Paediatrics (RCH) - Research Publications

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    Sustainability of evidence-based practices in the management of infants with bronchiolitis in hospital settings - a PREDICT study protocol.
    Ramsden, V ; Babl, FE ; Dalziel, SR ; Middleton, S ; Oakley, E ; Haskell, L ; Lithgow, A ; Orsini, F ; Schembri, R ; Wallace, A ; Wilson, CL ; McInnes, E ; Wilson, PH ; Tavender, E (Springer Science and Business Media LLC, 2022-08-29)
    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 qualitative component will consist of semi-structured interviews with three to five key emergency department and paediatric inpatient medical and nursing staff per site (total n = 78-130). Factors that may have contributed to sustaining outcomes and/or interventions will be explored and mapped to an established sustainability framework. DISCUSSION: This study will improve our understanding of the sustainability of evidence-based bronchiolitis management in infants. Results will also advance implementation science research by informing future de-implementation strategies to reduce low-value practices and sustain practice change in paediatric acute care. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry No: ACTRN12621001287820.
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    Treatment patterns and frequency of key outcomes in acute severe asthma in children: a Paediatric Research in Emergency Departments International Collaborative (PREDICT) multicentre cohort study
    Craig, S ; Powell, CVE ; Nixon, GM ; Oakley, E ; Hort, J ; Armstrong, DS ; Ranganathan, S ; Kochar, A ; Wilson, C ; George, S ; Phillips, N ; Furyk, J ; Lawton, B ; Borland, ML ; O'Brien, S ; Neutze, J ; Lithgow, A ; Mitchell, C ; Watkins, N ; Brannigan, D ; Wood, J ; Gray, C ; Hearps, S ; Ramage, E ; Williams, A ; Lew, J ; Jones, L ; Graudins, A ; Dalziel, S ; Babl, FE (BMJ PUBLISHING GROUP, 2022-03-01)
    RATIONALE: Severe acute paediatric asthma may require treatment escalation beyond systemic corticosteroids, inhaled bronchodilators and low-flow oxygen. Current large asthma datasets report parenteral therapy only. OBJECTIVES: To identify the use and type of escalation of treatment in children presenting to hospital with acute severe asthma. METHODS: Retrospective cohort study of children with an emergency department diagnosis of asthma or wheeze at 18 Australian and New Zealand hospitals. The main outcomes were use and type of escalation treatment (defined as any of intensive care unit admission, nebulised magnesium, respiratory support or parenteral bronchodilator treatment) and hospital length of stay (LOS). MEASUREMENTS AND MAIN RESULTS: Of 14 029 children (median age 3 (IQR 1-3) years; 62.9% male), 1020 (7.3%, 95% CI 6.9% to 7.7%) had treatment escalation. Children with treatment escalation had a longer LOS (44.2 hours, IQR 27.3-63.2 hours) than children without escalation 6.7 hours, IQR 3.5-16.3 hours; p<0.001). The most common treatment escalations were respiratory support alone (400; 2.9%, 95% CI 2.6% to 3.1%), parenteral bronchodilator treatment alone (380; 2.7%, 95% CI 2.5% to 3.0%) and both respiratory support and parenteral bronchodilator treatment (209; 1.5%, 95% CI 1.3% to 1.7%). Respiratory support was predominantly nasal high-flow therapy (99.0%). The most common intravenous medication regimens were: magnesium alone (50.4%), magnesium and aminophylline (24.6%) and magnesium and salbutamol (10.0%). CONCLUSIONS: Overall, 7.3% children with acute severe asthma received some form of escalated treatment, with 4.2% receiving parenteral bronchodilators and 4.3% respiratory support. There is wide variation treatment escalation.
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    Review article: Developing the Australian and New Zealand Guideline for Mild to Moderate Head Injuries in Children: An adoption/adaption approach
    Tavender, E ; Ballard, DW ; Wilson, A ; Borland, ML ; Oakley, E ; Cotterell, E ; Wilson, CL ; Ring, J ; Dalziel, SR ; Babl, FE (WILEY, 2021-02-02)
    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.
