GENERAL INFORMATION
Course Prerequisite: PHC 6000 – Introduction to Epidemiology, and PHC 6065 –
Health Statistics
DESCRIPTION
The fundamental concepts, principles, and methods of observational epidemiologic research at an intermediate level.
OBJECTIVES
The purpose of this course is to present the practical issues in the design, conduct, and analysis of observational epidemiologic studies, as well as theoretical issues in the analysis and interpretation of research findings.
Upon completion of this course, students should be able to:
1. Conceive and communicate research questions.
2. Understand and apply appropriately the basic research terms and concepts relating to populations, study sample, recruitment, retention, and sampling methods.
3. Understand and apply the components of a research proposal and critique of epidemiologic studies.
4. Describe methods for definition and measurement of exposures of interest.
5. Describe methods for classification, definition and surveillance of disease.
6. Discuss the data acquisition methods.
7. Discuss measurement errors and related terms: validity and reliability.
8. Determine conditions under which misclassification bias may compromise epidemiologic research. Be familiar with methods to quantify and/or minimize bias.
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PHC 6013 – Epidemiology Research Methods: Observational Study Design
Changes or Modifications: The Instructor reserves the right to change, alter, add, or delete from the content of this course as deemed appropriate by the Instructor based upon students’ needs.

9. Determine conditions under which selection bias may compromise epidemiologic research. Be familiar with methods to reduce or eliminate this bias.
10. Define confounding and understand methods to control confounding in the design or analysis stage of an observational epidemiologic study.
11. Examine data for confounding and effect modification and interpret appropriately
12. Explain effect modification in observational epidemiologic studies both conceptually and statistically.
13. Calculate point estimates and confidence intervals for crude and adjusted measures.
14. *Calculate and interpret measures of association
15. Understand approaches to causal inferences in epidemiology.
16. Identify a population and choose a method for sampling of that population.
Determine the required sample size.
17. Discuss methods of data processing and analysis, including quality control checks.
18. Discuss issues of concern regarding ethics, confidentiality and informed consent when conducting epidemiologic research.
19. Given a health problem, choose and implement an appropriate epidemiologic study design.
M
MPH CORE / CONCENTRATION-SPECIFIC COMPETENCIES
This course will assist students in developing the following MPH core competencies:
COMPETENCY
Examine data for confounding and effect modification and interpret appropriately .
COURSE OBJECTIVE
11
Calculate and interpret measures of association
14
Given a health problem, choose and implement an appropriate epidemiologic study design. 19
REQUIRED TEXTBOOK
Required:
Kelsey, JL, Thompson, WD, and Evans, AS. Methods in Observational Epidemiology .
New York, NY: Oxford University Press Inc., 1986. (1st edition).
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PHC 6013 – Epidemiology Research Methods: Observational Study Design
Changes or Modifications: The Instructor reserves the right to change, alter, add, or delete from the content of this course as deemed appropriate by the Instructor based upon students’ needs.

