Facial Function in Bell Palsy in a Cohort of Children Randomized to Prednisolone or Placebo 12 Months After Diagnosis.

BACKGROUND: Information on the medium-term recovery of children with Bell palsy or acute idiopathic lower motor neuron facial paralysis is limited. METHODS: We followed up children aged 6 months to <18 years with Bell palsy for 12 months after completion of a randomized trial on the use of prednisolone. We assessed facial function using the clinician-administered House-Brackmann scale and the modified parent-administered House-Brackmann scale. RESULTS: One hundred eighty-seven children were randomized to prednisolone (n = 93) or placebo (n = 94). At six months, the proportion of patients who had recovered facial function based on the clinician-administered House-Brackmann scale was 98% (n = 78 of 80) in the prednisolone group and 93% (n = 76 of 82) in the placebo group. The proportion of patients who had recovered facial function based on the modified parent-administered House-Brackmann scale was 94% (n = 75 of 80) vs 89% (n = 72 of 81) at six months (OR 1.88; 95% CI 0.60, 5.86) and 96% (n = 75 of 78) vs 92% (n = 73 of 79) at 12 months (OR 3.12; 95% CI 0.61, 15.98). CONCLUSIONS: Although the vast majority had complete recovery of facial function at six months, there were some children without full recovery of facial function at 12 months, regardless of prednisolone use.

Sepsis epidemiology in Australian and New Zealand children (SENTINEL): protocol for a multicountry prospective observational study.

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 Children's 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.

Mild Traumatic Brain Injury Characteristics and Symptoms in Preschool Children: How Do They Differ to School Age Children? A Multicenter Prospective Observational Study.

OBJECTIVE: To investigate if preschool children differ to school age children with mild traumatic brain injury (TBI) with respect to injury causes, clinical presentation, and medical management. DESIGN: A secondary analysis of a dataset from a large, prospective and multisite cohort study on TBI in children aged 0-18 years, the Australian Paediatric Head Injury Rules Study. SETTING: Nine pediatric emergency departments (ED) and 1 combined adult and pediatric ED located across Australia and New Zealand. PARTICIPANTS: 7080 preschool aged children (2-5 years) were compared with 5251 school-age children (6-12 years) with mild TBI (N= (N=12,331) MAIN OUTCOME MEASURES: Clinical report form on medical symptoms, injury causes, and management. RESULTS: Preschool children were less likely to be injured with a projectile than school age children (P<.001). Preschool children presented with less: loss of consciousness (P<.001), vomiting (P<.001), drowsiness (P=.002), and headache (P<.001), and more irritability and agitation (P=.003), than school-age children in the acute period after mild TBI. Preschool children were less likely to have neuroimaging of any kind (P<.001) or to be admitted for observation than school age children (P<.001). CONCLUSIONS: Our large prospective study has demonstrated that preschool children with mild TBI experience a different acute symptom profile to older children. There are significant clinical implications with symptoms post-TBI used in medical management to aid decisions on neuroimaging and post-acute intervention.

Pain in children with Bell's palsy: secondary analysis of a randomised controlled trial.

OBJECTIVE: To describe the prevalence and severity of pain experienced by children with Bell's palsy over the first 6 months of illness and its association with the severity of facial paralysis. METHODS: This was a secondary analysis of data obtained in a phase III, triple-blinded, randomised, placebo-controlled trial of prednisolone for the treatment of Bell's palsy in children aged 6 months to <18 years conducted between 13 October 2015 and 23 August 2020 in Australia and New Zealand. Children were recruited within 72 hours of symptom onset and pain was assessed using a child-rated visual analogue scale (VAS), a child-rated Faces Pain Score-Revised (FPS-R) and/or a parent-rated VAS at baseline, and at 1, 3 and 6 months until recovered, and are reported combined across treatment groups. RESULTS: Data were available for 169 of the 187 children randomised from at least one study time point. Overall, 37% (62/169) of children reported any pain at least at one time point. The frequency of any pain reported using the child-rated VAS, child-rated FPS-R and parent-rated VAS was higher at the baseline assessment (30%, 23% and 27%, respectively) compared with 1-month (4%, 0% and 4%, respectively) and subsequent follow-up assessments. At all time points, the median pain score on all three scales was 0 (no pain). CONCLUSIONS: Pain in children with Bell's palsy was infrequent and primarily occurred early in the disease course and in more severe disease. The intensity of pain, if it occurs, is very low throughout the clinical course of disease. TRIAL REGISTRATION NUMBER: ACTRN12615000563561.

