PVM 505 Epidemiology/Biostatistics
The purpose of this review course is to provide students with a working knowledge of key concepts in epidemiology and biostatistics. These concepts, presented as “important terms” in each lecture hour, have been selected based upon their coverage on the USMLE Board exam. Thus, this course will serve as a preparation for this exam. The course is team taught in a lecture format by epidemiologists and biostatisticians from the Departments of Preventive Medicine, Medicine, and Psychiatry. An assigned textbook that covers the key concepts is highly recommended; lecture handouts are provided.

PVM 531 Introduction to Preventive Medicine
PVM 532 Medical Decision Making
These courses provide students with an introduction to 1) the significant role played by the social and cultural milieu in which health care is practiced, 2) the influence of environmental and economic factors on the health and well-being of individuals, 3) how disease and illness are measured in a population, and 4) the application of this knowledge and skill to the health of both the individual and the community.

PVM 546 Principles of Biostatistics I
Covers statistical issues in clinical trial design. This includes blinding, randomization, bias, and intent to treat. Use of descriptive statistics and graphical techniques to explore patterns in data. A review of the basic properties of probability and the characteristics of the normal and binomial distributions. One and two sample inference and hypothesis testing for proportions, means and medians, one way analysis of variance and simple linear regression including diagnostics based on residuals and confidence intervals for regression coefficients are covered. Hypotheses testing for cross-classified data are also discussed. [3]

PVM 547 Principles of Biostatistics II
Covers multifactor analysis of variance, multiple regression, logistic regression including Hosmer-Lemeshow goodness-of-fit and receiver-operating curves. Survival analysis including log rank tests, Kaplan-Meier curves and Cox regression are covered. Additionally, statistical software packages such as SAS or SPSS are discussed. [3]

PVM 552 Principles of Clinical Research and Epidemiology
Introduction to the basic principles of epidemiology that form the basis for clinical research. This will include a discussion of: rates, risks, descriptive epidemiology, patterns of disease occurrence, screening, diagnostic testing, validity and reliability. The following areas will be emphasized: hierarchy of scientific evidence in medicine, distinguishing features of “good studies”, methods of analysis of event-driven trials along with their pros and cons, dealing with concomitant confounders e.g., risk adjustment, compliance issues in clinical trials e.g. intent to treat vs. actual on therapy analysis. [2]

PVM 553 Observational Epidemiology
Course will provide an in-depth description of case- control and cohort studies. This includes: the different types (e.g. hospital- or population-based controls, retrospective and prospective cohorts, nested case- control), their strengths, weaknesses and uses, the definition and selection of cases and controls, matching and sampling, the definition and selection of exposure and comparison groups, the ascertainment of disease status and exposure status, and issues in analysis and interpretation of data, including the role of bias (selection bias, confounding bias, recall bias, misclassification of disease and exposure status), the effect of non-participation and loss to follow-up, and the application of various analytic approaches (stratification, standardization, and multivariate models). The computation, interpretation and application of basic epidemiologic concepts and statistics will be reinforced throughout the course, including measures of disease frequency (prevalence, incidence, attack rate) and measures of association (relative risk, odds ratio, risk difference, population attributable risk). Landmark studies illustrating the different types of case-control and cohort studies will be described. Trainees will be assigned readings from basic epidemiologic texts as well as publications from major case-control and cohort studies. [3]

PVM 554 Management, Evaluation and Statistical Interpretation of Clinical Trials
Coordinating center activities, sample size, adjustments for multiple looks, interim analyses, oversight, final analyses and summarizing analyses will be discussed and criteria for critiquing the literature (publications in peer-reviewed journals) will be discussed. Course will apply concepts and techniques from earlier courses to analyze data from clinical trials. Will focus on behavioral and cognitive data (including recruitment, retention and compliance issues). [3]

PVM 555 Introduction to Clinical Outcomes Research
Outcomes research focuses on evaluation the effect of interventions on a broad range of outcomes beyond traditional physiologic measures. This lecture series will examine health status, health related “quality of life,” and patient satisfaction. [2]

