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  • 1
    In: Trials, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2021-12)
    Abstract: 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 for the comparative effectiveness of buffered/balanced crystalloids versus 0.9% saline for the initial fluid management of children with suspected septic shock in emergency settings. Trial registration PRoMPT BOLUS was first registered at ClinicalTrials.gov ( NCT04102371 ) on September 25, 2019. Enrollment started on August 25, 2020.
    Type of Medium: Online Resource
    ISSN: 1745-6215
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2040523-6
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  • 2
    In: Emergency Medicine Journal, BMJ, Vol. 37, No. 11 ( 2020-11), p. 686-689
    Abstract: CT of the brain (CTB) for paediatric head injury is used less frequently at tertiary paediatric emergency departments (EDs) in Australia and New Zealand than in North America. In preparation for release of a national head injury guideline and given the high variation in CTB use found in North America, we aimed to assess variation in CTB use for paediatric head injury across hospitals types. Methods Multicentre retrospective review of presentations to tertiary, urban/suburban and regional/rural EDs in Australia and New Zealand in 2016. Children aged 〈 16 years, with a primary ED diagnosis of head injury were included and data extracted from 100 eligible cases per site. Primary outcome was CTB use adjusted for severity (Glasgow Coma Scale) with 95% CIs; secondary outcomes included hospital length of stay and admission rate. Results There were 3072 head injury presentations at 31 EDs: 9 tertiary (n=900), 11 urban/suburban (n=1072) and 11 regional/rural EDs (n=1100). The proportion of children with Glasgow Coma Score ≤13 was 1.3% in each type of hospital. Among all presentations, CTB was performed for 8.2% (95% CI 6.4 to 10.0) in tertiary hospitals, 6.6% (95% CI 5.1 to 8.1) in urban/suburban hospitals and 6.1% (95% CI 4.7 to 7.5) in regional/rural. Intragroup variation of CTB use ranged from 0% to 14%. The regional/rural hospitals admitted fewer patients (14.6%, 95% CI 12.6% to 16.9%, p 〈 0.001) than tertiary and urban/suburban hospitals (28.1%, 95% CI 25.2% to 31.2%; 27.3%, 95% CI 24.7% to 30.1%). Conclusions In Australia and New Zealand, there was no difference in CTB use for paediatric patients with head injuries across tertiary, urban/suburban and regional/rural EDs with similar intragroup variation. This information can inform a binational head injury guideline.
    Type of Medium: Online Resource
    ISSN: 1472-0205 , 1472-0213
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2027092-6
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  • 3
    In: Acta Paediatrica, Wiley, Vol. 112, No. 10 ( 2023-10), p. 2182-2188
    Abstract: The incidence of anaphylaxis is increasing globally in tandem with changing environmental and lifestyle factors. There is very limited data on very early childhood presentations. We aim to assess changes in rates, characteristics and management of infant anaphylaxis in a paediatric ED over a 15‐year period. Methods We conducted a retrospective study of children 〈 2 years of age who presented with verified anaphylaxis comparing cases in years 2003–2007 with those in 2013–2017. Standardised information was collected on demographics, clinical presentation, management and triggers. Results Manually confirmed anaphylaxis rates in 〈 2 year olds increased from 3.6 to 6.2 per 10 4 population (OR 1.7, 95% CI: 1.3–2.7; p 〈 0.001) with the greatest increase in 〈 1 year olds. Anaphylaxis severity increased between 2003–2007 and 2013–2017 (OR 2.3, 95% CI: 1.2–4.3; p = 0.018). Failure to administer adrenaline was reduced in 2013–2017 ( p = 0.007). Food was the leading anaphylaxis trigger (97.85%). Conclusion This is the first study to suggest an increase in the incidence and severity of ED anaphylaxis presentations in children aged 〈 2 years. Increased awareness of specific characteristics in this age group is required to facilitate timely recognition and optimal management. Further large‐scale studies are warranted to understand underlying environmental drivers and find prevention strategies to reduce the burden of disease.
