Evidence Based Medicine:

The Introduction

Didik Setiawan, PhD., Apt

- Faculty of Pharmacy,
- Center for Health Economic Studies,
Universitas Muhammadiyah Purwokerto, Purwokerto, Indonesia
Why do we need Evidence Based Medicine
Daily Practice

• Familiar with “I’m doing this all the time and patients are ok with
that” sentence?
• What is “OK” means?
• Cured ✅
• Move to another dr or pharmacists ❌
• Move to another hospital ❌
• Dead ❌
Disparity between skills and clinical
judgement and total performance

Clinical Skills and

judgement
Performance

Total performance

Up-to-date knowledge

Time
Inadequacy of traditional sources for this
information

textbooks • out of date

expert • frequently wrong

didactic CPE • ineffective

• too overwhelming in their volume and too

medical journal variable in their validity for practical use
4S
principle

Compare the 4S approach

with your current practice.

Which evidence that you

usually use?
But is that enough to practice EBM?

• What is EBM?
• "the conscientious (hati-hati), explicit
(tegas), and judicious (bijaksana) use of
current best evidence in making clinical
decisions about the care of individual
patients.“
• EBM Component
Knowledge Before EBM
 Study Design in Pharmacoepidemiology

no intervention vs intervention

Observational Experimental
cause - effect relationship

Quasi
Descriptive Analytic RCT
Experimental

randomization

Cross Cross
Ecological Case report Case series Case control Cohort
sectional sectional

Time on data collection

How to Practice EBM?
How to Practice EBM

Converting the need of information into an answerable clinical

question

Tracking down the best evidence (searching and cleaning)

Critically appraise the evidence for its validity, impact, and

applicability
Integrating the critical appraisal with clinical expertise and patients
biology, value and circumstances
evaluate the effectiveness in executing steps 1-4 and seeking ways
to improve them for next time
Step 1: Asking Answerable Clinical Questions
Central issues in clinical work (source of
clinical questions)

Clinical findings • How to properly gather and interpret findings from the history and physical examination

Etiology • How to identify causes of risk factors for disease (including iatrogenic harms)

Clinical
manifestation of
• knowing how often and when a disease causes its clinical manifestations and how to use
disease this knowledge in classifying our patients' illness

Differential • When considering the possible causes of our patient's clinical problems, how to select
diagnosis those that are likely, serious, and responsive to treatment

• how to select and interpret diagnostic tests, in order to confirm or exclude a diagnosis,
Diagnostic tests
based on considering their precission, accuracy, acceptability, safety, expenses etc
Central issues in cllinical work (source of
clinical questions)

• How to estimate our patient's likely clinical course over time and anticipate likely
Prognosis complications of the disorder

• How to select treatments to offer our patients that do more good than harm abd
Therapy that are worth the efforts and costs of using them

• How to reduce the chance of disease by identifying and modifying risk factors and
Prevention how to diagnose disease early by screening

Experience • How to empathize with our patients situation, appreciate the meaning the find in
and meaning the experience, and understand how this meaning influences their healing

• How to keep up-to-date, improve our clinical and other skills, and run better, more
Improvement efficient, clinical care system
Background and Foreground Questions

Background ask for general knowledge about a condition or thing

two essential components: (1) A root questions (who, what where, when, how, why) and a
verb; (2) A disorder, test, treatment or other aspect of health-care

Ex: How NSAIDs increase the risk of GI disturbances?

Foreground Ask for specific knowledge to inform decision or actions

Patients/Problems, intervention or Exposure, Comparison (if relevant), Clinical Outcomes

(if relevant)

ex: in osteoarthritis patients, is rofecoxib better than naproxen in terms of

Gastrointestinal disturbances?
Question Therapy

• Seorang anak berumur 10 tahun MRS di diagnosis demam tifoid.

• Orang tua pasien yang seorang dokter menanyakan antibiotic mana
yang harus di pilih diantara Kloramfenikol dan Seftriakson?
Question Therapy

• Population/patient = patients with typhoid

• Intervention/indicator = Ceftriaxone
• Comparator/control = chloramphenicol
• Outcome = LoS, cure rate

Question: ‘In patients with typhoid fever, do Ceftriaxone,

compared to Chloramphenicol, reduce patient’s Length of Stay?’
Question Etiology or Risk Factors

Mr. Agus has come to you, to discuss the possibility of getting a

vasectomy.
He says he has heard something about vasectomy causing an
increase in testicular cancer later in life.
You know that the risk of this is low but want to give him a more
precise answer.
Question Etiology or Risk Factors

• Population/patient = adult males

• Intervention/indicator = vasectomy
• Comparator/control = no vasectomy
• Outcome = testicular cancer

Question: ‘In men, does having a vasectomy (compared to not

having one) increase the risk of getting testicular cancer in the
future?’
Clinical Question Prognosis

Childhood seizures are common and frightening for the parents

The decision to initiate prophylactic treatment after a first episode
is a difficult one.
To help parents make their decision, you need to explain the risk of
further occurrences following a single seizure of unknown cause.
Clinical Question Prognosis

• Population/patient = children
• Intervention/indicator = one seizure of unknown cause
• Comparator/control = no seizures
• Outcome = further seizures

