Early Primary Repair of Tetralogy of Fallot in Neonates

Competence and Credible, Excel in Organization, Excel in Operation, Beyond Expectations, Management by Objective
Evidence-Based Case Report

(EBCR)
Sudigdo Sastroasmoro, Siti Setiati,
Siti Rizny F. Saldi
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

Examples of famous case reports

1. William MacIntyre and Henry Bence-Jones contributed
greatly to our understanding of multiple myeloma by their

observation that the protein found in urine of multiple
myeloma is called Bence-Jones protein.
2. Many of Sigmund Freuds case reports helped further our
understanding of a number of mental health disorders,

such as obsessive compulsive disorder (rat man),
dissociative disorder (Anna O), phobias (Little Hans) and
post-traumatic disorder (wolf man).
3. Studies of Brocas area, the speech production centre in
the brain, was named after Paul Pierre Broca.

Case report
In 1967, when Christiaan Barnard carried out the first human heart transplants, there
were no guidelines for the diagnosis of death of beating heart donors
What a case report telling us about

1. Unusual presentations of common cases;
2. Inconclusive results;
3. Grey areas in indications for treatment;
4. Management challenges; or
5. Near misses case management.

Why Evidence-based Case Report?

During the course of a day in the office, many questions will
arise that will require decisions
1. Explanation of clinical profile: given the patient
profile, what the patients illness?
Diagnostic
knowledge
2. Explanation of illness: why did this illness occur in

this patient at this time?
Etiologic
knowledge
3. Prediction of course: given the patients illness, its

aetiology, the clinical and non-clinical profile, etc.,
what will be the future course of the illness,
depending on (absence of) treatment
Prognostic
knowledge
4. Treatment decision
5. Treatment execution
Prognostic &
Decision
analysis skill
Why Evidence-based Case Report?

Ways to seek answers:
Asks expert colleagues
To go to the literature for good quality studies
This process of questioning and seeking answers will
continue throughout our professional career

The purpose of the Evidence-based Case Report
(EBCR) is to allow you to test this strategy for a

question you would like to explore further
EBM Practice
Patient with
problems
Apply the
evidence
Critical
appraisal
Formulate
answerable
clinical questions
Search the
evidence

Karagz A, et.al. Sinus node dysfunction requiring permanent pacemaker implantation in a young adult with Klinefelter syndrome.
Am J Case Rep. 2015;16:136-9.
Case Presentation
Old fashion
Clinical problem is not
formulated
Critical appraisal (-)
Broad discussion
No explicit conclusion
EBCR
PICO
Critical appraisal (basic
procedure in EBM)
Focused discussion
Conclusion

Why evidence-based case report?

To show how evidence can be applied at all stages
of patient care: etiology, diagnosis, therapy, and

prognosis.
To provide reliable updates on the management of
clinical conditions

Evidence-based case report

Show how evidence can be applied at all stages of patient
care.
Define the clinical question in four parts: Patient,
Intervention, Comparison, Outcome (PICO)

Show that you have searched for, cited, and summarized
studies of appropriate relevance, design, and quality, and

should state which bibliographic databases you have
used.
Answer the clinical question or state that there is no
answer available.
www.bmj.com

A brief methods section explaining where you found
the information.
Max 1200 words (provide word count!)
Max 24 references
Max 4 illustrations (clinical photographs, imaging, line
drawings, figures, tables)

A summary box with up to five short single sentences
highlighting new or particularly interesting things

www.bmj.com

Report EBCR was launched by the BMJ (1998) in an
attempt to encourage the use of research-based

evidence in clinical practice
It documents how research evidence has been
applied to inform the management of a particular

case and evaluates the clinical outcome

Contents EBCR
Clinical case
Clinical scenario/case
Clinical question
Introduction, justification: management problem

Clinical question
Methods
Search strategy/selection
Critical appraisals
Results
Discussion
Interpretation of the results

Strong and weak points of the selected articles
Formulate recommendation
Conclusion
Answer question about patient
References
Relevant references in appropriate format
Search results (table, flowchart)

Appraisal results
Level of evidence
Study results
Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
Shorter than the conventional case report
Concise, highlights clinical problem in question

Do not describe clinical course in details, but sufficient
detailed description on:

Relevant characteristics
Findings and particularities
Motivation problem
knowledge gap (education, study book, practice)
why important?

Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
A 6-week-old male infant is referred to your clinic by the paediatric

cardiologists. He first presented with cyanosis and was found to
have severe right ventricular outflow tract obstruction (RVOT) with
pulmonary stenosis and a large ventricular septal defect (VSD) on
investigations. The cardiologist has just attended a national
conference and heard about the practice of one stage repair of
tetralogy of Fallot (TOF) in neonates as an alternative to a palliative
procedure followed by a later repair. He asks you whether you think
this case might be suitable for early primary repair. You discuss it
with your consultant who asks you to review the literature.
Interact Cardiovasc Thorac Surg. 2008;7(4):698-701
Challenges in clinical practices

1. Explanation of clinical profile: given the patient
profile, what the patients illness?
Diagnostic
knowledge
2. Explanation of illness: why did this illness occur

in this patient at this time?
Etiologic
knowledge
3. Prediction of course: given the patients illness,

its aetiology, the clinical and non-clinical
profile, etc., what will be the future course of
the illness, depending on (absence of)
treatment
Prognostic
knowledge
4. Treatment decision
5. Treatment execution
Prognostic &
Decision
analysis skill
Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
What is it?
Critical question related to a problem concerning
patient management for which a knowledge gap
exists
Specific, answerable
What is the aim?
Obtain clarity & certainty about the best patient
management

Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
Defining and describing your problem.

Avoid general (background) question.
Translation clinical bottom-line, follows from
description of problem
Patient, Intervention, Comparison, Outcome
PICO formula:
1. Patient/Population: type of patients
2. Intervention: the new approach or strategy of treatment
3. Comparison/Control: the control intervention
4. Outcomes: clinically meaningful outcomes that are important for
the patients
Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
Should a 35 year old health care worker with a needle

stick injury take AZT? (What is the evidence that a 35
years old health care worker who takes AZT will
reduce the risk of HIV infection?)
Patient: health workers getting needle stick injury
Intervention: AZT
Outcome: reduction of the risk of HIV

Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
In patients with TOF is early primary repair

comparable to surgery after 6 months of age in terms
of duration of post-operative ventilation, intensive
care unit (ICU) stay and hospital stay, and incidence
of post-operative morbidity?
Patient: patients with TOF
Intervention: early primary repair

Outcome: list of important outcomes

Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
Search
Search strategy
Sources:
Electronic searching
Database: Pubmed/MEDLINE, EMBASE, Cochrane
Keywords & combination of search term(s): AND, OR,
bracket
Hand searching
Make it transparent!
Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
Select
Article selection:
Reduction number titles
Prior definition of exclusion and inclusion criteria
study type (design)
Refer to PICO
Screening title/abstract
With doubt: screening full text

All decisions are made by consensus of at least 2 authors
Make it transparent!
Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
Critical appraisals
was the study Valid?
I
A
were the results clinically Important?
were the valid and important results

can be Applied to my patients?
Methods
(and Results)
Your clinical
judgement
Your patient
study domain

Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
Validity of the study (well performed?)

Selection/selection bias
Information bias
Confounding
RAMMbo
Recruitment : random? consecutive?
Allocation : randomization? inception cohort?
Maintenance : masking? similar treatment? drop out?
Measurement : blinded? objective?

Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
Critical appraisals
Several standard tools are available
Rank the evidence
Useful scheme:
Oxford Centre for Evidence based Medicine Levels of
Evidence (http://www.cebm.net)

Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
1. Search results:
a. Search strategy
b. Selection flowchart
2. Critical appraisal:
a.
Criteria validity
b.
Criteria relevance: similar PICO
3. The evidence: the answer/description of evidence

Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
1a. Search strategy (Table 1)

Source files searched (internet)
Combination of search terms (OR, AND)
Numbers
Database
Search strategy
Hits
Selected articles
PubMed/
Medline
((magnetic resonance imaging

[MeSH]) AND (mammography) AND
(breast neoplasms [MeSH])) AND
(specificity[Title/ Abstract])
57
Embase
(breast cancer) AND (MR) AND

(premenopausal)
Breast neoplasms AND Magnetic

Resonance Imaging
Cochrane

Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
1b. Flow chart selection (Figure 1)

Search results different databases (number)
Clear exclusion criteria
Numbers not selected (per exclusion criterion)
Number articles, selected for further assessment (critical
appraisal).