OR:
Kelsey, JL, Whittemore, AS, Evans, AS, and Thompson, WD. Methods in Observational
Epidemiology . New York, NY: Oxford University Press Inc., 1996. (2nd edition).
Hennekens, CH, & Buring, JE. Epidemiology in Medicine. Boston, MA: Little Brown and Company, 1987.
AND:
Hulley, SB, Cummings, SR et al. Designing clinical research: An Epidemiologic
Approach . Hagerstown, MD: Lippincott Williams, & Wilkins, 2007 (3rd edition).
Recommended :
Szyklo M and Nieto FJ. Epidemiology: Beyond the Basics . Boston: Jones and Bartlett,
Publishers, 2007. (2 nd edition).
Additional required readings
Additional readings will be posted and announced during the semester. Journal articles
(American Journal of Epidemiology, Epidemiology, Annals of Epidemiology,Epidemiologic
Review; Epidemiological Bulletin, International Journal of Epidemiology, Journal of Epidemiology and Community Health, American Journal of Public Health) may be assigned periodically.
CLASS POLICIES AND PROCEDURES
The class will meet once per week for two hours, 40 minutes with a 10-minute break in the middle of the session. The class sessions will consist of lectures, discussions, and case studies.
Students will be responsible for reading all assignments prior to class and for being prepared to discuss the readings.
Incomplete grade: The university policy on incomplete grades is as follows: "An incomplete grade is a temporary symbol given at the discretion of the instructor for work not completed because of serious interruption not caused by the student's own negligence."
Participation:
Participation will be evaluated based on classroom attendance and participation in class (student participating fully in discussions, demonstrating that he or she has read the assigned materials). Two absences are granted for each student
(excused or unexcused). For each additional absence the participation grade will decrease by 5 points (e.g. 1 additional absence will decrease a participation grade of 100 to 95, 2 from 100 to 90, etc.). Participation in class will be demonstrated by active participation in discussions. Points may be deducted from the grade for each time instructor notes lack of preparation. Bring a calculator to each class and to all exams.
Exams:
The mid-term and final exams will assess how well students have met the course objectives.
Short quizzes may also be given to assess student’s adherence to the reading schedule. Any anticipated absences should be discussed with the instructor ahead of time. Contact the instructor by e-mail or phone if you are sick or have another emergency preventing you from coming to class.
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PHC 6013 – Epidemiology Research Methods: Observational Study Design
Changes or Modifications: The Instructor reserves the right to change, alter, add, or delete from the content of this course as deemed appropriate by the Instructor based upon students’ needs.

Written assignments:
Any assigned exercises will be handed in by due date as determined by instructor. Timeliness of turned in assignments will be taken into consideration in determining your grade.
Student presentation / term paper:
Students will prepare a group term paper (10-15 pages) and a short presentation on a study proposal using an observational study design. As it relates to your topic, discuss:
1) Research question and choice of an observational design. State the hypothesis and review the literature (3-4 slides).
2) Subject selection and recruitment (1 slide).
3) Measurement of exposure, outcome and other pertinent variables (3-5 slides).
4) Analytic plan (1-2 slides).
5) Strategies to assess confounding and effect modification (1 slide).
6) Strategies to minimize error, bias and confounding (1 slide).
7) Advantages and disadvantages of the proposed study (1 slide).
8) References (1 slide).
Topics must be pre-approved by Instructor. Presentations are due at the time of class meeting one week before the final exam, and papers are due at the end of that week. Process indicators include individual draft submissions of paper sections and slides. More information will be given at the appropriate time. Use
APA style for referencing.
You will turn in your paper to Turnitin.com. Turnitin.com will give you a score of the amount of overlap of your writing with references. Your score must be less than 30% (excluding the bibliography). Therefore, you should turn it in to
Turnitin.com at least a week prior to your paper being due. If the score is over
30%, you will have to revise the paper by improving your paraphrasing. You can then resubmit the paper to turnitin.com. I will not consider any paper with a score higher than 30%. To be considered on time, your paper must be turned into me
(in a paper and electronic form) no later than the last lecture of the semester (ie. the lecture on the week before finals), and it must have a Turnitin score of less than 30%. You will lose 10 points per day after your paper is due. Exceptions are only for serious illnesses (e.g. hospitalization) for you or a family member, and exceptions will only be granted with proper documentation. A copy of the format required, as well as examples of successful papers, will be posted on the class web site.
Human Participant Protections Education for Research Teams self-study:
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PHC 6013 – Epidemiology Research Methods: Observational Study Design
Changes or Modifications: The Instructor reserves the right to change, alter, add, or delete from the content of this course as deemed appropriate by the Instructor based upon students’ needs.

