16 results on '"Dalziel, Stuart R."'
Search Results
2. Remote, real-time expert elicitation to determine the prior probability distribution for Bayesian sample size determination in international randomised controlled trials: Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone (BIPED) study
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Lan, Jingxian, Plint, Amy C., Dalziel, Stuart R., Klassen, Terry P., Offringa, Martin, and Heath, Anna
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- 2022
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3. Sustainability of evidence-based practices in the management of infants with bronchiolitis in hospital settings - a PREDICT study protocol
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Ramsden, Victoria, Babl, Franz E., Dalziel, Stuart R., Middleton, Sandy, Oakley, Ed, Haskell, Libby, Lithgow, Anna, Orsini, Francesca, Schembri, Rachel, Wallace, Alexandra, Wilson, Catherine L., McInnes, Elizabeth, Wilson, Peter H., and Tavender, Emma
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- 2022
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4. External validation of the Scandinavian guidelines for management of minimal, mild and moderate head injuries in children
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Undén, Johan, Dalziel, Stuart R., Borland, Meredith L., Phillips, Natalie, Kochar, Amit, Lyttle, Mark D., Bressan, Silvia, Cheek, John A., Neutze, Jocelyn, Donath, Susan, Hearps, Stephen, Oakley, Ed, Dalton, Sarah, Gilhotra, Yuri, Babl, Franz E., and on behalf of the Paediatric Research in Emergency Departments International Collaborative (PREDICT)
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- 2018
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5. Implementing evidence-based practices in the care of infants with bronchiolitis in Australasian acute care settings: study protocol for a cluster randomised controlled study
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Haskell, Libby, Tavender, Emma J., Wilson, Catherine, O’Brien, Sharon, Babl, Franz E., Borland, Meredith L., Cotterell, Liz, Schuster, Tibor, Orsini, Francesca, Sheridan, Nicolette, Johnson, David, Oakley, Ed, Dalziel, Stuart R., and on behalf of PREDICT
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- 2018
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6. The management of children with bronchiolitis in the Australasian hospital setting: development of a clinical practice guideline
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O’Brien, Sharon, Wilson, Sally, Gill, Fenella J., Cotterell, Elizabeth, Borland, Meredith L, Oakley, Edward, Dalziel, Stuart R, and on behalf of the Paediatric Research in Emergency Departments International Collaborative (PREDICT) network, Australasia
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- 2018
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7. Process evaluation of a cluster randomised controlled trial to improve bronchiolitis management - a PREDICT mixed-methods study.
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Haskell, Libby, Tavender, Emma J., O'Brien, Sharon, Wilson, Catherine L., Babl, Franz E., Borland, Meredith L., Schembri, Rachel, Orsini, Francesca, Cotterell, Elizabeth, Sheridan, Nicolette, Oakley, Ed, Dalziel, Stuart R., and Paediatric Research in Emergency Departments International Collaborative (PREDICT) network, Australasia
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BRONCHIOLITIS ,INFANT care ,THEMATIC analysis - Abstract
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 . [ABSTRACT FROM AUTHOR]- Published
- 2021
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8. PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial.
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Weiss, Scott L., Balamuth, Fran, Long, Elliot, Thompson, Graham C., Hayes, Katie L., Katcoff, Hannah, Cook, Marlena, Tsemberis, Elena, Hickey, Christopher P., Williams, Amanda, Williamson-Urquhart, Sarah, Borland, Meredith L., Dalziel, Stuart R., Gelbart, Ben, Freedman, Stephen B., Babl, Franz E., Huang, Jing, Kuppermann, Nathan, for the Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks, and Long, E.
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SEPTIC shock ,SALINE injections ,RESEARCH protocols ,SEPSIS ,RENAL replacement therapy ,MEDICAL personnel ,FLUIDS - Abstract
Background/aims: Despite evidence that preferential use of balanced/buffered fluids may improve outcomes compared with chloride-rich 0.9% saline, saline remains the most commonly used fluid for children with septic shock. We aim to determine if resuscitation with balanced/buffered fluids as part of usual care will improve outcomes, in part through reduced kidney injury and without an increase in adverse effects, compared to 0.9% saline for children with septic shock.Methods: The Pragmatic Pediatric Trial of Balanced versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) study is an international, open-label pragmatic interventional trial being conducted at > 40 sites in the USA, Canada, and Australia/New Zealand starting on August 25, 2020, and continuing for 5 years. Children > 6 months to < 18 years treated for suspected septic shock with abnormal perfusion in an emergency department will be randomized to receive either balanced/buffered crystalloids (intervention) or 0.9% saline (control) for initial resuscitation and maintenance fluids for up to 48 h. Eligible patients are enrolled and randomized using serially numbered, opaque envelopes concurrent with clinical care. Given the life-threatening nature of septic shock and narrow therapeutic window to start fluid resuscitation, patients may be enrolled under "exception from informed consent" in the USA or "deferred consent" in Canada and Australia/New Zealand. Other than fluid type, all decisions about timing, volume, and rate of fluid administration remain at the discretion of the treating clinicians. For pragmatic reasons, clinicians will not be blinded to study fluid type. Anticipated enrollment is 8800 patients. The primary outcome will be major adverse kidney events within 30 days (MAKE30), a composite of death, renal replacement therapy, and persistent kidney dysfunction. Additional effectiveness, safety, and biologic outcomes will also be analyzed.Discussion: PRoMPT BOLUS will provide high-quality evidence 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. [ABSTRACT FROM AUTHOR]- Published
- 2021
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9. Development of targeted, theory-informed interventions to improve bronchiolitis management.
