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INTRODUCTION: Sepsis affects 25.2 million children per year globally and causes 3.4 million deaths, with an annual cost of hospitalisation in the USA of US$7.3 billion. Despite being common, severe and expensive, therapies and outcomes from sepsis have not substantially changed in decades. Variable case definitions, lack of a reference standard for diagnosis and broad spectrum of disease hamper efforts to evaluate therapies that may improve sepsis outcomes. This landscape analysis of community-acquired childhood sepsis in Australia and New Zealand will characterise the burden of disease, including incidence, severity, outcomes and cost. Sepsis diagnostic criteria and risk stratification tools will be prospectively evaluated. Sepsis therapies, quality of care, parental awareness and understanding of sepsis and parent-reported outcome measures will be described. Understanding these aspects of sepsis care is fundamental for the design and conduct of interventional trials to improve childhood sepsis outcomes. METHODS AND ANALYSIS: This prospective observational study will include children up to 18 years of age presenting to 12 emergency departments with suspected sepsis within the Paediatric Research in Emergency Departments International Collaborative network in Australia and New Zealand. Presenting characteristics, management and outcomes will be collected. These will include vital signs, serum biomarkers, clinician assessment of severity of disease, intravenous fluid administration for the first 24 hours of hospitalisation, organ support therapies delivered, antimicrobial use, microbiological diagnoses, hospital and intensive care unit length-of-stay, mortality censored at hospital discharge or 30 days from enrolment (whichever comes first) and parent-reported outcomes 90 days from enrolment. We will use these data to determine sepsis epidemiology based on existing and novel diagnostic criteria. We will also validate existing and novel sepsis risk stratification criteria, characterise antimicrobial stewardship, guideline adherence, cost and report parental awareness and understanding of sepsis and parent-reported outcome measures. ETHICS AND DISSEMINATION: Ethics approval was received from the Royal Childrens Hospital of Melbourne, Australia Human Research Ethics Committee (HREC/69948/RCHM-2021). This included incorporated informed consent for follow-up. The findings will be disseminated in a peer-reviewed journal and at academic conferences. TRIAL REGISTRATION NUMBER: ACTRN12621000920897; Pre-results.

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 asked to achieve consensus on a core set of outcomes and to make recommendations for the conduct of clinical trials in acute severe asthma. If this is not possible, the group will agree on a series of prioritized steps to achieve this aim. DISCUSSION:The development of an international consensus on core outcomes is an important first step towards the development of consensus guidelines and standardised protocols for randomized controlled trials (RCTs) in this population. This will enable us to better interpret and compare future studies, reduce risks of study heterogeneity and outcome reporting bias, and improve the evidence base for the management of this important condition.

Objective: The objective was to investigate the feasibility of prospectively validating multiple clinical prediction scores (CPSs) for pediatric appendicitis in an Australian pediatric emergency department (ED). Methods: A literature search was conducted to identify potential CPSs and a single‐center prospective observational feasibility study was performed between November 2022 and May 2023 to evaluate the performance of identified CPSs. Children 5–15 years presenting with acute right‐sided or generalized abdominal pain and clinician suspicion of appendicitis were included. CPSs were calculated by the study team from prospectively clinician‐collected data and/or review of medical records. Accuracy of CPSs were assessed by area under the receiver operating characteristic curve (AUC) and proportions correctly identifiable as either low‐risk or high‐risk with the best performing CPS compared to clinician gestalt. Final diagnosis of appendicitis was confirmed on histopathology or by telephone/email follow‐up for those discharged directly from ED. Results: Thirty CPSs were identified in the literature search and 481 patients were enrolled in the study. A total of 150 (31.2%) patients underwent appendectomy with three (2.0%) having a normal appendix on histopathology. All identified CPSs were calculable for at least 50% of the patient cohort. The pediatric Appendicitis Risk Calculator for pediatric EDs (pARC‐ED; n = 317) was the best performing CPS with AUC 0.90 (95% confidence interval [CI] 0.86–0.94) and specificity 99.0% (95% CI 96.4%–99.7%) in diagnosing high‐risk cases and a misclassification rate of 4.5% for low‐risk cases. Conclusions: The study identified 30 CPSs that could be validated in a majority of patients to compare their ability to assess risk of pediatric appendicitis. The pARC‐ED had the highest predictive accuracy and can potentially assist in risk stratification of children with suspected appendicitis in pediatric EDs. A multicenter study is now under way to evaluate the potential of these CPSs in a broader range of EDs to aid clinical decision making in more varied settings. [ABSTRACT FROM AUTHOR]