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    Australian and New Zealand Guideline for Mild to Moderate Head Injuries in Children
    Babl, FE ; Tavender, E ; Ballard, DW ; Borland, ML ; Oakley, E ; Cotterell, E ; Halkidis, L ; Goergen, S ; Davis, GA ; Perry, D ; Anderson, V ; Barlow, KM ; Barnett, P ; Bennetts, S ; Bhamjee, R ; Cole, J ; Craven, J ; Haskell, L ; Lawton, B ; Lithgow, A ; Mullen, G ; O'Brien, S ; Paproth, M ; Wilson, CL ; Ring, J ; Wilson, A ; Leo, GSY ; Dalziel, SR (WILEY, 2021-02-02)
    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.
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    Process evaluation of a cluster randomised controlled trial to improve bronchiolitis management - a PREDICT mixed-methods study
    Haskell, L ; Tavender, EJ ; O'Brien, S ; Wilson, CL ; Babl, FE ; Borland, ML ; Schembri, R ; Orsini, F ; Cotterell, E ; Sheridan, N ; Oakley, E ; Dalziel, SR (BMC, 2021-11-29)
    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 the greatest barrier to their use. CONCLUSION: Our targeted, theory-informed interventions were delivered with moderate fidelity, and were well received by clinical leads. Despite clinical leads experiencing challenges of time constraints, the level of fidelity had a positive effect on successfully de-implementing non-evidence-based care in infants with bronchiolitis. These findings will inform widespread rollout of our bronchiolitis interventions, and guide future practice change in acute care settings. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry: ACTRN12616001567415 .
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    Development of targeted, theory-informed interventions to improve bronchiolitis management
    Haskell, L ; Tavender, EJ ; Wilson, CL ; O'Brien, S ; Babl, FE ; Borland, ML ; Cotterell, E ; Sheridan, N ; Oakley, E ; Dalziel, SR (BMC, 2021-08-03)
    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 techniques chosen to address these domains. Final interventions included: (1) Local stakeholder meetings, (2) Identification of medical and nursing clinical leads, (3) Train-the-trainer workshop for all clinical leads, (4) Local educational materials for delivery by clinical leads, (5) Provision of tools and materials targeting influencing factors, and prompting recommended behaviours, and (6) Audit and feedback. CONCLUSION: A stepped approach based on theory, evidence and issues of feasibility, local relevance and acceptability, was successfully used to develop interventions to improve management of infants with bronchiolitis. The rationale and content of interventions has been explicitly described allowing others to de-implement unnecessary bronchiolitis management, thereby improving care.
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    Does fluid bolus therapy increase blood pressure in children with sepsis?
    Long, E ; Babl, FE ; Oakley, E ; Hopper, S ; Sheridan, B ; Duke, T (WILEY, 2020-02-01)
    OBJECTIVE: To describe the effect of fluid bolus therapy (FBT) on blood pressure in children with sepsis. Secondary outcomes included the effect of FBT on systemic vascular resistance, shock index and shock phenotype (warm or cold). METHODS: This was a prospective observational study in the ED of The Royal Children's Hospital, Melbourne, Australia. Participants were children meeting international consensus criteria for sepsis who received FBT for tachycardia or hypotension. FBT was defined as 10-20 mL/kg of 0.9% saline. Mean blood pressure (MBP) was recorded at baseline, 5 and 60 min after FBT. Total systemic vascular resistance index (TSVRi), shock index, and shock phenotype were derived for each time point. Hypotension was defined as MBP <55 + 1.5 × age (years). Warm shock was defined as TSVRi <800 dyne s/cm5 /m2 . RESULTS: Fifty fluid boluses were recorded in 41 children. Median MBP was 78 mmHg (interquartile range [IQR] 63-86) at baseline, 72 mmHg (IQR 60-82) at 5 min, and 75 mmHg (IQR 66-84) at 60 min. Hypotension was observed in 16% at baseline, 26% at 5 min and 17% at 60 min. Median TSVRi was 1580 dyne s/cm5 /m2 (IQR 1242-2206) at baseline, 1254 dyne s/cm5 /m2 (IQR 1027-1787) at 5 min, and 1850 dyne s/cm5 /m2 (IQR 1265-2140) at 60 min. Median shock index was 1.60 (IQR 1.34-1.90) at baseline, 1.49 (IQR 1.25-1.76) at 5 min and 1.37 (IQR 1.22-1.61) at 60 min. Two percent of cases had warm shock at baseline, 12% at 5 min and 2% at 60 min. CONCLUSIONS: MBP initially decreased following FBT for paediatric sepsis, returning towards baseline over the subsequent 60 min. The utility of FBT for increasing MBP and its effect on patient-centred outcomes in children with sepsis warrants further exploration.
