1. Epidemiology and Biostatistics 679: Clinical Epidemiology June 5-28, 2006 Instructors: Dr. Jean Bourbeau (jean.bourbeau@mcgill.ca) Dr. Dick Menzies (dick.menzies@mcgill.ca) Dr. Kevin Schwartzman (course coordinator; kevin.schwartzman@mcgill.ca) Research Offices: Respiratory Epidemiology and Clinical Research Unit Montreal Chest Institute K1 3650 St. Urbain

2. Course Objectives The general objective of this 3-credit course is to provide students with a basic understanding of the methods of epidemiology, as applied to clinical practice and clinical research. Specifically, we will address key principles of testing and measurement in the clinical context, as well as study design, analysis, and inference in the clinical research setting. Students will be encouraged to apply concepts covered in the course to their own areas of interest.

3. Course Materials Textbook: Fletcher, Clinical Epidemiology: The Essentials, 4th edition (2005) Course pack with supplemental readings from McGill bookstore Lecture notes, handouts, assignments from course website (www.mcgill.ca/epi- biostat/summer/courses) Journal articles on-line from Health Sciences Library (www.health.library.mcgill.ca)

4. Format Ten classroom sessions, from 1:30-4:45 Mondays, Wednesdays, and Fridays for four weeks (no class June 23 and 30) Attendance at all sessions is mandatory. Students will be divided into teams of 3-4, for purposes of assignments and presentations (8 groups total)

5. Assignments Before each lecture, an assignment addressing key points of that day’s lecture will be distributed. During each classroom session, one team will give an oral presentation outlining its answers to the assignment on the topic of that day’s lecture. Over the month, all students will be expected to present in this fashion. The written assignments must be handed in (1 per team) at the beginning of the following lecture.

6. Assignments For lecture 1 (today: hierarchy of study designs) the oral presentation of the assignment will be during lecture 2, with the written assignment due at the beginning of lecture 3 For lecture 2 (Wednesday, June 7: measures of disease occurrence etc.) the oral presentation will also be during that class, with the written assignment due at the beginning of lecture 3 After that, there will be one oral presentation per classroom session, with the written assignment due at the beginning of the following session

7. Assignments The assignments will include questions about papers from the medical literature, which reflect issues addressed in the lectures With the exception of assignments 1 and 2, these papers will be selected by the group responsible for each oral presentation, and identified ahead of time so that all students in the class use the same paper. Papers should be available on-line through the health sciences library For example, the students responsible for the oral presentation on cohort studies will select a paper reporting a cohort study of interest to them.

8. Assignments For the final assignment, each group will hand in a summary (maximum 3 pages double- spaced) of an original proposed research protocol, addressing a clinical research question which group members consider relevant. Further details on content and format will be provided in class. These summaries will be presented by the groups in class on Monday, June 26, and handed in that day.

9. Final Exam A written final exam, in short-answer format, will be administered in class on Wednesday, June 28. The exam will cover all course content, with an emphasis on materials covered in lectures and assignments

10. Grading Written homework assignments (8):20% Oral presentation of homework assignment:10% Written protocol summary:20% Oral presentation of protocol summary:10% Final exam:30% Class participation:10% TOTAL100%

11. Academic Integrity It is understood that assignments submitted by groups of students will include contributions of all group members; for such assignments, a single copy submitted with all group members’ names will be sufficient. However, we expect that each group will submit its own assignment, written separately from those of other groups. The same holds true for the protocol summaries. Where assignments cite others’ research work, appropriate references must be provided. Direct quotes from other writers should be indicated by quotation marks.

12. Academic Integrity III. ACADEMIC OFFENCES The integrity of University academic life and of the degrees the University confers is dependent upon the honesty and soundness of the teacher- student learning relationship and, as well, that of the evaluation process. Conduct by any member of the University community that adversely affects this relationship or this process must, therefore, be considered a serious offence. 15 Plagiarism (a) No student shall, with intent to deceive, represent the work of another person as his or her own in any academic writing, essay, thesis, research report, project or assignment submitted in a course or program of study or represent as his or her own an entire essay or work of another, whether the material so represented constitutes a part or the entirety of the work submitted. (b) Upon demonstration that the student has represented and submitted another person’s work as his or her own, it shall be presumed that the student intended to deceive; the student shall bear the burden of rebutting this presumption by evidence satisfying the person or body hearing the case that no such intent existed, notwithstanding Article 22 of the Charter of Student Rights. (c) No student shall contribute any work to another student with the knowledge that the latter may submit the work in part or whole as his or her own. Receipt of payment for work contributed shall be cause for presumption that the student had such knowledge; the student shall bear the burden of rebutting this presumption by evidence satisfying the person or body hearing the case that no such intent existed (notwithstanding Article 22 of the Charter of Students’ Rights). Downloaded and excerpted from A Handbook on Student Rights and Responsibilities, 2003, p. 17. Available on-line at http://upload.mcgill.ca/secretariat/greenbookenglish.pdfhttp://upload.mcgill.ca/secretariat/greenbookenglish.pdf Additional information is available at www.mcgill.ca/integrity/www.mcgill.ca/integrity/

13. Meeting #DateTopicsInstructor(s) 1Mon June 5 Introduction, course overview From clinical observations to research: Hierarchy of study designs Planning and designing a first study All Menzies Guest lecturer: Dr. Sandra Dial, MUHC 2Wed June 7 Measures of disease occurrence and association Descriptive, cross-sectional, ecologic studies Menzies 3Fri June 9Cohort studies Survival analysis Selection bias Menzies 4Mon June 12 Clinical trialsBourbeau 5Wed June 14 Case-control studiesSchwartzman 6Fri June 16 Diagnostic tests, screening, prevention Beginning your own clinical research: research questions, scope of work, pilot studies, ethical considerations Description of protocol summary assignment; the peer- review process Schwartzman Menzies Schwartzman 7Mon June 19 Measurement issues: precision, validity, responsiveness; clinical scales/scores Bourbeau 8*Wed June 21 Confounding, matching, related issues in analysis Inference and hypothesis testing Schwartzman Fri June 23 HOLIDAY—NO CLASS 9Mon June 26 Student presentations of protocol summaries Exam review All 10Wed June 28 Final examAll