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All clinical research regardless if classified as patient-oriented, translational, epidemiologic, behavioral, outcomes, or health services research has individual human beings or groups of human beings as the unit of observation. As such, principles of epidemiology serve as the basic scientific methodology of clinical research.
The objectives of this course are to give trainees a detailed understanding of the:
- diverse array of study designs available in clinical research;
- importance of measurement;
- different types of measures of disease occurrence;
- methods to measure disease association; and
- how to identify and minimize selection, measurement and confounding bias in clinical research studies.
In addition, the course will give provide a conceptual understanding of multivariable regression analysis, a common tool used in epidemiologic analyses.
Designing Clinical
Research (Epi 180.04) and possession
of a MD, PhD, DDS or PharmD or equivalent postdoctoral
degree. Exceptions to these prerequisites may be made with the consent
of the Course Director, space permitting.
- Lectures: Tuesdays 8:15 to 9:45 am through 11/27/01, then 8:45 to 10:15 on Dec. 4 & 11.
- Section: Begins October 2. Tuesdays 1:00 to 2:00 pm. Note: Last Section is on Tuesday December 4, from 10:30 to 11:30.
Content: Overview and discussion of lectures, and review of homework assignments.
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TEXTBOOKS (provided to all enrolled trainees)
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Epidemiology: Beyond the Basics by M. Szklo and F.
Nieto (S & N). Aspen Publishers, Inc. 2000. (Note: There is a running
list of errata at www.aspenpublishers.com/books/szklo.html.)
Multivariable Analysis: A Practical Guide for Clinicians
by M. Katz. Cambridge University Press. 1999.
Grades will be based on total points achieved on homework (~80%) and the final exam (~20%). Late assignments are not accepted.
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Date / Time
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Lecture Title / Content
Assignment Due at Afternoon 1pm Session
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Lecturer
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Tues 9/25/01
8:15-9:45 am |
Understanding Measurement: Aspects of Reproducibility and Validity
How reproducibility influences validity; methods of characterizing reproducibility of measurements (within-subject standard deviation, coefficient of variation); methods of assessment of validity in the presence and absence of gold standards
Reading:
- Portions of Chapter 8 in S & N. Focus on p. 343 - 344, 352- 380, and 388 - 401
- Bland and Altman. Measurement error. BMJ 1996; 313:744.
(
PDF, 210KB)
- Bland and Altman. Measurement error and correlation coefficients. BMJ 1996; 313:41-42.
(
PDF, 492KB)
- Bland and Altman. Measurement error proportional to the mean. BMJ 1996; 313:106. (
PDF, 210KB)
- Excerpt on Validity, p. 59-66, from Chapter 4 "Measurement" in Research Methods in the Social Sciences by Nachmias and Nachmias. (
PDF, 904KB)
- Chapter 8 in S & N. Focus on p. 343 - 344, 352- 380, and 388
- 401
Homework: None
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J. Martin |
Tues 10/2/01
8:15-9:45 am |
Study Design
Designs where the unit of observation is a group of individuals vs. the individual; main types of studies based on the individual as the unit of observation; the study base as a unifying concept linking cohort and case-control designs; designs based on prevalent vs. incident disease
Reading:
- S & N: Ch. 1, p. 3-4, 17-40
- 2. Wachholder S. Selection of controls in case-control studies Am J Epidemiol 1992; 135:1019-1028. Focus on "Study Base Principle" p. 1021- 1024.
(
PDF, 2,368KB)
Homework: Problem set from lecture 1
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D. Osmond |
Tues 10/2/01
1:00-2:00 pm |
SECTION |
Schwarz/
Varosy |
| Tues 10/9/01 8:15-9:45 am |
Measures of Disease Occurrence I
The three components in measuring disease occurrence; incidence versus prevalence; incidence measures based on individuals at risk vs. person-time; uses of different incidence measures
Reading:
- S & N: Ch. 2
- OPTIONAL: Tapia Granados, JA. On the terminology and dimensions of incidence.
J Clin Epidemiol 1997;50:891-897.
