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AIM: This study aimed to determine whether targeted interventions, proven to be effective at improving evidence-based bronchiolitis management, changed factors previously found to influence variation in bronchiolitis management. METHODS: This survey assessed change in factors influencing clinicians' (nurses and doctors) bronchiolitis management at baseline and post-intervention in a cluster randomised controlled trial of targeted, theory-informed interventions aiming to de-implement non-evidence-based bronchiolitis management (no use of chest X-ray, salbutamol, antibiotics, glucocorticoids and adrenaline). Survey questions addressed previously identified factors influencing bronchiolitis management from six Theoretical Domains Framework domains (knowledge; skills; beliefs about consequences; social/professional role and identity; environmental context and resources; social influences). Data analysis was descriptive. RESULTS: A total of 1958 surveys (baseline = 996; post-intervention = 962) were completed by clinicians from the emergency department and paediatric inpatient units from 26 hospitals (intervention = 13; control = 13). Targeted bronchiolitis interventions significantly increased knowledge of the Australasian Bronchiolitis Guideline (intervention clinicians = 74%, control = 39%, difference = 34.7%, 95% confidence interval (CI) = 25.6-43.8%), improved skills in diagnosing (intervention doctors = 89%, control = 76%, difference = 12.6%, 95% CI = 6.2-19%) and managing bronchiolitis (intervention doctors = 87%, control = 76%, difference = 9.9%, 95% CI = 3.7-16.1%), positively influenced both beliefs about consequences regarding salbutamol use (intervention clinicians = 49%, control = 29%, difference = 20.3%, 95% CI = 13.2-27.4%) and nurses questioning non-evidence-based bronchiolitis management (chest X-ray: intervention = 71%, control = 51%, difference = 20.8%, 95% CI = 11.4-30.2%; glucocorticoids: intervention = 64%, control = 40%, difference = 21.9%, 95% CI

BACKGROUND: Understanding how and why de-implementation of low-value practices is sustained remains unclear. The Paediatric Research in Emergency Departments International CollaboraTive (PREDICT) Bronchiolitis Knowledge Translation (KT) Study was a cluster randomised controlled trial conducted in 26 Australian and New Zealand hospitals (May-November 2017). Results showed targeted, theory-informed interventions (clinical leads, stakeholder meetings, train-the-trainer workshop, targeted educational package, audit/feedback) were effective at reducing use of five low-value practices for bronchiolitis (salbutamol, glucocorticoids, antibiotics, adrenaline and chest x-ray) by 14.1% in acute care settings. The primary aim of this study is to determine the sustainability (continued receipt of benefits) of these outcomes at intervention hospitals two-years after the removal of study supports. Secondary aims are to determine sustainability at one-year after removal of study support at intervention hospitals; improvements one-and-two years at control hospitals; and explore factors that influence sustainability at intervention hospitals and contribute to improvements at control hospitals. METHODS: A mixed-methods study design. The quantitative component is a retrospective medical record audit of bronchiolitis management within 24 hours of emergency department (ED) presentations at 26 Australian (n = 20) and New Zealand (n = 6) hospitals, which participated in the PREDICT Bronchiolitis KT Study. Data for a total of 1800 infants from intervention and control sites (up to 150 per site) will be collected to determine if improvements (i.e., no use of all five low-value practices) were sustained two- years (2019) post-trial (primary outcome; composite score); and a further 1800 infants from intervention and control sites will be collected to determine sustained improvements one- year (2018) post-trial (secondary outcome). An a priori definition of sustainability will be used. The qual

OBJECTIVE: Paediatric status epilepticus (SE) has potential for long-term sequelae. Existing data demonstrate delays to aspects of care. The objective of the present study was to examine the feasibility of collecting data on children with paediatric SE and describe current management strategies in pre-hospital and in-hospital settings. METHODS: A pilot, prospective, observational cohort study of children 4 weeks to 16 years of age with SE, in four EDs in Australia. Clinical details including medications administered, duration of seizure and short-term outcomes were collected. Follow up occurred by telephone at 1 month. RESULTS: We enrolled 167 children with SE. Mean age was 5.4 years (standard deviation [SD] 4.1), and 81 (49%) male. Median seizure duration was 10 min (interquartile range 7-30). Midazolam was the first medication administered in 87/100 (87%) instances, mean dose of 0.21 mg/kg (SD 0.13). The dose of midazolam was adequate in 30 (35%), high (>0.2 mg/kg) in 44 (51%) and low (<0.1 mg/kg) in 13 (15%). For second-line agents, levetiracetam was administered on 33/55 (60%) occasions, whereas phenytoin and phenobarbitone were administered on 11/55 (20%) occasions each. Mean dose of levetiracetam was 26.4 mg/kg (SD 13.5). One hundred and four (62%) patients were admitted to hospital, with 13 (8%) admitted to ICU and seven (4%) intubated. CONCLUSION: In children presenting with SE in Australia medical management differed from previous reports, with midazolam as the preferred benzodiazepine, and levetiracetam replacing phenytoin as the preferred second-line agent. This pilot study indicates the feasibility of a paediatric SE registry and its utility to understand and optimise practice.

BACKGROUND: The Pediatric Emergency Care Applied Research Network (PECARN) head trauma clinical decision rules informed the development of algorithms that risk stratify the management of children based on their risk of clinically important traumatic brain injury (ciTBI). We aimed to determine the rate of ciTBI for each PECARN algorithm risk group in an external cohort of patients and that of ciTBI associated with different combinations of high- or intermediate-risk predictors. METHODS: This study was a secondary analysis of a large multicenter prospective data set, including patients with Glasgow Coma Scale scores of 14 or 15 conducted in Australia and New Zealand. We calculated ciTBI rates with 95% confidence intervals (CIs) for each PECARN risk category and combinations of related predictor variables. RESULTS: Of the 15,163 included children, 4,011 (25.5%) were aged <2 years. The frequency of ciTBI was 8.5% (95% CI = 6.0%-11.6%), 0.2% (95% CI = 0.0%-0.6%), and 0.0% (95% CI = 0.0%-0.2%) in the high-, intermediate-, and very-low-risk groups, respectively, for children <2 years and 5.7% (95% CI = 4.4%-7.2%), 0.7% (95% CI = 0.5%-1.0%), and 0.0% (95% CI = 0.0%-0.1%) in older children. The isolated high-risk predictor with the highest risk of ciTBI was "signs of palpable skull fracture" for younger children (11.4%, 95% CI = 5.3%-20.5%) and "signs of basilar skull fracture" in children ≥2 years (11.1%, 95% CI = 3.7%-24.1%). For older children in the intermediate-risk category, the presence of all four predictors had the highest risk of ciTBI (25.0%, 95% CI = 0.6%-80.6%) followed by the combination of "severe mechanism of injury" and "severe headache" (7.7%, 95% CI = 0.2%-36.0%). The very few children <2 years at intermediate risk with ciTBI precluded further analysis. CONCLUSIONS: The risk estimates of ciTBI for each of the PECARN algorithms risk group were consistent with the original PECARN study. The risk estimates of ciTBI within the high- and intermediate-risk predi