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Haskell, Libby, Tavender, Emma J., Wilson, Catherine L., O'Brien, Sharon, Babl, Franz E., Borland, Meredith L., Cotterell, Elizabeth, Sheridan, Nicolette, Oakley, Ed, Dalziel, Stuart R., and Paediatric Research in Emergency Departments International Collaborative (PREDICT) network, Australasia
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BRONCHIOLITIS ,INFANT care ,MEDICAL personnel ,ALBUTEROL ,EVIDENCE-based management ,NURSING interventions ,BRONCHIOLE diseases - Abstract
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. [ABSTRACT FROM AUTHOR]- Published
- 2021
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10. Emergency treatment with levetiracetam or phenytoin in status epilepticus in children—the EcLiPSE study: study protocol for a randomised controlled trial
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Lyttle, Mark D., Gamble, Carrol, Messahel, Shrouk, Hickey, Helen, Iyer, Anand, Woolfall, Kerry, Humphreys, Amy, Bacon, Naomi E. A., Roper, Louise, Babl, Franz E., Dalziel, Stuart R., Ryan, Mary, and Appleton, Richard E.
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Male ,Levetiracetam ,Time Factors ,Adolescent ,Randomised ,Trial ,Study Protocol ,Status Epilepticus ,Clinical Protocols ,Humans ,Child ,Infusions, Intravenous ,Age Factors ,Infant ,Seizure ,Piracetam ,United Kingdom ,Intention to Treat Analysis ,Treatment Outcome ,Paediatric ,Research Design ,Phenytoin ,Child, Preschool ,Anticonvulsants ,Female ,Emergencies ,Ireland - Abstract
Background Convulsive status epilepticus (CSE) is the most common life-threatening neurological emergency in childhood. These children are also at risk of significant morbidity, with acute and chronic impact on the family and the health and social care systems. The current recommended first-choice, second-line treatment in children aged 6 months and above is intravenous phenytoin (fosphenytoin in the USA), although there is a lack of evidence for its use and it is associated with significant side effects. Emerging evidence suggests that intravenous levetiracetam may be effective as a second-line agent for CSE, and fewer adverse effects have been described. This trial therefore aims to determine whether intravenous phenytoin or levetiracetam is more effective, and safer, in treating childhood CSE. Methods/design This is a phase IV, multi-centre, parallel group, randomised controlled, open-label trial. Following treatment for CSE with first-line treatment, children with ongoing seizures are randomised to receive either phenytoin (20 mg/kg, maximum 2 g) or levetiracetam (40 mg/kg, maximum 2.5 g) intravenously. The primary outcome measure is the cessation of all visible signs of CSE as determined by the treating clinician. Secondary outcome measures include the need for further anti-seizure medications or rapid sequence induction for ongoing CSE, admission to critical care areas, and serious adverse reactions. Patients are recruited without prior consent, with deferred consent sought at an appropriate time for the family. The primary analysis will be by intention-to-treat. The primary outcome is a time to event outcome and a sample size of 140 participants in each group will have 80% power to detect an increase in CSE cessation rates from 60% to 75%. Our total sample size of 308 randomised and treated participants will allow for 10% loss to follow-up. Discussion This clinical trial will determine whether phenytoin or levetiracetam is more effective as an intravenous second-line agent for CSE, and provide evidence for management recommendations. In addition, this trial will also provide data on which of these therapies is safer in this setting. Trial registration ISRCTN identifier, ISRCTN22567894. Registered on 27 August 2015 EudraCT identifier, 2014-002188-13. Registered on 21 May 2014 NIHR HTA Grant: 12/127/134 Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2010-8) contains supplementary material, which is available to authorized users.
