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Course content may vary slightly from these descriptions.
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Orientation: Ravindra Mehta, M.D., Allen McCutchan, M.D., Gerry Boss, M.D.
Course Content:
Goals and Overview of Program Components |
Overview of Evaluation Component |
Introduction of Scholars |
Research Component |
Mentoring Component |
Masters Degree Program |
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First Year Courses
Each course is given over one 10-week quarter.
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Epidemiology I: Suzanne Lindsay, Ph.D., MSW, MPH & Deborah Wingard, Ph.D.
Objectives: Scholars will recognize and understand different types of epidemiologic study designs, the relative strengths and limitations of each, and the proper choice of study design in conducting their own research. They will also be able to identify and calculate the correct measure of risk for each study design. Participants will recognize major sources of bias, confounding, interaction and misclassification, and understand design and analysis methods of dealing with each. They will also be familiar with criteria to differentiate association from causation, and understand the components of causality. Participants will conclude this course with a written final examination.
Course Content:
Topic |
Content |
Introduction |
Disease transmission, population based investigation |
Epidemiological Measurement |
Rates, adjusted rates, prevalence, incidence |
Cross-Sectional Studies |
Design, implementation and analysis |
Prospective/Cohort Studies |
Design, implementation and analysis |
Case Control Studies |
Design, implementation and analysis |
Intervention Studies/Experimental |
Design, implementation and analysis |
Bias, Confounding and Interaction |
How to recognize, avoid, or correct |
Screening and Diagnostic Testing |
Sensitivity, specificity, screening programs |
Causality |
Association vs. Causality, components of causality |
Review for Final Exam |
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Epidemiology II: Suzanne Lindsay, Ph.D., MSW, MPH & Deborah Wingard, Ph.D.
Objective: Scholars will build on the content of Epidemiology I by attending guest lectures given by epidemiologists currently active in their field. Both methodology and content will be addressed in these guest lectures including topics such as smoking studies, genetic epidemiology, reproductive epidemiology, ecological studies, and the epidemiology of violence. Students will also gain an understanding of health disparities in epidemiologic research and be exposed to additional and advanced epidemiologic methods such as meta-analysis and cluster analysis. Participants will become familiar with advanced epidemiological issues and understand how study designs are practically applied in specific content areas. Students conclude this course with a comprehensive written research proposal that could be submitted for funding.
Course Content:
Topic
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Content
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Epidemiology I Review
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Review basic epidemiologic concepts |
Smoking Studies |
Study design, outcomes, controversies |
Ecological Studies |
Current topics and examples of this study design |
Health Disparities |
How health disparities are defined and measured in epidemiologic studies |
Epidemiology of Violence |
How epidemiology is applied to the study of violence and public health |
Reproductive Epidemiology |
Current studies in reproductive epidemiology |
Genetic Epidemiology I |
Basic concepts |
Genetic Epidemiology II |
Advanced concepts |
Advanced Methods |
Meta-analysis, cluster analysis or others |
Final Proposal Review |
Final proposals are reviewed by faculty and peers. |
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Patient Oriented Research I (POR-I): Allen McCutchan, M.D., M.Sc.
Objectives : This course will develop and apply the theory of clinical trial design and analysis, discuss the practical issues of financing and implementation of clinical trials, and describe issues of monitoring trials and working in cooperative groups. The scholar will design and present to a group of peers a concept sheet for a
phase I/II and phase II/III clinical trial.
Course Content:
Topic
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Content
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Hypothesis Generation and Formulation |
Framework, Types, and Characteristics of Good Research Questions and formulating a testable hypothesis |
Introduction to POR |
Definition of POR; Origins & Scientific Basis; Causality; Validity of Inference; Classification of Clinical Research |
| Measurement |
Objectives, classes, and characteristics of measures in POR and their validity, accuracy, and precision |
Fundamentals of Clinical Trials |
Study Objectives, Target Populations, Comparison Groups, Blinds, Outcomes and Endpoints |
Overview of the Process of Drug and Device Development |
Preclinical and clinical development of drugs from an industrial prospective |
Statistical Issues in Clinical Trials |
Sample Size/ Power Analysis; Randomization Procedures; Analytic Strategies - Sequential, Interval and Terminal; Analysis Plan |
Selecting and Measuring Outcomes and Study Implementation I |
Outcomes: Selecting outcomes: who gets counted, clinical vs surrogates, and simple vs compound. Implementation: Defining, recruiting, consenting, initially assessing, tracking, and retaining participants; IRB submission. |
| Study Implementation II |
Assessing Adherence; Study Start-up Study Monitoring for adverse events and interacting with the IRB; Completing the study, DSMB review |
| Complex Trial Design |
Multi-centered studies, Crossover and Factorial Designs, equivalence vs superiority trials, and testing diagnostics |
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Patient Oriented Research II: Allen McCutchan, M.D.
Objectives: This course will review the ethics and basic regulatory issues for research involving human subjects; the principles of data management for clinical research, including architecture, access and confidentiality, and integrity of databases; and skills in graphic and verbal presentation of research data. Scholars will prepare a mock submission to the IRB for peer review and practice presenting graphic and tabular data.
