SPM 624 Introduction to Evidence-Based Medicine and
Clinical Epidemiology
Session 1, 1/22/02 “Covering
the basics”
Session, 2 1/29/02 “Finding
the evidence”
Session 4, 2/12/02 “Systematic
literature reviews and meta-analyses” 8
Session 5, 2/19/02 “Systematic
literature reviews and meta-analyses II”
Session 6, 2/26/02 “Diagnosis
I”
Session 7, 3/5/02 “Midterm
Exam or Project Presentation”
Session 9, 3/12/02 “Diagnosis
II”
Session 9, 3/19/02 “Screening”
Session 10, 4/2/02 “Prognosis
& Harm”
Session 12, 4/16/02
“Integrating patient preferences in Guidelines and Recommendations”
Session 13, 4/23/02 “Economic
Analysis”
Session 14, 4/30/02 “Selected
Topic”
Final Exam (Project Due), 5/7/02
SPM624 Introduction to Evidence-Based Medicine and
Clinical Epidemiology
Holger J. Schünemann, M.D., Ph.D.
Departments of
Medicine and of Social and Preventive Medicine
252D Farber Hall
Tel: 716 829 2975 x
610 or 898 5792
Email: hjs@buffalo.edu
Web: http://www.acsu.buffalo.edu/~hjs/SPM624.htm
Paola Muti, MD, MSc
Credits:
3
When:
Tuesdays,
Where:
Farber 180
Appointments
with instructors: to be
arranged by email
Remark: You are advised to check the following website
The day after and The day before any class to look for changes: http://www.acsu.buffalo.edu/~hjs/SPM624.htm
Introduction to Evidence-Based Medicine and Clinical Epidemiology
Title for Course Monitoring
EBM/Clinical Epidemiology
SPM 501, SPm 505
SPM 624 Introduction to Evidence-Based Medicine and Clinical Epidemiology. Lecture, 3 credits, 2 contact hours. This course provides a broad overview of basic epidemiologic concepts necessary for evidence-based studies of medicine and in clinical research. The course has the following objectives: a) familiarize students with techniques for critical appraisal of the medical literature, b) teach students how to apply critical appraisal techniques and c) familiarize students with new strategies and tactics in clinical epidemiology research (including the evaluation of diagnostic tests, clinical course and prognosis of disease, disease etiology or causation, therapy, quality of clinical care, economic evaluation, and meta-analysis). The spectrum of expected students includes, but is not limited to physicians, nurses and other health care professionals who are obtaining advanced training in epidemiology or public health with an interest in clinical research.
The course will cover the following topics (neither in order nor separated by sessions):
Understanding EBM and Clinical Epidemiology
This
course aims at students with interest in clinical research and a clinical
background. The spectrum of students
includes, but is not limited to, physicians, nurses and other health care
professionals who are obtaining advanced training in epidemiology or public
health. Students should have successfully completed courses SPM 501
(Introduction to Epidemiology) and SPM 505.
Students are expected to attend class. Two or more unexcused absences will adversely affect students’ grades.
There will be homework assignments based on the material covered in the individual sessions and reading material. Graduate students are expected to prepare critical appraisals on each topic covered and students will be given the opportunity to present one critically appraised topic. Assignments may be hand-written, typeset using a word-processing program, or posted in HTML format on a home page. Homework assignments will count for 20% of the final grade.
Depending upon class discussion and decision, there will be a mid-term exam and a final exam. These tests will consist of short questions and problems based on the session and lecture material as well as homework assignments. Alternatively, students are given the opportunity to conduct a research project instead of the exams. The type of examination, test versus project based, will be determined at the start of the course. The mid-term exam will count for 20% and the final for 30% of the grade or, alternatively, the project will constitute 50% of the grade. Class participation contributes the remaining 30%.
1) Users’
Guide to the Medical Literature: A Manual for Evidence-Based Clinical Practice.
Editors: G. Guyatt, D. Rennie, R
2) Clinical Epidemiology. Second Edition. Editors: DL Sackett, RB Haynes, GH Guyatt, P Tugwell. Little, Brown and Company, 1991.
