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Evidence-Based Medicine
            (EBM)
INDS 301, Jan. 2013
Prosanto Chaudhury, MD, MSc, FRCSC, FACS
Robin Featherstone, MLIS
Objectives
By the end of the lecture, you will be able to:
  1. Describe objectives and expectations for the
     course
  2. Describe the five stages of the EBM process
  3. Differentiate between background and
     foreground questions
  4. Describe the components of a PICO question
  5. Categorize PICO questions and identify the best
     studies to answer each question type
EBM Course Contents
Format          Content
Lecture 1       Overview of the course and an introduction to EBM, PICO
                question formation, and EBM resources
Workshop        Searching EBM resources
Small group 1   PICO question formation
Lecture 2       Critical appraisal of randomized controlled trials (RCT) and
                systematic reviews (SR)
Small group 2   Appraisal of a RCT
Small group 3   Appraisal of a SR
Small group 4   Appraisal of a diagnostic test study

Course website: http://www.jamaevidence.com/
Evaluation
Item           Description                                         Weight
Small Groups 4 interactive sessions with clinical tutors.          40%
             Evaluation based on participation.
Assignment     3 pages including:                                  30%
               • Clinical scenario
               • PICO
               • Search strategy
               • Name of chosen paper
               • Critical appraisal
               • Your conclusion
OSCE           15 minute station:                                  30%
               • Develop a question based on a clinical scenario
               • Perform a search based on your question
Introduction to EBM

Why are we doing this?
Why is EBM important?
“Evidence-based medicine is the integration of best
research evidence with clinical expertise and patient
values”

             Patient            - Dave Sackett
             Concerns


                EBM
      Best research Clinical
      evidence      Expertise


                                   Slide courtesy Prof Paul Glasziou, CEBM
EBM in practice
•   Took an “evidence cart” on rounds - 1995
•   Looked up 2-3 questions per patient
•   Took 15-90 seconds to find evidence
•   Changed about 1/3 decisions
•   Rounds took longer!




    Dave Sackett
Challenges to practicing EBM

                             RCTs published over the last 50 years
                     20000
                     18000
                     16000
                     14000
                     12000
              RCTs




                     10000
                      8000
                      6000
                      4000
                      2000
                         0
                             1960    1970    1980    1990    2000    2010




Source: PubMed data for "randomized controlled trial"[Publication Type]
How I use EBM
How you can use EBM
•   Keep a logbook of questions
•   Answer a few important questions
•   Identify important knowledge gaps
•   Discuss and share evidence with colleagues (journal
    club)
EBM Process
                                                   Formulating
           Evaluating                              the clinical
Assess                                                                   Ask
           the Process                             question



                         Your patient for whom
                         you are uncertain about
                         therapy, diagnosis, or           Searching
   Incorporating         prognosis                        the Evidence
   evidence into
   decision-making                                                  Acquire

                                 Appraise
Apply
                               Appraising
                               the Evidence
EBM Question Formation

1. Background vs Foreground
Can a 70 year old
                                                                                                    pancytopenic patient with
                                                                                                    suspected meningitis
                                                                                                    receive platelets before
                                                                                                    undergoing a lumbar
                                                                                                    puncture?




  What is pancytopenia?

  What is the diagnostic test
  for meningitis?
                                                                                             [1.]




Guyatt G, Rennie D, Cook D. Users' Guides to the Medical Literature : A Manual for Evidence-Based Clinical Practice (2nd Edition). New
York, NY, USA: McGraw-Hill Professional Publishing; 2008.
                                                                                                                                         Ask
A 25 year-old female has been recently diagnosed with
classical Hodgkin’s lymphoma (nodular sclerosing subtype).
Staging reveals that she is a stage IIA with a 4.5 cm nodal
mass in her neck and mediastinal nodes. Her hematologist
recommends            combined          modality         therapy
(chemotherapy/radiation therapy). The patient has done
some reading about therapy and is worried about the long
term effects of radiation especially the risk of breast cancer.