IMPORTANCE: In developed countries, bronchiolitis is the most common reason for infants to be admitted to the hospital, and all international bronchiolitis guidelines recommend supportive care; however, significant variation in practice continues with infants receiving non-evidence-based therapies. Deimplementation research aims to reduce the use of low-value care, and advancing science in this area is critical to delivering evidence-based care. OBJECTIVE: To determine the effectiveness of targeted interventions vs passive dissemination of an evidence-based bronchiolitis guideline in improving treatment of infants with bronchiolitis. DESIGN, SETTING, AND PARTICIPANTS: This international, multicenter cluster randomized clinical trial included 26 hospitals (clusters) in Australia and New Zealand providing tertiary or secondary pediatric care (13 randomized to intervention, 13 to control) during the 2017 bronchiolitis season. Data were collected on 8003 infants for the 3 bronchiolitis seasons (2014-2016) before the implementation period and 3727 infants for the implementation period (2017 bronchiolitis season, May 1-November 30). Data were analyzed from November 16, 2018, to December 9, 2020. INTERVENTIONS: Interventions were developed using theories of behavior change to target key factors that influence bronchiolitis management. These interventions included site-based clinical leads, stakeholder meetings, a train-the-trainer workshop, targeted educational delivery, other educational and promotional materials, and audit and feedback. MAIN OUTCOMES AND MEASURES: The primary outcome was compliance during the first 24 hours of care with no use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine, measured retrospectively from medical records of randomly selected infants with bronchiolitis who presented to the hospital. There were no patient-level exclusions. RESULTS: A total of 26 hospitals were randomized without dropouts. Analysis was by inten

OBJECTIVES: The Pediatric Emergency Research Network (PERN) was launched in 2009 with the intent for existing national and regional research networks in paediatric emergency care to organise globally for the conduct of collaborative research across networks. METHODS: PERN has grown from five to eight member networks over the past decade. With an executive committee comprising representatives from all member networks, PERN plays a supportive and collaborative rather than governing role. The full impact of PERN's facilitation of international collaborative research, although somewhat difficult to quantify empirically, can be measured indirectly by the observed growth of the field, the nature of the increasingly challenging research questions now being addressed and the collective capacity to generate and implement new knowledge in treating acutely ill and injured children. RESULTS: Beginning as a pandemic response studying H1N1 influenza risk factors in children, PERN research has progressed to multiple observational studies and ongoing global randomised controlled trials (RCTs). As a recent example, PERN has developed sufficient network infrastructure to enable the rapid initiation of a prospective observational study in response to the current COVID-19 pandemic. CONCLUSIONS: Following its success with developing global research, the PERN goal now is to promote the implementation of scientific advances into everyday clinical practice by: (i) expanding the capacity for global RCTs; (ii) deepening the focus on implementation science; (iii) increasing attention to healthcare disparities; and (iv) expanding PERN's reach into resource-restricted regions. Through these actions, PERN aims to meet the needs of acutely ill and injured children throughout the world.

BACKGROUND: Despite international guidelines providing evidence-based recommendations on appropriate management of infants with bronchiolitis, wide variation in practice occurs. This results in infants receiving care of no benefit, with associated cost and is potentially harmful. Theoretical frameworks are increasingly used to develop interventions, utilising behaviour change techniques specifically chosen to target factors contributing to practice variation, with de-implementation often viewed as harder than implementing. This paper describes the stepped process using the Theoretical Domains Framework (TDF) to develop targeted, theory-informed interventions which subsequently successfully improved management of infants with bronchiolitis by de-implementing ineffective therapies. Explicit description of the process and rationale used in developing de-implementation interventions is critical to dissemination of these practices into real world clinical practice. METHODS: A stepped approach was used: (1) Identify evidence-based recommendations and practice variation as targets for change, (2) Identify factors influencing practice change (barriers and enablers) to be addressed, and (3) Identification and development of interventions (behaviour change techniques and methods of delivery) addressing influencing factors, considering evidence of effectiveness, feasibility, local relevance and acceptability. The mode of delivery for the intervention components was informed by evidence from implementation science systematic reviews, and setting specific feasibility and practicality. RESULTS: Five robust evidence-based management recommendations, targeting the main variation in bronchiolitis management were identified: namely, no use of chest x-ray, salbutamol, glucocorticoids, antibiotics, and adrenaline. Interventions developed to target recommendations addressed seven TDF domains (identified following qualitative clinician interviews (n = 20)) with 23 behaviour change techni

BACKGROUND/AIMS: Despite evidence that preferential use of balanced/buffered fluids may improve outcomes compared with chloride-rich 0.9% saline, saline remains the most commonly used fluid for children with septic shock. We aim to determine if resuscitation with balanced/buffered fluids as part of usual care will improve outcomes, in part through reduced kidney injury and without an increase in adverse effects, compared to 0.9% saline for children with septic shock. METHODS: The Pragmatic Pediatric Trial of Balanced versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) study is an international, open-label pragmatic interventional trial being conducted at > 40 sites in the USA, Canada, and Australia/New Zealand starting on August 25, 2020, and continuing for 5 years. Children > 6 months to < 18 years treated for suspected septic shock with abnormal perfusion in an emergency department will be randomized to receive either balanced/buffered crystalloids (intervention) or 0.9% saline (control) for initial resuscitation and maintenance fluids for up to 48 h. Eligible patients are enrolled and randomized using serially numbered, opaque envelopes concurrent with clinical care. Given the life-threatening nature of septic shock and narrow therapeutic window to start fluid resuscitation, patients may be enrolled under "exception from informed consent" in the USA or "deferred consent" in Canada and Australia/New Zealand. Other than fluid type, all decisions about timing, volume, and rate of fluid administration remain at the discretion of the treating clinicians. For pragmatic reasons, clinicians will not be blinded to study fluid type. Anticipated enrollment is 8800 patients. The primary outcome will be major adverse kidney events within 30 days (MAKE30), a composite of death, renal replacement therapy, and persistent kidney dysfunction. Additional effectiveness, safety, and biologic outcomes will also be analyzed. DISCUSSION: PRoMPT BOLUS will provide high-quality evidence f

OBJECTIVES: The Pediatric Emergency Research Network (PERN) was launched in 2009 with the intent for existing national and regional research networks in pediatric emergency care to organize globally for the conduct of collaborative research across networks. METHODS: The Pediatric Emergency Research Network has grown from 5- to 8-member networks over the past decade. With an executive committee comprising representatives from all member networks, PERN plays a supportive and collaborative rather than governing role. The full impact of PERN's facilitation of international collaborative research, although somewhat difficult to quantify empirically, can be measured indirectly by the observed growth of the field, the nature of the increasingly challenging research questions now being addressed, and the collective capacity to generate and implement new knowledge in treating acutely ill and injured children. RESULTS: Beginning as a pandemic response with a high-quality retrospective case-controlled study of H1N1 influenza risk factors, PERN research has progressed to multiple observational studies and ongoing global randomized controlled trials. As a recent example, PERN has developed sufficient network infrastructure to enable the rapid initiation of a prospective observational study in response to the current coronavirus disease 2019 pandemic. In light of the ongoing need for translation of research knowledge into equitable clinical practice and to promote health equity, PERN is committed to a coordinated international effort to increase the uptake of evidence-based management of common and treatable acute conditions in all emergency department settings. CONCLUSIONS: The Pediatric Emergency Research Network's successes with global research, measured by prospective observational and interventional studies, mean that the network can now move to improve its ability to promote the implementation of scientific advances into everyday clinical practice. Achieving this goal will

