Developin

g
Answerable Clinical
Questions

Susan fitria
candradewi
 INTRODUCTION
Evidence-based medicine (EBM) is an important
change in the way physicians practice, teach, and do
research. 
It was initially proposed by Dr. David Sackett and
colleagues at McMasters University in Ontario,
Canada.  Dr. Sackett defines EBM as:
"...the conscientious, explicit, and judicious use of
current best evidence in making decisions about the
care of individual patients." (Sackett, 1997)
"Evidence based medicine is the
integration of the best research
evidence with clinical expertise and
patients value"
Best
Evidenc
e
Clinical
Patient
Expertis
value
e
 EVIDENCE-BASED PRACTICE
Patients value
Clinical Best Available
Expertis Evidence
e

DECISION MAKING
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indo nesia
◦ Why do we not answer more of these
questions?
◦ lack of convenient access to reference materials
◦ time needed to search for information
◦ Two characteristics that predict whether
physicians will seek and find an answer to
a clinical question are
◦ the urgency of the problem and
◦ their confidence that they will find an answer

ANSWERABLE CLINICAL QUESTI

Levels of Evidence and Grades of
Recommendation
1a
◦
Systematic review of randomised controlled trials
1b Individual randomised controlled trial
1c All or none series
2a Systematic review of cohort studies
2b Individual concurrent cohort study
2c Outcomes research
3a Systematic review of case-control-studies
3b Individual case-control-study
4 Case-series (uncontrolled trials)
5 Expert opinion without explicit critical appraisal,
animal studies, bench research
STEPS IN EBM
1. Formulate an answerable question
2. Information Search
3. Critically appraise the evidence for:
◦ Validity
◦ Impact (size of the benefit)
◦ Applicability
4. Integrate with clinical expertise and patient values
5. Evaluate our effectiveness and efficiency
◦ keep a record; improve the process

R
Importance of a well-defined
review question
Essential first step for your review

Guides many aspects of your methods

• eligibility criteria
• search strategy
• data collection and analysis

Think some details at the beginning of the process

➔ Plan your work

Clear Idea of the scope of your review ➔ avoid

bias, reduce the risk of making decisions
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Types of Clinical Questions

2. By
1. By Content
Format

Diagnosis Therapy Etiology Prognosis Backgroun

foreground
 Determining question type
Therapy –
Harm – effects of
effectDetermines
of treatments
on agents –
potentially harmful
improving or function or
function,
avoiding adverse morbidity, mortality
events

Diagnosis – power of Prognosis –

differentiate between
an intervention to estimating
those w/condition
and w/o a
the future course of a
target
patient’s
or
disease disease
Asking Questions
◦ Questions are usually of 2 types: background or foreground

FOREGROUND

BACKGROUND

NOVICE EXPERT
 Background
Questions
These questions are general in nature and
provide foundational information on a single
concept.

Background questions cover:

• Terminology
• General Pathology
• Patient Education Resources
• General Drug Information
• Examination/Assessment Procedures
Example
s What is the pathology of rhinosinusitis
•
• What drugs are used to treat asthma
• What education resources exist for
patients with gestational diabetes?
• How is rhinosinusitis diagnosed?
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Foregrou Questio
nd◦ These questions bring
ns together multiple concepts
related to a specific clinical situation or research topic.
◦ Discover cause and effect relationships by comparing
two
or more individuals or groups based on differing
outcomes
associated with exposures or interventions.
◦ Detailed information
◦ Diagnosis
◦ Therapy
◦ Prognosis
◦ Patient focus
◦ Age group
◦ Stage of the disease
◦ Certain risk factors
◦ Evidence-based process
Clinical scenario
◦ Real clinical cases
◦ From clinical rounds / consultations
◦ Journal clubs
◦ Online video clips
◦ News stories
◦ Newspapers, news web-sites
◦ Blogs
◦ Journal web-sites – In the news
Clinical Scenario (Home
Work)
◦ A 55 year old man, obesity, feel chest
pain while on the move. Doctor
diagnose patients experience Ischemic
heart disease.
◦ The doctors gave him simvastatin
and aspirin to prevent recurrent
chest pain
◦ ◦ Patient ask the doctor whether
consumption simvastatin and aspirin
in is effective for him and safe?
Background question

❑ ??????
Examples
Foreground question
(Therapy)

In adults with ischemic heart disease, does chest CT

scan

Diagnosis)

prognosis)

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Formulate an answerable clinical
question
◦ Structure of researchable questions – PICO-T
◦ Population/Patients
◦ Intervention
◦ (Comparison)
◦ Outcome
◦ (Time)
◦ The “best” research type depends
on the question type
PICO/T CONCEPT
The components: P
◦ Think about who / what you wish to apply
this evidence to… e.g.
◦ People with a particular disorder?
◦ e.g chronic recurrent cystitis
◦ People in a particular care setting?
◦ e.g. community
◦ particular groups of people
◦ e.g. sexually active young women?
◦ the elderly?
◦ children?
◦ How would you describe your clients /
setting?
The components: I

◦ The intervention / topic of interest (e.g.

cause, change in practice etc.) e.g.
◦ Use of guava juice (as a drink)
◦ Might want to specify how much / how often
◦ For complex interventions may need to give
specific
detail / consideration to the description…

◦ What exactly am I considering…?

The components: C
◦ The comparison or alternative (not
applicable to all questions) e.g.
◦ Anti-biotic therapy?
◦ Nothing?
◦ Fluids alone?
◦ What alternatives actions might I try?
The components: O
◦ The outcome…
e.g.
◦ Cure
◦ Duration of disease
◦ prevention
◦ Death
◦ Side effects
◦ Pain (reduced)
◦ Wellbeing
◦ What am I hoping to accomplish
(what outcomes might reasonably be
affected…)?
ELIGIBILITY
CRITER
IA
Eligibility criteria
◦ Eligibility criteria are the
essential components

determine whether a study is

included and
discussed in the review, or
whether it is excluded

◦ Based on:
• some or all of your PICO
components
plus
Type of Article and Best study
design
Type of Question Type of Study/Methodology
Therapy Information needed aboutAND Systematic review and Meta-
treatments (effectiveness, cost, analysis of RCTs
etc.) Double-Blind RCT
Diagnosis Information needed about a Cross-sectional study
diagnostic test (sensitivity,
Keyword Keyword
accuracy, etc.) 1 2
Prognosis Information needed about the Cohort/survival study
course of the disease over time,
expected complications, etc.

Etiology / Information needed about RCTs

Harm causes of disease or Smoking AND Cohort Acupuncture
study
contributing factors of disease
gyCase-control
Clinical Epidemiolo Study
and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Clinical Scenario
◦ A 26-year-old patient came with, cephalgia,
mucopurulent nasal discharge and nasal
blockage for 4 months
◦ Examination from anamnesis and physical finding
with nasoendoscopy, the diagnosis is Chronic
rhinosinusitis
◦ She’s been consumed antibiotics,
decongestants and antihistamines, and also
topical steroid nasal spray without sustained
benefit.
◦ She refused for sinus surgery and she read an
alternative therapy for chronic rhinosinusitis in
the internet, called ultrasound therapy
 Formulated question:*
◦ In adults with chronic rhinosinusitis, does
ultrasound therapy (as an adjuvant or
single therapy) would reduce the
symptoms and recurrence?

*Ranakusuma RW, Pitoyo Y, Safitri ED, Widyahening IS, Beller EM, Glasziou PP, Bashiruddin J. Therapeutic
ultrasound for chronic rhinosinusitis (Protocol). Cochrane Database of Systematic Reviews 2017, Issue 3. Art.
No.: CD011046. DOI: 10.1002/14651858.CD011046.pub
Eligibility
Criteria
◦ St
◦◦
Study Design: or Randomized
tri controlled
◦ Systematic Review of
◦ RCT
◦W e included
trials (RCTs) patientsof any age (children and
adults) with Chronic Rhinosinusitis
◦ Population: as defined in
either:
ei (CRS)
◦ the European Position Paper on Rhinosinusitis and Nasal Polyps 2012:
or
◦ the Rhinosinusitis Task Force Report (RTFR 1996) and its revision by the
Sinus and Allergy Health Partnership Task Force (including the
members of RTFR 1996 from the American Academy of
Otolaryngology - Head and Neck Surgery or
◦ sinusitis symptoms with/without endoscopic evidence and/or
radiological evidence of sinusitis for 12 weeks or more; or
◦ no complete resolution of rhinosinusitis symptoms
Clinical Epidemiology after
and Evidence-Based 12(CEEBM)
Medicine weeks Unit or
RSUPN Dr. Cipto Mangunkusumo – Fakulta
more (e.g. no treatment, failed therapy)
s Kedokteran Universitas Indonesia
Continue...
◦ We excluded patients in whom ultrasound
contraindicated,
is e.g. patients with
a
vascular cancer, pregnancy or impaired
pacemaker,
circulation
◦ Types of interventions
treatment
◦ The for is ultrasound
intervention either continuous
given as a or
CRS, pulsed,
atnumber of sessions
any intensity or or duration. and for any
frequency

