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  1. Article ; Online: The impact of implementing the 2016 WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience on perinatal deaths

    Yogan Pillay / Tina Lavin / Robert Clive Pattinson / Erin Kelty / David Brian Preen

    BMJ Global Health, Vol 5, Iss

    an interrupted time-series analysis in Mpumalanga province, South Africa

    2020  Volume 12

    Abstract: Objectives To investigate if the implementation of the 2016 WHO Recommendations for a Positive Pregnancy Experience reduced perinatal mortality in a South African province. The recommendations were implemented which included increasing the number of ... ...

    Abstract Objectives To investigate if the implementation of the 2016 WHO Recommendations for a Positive Pregnancy Experience reduced perinatal mortality in a South African province. The recommendations were implemented which included increasing the number of contacts and also the content of the contacts.Methods Retrospective interrupted time-series analysis was conducted for all women accessing a minimum of one antenatal care contact from April 2014 to September 2019 in Mpumalanga province, South Africa. Retrospective interrupted time-series analysis of province level perinatal mortality and birth data comparing the pre-implementation period (April 2014–March 2017) and post-implementation period (April 2018–September 2019). The main outcome measure was unadjusted prevalence ratio (PR) for perinatal deaths before and after implementation; interrupted time-series analyses for trends in perinatal mortality before and after implementation; stillbirth risk by gestational age; primary cause of deaths (and maternal condition) before and after implementation.Results Overall, there was a 5.8% absolute decrease in stillbirths after implementation of the recommendations, however this was not statistically significant (PR 0.95, 95% CI 0.90% to 1.05%; p=0.073). Fresh stillbirths decreased by 16.6% (PR 0.86, 95% CI 0.77% to 0.95%; p=0.003) while macerated stillbirths (p=0.899) and early neonatal deaths remained unchanged (p=0.499). When stratified by weight fresh stillbirths >2500 g decreased by 17.2% (PR 0.81, 95% CI 0.70% to 0.94%; p=0.007) and early neonatal deaths decreased by 12.8% (PR 0.88, 95% CI 0.77% to 0.99%; p=0.041). The interrupted time-series analysis confirmed a trend for decreasing stillbirths at 0.09/1000 births per month (−0.09, 95% CI −1.18 to 0.01; p=0.059), early neonatal deaths (−0.09, 95% CI −0.14 to 0.04; p=<0.001) and perinatal mortality (−1.18, 95% CI −0.27 to −0.09; p<0.001) in the post-implementation period. A decrease in stillbirths, early neonatal deaths or perinatal mortality was not observed in ...
    Keywords Medicine (General) ; R5-920 ; Infectious and parasitic diseases ; RC109-216
    Language English
    Publishing date 2020-12-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Statistical analysis plan for the Prophylactic Melatonin for Delirium in Intensive Care (ProMEDIC)

    Bradley Wibrow / F. Eduardo Martinez / Andrew Ford / Erin Kelty / Kevin Murray / Kwok M. Ho / Edward Litton / Erina Myers / Matthew Anstey

    Trials, Vol 22, Iss 1, Pp 1-

    a randomised controlled trial

    2021  Volume 7

    Abstract: Abstract Rationale Delirium is defined as acute organic brain dysfunction characterised by inattention and disturbance of cognition. It is common in the intensive care unit and is associated with poorer outcomes. Good quality sleep is important in the ... ...

    Abstract Abstract Rationale Delirium is defined as acute organic brain dysfunction characterised by inattention and disturbance of cognition. It is common in the intensive care unit and is associated with poorer outcomes. Good quality sleep is important in the prevention and management of delirium. Melatonin is a natural hormone secreted by the pineal gland which helps in the regulation of the sleep-wake cycle. It is possible that melatonin supplementation in intensive care improves sleep and prevents delirium. Methods and design The ‘Prophylactic Melatonin for Delirium in Intensive Care’ study is a multi-centre, randomised, double-blinded, placebo-controlled trial. The primary objective of this study is to determine whether melatonin given prophylactically decreases delirium in critically ill patients. A total of 850 ICU patients have been randomised (1:1) to receive either melatonin or a placebo. Participants were monitored twice daily for symptoms of delirium. Results This paper and the attached additional files describe the statistical analysis plan (SAP) for the trial. The SAP has been developed and submitted for publication before the database has been locked and before the treatment allocation has been unblinded. The SAP contains details of analyses to be undertaken, which will be reported in the primary and secondary publications. Discussion The SAP details the analyses that will be done to avoid bias coming from knowledge of the results in advance. This trial will determine whether prophylactic melatonin administered to intensive care unit patients helps decrease the rate and the severity of delirium. Trial registration Australian and New Zealand Clinical Trial Registry (ANZCTR) ACTRN1261600043647 , registration date: 06 April 2016. WHO Trial Number – U1111-1175-1814
    Keywords Delirium ; Melatonin ; Intensive care unit ; Sleep ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Generating Real-World Evidence on the Quality Use, Benefits and Safety of Medicines in Australia

    Sallie-Anne Pearson / Nicole Pratt / Juliana de Oliveira Costa / Helga Zoega / Tracey-Lea Laba / Christopher Etherton-Beer / Frank M. Sanfilippo / Alice Morgan / Lisa Kalisch Ellett / Claudia Bruno / Erin Kelty / Maarten IJzerman / David B. Preen / Claire M. Vajdic / David Henry

    International Journal of Environmental Research and Public Health, Vol 18, Iss 13345, p

    History, Challenges and a Roadmap for the Future

    2021  Volume 13345

    Abstract: Australia spends more than $20 billion annually on medicines, delivering significant health benefits for the population. However, inappropriate prescribing and medicine use also result in harm to individuals and populations, and waste of precious health ... ...

    Abstract Australia spends more than $20 billion annually on medicines, delivering significant health benefits for the population. However, inappropriate prescribing and medicine use also result in harm to individuals and populations, and waste of precious health resources. Medication data linked with other routine collections enable evidence generation in pharmacoepidemiology; the science of quantifying the use, effectiveness and safety of medicines in real-world clinical practice. This review details the history of medicines policy and data access in Australia, the strengths of existing data sources, and the infrastructure and governance enabling and impeding evidence generation in the field. Currently, substantial gaps persist with respect to cohesive, contemporary linked data sources supporting quality use of medicines, effectiveness and safety research; exemplified by Australia’s limited capacity to contribute to the global effort in real-world studies of vaccine and disease-modifying treatments for COVID-19. We propose a roadmap to bolster the discipline, and population health more broadly, underpinned by a distinct capability governing and streamlining access to linked data assets for accredited researchers. Robust real-world evidence generation requires current data roadblocks to be remedied as a matter of urgency to deliver efficient and equitable health care and improve the health and well-being of all Australians.
    Keywords prescribing ; quality use of medicines ; medication safety ; pharmacoepidemiology ; medication data ; data linkage ; Medicine ; R
    Subject code 360 ; 306
    Language English
    Publishing date 2021-12-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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