Fall 2013 - Interpretational Epidemiology: 16:375:508
Credits: 3
Course Director: Stuart L. Shalat, Sc.D.
Course Description:
This course is designed to provide an introduction to epidemiology and explore the
relevant aspects of study design and analysis as it relates to being able to read and
interpret epidemiologic studies that relate to the workplace, environmental toxicants, and
adverse effects of pharmacologic agents. Students will be instructed in assessing the
meaning of various statistical measures of association and stability employed in
epidemiologic studies. Emphasis will be placed on interpretational as opposed to
computational biostatistics. In class, students will receive instruction on the various types
of study design employed in epidemiologic studies, including their strengths and
weaknesses. Students will be instructed in how to critique epidemiologic studies and
how to summarize and incorporate epidemiologic findings in exposure science and
toxicology. This will be achieved by examining the existing literature with regard to
specific examples of epidemiologic findings in occupational, environmental, and clinical
studies of a variety of toxicants and a range of health endpoints. Health effects to be
considered include cancer, respiratory, cardiovascular, reproductive, and neurologic
outcomes. Topics will also include the strengths and limitations of meta- and pooledanalysis in risk assessment.
Learning Objectives:
Grading: Performance of students will be assessed through class participation (20%),
required homework (30%) critiques of assigned papers from the published literature, a
mid-term (25%) and a final examination (25%). Emphasis in both homework and
examinations will be on the student’s ability to critique and draw inference from the
published literature.
Critiques:
Each student will be required to complete 10 critiques during the semester. These
critiques will be carried out on papers that will be handed out in class. Students will have
a week to complete the critique. It will be due at the beginning of class 7 days from the
time the paper is handed out. Students are allowed and are encouraged to discuss the
assigned paper outside of class, but the actual critique must be the work of the individual
student. Each critique should be no more than one single spaced printed page. Critiques
that are significantly longer than one page will lose points. Margins should be at least 1”
from the edge of the paper on all sides. Print should be no smaller than Arial 11.
Critiques should be in the format of the guideline pages (see attached). As long as the
number of the item is included, the student need not re-write the question. The amount of
space between questions is meant as a guideline for the length of the an appropriate
correct response.
Examinations:
There will be two examinations, a mid-term and a final. The exams will consist of short
answer questions on the in-class material. Additionally, 2 papers will be handed out a
week before the examination and additional short answer questions and essays will be
based on these papers. Clean copies of the papers will be provided to students during the
exams. Calculators are allowed, but should not be needed.
Interpretational Epidemiology
Course Syllabus
Stuart L. Shalat, Sc.D.
Associate Professor
Office: EOHSI Building, Room 320
Email: shalat@eohsi.rutgers.edu
Telephone: (848) 445-1295
Dates Lecture Topics
9/3
1) Introduction
i.
ii.
iii.
iv.
9/4
2) Understanding study design and statistical analysis in epidemiologic studies
i.
ii.
iii.
iv.
v.
9/10
Why should you care? Exposure Science, Toxicology and
Epidemiology.
Role of epidemiology in risk assessment
Traditional risk assessment
Evaluating epidemiological literature for causality
Randomized control trials
Observational studies
Prospective and retrospective studies
Case control, cohort and nested case control
Measures of association
3) Measures of Association and Stability
i.
ii.
iii.
iv.
Incidence and prevalence
Risk estimates: RR, OR, HR
Confidence intervals and p values
Role of time
9/11
4) Bias in Epidemiologic Studies
i. Selection bias
ii. Observation bias
9/17
5) Bias and Study Design
i. Confounding Bias
ii. Effect Modifiers
iii. Types of Observational Epidemiologic Studies
1.
2.
3.
4.
cross-sectional
case-control
retrospective cohort
prospective cohort
iv. Examining quality of data
v. Study Validity
vi. Generalizability
9/18
6) Clinical Trials
i.
ii.
iii.
iv.