PVM 557 Clinical Trial Design I
Presents an overview of all types of trial designs including large simple trials, randomized double blinded trials, crossover studies and others. The course applies concepts obtained in Basic and Observational Epidemiology courses to address how studies are set up to answer specific research questions. The course reviews experimental designs in the context of specific hypotheses, bias, and confounding. Publications from existing peer-review journals will be used to illustrate various trial designs. [2]

PVM 558 Clinical Trial Design II
This course focuses on practical application of the concepts learned in Clinical Trial Design I. Trainees will be expected to design various types of clinical trials e.g. multicenter, double blind, placebo controlled studies as well as large simple trials and describe rationale for blinding, methods of randomization and planned analysis. Issues of data interpretation will be covered. [2]

PVM 559 Research in Special Populations
The material in this course will concentrate on public health and research issues in African-Americans, women, Hispanics and children. Issues that are accentuated include: barriers for recruitment of patients into clinical trials, role of the “Coorandero” in aiding with protocol
compliance and recruitment, influence of culture on disease processes, influence of environment and genetic predisposition for common disorders such as diabetes, hypertension, cancer and cardiovascular disease. [2]

PVM 561 Behavioral Approaches to Improve Compliance
The fellow will be exposed to the literature on the problems associated with compliance and retention in large-scale clinical and epidemiological research. A survey of behavioral barriers to compliance and retention will focus on emotional distress, health care beliefs, functional limitations, symptomatology, and cognitive deficits. Strategies to improve compliance and retention will be reviewed including doctor-patient communication, involvement of significant others, early identification of potential non-compliers or dropouts, and frequency of follow-up contacts. The fellow will be asked to conduct a case study with his/her own patients to determine o ptimum approaches to compliance and/or retention. This course will review data from the psychology literature that focuses on techniques to improve patient outcomes in clinical trials. [2]

PVM 562 Analysis of a Cardiovascular Population Database
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]

PVM 563 Psychosocial Influences on Clinical Trial Outcomes
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]

PVM 565 Readings in Cardiovascular Epidemiology
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]

PVM 571 Meta-analyses of Clinical Trials
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]

PVM 572 Advanced Logistic Regression Analysis and Interpretation of Survival Data
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]

PVM 573 The Economic Evaluation Of Medical Interventions
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]

PVM 575 Longitudinal Data Analysis
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]

PVM 576 Management of a Clinical Trial
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]

PVM 577 Readings in Trials of Renal Disease Progression
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]

PVM 578 Readings in Trials of Geriatric Populations
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]

PVM 581 Quality of Life Assessment
An introduction to quality of life measurement will include discussion of the construct of QOL, use of QOL instruments in clinical trials, evaluation of QOL instruments, issues in QOL data collection and data integrity, cross-cultural issues in QOL assessment, and specific issues in pediatric QOL assessment. [2]

PVM 582 Design of Research Outcomes Studies
Examples of various types of outcome studies will be reviewed, including: cohort studies (retrospective and prospective), studies of analysis of variations in clinical practice and experimental outcomes research studies. [3]

PVM 583 Critical Appraisal of Outcomes Research
This course will examine in-depth selected readings from outcomes research literature, with a focus on effectiveness and cost-effectiveness design. [2]

PVM 584 Data Sources for Outcomes Research
Various types of data are used in outcome research. Strengths and weakness of various types of data will be explored, including: administrative data, data collected during routine clinical care and data from clinical intervention studies. [1]

PVM 588 Overview of Outcomes Research
The lecture will review early outcomes studies from Codman through the current “outcomes movement,” focusing on measuring and assuring quality in the delivery of health care. As part of this lecture, the role of the Federal government in supporting outcomes research will be introduced [1]

PVM 593 Grants Workshop
The course builds on Tools for Research. The aim of this course is to teach the trainee how to organize and highlight the most important parts of a grant proposal. The course emphasizes writing style, consistency and integration of thought. All aspects of an NIH proposal are emphasized including the genesis of the budget and budget justification. P/N grading for clinical research students. Letter grade available for other majors. [1]

PVM 597 Clinical Thesis Research
For trainees doing thesis research or writing. Prerequisite: Consent of the trainee's advisor; and acceptance of the thesis topic and preliminary thesis outline by the thesis committee. A minimum of 6 hours is required. P/N grading only. [v]

PVM 900 Independent Study
Advanced topics by arrangement with instructor. [v]