The students will complete the Human Participant Protections Education for
Research Teams self-study at the NCI web site: http://phrp.nihtraining.com/users/login.php.
The certificate of completion is due by the end of semester. The certificate is required to pass this course. If you have already completed this course, please send the certificate to the instructor for verification.
1) Go to the following web page: http://phrp.nihtraining.com/users/login.php
2) Click on the "register" link. Provide the information in the required fields on the registration form. Please note your username and password for your records as the IRB Office will be unable to supply this information to you at a later date.
3) There are seven (7) chapters with an exercise at the end of each.
4) You must complete all seven chapters in order to receive a certificate. Please print your certificate and keep copies for future submissions to the IRB.
Exams: Exams will be short-answer exams, with some calculations. Exams assess how well students have met the course objectives. Contact the instructor by e-mail or phone if you are sick or have another emergency preventing you from taking the exam.. You must have a doctor's note if you are sick enough not to take your exam.
Important!: Bring a calculator to each class and all exams.
Disability
Exams may be timed. If you have any disability that may prevent you from completing the exam on time, please let the instructor know by the second week of class by email.
If you have disability and/or need special assistance, please make arrangements through the Office of Disability Services (305-348-4131).
EVALUATION AND GRADING
Students will be evaluated on the following basis:
Midterm Exam 30%
Term Paper / Presentation on an Observational
Study*
Classroom Participation
25%
15%
Final Exam 30%
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PHC 6013 – Epidemiology Research Methods: Observational Study Design
Changes or Modifications: The Instructor reserves the right to change, alter, add, or delete from the content of this course as deemed appropriate by the Instructor based upon students’ needs.

*Competency Assessment: Exercise will require that you examine data for confounding and effect modification and interpret appropriately, calculate and interpret measures of association, and , given a health problem, that you choose and implement an appropriate epidemiologic study design . The core competencies will be assessed using the rubric attached at the end of this syllabus. This assessment will constitute one-fifth (25%) of the total grade.
Grading Scale
A
A-
B+
B
B-
C+
92.6% – 100%
89.6% – 92.5%
86.9% – 89.5%
82.6% – 86.5%
79.6% – 82.5%
76.6% – 79.5%
C
C-
D+
D
D-
F
72.6% – 76.5%
69.6% – 72.5%
66.5% – 69.5%
62.6% – 66.5%
59.6% – 62.5%
< 59.5%
All students in this class are expected to abide by the university’s Code of Academic Integrity .
Florida International University is a community dedicated to generating and imparting knowledge through excellent teaching and research, the rigorous and respectful exchange of ideas and community service. All students should respect the right of others to have an equitable opportunity to learn and honestly to demonstrate the quality of their learning. Therefore, all students are expected to adhere to a standard of academic conduct, which demonstrates respect for themselves, their fellow students, and the educational mission of the University.
As a student of this university:
I will be honest in my academic endeavors
I will not represent someone else’s work as my own
I will not cheat, nor will I aid in another’s cheating
All students are deemed by the University to understand that if they are found responsible for academic misconduct, they will be subject to the Academic Misconduct procedures and sanctions, as outlined in the Student Handbook.
Misconduct includes: Cheating – The unauthorized use of books, notes, aids, electronic sources; or assistance from another person with respect to examinations, course assignments, field service reports, class recitations; or the unauthorized possession of examination papers or course materials, whether originally authorized or not. Plagiarism – The use and appropriation of another’s work without any indication of the source and the representation of such work as the student’s own. Any student who fails to give credit for ideas, expressions or materials taken from another source, including internet sources, is responsible for plagiarism.
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PHC 6013 – Epidemiology Research Methods: Observational Study Design
Changes or Modifications: The Instructor reserves the right to change, alter, add, or delete from the content of this course as deemed appropriate by the Instructor based upon students’ needs.

COURSE SCHEDULE AND ASSIGNMENTS
CLASS
1
DATE TOPIC
Review of mortality and morbidity measures (Kelsey Ch. 1&2)
2 Data sources (Kelsey Ch. 3)
7
8
9
5
6
3
4
Study proposal, Journal article critique
Prospective Cohort, Planning and Execution (Kelsey Ch. 4)
Retrospective designs, Planning and Execution (Kelsey Ch. 5 & 8)
Data interpretation issues- Confounding and effect modification (Hulley and handouts)
Confounding and effect modification
Midterm exam
Prospective Cohort studies, Statistical Analysis (Szyklo handout and Kelsey Ch. 7; optional Kelsey Ch. 6)
Spring Break
10
11
12
13
Retrospective Designs, Statistical Analysis (Kelsey Ch. 9,10)
Sampling Methods and Estimation of Sample Size (Kelsey Ch 12)
Measurement Error (Kelsey Ch. 13)
Measurement I: Questionnaires (Kelsey Ch. 14) and Measurement II: Other Types of Measurement (Kelsey Ch. 15)
Student Presentations 14
15 Final exam
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PHC 6013 – Epidemiology Research Methods: Observational Study Design
Changes or Modifications: The Instructor reserves the right to change, alter, add, or delete from the content of this course as deemed appropriate by the Instructor based upon students’ needs.

