Clinical Research Curriculum/Physician-Scientist Training Program

Introduction to Epidemiology/Observational Studies Fall 2015 Clinical Research Curriculum – UT Houston

Course Directors: Charles Miller, PhD 713-486-5100 [email protected] Joshua Samuels, MD, MPH 713 500-5675 [email protected]

Instructors Donald Molony, MD 713-500-6872 [email protected] Deborah del Junco, PhD 713-500-7902 [email protected]

Assistant: Deb Garcia 713 500 6708 [email protected]

Location : UT-Houston MSB 2.103

Course structure: Lectures, each 45 min - 1 hour in length Each lecture followed by 1/2 hour discussion of case for honors students (case distributed ahead) 1 Take-home Exam Textbook:

 Gordis, Leon, Epidemiology, 5th Edition, 2014 Saunders Elsevier, ISBN# 978-1-4557-3733-8

Course Requirements: Attendance: All 10 sessions must be attended or viewed on videotape. We will include the best 7 scores from in-class audience participation answers in your final grade.

Exam: Final - take home, open book, no shared work

Credit: All elements of the course must be completed satisfactorily to receive credit (no grades are given). Given that the examination is open book, a score of 75% on the examination must be attained in order for this element to be recorded as completed. Course Schedule: Date Topic/Objectives Reading Materials: Lecturer Book, chapter(s) Aug 26 1. Introduction Gordis 1 & 2 Samuels Research questions and hypotheses. Sept 2 2. Frequency of disease in populations Gordis 3 & 4 Samuels Sept 9 3. Measurement: Hully Ch 4 Molony Accuracy and Reliability (We’ll send) Sept 16 4. Studies of association (B) Gordis 10 & 13 Samuels Case-control studies Sept 23 5. Diagnosis Gordis 5 Molony Sept 30 6. Studies of association (A) Gordis 11 & 12 Miller Prospective studies (and 9 too) Oct 7 7. Causation Gordis 14 & 15 Samuels Oct 14 8. Risk and prognosis: Gordis 6 Miller Cohort studies ( and 9 again) Oct 21 9. Family studies: Gordis 16 TBA Genetic epidemiology Oct 28 10. Screening Gordis 18 Samuels Oct 28 Written assignment due: proposal for observational study Oct 28 Hand out final exam – open book, take home Nov 11 Final Exam Due Nov 25 All remediation due Nov 25 Course Closes/Grades published ALL attendance (including lectures attended via video) and assignments must be in for credit to be granted Honors Assignments

Extra Reading for seminar discussions Date Topic/Objectives Extra Reading Aug 26 1. Research questions and hypotheses. None Sept 2 2. Frequency of disease in populations Sept 9 3. Accuracy and Reliability Sept 16 4. Diagnosis Sept 23 5. Case-control studies Sept 30 6. Prospective studies Oct 7 7. Causation Oct 14 8. Risk and prognosis: Cohort studies Oct 21 9. Genetic epidemiology Oct 28 10. Screening

Cases for discussion: Cases and articles to be distributed a week prior to the relevant lecture; case will be discussed in detail after each lecture in a breakout session for students seeking honors.

Written assignment: Assignments: 2-4 page proposal for an observational study in your area of interest. To be turned in on last day of class. The brevity of the proposal does not mean that it should not be carefully considered; in fact, brevity necessitates clarity.

Essential components include:  Background/Significance, including brief review of the literature  Question or hypothesis (PICO format)  Methods  Population (Inclusion/Exclusion Criteria)  Recruitment/Sampling methods  Measurements  Outcomes (primary and secondary) with methods of assessment  Analysis plan  Limitations  References