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- 2017
11. Understanding factors that contribute to variations in bronchiolitis management in acute care settings: a qualitative study in Australia and New Zealand using the Theoretical Domains Framework.
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Haskell, Libby, Tavender, Emma J., Wilson, Catherine, Babl, Franz E., Oakley, Ed, Sheridan, Nicolette, Dalziel, Stuart R., and Paediatric Research in Emergency Departments International Collaborative (PREDICT) nectwork, Australia
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DRUG resistance in bacteria ,SOCIAL influence ,OCCUPATIONAL roles ,BRONCHIOLITIS ,GUIDELINES ,MEDICAL care ,PEDIATRICS - Abstract
Background: Bronchiolitis is the most common reason for infants under one year of age to be hospitalised. Despite management being well defined with high quality evidence of no efficacy for salbutamol, adrenaline, glucocorticoids, antibiotics or chest x-rays, substantial variation in practice occurs. Understanding factors that influence practice variation is vital in order to tailor knowledge translation interventions to improve practice. This study explores factors influencing the uptake of five evidence-based guideline recommendations using the Theoretical Domains Framework.Methods: Semi-structured interviews were undertaken with clinicians in emergency departments and paediatric inpatient areas across Australia and New Zealand exploring current practice, and factors that influence this, based on the Theoretical Domains Framework. Interview transcripts were coded using thematic content analysis.Results: Between July and October 2016, 20 clinicians (12 doctors, 8 nurses) were interviewed. Most clinicians believed chest x-rays were not indicated and caused radiation exposure (beliefs about consequences). However, in practice their decisions were influenced by concerns about misdiagnosis, severity of illness, lack of experience (knowledge) and confidence in managing infants with bronchiolitis (skills), and parental pressure influencing practice (social influences). Some senior clinicians believed trialling salbutamol might be of benefit for some infants (beliefs about consequences) but others strongly discounted this, believing salbutamol to be ineffective, with high quality evidence supporting this (knowledge). Most were concerned about antibiotic resistance and did not believe in antibiotic use in infants with bronchiolitis (beliefs about consequences) but experienced pressure from parents to prescribe (social influences). Glucocorticoid use was generally believed to be of no benefit (knowledge) with concerns surrounding frequency of use in primary care, and parental pressure (social influences). Nurse's reinforced evidence-based management of bronchiolitis with junior clinicians (social/professional role and identity). Regular turnover of medical staff, a lack of 'paediatric confident' nurses and doctors, reduced senior medical coverage after hours, and time pressure in emergency departments were factors influencing practice (environmental context and resources).Conclusions: Factors influencing the management of infants with bronchiolitis in the acute care period were identified using the Theoretical Domains Framework. These factors will inform the development of tailored knowledge translation interventions. [ABSTRACT FROM AUTHOR]- Published
- 2020
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12. Acute severe paediatric asthma: study protocol for the development of a core outcome set, a Pediatric Emergency Reserarch Networks (PERN) study.
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Craig, Simon, Babl, Franz E., Dalziel, Stuart R., Gray, Charmaine, Powell, Colin, Al Ansari, Khalid, Lyttle, Mark D., Roland, Damian, Benito, Javier, Velasco, Roberto, Hoeffe, Julia, Moldovan, Diana, Thompson, Graham, Schuh, Suzanne, Zorc, Joseph J., Kwok, Maria, Mahajan, Prashant, Johnson, Michael D., Sapien, Robert, and Khanna, Kajal
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PEDIATRIC emergencies ,ASTHMA in children ,ASTHMA ,HOSPITAL care of children ,RANDOMIZED controlled trials ,INHALERS ,HIV-positive children - Abstract
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. [ABSTRACT FROM AUTHOR]- Published
- 2020
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13. A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study.
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Dalziel, Stuart R., Furyk, Jeremy, Bonisch, Megan, Oakley, Ed, Borland, Meredith, Neutze, Jocelyn, Donath, Susan, Sharpe, Cynthia, Harvey, Simon, Davidson, Andrew, Craig, Simon, Phillips, Natalie, George, Shane, Rao, Arjun, Nicholas Cheng, Michael Zhang, Sinn, Kam, Kochar, Amit, Brabyn, Christine, and Babl, Franz E.
