225 research outputs found
Australian Health Research Alliance: national priorities in data-driven health care improvement
No full textAbstract not available.Helena J Teede, Alison Johnson, Jim Buttery, Cheryl A Jones, Douglas IR Boyle, Garry LR Jennings, Tim Sha
Human papillomavirus vaccine safety in Australia: experience to date and issues for surveillance
No full textAustralia was one of the first countries to licence a quadrivalent human papillomavirus (HPV) vaccine, rapidly followed by a federally funded program of universal vaccination of a broad age group of females through schools (12 to 18 years) and primary care (19 to 26 years). As of August 2009, more than 5.8 million doses of Gardasil® (quadrivalent; Merck, New Jersey, USA) have been distributed in Australia and a total of 1394 suspected adverse events following immunisation (AEFI) have been reported to the passive surveillance system. Most reports are of common and expected reactions. Case series of more uncommon and serious AEFI, both known to be potentially vaccine related (anaphylaxis, conversion disorders and lipoatrophy) and otherwise (multiple sclerosis and pancreatitis) have been published.Michael S. Gold, Jim Buttery and Peter McIntyr
Case for varicella surveillance in Australia
No full textThe definitive version is available at www.blackwell-synergy.comElizabeth Peadon, David Burgner, Michael Nissen, Jim Buttery, Yvonne Zurynski, Elizabeth Elliott, Michael Gold, Helen Marshall and Robert Boo
Febrile seizures following measles and varicella vaccines in young children in Australia
No full textAbstract not availableKristine K. Macartney, Heather F. Gidding, Lieu Trinh, Han Wang, Jocelynne McRae, Nigel Crawford, Michael Gold, Anne Kynaston, Christopher Blyth, Zurynski Yvonne, Elizabeth Elliott, Robert Booy, Jim Buttery, Helen Marshall, Michael Nissen, Peter Richmond, Peter B. McInytre, Nicholas Woo
Rotavirus gastroenteritis and asymptomatic infections in community child care centres
No full textThis thesis was scanned from the print manuscript for digital preservation and is copyright the author.
Researchers can access this thesis by asking their local university, institution or public library to
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Comparative effectiveness of lung volume reduction surgery for emphysema and bronchoscopic lung volume reduction with valve placement: a randomised controlled trial
No full textBackground: lung volume reduction surgery (LVRS) and bronchoscopic lung volume reduction (BLVR) with endobronchial valves (EBVs) can improve lung function, exercise capacity and quality of life in appropriately selected patients with emphysema. However, no direct comparison data exists to inform clinical decision-making in people who appear suitable for both procedures. Our aim was to investigate whether LVRS produces superior health outcomes when compared to BLVR at 12 months.Methods: the CELEB study was a multi-centre, single-blind parallel-group trial randomising patients from five UK hospitals, who were suitable for a targeted lung volume reduction procedure, to either LVRS or BLVR, and comparing outcomes at one year using the i-BODE score. This composite disease severity measure includes body mass index, airflow obstruction, dyspnoea and exercise capacity (incremental shuttle walk test). The researchers responsible for collecting outcomes were masked to treatment allocation. All outcomes were assessed in the intention-to-treat population.Findings: between 16 th September 2016 and 22 nd July 2019, 88 participants (48% female, mean (±SD) age 64.6±7.7, FEV 1 %predicted 31.0±7.9) were recruited at five specialist centres across the UK and randomised to either LVRS(n=41) or BLVR(n=47). At 12 months follow up, the complete i-BODE was available in 49 participants (21 LVRS/ 28 BLVR). Neither improvement in the i-BODE composite score (LVRS: -1.10 (1.44), BLVR: -0.82 (1.61) p=0.54) nor its individual components differed between treatment arms. Both treatments produced similar improvements in gas trapping; RV% predicted (LVRS -36.1 (-54.1, -10), BLVR: -30.1 (-53.7, -9) p=0.81). There was one death in each treatment arm.Interpretation: our findings do not support the hypothesis that LVRS is a substantially superior treatment to BLVR in individuals who are suitable for both treatments.Trial Registration Details: the trial was registered prospectively; ISRCTN19684749.Funding Information: this project was funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1014-35051). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Imperial College, London will support the reporting of this manuscript. Trial sponsor representative: Patrik Pettersson, Royal Brompton and Harefield NHS Foundation Trust (RB&HFT), Royal Brompton Hospital.Declaration of Interests: PLS and DW have received payment from PulmonX for educational lectures. NG has received grants to institution from GSK and Genentech and grants for lectures and travel from AZ and Chiesi. RL is a member of the British Thoracic Society COPD Specialist Advisory group, a member of South Yorkshire Clinical Senate and a member of South Yorkshire and Bassetlaw Respiratory Clinical Network. All other authors have nothing to declare.Ethics Approval Statement: ethical approval was obtained from Fulham Research Ethics Committee, London, UK (REC reference: 16/LO/0286). The trial protocol has been published previously (20). A trial steering committee with an independent chair met quarterly to review progress, conduct and safety throughout the course of the trial
Adverse events following HPV immunization in Australia: establishment of a clinical network
No full textObjective: To formalise a collaborative national Adverse Events Following Immunisation Clinical Assessment Network (AEFI-CAN) following the expansion of the Australian Human Papillomavirus (HPV) immunisation program to boys in 2013. Methods: AEFI-CAN linked state-based vaccine safety clinics and the Department of Health including the Therapeutic Goods Administration (TGA). Monthly teleconferences held to discuss HPV related cases. AEFI conditions of interest recorded in a centralised database. Results: Between 1st January 2013 - 31st October 2014, 118 HPV AEFI were documented, 56% in males. The median age was 13 y (range 12–16 years). The majority of AEFI reports were after dose 1 (59%). 76 of 118 (64%) AEFI were seen in a vaccine safety clinic: 62% in Victoria, NSW (16%), South Australia (9%) and Western Australia (8%). Eight TeleHealth consultations were undertaken. AEFI were categorised as: rash 24% of reports (n = 28), urticaria/angioedema 23% (n = 27), anaphylaxis 3% (n = 4). Syncope was also reported (n = 12, 10%) and other neurological events (n = 22, 19%). Conclusions: We demonstrated the advantages of a national network, providing a collaborative approach to AEFI review and management. The vaccine safety network has applicability to any vaccination program, and has potential to collaborate more broadly with regional pharmacovigilance partners such as New Zealand.Nigel W. Crawford, Kate Hodgson, Mike Gold, Jim Buttery, Nicholas Wood and on behalf of the AEFI-CAN networ
Information systems for vaccine safety surveillance
No full textImmunization implementation in the community relies upon post-licensure vaccine safety surveillance to maintain safe vaccination programs and to detect rare AEFI not observed in clinical trials. The increasing availability of electronic health-care related data and correspondence from both health-related providers and internet-based media has revolutionized health-care information. Many and varied forms of health information related to adverse event following immunization (AEFI) are potentially suitable for vaccine safety surveillance. The utilization of these media ranges from more efficient use of electronic spontaneous reporting, automated solicited surveillance methods, screening various electronic health record types, and the utilization of natural language processing techniques to scan enormous amounts of internet-based data for AEFI mentions. Each of these surveillance types have advantages and disadvantages and are often complementary to each other. Most are “hypothesis generating,” detecting potential safety signals, where some, such as vaccine safety datalinking, may also serve as “hypothesis testing” to help verify and investigate those potential signals
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