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Course Criteria
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3.00 Credits
The focus of this course will be on the application of methodological skills to help in the development of research hypotheses, and the analysis and interpretation of data. The fellow will have access to established databases which provide them with the opportunity to formulate research hypotheses. Then, under the supervision of an established investigator, they will learn how to translate hypotheses into statistical questions, manage data, organize a database for analysis, analyze data, and interpret results. Databases available include a) the Chicago Health and Aging Project, a longitudinal, population-based dataset of 6,162 adults, ages 65 and over, with a participation rate of 78.9 percent. The baseline dataset from this study is currently available. The first incidence cycle dataset will be available in 1999. The dataset includes interview and clinical examination data on the health and social problems of older adults, with a particular emphasis on risk factors for neurodegenerative diseases; b) database from the Chicago Study of Women's Health Across the Nation, a population-based study of women's' health at midlife with 2 parts: a cross-sectional telephone survey of 2,582 women between the ages of 40-55; and a longitudinal study of 1,000 pre-menopausal women, between the ages of 42-52, who will be followed as they undergo the menopausal transition. The cross-sectional survey dataset is currently available. The baseline dataset of the longitudinal study will be ready in early 1999. Variables in the dataset include endocrinological, cardiovascular, psychosocial, and risk factor influences on the course and outcome of the menopausal transition. Other datasets of post-MI patients, hypertensive patients, and post-menopausal women are available for study. Fellows will work closely with Dr. Powell and/or Dr. Denis Evans, MD, depending upon the research question of interest, in the formulation of questions and the interpretation of data. Assistance with programming and data management will be provided by the Department of Preventive Medicine. [3]
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2.00 Credits
The course reviews psychosocial factors affecting participation in clinical trials such as medication compliance, frequency of ide effects reported by the patients based on race and ethnicity and other related aspects. Focus will be on the case identification methods and clinical description, examination of laboratory and family studies, and follow-up studies. Risk factors and implications for treatment and prevention will be discussed. The course objectives are 1) review the major diagnostic entities in DSM-IV; 2) become conversant with the relevant literature in which the validity of these entities have been studied using descriptive, analytic, and experimental methods (particular attention will be focused on the Epidemiologic Catchment Area (ECA) Study and on the National Comorbidity Study for prevalence data, and on risk factor and outcomestudies. (2 Credits)
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3.00 Credits
The objective of this course is to provide an overview of epidemiological research and clinical trials that cover the breath of cardiovascular disease. Readings will be selected from major population-based, observational studies (e.g., Atherosclerosis Risk In Communities - ARIC, the Cardiovascular Health Study - CHS), and from cardiovascular intervention outcome trials (SOLVD, ELITE). Discussions will focus on study design issues, such as sampling, assessment, randomization, and selection of primary and secondary outcomes. Additionally, attention will be given to important methodological concepts, such as confounding, selection bias and other sources of bias that may affect interpretation of the study findings. Special emphasis will also be given to determining statistical versus clinical significance, and how results from major epidemiological studies and clinical trials affect clinical practice. [3]
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2.00 Credits
Methods and pitfalls of this methodology will be discussed. Fellows will perform a meta-analyses using various computer programs concerning unanswered questions in their respective area of research, where data exist but no large trial has been performed. Results will be presented to the class and critiqued. (2 Credits)
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2.00 Credits
The course will extend the introduction to these topics provided in Principles of Biostat II. Model selection, goodness-of-fit, confidence intervals for parameter estimates and testing of model assumptions will be covered. The proper reporting of results from these analyses and useful graphical techniques for analysis and presentation will be discussed. (2 Credits)
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3.00 Credits
This course will train medical professionals in the basic methods of economic evaluation of medical interventions. Instruction will be primarily by case-study review of published studies, supplemented with theoretical presentations as needed. A wide range of intervention modes with different implications for study design will be considered, including surgery, secondary prevention, primary prevention, and screening. Topics common to all will include a) the different types of outcome measurement: mortality and life expectancy, functional limitations, quality of life, and health utilities; b) the different components of costs: direct medical costs of an intervention, medical cost savings from reduced morbidity, indirect costs such as lost work productivity, and future costs; and c) how these elements are combined into the most common types of economic evaluations: cost-effectiveness, cost-benefit, and cost-utility analyses. We will consider the design of clinical trials to include economic assessment as well as the use of published studies in secondary evaluations. [3]
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2.00 Credits
Analytic techniques discussed will include repeated measures ANOVA, Friedman's test, mixed effects models and generalized estimating equations. The strengths and weaknesses of the various approaches will be discussed. Graphical techniques for analysis and presentation and the reporting of longitudinal analyses will be discussed. (2 Credits)
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3.00 Credits
The course will cover have the applicant aspects of the management of a clinical trial including resolution of problems by data safety monitoring board, protocol violations, impact of failing to achieve a particular target goal on outcome, etc. [3]
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3.00 Credits
The objective of this course is to provide an overview of clinical trials that cover the breath of renal disease progression. Readings will be selected from major multicentered, randomized double blind trials (e.g., The Captopril, REIN, AIPRI and MDRD, UKPDS Trials), and from smaller well-controlled randomized multicentered crossover studies. Discussions will focus on study design issues, such as sampling, assessment, randomization, and selection of primary and secondary outcomes. Additionally, attention will be given to important methodological concepts, such as confounding, selection bias and other sources of bias that may affect interpretation of the study findings. Special emphasis will also be given to determining statistical versus clinical significance, and how results from major epidemiological studies and clinical trials affect clinical practice. [1-2]
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3.00 Credits
The objective of this course is to provide an overview of clinical trials that cover the breath of cardiovascular disease in elderly populations. Readings will be selected from major multicentered, randomized double blind trials (e.g., The SHEP, Syst-Eur, MRC and Australian Trials). Emphasis will be placed on systolic hypertension and its impact on disease development. Discussions will focus on study design issues, such as sampling, assessment, randomization, and selection of primary and secondary outcomes. Additionally, attention will be given to important methodological concepts, such as confounding, selection bias, and other sources of bias that may affect interpretation of the study findings. Special emphasis will also be given to determining statistical versus clinical significance, and how results from major epidemiological studies and clinical trials affect clinical practice. [1-2]
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