Over 10 million ED visits occur each year across Australia and Aotearoa New Zealand. Outside basic administrative data focused on time‐based targets, there is minimal information about clinical performance, quality of care, patient outcomes, or equity in emergency care. The lack of a timely, accurate or clinically useful data collection represents a missed opportunity to improve the care we deliver each day. The present paper outlines a proposal for a National Acute Care Secure Health Data Environment, including design, possible applications, and the steps taken to date by the Australasian College for Emergency Medicine ED Epidemiology Network in collaboration with the College of Emergency Nursing Australasia. Optimal use of the existing information collected routinely during clinical care of emergency patients has the potential to enable data‐driven quality improvement and research, leading to better care and better outcomes for millions of patients and families each year. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to describe and compare the proportion of patients classified as an emergency department (ED) mental health presentation under different definitions, including the Australian Institute of Health and Welfare (AIHW) definition. Methods: This retrospective cohort study enrolled all patients that presented to the EDs of a multi-centre Victorian health service between 1 January 2020 and 30 June 2023. Varying definitions of a mental health presentation were applied to each ED attendance, applying the current AIHW definition (using selected diagnosis codes), broader diagnosis-based coding, the presenting complaint recorded at triage and whether the patient was seen by or referred to the emergency psychiatric service (EPS). The proportion of all ED presentations meeting each definition and any overlap between definitions were calculated. The agreement between each definition and the AIHW definition was evaluated using Kappa's coefficient. Results: There were 813,078 presentations to ED of which 34,248 (4.2%) met the AIHW definition for a mental health presentation. Throughout the study, 45,376 (5.6%) patients were seen and/or referred to EPS, and 36,160 (4.4%) patients were allocated a mental health presenting complaint by triage staff. There was moderate interrater agreement between these definitions, with a kappa statistic (95% confidence interval) between the AIHW definition and a mental health presenting complaint recorded at triage of 0.58 (0.58–0.59) and between the AIHW definition and review by EPS of 0.58 (0.57–0.58). Conclusions: The AIHW definition is a conservative measure of ED mental health presentations and may underestimate emergency psychiatry workload in Australian EDs. What is known about this topic? It is unknown whether the Australian Institute of Health and Welfare (AIHW) definition of an emergency department (ED) mental health presentation definition accurately reflects ED mental health workload. What does this paper add? The AIHW definition appears to underestimate the clinical workload related to ED mental health presentations. There is moderate agreement between the AIHW definition and mental health presentations classified according to complaint recorded at triage, or whether the patient is reviewed by psychiatry services. What are the implications for practitioners? Accurate measurement of emergency psychiatry workload should not rely on the AIHW definition alone. [ABSTRACT FROM AUTHOR]

Objective: Clinical practice guidelines (CPGs) are an important tool for the management of children with sepsis. The quality, consistency and concordance of Australian and New Zealand (ANZ) childhood sepsis CPGs with the Australian Commission on Safety and Quality in Healthcare (ACSQHC) sepsis clinical care standards and international sepsis guidelines is unclear. Methods: We accessed childhood sepsis CPGs for all ANZ states and territories through Paediatric Research in Emergency Departments International Collaborative members. The guidelines were assessed for quality using the AGREE‐II instrument. Consistency between CPG treatment recommendations was assessed, as was concordance with the ACSQHC sepsis clinical care standards and international sepsis guidelines. Results: Overall, eight CPGs were identified and assessed. CPGs used a narrative and pathway format, with those using both having the highest quality overall. CPG quality was highest for description of scope and clarity of presentation, and lowest for editorial independence. Consistency between guidelines for initial treatment recommendations was poor, with substantial variation in the choice and urgency of empiric antimicrobial administration; the choice, volume and urgency of fluid resuscitation; and the choice of first‐line vasoactive agent. Most CPGs were concordant with time‐critical components of the ACSQHC sepsis clinical care standard, although few addressed post‐acute care. Concordance with international sepsis guidelines was poor. Conclusion: Childhood sepsis CPGs in current use in ANZ are of variable quality and lack consistency with key treatment recommendations. CPGs are concordant with the ACSQHC care standard, but not with international sepsis guidelines. A bi‐national sepsis CPG may reduce unnecessary variation in care. [ABSTRACT FROM AUTHOR]