Background                       Foreground
What is the pathophysiology of   For a 25 year old female with
Hodgkin’s lymphoma?              stage IIA Hodgkin’s lymphoma,
                                 is combined modality therapy
                                 superior to chemotherapy
                                 alone?




                                                                   Ask
A 35 year-old patients presents to the ER with a left leg swelling x
            3 days. The patient recently returned from a business trip in
            Malaysia and therefore you suspect a deep vein thrombosis
            (DVT). It is the weekend and so the patient receives a CT
            angiogram that does not reveal any pulmonary embolism and the
            venous portion of the study does not reveal any above or below
            knee clots. That said, you are still convinced that the patient may
            have a lower limb DVT and so you ask for a lower limb doppler
            which requires the radiologist to come into the hospital in the
            middle of the night to perform the study. The radiologist is
            reluctant to come as the venous phase of the CT angiogram was
            negative.

    Discuss with your
    neighbour. Record one
    background and one
    foreground question.



Creative copyright image. Attribution: James Heilman, MD. Accessed from            Ask
http://upload.wikimedia.org/wikipedia/commons/0/0a/DVT2010.JPG
Background
                                                             Questions


Sources for Background Questions (AKA “Filtered Information”)
• Textbooks
• Handbooks
• Manuals
• etc

                                                          [1.]




                                                                         Acquire
EBM Question Formation

2. P.I.C.O.
  Patient, Population, or Problem
  Intervention or exposure
  Comparison
  Outcome
Simple
You have been asked to review the
practice guidelines for treating warts. You
are confident that cryotherapy is the most
effective treatment but a colleague
suggested some alternatives to
investigate, including duct tape.



                                              Ask
Simple
Patient, Population, or   Patients with common warts
Problem
Intervention or           Duct tape
exposure
Comparison                Cryotherapy
Outcome                   Eliminating warts




Answerable clinical question:

In patients with common warts, is duct tape as effective as
cryotherapy in eliminating warts?


                                                              Ask
Intermediate
You are following a 35 year-old pregnant female for low
platelets thought to be due to immune thrombocytopenia as
she had thrombocytopenia prior to her pregnancy. She
undergoes a delivery without complications. She and the
baby are medically ready to leave the hospital 48 hours
later. She asked if she should be concerned for her
newborn, knowing that her antibodies, the same that are
causing her immune thrombocytopenia, are passed along
to the baby.




                                                            Ask
Intermediate
Patient, Population, or   Newborns with suspected immune thrombocytopenia
Problem
Intervention or           Blood test to check platelets
exposure
Comparison                No blood test
Outcome                   Diagnosis of immune thrombocytopenia


Answerable clinical question 1:

For newborns with suspected immune thrombocytopenia, is a blood test to determine
platelet count recommended to diagnose immune thrombocytopenia?

Answerable clinical question 2:

For newborns with suspected immune thrombocytopenia, when should a blood test
be given to diagnose immune thrombocytopenia?
                                                                                Ask
Best studies to answer each
       question type
Question                                                         Best Evidence
                                     Cost • Cost-effectiveness study
                         Diagnosis • Diagnostic validation studies
                                   • Prospective studies / blind comparison to a
                                   gold standard
             Etiology/Harm • Cohort study
                           • Case control study
                         Prognosis • Cohort study
                                   • Case control study
                Quality of life • Qualitative studies
                     Therapy • Systematic review of Randomized Controlled
                                Trials (RCTs)
                                • Single RCT

1
2
    Heneghan, Carl, and Douglas Badenoch. Evidence-Based Medicine Toolkit. 2nd ed. Malden, Mass.: BMJ Books/Blackwell Pub., 2006.
    Glover, Jan, and Lei Wang. Find it Fast: The Clinical Question : www.med.yale.edu/library/education/guides/screencasts/finditfast/finditfast_2/
                                                                                                                                                      Acquire
Levels of Evidence
                                          for Therapy Question