Identification
Screening
the abstract
Search terms
Search terms
Number of records
identified through database
searching
Number of additional
records identified through
other database/sources
Number of records after duplicates removed

Number of records
excluded, with reasons
Number of records screened
Inclusion
criteria
Number of full-text articles
assessed for eligibility
Number of full-text articles
excluded, with reasons
Eligibility
Included
Search date: dd/mm/yyyy
Number of studies included

(useful articles)
## article found by
screening references
## articles
useful/not useful
Identification
children AND (pneumococcal meningitis) AND

(cerebrospinal fluid) AND mortality
PubMed/MEDLINE
N = 79
Screening
the abstract
EMBASE
N = 51
55 records after duplicates removed

37 records excluded:
Inclusion criteria:
Prognostic study;
Mortality as
outcome; CSF
composition as
prognostic factor
18 records screened
13 full-text articles
assessed for eligibility
Animals (N=5); Neonates (N=7);

Adults (N=10); Therapeutic study
(N=12); CSF composition
not specified (N=3)
3 records excluded:
Eligibility
Insufficient outcome (mortality)

(N=1); Experimental, noncomparable CSF measurement
(N=1); Therapeutic study (N=1)
Included
1 article found by
screening references
Search date: 30 Nov 2005
3 studies included
(useful articles)
not useful (domain:

adults also included)
Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
2a. Criteria validity:
Nursalim et al. J Indon Med Assoc 2011;61(9):366

Results
Study B, 2010
+/-
Study C, 2006
Specific for patients case
Own simply applied

Never forget legends
Conclusion
Study A yyyy
2b. Criteria relevance:

similar PICO
system
Discussion
Similarity outcomes
Methods
Similarity determinant/
intervention/ indicators
Clinical
Questions
Similarity domain/
population
Case
Description
Etc.

The evidence: the answer/description of evidence
Each question has own design

Diagnosis
Prognosis
Therapy
Etiology
Presence/
absence
disease
Course of
disease
Result of
treatment
Relation of a
risk (etiology)
factor
Domain (Patient)
Patient
suspected of
disease
Patient with
diagnosis and
probability
endpoint
Patient with
diagnosis and
probability
endpoint
Population at
risk
Determinant
(Indicator/Compar
ator)
As in practice
As in practice
Manipulated
As in practice
(exposure/risk
factors)
Outcome
reference test
or -criterium
Mortality,
morbidity,
QoL
Mortality,
morbidity,
QoL
Mortality,
morbidity, QoL
Type of study
Cross sectional
Follow up (time
until outcome)
Follow up (time
until outcome)
Follow up, casecontrol
Design study
Descriptive
Descriptive
Causal
Causal
AR
AR
RR/RD
RR
Inference
Outcome measure
Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
Interpretation results (and precision) based on
best available evidence

Consistency discrepancy result
Formulation recommendation patient

Explicit motivation recommendation
Considerations concerning
relevance (restrictions?)
validity (restrictions?)
Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
Overall conclusion is the answer of your previous
clinical question.
Evidence-based recommendations for your
patient.

Case
Description
Clinical
Questions
Methods
Results
Discussion
Conclusion
Early primary repair of TOF is comparable to later

repair, with several retrospective reviews concluding
that there is no increase in mortality and reintervention in infants -6 months of age. However, it
has been consistently shown that the length of ICU
stay, requirement for ventilation and the need for
inotropes is increased in patients undergoing primary
repair at -3 months of age.
Interact Cardiovasc Thorac Surg. 2008;7(4):698-701

Advantages and Disadvantages

Advantages
Learn to apply evidence-based practice
Fill the knowledge gap
Disadvantages
Detailed / minute-to-minute management might be
lacking
Background knowledge might also be lacking
e-library available?
Group Assignment
Write a complete EBCR with the following structure:
Case illustration
Existing knowledge on the problem (comparison from several sources).
Clinical question and PICO
Methods : literature search (flowchart) and critical appraisal (table)
Result as stated in the selected articles

