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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07411235

Acronym

WHOLE

Enrollment

407

Registered

2026-02-13

Start date

2022-10-22

Completion date

2023-10-22

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma Injury

Keywords

Pediatric Trauma

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Months to 18 Years

Healthy volunteers

Inclusion criteria

* All trauma patients under 18 years of age who presented to the emergency department and underwent whole-body computed tomography (WBCT) based on the decision of the attending emergency medicine specialist at the time of presentation were included in the study

Exclusion criteria

* Patients with missing data in the hospital information system or those who left the hospital for any reason before completion of the emergency department diagnostic and treatment process were excluded

Design outcomes

Primary

Measure	Time frame	Description
Detection of injuries involving more than one anatomical region on whole-body computed tomography	At the time of initial whole body computed tomography acquisition during the index emergency department evaluation (baseline / Emergency Department presentation)	The primary outcome was defined as the detection of injuries involving more than one anatomical region on whole-body computed tomography (WBCT). Patients were considered to have positive imaging findings if any trauma-related injury was identified on computed tomography. Incidental findings or abnormalities not related to trauma were not considered positive imaging findings.

Countries

Turkey (Türkiye)

Outcome results