Suchergebnisse

IntroductionRotavirus vaccine, RV1 (Rotarix), was included in the immunisation programs in Western Australia (WA) and New South Wales from mid-2007. In WA, RV1 was replaced with RV5 (RotaTeq) in mid-2009. Marked declines in rotavirus-related hospitalisations in both Aboriginal and non-Aboriginal children have been demonstrated following the implementation of the program.
Objectives and ApproachWe aimed to assess RV1 vaccine effectiveness (VE) against rotavirus-coded hospitalisations among Aboriginal and non-Aboriginal children aged (1-hazard ratio*100) were obtained from Cox proportional hazards models (adjusted for infant, maternal and demographic factors and stratified by state of birth) for Aboriginal and non-Aboriginal children.
ResultsThere were a total of 623 rotavirus-coded hospitalisations among the cohort children aged <2 years. Rotavirus hospitalisation rates were 143.0/100,000 child-years (95% confidence interval [CI]: 113.3-180.4) among Aboriginal children and 49.0/100,000 child-years (95% CI: 44.8-53.5) among non-Aboriginal children.
Compared to unvaccinated children, 1-dose VE among Aboriginal children against rotavirus-coded hospitalisations was 52.1% (95% CI: -0.02-77.1%) and 2-dose VE was 62.4% (95% CI: 26.9-80.7%) adjusting for birthweight, region of residence, socio-economic status, and year of birth. Among non-Aboriginal children, 1-dose VE was 39.0% (95% CI: 13.1-57.2%) and 2-dose VE was 53.4% (95% CI: 38.1-65.1%) adjusting for birth weight, mode of delivery and maternal age at birth and year of birth.
Conclusion/ImplicationsBurden of rotavirus gastroenteritis remains significant in Aboriginal children. Given the previously demonstrated declines in rotavirus-related hospitalisations in this population following vaccine introduction, our lower-than-expected VE estimates might represent bias introduced by differences in health-seeking behaviour between the vaccinated and unvaccinated, herd immunity and/or possible non-differential misclassification of the outcome.

IntroductionRespiratory Syncytial Virus (RSV) causes considerable morbidity in children. RSV vaccines are in development, but the only current preventive measure is immunoprophylaxis with monoclonal antibody, palivizumab. Australia has no uniform palivizumab guidelines. In Western Australia palivizumab is licensed for use in high risk children but compliance and effectiveness is unknown.
Objectives and ApproachWe conducted a retrospective cohort study using palivizumab data from multiple pharmacy dispensing datasets which had been linked with routine laboratory, hospital morbidity, emergency department presentations, deaths and perinatal data for a cohort of infants admitted to Level 3 Neonatal Intensive Care Units (NICU) between 2002 and 2013. We identified palivizumab eligible infants as those who were extremely premature (<28 weeks gestation) with bronchopulmonary dysplasia and/or who identified as Indigenous and were NICU inpatients during the annual winter RSV season (May-October). We describe the use of palivizumab in infants that did and did not fit the eligibility criteria.
ResultsThe NICU cohort included 24,367 infants, of which 1754 had at least 1 RSV-confirmed infection before age 5 years. A total of 686 (2.8%) cohort infants were eligible for palivizumab. Palivizumab dispensing data were amalgamated from 5 pharmacy datasets. Overall, 173 of the palivizumab eligible infants (25.2%) had at least 1 palivizumab dose (27% 1 dose, 34% 2 doses, 28% 3 doses and 11% 4 or more doses). From 2011 when palivizumab guidelines were formalised, 143 (75%) had at least 1 dose. Compliance with at least 1 palivizumab dose was highest in 2011 (84.9%). From 2002-2013, 98 infants were given palivizumab outside eligibility criteria (33% 1 dose, 33% 2 doses, 34% 3 or more doses) with annual use increasing since 2008.
Conclusion/ImplicationsThis is the first time pharmacy dispensing data have been linked to other datasets to measure use and effectiveness. Compliance with palivizumab guidelines was high from 2011. These data will be used to measure the effectiveness of palivizumab against RSV-confirmed infections and respiratory infection-related hospitalisations up to age 5 years.