(PDF, 1,283KB)
Homework: Problem set from lecture 2
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D. Osmond |
Tues 10/9/01
1:00-2:00 pm |
SECTION |
Schwarz/
Varosy |
| Tues 10/16/01 8:15-9:45 am |
Measures of Disease Occurrence II
Censoring; estimating cumulative incidence using Kaplan-Meier and life-table estimation; prevalence measures; odds versus probability
Reading: S & N: Ch. 2
Homework: Problem set from lecture 3
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D. Osmond |
Tues 10/16/01
1:00-2:00 pm |
SECTION |
Schwarz/
Varosy |
| Tues 10/23/01 8:15-9:45 am |
Measures of Disease Association I
Fundamental differences between ratio and difference measures; forming ratio and difference measures in cohort studies; confidence interval and hypothesis testing in cohort studies
Reading:
- S & N: Ch. 3: p. 91- 98, p. 105 -117, p. 118 - 120 (i.e., skip sections on attributable risk); Appendix A3
- Schulman, et al. The Effect of Race and Sex on Physician's Recommendations for Cardiac Catheterization, NEJM 1999: 618-626. (PDF, 214KB)
- Schartz, et al. Misunderstandings About the Effects of Race and Sex on Physicians' Referrals for Cardiac Catheterization. NEJM 1999,341:279-283. (PDF, 853KB)
Homework: Problem set from lecture 4
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D. Osmond |
Tues 10/23/01
1:00-2:00 pm
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SECTION |
Schwarz/
Varosy |
| Tues 10/30/01 8:15-9:45 am |
Measures of Disease Association II
Forming measures in cross-sectional and case-control studies; relationship between incidence ratio and prevalence ratio; confidence interval and hypothesis testing in cross-sectional and case-control studies
Reading: S & N: Ch. 3: p. 91- 99, p. 105 -117, p. 118 - 120 (i.e., skip sections on attributable risk);
Ch. 4: p. 155-161; Appendix A4
Homework: Problem set from lecture 5
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D. Osmond |
Tues 10/30/01
1:00-2:00 pm |
SECTION |
Schwarz/
Varosy |
| Tues 11/6/01 8:15-9:45 am |
Bias in Epidemiologic Studies: Selection Bias & Measurement Bias
Definition and classification of bias; distinguishing from random error; spotting and avoiding selection bias; influence (magnitude and direction of bias) of differential vs. non-differential misclassification of exposure, outcome, and confounding variables
Reading:
- S & N: Ch. 4: p. 125-155
Homework: Problem set from lecture 6
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K. Shafer |
Tues 11/6/01
1:00-2:00 pm |
SECTION |
Schwarz/
Varosy |
| Tues 11/13/01 8:15-9:45 am |
Confounding and Interaction I: General Principles
Properties of confounding variables; types and magnitude of confounding; importance of defining the research question and the biological system in deciding whether confounding is present; strategies to minimize confounding
Reading: S & N: Ch. 5 and Ch. 1: p. 40 - 48 (section on
Matching)
Homework: Problem set from lecture 7
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J. Martin |
Tues 11/13/01
1:00-2:00 pm |
SECTION |
Schwarz/
Varosy |
| Tues 11/20/01 8:15-9:45 am |
Confounding and Interaction II: Assessment of Interaction
Interaction vs. confounding; assessing for interaction; tests of homogeneity; computer implementation
Reading: S & N: Ch. 6, p. 211 - 223, p. 233 - 251
Homework: Problem set from lecture 8
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J. Martin |
Tues 11/20/01
1:00-2:00 pm |
SECTION |
Schwarz/
Varosy |
| Tues 11/27/01 8:15-9:45 am |
Confounding and Interaction III: Stratified Analysis
Use of stratification to form adjusted measures; concept of weighted averages; interpreting presence or absence of confounding; limitations of stratification
Reading: S & N: Ch. 7: p. 257 - 264; p. 273 - 280
Homework: Problem set from lecture 9
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J. Martin |
Tues 11/27/01
1:00-2:00 pm |
SECTION |
Schwarz/
Varosy |
| Tues 12/4/01 8:45-10:15 am |
Conceptual Approach to Multivariable Analysis I
When to use multivariable analysis; choosing the best type of multivariable analysis for your data; assumptions underlying multivariable models; assessing the impact of individual variables on outcome
Reading: Katz: Ch. 1 - 3
Homework: Problem set from lecture 10
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M. Katz |
| Tues 12/4/01 10:30-11:30 |
SECTION |
Schwarz/
Varosy |
| Tues
12/11/01 8:45-10:15 am |
Conceptual Approach to Multivariable Analysis II
Handling common situations in multivariable analysis: missing data; losses to follow-up; including the
right variables in the model; assessing the reliability of models
Reading: Katz: Ch. 4 , 7 and 8
Homework: None
Final Examination Distributed. Due 12/18/01 by 5 pm.
Deliver to Olivia DeLeon in Millberry Union 427W.
Final Exam (Word file, 384 KB)
Data Set (.dta, 5KB)
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M. Katz |
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