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INTRODUCTION TO EVIDENCE BASED
MEDICINE
Sama’ Abderahman, PharmD Msc
INTRODUCTION:
EDUCATION
 University: Jordan University of Science and
Technology
 Specialty: PharmD
 Graduated in June / 2008, (GPA: Excellent, second on my
class)
 University: Jordan University
 Specialty: Master of Clinical Pharmacy
 Thesis: " Evaluation of the Impact of Pharmaceutical Care on
Patients Undergoing Anticoagulation Therapy: A Randomized
Controlled Trial"
 Graduated in August/ 2013, (GPA: Excellent)
AWARDS:
 The Scientific Research Fund grant
 Awarded by Jordan Ministry of Higher Education to the
postgraduate students with distinguished academic records.
PROFESSIONAL EXPERTISE:
 "Research & Teaching Assistant at Jordan
University of Science & Technology (September/2008-
November/2009)
 Community Pharmacist at Iptihal Pharmacy/Irbid
 Teaching Assistant at the University of Jordan
(December/2011-June/ 2013)
 Ambulatory care: Anticoagulant clinic (October/ 2012- June/
2013)
 Clinical pharmacist- medical research field (February
2014 – May 2014):
 Tabuk Pharmaceutical Manufacturing Company-
Business Development Department
 Research assistant at the University of Jordan
(November/ 2013-February/ 2015)
WHAT IS EVIDENCE-BASED MEDICINE?
is an approach to medical practice …
EBM
Best
Practice
Best
Evidence
Patients
Values
EBM
 EBM
EBM
 New Paradigm??
 The term “evidence-based” was introduced for the
first time in 1987 by David M. Eddy…
 Its philosophic origin dated back to mid 19 century
 However, it is believed to be practiced prior to that
…
The great Muslim physician, Rhazes (AD 865–925)
believed the experience of one wise doctor was worth
more than all of what was written in books:
 ‘So when you see these
symptoms, then proceed
with bloodletting. For I
once saved one group
[of patients] by it, while I
intentionally neglected
[to bleed] another group.
By doing that, I wished to
reach a conclusion.’
PRACTICING EBM – THE 4 A’S
Ask a
clinical
question
Acquire
the best
evidence
Appraise
the
evidence
Apply
the
evidence
Step 1
Step 2
Step 4
Step 3
1. ASKING CLINICAL QUESTION
 Background vs. Foreground Clinical Questions…
CLINICAL QUESTIONS (CONTINUED)
 Background questions:
 have been answered in the past now part
of the “fiber of medicine”.
 Knowledge about: nature disease, diagnosis,
treatment of illnesses…
 Sometimes inaccurate
CLINICAL QUESTIONS (CONTINUED)
 Foreground Questions:
 Found at the cutting edge of medicine.
 They are questions about the most recent
therapies, diagnostic tests, or current theories of
illness causation.
 Considered the heart of the practice of EBM
FOREGROUND QUESTION (PICO)…
 A Focused clinical question
CLINICAL CASE SCENARIO:
 C.R. 30 year old female G4P1+2 (gravid four para
one+2) gestational age 24 week was found to have
high blood glucose level (135 dl/L and fasting blood
glucose of 98 dl/L) C.R. was diagnosed as
gestational diabetes
 She is obese (weighing 96 kg with BMI of 35)
 The obstetrician was not sure if he can prescribe
metformin for this patient instead of insulin therapy.
The obstetrician called the clinical pharmacist and
asked for his advice.
 In pregnant women with gestational diabetes does the
use of metformin decrease maternal and fetal
morbidity compared with insulin therapy?
2. ACQUIRE THE BEST EVIDENCE…
 Search for Evidence
 Data bases
 Medical Literature
HIERARCHY OF MAJOR STUDY DESIGNS
Cohort
Case Control
Cross sectional study
Case report
RCT
Observational
Studies
Interventional
Studies
Level of evidence Systematic Review
of RCT
“A 21st century clinician
who cannot critically read a
study is as unprepared as
one who cannot take a
blood pressure or examine
the cardiovascular system.”
BMJ 2008:337:704-705
3. APPRAISE THE EVIDENCE…
 CRITICAL APPRAISAL….
 is the process of carefully and systematically
examining research to judge its trustworthiness,
and its value and relevance in a particular context.
 You need the skills to think broadly and detect the
flaws that might distract you from finding the true
answer.
RISK OF BIAS
The degree to which the result is skewed away from the
truth
 CRITICAL APPRAISAL….
 careful assessment of the study design (Question it
answers, population of interest, type of study…)
 Evaluation of the results (statistically vs clinically
significant)
 potential conflicts of interest are also essential.
 CRITICAL APPRAISAL….
 Has the research been conducted in such a way as
to minimize bias?