Description about articles found during the search, report on their
relevance and validity after critical appraisal (for sub-group with

problem on therapy & diagnosis), presented in a table.
Discussion: strengths and weaknesses of the selected evidences
Conclusion & recommendation for patient

Contents EBCR
Clinical case
Clinical scenario/case
Clinical question
Introduction, justification: management problem

Clinical question
Methods
Search strategy/selection
Critical appraisals
Results
Discussion
Interpretation of the results

Strong and weak points of the selected articles
Formulate recommendation
Conclusion
Answer question about patient
References
Relevant references in appropriate format
Search results (table, flowchart)

Appraisal results
Level of evidence
Study results
PENCEGAHAN PLAGIARISME
Pernyataan bebas plagiarisme pada halaman kedua setelah
judul Tugas kuliah/ Makalah/ Karya ilmiah/ Laporan/
Penelitian/ Skripsi/ Tesis/ Disertasi
SK Rektor UI no 208 tahun 2009
Milestones
8 April 2016
29 April 2016
1st submission:
2nd submission:
Clinical scenario
Search strategy
Clinical scenario
Search strategy
Critical appraisals
9 May 2016
13 May 2016
3rd submission:
Final submission:
Complete EBCR (paper)

Make a brief presentation
(max 10 slides) on EBCR
Complete EBCR
(revised paper, if any)

Milestones
Submit your group assignment for each

milestone to:
To
: ce-ebm@ceebm.org
Cc
: sekretariatppdsfkui@gmail.com
Subject :EBCR group ## - [1st/2nd/3rd submission]

Facilitators
Name
Email
Groups
Dr. dr. Kuntjoro Harimurti, SpPD-KGer, MSc
kuntjoro.harimurti@ceebm.org
1-3
dr. Esthika Dewiasty, SpPD, MSc
edewiasty@gmail.com
4-6
Siti Rizny Fitriana Saldi, Apt, MSc
rizny.saldi@ceebm.org
7-9
dr. Yupitri Pitoyo, SpTHT-KL
yupitri.pitoyo@ceebm.org
10-12
dr. Eka Dian Safitri, SpTHT-KL
ekadian.safitri@ceebm.org
13-15
dr. Arie Sulistyowati, SpA, MSc
arie.sulistyowati@ceebm.org
16-18
dr. L. Aswin Pramono, SpPD, M.Epid
L_aswin@hotmail.com
19-21
Unit CEEBM RSCM-FKUI, Gedung H Lantai 2, RSCM

+62 21 316 1760 (by appointment)


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Competence and Credible, Excel in Organization, Excel in Operation, Beyond Expectations, Management by Objective

Evidence-Based Case Report

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

Examples of famous case reports

greatly to our understanding of multiple myeloma by their

understanding of a number of mental health disorders,

the brain, was named after Paul Pierre Broca.

What a case report telling us about

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

Why Evidence-based Case Report?

2. Explanation of illness: why did this illness occur in

3. Prediction of course: given the patients illness, its

Why Evidence-based Case Report?

This process of questioning and seeking answers will

continue throughout our professional career

(EBCR) is to allow you to test this strategy for a

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

Why evidence-based case report?

of patient care: etiology, diagnosis, therapy, and

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

Evidence-based case report

Intervention, Comparison, Outcome (PICO)

studies of appropriate relevance, design, and quality, and

Evidence-based case report

drawings, figures, tables)

highlighting new or particularly interesting things

Evidence-based case report

attempt to encourage the use of research-based

applied to inform the management of a particular

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

Introduction, justification: management problem

Interpretation of the results

Answer question about patient

Relevant references in appropriate format

Search results (table, flowchart)

Shorter than the conventional case report

Concise, highlights clinical problem in question

detailed description on:

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

A 6-week-old male infant is referred to your clinic by the paediatric

Challenges in clinical practices

2. Explanation of illness: why did this illness occur

3. Prediction of course: given the patients illness,

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

Defining and describing your problem.

Should a 35 year old health care worker with a needle

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

In patients with TOF is early primary repair

Intervention: early primary repair

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

With doubt: screening full text

was the study Valid?

were the results clinically Important?

were the valid and important results

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

Validity of the study (well performed?)

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit

Criteria relevance: similar PICO

3. The evidence: the answer/description of evidence

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit