SPM 624 Introduction to Evidence-Based Medicine and Clinical Epidemiology

Course Coordinator: 2

Other Instructors: 2

Prerequisites. 2

Description for catalog. 2

Course Outline. 3

Course Content 3

Audience. 3

Evaluation. 3

Class attendance. 3

Homework. 4

Examinations. 4

Texts. 4

Required Texts. 4

Recommended Text 4

Session 1, 1/22/02 “Covering the basics” 5

Session, 2 1/29/02 “Finding the evidence” 6

Session 3, 2/5/02 “Therapy” 7

Session 4, 2/12/02 “Systematic literature reviews and meta-analyses” 8

Session 5, 2/19/02 “Systematic literature reviews and meta-analyses II” 9

Session 6, 2/26/02 “Diagnosis I” 10

Session 7, 3/5/02 “Midterm Exam or Project Presentation” 11

Session 9, 3/12/02 “Diagnosis II” 12

Session 9, 3/19/02 “Screening” 13

Session 10, 4/2/02 “Prognosis & Harm” 14

Session 11, 4/9/02 “Patient important outcomes & health related quality of life; Trading off benefit and harm” 15

Session 12, 4/16/02 “Integrating patient preferences in Guidelines and Recommendations” 16

Session 13, 4/23/02 “Economic Analysis” 17

Session 14, 4/30/02 “Selected Topic” 18

Final Exam (Project Due), 5/7/02. 19


 

SPM624 Introduction to Evidence-Based Medicine and Clinical Epidemiology

Course Coordinator:                      

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

Other Instructors:                         

Brydon Grant, MD

Paola Muti, MD, MSc

 

 

Credits: 3

When: Tuesdays, 18:00 – 20.15 h

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

 

Full Course Title

Introduction to Evidence-Based Medicine and Clinical Epidemiology

 

Title for Course Monitoring

EBM/Clinical Epidemiology

 

Prerequisites

SPM 501, SPm 505

 

Description for catalog

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.

 

Course Outline

 

Course Content

The course will cover the following topics (neither in order nor separated by sessions):

 

Understanding EBM and Clinical Epidemiology

  1. The philosophy of evidence based medicine
  2. Finding the evidence
  3. Critical appraisal of studies about therapy
  4. Understanding systematic literature reviews and meta-analysis
  5. The process of Diagnosis
  6. Interpretation of diagnostic data
  7. Selection of diagnostic tests
  8. Early diagnosis and screening
  9. Critical appraisal of studies about screening
  10. Critical appraisal of studies about prognosis & making a prognosis
  11. Critical appraisal of studies about harm
  12. Outcome measurements in clinical epidemiology – health related quality of life
  13. Tradeoff between Benefit and Harm
  14. Guidelines and Recommendations
  15. Developing a clinical research protocol or conducting a systematic review

 

 

Audience

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.

 

Evaluation

 

Class attendance

Students are expected to attend class. Two or more unexcused absences will adversely affect students’ grades.

 

Homework

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.

 

Examinations

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%.

 

Texts

 

Required Texts

1)       Users’ Guide to the Medical Literature: A Manual for Evidence-Based Clinical Practice. Editors: G. Guyatt, D. Rennie, R Hayward. AMA-Press, 2002

2)       Clinical Epidemiology. Second Edition. Editors: DL Sackett, RB Haynes, GH Guyatt, P Tugwell.  Little, Brown and Company, 1991.

 

Recommended Text

1)       Evidence Based Medicine. Editors: DL Sackett, RB Haynes, SE Straus, WS Richardson, W Rosenberg. Churchill Livingstone, 2000.

 


Session 1, 1/22/02 “Covering the basics”

 

Attendance check

Introduction

Students’ objectives

Review of Course description

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

History of Clinical Epidemiology & EBM

The clinical and research question

For discussion: Richardson WS, Wilson MC, Nishikawa J, Hayward RS. The well-built clinical question: a key to evidence-based decisions. ACP J Club. 1995;123:A12-3.

 

Assignment for next session:

Provide a brief description of your objectives and you background – 2 paragraphs, 200 words

  1. Reading assignments. Primary: Chapter 1A1, Finding the evidence, Users’ Guide; Secondary: page 335 – 378, Clinical Epidemiology
  2. Formulate a well built clinical or research question
  3. Be prepared to answer “What sources would you use to search for the evidence?”
  4. Identify an article about therapy

 


Session, 2 1/29/02 “Finding the evidence”

 

Attendance check

 

Objectives

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:

  1. Reading assignments. Primary: Chapter 1B and 1B1, Users’ Guide; Secondary: Chapter 2B, 2B1 (Surprising Results of Randomized Controlled Trials, The Principle of Intention-to-Treat, N of 1 Randomized Controlled Trials), 2B2, 2B3 (Example Numbers Needed to Treat 385 - 392); Tertiary: page 187 -196, Clinical Epidemiology, http://www.consort-statement.org
  2. Read and critically appraise the identified article about therapy

 

 

 

 


Session 3, 2/5/02 “Therapy”

 

Attendance check

Objectives

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)

 

Feedback

 

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) Reading assignments:

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, Henderson MC. Using Systematic Reviews in Clinical Education. Ann Intern Med 1997;126:886-891.

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.

Meade MO, Richardson WS. Selecting and Appraising Studies for a Systematic Review. Ann Intern Med 1997;127:531-7.

Lau J, Ioannidis JPA, Schmid CH. Quantitative synthesis in systematic reviews. Ann Intern Med 1997;127:820-26.

Mulrow C, Langhorne P, Grimshaw J. Integrating heterogeneous pieces of evidence in

systematic Reviews. Ann Intern Med 1997;127:989-995.


Session 4, 2/12/02 “Systematic literature reviews and meta-analyses”

 

Attendance check

Objectives

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


Session 5, 2/19/02 “Systematic literature reviews and meta-analyses II”

 

Attendance check

Objectives

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

 


Session 6, 2/26/02 “Diagnosis I”

 

Instructor: Brydon Grant, MD

 

Attendance check

Objectives

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

 


Session 7, 3/5/02 “Midterm Exam or Project Presentation”

 

Attendance check

Objectives

5 minute presentation on final project on one overhead – with class feedback

 

 

 

Assignment for next session:

15.   Reading Assignment “Diagnosis of Iron deficient anemia”

 


Session 9, 3/12/02 “Diagnosis II”

 

Instructor: Brydon Grant, MD

 

Attendance check

Objectives

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

 


Session 9, 3/19/02 “Screening”

 

Instructor: Paola Muti, MD, MSc

Attendance check

Objectives

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

 


Session 10, 4/2/02 “Prognosis & Harm”

 

Instructor: Brydon Grant, MD

 

Attendance check

Objectives

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

 


Session 11, 4/9/02 “Patient important outcomes & health related quality of life; Trading off benefit and harm”

 

Attendance check

Objectives

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

 


Session 12, 4/16/02 “Integrating patient preferences in Guidelines and Recommendations”

 

Attendance check

Objectives

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

 


Session 13, 4/23/02 “Economic Analysis”

 

Attendance check

Objectives

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

 


Session 14, 4/30/02 “Selected Topic – Clinical Prediction Rules”

 

Attendance check

Objectives

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


Final Exam (Project Due), 5/10/02