 Level of Evidence Type of Study

             1a                   Systematic reviews of randomized controlled trials
                                  (RCTs)
             1b                   Individual RCTs with narrow confidence interval
             2a                   Systematic reviews of cohort studies
             2b                   Individual cohort studies and low-quality RCTs
             3a                   Systematic reviews of case-control studies
             3b                   Case-control studies
              4                   Case series and poor quality cohort and case-control
                                  studies
              5                   Expert opinion


Levels of evidence (2001). Centre for Evidence Based Medicine. Retrieved 26 Aug 2008 from
        http://www.cebm.net/index.aspx?o=1025
                                                                                            Acquire
                                                                                              24
Filtered vs Unfiltered Information Sources
    Less time                                  1a - SRs of
    Less work                                     RCTs
    Less evidence

                             Summaries

                                         Filtered




                                     1b                       1b


                        2b     2a                        2b        2a
                                     Unfiltered
More time
                                          3b        3b
More work           4                                              4    5
                               5
More evidence
                                                                            Acquire
Filtered




                 Unfiltered


Expert Opinion
                              Acquire
Summary
EBM Process
                                                Formulating
        Evaluating                              the clinical
?                                                                     ?
        the Process                             question



                      Your patient for whom
                      you are uncertain about
                      therapy, diagnosis, or           Searching
Incorporating         prognosis                        the Evidence
evidence into
decision-making                                                       ?

                                 ?
?
                            Appraising
                            the Evidence
What kind of question is this:

             What causes jaundice?
A.   Background
B.   Etiology
C.   Foreground
D.   PICO
What is the “O” in this question:

When should fibreoptic phototherapy be initiated to
 prevent brain damage for a jaundiced newborn?



A. Fibreoptic phototherapy
B. Jaundiced newborn
C. Prevent brain damage
Which of the following is the best source of
          evidence to answer the question:

  In jaundiced infants, is single volume exchange
transfusion superior to double volume exchange?

A.   Case series
B.   Cohort study
C.   Diagnostic validation study
D.   RCT

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Here are the best types of studies to answer different PICO questions:- Therapy/Prevention: - Randomized controlled trial (RCT) - Systematic review/meta-analysis of RCTs- Prognosis: - Cohort study - Systematic review/meta-analysis of cohort studies- Diagnosis: - Cross-sectional studies (to determine test accuracy) - Systematic review/meta-analysis of cross-sectional studies- Harm/Side effects: - RCT - Systematic review/meta-analysis of RCTs - Observational studies- Etiology/Risk factors: - Cohort study - Case-control study

