EVIDENCE-BASED MEDICINE (EBM)

Laboratorium Farmakoterapi & Farmasi klinik

Fakultas Farmasi UGM
 OUTLINE PRESENTATION
 Introduction to Evidence-Based
Medicine (EBM)
 Why is EBM ?
 What is EBM ?
 5 Steps of EBM
 Conclusion

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 INTRODUCTION TO EBM
Obsolete vs Current Techology
Technology Past Present
Fever in Children Cold water Warm water
Hipertension SBP >160 SBP >140
Foetal heart rate Laenec stethoscope Doopler

The purpose of a warm compress is

to facilitate blood circulation,
reduce pain, provide warmth,
comfort, and calm to the client,
expedite exudate expenditure,
stimulate intestinal peristalsis
Journal Of Nursing Practice No.2. April 2020. Page.226-232

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 INTRODUCTION TO EBM
JNC-7 vs JNC-8
BP Goal JNC-7 (2003) JNC-8 (2013)
Age < 60 <140/90 < 140/90
Age 60-79 <140/90 < 150/90
Age 80 + <140/90 < 150/90
DM <130/90 <140/90
CKD <130/90 <140/90

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 INTRODUCTION TO EBM
Cox2 inhibitor, Rofecoxib: its history
YEAR JOURNAL NO. CONCLUSION
SUBJECT
2000 NEJM 8076 Risk of GI bleeding is much
lower than NSAID
2001 Circulation >28.000 Risk of CVD is similar to NSAID
2002 Lancet >200.00 Risk of CHD at a dose > 25 mg
2004 Lancet >39.000 Risk of CHF 2.5 times greater
than NSAID

Was withdrawn
Sept, 2004 VIOXX (Rofecoxib) from the market

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 WHY IS EVIDENCE-BASED MEDICINE ?
 Our daily need for valid information about
dx, rx, prognosis, prevention… etc
 The inadequacy of traditional source for
information because the are out of date
(textbook), frequently wrong (expert)..etc
 Disparity between clinical skill which
increase with experience and up to date
knowledge which decline overtime
 A 2010 study indicated that there were over
75 clinical trials and 11 systematic review
publishes everyday in medicine

Straus SE, Richardson WS, Glasziou P, Rosenberg W, and R. Brian Haynes RB, Evidence-Based
Medicine: How to Practice and Teach EBM, 5th Edition, Elseiver, 2019
Bastian H, Glasziou P, Chalmers I (2010) Seventy-Five Trials and Eleven Systematic Reviews a Day: How
Will We Ever Keep Up? PLoS Med 7(9): e1000326. https://doi.org/10.1371/journal.pmed.1000326
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 WHY IS EVIDENCE-BASED MEDICINE ?
Why do we need to use the evidence more efficiently today?

Clinical evidence increasing so rapidly

we need better skills to keep up-to-
Because there is an epidemic of evidence we need to date more efficiently than previous
keep up with and we cannot do this without new skills generations of clinicians

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WHY IS EVIDENCE-BASED MEDICINE ?
From Experience to Evidence-based Medicine
OLD PARADIGM NEW PARADIGM

Why did dr prescribe Why antibiotics are not

antibiotics for common cold presribed for your patient ?

Effecacious because patient Recent evidence shows that

did not come back soon to no antibiotic is required for
dr after treatment common cold

Experience-based medicine Evidence-based medicine

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 WHAT IS EVIDENCE-BASED MEDICINE ?
Evidence-based Medicine is …

“… the conscientious, explicit,

and judicious use of current
best evidence in making
decisions about the care of
individual patients.”
Sackett DL, Rosenberg W, Mc Gray JA, haynes RB, Richardson WS. Evidence-
https://www.thesgem.com/2020/07/sgem-xtra-ebm-and-the-changingman/
based medicine: what it is and what it isn’t. BMJ, 1996; 312: 71-2.

