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IDC 213

Introduction to Evidence-Based Medicine


Trans 01 Exam 1
Dr. Jacinto Blas Mantaring, Dr. Emmanuel Estrella
08/05/2019

OUTLINE
I. What is EBM? III. How to practice EBM C.EBM Cycle
A. Definition IV. Example • This guide is a modified version of Sackett’s EBM cycle: Dr.
B. Framework Mantaring added directness and individualization, which are not
C. EBM Cycle part of Sackett’s model
II. Why do we need EBM? • It’s not enough to know what’s in the book. You still have to know
T/N: Italicized sections are found in the 2021 Trans/ Dr. Mantaring’s where to look for information that’s not found in the book
lecture but not discussed. Generate
Conduct
the
the search
I. WHAT IS EBM question
A. DEFINITION
• “The conscientious, explicit, and judicious use of current best
evidence in making decisions about the care of individual patients” Individualize Appraise
(Sackett, 1996) results directness
o Flawed because it assumes that we only use evidence in clinical
decision making, but this is not true because we don’t have
evidence all the time
o If you follow this definition, you can’t make medical decisions Appraise Appraise
unless there is evidence applicability validity
o Assumes that all patients are treated ‘de kahon’ and physicians
are the one completely in charge of treating their patients Appraise
• “Systematic approach to clinical problem solving which allows the results
integration of the best available research evidence with clinical Figure 2. EBM Cycle
expertise and patient values” (Sackett, 2000)
o Addresses limitations of the first definition by integrating clinical II. WHY DO WE NEED EBM?
expertise and patient values • 3 research studies
o Still not enough since there are other factors which are o Internal Medicine Residents
necessary to make clinical decisions that are not covered by this  2 questions for every 3 outpatients; 5 for every inpatient
definition.  29% pursued (the question/s)
• “A systematic approach to acquisition, appraisal and application of  Results: textbook (31%); journals (21%); attendings (17%)
research evidence to guide decision in healthcare” (Dans,2008)
 Barriers among medical practitioners: lack of time (60%),
o Best description of EBM
forgot (29%)
o Emphasis on acquisition, appraisal and application in the
approach to making a clinical decision Table 1. Readless Weeks
o The factors not considered in the previous definitions are Stage of career % No reading in last
considered in the application; this is where you think “can I apply
Med students 0%
what I read to my patient considering his/her socioeconomic
Residents Up to 15%
status, pathophysiology of the disease, etc.
Consultants, 1975 grad Up to 30%
o Tells us the skills needed to practice EBM (see next section)
Consultant, pre 1975 Up to 40%
B. THE EBM FRAMEWORK
• From Fig 3- decay of performance due to lack of reading or
• Stepwise
updating knowledge:
• Suggests skills necessary for EBM (generate the question, conduct
• Why we need EBM:
the search, appraise directness, etc.)
o We need the information
• In the end you have to individualize results apply it for the specific
o We don’t have time to find it
patient you have in mind which led you to read the article
o Traditional CME (continuing medical education, such as
master’s and doctoral degrees) does not work. It is self-directed
ACQUIRE APPRAISE APPLY learning that works!
• Generate the • Appraise • Appraise
question directness applicability C. APPRAISING THE EVIDENCE
• Conduct the • Appraise • Individualize • There are different rules of appraisal on different types of articles:
search validity results o Therapy
• Appraise o Diagnosis
results
o Prognosis
Figure 1. Framework of EBM (3 A’s of EBM) o Causation
o Meta-analysis
• Two methods of getting answers to questions o Clinical Practice Guidelines
o Just in case: you read an article before your encounter with your o Economic Evaluation
patient and remember the study just in case it might be helpful o Decision Tree Analysis
in the future. This does not work! A few months later that
information can be obsolete.
o Just in time: while making rounds, you generate questions about
a patient, and you do a computer literature search afterwards
to find the answers. This is the way to go!

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IDC 213 Introduction to Evidence-Based Medicine

Table 2. Differences in the approach to appraisal according to Sackett (left)


and Dans’ Painless EBM (right).
Sackett’s Three Pillars Painless Medicine
Are the results valid? Directness
Validity
What are the results? Results
How can I apply the results? Applicability
Individualization

