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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)

A prospective observational study of children presenting to the Emergency Department with head injury, comparing three high quality international decision rules regarding CT scan and assess their accuracy in identifying clinically important traumatic brain Injuries

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12614000463673
Acronym
APHIRST (Australasian Paediatric Head Injury Rules Study)
Enrollment
20137
Registered
2014-05-02
Start date
2011-04-11
Completion date
2014-05-26
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Children with clinically significant intracranial injuries require rapid identification in the acute care setting in order to prevent further damage to the brain. Head CT scans can quickly identify the presence or absence of intracranial injuries, and help guide subsequent management (including neurosurgical intervention) where intracranial injuries are identified. However, head CT scans also have negative effects, particularly in children, who are more vulnerable to radiation-associated cell damage and may require sedation to allow imaging with consequent sedation-associated risks. Radiation from cranial CT scans can cause lethal malignancies later in life, with a reported cancer related mortality between 1:1000 and 1:10000 paediatric cranial CT scans, with higher risk in younger age groups. They also have resource implications for Emergency Departments and the health system as a whole. Despite this, the number of cranial CT scans performed for head injuries in children is increasing, in part due to concern amongst physicians regarding the consequences of being unable to reliably identify intracranial injury based solely on a child’s clinical condition. Clinical decision rules are a combination of clinical variables. These may include elements of the patient's history, physical examination findings, or simple tests that guide clinicians in their decision making process for optimal patient care. There are three high-quality, international clinical decision rules that have been developed to decide which children need a CT scan following a head injury and which can be safely managed without. They are very accurate in identifying children with intracranial injuries, however they are quite different in terms of applicable populations and definitions of a significant intracranial injury. In addition these three rules have not been compared in the same population to assess which is the best rule to be used in clinical practice. The primary aim of the current study is to determine the accuracy of the three major international paediatric head injury clinical decision rules when applied to a single population of consecutive children presenting to the Emergency Department with head injury in Australia and New Zealand. The hypothesis is that the simultaneous comparative application and validation of three major paediatric head injury clinical decision rules outside their derivation setting, will allow the determination of the optimal rule for use in the Australasian Emergency Department setting.

Interventions

Condition observed: traumatic brain injury on CT scan and clinically important traumatic brain injury. CT scan is undertaken on a single occasion, only at admission to hospital. Patients who do not have a CT scan performed in the emergency department receive a telephone call between 14 and 90 days after discharge to administer specific questionnaires and to screen for possible initially missed clinically important traumatic brain injury. The 3 highest quality clinical decision rules for CT sca

Condition observed: traumatic brain injury on CT scan and clinically important traumatic brain injury. CT scan is undertaken on a single occasion, only at admission to hospital. Patients who do not have a CT scan performed in the emergency department receive a telephone call between 14 and 90 days after discharge to administer specific questionnaires and to screen for possible initially missed clinically important traumatic brain injury. The 3 highest quality clinical decision rules for CT scan in children presenting to the Emergency Department following a head injury are compared in the same cohort of patients. * CHALICE - Children’s Head Injury Algorithm for the Prediction of Important Clinical Events (Dunning J et al, Arch Dis Child 2006) * PECARN rule – Paediatric Emergency Care Applied Research Network (Kupperman N at al, Lancet 2009) * CATCH – Canadian Assessment of Tomography for Childhood Head Injury (Osmond M et al, CAMJ 2010)

Sponsors

Prof Franz Babl
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
0 to 17 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 20, 2026