◦ Types of Comparison
therapy,
◦ The no treatment
comparisons or other
were sham treatment.
ultrasound
Continue...
◦ Types of outcome measures

1. Resolution of symptoms or reduction in overall

sympto severity. Reduction
sympt Reduction inin
symptom
symptosevseverit
may
m be measured
. using visualm analogueyscales or a
validated symptom scale, e.g. Sinonasal Outcome
Test/SNOT-20

2. Reduction in overall symptom duration.

3. Recurrency of symptoms, defined as new

of rhinosinusitis or the proportion of patients
episodes
with
recurrent rhinosinusitis after four weeks from the
of therapeutic ultrasound.
start

4. Adverse effects of treatment.

 QUESTION
CATEGORIE
S
 Question Categories
◦ Diagnosis How to select a diagnostic test or
how to interpret the results of a particular
test.
◦ Therapy Which treatment is the most
effective, or what is an effective treatment
given a particular condition.
◦ Harm or Etiology Are there harmful effects of
a
particular treatment or exposure or risk factor
◦ Prognosis What is the patient's likely
course of disease given the characteristic
Exercise
In
In pregnant women,
patients with how is the
accuracy of nitrite test in finding
osteoarthritis,
could corticosteroid injections of
asymptomatic
the knee reduce urinary tract infection?
the symptoms?

In women taking oral contraceptives,

is there an association between their
use and cardiovascular disease?
EXERCISE
Laki-laki 55 tahun obesitas mengalami
nyeri dada sebelah kiri pada saat aktivitas,
Dokter berencana memberikan
simvastatin untuk mencegah keluhan dan
nyeri dada berulang

P
=I
=C
= O
EXERCISE

Seorang ibu datang ke Apotek untuk

membeli obat asma karena alergi
untuk anaknya. Anaknya berusia 5
tahun. Ibu tersebut bertanya obat
yang paling bagus untuk mengatasi
asma pada anaknya .

P
=I
=C
EXERCISE
In patients with osteoarthritis,
do corticosteroid of the knee
reduce symptoms?

P
=I
=C
= O
=
PICO & Applicability

Adapted from: Sackett et al.’s Evidence-Based Medicine: How to Practice and Teach EBM
 GUIDE TO PICO APPLICABILITY
PATIENT/PROBLEM INDICATOR COMPARISON
OUTCOME

PICO:

Type

of
Questi
on:
 SCENARIO
◦ Angela is a patient on the general medical ward who recently
moved to the area to be closer to her son and his family.
◦ She is 72 years old and has a history of congestive heart failure.
◦ She was admitted 2 days ago having presented with non
specific chest pain, shortness of breath, an enlarged liver,
swollen ankles and has been diagnosed with a non-ST
elevation MI.
◦ She is extremely diligent about taking her medications
(Lisinopril and aspirin). She also tells you she is a bit hard of
hearing, has a slight cough, is a smoker of 20 cigarettes a
day for 40 years.
◦ When you examine her: BP is 170/90 and her pulse is 80
and irregular. She is about to be discharged home on her
previous medications plus 25 mg spironolactone od.
◦ She is happy to be going home and asks you if this new
medication will help her stay out of hospital?
Courtesy: http://www.cebm.net/makes-good-clinical-question-fellows-view/
 PATIENT/PROBLEM INDICATOR COMPARISON
OUTCOME
Elderly patient with Spironolacton Standard therapy Reduce
congestive heart
hospitalizaion failure.

PICO: In Elderly Patients with Congestive Heart Failure does

treatment with spironolactone when compared with standard
tehrapy alone lead to decrease hospitalization?

Type of Question: Therapy

Type of study/methodology: Systematic review on RCT/RCT

EXERCISE
Case #1
◦ Your next patient is a 72-year-old
woman with osteoarthritis of the knees
and moderate hypertension,
accompanied by her daughter, a lab tech
from the
hospital. The daughter wants you to
give her mother a prescription for one
of the new COX-2 inhibitors. She has
heard that they cause less GI bleeding.
 FILL IN THE COLUMN
PATIENT/PROBLEM INDICATOR COMPARISON
OUTCOME

PICO:

