NCT07411235

Development of WHOLE Score

Development of a Novel Clinical Decision Support Tool for Determining the Need for Whole-body Computed Tomography in Pediatric Trauma Patients: the WHOLE Score

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 407 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 0 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to investigate the association between injury mechanism, physical examination findings, and laboratory parameters, and the presence of injuries involving multiple computed tomography (CT) regions on whole-body computed tomography (WBCT) in trauma patients under 18 years of age. Additionally, this study sought to develop a clinical risk assessment score to assist emergency medicine specialists in decision-making, with the goal of reducing unnecessary WBCT utilization.

Detailed description

Whole-body computed tomography (WBCT) is widely used in the initial assessment of pediatric trauma patients to rapidly identify injuries; however, its routine use exposes children to substantial ionizing radiation. Clear guidance on which pediatric trauma patients truly benefit from WBCT is lacking, leading to practice variability and potential overuse in emergency departments. This study included trauma patients under 18 years of age who underwent WBCT in a tertiary pediatric trauma center . The primary outcome was the presence of traumatic injuries involving two or more anatomical regions on WBCT. Candidate predictors were identified from the literature and clinical practice and evaluated using multivariable logistic regression. Continuous variables were dichotomized based on receiver operating characteristic (ROC) analysis. Independent predictors were used to develop a clinical decision support tool, the WHOLE score. Model performance was assessed using ROC analysis and diagnostic accuracy metrics.

Conditions

• Trauma Injury

Timeline

• Start date: 2022-10-22
• Primary completion: 2023-06-22
• Completion: 2023-10-22
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: Turkey (Türkiye)