Epidemiology
Epidemiology
Biostatistics
Use epidemiologic measures to describe public health conditions in a population in terms of magnitude, person, place, and time.
Use information technology to interpret and communicate public health data to lay and professional audiences.
Use biostatistical measures of distribution shape, central tendency, and variability, and apply statistical analysis software to describe population health and demographic data,
Access and evaluate public health data by using information technology.
Biostatistics
Health Promotion and
Disease Prevention
Assess the behavioral, social and cultural determinants of health and their impact on the health status of populations.
Health Promotion and
Disease Prevention
Propose public health policies and programs that are collaborative, culturally appropriate, and address the causes of health problems.
Environmental and
Occupational Health
Identify environmental and occupational determinants of health and illness in a population.
Environmental and
Occupational Health
Differentiate applications of environmental health science tools in public health core functions.
Health Policy and
Management
Apply principles of public health budgeting.
Health Policy and
Management
Use policy information (health, fiscal, administrative, legal, ethical, social, and political) to inform public health decisions.
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PHC 6013 – Epidemiology Research Methods: Observational Study Design
Changes or Modifications: The Instructor reserves the right to change, alter, add, or delete from the content of this course as deemed appropriate by the Instructor based upon students’ needs.

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PHC 6013 – Epidemiology Research Methods: Observational Study Design
Changes or Modifications: The Instructor reserves the right to change, alter, add, or delete from the content of this course as deemed appropriate by the Instructor based upon students’ needs.

Assessment: TERM PAPER/PRESENTATION
Category Undeveloped
0
Developing
1
Adequate
2
Proficient
3
Given a health problem, choose an implement an appropriate epidemiologic study design
0-Did not choose an appropriate study design for health problem; did not defend choice of study design; methods for implementation were
1-Chose an appropriate study design but did not describe methods for implementation, or methods were not consistent with design;
2-Chose an appropriate design for health problem; gave adequate justification for choice of design but missing all important points to be made; description of did not do adequate job methods was missing some not appropriate to health problem. in justifying design. details, or unclear, or had some small errors in consistency with study design chosen.
3- Chose an appropriate study design and justified the design clearly and completely with no important points missing;
Methods chosen were all consistent with design chosen, clearly explained and well-detailed with no errors.
Total points and how to improve
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PHC 6013 – Epidemiology Research Methods: Observational Study Design
Changes or Modifications: The Instructor reserves the right to change, alter, add, or delete from the content of this course as deemed appropriate by the Instructor based upon students’ needs.

Assessment: homework problem
Category Undeveloped
0
Developing
1
Examine data for confounding and effect modification and interpret appropriately
0-- Interpreted data incorrectly for both correctly for either confounding and effect confounding or effect modification.
1- Interpreted data modification but not both; explanation has many gaps and/or mistakes .
Adequate
2
Proficient
3
Calculates and interprets measures of association
0-did not use correct numerator or denominator data for
IRR (part a) and did not set up subtraction for RD (part c) correctly; did not obtain correct answer for part E (hypothetical measure values for no association).
1-set up either IRR formula or RD formula correctly but not both; correct interpretation for not more than one measure, out of parts b,d,e
Assessment: homework problem
2-Calculated both IRR and
RD correctly and interpreted at least one correctly, but not both; and obtains correct answer for part e.
3- Calculated both IRR and
RD correctly and interpreted both correctly; obtains correct answer for part e.
Category Undeveloped
0
Developing
1
Adequate
2
Proficient
3
Total points and how to improve
2- Interpreted data correctly for either confounding or effect modification but not both; explains substantially but with some gaps and/or mistakes.
3- Interpreted data correctly for both confounding and effect modification, explains completely and with no mistakes.
Total points and how to improve
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PHC 6013 – Epidemiology Research Methods: Observational Study Design
Changes or Modifications: The Instructor reserves the right to change, alter, add, or delete from the content of this course as deemed appropriate by the Instructor based upon students’ needs.