9/24
7) Genetic Epidemiology
i.
ii.
iii.
iv.
v.
vi.
9/25
Disease characteristics
Familial clustering
Genetic or environmental, that is the question
Mode of inheritance
Disease susceptibility loci
Disease susceptibility markers
8) SNPs, Gene expression and what does it all mean?
i.
ii.
iii.
iv.
v.
vi.
10/1
Experimental Studies
Randomization
Intention-to-treat analysis
Dealing with lost to follow-up
9)
SNPs
DNA
a. Base pairs
b. Codons
c. Amino acids
What do proteins do?
a. Code for antibodies
b. Enzymes
c. Structural proteins
d. Messengers (i.e. hormones)
e. Transport/Storage
Gene Expression Analysis
SNPs and Expression Studies
Epigenetics
Critiquing the Literature
i.
ii.
iii.
Type of Study
Size
Collection of data
10/2
10)
Critiquing the Literature (Part 2)
i.
ii.
10/8
11)
The Study of Respiratory Illnesses – Introduction
i.
ii.
10/9
12)
Analysis of data
Interpretation of study findings
Objective measures - Pulmonary function tests
Symptom questionnaires
Discussion of Respiratory Disease Paper (Tegethoff, et al. 2013)
10/15 13)
Meta-analysis, pooled- analysis and systematic reviews
10/16
Review for Mid-Term Exam
10/22
Mid-Term Exam
10/23 14)
Pesticides
i. Organochlorines
ii. Organophosphates
iii. Pyrethroids
10/29 15)
10/30 16)
Discussion of Pesticide Papers
The study of reproductive outcomes - Thalidomide and Birth Defects and
reproductive outcomes.
i. Selection bias in sampling from fertility clinics
ii. Adverse pregnancy outcomes (miscarriages, stillbirth, low birth weight,
congenital malformations)
iii. Measurement error in pregnancy
11/5
17)
Arsenic, Toxic Torts and Neural Tube Defects
11/6
18)
Epidemiology and Children’s Studies
i. Diagnostic challenges
ii. Exposures
11/12 19)
The Vaccine and Autism Controversy
11/13 20)
Plasticizer Peril? The case against BPA and Pthalates.
11/19 21)
DDT Revisited: Did Rachel Carson get it right?
11/20 22)
Hazards in the Workplace and Occupational Epidemiology
11/26
NO CLASS THANKSGIVING WEEK SCHEDULE
11/27
NO CLASS THANKSGIVING WEEK SCHEDULE
12/3
23)
The study of cardiovascular disease - When treatment goes wrong, the
case of Vioxx.
12/4
24)
Epidemiology of Disasters
12/10 25)
MTBE: Did EPA and Congress get it wrong?
12/11
REVIEW FOR FINAL EXAMINATION
Interpretational Epidemiology: 16:375:508
Study Critique Form
Name:
Title of Paper:
1. What was the study’s hypothesis(es)?
Collection of Data
2. What type of study was done?
3. How was the size of the study determined?
4. How were study subject’s selected and would this have tended to introduce any
selection bias?
5. How was information collected on the study subjects and could this have introduced
any observation bias?
6. How was confounding bias dealt with in the study design and was it effective?
Analysis of Data
1. Describe and criticize the methods used to control for confounding bias in the study
analysis (i.e. stratification of data, multivariate analysis, etc.).
2. Describe and criticize the methods used for the measure of association
between disease and exposure.
3. Describe and criticize the methods used to provide the measure of stability of the
measures of association between disease and exposure.
Interpretation of the Data
1. What was the major finding of the study?
2. How might any scientific biases (i.e. selection, observation, confounding) have
affected the study’s finding?
3. Other than biasing the overall study results toward the null, how might random
misclassification have affected the results?
4. To what population may the results of this study be generalized?
5. Are the author’s conclusions supported by the study’s results?
6. Do you believe the results (why or why not?)