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University of Technology Sydney. Faculty of Health. Vaccination programs can provide an effective means to control infectious diseases at a population level. Evaluating the impact of these programs after implementation can be complicated by limitations of routine surveillance systems and lack of routine testing to confirm diagnosis, as well as natural fluctuations in disease rates over time. This thesis provides a structured explanation of statistical methods and how they can be used to address the epidemiological challenges in assessing changes in burden of disease as a result of vaccination programs. It explores statistical approaches to the evaluation of vaccination programs at a population level, using rotavirus vaccination in New South Wales (NSW), Australia, as a case study. A summary of the key features that need to be considered when trying to detect any changes in the burden of infectious diseases due to vaccination is given. An assessment of the impact of the Australian rotavirus vaccination program, introduced in 2007, on hospitalisations and emergency department (ED) presentations of children aged under five years for all-cause gastroenteritis in NSW from July 2001 to June 2013 was conducted. Previously published methods that separate these hospitalisations and ED presentations into those due to rotavirus and those that are not are compared. A simulation study is used to explore these methods in controlled scenarios to determine the most appropriate method for these data. The Australian rotavirus vaccination program had an almost immediate impact and led to a fifty and sixteen percent reduction in the rate of hospitalisations and ED presentations for acute gastroenteritis within the first 2.5 years. These declines were mostly attributed to a decline in the size of the seasonal peak. The methods to determine rotavirus cases from all-cause gastroenteritis cases had different strengths and limitations and the derived estimates varied. No robust method was identified from the simulation study for our data. Each method that relied on using weekly counts of positive rotavirus laboratory tests to estimate rotavirus-attributable cases underestimated the true number of rotavirus cases when their assumptions held. The evaluation of the effectiveness of vaccination programs requires the use of rigorous statistical methods to ensure the robustness and validity of findings. Appropriate statistical methods that account for temporal trends are needed to provide a detailed understanding of any changes in disease burden observed. While this thesis focused on rotavirus disease burden in NSW, Australia, many of the concepts discussed are applicable to other infectious diseases.

OBJECTIVE: To examine whether acute dysglycaemia predicts death in people admitted to hospital with community acquired pneumonia. DESIGN: Multicentre prospective cohort study. SETTING: Hospitals and private practices in Germany, Switzerland, and Austria. PARTICIPANTS: 6891 patients with community acquired pneumonia included in the German community acquired pneumonia competence network (CAPNETZ) study between 2003 and 2009. MAIN OUTCOME MEASURES: Univariable and multivariable hazard ratios adjusted for sex, age, current smoking status, severity of community acquired pneumonia using the CRB-65 score (confusion, respiratory rate >30/min, systolic blood pressure /= 65 years), and various comorbidities for death at 28, 90, and 180 days according to serum glucose levels on admission. RESULTS: An increased serum glucose level at admission to hospital in participants with community acquired pneumonia and no pre-existing diabetes was a predictor of death at 28 and 90 days. Compared with participants with normal serum glucose levels on admission, those with mild acute hyperglycaemia (serum glucose concentration 6-10.99 mmol/L) had a significantly increased risk of death at 90 days (1.56, 95% confidence interval 1.22 to 2.01; P/= 14 mmol/L. In sensitivity analyses the predictive value of serum glucose levels on admission for death was confirmed at 28 days and 90 days. Patients with pre-existing diabetes had a significantly increased overall mortality compared with those without diabetes (crude hazard ratio 2.47, 95% confidence interval 2.05 to 2.98; P

Introduction: Despite the widespread availability of clinical guidelines, considerable gaps remain between the care that is recommended (appropriate care) and the care provided. This protocol describes a research methodology to develop clinical indicators for appropriate care for common paediatric conditions. Methods and analysis: We will identify conditions amenable to population-level appropriateness of care research and develop clinical indicators for each condition. Candidate conditions have been identified from published research; burden of disease, prevalence and frequency of presentation data; and quality of care priority lists. Clinical indicators will be developed through searches of national and international guidelines, and formatted with explicit criteria for inclusion, exclusion, time frame and setting. Experts will review the indicators using a wiki-based approach and modified Delphi process. A formative evaluation of the wiki process will be undertaken Ethics and dissemination: Human Research Ethics Committee approvals have been received from Sydney Children's Hospital Network, Children's Health Queensland Hospital and Health Service, and the Women's and Children's Health Network (South Australia). Applications are under review with Macquarie University and the Royal Australian College of General Practitioners. We will submit the results of the study to relevant journals and offer national and international presentations. Refereed/Peer-reviewed

Introduction: Australian and international clinical practice guidelines are available for common paediatric conditions. Yet there is evidence that there are substantial variations between the guidelines, recommendations (appropriate care) and the care delivered. This paper describes a study protocol to determine the appropriateness of the healthcare delivered to Australian children for 16 common paediatric conditions in acute and primary healthcare settings. Methods and analysis: A random sample of 6000-8000 medical records representing a cross-section of the Australian paediatric population will be reviewed for appropriateness of care against a set of indicators within three Australian states (New South Wales, Queensland and South Australia) using multistage, stratified sampling. Medical records of children aged