Activities critical to success and growth of clinical trials networks. What is needed and how are we doing? An Australian and New Zealand perspective.

BACKGROUND: Clinical trial evidence underpins evidence-based medicine and the improvement of healthcare worldwide. In Australasia, a significant proportion of clinical trials are conducted by geographically dispersed and multidisciplinary clinical researchers under the auspices of Clinical Trials Networks (CTNs). These groups play an important role in contributing to evidence-based medicine, primarily by conducting investigator-initiated clinical trials. Despite their clear benefits in terms of return on investment, CTNs suffer significant challenges. METHODS: We conducted surveys and focus groups with Australian and New Zealand CTNs to identifying the activities and attributes that enable CTNs to operate successfully. Based on our findings, we then conducted further surveys of Australian and New Zealand CTNs to identify the prevalence of these success factors in existing CTNs. RESULTS: Our focus groups identified three key themes associated with success and growth of a CTN: engaged membership, established infrastructure, and sustainability; and thirteen critical success factors: shared vision and motivation; strong leaders, governance and succession planning; an executive officer; sustainable funding for operations; effective communication; diverse representation and consumer input; transparent processes; a strong pipeline of trials; a reputable and recognised CTN brand; innovation and adaption; an effective group of network sites with a skilled workforce; embedded trials and prioritisation of research. These key themes and the relevant key areas were presented to 30 CTNs. Two factors were almost universally present in CTNs, reflecting the importance of these attributes: the presence of an executive officer, and a strong pipeline of trials. Three factors had a particularly low prevalence: sustainable funding for operations, effective communication, and embedded trials. CONCLUSIONS: By supporting both emerging and established CTNs to achieve critical success factors, we can improve the efficiency of CTNs to continue to contribute and expand their clinical trial activities. Particular focus needs to be on finding sustainable funding for CTNs, and raising awareness of the critical role undertaken by CTNs to improve healthcare and health outcomes.

Factors influencing health professionals' use of high-flow nasal cannula therapy for infants with bronchiolitis - A qualitative study.

Aim: To explore the factors influencing the use of high-flow nasal cannula (HFNC) therapy for infants with bronchiolitis. Design: Qualitative approach using semi-structured interviews. Methods: The semi-structured interviews (face-to-face or virtual) were conducted between September 2020 and February 2021. Deductive content analysis was used to map key influencing factors for use of HFNC therapy to the Theoretical Domains Framework (TDF). Results: Nineteen interviews were undertaken before reaching thematic saturation (7 nurses, 12 doctors) in emergency departments and paediatric wards from four purposively selected hospitals in Australia and New Zealand. Influencing factors were mapped to eight domains in the TDF with 21 themes identified. Main findings included: (1) Health professionals' expectations of HFNC therapy on patient deterioration, work of breathing and oxygenation; (2) Staff emotions relating to concern and anxiety about deterioration and "need to do something"; (3) Social influences from other health professionals and parents and (4) Environmental factors relating to logistics of care and patient transfer considerations. These factors, combined with the ready availability of HFNC equipment and health professionals having the required skills to administer the therapy, contributed to its initiation. Conclusion: Individual/personal and contextual/environmental factors contribute to the use of HFNC therapy for infants with bronchiolitis. It is evident these influences contribute substantially to increased use, despite evidence-based guidelines recommending a more nuanced approach to this therapy. These findings will inform a targeted implementation intervention to promote evidence-based use of HFNC therapy in infants with bronchiolitis.

