73 research outputs found
Adverse events following immunisation (AEFI): Optimising passive surveillance to improve immunisation safety in Victoria
No full text© 2020 Hazel Joanne ClothierVaccines are a cornerstone of public health saving millions of lives each year, however, adverse events following immunisation (AEFI) are a reality. Comprehensive post-licensure vaccine safety surveillance is therefore essential to maintain confidence in immunisation, inform policy and ensure the ongoing safety of immunisation programs.
Vaccine pharmacovigilance in Australia has been criticised and found inadequate due to its inability to inform on vaccine safety events in a timely manner. In 2010 this meant failure to prevent serious neurological sequalae arising from increased febrile reactions with one particular brand of influenza vaccine. Subsequent expert reviews of Australian AEFI surveillance proposed the Victorian state-level enhanced passive surveillance system “SAEFVIC” as a potential model system, with suggestion to expand to jurisdictions that did not have robust AEFI surveillance. However, despite this recommendation, no evaluation of SAEFVIC’s ability to provide effective vaccine pharmacovigilance had been undertaken.
My doctoral research evaluates “SAEFVIC”, the Victorian AEFI surveillance system’s ability to detect and investigate emergent vaccine safety issues with the findings presented in a range of publications and discrete reviews. Within this thesis I have developed real-time investigation of vaccine safety issues, which have informed policy decisions on immunisation program delivery and ensured community confidence. Description of the system epidemiology provides a foundation for research integrity. Individual studies have identified opportunities for improvement and guided amendments to data collection to better inform on at-risk populations.
I explored and applied a simple, feasible and replicable measure of disproportionality for signal detection enabling implementation of routine signal detection. The establishment of contemporary reporting and visualisation has contributed to national expansion of SAEFVIC as an integrated surveillance platform, markedly increasing national capability to provide “comprehensive and effective post-licensure AEFI surveillance critical to maintain confidence in immunisation and inform evidence-based policy for vaccine safety”.
My research has provided the evidence-base to optimise the SAEFVIC passive AEFI surveillance system and—through translation of the findings into policy and practice—helped consolidate Victoria as a leader in Australian AEFI surveillance, a major southern hemisphere partner in global AEFI surveillance and ultimately made immunisations safer.
The timeliness of my doctoral thesis has become prophetically pertinent in the midst of the 2020 global Coronavirus SARS-CoV-2 crisis, with calls for development and release of novel vaccines at “pandemic speed”, highlighting the need for robust and timely vaccine safety surveillance
Fresh-water algae
No full textCitation: Clothier, Geo L. Fresh-water algae. Senior thesis, Kansas State Agricultural College, 1892.Morse Department of Special CollectionsIntroduction: This fragmentary treatise upon the Fresh-water Algae of this neighborhood makes no pretense at completeness. It is a nucleus of original investigations about which the author expects to group other facts in future years. In the preparations of this paper, I am greatly indebted to Professor Hitchcock, of the Kansas State Agricultural College, for valuable hints and assistance. To Rev. Francis Nolle of Bethlehem, Pennsylvania, author of “Fresh-Water Algae of the United States”, I owe the acknowledgment of valuable aid through the means of correspondence. Algae are divided according to the coloring matters contained into four classes; namely the Red, or Rhodophyceae; The Olive, or Melanophyceae; the Green, or Chlorophyceae; and the Blue, or Cyanophyceae. The Melanophyceae are found only in salt-water. All my researches have been confined to the Chlorophyceae, although I occasionally had the pleasure of seeing a crawling Oscillaria
The DSM-5 controversies: How should psychologists respond?