ABSTRACT
ObjectiveImmunisation remains one of the most important public health interventions. However, linkage of population-based immunisation registers to perinatal and health outcome datasets to evaluate immunisation programs is limited. We have conducted the first-ever linkages of immunisation records from Australia's Childhood Immunisation Register (ACIR) for the purposes of evaluating Australia's unique national immunisation program. As an initial outcome of our linkage study we present estimates of pneumococcal conjugate vaccine (PCV) coverage for the 3rd dose assessed at 12 months of age in extremely preterm children (gestational age <28 weeks), in whom a funded vaccination program was established in 2001 prior to a universal funded program for all children in 2005.
ApproachIndividual immunisation records from ACIR, hospital admissions, deaths and infectious diseases notifications were linked to perinatal records for a cohort of births from 1996 to 2012 in two Australian states. Three separate data linkage units were involved in the process with varying procedures for linkage. The perinatal datasets were used to identify extremely preterm children.
ResultsThe birth cohort for the study included 1,958,537 live births in New South Wales (1,492,399) and Western Australia (461,620). Linkage weights based on sensitivity and positive predictive value of >99% were used to identify immunisation records from ACIR to link to the birth cohort. A unique scrambled pin on ACIR was used to link immunisation records to birth cohort datasets. The final cohort consisted of 1,954,019 children with 95.5% linking to at least 1 ACIR record from a total of >26.6 million ACIR records. In 2001, coverage of the 3rd dose of PCV in extremely preterm children was 0.9% and increased to 69.1% in 2004 (overall coverage 2001-2004: 25.3%). From 2005 to 2012, coverage increased to an average of 89.7%.
ConclusionThese are the first results of cross-jurisdictional linkages of immunisation records to state-based administrative datasets in Australia. This process has identified some improvements that are needed to streamline future linkage projects of this scale. Linkage of perinatal datasets to ACIR has enabled us to assess the first-ever coverage estimates in specific medically at-risk population subgroups. Future analyses will focus on the predictors and timeliness of vaccination coverage and population based estimates of vaccine effectiveness.

Increased febrile reactions in Australian children from one influenza vaccine brand in 2010 diminished confidence in influenza immunisation, highlighting the need for improved vaccine safety surveillance. AusVaxSafety, a national vaccine safety surveillance system collected adverse events in young children for 2015 influenza vaccine brands in real time through parent/carer reports via SMS/email. Weekly cumulative data on 3,340 children demonstrated low rates of fever (4.4%) and medical attendance (1.1%). Fever was more frequent with concomitant vaccination. ; AusVaxSafety surveillance was funded under a contract with the Australian Government Department of Health.

Introduction Pregnant women and infants are at risk of severe influenza and pertussis infection. Inactivated influenza vaccine (IIV) and diphtheria-tetanus-acellular pertussis vaccine (dTpa) are recommended during pregnancy to protect both mothers and infants. In Australia, uptake is not routinely monitored but coverage appears sub-optimal. Evidence on the safety of combined antenatal IIV and dTpa is fragmented or deficient, and there remain knowledge gaps of population-level vaccine effectiveness. We aim to establish a large, population-based, multi-jurisdictional cohort of mother-infant pairs to measure the uptake, safety and effectiveness of antenatal IIV and dTpa vaccines in three Australian jurisdictions. This is a first step toward assessing the impact of antenatal vaccination programmes in Australia, which can then inform government policy with respect to future strategies in national vaccination programmes. Methods and analysis ' Links2HealthierBubs' is an observational, population-based, retrospective cohort study established through probabilistic record linkage of administrative health data. The cohort includes births between 2012 and 2017 (∼607 605 mother-infant pairs) in jurisdictions with population-level antenatal vaccination and health outcome data (Western Australia, Queensland and the Northern Territory). Perinatal data will be the reference frame to identify the cohort. Jurisdictional vaccination registers will identify antenatal vaccination status and the gestational timing of vaccination. Information on maternal, fetal and child health outcomes will be obtained from hospitalisation and emergency department records, notifiable diseases databases, developmental anomalies databases, birth and mortality registers. Ethics and dissemination Ethical approval was obtained from the Western Australian Department of Health, Curtin University, the Menzies School of Health Research, the Royal Brisbane and Women's Hospital, and the West Australian Aboriginal Health Ethics Committees. Research findings will be disseminated in peer-reviewed journals, at scientific meetings, and may be incorporated into communication materials for public health agencies and the public.

Objectives: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient relevance, limiting their applicability for clinical decision-making. The aim of this workshop was to establish a core outcomes set for trials in people with suspected or confirmed coronavirus disease 2019. Design: Four international online multistakeholder consensus workshops were convened to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019, informed by a survey involving 9,289 respondents from 111 countries. The transcripts were analyzed thematically. The workshop recommendations were used to finalize the core outcomes set. Setting: International. Subjects: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public and health professionals (including clinicians, policy makers, regulators, funders, researchers). Interventions: None. Measurements: None. Main Results: Six themes were identified. "Responding to the critical and acute health crisis" reflected the immediate focus on saving lives and preventing life-threatening complications that underpinned the high prioritization of mortality, respiratory failure, and multiple organ failure. "Capturing different settings of care" highlighted the need to minimize the burden on hospitals and to acknowledge outcomes in community settings. "Encompassing the full trajectory and severity of disease" was addressing longer term impacts and the full spectrum of illness (e.g. shortness of breath and recovery). "Distinguishing overlap, correlation and collinearity" meant recognizing that symptoms such as shortness of breath had distinct value and minimizing overlap (e.g. lung function and pneumonia were on the continuum toward respiratory failure). "Recognizing adverse events" refers to the potential harms of new and evolving interventions. "Being cognizant of family and psychosocial wellbeing" reflected the pervasive impacts of coronavirus disease 2019. Conclusions: Mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in coronavirus disease 2019 trials. ; Flinders University National Coronavirus Disease 2019 Clinical Evidence Taskforce Australian Government CGIAR Victorian Department of Health and Human Services Ian Potter Foundation Walter Cottman Endowment Fund Lord Mayor's Charitable Foundation

