuse of CT leads to inefficient care and radiation-induced malignancies. Therefore, to maximize precision and minimize the overuse of CT, the Pediatric Emergency Care Applied Research Network (PECARN) previously derived clinical prediction rules for identifying children at high risk and very low risk for IAIs undergoing acute intervention and clinically important TBIs after blunt trauma in large cohorts of children who are injured. Objective: This study aimed to validate the IAI and age-based TBI clinical prediction rules for identifying children at high risk and very low risk for IAIs undergoing acute intervention and clinically important TBIs after blunt trauma. Methods: This was a prospective 6-center observational study of children aged <18 years with blunt torso or head trauma. Consistent with the original derivation studies, enrolled children underwent routine history and physical examinations, and the treating clinicians completed case report forms prior to knowledge of CT results (if performed). Medical records were reviewed to determine clinical courses and outcomes for all patients, and for those who were discharged from the emergency department, a follow-up survey via a telephone call or SMS text message was performed to identify any patients with missed IAIs or TBIs. The primary outcomes were IAI undergoing acute intervention (therapeutic laparotomy, angiographic embolization, blood transfusion, or intravenous fluid for ≥2 days for pancreatic or gastrointestinal injuries) and clinically important TBI (death from TBI, neurosurgical procedure, intubation for >24 hours for TBI, or hospital admission of ≥2 nights due to a TBI on CT). Prediction rule accuracy was assessed by measuring rule classification performance, using standard point and 95% CI estimates of the operational characteristics of each prediction rule (sensitivity, specificity, positive and negative predictive values, and diagnostic likelihood ratios). Results: The project was funded in 2016, and enrollment was completed on September 1, 2021. Data analyses are expected to be completed by December 2022, and the primary study results are expected to be submitted for publication in 2023. Conclusions: This study will attempt to validate previously derived clinical prediction rules to accurately identify children at high and very low risk for clinically important IAIs and TBIs. Assuming successful validation, widespread implementation is then indicated, which will optimize the care of children who are injured by better aligning CT use with need. International Registered Report Identifier (IRRID): RR1-10.2196/43027
AB - Background: Traumatic brain injuries (TBIs) and intra-abdominal injuries (IAIs) are 2 leading causes of traumatic death and disability in children. To avoid missed or delayed diagnoses leading to increased morbidity, computed tomography (CT) is used liberally. However, the overuse of CT leads to inefficient care and radiation-induced malignancies. Therefore, to maximize precision and minimize the overuse of CT, the Pediatric Emergency Care Applied Research Network (PECARN) previously derived clinical prediction rules for identifying children at high risk and very low risk for IAIs undergoing acute intervention and clinically important TBIs after blunt trauma in large cohorts of children who are injured. Objective: This study aimed to validate the IAI and age-based TBI clinical prediction rules for identifying children at high risk and very low risk for IAIs undergoing acute intervention and clinically important TBIs after blunt trauma. Methods: This was a prospective 6-center observational study of children aged <18 years with blunt torso or head trauma. Consistent with the original derivation studies, enrolled children underwent routine history and physical examinations, and the treating clinicians completed case report forms prior to knowledge of CT results (if performed). Medical records were reviewed to determine clinical courses and outcomes for all patients, and for those who were discharged from the emergency department, a follow-up survey via a telephone call or SMS text message was performed to identify any patients with missed IAIs or TBIs. The primary outcomes were IAI undergoing acute intervention (therapeutic laparotomy, angiographic embolization, blood transfusion, or intravenous fluid for ≥2 days for pancreatic or gastrointestinal injuries) and clinically important TBI (death from TBI, neurosurgical procedure, intubation for >24 hours for TBI, or hospital admission of ≥2 nights due to a TBI on CT). Prediction rule accuracy was assessed by measuring rule classification performance, using standard point and 95% CI estimates of the operational characteristics of each prediction rule (sensitivity, specificity, positive and negative predictive values, and diagnostic likelihood ratios). Results: The project was funded in 2016, and enrollment was completed on September 1, 2021. Data analyses are expected to be completed by December 2022, and the primary study results are expected to be submitted for publication in 2023. Conclusions: This study will attempt to validate previously derived clinical prediction rules to accurately identify children at high and very low risk for clinically important IAIs and TBIs. Assuming successful validation, widespread implementation is then indicated, which will optimize the care of children who are injured by better aligning CT use with need. International Registered Report Identifier (IRRID): RR1-10.2196/43027
KW - clinical prediction rules
KW - emergency medicine
KW - intra-abdominal injury
KW - pediatric trauma
KW - traumatic brain injury
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U2 - 10.2196/43027
DO - 10.2196/43027
M3 - Article
C2 - 36422920
AN - SCOPUS:85144746423
SN - 1929-0748
VL - 11
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 11
M1 - e43027
ER -