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RANDOMIZED controlled trials ,PHENYTOIN ,SEIZURES in children ,PEDIATRICS ,NEUROLOGICAL emergencies ,PREVENTION ,THERAPEUTICS ,ANTICONVULSANTS ,COMPARATIVE studies ,HOSPITAL emergency services ,INTRAVENOUS therapy ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,MEDICAL emergencies ,MEDICAL protocols ,RESEARCH ,EVALUATION research ,TREATMENT effectiveness ,BLIND experiment ,NEUROPROTECTIVE agents ,STATUS epilepticus - Abstract
Background: Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of CSE in children.Methods/design: 200 children aged between 3 months and 16 years presenting to 13 emergency departments in Australia and New Zealand with CSE, that has failed to stop with first line benzodiazepines, will be enrolled into this multicentre open randomised controlled trial. Participants will be randomised to 40 mg/kg IV levetiracetam infusion over 5 min or 20 mg/kg IV phenytoin infusion over 20 min. The primary outcome for the study is clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. Blinded confirmation of the primary outcome will occur with the primary outcome assessment being video recorded and assessed by a primary outcome assessment team blinded to treatment allocation. Secondary outcomes include: Clinical cessation of seizure activity at two hours; Time to clinical seizure cessation; Need for rapid sequence induction; Intensive care unit (ICU) admission; Serious adverse events; Length of Hospital/ICU stay; Health care costs; Seizure status/death at one-month post discharge.Discussion: This paper presents the background, rationale, and design for a randomised controlled trial comparing levetiracetam to phenytoin in children presenting with CSE in whom benzodiazepines have failed. This study will provide the first high quality evidence for management of paediatric CSE post first-line benzodiazepines.Trial Registration: Prospectively registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR): ACTRN12615000129583 (11/2/2015). UTN U1111-1144-5272. ConSEPT protocol version 4 (12/12/2014). [ABSTRACT FROM AUTHOR]- Published
- 2017
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14. A prospective observational study to assess the diagnostic accuracy of clinical decision rules for children presenting to emergency departments after head injuries (protocol): the Australasian Paediatric Head Injury Rules Study (APHIRST).
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Babl, Franz E., Lyttle, Mark D., Bressan, Silvia, Borland, Meredith, Phillips, Natalie, Kochar, Amit, Dalziel, Stuart R., Dalton, Sarah, Cheek, John, Furyk, Jeremy, Gilhotra, Yuri, Neutze, Jocelyn, Ward, Brenton, Donath, Susan, Jachno, Kim, Crowe, Louise, Williams, Amanda, and Oakley, Ed
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LONGITUDINAL method ,SCIENTIFIC observation ,MEDICAL decision making ,MEDICAL emergencies ,HEAD injuries ,JUVENILE diseases - Abstract
Background Head injuries in children are responsible for a large number of emergency department visits. Failure to identify a clinically significant intracranial injury in a timely fashion may result in long term neurodisability and death. Whilst cranial computed tomography (CT) provides rapid and definitive identification of intracranial injuries, it is resource intensive and associated with radiation induced cancer. Evidence based head injury clinical decision rules have been derived to aid physicians in identifying patients at risk of having a clinically significant intracranial injury. Three rules have been identified as being of high quality and accuracy: the Canadian Assessment of Tomography for Childhood Head Injury (CATCH) from Canada, the Children's Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE) from the UK, and the prediction rule for the identification of children at very low risk of clinically important traumatic brain injury developed by the Pediatric Emergency Care Applied Research Network (PECARN) from the USA. This study aims to prospectively validate and compare the performance accuracy of these three clinical decision rules when applied outside the derivation setting. Methods/design This study is a prospective observational study of children aged 0 to less than 18 years presenting to 10 emergency departments within the Paediatric Research in Emergency Departments International Collaborative (PREDICT) research network in Australia and New Zealand after head injuries of any severity. Predictor variables identified in CATCH, CHALICE and PECARN clinical decision rules will be collected. Patients will be managed as per the treating clinicians at the participating hospitals. All patients not undergoing cranial CT will receive a follow up call 14 to 90 days after the injury. Outcome data collected will include results of cranial CTs (if performed) and details of admission, intubation, neurosurgery and death. The performance accuracy of each of the rules will be assessed using rule specific outcomes and inclusion and exclusion criteria. Discussion This study will allow the simultaneous comparative application and validation of three major paediatric head injury clinical decision rules outside their derivation setting. [ABSTRACT FROM AUTHOR]
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- 2014
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15. The management of children with bronchiolitis in the Australasian hospital setting: development of a clinical practice guideline.