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    Effectiveness of Targeted Interventions on Treatment of Infants With Bronchiolitis A Randomized Clinical Trial
    Haskell, L ; Tavender, EJ ; Wilson, CL ; O'Brien, S ; Babl, FE ; Borland, ML ; Cotterell, E ; Schembri, R ; Orsini, F ; Sheridan, N ; Johnson, DW ; Oakley, E ; Dalziel, SR (AMER MEDICAL ASSOC, 2021-04-12)
    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 intention to treat. Baseline data collected on 8003 infants for 3 bronchiolitis seasons (2014-2016) before the implementation period were similar between intervention and control hospitals. Implementation period data were collected on 3727 infants, including 2328 boys (62%) and 1399 girls (38%), with a mean (SD) age of 6.0 (3.2) months. A total of 459 (12%) were Māori (New Zealand), and 295 (8%) were Aboriginal/Torres Strait Islander (Australia). Compliance with recommendations was 85.1% (95% CI, 82.6%-89.7%) in intervention hospitals vs 73.0% (95% CI, 65.3%-78.8%) in control hospitals (adjusted risk difference, 14.1%; 95% CI, 6.5%-21.7%; P < .001). CONCLUSIONS AND RELEVANCE: Targeted interventions led to improved treatment of infants with bronchiolitis. This study has important implications for bronchiolitis management and the development of effective interventions to deimplement low-value care. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry: ACTRN12616001567415.
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    High flow in children with respiratory failure: A randomised controlled pilot trial - A paediatric acute respiratory intervention study
    Franklin, D ; Shellshear, D ; Babl, FE ; Hendrickson, R ; Williams, A ; Gibbons, K ; McEnery, K ; Kennedy, M ; Pham, TMT ; Acworth, J ; Levitt, D ; Oakley, E (WILEY, 2020-12-30)
    AIMS: High-flow is increasingly used in children with acute hypoxaemic respiratory failure (AHRF), despite limited evidence. The primary feasibility endpoint for this pilot-study was the proportion of treatment failure, secondary outcomes being intensive care unit (ICU) admissions and proportion of patients requiring escalation of care. We measured duration of hospital stay, duration of oxygen therapy and rates of ICU admission. METHODS: An open-labelled randomised controlled trial feasibility design was used in two tertiary children's hospitals in the emergency department and general wards. Children aged 0-16 years with AHRF were randomised (1:1) to either high-flow or standard-oxygen. Children on standard-oxygen received rescue high-flow in general wards if failure criteria were met. RESULTS: Of 563 randomised, 283 received high-flow and 280 standard-oxygen with no adverse events. The proportion of children who failed treatment and receiving escalation of care was 11.7% (32/283 children) on high-flow and 18.1% (50/280 infants) on standard-oxygen (odds ratio 0.68, 95% confidence interval 0.38-1.00). In children with obstructive airway disease, 9.7% on high-flow and 17.4% on standard-oxygen required escalation (risk-difference -7.7% percentage points; 95% confidence interval -14.3, -1.1); in children with non-obstructive disease no difference was observed. Neither difference in ICU admissions nor any difference in length of hospital stay was observed. Sixty percent of children who failed standard-oxygen responded to rescue high-flow. CONCLUSION: High-flow outside ICU appears to be feasible in children with AHRF and the required proportion of escalation was lower compared to standard-oxygen. The trial design can be applied in a future large randomised controlled trial.
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    Risk of traumatic intracranial haemorrhage in children with bleeding disorders
    Bressan, S ; Monagle, P ; Dalziel, SR ; Borland, ML ; Phillips, N ; Kochar, A ; Lyttle, MD ; Cheek, JA ; Neutze, J ; Oakley, E ; Dalton, S ; Gilhotra, Y ; Hearps, S ; Furyk, J ; Babl, FE (WILEY, 2020-08-18)
    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.