A prospective observational study to assess the diagnostic accuracy of clinical decision rules for children presenting to emergency departments after head injuries: The Australasian Paediatric Head Injury Rules Study (APHIRST)

Not Applicable

Completed

• Conditions: Head Injury; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12614000463673
• Lead Sponsor: Prof Franz Babl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

Patients between birth and less than 18 years of age with head injuries of all severities. The definition of head injury does not include patients who have sustained a trivial facial injury defined as a ground level fall or walking or running into an object with no signs or symptoms of injury other than facial abrasions or lacerations below the eyebrows.

Exclusion Criteria

- Refusal to participate to the study
- Direct referral from the emergency department triage to a general practitioner or other external provider (i.e. not seen in the emergency department)
- Departure from the emergency department before being seen
- Neuroimaging prior to presentation for the same injury

Individual exclusion criteria (relevant to each Clinical Decision Rule) will be applied when comparing data with each Clinical Decision Rule.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy (sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV)) of each of the three clinical decision rules in identifying rule specific outcomes when applied to those patients who meet the individual inclusion and exclusion criteria: <br><br>CATCH: need for neurologic intervention or presence of brain injury on CT<br><br>CHALICE: clinically significant intracranial injury (CSII), presence of skull fracture, or admission to hospital<br><br>PECARN: clinically important traumatic brain injury (ciTBI)<br>[Time of CT scan for patients who undergo a CT scan during initial assessment in the emergency department.<br><br>Within 3 months for patients who do not undergo neuroimaging at the time of initial assessment. These patients receive a structured telephone follow up within 3 months from initial assessment.]