1) Evidence
Based Medicine. Editors: DL Sackett, RB Haynes, SE Straus, WS Richardson,
q
General Course
objectives
q
Review of
evaluation
q
Exams (essay +
multiple choice versus project)
q
Vote on how to
evaluate (or defer until 1/29)
q
Review of
Course and other material
q
Class format
For discussion:
Assignment for next session:
Provide a brief description of your objectives and you background – 2 paragraphs, 200 words
Understanding the assignments
Know or learn about:
q Sources of evidence
q Primary versus secondary sources
q Being on-line getting you off-guard?
q Literature searches/Searching the internet
Assignment for next session:
Understanding
the assignments
Know or
learn about:
q
Review of Study design and
quality of evidence
q
Critical appraisal of studies
about therapy
q
Applying study results to
“your” patient population
q
Measures of association in a
clinical context
q
Understanding the number
needed to treat (NNT)
Assignment
for next two sessions:
7.
Reading assignments. Primary:
Chapters 1E & 2E, Users’ Guide & identified Systematic Review
8.
Develop a question for a systematic
review and provide search results
9. Secondary (absolutely voluntary)
Egger M, Smith GD, Meta-analysis: potential and promise.
BMJ 1997;315:1371-4
Egger M, Smith GD, Phillips AN, Meta-analysis: principles
and procedures. BMJ 1997;315:1533-7
Smith GD, Egger M, Phillips AN, Meta-analysis: beyond the
grand mean? BMJ 1997;315:1610-4
Egger M, Smith GD, Meta-analysis: bias in location and
selection of studies. BMJ 1998;316:61-6
Egger M, Schneider M, Smith GD, Meta-analysis: spurious
precision? BMJ 1998;316:140-4
Smith GD, Egger M, Meta-analysis: unresolved issues and
future developments. BMJ 1998;316:221-5
Mulrow CD, Cook DJ, Davidoff F. Systematic Reviews:
critical links in the great chain of evidence [Editorial]. Ann Intern Med
1997;126:389-391.
Cook DJ, Mulrow CD, Haynes RB. Systematic Reviews:
synthesis of best evidence for clinical decisions. Ann Intern Med
1997;126:364-371.
Hunt DL, McKibbon KA. Locating and Appraising Systematic
Reviews. Ann Intern Med 1997;126:532-538.
McQuay HJ, Moore RA. Using Numerical Results from Systematic Reviews in Clinical Practice. Ann Intern Med 1997;126:712-20
Badgett RG, O'Keefe M,
Bero LA, Jadad AR. How Consumers and Policymakers Can Use
Systematic Reviews for Decision Making. Ann Intern Med 1997;127:37-42.
Cook DJ, Greengold NL, Ellrodt AG, SR Weingarten. The
Relation between Systematic Reviews and Practice Guidelines. Ann Intern Med
1997;127:210-216.
Counsell C. Formulating Questions and Locating Primary
Studies for Inclusion in Systematic Reviews. Ann Intern Med 1997;127:380-387.
Lau J,
Mulrow C, Langhorne P, Grimshaw J. Integrating
heterogeneous pieces of evidence in
systematic Reviews. Ann Intern Med 1997;127:989-995.
Understanding
the assignments
Present
assignments (everyone)
Know or
learn about:
q
Systematic reviews
i.
Why the fuss
ii.
Differences between narrative
and systematic reviews
q
Conducting a systematic
review
q
Should one include
unpublished studies in systematic reviews
q
Developing a protocol for a
systematic review
Assignment
for next session:
see Session 3
10. Critically appraise
the systematic review handed out
Understanding
the assignments
Know or
learn about:
q
Bias in systematic reviews
q
Meta Analysis (the basics)
q
Statistical Issues
i.
Pooling across different
outcomes
ii.
Random versus fixed effect
models
iii.
Relative and absolute
measures of effect
iv.
Heterogeneity
v.