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 WHAT IS EVIDENCE-BASED MEDICINE ?
Evidence-based medicine (EBM)
required…
Clinical
expertise
“The integration of the best
research evidence with our
clinical expertise and our EBM
patient unique values and Best Patient
research values &
circumstances.” evidence Expectations
Straus SE, Richardson WS, Glasziou P, Rosenberg W, and R. Brian Haynes RB, Evidence-Based
Medicine: How to Practice and Teach EBM, 5th Edition, Elseiver, 2019

Evidence-based medicine triad

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 RELEVANCE: TYPE OF EVIDENCE
DOE: Disease-oriented
evidence
 Intermediate, histopathologic,
physiologic, or surrogate results
 Examples: blood sugar, blood pressure,
flow rate, coronary plaque thickness
 May or may not reflect improvement in
patient outcomes
POE: Patient-oriented
evidence
 Outcomes that matter to patients and
help them live longer or better lives
 Examples: including reduced morbidity,
reduced mortality, symptom
improvement, improved quality of life,
or lower cost

 Pathophysiology  Mortality
 Pharmacology  Morbidity
 Etiology  Quality of life
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 RELEVANCE: TYPE OF EVIDENCE
low-quality = subyeknya sedikit, variasi besar, confidence intervalnya agak lebar

DOE Intermediate POE

Disease-oriented Patient-oriented
evidence evidence
Lipid lowering Lower serum Reduced cardiac Improved all-
Drug cholesterol events cause mortality
Consuming a Lower serum Improved self Improved life
Low-fat diet cholesterol esteem expectancy
Hormon Increased bone Reduced risk of Improved life
Replacement density fractures expectancy &
Therapy qualty
grade of recommendation
A: Grade C = 4. case series, low-quality cohort or case-control studies
1a = systematic review (homogenous) randomized cotrolled trials Grade D = 5. expert opinions based on non systematic reviews of results
1b = individual randomized controlled trials (with narrow confidence intervals) or mechanistic studies
B:
2a = cohort studies 3a = systematic review of (homogenous) case control studies
2b = individual cohort studies/low-quality randomized controlled trials 3b = individual case-control studies
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 5 STEPS OF EVIDENCE-BASED MEDICINE
The 5 A’s of EBM (1) ASK - THE QUESTION
= Develop your answearable clinical question
ASK
ACQUIRE (2) ACQUIRE - THE EVIDENCE
=Efficiently find the best evidence
APPRAISE
(3) APPRAISE – THE EVIDENCE
APPLY = Critically evaluate the evidence for its validity and usefuness
ASSESS
(4) APPLY - THE PATIENT
= Use the results of the appraisal in your clinical practice

(5) ASSESS - THE PROBLEM

= Evaluate your performance
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 STEPS OF EVIDENCE-BASED MEDICINE
1. Converting the need for information
into answerable Question

FOREGROUND QUESTION Foreground Questions

In a patient with stroke, does aspirin P = Patient Population
or Problem
reduces the risk of recurrent stroke
compared to no treatment ? I = Intervention

C = Comparison
pasien stroke bisa gak kekambuhannya dikurangin dengan aspirin?
P = patient dengan stroke
I = pemberian aspirin

O = Outcome
C = no treatment
O = recurrent stroke

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 STEPS OF EVIDENCE-BASED MEDICINE (1)
Clinical questions

Background question Foreground questions

Any medical/clinical PICO
question

What, why, when, where, Patient, Intervention,

How
 What is the etiology of DM ?
 What are risk factors for stroke?
 What makes blood pressure increase ?
 What is the best treatment for UTI ?
Comparison, Outcome
In patients with an acute MI, are
antiarrhytmic drugs more effective than
standard therapy in preventing sudden
cardiac death ?
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 STEPS OF EVIDENCE-BASED MEDICINE (1)

THERAPY
“In patients with an acute MI, are antiarrhytmic
drugs more effective than standard therapy in
preventing sudden cardiac death ?”