Objectives: There are over 4,000 trials conducted in people with coronavirus disease 2019. However, the variability of outcomes and the omission of patient-centered outcomes may diminish the impact of these trials on decision-making. The aim of this study was to generate a consensus-based, prioritized list of outcomes for coronavirus disease 2019 trials. Design: In an online survey conducted in English, Chinese, Italian, Portuguese, and Spanish languages, adults with coronavirus disease 2019, their family members, health professionals, and the general public rated the importance of outcomes using a 9-point Likert scale (7-9, critical importance) and completed a Best-Worst Scale to estimate relative importance. Participant comments were analyzed thematically. Setting: International. Subjects: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public, and health professionals (including clinicians, policy makers, regulators, funders, and researchers). Interventions: None. Measurements: None. Main Results: In total, 9,289 participants from 111 countries (776 people with coronavirus disease 2019 or family members, 4,882 health professionals, and 3,631 members of the public) completed the survey. The four outcomes of highest priority for all three groups were: mortality, respiratory failure, pneumonia, and organ failure. Lung function, lung scarring, sepsis, shortness of breath, and oxygen level in the blood were common to the top 10 outcomes across all three groups (mean > 7.5, median >= 8, and > 70% of respondents rated the outcome as critically important). Patients/family members rated fatigue, anxiety, chest pain, muscle pain, gastrointestinal problems, and cardiovascular disease higher than health professionals. Four themes underpinned prioritization: fear of life-threatening, debilitating, and permanent consequences; addressing knowledge gaps; enabling preparedness and planning; and tolerable or infrequent outcomes. Conclusions: Life-threatening respiratory and other organ outcomes were consistently highly prioritized by all stakeholder groups. Patients/family members gave higher priority to many patient-reported outcomes compared with health professionals. ; Flinders University National Coronavirus Disease 2019 Clinical Evidence Taskforce Australian Government CGIAR Victorian Department of Health and Human Services Ian Potter Foundation Walter Cottman Endowment Fund Lord Mayor's Charitable Foundation

ABSTRACT Objective: There are over 4000 trials conducted in people with COVID-19. However, the variability of outcomes and the omission of patient-centered outcomes may diminish the impact of these trials on decision-making. The aim of this study was to generate a consensus-based, prioritized list of outcomes for COVID-19 trials. Design: In an online survey conducted in English, Chinese, Italian, Portuguese and Spanish languages, adults with COVID-19, their family members, health professionals and the general public rated the importance of outcomes using a 9-point Likert scale (7-9, critical importance) and completed a Best-Worst Scale to estimate relative importance. Participant comments were analysed thematically. Setting: International Participants: Adults aged 18 years and over with confirmed or suspected COVID-19, their family members, members of the general public and health professionals (including clinicians, policy makers, regulators, funders, researchers). Main Results: In total, 9289 participants from 111 countries (776 people with COVID-19 or family members, 4882 health professionals, and 3631 members of the public) completed the survey. The four outcomes of highest priority for all three groups were: mortality, respiratory failure, pneumonia and organ failure. Lung function, lung scarring, sepsis, shortness of breath, and oxygen level in the blood were common to the top 10 outcomes across all three groups (mean >7.5, median ≥ 8, and >70% of respondents rated the outcome as critically important). Patients/family members rated fatigue, anxiety, chest pain, muscle pain, gastrointestinal problems and cardiovascular disease higher than health professionals. Four themes underpinned prioritization: fear of life-threatening, debilitating and permanent consequences; addressing knowledge gaps; enabling preparedness and planning; and tolerable or infrequent outcomes. Conclusions: Life-threatening respiratory and other organ outcomes were consistently highly prioritized by all stakeholder groups. Patients/family members gave higher priority to many patient-reported outcomes compared with health professionals. ; The project is funded by the Flinders University and the National COVID-19 Clinical Evidence Taskforce, convened by the Australian Living Evidence Consortium, hosted by Cochrane Australia, School of Public Health and Preventive Medicine, Monash University supported by the Australian Government, Victorian Department of Health and Human Services, Ian Potter Foundation, Walter Cottman Endowment Fund (managed by Equity Trustees) and the Lord Mayor's Charitable Foundation). AT is supported by The University of Sydney Robinson Fellowship. ACM is supported by a Clinical Research Career Development Fellowship from the Wellcome Trust (WT 2055214/Z/16/Z)