Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study
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 201...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/4/e078622.full |
| _version_ | 1797224556584239104 |
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| author | Niklas Marklund Johan Unden Fredrik Wickbom Olga Calcagnile |
| author_facet | Niklas Marklund Johan Unden Fredrik Wickbom Olga Calcagnile |
| author_sort | Niklas Marklund |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T13:55:00Z |
| format | Article |
| id | doaj.art-b68c062c56584f58807c43dd9453effa |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-24T13:55:00Z |
| publishDate | 2024-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-b68c062c56584f58807c43dd9453effa2024-04-03T18:25:08ZengBMJ Publishing GroupBMJ Open2044-60552024-04-0114410.1136/bmjopen-2023-078622Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort studyNiklas Marklund0Johan Unden1Fredrik Wickbom2Olga Calcagnile31Lund University, Department of Clinical Sciences, Neurosurgery, Klinikgatan 17A, SwedenDepartment of Operation and Intensive Care, Halland Hospital Halmstad, Halmstad, SwedenDepartment of Clinical Sciences, Malmö, Lund University Faculty of Medicine, Lund, SwedenDepartment of Paediatric Medicine, Halland Hospital Halmstad, Halmstad, SwedenIntroduction 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.https://bmjopen.bmj.com/content/14/4/e078622.full |
| spellingShingle | Niklas Marklund Johan Unden Fredrik Wickbom Olga Calcagnile Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study 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 |
| title_full | Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study |
| title_fullStr | Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study |
| title_full_unstemmed | Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study |
| title_short | Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study |
| title_sort | validation of the scandinavian guidelines for minor and moderate head trauma in children protocol for a pragmatic prospective observational multicentre cohort study |
| url | https://bmjopen.bmj.com/content/14/4/e078622.full |
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