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

Franz E Babl 0 1 2 10 11 16 Mark D Lyttle 1 2 11 14 15 Silvia Bressan 0 1 2 11 13 Meredith Borland 2 17 Natalie Phillips 2 Amit Kochar 2 12 Stuart R Dalziel 2 8 9 Sarah Dalton 2 6 John A Cheek 0 1 2 7 11 Jeremy Furyk 2 4 Yuri Gilhotra 2 5 Jocelyn Neutze 2 3 Brenton Ward 0 2 Susan Donath 0 2 10 Kim Jachno 0 2 10 Louise Crowe 0 2 10 Amanda Williams 0 2 10 Ed Oakley 0 1 2 10 11 0 Murdoch Childrens Research Institute , Parkville, VIC , Australia 1 Department of Emergency Medicine, Royal Children's Hospital , Flemington Rd, Parkville, Vic 3052 , Australia 2 Children's Hospital and Queensland Children's Medical Research Institute, Queensland University , Brisbane , Australia 3 Kidzfirst Middlemore Hospital , Auckland , New Zealand 4 Townsville Hospital , Townsville , Australia 5 Mater Children's Hospital , Brisbane , Australia 6 The Children's Hospital at Westmead , Sydney , Australia 7 Monash Medical Centre , Clayton, VIC , Australia 8 Starship Hospital , Auckland , New Zealand 9 Liggins Institute, University of Auckland , Auckland , New Zealand 10 Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne , Melbourne, VIC 3010 , Australia 11 Department of Emergency Medicine, Royal Children's Hospital , Flemington Rd, Parkville, Vic 3052 , Australia 12 Women's & Children's Hospital , Adelaide , Australia 13 University of Padova , Padova , Italy 14 Academic Department of Emergency Care, University of the West of England , Bristol , UK 15 Bristol Royal Hospital for Children , Bristol , UK 16 National Trauma Research Institute , Prahan, VIC , Australia 17 Princess Margaret Hospital for Children , Perth , Australia Background: Head injuries in children are responsible for a large number of emergency department visits. Failure to identify a clinically significant intracranial injury in a timely fashion may result in long term neurodisability and death. Whilst cranial computed tomography (CT) provides rapid and definitive identification of intracranial injuries, it is resource intensive and associated with radiation induced cancer. Evidence based head injury clinical decision rules have been derived to aid physicians in identifying patients at risk of having a clinically significant intracranial injury. Three rules have been identified as being of high quality and accuracy: the Canadian Assessment of Tomography for Childhood Head Injury (CATCH) from Canada, the Children's Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE) from the UK, and the prediction rule for the identification of children at very low risk of clinically important traumatic brain injury developed by the Pediatric Emergency Care Applied Research Network (PECARN) from the USA. This study aims to prospectively validate and compare the performance accuracy of these three clinical decision rules when applied outside the derivation setting. Methods/design: This study is a prospective observational study of children aged 0 to less than 18 years presenting to 10 emergency departments within the Paediatric Research in Emergency Departments International Collaborative (PREDICT) research network in Australia and New Zealand after head injuries of any severity. Predictor variables identified in CATCH, CHALICE and PECARN clinical decision rules will be collected. Patients will be managed as per the treating clinicians at the participating hospitals. All patients not undergoing cranial CT will receive a follow up call 14 to 90 days after the injury. Outcome data collected will include results of cranial CTs (if performed) and details of admission, intubation, neurosurgery and death. The performance accuracy of each of the rules will be assessed using rule specific outcomes and inclusion and exclusion criteria. (Continued on next page) - (Continued from previous page) Discussion: This study will allow the simultaneous comparative application and validation of three major paediatric head injury clinical decision rules outside their derivation setting. Trial registration: The study is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR)- ACTRN12614000463673 (registered 2 May 2014). Background Children with clinically significant intracranial injuries require urgent identification to prevent further damage to the brain. Cranial computed tomography (CT) scans provide rapid and definitive identification of the presence or absence of intracranial injuries, and help guide subsequent management. Positive results allow early intervention and optimise outcomes whilst negative results are reassuring and may allow accelerated discharge and reduce unnecessary admissions. However, cranial CT scans also have negative effects, particularly in children, who are more vulnerable to radiation-associated cell damage [1]. Radiation from cranial CT scans can cause lethal malignancies with higher risk in younger age groups [1-4]. Children may require sedation to allow imaging with consequent sedationassociated risks [5,6]. They also have resource implications for Emergency Departments (EDs) and the health system as a whole [7]. Despite this, the number of cranial CT scans performed for head injuries in children has increased in a number of countries [8-11]. This increase is likely due to a combination of easier access to CT scanners and more efficient technology and concern amongst physicians of being unable to reliably identify intracranial injury based solely on a childs clinical condition. One way of increasing clinical sensitivity and specificity (i.e. minimising both missed clinically significant intracranial injuries and unnecessary investigations) is to develop and use clinical decision rules (CDRs). CDRs help physicians with diagnostic and therapeutic decisions, and can be defined as decision making tools derived from original research (as opposed to a consensusbased clinical practice guideline) which incorporate three or more variables from the history, physical examination, or simple tests. These tools help clinicians cope with the uncertainty of medical decision making and improve their efficiency [12]. Several recent systematic reviews of existing paediatric head injury CDRs have been published [13-15]. The three CDRs of highest quality and accuracy [15] are the Canadian Assessment of Tomography for Childhood Head Injury (CATCH) from Canada [11], the Childrens Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE) from the UK [16] and the prediction rule for the identification of children at very low risk of clinically important traumatic brain injury developed by the Pediatric Emergency Care Applied Research Network (PECARN) from the USA [17]. All three CDRs were derived with high methodological standards using large multicentre data sets. However, they differ in key areas, including study population, predictor variables (based on mechanism of injury, clinical history, and clinical examination) (Table 1), inc (...truncated)