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
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/epibiostat/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 doublespaced) 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):
Oral presentation of homework assignment:
Written protocol summary:
Oral presentation of protocol summary:
Final exam:
Class participation:
TOTAL
20%
10%
20%
10%
30%
10%
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 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.pdf
Additional information is available at www.mcgill.ca/integrity/
Meeting #
Date
Topics
Instructor(s)
1
Mon
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
2
Wed
June 7
Measures of disease occurrence and association
Descriptive, cross-sectional, ecologic studies
Menzies
3
Fri June 9
Cohort studies
Survival analysis
Selection bias
Menzies
4
Mon June
12
Clinical trials
Bourbeau
5
Wed
June 14
Case-control studies
Schwartzman
6
Fri
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 peerreview process
Schwartzman
Schwartzman
Menzies
Schwartzman
7
Mon
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
Schwartzman
Fri
June 23
HOLIDAY—NO CLASS
9
Mon
June 26
Student presentations of protocol summaries
Exam review
All
10
Wed
June 28
Final exam
All