Agreement of Clinician-Administered and Modified Parent-Administered House-Brackmann Scales in Children with Bell's Palsy.

Objective: Currently there is no parent administered scale for facial nerve function in children. We set out to assess the agreement between a newly developed parent-administered modified version of the House-Brackmann (HB) scale and the standard clinician-administered HB scale in children with Bell's palsy. Study Design: Secondary analysis of a triple-blind, randomized, placebo-controlled trial of corticosteroids to treat idiopathic facial paralysis (Bell's palsy) in children (6 months to <18 years). Setting: Multicenter study at pediatric hospitals with recruitment in emergency departments. Methods: Children were recruited within 72 hours of symptom onset and assessed using the clinician-administered and the parent-administered modified HB scales at baseline, and at 1, 3, and 6 months until recovered. Agreement between the 2 scales was assessed using intraclass coefficient (ICC) and a Bland-Altman plot. Results: Data were available for 174 of the 187 children randomized from at least 1 study time point. The mean ICC between clinician and parent HB scores across all time points was 0.88 (95% confidence interval, CI: 0.86, 0.90). The ICC for the data collected at baseline was 0.53 (95% CI: 0.43, 0.64), at 1 month was 0.88 (95% CI: 0.84, 0.91), at 3 months was 0.80 (95% CI: 0.71, 0.87) and at 6 months was 0.73 (95% CI: 0.47, 0.89). A Bland-Altman plot indicated a mean difference between the 2 scores (clinician-reported minus parent-reported) of only -0.07 (95% limits of agreement -1.37 to 1.23). Conclusion: There was good agreement between the modified parent-administered and the clinician-administered HB scales.

Effect of Early High-Flow Nasal Oxygen vs Standard Oxygen Therapy on Length of Hospital Stay in Hospitalized Children With Acute Hypoxemic Respiratory Failure: The PARIS-2 Randomized Clinical Trial.

Importance: Nasal high-flow oxygen therapy in infants with bronchiolitis and hypoxia has been shown to reduce the requirement to escalate care. The efficacy of high-flow oxygen therapy in children aged 1 to 4 years with acute hypoxemic respiratory failure without bronchiolitis is unknown. Objective: To determine the effect of early high-flow oxygen therapy vs standard oxygen therapy in children with acute hypoxemic respiratory failure. Design, Setting, and Participants: A multicenter, randomized clinical trial was conducted at 14 metropolitan and tertiary hospitals in Australia and New Zealand, including 1567 children aged 1 to 4 years (randomized between December 18, 2017, and March 18, 2020) requiring hospital admission for acute hypoxemic respiratory failure. The last participant follow-up was completed on March 22, 2020. Interventions: Enrolled children were randomly allocated 1:1 to high-flow oxygen therapy (n = 753) or standard oxygen therapy (n = 764). The type of oxygen therapy could not be masked, but the investigators remained blinded until the outcome data were locked. Main Outcomes and Measures: The primary outcome was length of hospital stay with the hypothesis that high-flow oxygen therapy reduces length of stay. There were 9 secondary outcomes, including length of oxygen therapy and admission to the intensive care unit. Children were analyzed according to their randomization group. Results: Of the 1567 children who were randomized, 1517 (97%) were included in the primary analysis (median age, 1.9 years [IQR, 1.4-3.0 years]; 732 [46.7%] were female) and all children completed the trial. The length of hospital stay was significantly longer in the high-flow oxygen group with a median of 1.77 days (IQR, 1.03-2.80 days) vs 1.50 days (IQR, 0.85-2.44 days) in the standard oxygen group (adjusted hazard ratio, 0.83 [95% CI, 0.75-0.92]; P < .001). Of the 9 prespecified secondary outcomes, 4 showed no significant difference. The median length of oxygen therapy was 1.07 days (IQR, 0.50-2.06 days) in the high-flow oxygen group vs 0.75 days (IQR, 0.35-1.61 days) in the standard oxygen therapy group (adjusted hazard ratio, 0.78 [95% CI, 0.70-0.86]). In the high-flow oxygen group, there were 94 admissions (12.5%) to the intensive care unit compared with 53 admissions (6.9%) in the standard oxygen group (adjusted odds ratio, 1.93 [95% CI, 1.35-2.75]). There was only 1 death and it occurred in the high-flow oxygen group. Conclusions and Relevance: Nasal high-flow oxygen used as the initial primary therapy in children aged 1 to 4 years with acute hypoxemic respiratory failure did not significantly reduce the length of hospital stay compared with standard oxygen therapy. Trial Registration: anzctr.org.au Identifier: ACTRN12618000210279.