OBJECTIVE: Children frequently present with head injuries to acute care settings. Although international paediatric clinical practice guidelines for head injuries exist, they do not address all considerations related to triage, imaging, observation versus admission, transfer, discharge and follow-up of mild to moderate head injuries relevant to the Australian and New Zealand context. The Paediatric Research in Emergency Departments International Collaborative (PREDICT) set out to develop an evidence-based, locally applicable, practical clinical guideline for the care of children with mild to moderate head injuries presenting to acute care settings. METHODS: A multidisciplinary Guideline Working Group (GWG) developed 33 questions in three key areas - triage, imaging and discharge of children with mild to moderate head injuries presenting to acute care settings. We identified existing high-quality guidelines and from these guidelines recommendations were mapped to clinical questions. Updated literature searches were undertaken, and key new evidence identified. Recommendations were created through either adoption, adaptation or development of de novo recommendations. The guideline was revised after a period of public consultation. RESULTS: The GWG developed 71 recommendations (evidence-informed = 35, consensus-based = 17, practice points = 19), relevant to the Australian and New Zealand setting. The guideline is presented as three documents: (i) a detailed Full Guideline summarising the evidence underlying each recommendation; (ii) a Guideline Summary; and (iii) a clinical Algorithm: Imaging and Observation Decision-making for Children with Head Injuries. CONCLUSIONS: The PREDICT Australian and New Zealand Guideline for Mild to Moderate Head Injuries in Children provides high-level evidence and practical guidance for front line clinicians.

The Paediatric Research in Emergency Departments International Collaborative (PREDICT) released the Australian and New Zealand Guideline for Mild to Moderate Head Injuries in Children in 2021. We describe innovative and practical methods used to develop this guideline. Informed by GRADE-ADOLOPMENT and ADAPTE frameworks, we adopted or adapted recommendations from multiple high-quality guidelines or developed de novo recommendations. A Guideline Steering Committee and a multidisciplinary Guideline Working Group of 25 key stakeholder representatives formulated the guideline scope and developed 33 clinical questions. We identified four relevant high-quality source guidelines; their recommendations were mapped to clinical questions. The choice of guideline recommendation, if more than one guideline addressed a question, was based on its appropriateness, currency of the literature, access to evidence, and relevance. Updated literature searches identified 440 new studies and key new evidence identified. The decision to develop adopted, adapted or de novo recommendations was based on the supporting evidence-base and its transferability to the local setting. The guideline underwent a 12-week consultation period. The final guideline consisted of 35 evidence-informed and 17 consensus-based recommendations and 19 practice points. An algorithm to inform imaging and observation decision-making was also developed. The resulting process was an efficient and rigorous way to develop a guideline based on existing high-quality guidelines from different settings.

BACKGROUND: Bronchiolitis is the most common reason for hospitalisation in infants. All international bronchiolitis guidelines recommend supportive care, yet considerable variation in practice continues with infants receiving non-evidence based therapies. We developed six targeted, theory-informed interventions; clinical leads, stakeholder meeting, train-the-trainer, education delivery, other educational materials, and audit and feedback. A cluster randomised controlled trial (cRCT) found the interventions to be effective in reducing use of five non-evidence based therapies in infants with bronchiolitis. This process evaluation paper aims to determine whether the interventions were implemented as planned (fidelity), explore end-users' perceptions of the interventions and evaluate cRCT outcome data with intervention fidelity data. METHODS: A pre-specified mixed-methods process evaluation was conducted alongside the cRCT, guided by frameworks for process evaluation of cRCTs and complex interventions. Quantitative data on the fidelity, dose and reach of interventions were collected from the 13 intervention hospitals during the study and analysed using descriptive statistics. Qualitative data identifying perception and acceptability of interventions were collected from 42 intervention hospital clinical leads on study completion and analysed using thematic analysis. RESULTS: The cRCT found targeted, theory-informed interventions improved bronchiolitis management by 14.1%. The process evaluation data found variability in how the intervention was delivered at the cluster and individual level. Total fidelity scores ranged from 55 to 98% across intervention hospitals (mean = 78%; SD = 13%). Fidelity scores were highest for use of clinical leads (mean = 98%; SD = 7%), and lowest for use of other educational materials (mean = 65%; SD = 19%) and audit and feedback (mean = 65%; SD = 20%). Clinical leads reflected positively about the interventions, with time constraints being th

BACKGROUND: Asthma is an illness that commonly affects adults and children, and it serves as a common reason for children to attend emergency departments. An asthma exacerbation is characterised by acute or subacute worsening of shortness of breath, cough, wheezing, and chest tightness and may be triggered by viral respiratory infection, poor compliance with usual medication, a change in the weather, or exposure to allergens or irritants. Most children with asthma have mild or moderate exacerbations and respond well to first-line therapy (inhaled short-acting beta-agonists and systemic corticosteroids). However, the best treatment for the small proportion of seriously ill children who do not respond to first-line therapy is not well understood. Currently, a large number of treatment options are available and there is wide variation in management. OBJECTIVES: Main objective - To summarise Cochrane Reviews with or without meta-analyses of randomised controlled trials on the efficacy and safety of second-line treatment for children with acute exacerbations of asthma (i.e. after first-line treatments, titrated oxygen delivery, and administration of intermittent inhaled short-acting beta2-agonists and oral corticosteroids have been tried and have failed) Secondary objectives - To identify gaps in the current evidence base that will inform recommendations for future research and subsequent Cochrane Reviews - To categorise information on reported outcome measures used in trials of escalation of treatment for acute exacerbations of asthma in children, and to make recommendations for development and reporting of standard outcomes in future trials and reviews - To identify relevant randomised controlled trials that have been published since the date of publication of each included review METHODS: We included Cochrane Reviews assessing interventions for children with acute exacerbations of asthma. We searched the Cochrane Database of Systematic Reviews. The search is current t

BACKGROUND: Bronchiolitis is the most common reason for infants under one year of age to be hospitalised. Despite management being well defined with high quality evidence of no efficacy for salbutamol, adrenaline, glucocorticoids, antibiotics or chest x-rays, substantial variation in practice occurs. Understanding factors that influence practice variation is vital in order to tailor knowledge translation interventions to improve practice. This study explores factors influencing the uptake of five evidence-based guideline recommendations using the Theoretical Domains Framework. METHODS: Semi-structured interviews were undertaken with clinicians in emergency departments and paediatric inpatient areas across Australia and New Zealand exploring current practice, and factors that influence this, based on the Theoretical Domains Framework. Interview transcripts were coded using thematic content analysis. RESULTS: Between July and October 2016, 20 clinicians (12 doctors, 8 nurses) were interviewed. Most clinicians believed chest x-rays were not indicated and caused radiation exposure (beliefs about consequences). However, in practice their decisions were influenced by concerns about misdiagnosis, severity of illness, lack of experience (knowledge) and confidence in managing infants with bronchiolitis (skills), and parental pressure influencing practice (social influences). Some senior clinicians believed trialling salbutamol might be of benefit for some infants (beliefs about consequences) but others strongly discounted this, believing salbutamol to be ineffective, with high quality evidence supporting this (knowledge). Most were concerned about antibiotic resistance and did not believe in antibiotic use in infants with bronchiolitis (beliefs about consequences) but experienced pressure from parents to prescribe (social influences). Glucocorticoid use was generally believed to be of no benefit (knowledge) with concerns surrounding frequency of use in primary care, and pare