Question: ‘In children who have had one seizure of unknown

cause, compared with children who have had no seizures, what is
the increased risk of further seizures?’
Step 2: How to find current best evidence
MEDLINE (PubMed)

• MeSH Term and text word (tw)

• Osteoarthritis
• Rofecoxib
• Naproxen
• GI Disturbances (Bleeding/side effects)
• Thesaurus
• Boolean Logic
Text word
[tw]
Example for search terms osteoarthritis

• "Osteoarthritis"[Mesh] OR "Osteoarthritis"[tw] OR
“Osteoarthritides”[tw] OR “Osteoarthrosis”[tw] OR
“Osteoarthroses”[tw] OR “Arthritis, Degenerative”[tw] OR
“Arthritides, Degenerative”[tw] OR “Degenerative Arthritides”[tw]
OR “Degenerative Arthritis”[tw] OR “Osteoarthrosis
Deformans”[tw]
Example for search terms Rofecoxib

• "rofecoxib"[Supplementary Concept] OR "rofecoxib"[tw] OR

“refecoxib”[tw] OR “Vioxx”[tw] OR “Vioxx Dolor”[tw] OR “MK
0966”[tw] OR “MK 966”[tw] OR “MK-966”[tw] OR “MK-0966”[tw]
Boolean Logic (Between A and B)

http://www.electronics-micros.com/img/electronics/venn-logic1.jpg
Combined using Boolean logic

• ("Osteoarthritis"[Mesh] OR "Osteoarthritis"[tw] OR “Osteoarthritides”[tw]

OR “Osteoarthrosis”[tw] OR “Osteoarthroses”[tw] OR “Arthritis,
Degenerative”[tw] OR “Arthritides, Degenerative”[tw] OR “Degenerative
Arthritides”[tw] OR “Degenerative Arthritis”[tw] OR “Osteoarthrosis
Deformans”[tw]) AND ("rofecoxib" [Supplementary Concept] OR
"rofecoxib" [tw] OR “refecoxib”[tw] OR “Vioxx”[tw] OR “Vioxx Dolor”[tw]
OR “MK 0966”[tw] OR “MK 966”[tw] OR “MK-966”[tw] OR “MK-
0966”[tw])
The results
Step 3: Critical Appraisal

Diagnosis, Prognosis, Therapy, Harm

Evaluate the Evidence

Go to:
www.cebm.net
> Resources
> EBM Tools
> Critical Appraisal Tools
> Find the Worksheet
> Use the worksheet
Let’s use the RCTs worksheet
Example: RCT Tool

• (Internal) Validity
• Impact
• Applicability
 Step 4: Integrating the Critical Appraisal with clinical
expertise and patient’s biology, value and preferences
The questions that you should ask before you decide to
apply the results of the study to your patient are:

• Is my patient so different to those in the study that the results

cannot apply?
• Is the treatment feasible in my setting?
• Will the potential benefits of treatment outweigh the potential
harms of treatment for my patient?
Step 5: Evaluation
Self evaluation in asking answerable
questions

• Am I asking any clinical questions at all?

• Am I asking well-formulated questions (2 background and at least
three foreground questions)
• Am I using a “map” to locate my knowledge gaps and articulate
questions?
• Can I get myself “unstuck” when asking questions?
• Do I have a working method to save my questions for later
answering?
Self evaluation in finding the best external
evidence
• Am I searching at all?
• Do I know the best sources of current evidence for my clinical discipline?
• Have I achieved immediate access to searching hardware, software, and
the best evidence for my clinical discipline?
• Am I finding useful external evidence from a widening array of sources?
• Am I becoming more efficient in my searching?
• Am I using truncation, booleans, MeSH headings, thesaurus, limiters, and
intelegent free text when searching MEDLINE?
• How do my searches compared to with those of research librarians or
other respected colleagues who have a passion for providing best current
patient care?
A self evaluation in critically appraising the
evidence for its validity and potential usefulness

• Am I critically appraising external evidence at all?

• Are the critical appraisal guides becoming easier for me to apply?
• Am I becoming more accurate and efficient in applying some of
the critical appraisal measures (such as likelihood ratios, NNTs,
and the like)?
• Am I creating any appraisal summaries?
A self evaluation in integrating the critical
appraisal with clinical expertise and applying the
result in clinical practice
• Am I integrating my critical appraisals into my practice at all?
• Am I becoming more accurate and efficient in adjusting some of
the critical appraisal. Measures to fit my individual patients (pre-
test probabilities, NNTs etc)
• Can I explain (and resolve) disagreement about management
decision in terms of this integration?
Self evaluation of changing practice
behaviour

• When new evidence suggests a change in practice, am I identifying

barriers to this change?
• Have I carried out any check, such as audits of my diagnostic,
therapeutics, or other EBM performances?
What’s Next?
Limitation, mainly because of
misunderstanding and misconception

• It will ignore patient’s value and preferences

• Promote cookbook approach
• EBM will hijacked by manager to promote cost-cutting services
Take home messages

develop new skills in seeking and

appraising evidence

apply these skills within the

time constrain of our clinical
practice
Didik Setiawan, PhD., Apt

Email: d.didiksetiawan@gmail.com
Phone/WA: +62 81 226 700 119
www.ches.ump.ac.id