Incidence of traumatic brain injuries in head-injured children with seizures.

OBJECTIVE: Incidence and short-term outcomes of clinically important traumatic brain injury (ciTBI) in head-injured children presenting to ED with post-traumatic seizure (PTS) is not described in current literature. METHODS: Planned secondary analysis of a prospective observational study undertaken in 10 Australasian Paediatric Research in Emergency Departments International Collaborative (PREDICT) network EDs between 2011 and 2014 of head-injured children <18 years with and without PTS. Clinical predictors and outcomes were analysed by attributable risk (AR), risk ratios (RR) and 95% confidence interval (CI), including the association with Glasgow Coma Scale (GCS) scores. RESULTS: Of 20 137 head injuries, 336 (1.7%) had PTS with median age of 4.8 years. Initial GCS was 15 in 268/336 (79.8%, AR -16.1 [95% CI -20.4 to -11.8]), 14 in 24/336 (7.1%, AR 4.4 [95% CI 1.6-7.2]) and ≤13 in 44/336 (13.1%, AR 11.7 [95% CI 8.1-15.3]) in comparison with those without PTS, respectively. The ciTBI rate was 34 (10.1%) with PTS versus 219 (1.1%) without PTS (AR 9.0 [95% CI 5.8-12.2]) with 5/268 (1.9%), 6/24 (25.0%) and 23/44 (52.3%) with GCS 15, 14 and ≤13, respectively. In PTS, rates of admission ≥2 nights (34 [10.1%] AR 9.0 [95% CI 5.8-12.3]), intubation >24 h (9 [2.7%] AR 2.5 [95% CI 0.8-4.2]) and neurosurgery (8 [2.4%] AR 2.0 [95% CI 0.4-3.7]), were higher than those without PTS. Children with PTS and GCS 15 or 14 had no neurosurgery, intubations or death, with two deaths in children with PTS and GCS ≤13. CONCLUSIONS: PTS was uncommon in head-injured children presenting to the ED but associated with an increased risk of ciTBI in those with reduced GCS on arrival.

Predictors of Intensive Care Admission in Hypoxemic Bronchiolitis Infants, Secondary Analysis of a Randomized Trial.

OBJECTIVES: To evaluate in a preplanned secondary analysis of our parent randomized controlled trial predictors of intensive care unit (ICU) admission in infants with bronchiolitis and analyze if these predictors are equally robust for children receiving high-flow or standard-oxygen. STUDY DESIGN: A secondary analysis of a multicenter, randomized trial of infants aged <12 months with bronchiolitis and an oxygen requirement was performed using admission and outcome data of all 1472 enrolled infants. The primary outcome was ICU admission. The predictors evaluated were baseline characteristics including physiological data and medical history. RESULTS: Of the 1472 enrolled infants, 146 were admitted to intensive care. Multivariate predictors of ICU admission were age (weeks) (OR: 0.98 [95% CI: 0.96-0.99]), pre-enrolment heart rate >160/min (OR: 1.80 [95% CI: 1.23-2.63]), pre-enrolment SpO2 (transcutaneous oxygen saturation) (%) (OR: 0.91 [95% CI: 0.86-0.95]), previous ICU admission (OR: 2.16 [95% CI: 1.07-4.40]), and time of onset of illness to hospital presentation (OR: 0.78 [95% CI: 0.65-0.94]). The predictors were equally robust for infants on high-flow nasal cannula therapy or standard-oxygen therapy. CONCLUSION: Age <2 months, pre-enrolment heart rate >160/min, pre-enrolment SpO2 of <87%, previous ICU admission and time of onset of ≤2 days to presentation are predictive of an ICU admission during the current hospital admission of infants with bronchiolitis independent of oxygenation method used. TRIAL REGISTRATION: ACTRN12613000388718.