• Two additional components were added by Dans et al. to Sackett’s


three pillars: Directness & Individualization
o These were added because most of the literature used in the
Philippines are from developed countries.
• Directness
o Having an idea of what you want (e.g. shopping: you know what
you are looking for, such as shoes)
o A form of applicability as well
• If the study is not valid, don’t bother looking at the results anymore.
If it is not valid, then the study has some biases.
• If after appraining the results it was found that the results were
useless, then no need to appraise for applicability and
individualization.
• Applicability • Elements:
o Important especially when practicing in a developing country. o P – preterm neonates < 1500 g
You have to tailor your treatment to suit your patient. o I – VCO
o If your patient is rich, you can do de kahon since the patient can o C – placebo
afford it (e.g. like the shopping for shoes example: fitting the o O – lower risk of sepsis and all cause mortality
shoe, seeing if the color suits you, the cost, etc.) ▪ As measured by number of deaths and sepsis
rates
III. HOW TO PRACTICE EBM? QUESTION: Among preterm neonates weighing <1500g born
Skills to Develop: in the UP PGH Medical Center, will those whose diets are
• Research question formulation ACQUIRE supplemented with virgin coconut oil, compared to an
• Searching the literature APPRAISE equivalent amount of placebo, have a lower risk of mortality
• Appraisal of evidence and sepsis?
• Application of evidence APPLY • For the purpose of appraising evidence, this would suffice,
but if you want to do your own study sometimes you need
A. QUESTION FORMULATION to be more specific, sometimes you need to specify the
• Elements of a well formulated research question: dose and duration.
o Patient, population or person
o Exposure/ Comparison (if applicable) Table 4. Tips for building questions.
▪ Treatment vs no treatment P E C O
o Outcome
Therapy Placebo Measures of
▪ Results
(you want to Drug or or active efficacy or
• Clinical question is individualized. Research question more prevent
Patients w/
pharmaceut control or effectiveness
encompassing. disease
adverse i-cal agent standard (RRR, ARR,
• Example: outcome) of care NNT)
o While making the rounds in the nursery with students, Preventive No
it is explained that one of the most important causes Patients interventi Measures of
intervention
of morbidity among newborns is sepsis. One of the Prevention w/o on or efficacy or
including
disease usual effectiveness
students asks of supplementing the diet of the babies educational
care
with virgin coconut oil can help. How would you
formulate a question to allow you to search this? Patients w/ Measures of
Diagnostic Gold or
findings accuracy
Diagnosis tool of reference
suggestive (Sn, Sp,
interest standard
of disease PPV, NPV)

Survival from
Patients w/ Prognostic No risk disease of
Prognosis
disease factor factor interest or
hazards ratio

Patients No Risks of
Causation Causative
w/o causative disease of
or Harm or risk factor
disease factor interest (RFI)

• Example on prognosis: Angelina Jolie’s elective


Table 3. Tips for formulating your research question. mastectomy, where BRCA gene is the risk factor:
o PROGNOSIS QUESTION: “Among females, would

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IDC 213 Introduction to Evidence-Based Medicine

the presence of a BRCA gene compared to no BRCA search


gene increase your risk for breast cancer?” o Sensitivity–the likelihood of retrieving relevant
o TREATMENT QUESTION: “Among females that citations
have the BRCA gene, will elective mastectomy o Tips for increasing sensitivity
compared to no elective mastectomy • Broadening your question
• Finding more search terms from hits
B. COMPUTER LITERATURE SEARCH • Using wildcards
Steps in conducting a Literature Search: • Using a combination of MeSH search and
• Identify the concepts in the question phrased. free text
– (Population, Exposure, Outcome) • Using more general MeSH headings
– Identify a methodological filter (M) • Do not limit
• Rank the concepts according to importance. o Specificity–the likelihood of excluding irrelevant
citations
• Expand the concepts and intersect them sequentially as
o Tips for increasing specificity
ranked.
• Narrowing the question
• Examine the yield for hits and misses and modify the search, • Using more specific terms in free text
if necessary. • Using a MeSH search rather than free text
• Using more specific MeSH headings
Sample Scenario • Adding in terms (using AND) to represent
While listening to the radio on your way to school, the other aspects of the question
commentator states that ever since she had given birth she • Limiting yield
has experienced memory lapses. You then realize that this is ➢ Language
not the first time you have heard people make this comment, ➢ Human or animal subjects
although your sister relates this to the anesthesia. Intrigued, ➢ Publication types
you decide to search literature to confirm claims of this ➢ Country
association. • Know “method filters”
• Therapy/Prevention Meta-analysis
Question: Among women, will those who have given birth have
a higher risk of memory lapse compared to those who haven’t Table 5. Method filters
given birth? RCT
Diagnosis Sensitivity and Specificity
1. Identifying the concepts Likelihood Ratio
• P=Women of child bearing age Prognosis Survival
• E=Parturition Cohort study
• C=No parturition • *Or use “clinical queries”
• O=Memory lapses
• M=Cohort / Case control studies C. APPRAISING THE EVIDENCE
2. Rank the concepts
O- Memory lapses
E- Parturition
C- No parturition
P- Women (of childbearing age)
M- Cohort studies

