EPID 642: Advanced Epidemiological Protocol Design
EPID 642 Shelley Harris, PhD
Advanced Epidemiological Protocol Design
Semester course; 3 lecture hours. 3 credits. Prerequisites: EPID 571, EPID
606, BIOS 553 and BIOS 554 Develops skills needed to design and describe
in written format a valid and appropriate epidemiology study to address specific
hypotheses. Hypotheses and possible design methods will be discussed in class
and subsequently students will present (both orally and in written form)
a research design to include a critical review of the literature and hypotheses
to be tested. The proposal must address sample size and power, exposure definition,
methods for accurate exposure assessment, prevention of measurement errors,
and statistical methods proposed for analysis. Doctoral students only. Spring
semester
Instructor:
Shelley Harris, PhD, Associate Professor
Department of Epidemiology and Community Health & Center for Environmental
Studies
Virginia Commonwealth University
Life Sciences Building, 1000 West Cary Street, Room 107
P.O. Box 843050
Richmond, Virginia 23284-3050
Phone: (804) 828-1582
Fax: (804) 828-1622
Email: saharris@vcu.edu
Americans with Disabilities Act:
Section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities
Act of 1990 require
Virginia Commonwealth University to provide academic adjustments or accommodations
for students
with documented disabilities. Students seeking academic adjustments or
accommodations must selfidentify
with the Coordinator of Services for Students with Disabilities on the
appropriate campus.
After meeting with instructors to discuss their needs and, if applicable,
any laboratory safety concerns
related to their disabilities.
For additional information, consult the following on-line resources:
Services for Students with Disabilities: http://www.students.vcu.edu/rg/rg1access.html
Course Description:
Semester course: 3 seminar hours. 3 credits.
Prerequisites: EPID 571, EPID 606, BIOS 553 and BIOS 554 (with grades of
B or higher).
This course is open to doctoral students in the Epidemiology Program.
Develops skills needed to design and describe in written format a valid
and appropriate epidemiology
study to address specific research question(s). Research ideas, the development
of hypotheses to be
tested and methods of study design will be explored and discussed in class.
Students will present
(both orally and in written form) a research protocol that will include
a critical review of the literature,
study objectives, and study relevance in a NIH format. At a minimum, the
proposal will address
sample size and power, disease definition, exposure definition, methods
for accurate exposure
assessment, prevention of measurement errors, statistical methods proposed
for analysis, human
subjects, and budget. All studies will be observational in design.
Text books and seminar materials
There are no required textbooks for this class although it is expected
that students have their own
personal library developed at this point in their education. Classic epidemiology
textbooks are
available in the university and department libraries and from faculty.
Seminar and other materials for
the workshop classes will be handed out when necessary without cost to
the student.
Students will also be expected to identify, read and assess the relevant
literature in their chosen area
of research.
Course Requirements and Evaluation
Study design assignment (5%)
Sample size assignment (5%)
Written protocol outline (10%)
1st oral presentation (10%),
Critiques of full research protocols (5%)
2nd oral presentation (15%),
Final written protocol (40%).
Class participation (10%)
IRB/CITI exam (0%) - copy of the certificate of completion due by April
11th 2006.
Written homework or assignments are generally due in class by 5:00 p.m.
(paper copies) and will be
penalized by 15% per day if handed in late. Anything more than 1 week late
will receive 0%. The
hard copy and an electronic copy of the final project must be sent to the
instructor by the due date at
5:00 p.m.
General class outline
Section 1: Topic selection and identification of research questions with
testable hypotheses
Consider a topic area in which they plan to develop a research proposal
during the course. This topic
area must be substantially different from that for the thesis. Guidelines
for topic selection are below. A
final topic, approved by the course instructors, must be submitted by January
24th
Section 2: Development of appropriate research methods for testing these
hypotheses
In each seminar up to 2 students will present (30 minutes) an outline
of the proposed research. A
further 40 minutes has been allocated for the students and instructors
to discuss any issues raised.
(The total time available will depend on the final class size). The presentation
and discussion will be
worth 10% of the final grade. A written outline of the proposed research
(maximum 3 pages) will be
due one week after the presentation, and will be worth 10% of the total
grade.
Section 3: Presentations of Research Proposals. During these seminars, up to 2 students will present their full protocol (maximum 30 minutes) and will engage in a discussion with the class and instructors for a further 30-45 minutes. The presentation will be worth 10% of the final grade.
Section 4: Peer-review /work days/ faculty consultation days/full research
protocol
During these seminars, the instructors and students will have the further
opportunity to discuss issues
which have arisen during the presentations or during the preparation of
the final protocols (and
brought to the attention of the instructors by individual students) which
are general to research
design, rather than specific to a particular research question.
In the last seminar each student will present for general discussion a
list of issues that they now
consider important in selecting a topic suitable for research.