Course Content:
Topic
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Content
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Foundations of Research Regulation
Introduction to the IRB: |
Overview of the regulation of human experimentation; Structure and Function of IRBs |
Writing and reviewing an IRB Proposal
(monitoring boards) |
Principles of IRB review
Preparation and review of applications to the IRB |
| Monitoring of Research |
Composition and functions of Data and Safety Monitoring Boards (DSMB) |
| Ethical Basis of protection of research subjects |
Ethical principles for protection of human research subjects |
| Research Ethics - Responsible conduct |
Conflict of interest and commitment, scientific integrity, misconduct, ethics of publishing |
| Business ethics, research budgeting, and contracts |
Preparing and managing a research budget |
| Selected topics in the ethics of patient oriented research |
Discussion by students of their personal case studies in ethics |
Peer Critique of Student IRB submissions I
(Simulated IRB review panel) |
Discussion of student IRB proposals by peer reviewers |
| Legal Aspects of informed Consent |
Introduction to legal issues related to informed consent |
| Peer Critique of Student IRB submissions II (Simulated IRB review panel) |
Discussion of student IRB proposals by peer reviewers |
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Professional Development I: Gerry Boss, M.D.
Objectives : Scholars will learn the fundamentals of clear scientific writing and oral presentation of scientific work. They will also learn how to write an NIH-style grant including all components of a grant.
Course Content
Topic |
Content |
Overview |
General principles of scientific writing and oral presentation |
Scientific Writing |
Specific examples of good and bad writing; in-depth discussion of all parts of a scientific paper; scholars will be expected to write an abstract which will be reviewed in class. |
Presentation Skills |
Instruction in how to give oral presentations and how to prepare posters; scholars will give a 10-15 minute presentation to the class. |
Grant writing -A |
Scholars will learn how to write a KO8 or K23 type NIH grant with detailed instruction in all parts of a grant. Scholars will write a grant which will be reviewed by the instructor. |
Grant writing -B |
Scholars will review a grant and will participate in a mock study section led by a faculty member. |
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Second Year Courses
Each course is given over one 10-week quarter.
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Biostatistics I : W. Christopher Mathews, M.D., M.S.P.H.; Simon Frost, Ph.D.
Objectives : Scholars will understand principles of measurement of clinical data, recognize data types, and correctly identify statistical methods appropriate for analysis of a given clinical data set. They will gain experience in assembling a clinical dataset in formats suitable for analysis by NCSS or other comparable statistical packages. They will learn skills to conduct graphical and numerical exploratory data analysis, comparative tests of categorical, ordinal, and continuous data, elementary probability theory, hypothesis testing and interval estimation, sample size calculation and power analysis.
Course Content:
Topic |
Content |
Introduction |
Demonstration of NCSS/PASS |
Data presentation |
Graphical and tabular methods |
Probability |
Elementary probability theory |
Sampling Distributions |
Applications to statistical inference |
Statistical Inference |
Hypothesis testing and interval estimation; Type I and II errors, one and 2-sided tests |
Inference regarding one or two means |
Independent and matched t-tests |
Non-parametric methods |
Independent and matched data |
Inference regarding Proportions |
Contingency table analysis; binomial approximation to z-distribution; exact tests |
Diagnostic test evaluation |
Sensitivity, specificity, predictive values, likelihood ratios, ROC curves |
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Biostatistics II : W. Christopher Mathews, M.D., M.S.P.H.; Simon Frost, Ph.D.
Objectives : Scholars will understand and conduct more advanced biostatistical analyses including: ANOVA, multiple linear and logistic regression, survival analysis, and Cox proportional hazards modeling. The scholar will also be familiar with person-time rate analysis with Poisson regression and develop a conceptual understanding of major multivariate methods. Quantitative aspects of decision analysis and cost-effectiveness analysis will be covered. Analysis of survey research data will focus on measures of reliability and validity and on sampling designs.
Course Content:
Topic |
Content |
Analysis of Variance |
1- and 2-way ANOVA |
Correlation and simple linear regression |
Measures of association; concepts and procedures |
Multiple Linear Regression |
Continuous and indicator predictor variables |
Logistic Regression |
Odds ratios, model discrimination and calibration |
Survival Analysis |
Life tables, Kaplan-Meier, log rank tests, Cox proportional hazards model |
Person-Time Rate Analysis |
Poisson regression |
Other multivariable methods |
Factor analysis, discriminant analysis, cluster analysis, MANOVA, CART |
Clinical Decision Analysis |
Setting up and folding back trees, sensitivity analysis, cost-effectiveness analysis |
Analytic methods in survey research |
Reliability, Validity, Sampling designs |
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Health Services Research: Theodore Ganiats, M.D.
Objectives : Scholars will evaluate relevant outcomes in patient-oriented research from the patient (quality of life) and societal (economic) perspectives and locate potential resources for assessing the relevant outcomes in a wide variety of study designs. They will also be able to describe the relative strengths of different health services research approaches to a clinical problem. Finally, they will understand the components of clinical practice guidelines, including patient preferences, and how these guidelines both depend upon as well as inform patient-oriented research.
Course Content:
Topic
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Content
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Evidence-based medicine |
Fundamentals of EBM; Reading the literature;
Levels of evidence |
Survey Research |
Types of survey questions, Developing surveys Measurement principles |
Patient Safety |
Safety research; JCAHO safety goals |
Costs |
Types of costs, Costs vs. charges, Data collection Incremental & marginal costs, Types of analyses Perspective |
Qualitative Research |
Principles of qualitative research, How to perform |
Quality of Life Measurement |
Quality of life instruments, Patient preferences
Measuring QOL |
Guidelines and Quality |
Level of evidence/ strength of recommendation
Practice guidelines, Patient preferences
Quality Improvement/ Quality Assurance |
Cost-effectiveness Cost-effectiveness |
Theoretical foundation, Assumptions, Practical overview |
| Effectiveness Research |
Disease reservoir, Practice variation |
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Data Management & Informatics: Les Lenert, M.D.
Objectives: This module provides an orientation to database design and management and covers key issues regarding data handling for clinical research and clinical trials.
Course Content:
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Question/suggestion, email the webmaster: Seble Chernet
Last updated:
August 18, 2008
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