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O'Brien S, Wilson S, Gill FJ, Cotterell E, Borland ML, Oakley E, and Dalziel SR
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- Australia, Consensus, Evidence-Based Medicine methods, Humans, Infant, Infant, Newborn, New Zealand, Bronchiolitis diagnosis, Bronchiolitis therapy, Hospitals, Practice Guidelines as Topic
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Background: Bronchiolitis is the commonest respiratory infection in children less than 12 months and cause of hospitalisation in infants under 6 months of age in Australasia. Unfortunately there is substantial variation in management, despite high levels of supporting evidence. This paper reports on the process, strengths and challenges of the hybrid approach used to develop the first Australasian management guideline relevant to the local population., Method: An adaption of the nine steps recommended by the National Health and Medical Research Council (NHMRC) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology were utilised. Following establishment of the Guideline Development Committee (GDC), we identified the population, intervention, comparator, outcomes and time of interest (PICOt) questions, undertook a systematic literature search and graded the evidence and recommendations using the NHMRC and GRADE processes. Using Nominal Group Techniques (NGT), consensus was sought in formulating the clinical practice recommendations and practice points. Key health professional bodies were consulted to ensure relevance in the Australasian emergency and ward settings., Results: From 33 PICOT questions, clinical recommendations for practice that were deemed relevant to the Australasian population were identified. Specific considerations for the management of Australian and New Zealand indigenous infants in relation to the use of azithromycin and risk factors for more serious illness are included. Using NGT, consensus demonstrated by a median Likert score > 8 for all recommendations was achieved. The guideline presents clinical guidance, followed by the key recommendations and evidence review behind each recommendation., Conclusion: Developing evidence-based clinical guidelines is a complex process with considerable challenges. Challenges included having committee members located over two countries and five time zones, large volume of literature and variation of member's knowledge of grading of evidence and recommendations. The GRADE and NHMRC processes provided a systematic and transparent approach ensuring a final structure including bedside interface, and a descriptive summary of the evidence base and tables for each key statement. Involvement of stakeholders who will ultimately be end-users as members of the GDC provided valuable knowledge. Lessons learnt during this guideline development process provide valuable insight for those planning development of evidence-based guidelines.
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- 2018
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16. Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial.
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Babl FE, Mackay MT, Borland ML, Herd DW, Kochar A, Hort J, Rao A, Cheek JA, Furyk J, Barrow L, George S, Zhang M, Gardiner K, Lee KJ, Davidson A, Berkowitz R, Sullivan F, Porrello E, Dalziel KM, Anderson V, Oakley E, Hopper S, Williams F, Wilson C, Williams A, and Dalziel SR
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- Adolescent, Bell Palsy epidemiology, Bell Palsy physiopathology, Child, Child, Preschool, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Glucocorticoids administration & dosage, Humans, Incidence, Infant, Male, New Zealand epidemiology, Time Factors, Treatment Outcome, Bell Palsy drug therapy, Prednisolone administration & dosage, Quality of Life, Recovery of Function
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Background: Bell's palsy or acute idiopathic lower motor neurone facial paralysis is characterized by sudden onset paralysis or weakness of the muscles to one side of the face controlled by the facial nerve. While there is high level evidence in adults demonstrating an improvement in the rate of complete recovery of facial nerve function when treated with steroids compared with placebo, similar high level studies on the use of steroids in Bell's palsy in children are not available. The aim of this study is to assess the utility of steroids in Bell's palsy in children in a randomised placebo-controlled trial., Methods/design: We are conducting a randomised, triple-blinded, placebo controlled trial of the use of prednisolone to improve recovery from Bell's palsy at 1 month. Study sites are 10 hospitals within the Australian and New Zealand PREDICT (Paediatric Research in Emergency Departments International Collaborative) research network. 540 participants will be enrolled. To be eligible patients need to be aged 6 months to < 18 years and present within 72 hours of onset of clinician diagnosed Bell's palsy to one of the participating hospital emergency departments. Patients will be excluded in case of current use of or contraindications to steroids or if there is an alternative diagnosis. Participants will receive either prednisolone 1 mg/kg/day to a maximum of 50 mg/day or taste matched placebo for 10 days. The primary outcome is complete recovery by House-Brackmann scale at 1 month. Secondary outcomes include assessment of recovery using the Sunnybrook scale, the emotional and functional wellbeing of the participants using the Pediatric Quality of Life Inventory and Child Health Utility 9D Scale, pain using Faces Pain Scale Revised or visual analogue scales, synkinesis using a synkinesis assessment questionnaire and health utilisation costs at 1, 3 and 6 months. Participants will be tracked to 12 months if not recovered earlier. Data analysis will be by intention to treat with primary outcome presented as differences in proportions and an odds ratio adjusted for site and age., Discussion: This large multicenter randomised trial will allow the definitive assessment of the efficacy of prednisolone compared with placebo in the treatment of Bell's palsy in children., Trial Registration: The study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12615000563561 (1 June 2015).
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- 2017
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