Full research protocol (maximum 20 pages, double spaced + appendices and
forms) due May 2,
2006. This will be worth 40% of the final grade. Detailed guidelines will
be provided in class.
Guidelines for Topic Area Selection
In order to receive approval for your topic area, please submit the attached
form to the instructor by
January 24th, 2006. The earlier that you submit the form, the more quickly
you will be able to start
serious work on your research. If your first topic is not found to be appropriate
(as determined by the
instructor), early submission will also afford you with more time to select
another area. Students must
choose different topics for the class – if the same topic is selected
by more than one student, the
student who submits the form first will have priority. We may need to flip
a coin.
The topic you select must be substantially different from the area in which
you are doing thesis
research. This will broaden your experience, and your knowledge of the
epidemiologic literature. By
“Substantially different” means that both the health outcome
and the nature of exposures under study
should be different from those involved in your thesis. For example, a
student whose thesis will deal
with pesticides and childhood leukemia should not propose a study of PCBs
and leukemia. It would
be acceptable for such a student to study PCBs or genetic risk factors
for ovarian cancer. Similarly, a
student with a thesis involving risk factors for an infectious disease
should not plan to study another
infectious disease for this course, unless the issues involved were markedly
different.
Spring 2006 Topic Areas (all studies must be observational):
Environmental exposures and neurodegenerative disease
Nutrition and/or supplements and cancer
Gene/environment/susceptibility and cancer
Biomarkers and childhood cancers
Etiology of Diabetes in adults or children
Occupational exposures and reproductive outcomes
Endocrine modulators and cardiovascular disease and
Factors affecting survival following a cancer diagnosis or myocardial infarction.
Lecture and Seminar Topics (schedule, dates, and content subject to change):
Date WK# Content / Special Topics /Due dates Notes/Assignments
Jan 17 1 -Introductions
-Overview of course/syllabus
-Administrative issues and schedules
-Research topic ideas
Jan 24** 2 -Beginning research projects and conducting effective
literature searches -Guest: Dr. Tarynn Witten, PhD,
MSW, FGSA, CSBC.
-Study design assignment handed-out
Topic selection due
Jan 31 3 -Come to class prepared to discuss the study design
review/new designs/different approaches
-Discussion of research topics and ideas
-Sample size assignment handed-out
Study design
assignment due
Feb 7 4 -Sample size workshop
-Examples of NIH requests for proposals
Sample size
assignment due
Feb 14 5 -Measurement workshop
-Come to class prepared to talk about measurement of
one of your outcomes, exposures or confounders
Feb 21 6 -Presentation of protocol outlines #1 and #2
Feb 28 7 -Presentation of protocol outline #3
Mar 7 8 -Human subjects reviews (IRB/CITI exam) Written protocol outline
due
Mar 14 - -Spring break – Mar. 12-19
Mar 21 9 -Sponsored programs and grants
Mar 28 - - Work week – no class
Apr 4 10 -Come to class to hand-in protocols, photocopy and
distribute to each other for critiques
-Questions/help from instructor
Draft of full research
protocol due
Apr 11 11 -Final presentation #1 Critique of pres#1 due
Apr 18 12 -Final presentation #2 Critique of pres#2 due
Apr 25 13 -Final presentation #3 Critique of pres#3 due
May 2 14 -Peer-review /faculty consultation day
-Students present list of issues important to research
Final research protocol
due
May 9 - -No class - final exam week
** this class will be held in the Biocomplexity Teaching Laboratory, BCCL
Room 104, in the Life
Sciences Building on the Monroe Park Campus (directly across from Dr. Harris’ office,
Room 107).
The Trani Life Sciences building is located on 1000 West Cary Street, and
you generally can find free
street parking nearby. The M deck (Cary and Harrison) is available to students
for $3-4. Give
yourself plenty of time to find the building and park, since we have a
guest speaker that day. You can
also take the campus bus connector.
EPID 642: Advanced Epidemiological Protocol Design – Topic Selection
Form
Spring 2006
This form must be submitted by January 24th 2006.
Please submit your first choice for topic area as outlined in the syllabus.
Please also indicate the
area in which you are expecting to do your doctoral dissertation. If you
have not yet decided on a
defined topic, indicate the likely area of the research, including both
the likely type of health
condition(s) and the types of risk factors to be studied. The instructor
will contact you as quickly as
possible if your selected topic is not acceptable.
Student Name: ___________________________________
Area of planned dissertation (if known): ___________________________________
Disease/health condition(s) under study: ___________________________________
Risk factors under study: ___________________________________
Dissertation supervisor (if known): ___________________________________
Elective epidemiology courses taken: ___________________________________
Area of planned protocol for this course: ___________________________________
Disease/health condition(s) under study: ___________________________________
Risk factors under study: ___________________________________
Signature: ________________________
Date submitted: ________________________
Approved by: ________________________ Date: __________________
