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Validation of the Scandinavian guidelines for minor and moderate head trauma in children : protocol for a pragmatic, prospective, observational, multicentre cohort study

Wickbom, Fredrik LU ; Calcagnile, Olga ; Marklund, Niklas LU orcid and Undén, Johan LU (2024) In BMJ Open 14(4).
Abstract

Introduction Mild traumatic brain injury is common in children and it can be challenging to accurately identify those in need of urgent medical intervention. The Scandinavian guidelines for management of minor and moderate head trauma in children, the Scandinavian Neurotrauma Committee guideline 2016 (SNC16), were developed to aid in risk stratification and decision-making in Scandinavian emergency departments (EDs). This guideline has been validated externally with encouraging results, but internal validation in the intended healthcare system is warranted prior to broad clinical implementation. Objective We aim to validate the diagnostic accuracy of the SNC16 to predict clinically important intracranial injuries (CIII) in paediatric... (More)

Introduction Mild traumatic brain injury is common in children and it can be challenging to accurately identify those in need of urgent medical intervention. The Scandinavian guidelines for management of minor and moderate head trauma in children, the Scandinavian Neurotrauma Committee guideline 2016 (SNC16), were developed to aid in risk stratification and decision-making in Scandinavian emergency departments (EDs). This guideline has been validated externally with encouraging results, but internal validation in the intended healthcare system is warranted prior to broad clinical implementation. Objective We aim to validate the diagnostic accuracy of the SNC16 to predict clinically important intracranial injuries (CIII) in paediatric patients suffering from blunt head trauma, assessed in EDs in Sweden and Norway. Methods and analysis This is a prospective, pragmatic, observational cohort study. Children (aged 0–17 years) with blunt head trauma, presenting with a Glasgow Coma Scale of 9–15 within 24 hours postinjury at an ED in 1 of the 16 participating hospitals, are eligible for inclusion. Included patients are assessed and managed according to the clinical management routines of each hospital. Data elements for risk stratification are collected in an electronic case report form by the examining doctor. The primary outcome is defined as CIII within 1 week of injury. Secondary outcomes of importance include traumatic CT findings, neurosurgery and 3-month outcome. Diagnostic accuracy of the SNC16 to predict endpoints will be assessed by point estimate and 95% CIs for sensitivity, specificity, likelihood ratio, negative predictive value and positive predictive value. Ethics and dissemination The study is approved by the ethical board in both Sweden and Norway. Results from this validation will be published in scientific journals, and a tailored development and implementation process will follow if the SNC16 is found safe and effective. Trial registration number NCT05964764.

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author
; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
BMJ Open
volume
14
issue
4
article number
e078622
publisher
BMJ Publishing Group
external identifiers
  • scopus:85190072757
  • pmid:38569695
ISSN
2044-6055
DOI
10.1136/bmjopen-2023-078622
language
English
LU publication?
yes
id
990a72e6-922f-4e86-9faa-f6cb912170d0
date added to LUP
2024-04-25 10:53:56
date last changed
2024-06-20 16:03:57
@article{990a72e6-922f-4e86-9faa-f6cb912170d0,
  abstract     = {{<p>Introduction Mild traumatic brain injury is common in children and it can be challenging to accurately identify those in need of urgent medical intervention. The Scandinavian guidelines for management of minor and moderate head trauma in children, the Scandinavian Neurotrauma Committee guideline 2016 (SNC16), were developed to aid in risk stratification and decision-making in Scandinavian emergency departments (EDs). This guideline has been validated externally with encouraging results, but internal validation in the intended healthcare system is warranted prior to broad clinical implementation. Objective We aim to validate the diagnostic accuracy of the SNC16 to predict clinically important intracranial injuries (CIII) in paediatric patients suffering from blunt head trauma, assessed in EDs in Sweden and Norway. Methods and analysis This is a prospective, pragmatic, observational cohort study. Children (aged 0–17 years) with blunt head trauma, presenting with a Glasgow Coma Scale of 9–15 within 24 hours postinjury at an ED in 1 of the 16 participating hospitals, are eligible for inclusion. Included patients are assessed and managed according to the clinical management routines of each hospital. Data elements for risk stratification are collected in an electronic case report form by the examining doctor. The primary outcome is defined as CIII within 1 week of injury. Secondary outcomes of importance include traumatic CT findings, neurosurgery and 3-month outcome. Diagnostic accuracy of the SNC16 to predict endpoints will be assessed by point estimate and 95% CIs for sensitivity, specificity, likelihood ratio, negative predictive value and positive predictive value. Ethics and dissemination The study is approved by the ethical board in both Sweden and Norway. Results from this validation will be published in scientific journals, and a tailored development and implementation process will follow if the SNC16 is found safe and effective. Trial registration number NCT05964764.</p>}},
  author       = {{Wickbom, Fredrik and Calcagnile, Olga and Marklund, Niklas and Undén, Johan}},
  issn         = {{2044-6055}},
  language     = {{eng}},
  month        = {{04}},
  number       = {{4}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{Validation of the Scandinavian guidelines for minor and moderate head trauma in children : protocol for a pragmatic, prospective, observational, multicentre cohort study}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2023-078622}},
  doi          = {{10.1136/bmjopen-2023-078622}},
  volume       = {{14}},
  year         = {{2024}},
}