Qualitative study of emergency clinicians to inform a national guideline on the management of children with mild-to-moderate head injuries.

BACKGROUND: Head injury is a common reason children present to EDs. Guideline development to improve care for paediatric head injuries should target the information needs of ED clinicians and factors influencing its uptake. METHODS: We conducted semi-structured qualitative interviews (November 2017-November 2018) with a stratified purposive sample of ED clinicians from across Australia and New Zealand. We identified clinician information needs, used the Theoretical Domains Framework (TDF) to explore factors influencing the use of head CT and clinical decision rules/guidelines in CT decision-making, and explored ways to improve guideline uptake. Two researchers coded the interview transcripts using thematic content analysis. RESULTS: A total of 43 clinicians (28 doctors, 15 nurses), from 19 hospitals (5 tertiary, 8 suburban, 6 regional/rural) were interviewed. Clinicians sought guidance for scenarios including ED management of infants, children with underlying medical issues, delayed or representations and potential non-accidental injuries. Improvements to the quality and content of discharge communication and parental discussion materials were suggested. Known risks of radiation from head CTs has led to a culture of observation over use of CT in Australasia (TDF domain: beliefs about consequences). Formal and informal policies have resulted in senior clinicians making most head CT decisions in children (TDF domain: behavioural regulation). Senior clinicians consider their gestalt to be more accurate and outperform existing guidance (TDF domain: beliefs about capabilities), although they perceive guidelines as useful for training and supporting junior staff. Summaries, flow charts, publication in ED-specific journals and scripted training materials were suggestions to improve uptake. CONCLUSION: Information needs of ED clinicians, factors influencing use of head CT in children with head injuries and the role of guidelines were identified. These findings informed the scope and implementation strategies for an Australasian guideline for mild-to-moderate head injuries in children.

Prevalence of high flow nasal cannula therapy use for management of infants with bronchiolitis in Australia and New Zealand.

AIM: To determine the prevalence of high flow nasal cannula (HFNC) therapy in infants presenting to hospital in Australia and New Zealand with bronchiolitis over four bronchiolitis seasons. Secondary aims were to determine temporal trends in HFNC use, and associations between HFNC, hospital length of stay (LOS) and intensive care unit (ICU) admission. METHODS: A planned sub-study of a multi-centre international cluster randomised controlled trial investigating knowledge translation strategies for a bi-national bronchiolitis guideline. Demographics, management and outcomes data were collected retrospectively for infants presenting with bronchiolitis to 26 hospitals between 1 May 2014 and 30 November 2017. Prevalence data are presented as absolute frequencies (95% confidence interval (CI)) with differences between groups for continuous and categorical variables analysed using linear and logistic regression, respectively. RESULTS: 11 715 infants were included with 3392 (29.0%, 95% CI (28.1-29.8%)) receiving oxygen therapy; of whom 1817 (53.6%, 95% CI (51.9-55.3%)) received HFNC. Use of oxygen therapy did not change over the four bronchiolitis seasons (P = 0.12), while the proportion receiving HFNC increased (2014, 336/2587 (43.2%); 2017, 609/3720 (57.8%); P ≤ 0.001). Infants who received HFNC therapy were not substantially different to infants who received oxygen therapy without HFNC. HFNC use was associated with increases in both hospital LOS (P < 0.001) and ICU admissions (P < 0.001). CONCLUSION: Use of HFNC therapy for infants with bronchiolitis increased over 4 years. Of those who received oxygen therapy, the majority received HFNC therapy without improvement in hospital LOS or ICU admissions. Strategies to guide appropriate HFNC use in infants with bronchiolitis are required.