OBJECTIVE: Intubation of children in the emergency setting is a high-risk, low incidence event. Standardisation of clinical practice has been hampered by a lack of high-quality evidence to support one technique over another. The aim of the present study is to determine clinician preference in intubation practice of children in EDs and ICUs in Australia and New Zealand to provide baseline information to allow future targeted research focused on improving the safety and efficacy of paediatric emergency airway management. METHODS: The present study was a voluntary questionnaire undertaken by medical staff at registrar level or above in EDs and ICUs associated with the Paediatric Research in Emergency Departments International Collaborative (PREDICT) and Australia and New Zealand Intensive Care Society Paediatric Study Group (ANZICS PSG) research networks. Respondents reported on their individual intubation practices, with a focus on pre-oxygenation and apnoeic oxygenation techniques, and the use of video laryngoscopy. RESULTS: A total of 502 clinicians were invited to complete the survey between May and October 2018 with 336 (66.9%) responded. There was marked variation in practice between ED clinicians and ICU clinicians in the techniques used for pre-oxygenation, the frequency of use of apnoeic oxygenation and the reported use of video laryngoscopy. CONCLUSIONS: Within Australia and New Zealand there is considerable variation in paediatric emergency airway clinical practice, in particular with respect to pre-oxygenation, apnoeic oxygenation and use of video laryngoscopy. Definitive clinical trials are required to best inform clinical practice in this area.

BACKGROUND: Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency condition. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct clinical trials, so that valid comparisons can be made between future studies. We have formed an international working group comprising paediatricians and emergency physicians from North America, Europe, Asia, the Middle East, Africa, South America, Central America, Australasia and the United Kingdom. METHODS/DESIGN: A 5-stage approach will be used: (1) a comprehensive list of outcomes relevant to stakeholders will be compiled through systematic reviews and qualitative interviews with patients, families, and clinicians; (2) Delphi methodology will be applied to reduce the comprehensive list to a core outcome set; (3) we will review current clinical practice guidelines, existing clinical trials, and literature on bedside assessment of asthma severity. We will then identify practice differences in tne clinical assessment of asthma severity, and determine whether further prospective work is needed to achieve agreement on inclusion criteria for clinical trials in acute paediatric asthma in the emergency department (ED) setting; (4) a retrospective chart review in Australia and New Zealand will identify the incidence of serious clinical complications such as intubation, ICU admission, and death in children hospitalized with acute severe asthma. Understanding the incidence of such outcomes will allow us to understand how common (and therefore how feasible) particular outcomes are in asthma in the ED setting; and finally (5) a meeting of the Pediatric Emergency Research Networks (PERN) asthma working group will be held, with invitation of other clinicians interested in acute asthma research, and patients/families. The group will be a

BACKGROUND: Bronchiolitis is the most common reason for hospital admission in infants. High-flow oxygen therapy has emerged as a new treatment; however, the cost-effectiveness of using it as first-line therapy is unknown. OBJECTIVE: To compare the cost of providing high-flow therapy as a first-line therapy compared with rescue therapy after failure of standard oxygen in the management of bronchiolitis. METHODS: A within-trial economic evaluation from the health service perspective using data from a multicentre randomised controlled trial for hypoxic infants (≤12 months) admitted to hospital with bronchiolitis in Australia and New Zealand. Intervention costs, length of hospital and intensive care stay and associated costs were compared for infants who received first-line treatment with high-flow therapy (early high-flow, n=739) or for infants who received standard oxygen and optional rescue high-flow (rescue high-flow, n=733). Costs were applied using Australian costing sources and are reported in 2016-2017 AU$. RESULTS: The incremental cost to avoid one treatment failure was AU$1778 (95% credible interval (CrI) 207 to 7096). Mean cost of bronchiolitis treatment including intervention costs and costs associated with length of stay was AU$420 (95% CrI -176 to 1002) higher per infant in the early high-flow group compared with the rescue high-flow group. There was an 8% (95% CrI 7.5 to 8.6) likelihood of the early high-flow oxygen therapy being cost saving. CONCLUSIONS: The use of high-flow oxygen as initial therapy for respiratory failure in infants with bronchiolitis is unlikely to be cost saving to the health system, compared with standard oxygen therapy with rescue high-flow.

INTRODUCTION: Pneumonia is a frequent and costly cause of emergency department (ED) visits and hospitalisations in children. There are no evidence-based, validated tools to assist physicians in management and disposition decisions for children presenting to the ED with community-acquired pneumonia (CAP). The objective of this study is to develop a clinical prediction model to accurately stratify children with CAP who are at risk for low, moderate and severe disease across a global network of EDs. METHODS AND ANALYSIS: This study is a prospective cohort study enrolling up to 4700 children with CAP at EDs at ~80 member sites of the Pediatric Emergency Research Networks (PERN; https://pern-global.com/). We will include children aged 3 months to <14 years with a clinical diagnosis of CAP. We will exclude children with hospital admissions within 7 days prior to the study visit, hospital-acquired pneumonias or chronic complex conditions. Clinical, laboratory and imaging data from the ED visit and hospitalisations within 7 days will be collected. A follow-up telephone or text survey will be completed 7-14 days after the visit. The primary outcome is a three-tier composite of disease severity. Ordinal logistic regression, assuming a partial proportional odds specification, and recursive partitioning will be used to develop the risk stratification models. ETHICS AND DISSEMINATION: This study will result in a clinical prediction model to accurately identify risk of severe disease on presentation to the ED. Ethics approval was obtained for all sites included in the study. Cincinnati Children's Hospital Institutional Review Board (IRB) serves as the central IRB for most US sites. Informed consent will be obtained from all participants. Results will be disseminated through international conferences and peer-reviewed publications. This study overcomes limitations of prior pneumonia severity scores by allowing for broad generalisability of findings, which can be actively implement

AIM: To assess computerised tomography (CT) use and the risk of intracranial haemorrhage (ICH) in children with bleeding disorders following a head trauma. METHODS: Design: Multicentre prospective observational study. SETTING: 10 paediatric emergency departments (ED) in Australia and New Zealand. PATIENTS: Children <18 years with and without bleeding disorders assessed in ED following head trauma between April 2011 and November 2014. INTERVENTIONS: Data collection of patient characteristics, management and outcomes. MAIN OUTCOME MEASURES: Rate of CT use and frequency of ICH on CT. RESULTS: Of 20 137 patients overall, 103 (0.5%) had a congenital or acquired bleeding disorder. CT use was higher in these patients compared with children without bleeding disorders (30.1 vs. 10.4%; rate ratio 2.91 95% CI 2.16-3.91). Only one of 31 (3.2%) children who underwent CT in the ED had an ICH. This patient rapidly deteriorated in the ED on arrival and required neurosurgery. None of the patients with bleeding disorders who did not have a CT obtained in the ED or had an initial negative CT had evidence of ICH on follow up. CONCLUSIONS: Although children with a bleeding disorder and a head trauma more often received a CT scan in the ED, their risk of ICH seemed low and appeared associated with post-traumatic clinical findings. Selective CT use combined with observation may be cautiously considered in these children based on clinical presentation and severity of bleeding disorder.

