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 UnitMontreal Chest Institute K1

3650 St. Urbain

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.

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)

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)

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.

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

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.

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.

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

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%

TOTAL 100%

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.

Academic Integrity

III. ACADEMIC OFFENCESThe integrity of University academic life and of the degrees the University confers is dependent uponthe honesty and soundness of the teacher- student learning relationship and, as well, that of theevaluation process. Conduct by any member of the University community that adversely affects thisrelationship 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 inany academic writing, essay, thesis, research report, project or assignment submitted in a course orprogram of study or represent as his or her own an entire essay or work of another, whether thematerial 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 workas his or her own, it shall be presumed that the student intended to deceive; the student shall bear theburden 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 maysubmit the work in part or whole as his or her own. Receipt of payment for work contributed shall because for presumption that the student had such knowledge; the student shall bear the burden ofrebutting 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.pdfAdditional information is available at www.mcgill.ca/integrity/

Meeting # Date Topics Instructor(s)

1 MonJune 5

Introduction, course overviewFrom clinical observations to research: Hierarchy of study designsPlanning and designing a first study

AllMenziesGuest lecturer: Dr. Sandra Dial, MUHC

2 WedJune 7

Measures of disease occurrence and associationDescriptive, cross-sectional, ecologic studies

Menzies

3 Fri June 9 Cohort studiesSurvival analysisSelection bias

Menzies

4 Mon June 12

Clinical trials Bourbeau

5 WedJune 14

Case-control studies Schwartzman

6 FriJune 16

Diagnostic tests, screening, preventionBeginning your own clinical research: research questions, scope of work, pilot studies, ethical considerationsDescription of protocol summary assignment; the peer-review process

SchwartzmanSchwartzmanMenziesSchwartzman

7 MonJune 19

Measurement issues: precision, validity, responsiveness; clinical scales/scores

Bourbeau

8* WedJune 21

Confounding, matching, related issues in analysisInference and hypothesis testing

SchwartzmanSchwartzman

FriJune 23

HOLIDAY—NO CLASS

9 MonJune 26

Student presentations of protocol summariesExam review

All

10 WedJune 28

Final exam All