Sensitivity analysis
q
Applying results of
meta-analysis to patient care
Assignment
for next session:
11. Read the following article: “Diagnosis in Patients with
Proximal Deep Vein Thrombosis” – posted on Blackboard
12. Reading assignments. Primary (for Session 6 and 9):
Chapters 1C, 1C1, 1C2, 2C, Users’ Guide; Page 3 – 18, Clinical Epidemiology
Understanding
the assignments
Know or
learn about:
q
The diagnostic process
q
Diagnostic tests
q
Choice of a reference
(“gold”) standard
q
Sensitivity and Specificity, the
receiving operator curve or better: likelihood ratios
Assignment
for next session:
13. Written critical appraisal of “Diagnosis in Patients with
Proximal Deep Vein Thrombosis”
14. Presentation of Project
5 minute
presentation on final project on one overhead – with class feedback
Assignment
for next session:
15. Reading Assignment “Diagnosis of Iron deficient anemia”
Understanding
the assignments
Know or
learn about:
q
Measuring agreement between
raters (Kappa and Phi Statistics)
q
Critically appraising studies
about diagnosis
q
Clinical prediction rules
Assignment
for next session:
16. Reading assignment.
Primary: 2F Recommendations About Screening, Users’ Guide.
17. Reading assignment.
Primary: Miller A. et al Canadian National breast screening study-2:
13-year results of a randomized trial in women aged 50-59 JNCI 2000, 29: 1490-9
18. Reading assignment.
Primary: Kelikowske K. Efficacy of screening mammography among women
aged 40-49 years and 50-59 years: comparison of relative and absolute benefit
JNCI 1997; 22:79-86
Instructor:
Understanding
the assignments
Know or
learn about:
q
Definition of Screening
Programs
q
Screening programs applied to
chronic disease: the case of breast cancer screening
q
Mammography versus Breast
Exams
q
Efficacy of breast cancer
screening among women younger than age 50
Assignment
for next session:
19. Reading assignment. Primary: Chapters 1D & 2D, Users’
Guide;
20. Reading assignment.
Primary: Chapter 1B2, Users’ Guide
21. Critically appraise the one of the two articles (Miller et
al and Kelikowske above).
22. Reading assignment. Primary: Phenylpropanolamin and the
risk of stroke. NEJM 2001; 341: 1826-36
See
Session 5
Understanding
the assignments
Know or
learn about:
q
Critical appraisal of an
article about prognosis
q
Applying results of
therapeutic studies to our patients
q
The number needed to be
exposed (NNE)
q
When therapy means harm
q
Identifying harm
q
Critical appraisal of an
article about harm
Assignment
for next session:
23. Reading assignment.
Primary: Chapter 2B2, 2B3 (Applying Results to individual patients), 2F
(Incorporating patient values) Users’ Guide
24. Guyatt GH,
Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med
1993;118:622-9, 1993
25. Critically
appraise the article about harm: Phenylpropanolamin
and the risk of stroke. NEJM 2001; 341: 1826-36
Understanding
the assignments
Know or
learn about:
q
Patient important outcomes
q
Health Related Quality of
Life
q
Utilities and Preferences
q
Trading off benefit against
harm
Assignment
for next session:
26. Reading assignment.
Primary: Chapter 1F, 2F (Grading Recommendations – A qualitative
approach; Grading Recommendations – A quantitative approach), (Incorporating
patient values) Users’ Guide
27. Reading assignment.
Primary: Clinical practice guidelines
Understanding
the assignments
Know or
learn about:
q
Guidelines and
Recommendations
q
The process of developing
guidelines
q
Systematic approaches to
developing guidelines
q
Critically appraising
clinical practice guidelines
q
Different approaches to
grading of evidence
q
Integrating patient
preferences in guidelines and recommendations
q
Decision analysis
Assignment
for next session:
28. Reading assignment.
Primary: Chapter 2F Economic Analysis, Users’ Guide
29. Reading assignment: “Cost-effectiveness of inhaled
corticosteroids in adults with mild-to-moderate asthma: Results from the Asthma
Policy Model” David et al. J All Clin Immunol 2001;108:39-46
Understanding
the assignments
Know or
learn about:
q
Cost-effectiveness
q
Cost-utility
q
Cost-benefit
q
Critical Appraisal of an
article on cost analysis
Assignment
for next session:
30. Reading assignment.
Primary: Chapter 2C Clinical Prediction Rules, Users’ Guide
31. Read Article: Development and Validation of a Clinical
Prediction Rule for Major Adverse Outcomes in Coronary Bypass Grafting
Understanding
the assignments
Know or
learn about:
q
Clinical Prediction Rules
q
Critical Appraisal of Studies
about Clinical Prediction Rules
Assignment
for 5/10/02:
32. Final Exam or Final Project Due