Efficacy of Prednisolone for Bell Palsy in Children: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.

BACKGROUND AND OBJECTIVE: Corticosteroids are used to treat the early stages of idiopathic facial paralysis (Bell's palsy) in children, but their effectiveness is uncertain. We set out to determine if prednisolone improves the proportion of children with Bell's palsy with complete recovery at one month. METHODS: We conducted a double-blind, placebo-controlled, randomised trial of prednisolone in children presenting to emergency departments with Bell's palsy. Patients aged 6 months to less than 18 years, recruited within 72 hours after symptom onset, were randomly assigned to receive 10 days of treatment with oral prednisolone (approximately 1 mg/kg) or placebo. The primary outcome was complete recovery of facial function at 1 month rated on the House-Brackmann scale. Secondary outcomes included facial function, adverse events and pain up to 6 months. Target recruitment was n=540 (270 per group). RESULTS: Between 13 October 2015 to 23 August 2020, 187 children were randomised (94 to prednisolone and 93 to placebo) and included in the intention-to-treat analysis. At 1 month, the proportions of patients who had recovered facial function were 49% (n=43/87) in the prednisolone group compared with 57% (n=50/87) in the placebo group (risk difference -8.1%, 95% CI -22.8 to 6.7; adjusted odds ratio [aOR] 0.7, 95% CI 0.4 to 1.3). At 3 months these proportion were 90% (n=71/79) for the prednisolone group versus 85% (n=72/85) for the placebo group (risk difference 5.2%, 95%, CI -5.0 to 15.3; aOR 1.2, 95% CI 0.4 to 3.0) and at 6 months 99% (n=77/78) and 93% (n=76/82) respectively (risk difference 6.0%, 95% CI -0.1 to 12.2; aOR 3.0 95% CI 0.5 to 17.7) There were no serious adverse events and little evidence for group differences in secondary outcomes. DISCUSSION: In children with Bell's palsy the vast majority recover without treatment. The study, although underpowered, does not provide evidence that early treatment with prednisolone improves complete recovery. REGISTRATION: Registered with the Australian New Zealand Clinical Trials Registry ACTRN12615000563561, registered 1 June 2015, ://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368505&isReview=true CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for children with Bell's palsy, prednisolone does not significantly change recovery of complete facial function at one month. However, the study lacked the precision to exclude an important harm or benefit from prednisolone.

Sustainability of evidence-based practices in the management of infants with bronchiolitis in hospital settings - a PREDICT study protocol.

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.

Bronchiolitis.

Viral bronchiolitis is the most common cause of admission to hospital for infants in high-income countries. Respiratory syncytial virus accounts for 60-80% of bronchiolitis presentations. Bronchiolitis is diagnosed clinically without the need for viral testing. Management recommendations, based predominantly on high-quality evidence, advise clinicians to support hydration and oxygenation only. Evidence suggests no benefit with use of glucocorticoids or bronchodilators, with further evidence required to support use of hypertonic saline in bronchiolitis. Evidence is scarce in the intensive care unit. Evidence suggests use of high-flow therapy in bronchiolitis is limited to rescue therapy after failure of standard subnasal oxygen only in infants who are hypoxic and does not decrease rates of intensive care unit admission or intubation. Despite systematic reviews and international clinical practice guidelines promoting supportive rather than interventional therapy, universal de-implementation of interventional care in bronchiolitis has not occurred and remains a major challenge.

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.

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.

Nonindicated Brain Computed Tomography Scans for Children: Adaptation of an American Measurement Tool and Contrast of Current Practice in an Australian Hospital.