  • 1. Evidence-Based Medicine (EBM) INDS 301, Jan. 2013 Prosanto Chaudhury, MD, MSc, FRCSC, FACS Robin Featherstone, MLIS
  • 2. Objectives By the end of the lecture, you will be able to: 1. Describe objectives and expectations for the course 2. Describe the five stages of the EBM process 3. Differentiate between background and foreground questions 4. Describe the components of a PICO question 5. Categorize PICO questions and identify the best studies to answer each question type
  • 3. EBM Course Contents Format Content Lecture 1 Overview of the course and an introduction to EBM, PICO question formation, and EBM resources Workshop Searching EBM resources Small group 1 PICO question formation Lecture 2 Critical appraisal of randomized controlled trials (RCT) and systematic reviews (SR) Small group 2 Appraisal of a RCT Small group 3 Appraisal of a SR Small group 4 Appraisal of a diagnostic test study Course website: http://www.jamaevidence.com/
  • 4. Evaluation Item Description Weight Small Groups 4 interactive sessions with clinical tutors. 40% Evaluation based on participation. Assignment 3 pages including: 30% • Clinical scenario • PICO • Search strategy • Name of chosen paper • Critical appraisal • Your conclusion OSCE 15 minute station: 30% • Develop a question based on a clinical scenario • Perform a search based on your question
  • 5. Introduction to EBM Why are we doing this?
  • 6. Why is EBM important? “Evidence-based medicine is the integration of best research evidence with clinical expertise and patient values” Patient - Dave Sackett Concerns EBM Best research Clinical evidence Expertise Slide courtesy Prof Paul Glasziou, CEBM
  • 7. EBM in practice • Took an “evidence cart” on rounds - 1995 • Looked up 2-3 questions per patient • Took 15-90 seconds to find evidence • Changed about 1/3 decisions • Rounds took longer! Dave Sackett
  • 8. Challenges to practicing EBM RCTs published over the last 50 years 20000 18000 16000 14000 12000 RCTs 10000 8000 6000 4000 2000 0 1960 1970 1980 1990 2000 2010 Source: PubMed data for "randomized controlled trial"[Publication Type]
  • 9. How I use EBM
  • 10. How you can use EBM • Keep a logbook of questions • Answer a few important questions • Identify important knowledge gaps • Discuss and share evidence with colleagues (journal club)
  • 11. EBM Process Formulating Evaluating the clinical Assess Ask the Process question Your patient for whom you are uncertain about therapy, diagnosis, or Searching Incorporating prognosis the Evidence evidence into decision-making Acquire Appraise Apply Appraising the Evidence
  • 12. EBM Question Formation 1. Background vs Foreground
  • 13. Can a 70 year old pancytopenic patient with suspected meningitis receive platelets before undergoing a lumbar puncture? What is pancytopenia? What is the diagnostic test for meningitis? [1.] Guyatt G, Rennie D, Cook D. Users' Guides to the Medical Literature : A Manual for Evidence-Based Clinical Practice (2nd Edition). New York, NY, USA: McGraw-Hill Professional Publishing; 2008. Ask
  • 14. A 25 year-old female has been recently diagnosed with classical Hodgkin’s lymphoma (nodular sclerosing subtype). Staging reveals that she is a stage IIA with a 4.5 cm nodal mass in her neck and mediastinal nodes. Her hematologist recommends combined modality therapy (chemotherapy/radiation therapy). The patient has done some reading about therapy and is worried about the long term effects of radiation especially the risk of breast cancer. Background Foreground What is the pathophysiology of For a 25 year old female with Hodgkin’s lymphoma? stage IIA Hodgkin’s lymphoma, is combined modality therapy superior to chemotherapy alone? Ask
  • 15. A 35 year-old patients presents to the ER with a left leg swelling x 3 days. The patient recently returned from a business trip in Malaysia and therefore you suspect a deep vein thrombosis (DVT). It is the weekend and so the patient receives a CT angiogram that does not reveal any pulmonary embolism and the venous portion of the study does not reveal any above or below knee clots. That said, you are still convinced that the patient may have a lower limb DVT and so you ask for a lower limb doppler which requires the radiologist to come into the hospital in the middle of the night to perform the study. The radiologist is reluctant to come as the venous phase of the CT angiogram was negative. Discuss with your neighbour. Record one background and one foreground question. Creative copyright image. Attribution: James Heilman, MD. Accessed from Ask http://upload.wikimedia.org/wikipedia/commons/0/0a/DVT2010.JPG