OBJECTIVES: Variation in the management of paediatric head injury has been identified worldwide. This prospective study describes imaging and admission practices of children presenting with head injury across 10 hospital EDs in Australia and New Zealand. METHODS: Prospective observational multicentre study of 20 137 children (under 18 years) as a planned secondary analysis of the Australasian Paediatric Head Injury Rules Study. All presentations with head injury without prior imaging were eligible for inclusion. Variations in rates of computed tomography of the brain (CTB) and admission practices between sites, ED type and country were investigated, as were clinically important traumatic brain injuries (ciTBIs) and abnormal CTBs within CTBs. RESULTS: Among the 20 137 enrolled patients, the site adjusted CTB rate was 11.2% (95% confidence interval [CI] 7.8-14.6); individual sites ranged from 2.6 to 18.6%. ciTBI was found in 0.4-2.2%, with abnormal scans documented in 0.7-6.5%. As a percentage of CTBs undertaken, ciTBIs were found in 12.8% (95% CI 10.8-14.7) with individual site variation of 8.8-16.9%, and no statistically significant difference noted, and traumatic abnormalities in 29.3% (95% CI 26.2-32.3) with individual site variation between 19.4 and 35.6%. Among those under 2 years,traumatic abnormalities were found in greater than 50% of CTBs at 90% of sites. Admission rate overall was 24.0% (site adjusted) with wide variation between sites (5.0-48.9%). CONCLUSION: Across the 10 largely tertiary EDs included in this study, the overall CTB rate was low with no significant variation between sites when adjusted for ciTBIs.

Multicentre research provides advantages over single‐centre research by maximising available patient numbers while pooling varied expertise and resources available across different participating investigators and sites. The increased complexity of multicentre regulatory approvals, communication and study management, can be mitigated by the formation of a research network where multicentre efforts move from ad hoc, single projects to formalised ongoing collaboration. Network research helps prioritise research efforts and importantly fosters the development of a collaborative track record in terms of research expertise, research capacity and grant success. It also has the potential to rapidly change patient care across many hospitals as research results will be more generalizable and definitive. This paper sets out the key elements of network research, its benefits and possible challenges drawing on the example of PREDICT (Paediatric Research in Emergency Departments International Collaborative) an established paediatric emergency research network in Australia and New Zealand.

BACKGROUND: Management of children with minor blunt head trauma often includes a period of observation to determine the need for cranial computed tomography (CT). Our objective was to estimate the effect of planned observation on CT use for each Pediatric Emergency Care Applied Research Network (PECARN) traumatic brain injury (TBI) risk group among children with minor head trauma. METHODS: This was a secondary analysis of a prospective observational study at 10 emergency departments (EDs) in Australia and New Zealand, including 18,471 children < 18 years old, presenting within 24 hours of blunt head trauma, with Glasgow Coma Scale scores of 14 to 15. The planned observation cohort was defined by those with planned observation and no immediate plan for cranial CT. The comparison cohort included the rest of the patients who were either not observed or for whom a decision to obtain a cranial CT was made immediately after ED assessment. The outcome clinically important TBI (ciTBI) was defined as death due to head trauma, neurosurgery, intubation for > 24 hours for head trauma, or hospitalization for ≥ 2 nights in association with a positive cranial CT scan. We estimated the odds of cranial CT use with planned observation, adjusting for patient characteristics, PECARN TBI risk group, history of seizure, time from injury, and hospital clustering, using a generalized linear model with mixed effects. RESULTS: The cranial CT rate in the total cohort was 8.6%, and 0.8% had ciTBI. The planned observation group had 4,945 (27%) children compared to 13,526 (73%) in the no planned observation group. Cranial CT use was significantly lower with planned observation (adjusted odds ratio [OR] = 0.2, 95% confidence interval [CI] = 0.1 to 0.1), with no difference in missed ciTBI rates. There was no difference in the odds of cranial CT use with planned observation for the group at very low risk for ciTBI (adjusted OR = 0.9, 95% CI = 0.5 to 1.4). Planned observation was associated with sig

AIM: To characterise the causes, clinical characteristics and short-term outcomes of neonates who presented to paediatric emergency departments with a head injury. METHODS: Secondary analysis of a prospective data set of paediatric head injuries at 10 emergency departments in Australia and New Zealand. Patients without neuroimaging were followed up by telephone call. We extracted epidemiological information, clinical findings and outcomes in neonates (≤28 days). RESULTS: Of 20 137 children with head injuries, 93 (0.5%) occurred in neonates. These were mostly fall-related (75.2%), commonly from a care giver's arms, or due to being accidentally struck by a person/object (20.4%). There were three cases of non-accidental head injuries (3.2%). Most neonates were asymptomatic (67.7%) and many had no findings on examination (47.3%). Most neonates had a Glasgow Coma Scale 15 (89.2%) or 14 (7.5%). A total of 15.1% presented with vomiting and 5.4% were abnormally drowsy. None had experienced a loss of consciousness. The most common findings on examination were scalp haematoma (28.0%) and possible palpable skull fracture (6.5%); 8.6% underwent computed tomography brain scan and 4.3% received an ultrasound. Five of eight computed tomography scan (5.4% of neonates overall) showed traumatic brain injury and two of four (2.2% overall) had traumatic brain injury on ultrasound. Thirty-seven percent were admitted, one patient was intubated and none had neurosurgery or died. CONCLUSIONS: Neonatal head injuries are rare with a mostly benign short-term outcome and are appropriate for observation. However, non-accidental injuries need to be considered.

AIM: Abusive head trauma (AHT) is associated with high morbidity and mortality. We aimed to describe characteristics of cases where clinicians suspected AHT and confirmed AHT cases and describe how they differed. METHODS: This was a planned secondary analysis of a prospective multicentre cohort study of head injured children aged <18 years across five centres in Australia and New Zealand. We identified cases of suspected AHT when emergency department clinicians raised suspicion on a clinical report form or based on research assistant-assigned epidemiology codes. Cases were categorised as AHT positive, negative and indeterminate after multidisciplinary review. Suspected and confirmed AHT and non-AHT cases were compared using odds ratios with 95% confidence intervals. RESULTS: AHT was suspected in 70 of 13 371 (0.5%) head-injured children. Of these, 23 (32.9%) were categorised AHT positive, 18 (25.7%) AHT indeterminate and 29 (27.1%) AHT negative. Median age was 0.8 years in suspected, 1.4 years in confirmed AHT and 4.1 years in non-AHT cases. Odds ratios (95% confidence interval) for presenting features and outcomes in confirmed AHT versus non-AHT were: loss of consciousness 2.8 (1.2-6.9), scalp haematoma 3.9 (1.7-9.0), seizures 12.0 (4.0-35.5), Glasgow coma scale ≤12 30.3 (11.8-78.0), abnormal neuroimaging 38.3 (16.8-87.5), intensive care admission 53.4 (21.6-132.5) and mortality 105.5 (22.2-500.4). CONCLUSIONS: Emergency department presentations of children with suspected and confirmed AHT had higher rates of loss of consciousness, scalp haematomas, seizures and low Glasgow coma scale. These cases were at increased risk of abnormal computed tomography scans, need for intensive care and death.