No full textThe American Psychiatric Association (APA) published DSM-5 in May 2013. The revision process was fraught with controversy. In the first section of this article, we briefly summarise the controversies related to the actions of the APA and the Task Force responsible for the revision process. These include allegations of secrecy, accusations of conflicts of interest, apprehension over a promised paradigm shift, concerns about the definition of mental disorder, charges of medicalizing normality, and claims of poor methodology. In the second section, we briefly summarise the controversies related to some of the revisions to the DSM-5 disorders and diagnostic criteria. In the third section, we argue that DSM-5 development was unnecessarily contentious for reasons that could have been foreseen and prevented. Because incremental updates to the DSM-5 are anticipated in the near future (American Psychiatric Association, 2010, APA modifies DSM naming convention to reflect publication changes, Washington, DC: Author), we propose that psychologists external to the revision process should use their unique expertise to assist in resolving the controversies that have beset the DSM-5 and thereby facilitate a less contentious development of the next iteration of the DSM.Peer reviewedResearch articleDSM-5ControversiesPsychologist
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
Early signal detection of adverse events following influenza vaccination using proportional reporting ratio, Victoria, Australia
No full textIntroduction Timely adverse event following immunisation (AEFI) signal event detection is essential to minimise further vaccinees receiving unsafe vaccines. We explored the proportional reporting ratio (PRR) ability to detect two known signal events with influenza vaccines with the aim of providing a model for prospective routine signal detection and improving vaccine safety surveillance in Australia. Methods Passive AEFI surveillance reports from 20082017 relating to influenza vaccines were accessed from the Australian SAEFVIC (Victoria) database. Proportional reporting ratios were calculated for two vaccine-event categories; fever and allergic AEFI. Signal detection sensitivity for two known signal events were determined using weekly data; cumulative data by individual year and; cumulative for all previous years. Signal event thresholds of PRR ?2 and Chi-square ?4 were applied. Results PRR provided sensitive signal detection when calculated cumulatively by individual year or by all previous years. Known signal events were detected 15 and 11 days earlier than traditional methods used at the time of the actual events. Conclusion Utilising a single jurisdictions data, PRR improved vaccine pharmacovigilance and showed the potential to detect important safety signals much earlier than previously. It has potential to maximise immunisation safety in Australia. This study progresses the necessary work to establish national cohesion for passive surveillance signal detection and strengthen routine Australian vaccine pharmacovigilance. 2019 Clothier et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Evaluation of 'SAEFVIC', A Pharmacovigilance Surveillance Scheme for the Spontaneous Reporting of Adverse Events Following Immunisation in Victoria
No full textINTRODUCTION:
Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called 'SAEFVIC' (Surveillance of Adverse Events Following Vaccination In the Community).
OBJECTIVE:
The aim of this study was to evaluate Victoria's current AEFI surveillance system 'SAEFVIC' and inform ongoing quality improvement of vaccine pharmacovigilance in Victoria and Australia.
METHODS:
We conducted a retrospective structured desktop evaluation of AEFI reporting received by SAEFVIC from 2007 to 2014, to evaluate the system according to its stated objectives, i.e. to improve AEFI reporting; provide AEFI signal detection; and to maintain consumer confidence in vaccination.
RESULTS:
AEFI reporting has tripled since SAEFVIC commenced (incidence risk ratio [IRR] 3.04, 95% confidence interval [CI] 2.35-3.93), raising Victoria to be the lead jurisdiction by AEFI reporting volume and to rank third by population reporting rate nationally. The largest increase was observed in children. Data were utilised to investigate potential signal events and inform vaccine policy. Signal detection required clinical suspicion by surveillance nurses, or prior vaccine-specific concerns. Subsequent vaccination post-AEFI was documented for 56.2% (95% CI 54.1-58.4) of reports, and the proportion of children due or overdue for vaccination was 2.3% higher for those reporting AEFI compared with the general population.
CONCLUSION:
SAEFVIC has improved AEFI surveillance, facilitates signal investigation and validation, and supports consumer confidence in immunisation. Expansion of the system nationally has the potential to improve capacity and capability of vaccine pharmacovigilance, particularly through data consistency and jurisdictional comparability in Australia.SAEFVIC is funded by the Department of Health and
Human Services, Melbourne, VIC, Australia. Hazel Clothier is the
recipient of an Australian Government Research Training Program
Scholarship
[Photograph 2012.201.B0229.0205]
No full textPhotograph taken for a newspaper owned by the Oklahoma Publishing Company. Caption: "A. T. CLOTHIER, Carter Oil Co., Tulsa, Okla., is co-author, with F. T. Gardner and Francis Coryell, of a paper entitled "Control of Vapor-Zone Corrosion in Storage Tanks by the USE of Ammonia," which will be presented to a Pipe-Line Symposium of the Division of Transportation, during the 29th. Annual Meeting of the American Petroleum Institute, in the Palmer House, Chicago, Ill., November 4-11, 1949.
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