The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaivers[1] for other types of oral dosage forms based on pre-defined criteria may also be acceptable. Similarly, biowaivers for dosage forms such as injectable products may also be allowed if certain criteria are met. The current paper summarises the biowaiver requirements for oral solutions and suspensions, soft gelatin capsules and injectable products (intravenous injections, subcutaneous and intramuscular injections, emulsions for injection and micellar solutions for injection) among the participants of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Programme (IPRP). A review of the requirements indicated that there was a trend towards convergence when the dosage form became less complex; however, the most common approach used by each of the jurisdictions was a case-by-case approach given that most jurisdictions do not have well defined guidelines to support all possible scenarios. Even in the simplest case of intravenous solutions, the acceptability of qualitative changes in excipients differ between the IPRP members. Notwithstanding the differences, the dissemination of the information is a first step towards regulatory convergence regarding biowaivers for certain dosage forms and should be useful for pharmaceutical companies currently developing generic medicinal products for IPRP jurisdictions.

Objective: To investigate characteristics and management of children presenting with chest complaints to a tertiary paediatric ED post‐mRNA COVID‐19 vaccine. Methods: This was a retrospective medical record review with data linkage to the Australian Immunisation Register. The study setting was the Royal Children's Hospital, Melbourne, Australia. Children <18 years who had a troponin blood test performed in hospital within 14 days of receiving mRNA COVID‐19 vaccination were included. Elevated troponin and myocarditis or pericarditis as per Brighton criteria was the primary outcome. Vaccination status, length of stay, investigations and clinical management were secondary outcomes. Results: Six hundred and ten patients had a troponin test in 13 months. After exclusion of trauma‐related tests (n = 31), known cardiac patients (n = 75) and others (n = 145), 359 troponins were obtained due to chest complaints and related symptoms, with 283 troponins assessed to be mRNA vaccination‐related. There was a temporal peak in presentations with a 30‐fold monthly increase in troponin post‐commencement of mRNA COVID‐19 vaccines. In those with chest complaints following mRNA vaccination, mean age was 14 years and 50.4% were female. Fourteen out of 283 (5%) vaccine‐related troponins were abnormal with 14 patients assessed to have vaccine‐associated myocarditis. No patients had pericarditis. Conclusions: There was a large number of possible mRNA COVID‐19 vaccine‐related chest complaints presenting to the ED. Few patients had abnormal troponins or myocarditis. [ABSTRACT FROM AUTHOR]

Objective: To identify external causes of unintentional childhood injury presenting to Australian EDs. Methods: Six major paediatric hospitals in four Australian states supplied de‐identified ED data for 2011–2017 on age, sex, attendance time/date, presenting problem, injury diagnosis, triage category and mode of separation. Three hospitals supplied data on external cause and intent of injury. A machine classifier tool was used to supplement the missing external cause coding in the remaining hospitals to enable the compilation of a standardised dataset for childhood injury causes analysis. Results: A total of 486 762 ED presentations for unintentional injury in children aged 0–14 years were analysed. The leading specified cause of ED presentations was low fall (35.0%) followed by struck/collision with an object (13.8%) with little sex difference observed. Males aged 10–14 years had higher rates of motorcycle, pedal cycle and fire/flame‐related injury and lower rates of horse‐related injury and drug/medicinal substance poisoning compared with females. The leading specified external cause resulting in hospitalisation was low fall (32.2%) followed by struck/collision with an object (11.1%). The injuries with the highest proportion of children being hospitalised were drownings (64.4%), pedestrian (53.4%), motorcycle (52.7%) and horse‐related injuries (50.0%). Conclusions: This is the first large‐scale study since the 1980s to explore external causes of unintentional childhood injury presenting to Australian paediatric EDs. It demonstrates a hybrid human–machine learning approach to create a standardised database to overcome data deficiencies. The results supplement existing knowledge of hospitalised paediatric injury to better understand the causes of childhood injury by age and sex, which require health service utilisation. [ABSTRACT FROM AUTHOR]