Type

of
Questi
on:
 CASE #1
PATIENT/PROBLEM INTERVENTION
COMPARISON OUTCOME

72 year old COX-2 Inhibitor other NSAIDS less GI

bleeding woman with
osteoarthritis
of the knee
and moderate
hypertension
PICO:
In a 72 year
old woman
with
osteoarthritis
of the knee,
can COX-2
Inhibitor use
decrease the
risk of GI
bleeding
compared with
other
Case #2
◦ You see a 70 year old man in your outpatient
clinic 3 months after he was discharged from
your service with an ischemic stroke. He is in
sinus rhythm, has mild residual left-sided
weakness but is otherwise well. His only
medication is ASA and
he has no allergies. He recently saw an article
on the BMJ website describing the risk of
seizure
after a stroke and is concerned that this will
happen to him.
 FILL IN THE COLUMN
PATIENT/PROBLEM INDICATOR COMPARISON
OUTCOME

PICO:

Type

of
Questi
on:
 Case #2
PATIENT/PROBLEM
INTERVENTION
COMPARISON OUTCOME

70 year old man Stroke

Seizure

PICO:
In a 70 year old man does a history of
stroke increase his risk for seizure?

Type of
Question:

Prognosis

Type of study/methodology:
 Case #3
◦ You admit a 75 year old woman with community-
acquired pneumonia. She responds nicely to
appropriate antibiotics but her hemoglobin
remains
at 10 g/dl with an MCV of 80. Her peripheral blood
smear shows hypochromia, she is otherwise well
and is
on no incriminating medications.
◦ You contact her family physician and find out that
her
Hgb was 10,5 g/dl about 6 months ago. She has
never been investigated for anaemia. A ferritin has
been ordered and comes back at 10 mmol/l. You
admit to yourself that you're unsure how to
interpret a
 FILL IN THE COLUMN
PATIENT/PROBLEM INDICATOR COMPARISON
OUTCOME

PICO:

Type

of
Questi
on:
 Case #3
PATIENT/PROBLEM
INTERVENTION COMPARISON
OUTCOME

Elderly woman Ferritin

Gold standard Iron deficiency
with anaemia
anaemia

PICO:
In an elderly woman with
hypochromic, microcytic anaemia,
can
a low ferritin diagnose iron deficiency
anaemia?

Type of
Question:

Diagnosis
Conclusion
◦ Using the PICO model to determine your
clinical question will help you get an answer
efficiently
◦ Knowing what type of clinical question you
are asking will help you know what is the
best study design to provide evidence to
answer your clinical question.

C
 Tentukan PICO dari jurnal tersebut
 Formulasikan pertanyaan klinis berdasarkan
jurnal tersebut
 Tentukan jenis formulasi pertanyaan klinis
pada jurnal tersebut
 Tentukan PICO dari jurnal tersebut
 Formulasikan pertanyaan klinis berdasarkan
jurnal tersebut
 Tentukan jenis formulasi pertanyaan klinis
pada jurnal tersebut
 Tentukan PICO dari jurnal tersebut
 Formulasikan pertanyaan klinis berdasarkan
jurnal tersebut
 Tentukan jenis formulasi pertanyaan klinis
pada jurnal tersebut
 A Randomized Trial of Low-Dose Aspirin
in the Primary Prevention of Cardiovascular Disease in
Women

A Randomized Trial of Low-Dose

Aspirin
in the Primary Prevention of
Cardiovascular Disease in Women
Klasifikasi Pustaka Obat
Berdasarkan Orisinalitas

Primer

Sekunder

Tersier
 Klasifikasi Pustaka Obat
Berdasarkan Tujuan/outcome
Efikasi/terapi/kemanjuran

Safety / keamanan

Diagnosis

Prognosis

Farmakoekonomi
 Klasifikasi Pustaka Obat
Berdasarkan level of evidence
Level 1 Level 2 Level 3 Level 4 Level 5
• Sistem • RCT • Case • Case • Pendap
atik tunggal series report at ahli
review desain • Case • Case • Textboo
• Meta baik control control k
analisa • SR • Cohort desain • Review
cohort desain kurang artikel
• Cohort tidak baik
tunggal baik • In vitro
desain • Clinical
baik trial
Piramida tingkatan bukti Ilmiah
Uji Efikasi/kemanjuran
Uji Efikasi/kemanjuran
Uji safety/keamanan
Uji diagnosis
Uji Prognosis
 Home Work

1. Cari masing-masing artikel tentang

uji efikasi, uji keamanan, uji
diagnosis, uji prognosis, dan uji
farmakoekonomi
2. Analisis berdasarkan originalitasnya
(primer, sekunder, tersier)
3. Analisis berdasarkan level evidence
nya (I,II,III,IV,V)