P = Acute myocardial infarction

I = Antiarrhytmic drugs

C = Standar therapy

O = Sudden cardiac death

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 STEPS OF EVIDENCE-BASED MEDICINE (1)

DIAGNOSIS HARM
P In 7 year old child with sore
throat P In patient with
osteoarthritis

I Does clinical findings

I Does the use of meloxicam

C Compare to culture of
pharyngeal swab C Compare to piroxicam

O More sensitive in detecting

Streptococcus beta
O Result in less gastric
bleeding ?
hemoliticus Group A

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 STEPS OF EVIDENCE-BASED MEDICINE
2. Collect evidence to answer Question

Where to search for “evidence”

Textbooks ? Electronic evidence databases

Pubmed
MEDLINE
Cohchrane
Diagnosis EBMR (EB-Medicine Review)
Terapi Evidenve-Based Medicine
Prognosis Evidenve-Based Nursing
Survival Cancerlit, Aidsline
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 STEPS OF EVIDENCE-BASED MEDICINE (2)
Additional Elements to add to PICO
T = Type of Question PICO(+)TT
T = Type of Study
Question Type This Evidence Shows Study Type
Diagnostic Test How to select and interpret diagnostic tests, in order to Prospective studies, blind
confirm or exclude a diagonis, based on considering their comparison to Gold Standar
specificity, sensitivity, likehood ratios, expense, safety, etc
Prognosis How to estimate the patient’s likely clinical course over Cohort Study is best, Case Control
time and anticipate likely complications of disease and Case Series also fit
Therapy How to estimate the patient’s likely clinical course over RCTs are really the only way to
time and anticipate likely complications of disease answer this question
Etiology/Harm How to identify causes for the disease RCTs are the best. Cohort Study, Case
Control and Case Series also fit
Prevention How to reduce the chance of disease by identifying and RCTs are the best. Cohort Study, Case
modifying risk factors and how to diagnose early by Control and Case Series also fit
screening
Cost-Analysis How to compare the cost and consequences of different Economic analysis
treatments
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 STEPS OF EVIDENCE-BASED MEDICINE (2)
The clinical question ….
In a pregnant patient with low back pain, what intervention will bring relief
without harm to the mother and fetus ?
cohort = sesuatu yang sudah terjadi --> retrospektif

PICO-TT Search Strategy

P Patient/ Problem Pregnant, suffering from low back pain case control cari org
yang udah kena
kanker paru kalo

I Intervention Physical therapy cohort yang ngerokok

C Comparison (if any) None

O Outcome Relief from back pain

T Type of Question Therapy

T Type of Study Randomized Controlled Trials

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STEPS OF EVIDENCE-BASED MEDICINE (2)

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 STEPS OF EVIDENCE-BASED MEDICINE (2)
Hierarchy of Evidence
Access evidence at the level that
will give you the best evidence
Track Down

Filtered & Critically Appraised

Expert Opinion and Not Filtered

Background info.
Most clinically relevant (at the top) Least clinically relevant (at the bottom)
STEPS OF EVIDENCE-BASED MEDICINE (2)

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 STEPS OF EVIDENCE-BASED MEDICINE
3. Critically appraise that evidence for it’s
validity, impact and applicability

USERS’GUIDE”

Diagnosis Prognosis Therapy Harm Cost analysis

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 STEPS OF EVIDENCE-BASED MEDICINE (3)
Three Basic Questions For Every Study
1. Are the results of the study valid ?
2. What are the result ?
3. Will the results help in caring for my
patient?
Appraisal principles (primary and secondary research)
 What is the PICO of the study? Does it match my
question?
 How well was the study done? Is it biased?
 What do the results mean? Are they real and
relevant?
Many resources are available to help
with the critical appraisal process.
Duke University Critical Appraisal Worksheets
Critical Appraisal Skills Programme (CASP) Checklists
Your brief answers would be entered in the right side
column
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STEPS OF EVIDENCE-BASED MEDICINE (3)