 If so, what does the study show?
 What do the results mean for the particular patient
or context in which a decision is being made?
CLINICAL CASE SCENARIO (CONTINUED):
 In pregnant women with gestational diabetes does
the use of metformin decrease maternal and fetal
morbidity compared with insulin therapy?
SEARCHING FOR THE EVIDENCE
 Step 1: Systems
 Step 2: Summaries
 Step 3: synopsis of synthesis
 Step 4: Synthesis
 Step 5: Clinical studies
STEP 1 SYSTEMS:
STEP 2 SUMMARIES:
 Evidence Based Updated Text Books:
(Pharmacotherapy; A Pathophysyological approach; 8th
ed)
 Metformin did not increase any complications associated with
GDM when compared with insulin even though it cross the
placenta.
 Further study is needed prior to recommending metformin in
GDM.
 Guidelines:
(American Association of Clinical Endocrinologists medical
guidelines for clinical practice for developing a diabetes
mellitus comprehensive care plan)*:
 Regular or rapid-acting insulin analogues are the preferred
treatment for postprandial hyperglycemia in pregnant women.
 Metformin has been shown to be an effective alternative and
without adverse effects in some women.
STEP 3 SYNOPSES OF SYNTHESIS:
STEP 4 SYNTHESIS:
 The Independent highly quality evidence: The
Cochrane Library:
TRIP
4. APPLY THE EVIDENCE…
 Application and assessment of the best evidence
CLINICAL CASE SCENARIO (CONTINUED):
 Finally,
 EBM is “Not a cookbook”“Not a cookbook”
Introduction to EBM

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Introduction to EBM

  • 1. INTRODUCTION TO EVIDENCE BASED MEDICINE Sama’ Abderahman, PharmD Msc
  • 2. INTRODUCTION: EDUCATION  University: Jordan University of Science and Technology  Specialty: PharmD  Graduated in June / 2008, (GPA: Excellent, second on my class)  University: Jordan University  Specialty: Master of Clinical Pharmacy  Thesis: " Evaluation of the Impact of Pharmaceutical Care on Patients Undergoing Anticoagulation Therapy: A Randomized Controlled Trial"  Graduated in August/ 2013, (GPA: Excellent) AWARDS:  The Scientific Research Fund grant  Awarded by Jordan Ministry of Higher Education to the postgraduate students with distinguished academic records.
  • 3. PROFESSIONAL EXPERTISE:  "Research & Teaching Assistant at Jordan University of Science & Technology (September/2008- November/2009)  Community Pharmacist at Iptihal Pharmacy/Irbid  Teaching Assistant at the University of Jordan (December/2011-June/ 2013)  Ambulatory care: Anticoagulant clinic (October/ 2012- June/ 2013)  Clinical pharmacist- medical research field (February 2014 – May 2014):  Tabuk Pharmaceutical Manufacturing Company- Business Development Department  Research assistant at the University of Jordan (November/ 2013-February/ 2015)
  • 4.
  • 5. WHAT IS EVIDENCE-BASED MEDICINE? is an approach to medical practice … EBM Best Practice Best Evidence Patients Values EBM  EBM
  • 6. EBM  New Paradigm??  The term “evidence-based” was introduced for the first time in 1987 by David M. Eddy…  Its philosophic origin dated back to mid 19 century  However, it is believed to be practiced prior to that …
  • 7. The great Muslim physician, Rhazes (AD 865–925) believed the experience of one wise doctor was worth more than all of what was written in books:  ‘So when you see these symptoms, then proceed with bloodletting. For I once saved one group [of patients] by it, while I intentionally neglected [to bleed] another group. By doing that, I wished to reach a conclusion.’
  • 8. PRACTICING EBM – THE 4 A’S Ask a clinical question Acquire the best evidence Appraise the evidence Apply the evidence Step 1 Step 2 Step 4 Step 3
  • 9. 1. ASKING CLINICAL QUESTION  Background vs. Foreground Clinical Questions…
  • 10. CLINICAL QUESTIONS (CONTINUED)  Background questions:  have been answered in the past now part of the “fiber of medicine”.  Knowledge about: nature disease, diagnosis, treatment of illnesses…  Sometimes inaccurate
  • 11. CLINICAL QUESTIONS (CONTINUED)  Foreground Questions:  Found at the cutting edge of medicine.  They are questions about the most recent therapies, diagnostic tests, or current theories of illness causation.  Considered the heart of the practice of EBM
  • 12.
  • 13. FOREGROUND QUESTION (PICO)…  A Focused clinical question
  • 14. CLINICAL CASE SCENARIO:  C.R. 30 year old female G4P1+2 (gravid four para one+2) gestational age 24 week was found to have high blood glucose level (135 dl/L and fasting blood glucose of 98 dl/L) C.R. was diagnosed as gestational diabetes  She is obese (weighing 96 kg with BMI of 35)  The obstetrician was not sure if he can prescribe metformin for this patient instead of insulin therapy. The obstetrician called the clinical pharmacist and asked for his advice.