OBJECTIVE: Although there is a large body of research on head injury (HI) inflicted by caregivers in young children, little is known about intentional HI in older children and inflicted HI by perpetrators other than carers. Therefore, we set out to describe epidemiology, demographics and severity of intentional HIs in childhood. METHODS: A planned secondary analysis of a prospective multicentre cohort study was conducted in 10 EDs in Australia and New Zealand, including children aged <18 years with HIs. Epidemiology codes were used to prospectively code the injuries. Demographic and clinical information including the rate of clinically important traumatic brain injury (ciTBI: HI leading to death, neurosurgery, intubation >1 day or admission ≥2 days with abnormal computed tomography [CT]) was descriptively analysed. RESULTS: Intentional injuries were identified in 372 of 20 137 (1.8%) head-injured children. Injuries were caused by caregivers (103, 27.7%), by peers (97, 26.1%), by siblings (47, 12.6%), by strangers (35, 9.4%), by persons with unknown relation to the patient (21, 5.6%), other intentional injuries (8, 2.2%) or undetermined intent (61, 16.4%). About 75.7% of victims of assault by caregivers were <2 years, whereas in other categories, only 4.9% were <2 years. Overall, 66.9% of victims were male. Rates of CT performance and abnormal CT varied: assault by caregivers 68.9%/47.6%, by peers 18.6%/27.8%, by strangers 37.1%/5.7%. ciTBI rate was 22.3% in assault by caregivers, 3.1% when caused by peers and 0.0% with other perpetrators. CONCLUSIONS: Intentional HI is infrequent in children. The most frequently identified perpetrators are caregivers and peers. Caregiver injuries are particularly severe.

AIM: Bronchiolitis is the most common lower respiratory tract disorder in infants aged less than 12 months, and research has demonstrated that there is substantial variation in practice patterns despite treatment being well defined. In order to align and improve the consistency of the management of bronchiolitis, an evidence-based guideline was developed for the Australasian population. METHODS: The guideline development committee included representation from emergency and paediatric specialty medical and nursing personnel in addition to geographical representation across Australia and New Zealand - rural, remote and metropolitan. Formulation of the guideline included identification of population, intervention, comparator, outcomes and time questions and was associated with an extensive literature search from 2000 to 2015. Evidence was summarised and graded using the National Health and Medical Research Council and Grading of Recommendations Assessment, Development and Evaluation methodology, and consensus within the guideline group was sought using nominal group technique principles to formulate the clinical practice recommendations. The guideline was reviewed and endorsed by key paediatric health bodies. RESULTS: The guideline consists of a usable clinical interface for bedside functionality supported by evidence summary and tables. The Grading of Recommendations Assessment, Development and Evaluation and National Health and Medical Research Council processes provided a systematic and transparent process to review and assess the literature, resulting in a guideline that is relevant to the management of bronchiolitis in the Australasian setting. CONCLUSION: This is the first robust Australasian acute paediatric guideline and provides clear guidance for the management of the vast majority of patients seen in Australasian emergency departments and general paediatric wards with bronchiolitis.

In this series we address important topics for clinicians who participate in research or are considering research as part of their career path in emergency medicine. While much emergency research is successfully done by clinicians without a research higher degree (RHD), undertaking a master's degree or doctorate allows a research topic to be pursued in greater depth. It also provides a solid basis for a future research career in terms of research quality, advanced skills, academic progression and track record, as well as eligibility for grants and RHD supervision. The decision to undertake a RHD is not an easy one, and requires consideration of the time and cost involved, as well as the impact on a clinician's life plans. However, the expertise provided through a RHD often ultimately complements clinical training and establishes an excellent foundation for future research and career. This article provides an overview of RHDs and what to consider before embarking on one.

Bronchiolitis is the most common reason for infants to be hospitalised. Over the past decade, the use of high-flow nasal cannulae (HFNC) therapy has increased markedly and it is now utilised not only in the intensive care unit setting but in general paediatric wards and emergency departments. The aim of this systematic review was to summarise and critique the current evidence-base for the use of HFNC in infants with bronchiolitis. We searched Ovid Medline, OvidEmbase, PubMed, Cinahl, Cochrane Library, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials for systematic reviews and randomised controlled trials of HFNC therapy in infants with bronchiolitis from 1 January 2000 to 27 June 2018. We identified four randomised controlled trials (n = 1891) of HFNC in infants with bronchiolitis: three of these studies involved infants treated in emergency departments and inpatient paediatric wards in Spain, Australia and New Zealand, and one study involved infants treated in paediatric intensive care units in France. The findings of this review suggest that HFNC should be used as a rescue treatment for hypoxaemic infants who have not responded to standard sub nasal oxygen therapy. The use of HFNC for work of breathing in the absence of hypoxaemia, and severe disease, is not currently supported by the evidence, and should only be considered in the context of an appropriate research trial.

In this series we address important topics for clinicians who participate in research as part of their work in the ED. The overarching goal of clinical research is to improve care and determine which treatment is best. Yet, defining and measuring outcomes - what is 'best' - can be one of the most difficult steps in the design of a study, in particular when answers to research questions cannot be captured in simple binary results. This article addresses how to choose outcome measures and highlights the increasingly important concept of core outcome sets.

AIM: Penetrating head injuries (pHIs) are associated with high morbidity and mortality. Data on pHIs in children outside North America are limited. We describe the mechanism of injuries, neuroimaging findings, neurosurgery and mortality for pHIs in Australia and New Zealand. METHODS: This was a planned secondary analysis of a prospective observational study of children <18 years who presented with a head injury of any severity at any of 10 predominantly paediatric Australian/New Zealand emergency departments (EDs) between 2011 and 2014. We reviewed all cases where clinicians had clinically suspected pHI as well as all cases of clinically important traumatic brain injuries (death, neurosurgery, intubation >24 h, admission >2 days and abnormal computed tomography). RESULTS: Of 20 137 evaluable patients with a head injury, 21 (0.1%) were identified to have sustained a pHI. All injuries were of non-intentional nature, and there were no gunshot wounds. The mechanisms of injuries varied from falls, animal attack, motor vehicle crashes and impact with objects. Mean Glasgow Coma Scale on ED arrival was 10; 10 (48%) had a history of loss of consciousness, and 7 (33%) children were intubated pre-hospital or in the ED. Fourteen (67%) children underwent neurosurgery, two (10%) craniofacial surgery, and five (24%) were treated conservatively; four (19%) patients died. CONCLUSIONS: Paediatric pHIs are very rare in EDs in Australia and New Zealand but are associated with high morbidity and mortality. The absence of firearm-related injuries compared to North America is striking and may reflect Australian and New Zealand firearm regulations.