    Type of Medium: Online Resource
    ISSN: 0803-5253 , 1651-2227
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 1492629-5
    detail.hit.zdb_id: 1501466-6
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  • 4
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2009
    In:  Intensive Care Medicine Vol. 35, No. 9 ( 2009-9), p. 1532-1538
    In: Intensive Care Medicine, Springer Science and Business Media LLC, Vol. 35, No. 9 ( 2009-9), p. 1532-1538
    Type of Medium: Online Resource
    ISSN: 0342-4642 , 1432-1238
    RVK:
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2009
    detail.hit.zdb_id: 1459201-0
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  • 5
    In: Emergency Medicine Australasia, Wiley, Vol. 33, No. 2 ( 2021-04), p. 195-201
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1742-6731 , 1742-6723
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 1502447-7
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  • 6
    In: Open Forum Infectious Diseases, Oxford University Press (OUP)
    Abstract: To assist clinicians with identifying children at risk of severe outcomes, we assessed the association between laboratory findings and severe outcomes among SARS-CoV-2 infected children and determined if SARS-CoV-2 test result status modified the associations. Methods We conducted a cross-sectional analysis of participants tested for SARS-CoV-2 infection in 41 pediatric emergency departments in 10 countries. Participants were hospitalized, had laboratory testing performed, and completed 14-day follow-up. The primary objective was to assess the associations between laboratory findings and severe outcomes. The secondary outcome was to determine if the SARS-CoV-2 test result modified the associations. Results We included 1817 participants; 522 (28.7%) SARS-CoV-2 test-positive and 1295 (71.3%) test-negative. Seventy-five (14.4%) test-positive and 174 (13.4%) test-negative children experienced severe outcomes. In regression analysis, we found that among SARS-CoV-2 positive children, procalcitonin ≥0.5 ng/mL [9.14 (2.90, 28.80)], ferritin & gt;500 ng/mL [aOR (95%CI): 7.95 (1.89, 33.44)], D-dimer ≥1500 ng/mL [4.57 (1.12, 18.68)] , serum glucose ≥120 mg/dL [2.01 (1.06, 3.81)], and lymphocyte count & lt;1.0×109/L [3.21 (1.34, 7.69)], and platelet count & lt;150×109/L [2.82 (1.31, 6.07)] were associated with severe outcomes. Evaluation of the interaction term revealed that a positive SARS-CoV-2 result increased the associations with severe outcomes for elevated procalcitonin, C-Reactive Protein (CRP), D-dimer, and for reduced lymphocyte and platelet counts. Conclusions Specific laboratory parameters are associated with severe outcomes in SARS-CoV-2-infected children and elevated serum procalcitonin, CRP, and D-dimer, and low absolute lymphocyte and platelet counts were more strongly associated with severe outcomes in children testing positive compared to those testing negative.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 2757767-3
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  • 7
    In: BMC Health Services Research, Springer Science and Business Media LLC, Vol. 21, No. 1 ( 2021-12)
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1472-6963
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2050434-2
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  • 8
    In: BMC Pulmonary Medicine, Springer Science and Business Media LLC, Vol. 19, No. 1 ( 2019-12)
    Type of Medium: Online Resource
    ISSN: 1471-2466
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2019
    detail.hit.zdb_id: 2059871-3
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  • 9
    In: BMC Medical Research Methodology, Springer Science and Business Media LLC, Vol. 23, No. 1 ( 2023-03-29)
    Abstract: COVID-19 is a new multi-organ disease causing considerable worldwide morbidity and mortality. While many recognized pathophysiological mechanisms are involved, their exact causal relationships remain opaque. Better understanding is needed for predicting their progression, targeting therapeutic approaches, and improving patient outcomes. While many mathematical causal models describe COVID-19 epidemiology, none have described its pathophysiology. Methods In early 2020, we began developing such causal models. The SARS-CoV-2 virus’s rapid and extensive spread made this particularly difficult: no large patient datasets were publicly available; the medical literature was flooded with sometimes conflicting pre-review reports; and clinicians in many countries had little time for academic consultations. We used Bayesian network (BN) models, which provide powerful calculation tools and directed acyclic graphs (DAGs) as comprehensible causal maps. Hence, they can incorporate both expert opinion and numerical data, and produce explainable, updatable results. To obtain the DAGs, we used extensive expert elicitation (exploiting Australia’s exceptionally low COVID-19 burden) in structured online sessions. Groups of clinical and other specialists were enlisted to filter, interpret and discuss the literature and develop a current consensus. We encouraged inclusion of theoretically salient latent (unobservable) variables, likely mechanisms by extrapolation from other diseases, and documented supporting literature while noting controversies. Our method was iterative and incremental: systematically refining and validating the group output using one-on-one follow-up meetings with original and new experts. 35 experts contributed 126 hours face-to-face, and could review our products. Results We present two key models, for the initial infection of the respiratory tract and the possible progression to complications, as causal DAGs and BNs with corresponding verbal descriptions, dictionaries and sources. These are the first published causal models of COVID-19 pathophysiology. Conclusions Our method demonstrates an improved procedure for developing BNs via expert elicitation, which other teams can implement to model emergent complex phenomena. Our results have three anticipated applications: (i) freely disseminating updatable expert knowledge; (ii) guiding design and analysis of observational and clinical studies; (iii) developing and validating automated tools for causal reasoning and decision support. We are developing such tools for the initial diagnosis, resource management, and prognosis of COVID-19, parameterized using the ISARIC and LEOSS databases.
    Type of Medium: Online Resource
    ISSN: 1471-2288
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2041362-2
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  • 10
    In: Journal of Paediatrics and Child Health, Wiley, Vol. 58, No. 2 ( 2022-02), p. 302-311
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1034-4810 , 1440-1754
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2007577-7
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