  • 15.  In pregnant women with gestational diabetes does the use of metformin decrease maternal and fetal morbidity compared with insulin therapy?
  • 16. 2. ACQUIRE THE BEST EVIDENCE…  Search for Evidence  Data bases  Medical Literature
  • 17. HIERARCHY OF MAJOR STUDY DESIGNS Cohort Case Control Cross sectional study Case report RCT Observational Studies Interventional Studies Level of evidence Systematic Review of RCT
  • 18.
  • 19. “A 21st century clinician who cannot critically read a study is as unprepared as one who cannot take a blood pressure or examine the cardiovascular system.” BMJ 2008:337:704-705
  • 20. 3. APPRAISE THE EVIDENCE…  CRITICAL APPRAISAL….  is the process of carefully and systematically examining research to judge its trustworthiness, and its value and relevance in a particular context.  You need the skills to think broadly and detect the flaws that might distract you from finding the true answer.
  • 21. RISK OF BIAS The degree to which the result is skewed away from the truth
  • 22.  CRITICAL APPRAISAL….  careful assessment of the study design (Question it answers, population of interest, type of study…)  Evaluation of the results (statistically vs clinically significant)  potential conflicts of interest are also essential.
  • 23.  CRITICAL APPRAISAL….  Has the research been conducted in such a way as to minimize bias?  If so, what does the study show?  What do the results mean for the particular patient or context in which a decision is being made?
  • 24.
  • 25.
  • 26. CLINICAL CASE SCENARIO (CONTINUED):  In pregnant women with gestational diabetes does the use of metformin decrease maternal and fetal morbidity compared with insulin therapy?
  • 27. SEARCHING FOR THE EVIDENCE  Step 1: Systems  Step 2: Summaries  Step 3: synopsis of synthesis  Step 4: Synthesis  Step 5: Clinical studies
  • 29.
  • 30.
  • 31. STEP 2 SUMMARIES:  Evidence Based Updated Text Books: (Pharmacotherapy; A Pathophysyological approach; 8th ed)  Metformin did not increase any complications associated with GDM when compared with insulin even though it cross the placenta.  Further study is needed prior to recommending metformin in GDM.  Guidelines: (American Association of Clinical Endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus comprehensive care plan)*:  Regular or rapid-acting insulin analogues are the preferred treatment for postprandial hyperglycemia in pregnant women.  Metformin has been shown to be an effective alternative and without adverse effects in some women.
  • 32. STEP 3 SYNOPSES OF SYNTHESIS:
  • 33.
  • 34.
  • 35.
  • 36. STEP 4 SYNTHESIS:  The Independent highly quality evidence: The Cochrane Library:
  • 37.
  • 38. TRIP
  • 39.
  • 40. 4. APPLY THE EVIDENCE…  Application and assessment of the best evidence
  • 41. CLINICAL CASE SCENARIO (CONTINUED):
  • 42.
  • 43.  Finally,  EBM is “Not a cookbook”“Not a cookbook”

Editor's Notes

  1. It is an integration of Best Practice ( taking into account the clinical situation and the clinical experience), besides of the best available evidence and it takes in consideration patients believes or values.
  2. BMJ VOLUME 312 13 JANuARY 1996 JAMA Nov 4 1992 According to this paradigm clinicians have a number of options for sorting out clinical problems they face. They can reflect on their own clinical experience, reflect on the underlying biology, go to a textbook, or ask a local expert. Read¬ ing the introduction and discussion sec¬ tions of a paper could be considered an appropriate way of gaining the relevant information from a current journal. This paradigm puts a high value on traditional scientific authority and ad¬ herence to standard approaches, and an¬ swers are frequently sought from direct contact with local experts or reference to the writings ofinternational experts.1
  3. The experienced clinician will have very few background questions that need to be researched. On the other hand, the novice has somany unanswered questions thatmost are of a background nature.
  4. meta-analysis is a mathematical procedure for combining the quantitative study
  5. Selection bias: Biased allocation to comparison groups Performance bias: Unequal provision of care apart from treatment under evaluation Detection bias: Biased assessment of outcome Attrition bias: Biased occurrence and handling of deviations from protocol and loss to follow up
  6. Conducting a study in a way that tends to lead to a particular conclusion, regardless of the truth, is known as bias
  7. (5) American Association of Clinical Endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract 2011 Mar-Apr;17(Suppl 2):1-53.
  8. EBM practice is a continuous procedure… after application of evidence>> reevaluation>>> question>>> search>>>>…..