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.
0182114
Consider the first question, Were patients randomized?
Where can you locate this information in the article?
What information from the article is relevant to this
question?
Here is one possible answer
Page 2. The participants were randomly assigned to
either the intervention/therapy or the control group
(ratio 1:1) at baseline by a computer-generated random
sequence, using random permuted block sizes (two, four
or six).
https://unmc.libwizard.com/f/EBM-Appraisal
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STEPS OF EVIDENCE-BASED MEDICINE (3)

critical appraisal = evaluasi secara kritis terhadap paper tersebut

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 STEPS OF EVIDENCE-BASED MEDICINE
4. Integrating the appraisal with our
clinical axpertise & our patient unique
biology, values dan cicumstances
Question to ask:  Even if you have found the evidence
 Is the intervention feasible ? to be valid, significant and
 What alternatives are generalizable from the study
available? population to your patient, you must
 Is my patient so different still decide how — or whether — to
then those in the study that apply the findings to your patient's
the results cannot apply ? care.
 Will the potential benefits  The evidence alone is never enough,
outweigh the potential harms and the last step of the EBM process
of treatment ? arguably requires the most skill.
 What does my patient think?  It is here that you synthesize the
 What are his cultural beliefs? best scientific knowledge with your
 Individual/group decision clinical expertise and the patient's
making/choice unique values and circumstances to
 Explaining risks - benefits to reach a clinical decision.
Patient’s value and expectation
patients
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STEPS OF EVIDENCE-BASED MEDICINE
5. Evaluate our effectiveness & efficiency in
steps 1-4 and seeking ways to improve them

STOP TREATMENT SWITCH THERAPY REFER

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 LIMITATION OF EVIDENCE-BASED MEDICINE
 Time consuming
 Requires access to medical literature
 Requires some knowledge of
statistics hierarchy
 Publication bias 1. Clincial practice guidelines [SECONDARY, PRE-APPRAISE, OR
FILTERED STUDIES]
 Confilcts of Interest yang paling tinggi kalo dia udh masuk ke dalam panduan (clinical
practice guidelines) --> yang menyusun dokter si panduan-panduan itu
2. meta-analysis systematic review
[SECONDARY]
3. randomized controlled trial (randomisasi) --> setiap sbyek
mendapatkan kesempatan yang sama untuk perlakuan tertentu -->
biar gak biased. sifatnya prospektif [PRIMARY STUDIES]
4. cohort studies (observational) sifatnya prospektif makanya di atas
case control. mengurangi lebih banyak faktor risiko bisa lebih banyak
mengontrol
[PRIMARY STUDIES]
5. case control studies (observational) --> lebih banyak biasnya
[PRIMARY STUDIES]
6. case report or case series [NO DESIGN]
7. animal and laboratory studies [not involved with humans]
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Finding Evidence-based Answers
• Trip Database (http://www.tripdatabase.com/)
• Database of Abstracts of Reviews of Effectiveness
(http://www.crd.york.ac.uk/crdweb/)
• DynaMed (http://www.dynamicmedical.com/)
– *Subscription required.
• Essential Evidence Plus (http://www.essentialevidenceplus.com/)
– *Subscription required.
• Cochrane Library (http://www.cochrane.org/)
– *Subscription for full access, abstracts free.
• FPIN (http://www.fpin.org/)
– *Subscription required.
• Clinical Evidence (www.clinicalevidence.com/)
– *Subscription required.
 For further reading…
• Woolever DR. The art and science of clinical decision making. Fam Pract Manag.
2008 May;15(5):31-6. PMID: 18546805
(http://www.aafp.org/fpm/20080500/31thea.html)
• Krumholz H, Lee T. Redefining Quality -- Implications of Recent Clinical Trials. N
Engl J Med 2008 358: 2537-2539
(http://content.nejm.org/cgi/content/full/358/24/2537)
• Ebell MH. How to find answers to clinical questions. Am Fam Physician. 2009 Feb
15;79(4):293-6. PubMed PMID: 19235495.
(http://www.aafp.org/afp/2009/0215/p293.html)
 SUMMARY

See a patient Ask a question Seek the best evidence

Monitor the cange Apply the evidence Appraise that evidence

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 CONCLUSION
In short…
 EBM is the conscientious,
explicit, and judicious use of
current best evidence in Patient-oriented evidence
making decisions about the
preferable to
care of individual patients.
Stage of disease
preferable to
Surrogate markers
 Evidence
Systematic observation =
high-quality evidence
SEMOGA BERMANFAAT

Open for Discussion