OBJECTIVES: Clinical guidelines state brain computed tomography (CT) for atraumatic headache or first generalized afebrile, atraumatic seizure as nonindicated in neurologically normal children. We aimed to adapt 2 rigorously validated United States-based measures that examine overuse of CT in children with these conditions, and to determine whether these measures can be used in an Australian setting to determine rates of CT scanning in current practice. METHODS: Within an Australian tertiary pediatric hospital, we successfully adapted the measures from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) coding system of the United States measures to the International Classification of Diseases, Tenth Revision, Australian Modification (ICD-10-AM) coding system used in Australia. We conducted a retrospective audit of electronic medical record data from April 1, 2017, to March 31, 2018. Eligible patients were children aged 4 to 17 years who attended one of the hospital outpatient clinics and/or emergency department and/or were admitted to an inpatient ward. The conditions of interest were (1) atraumatic headache and (2) first generalized afebrile, atraumatic seizure. RESULTS: The measure for afebrile seizure was found to have low accuracy and low feasibility in this setting and was not tested further. The adapted measure for atraumatic headache was highly accurate in determining the encounters of interest; however, manual chart review was required to identify nonindicated brain CTs. Using this measure, 601 encounters for atraumatic headache were identified, of which 98 (16.3%) received at least 1 brain CT. We found that 14.1% of these scans were nonindicated, meaning 2% all atraumatic headache encounters received a nonindicated scan; lower than rates reported in international literature. CONCLUSIONS: Using the tool developed in this study, rigorous measurement of the overuse of CT scans in other settings may determine the reasons for the lower rates observed in this study; inform future interventions to minimize overuse; and provide safer, higher quality care to children.

Can targeted interventions change the factors influencing variation in management of infants with bronchiolitis? A survey of Australian and New Zealand clinicians: A paediatric research in emergency departments international collaborative (PREDICT) study.

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 = 10.4-33.5%) (social/professional role and identity). A 14% improvement in evidence-based bronchiolitis management favouring intervention hospitals was demonstrated in the cluster randomised controlled trial. CONCLUSION: Targeted interventions positively changed factors influencing bronchiolitis management resulting in improved evidence-based bronchiolitis care. This study has important implications for improving bronchiolitis management and future development of interventions to de-implement low-value care.

Process evaluation of a cluster randomised controlled trial to improve bronchiolitis management - a PREDICT mixed-methods study.

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 .

Characteristics of concussion based on patient age and sex: a multicenter prospective observational study.

OBJECTIVE: Children with concussion frequently present to emergency departments (EDs). There is limited understanding of the differences in signs, symptoms, and epidemiology of concussion based on patient age. Here, the authors set out to assess the association between age and acute concussion presentations. METHODS: The authors conducted a multicenter prospective observational study of head injuries at 10 EDs in Australia and New Zealand. They identified children aged 5 to < 18 years, presenting with a Glasgow Coma Scale score of 13-15, presenting < 24 hours postinjury, with no abnormalities on CT if performed, and one or more signs or symptoms of concussion. They extracted demographic, injury-related, and signs and symptoms information and stratified it by age group (5-8, 9-12, 13 to < 18 years). RESULTS: Of 8857 children aged 5 to < 18 years, 4709 patients met the defined concussion criteria (5-8 years, n = 1546; 9-12 years, n = 1617; 13 to < 18 years, n = 1546). The mean age of the cohort was 10.9 years, and approximately 70% of the patients were male. Sport-related concussion accounted for 43.7% of concussions overall, increasing from 19.1% to 48.9% to 63.0% in the 5-8, 9-12, and 13 to < 18 years age groups. The most common acute symptoms postinjury were headache (64.6%), disorientation (36.2%), amnesia (30.0%), and vomiting (27.2%). Vomiting decreased with increasing age and was observed in 41.7% of the 5-8 years group, 24.7% of the 9-12 years group, and 15.4% of the 13 to < 18 years group, whereas reported loss of consciousness (LOC) increased with increasing age, occurring in 9.6% in the 5-8 years group, 21.0% in the 9-12 years group, 36.7% in the 13 to < 18 years group, and 22.4% in the entire study cohort. Headache, amnesia, and disorientation followed the latter trajectory. Symptom profiles were broadly similar between males and females. CONCLUSIONS: Concussions presenting to EDs were more sports-related as age increased. Signs and symptoms differed markedly across age groups, with vomiting decreasing and headache, LOC, amnesia, and disorientation increasing with increasing age.