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  • PVM 546: Principles of Biostatistics I

    3.00 Credits
    Rush University

    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]
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  • PVM 547: Principles of Biostatistics II

    3.00 Credits
    Rush University

    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]
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  • PVM 552: Principles of Clinical Research and Epidemiology

    2.00 Credits
    Rush University

    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 Credits)
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  • PVM 553: Observational Epidemiology

    3.00 Credits
    Rush University

    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]
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  • PVM 554: Management,Evaluation and Statistical Interpretation of Clinical Trials

    3.00 Credits
    Rush University

    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]
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  • PVM 555: Introduction to Clinical Outcomes Research

    2.00 Credits
    Rush University

    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 Credits)
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  • PVM 557: Clinical Trial Design I

    2.00 Credits
    Rush University

    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 Credits)
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  • PVM 558: Clinical Trial Design II

    2.00 Credits
    Rush University

    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 Credits)
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  • PVM 559: Research in Special Populations

    2.00 Credits
    Rush University

    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 Credits)
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  • PVM 561: Behavioral Approaches to Improve Compliance

    2.00 Credits
    Rush University

    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 Credits)
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