BACKGROUND: Bronchiolitis is the most common reason for admission to hospital for infants less than one year of age. Although management is well defined, there is substantial variation in practice, with infants receiving ineffective therapies or management. This study will test the effectiveness of tailored, theory informed knowledge translation (KT) interventions to decrease the use of five clinical therapies or management processes known to be of no benefit, compared to usual dissemination practices in infants with bronchiolitis. The primary objective is to establish whether the KT interventions are effective in increasing compliance to five evidence based recommendations in the first 24 h following presentation to hospital. The five recommendations are that infants do not receive; salbutamol, antibiotics, glucocorticoids, adrenaline, or a chest x-ray. METHODS/DESIGN: This study is designed as a cluster randomised controlled trial. We will recruit 24 hospitals in Australia and New Zealand, stratified by country and provision of tertiary or secondary paediatric care. Hospitals will be randomised to either control or intervention groups. Control hospitals will receive a copy of the recent Australasian Bronchiolitis Guideline. Intervention hospitals will receive KT interventions informed by a qualitative analysis of factors influencing clinician care of infants with bronchiolitis. Key interventions include, local stakeholder meetings, identifying medical and nursing clinical leads in both emergency departments and paediatric inpatient areas who will attend a single education train-the-trainer day to then deliver standardised staff education with the training materials provided and coordinate audit and feedback reports locally over the study period. Data will be extracted retrospectively for three years prior to the study intervention year, and for seven months of the study intervention year bronchiolitis season following intervention delivery to determine compliance

BACKGROUND: There are no medications known that improve the outcome of infants with bronchiolitis. Studies have shown the management of bronchiolitis to be varied. OBJECTIVES: To describe medication use at the seven study hospitals from a recent multi-centre randomised controlled trial on hydration in bronchiolitis (comparative rehydration in bronchiolitis [CRIB]). METHODS: A retrospective analysis of extant data of infants between 2 months (corrected for prematurity) and 12 months of age admitted with bronchiolitis identified through the CRIB trial. CRIB study records, medical records, pathology and radiology databases were used to collect data using a standardised form and entered in a single site database. Medications investigated included salbutamol, adrenaline, steroids, ipratropium bromide, normal saline, hypertonic saline, steroids and antibiotics. RESULTS: There were 3456 infants available for analysis, of which 42.0% received at least one medication during hospitalisation. Medication use varied by site between 27.0 and 48.7%. The most frequently used medication was salbutamol (25.5%). Medication use in general, and salbutamol use in particular, increased by 8.2 and 9.3%, respectively, per month after 4 months of age; from 22.9 and 3.6% at 4 months to 81.4 and 68.8% at 11 months. In infants admitted to the intensive care unit (ICU) compared with those not admitted to ICU 81.6 and 39.5%, respectively, received medication at one point during the hospital stay. CONCLUSIONS: Medication was used for infants with bronchiolitis frequently and variably in Australia and New Zealand. Medication use increased with age. Better strategies for translating evidence into practice are needed.

BACKGROUND: Bronchiolitis is the commonest respiratory infection in children less than 12 months and cause of hospitalisation in infants under 6 months of age in Australasia. Unfortunately there is substantial variation in management, despite high levels of supporting evidence. This paper reports on the process, strengths and challenges of the hybrid approach used to develop the first Australasian management guideline relevant to the local population. METHOD: An adaption of the nine steps recommended by the National Health and Medical Research Council (NHMRC) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology were utilised. Following establishment of the Guideline Development Committee (GDC), we identified the population, intervention, comparator, outcomes and time of interest (PICOt) questions, undertook a systematic literature search and graded the evidence and recommendations using the NHMRC and GRADE processes. Using Nominal Group Techniques (NGT), consensus was sought in formulating the clinical practice recommendations and practice points. Key health professional bodies were consulted to ensure relevance in the Australasian emergency and ward settings. RESULTS: From 33 PICOT questions, clinical recommendations for practice that were deemed relevant to the Australasian population were identified. Specific considerations for the management of Australian and New Zealand indigenous infants in relation to the use of azithromycin and risk factors for more serious illness are included. Using NGT, consensus demonstrated by a median Likert score > 8 for all recommendations was achieved. The guideline presents clinical guidance, followed by the key recommendations and evidence review behind each recommendation. CONCLUSION: Developing evidence-based clinical guidelines is a complex process with considerable challenges. Challenges included having committee members located over two countries and five time zones, large volume of li

BACKGROUND: Clinical decision rules (CDRs) aid in the management of children with traumatic brain injury (TBI). Recently, the Scandinavian Neurotrauma Committee (SNC) has published practical, evidence-based guidelines for children with Glasgow Coma Scale (GCS) scores of 9-15. This study aims to validate these guidelines and to compare them with other CDRs. METHODS: A large prospective cohort of children (< 18 years) with TBI of all severities, from ten Australian and New Zealand hospitals, was used to assess the SNC guidelines. Firstly, a validation study was performed according to the inclusion and exclusion criteria of the SNC guideline. Secondly, we compared the accuracy of SNC, CATCH, CHALICE and PECARN CDRs in patients with GCS 13-15 only. Diagnostic accuracy was calculated for outcome measures of need for neurosurgery, clinically important TBI (ciTBI) and brain injury on CT. RESULTS: The SNC guideline could be applied to 19,007/20,137 of patients (94.4%) in the validation process. The frequency of ciTBI decreased significantly with stratification by decreasing risk according to the SNC guideline. Sensitivities for the detection of neurosurgery, ciTBI and brain injury on CT were 100.0% (95% CI 89.1-100.0; 32/32), 97.8% (94.5-99.4; 179/183) and 95% (95% CI 91.6-97.2; 262/276), respectively, with a CT/admission rate of 42% (mandatory CT rate of 5%, 18% CT or admission and 19% only admission). Four patients with ciTBI were missed; none needed specific intervention. In the homogenous comparison cohort of 18,913 children, the SNC guideline performed similar to the PECARN CDR, when compared with the other CDRs. CONCLUSION: The SNC guideline showed a high accuracy in a large external validation cohort and compares well with published CDRs for the management of paediatric TBI.