  • 16. Background Questions Sources for Background Questions (AKA “Filtered Information”) • Textbooks • Handbooks • Manuals • etc [1.] Acquire
  • 17. EBM Question Formation 2. P.I.C.O. Patient, Population, or Problem Intervention or exposure Comparison Outcome
  • 18. Simple You have been asked to review the practice guidelines for treating warts. You are confident that cryotherapy is the most effective treatment but a colleague suggested some alternatives to investigate, including duct tape. Ask
  • 19. Simple Patient, Population, or Patients with common warts Problem Intervention or Duct tape exposure Comparison Cryotherapy Outcome Eliminating warts Answerable clinical question: In patients with common warts, is duct tape as effective as cryotherapy in eliminating warts? Ask
  • 20. Intermediate You are following a 35 year-old pregnant female for low platelets thought to be due to immune thrombocytopenia as she had thrombocytopenia prior to her pregnancy. She undergoes a delivery without complications. She and the baby are medically ready to leave the hospital 48 hours later. She asked if she should be concerned for her newborn, knowing that her antibodies, the same that are causing her immune thrombocytopenia, are passed along to the baby. Ask
  • 21. Intermediate Patient, Population, or Newborns with suspected immune thrombocytopenia Problem Intervention or Blood test to check platelets exposure Comparison No blood test Outcome Diagnosis of immune thrombocytopenia Answerable clinical question 1: For newborns with suspected immune thrombocytopenia, is a blood test to determine platelet count recommended to diagnose immune thrombocytopenia? Answerable clinical question 2: For newborns with suspected immune thrombocytopenia, when should a blood test be given to diagnose immune thrombocytopenia? Ask
  • 22. Best studies to answer each question type
  • 23. Question Best Evidence Cost • Cost-effectiveness study Diagnosis • Diagnostic validation studies • Prospective studies / blind comparison to a gold standard Etiology/Harm • Cohort study • Case control study Prognosis • Cohort study • Case control study Quality of life • Qualitative studies Therapy • Systematic review of Randomized Controlled Trials (RCTs) • Single RCT 1 2 Heneghan, Carl, and Douglas Badenoch. Evidence-Based Medicine Toolkit. 2nd ed. Malden, Mass.: BMJ Books/Blackwell Pub., 2006. Glover, Jan, and Lei Wang. Find it Fast: The Clinical Question : www.med.yale.edu/library/education/guides/screencasts/finditfast/finditfast_2/ Acquire
  • 24. Levels of Evidence for Therapy Question Level of Evidence Type of Study 1a Systematic reviews of randomized controlled trials (RCTs) 1b Individual RCTs with narrow confidence interval 2a Systematic reviews of cohort studies 2b Individual cohort studies and low-quality RCTs 3a Systematic reviews of case-control studies 3b Case-control studies 4 Case series and poor quality cohort and case-control studies 5 Expert opinion Levels of evidence (2001). Centre for Evidence Based Medicine. Retrieved 26 Aug 2008 from http://www.cebm.net/index.aspx?o=1025 Acquire 24
  • 25. Filtered vs Unfiltered Information Sources Less time 1a - SRs of Less work RCTs Less evidence Summaries Filtered 1b 1b 2b 2a 2b 2a Unfiltered More time 3b 3b More work 4 4 5 5 More evidence Acquire
  • 26. Filtered Unfiltered Expert Opinion Acquire
  • 28. EBM Process Formulating Evaluating the clinical ? ? the Process question Your patient for whom you are uncertain about therapy, diagnosis, or Searching Incorporating prognosis the Evidence evidence into decision-making ? ? ? Appraising the Evidence
  • 29. What kind of question is this: What causes jaundice? A. Background B. Etiology C. Foreground D. PICO
  • 30. What is the “O” in this question: When should fibreoptic phototherapy be initiated to prevent brain damage for a jaundiced newborn? A. Fibreoptic phototherapy B. Jaundiced newborn C. Prevent brain damage
  • 31. Which of the following is the best source of evidence to answer the question: In jaundiced infants, is single volume exchange transfusion superior to double volume exchange? A. Case series B. Cohort study C. Diagnostic validation study D. RCT

Editor's Notes

  1. Q:What are the five A’s?A:Ask, Acquire, Appraise, Apply and Assess
  2. Either A or B are correct.
  3. Outcomeis to prevent brain damage – C
  4. This is a therapy question – answer is D (even better to have a SR of an RCT)