(another example)
P=Normal individuals O=Avian flu
E=Oseltamivir E=Oseltamivir
O=Avian flu → M=Meta-analysis
M=Meta-analysis M=Randomized trial
M=Randomized trial P=Normal individuals
Figure 3. Factors to consider when practicing EBM.
3. Expand the concepts and intersect sequentially as
• Research evidence along with patient preferences, and keep in
needed *Note that concepts may have variations mind that there could be a clinical circumstance that has led to the
• Make use of MeSH condition that you are trying to treat.
o Medical Subject Headings • Integration of these three is what makes up clinical expertise.
o 17,000 concepts • Disease → Illness → Predicament
o Arranged in a hierarchy (MeSH tree) o Disease is the organic condition/pathology. A constellation of
o Concepts become more specific as there are signs and symptoms.
more branches o Illness is when social, emotional, and other factors that come
into play in the disease
4. Examine yield for mishits and misses and modify search o Predicament is the situation that may have perpetuated the
if necessary disease of contributated to the development of the disease (eg.
• Know the difference between a sensitive and specific Poverty)
• Skills in applying evidence:

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IDC 213 Introduction to Evidence-Based Medicine

o Clinical skills in Hx and PE C. THE CITATION


o Skills in eliciting personal and social history
o Clinical empathy

IV. EXAMPLE
• 54-year-old
• Male
• Asymptomatic
• Unremarkable PE
• TC = 210; LDL = 170; HDL = 42

WOULD YOU PRESCRIBE STATIN OR NOT?

A. THE QUESTION
• Among middle-aged males with average cholesterol levels, would
treatment with statins versus no treatment lower the risk of Figure 6. Landmark article. From Sir’s powerpoint. You can find it here:
cardiovascular events? https://www.ncbi.nlm.nih.gov/pubmed/9613910
• P = Middle-aged asymptomatic males
• E = Statins D. THE APPRAISAL
• C = No treatment Table 6. Appraising the article
• O = Cardiovascular events (MI or Stroke) USER’S GUIDES
Is the article’s PECO similar to our PECO? ✓
B. THE SEARCH Randomized ✓
Randomized concealed ✓
Baseline characteristics similar ✓
Patients masked ✓
Caregivers masked ✓
Outcome assessors masked ✓
Intention-to-treat ✓
Follow-up complete ✓

• If the article is yes to all of these, there is minimal chance of bias

E. THE RESULTS
• In the CLINICIAN’S Point-of-view
Figure 4. The search. Please note that this is not exactly from Sir’s • 6605 healthy patients with average cholesterol:
powerpoint as his screenshot started at #3.
Table 7. The results
Placebo 11 acute events (either MI or stroke) per 1000
(p.a.)
Lovastatin 7 acute events (either MI or stroke) per 1000
(p.a.)

• RR = 0.64; RRR = 0.36; ARR = 0.004; NNT = 254


• There is a 36% reduction in the risk of an acute event for 1000
patient years
• NNT – for every for every 254 patients you treat, you can correct
an MI or a stroke
• The question is, will you now give statins to the 54-year-old male?

Table 8. Comparing views


Clinician Health Economist
No question, we will save It will cost up $600,000 to buy
hundreds of lives the drug for 1000 patients
Will eat up funds for TB,
pneumonia, diarrhea, etc.
We could actually lose lives

Socio-Economic Predicaments
Table 9. Socio-economic predicaments
Clinical Medicine Health Economics
Objective Maximize Maximize efficacy
effectiveness
Philosophy Cumulative benefits Opportunity costs –
– if I give the drug that when you spend the
can reduce stroke by money for an
Figure 5. The results. Sample only, since search was not exactly the same. 1% and I try another intervention, you lose
drug that will the opportunity for
decrease stroke by another intervention

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IDC 213 Introduction to Evidence-Based Medicine

3%, I will reduce


stroke by 4%.
Assumption Infinite resources Finite resources

Figure 7. How spending for food and health care appears in infinite
resources (black) and finite resources (red).

• Infinite resources – the more you spend for healthcare, you still
have more to spend for food
• Finite reseources – the more you spend for healthcare, you have
less money to spend for food

EBM Practitioner’s Point of View


• Interviews the patient (very complete personal and social history)
and finds out:
o Farmer
o 5 kids
o Earns $100 a month
• Informs patient
 NNT = 250
 Drug costs $600/year and needs to be taken for years
o Allows patient to decide for himself to take the statin or perhaps
find another intervention.

Poverty should not be an obstacle to EBM,


It’s the reason for it!

END OF TRANS

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