Background: Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of CSE in children. Methods/Design: 200 children aged between 3 months and 16 years presenting to 13 emergency departments in Australia and New Zealand with CSE, that has failed to stop with first line benzodiazepines, will be enrolled into this multicentre open randomised controlled trial. Participants will be randomised to 40 mg/kg IV levetiracetam infusion over 5 min or 20 mg/kg IV phenytoin infusion over 20 min. The primary outcome for the study is clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. Blinded confirmation of the primary outcome will occur with the primary outcome assessment being video recorded and assessed by a primary outcome assessment team blinded to treatment allocation. Secondary outcomes include: Clinical cessation of seizure activity at two hours; Time to clinical seizure cessation; Need for rapid sequence induction; Intensive care unit (ICU) admission; Serious adverse events; Length of Hospital/ICU stay; Health care costs; Seizure status/death at one-month post discharge. Discussion: This paper presents the background, rationale, and design for a randomised controlled trial comparing levetiracetam to phenytoin in chil

Background: Bell's palsy or acute idiopathic lower motor neurone facial paralysis is characterized by sudden onset paralysis or weakness of the muscles to one side of the face controlled by the facial nerve. While there is high level evidence in adults demonstrating an improvement in the rate of complete recovery of facial nerve function when treated with steroids compared with placebo, similar high level studies on the use of steroids in Bell's palsy in children are not available. The aim of this study is to assess the utility of steroids in Bell's palsy in children in a randomised placebo-controlled trial. Methods/Design: We are conducting a randomised, triple-blinded, placebo controlled trial of the use of prednisolone to improve recovery from Bell's palsy at 1 month. Study sites are 10 hospitals within the Australian and New Zealand PREDICT (Paediatric Research in Emergency Departments International Collaborative) research network. 540 participants will be enrolled. To be eligible patients need to be aged 6 months to < 18 years and present within 72 hours of onset of clinician diagnosed Bell's palsy to one of the participating hospital emergency departments. Patients will be excluded in case of current use of or contraindications to steroids or if there is an alternative diagnosis. Participants will receive either prednisolone 1 mg/kg/day to a maximum of 50 mg/day or taste matched placebo for 10 days. The primary outcome is complete recovery by House-Brackmann scale at 1 month. Secondary outcomes include assessment of recovery using the Sunnybrook scale, the emotional and functional wellbeing of the participants using the Pediatric Quality of Life Inventory and Child Health Utility 9D Scale, pain using Faces Pain Scale Revised or visual analogue scales, synkinesis using a synkinesis assessment questionnaire and health utilisation costs at 1, 3 and 6 months. Participants will be tracked to 12 months if not recovered earlier. Data analysis will be by intention to

Background: A challenge of conducting research in critically ill children is that the therapeutic window for the intervention may be too short to seek informed consent prior to enrolment. In specific circumstances, most international ethical guidelines allow for children to be enrolled in research with informed consent obtained later, termed deferred consent (DC) or retrospective consent. There is a paucity of data on the attitudes of parents to this method of enrolment in paediatric emergency research. Objectives: To explore the attitudes of parents to the concept of DC and to expand the knowledge of the limitations to informed consent and DC in these situations.MethodChildren presenting with uncomplicated febrile seizures or bronchiolitis were identified from three separate hospital emergency department databases. Parents were invited to participate in a semistructured telephone interview exploring themes of limitations of prospective informed consent, acceptability of the DC process and the most appropriate time to seek DC. Transcripts underwent inductive thematic analysis with intercoder agreement, using Nvivo 11 software. Results: A total of 39 interviews were conducted. Participants comprehended the limitations of informed consent under emergency circumstances and were generally supportive of DC. However, they frequently confused concepts of clinical care and research, and support for participation was commonly linked to their belief of personal benefit. Conclusion: Participants acknowledged the requirement for alternatives to prospective informed consent in emergency research, and were supportive of the concept of DC. Our results suggest that current research practice

BACKGROUND: A challenge of conducting research in critically ill children is that the therapeutic window for the intervention may be too short to seek informed consent prior to enrolment. In specific circumstances, most international ethical guidelines allow for children to be enrolled in research with informed consent obtained later, termed deferred consent (DC) or retrospective consent. There is a paucity of data on the attitudes of parents to this method of enrolment in paediatric emergency research. OBJECTIVES: To explore the attitudes of parents to the concept of DC and to expand the knowledge of the limitations to informed consent and DC in these situations. METHOD: Children presenting with uncomplicated febrile seizures or bronchiolitis were identified from three separate hospital emergency department databases. Parents were invited to participate in a semistructured telephone interview exploring themes of limitations of prospective informed consent, acceptability of the DC process and the most appropriate time to seek DC. Transcripts underwent inductive thematic analysis with intercoder agreement, using Nvivo 11 software. RESULTS: A total of 39 interviews were conducted. Participants comprehended the limitations of informed consent under emergency circumstances and were generally supportive of DC. However, they frequently confused concepts of clinical care and research, and support for participation was commonly linked to their belief of personal benefit. CONCLUSION: Participants acknowledged the requirement for alternatives to prospective informed consent in emergency research, and were supportive of the concept of DC. Our results suggest that current research practice seems to align with community expectations.

BACKGROUND: Convulsive status epilepticus (CSE) is the most common life-threatening neurological emergency in childhood. These children are also at risk of significant morbidity, with acute and chronic impact on the family and the health and social care systems. The current recommended first-choice, second-line treatment in children aged 6 months and above is intravenous phenytoin (fosphenytoin in the USA), although there is a lack of evidence for its use and it is associated with significant side effects. Emerging evidence suggests that intravenous levetiracetam may be effective as a second-line agent for CSE, and fewer adverse effects have been described. This trial therefore aims to determine whether intravenous phenytoin or levetiracetam is more effective, and safer, in treating childhood CSE. METHODS/DESIGN: This is a phase IV, multi-centre, parallel group, randomised controlled, open-label trial. Following treatment for CSE with first-line treatment, children with ongoing seizures are randomised to receive either phenytoin (20 mg/kg, maximum 2 g) or levetiracetam (40 mg/kg, maximum 2.5 g) intravenously. The primary outcome measure is the cessation of all visible signs of CSE as determined by the treating clinician. Secondary outcome measures include the need for further anti-seizure medications or rapid sequence induction for ongoing CSE, admission to critical care areas, and serious adverse reactions. Patients are recruited without prior consent, with deferred consent sought at an appropriate time for the family. The primary analysis will be by intention-to-treat. The primary outcome is a time to event outcome and a sample size of 140 participants in each group will have 80% power to detect an increase in CSE cessation rates from 60% to 75%. Our total sample size of 308 randomised and treated participants will allow for 10% loss to follow-up. DISCUSSION: This clinical trial will determine whether phenytoin or levetiracetam is more effective as an intravenous

AIM: We aimed to examine the impact of weather on hospital admissions with bronchiolitis in Australia and New Zealand. METHODS: We collected data for inpatient admissions of infants aged 2-12 months to seven hospitals in four cities in Australia and New Zealand from 2009 until 2011. Correlation of hospital admissions with minimum daily temperature, wind speed, relative humidity and rainfall was examined using linear, Poisson and negative binomial regression analyses as well as general estimated equation models. To account for possible lag between exposure to weather and admission to hospital, analyses were conducted for time lags of 0-4 weeks. RESULTS: During the study period, 3876 patients were admitted to the study hospitals. Hospital admissions showed strong seasonality with peaks in wintertime, onset in autumn and offset in spring. The onset of peak incidence was preceded by a drop in temperature. Minimum temperature was inversely correlated with hospital admissions, whereas wind speed was directly correlated. These correlations were sustained for time lags of up to 4 weeks. Standardised correlation coefficients ranged from -0.14 to -0.54 for minimum temperature and from 0.18 to 0.39 for wind speed. Relative humidity and rainfall showed no correlation with hospital admissions in our study. CONCLUSION: A decrease in temperature and increasing wind speed are associated with increasing incidence of bronchiolitis hospital admissions in Australia and New Zealand.