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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

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.


Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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.

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

EBM Practice
Patient with
problems
Apply the
evidence

Critical
appraisal

Formulate
answerable
clinical questions

Search the
evidence

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

Evidence-based case report


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
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

Evidence-based case report


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

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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?

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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!
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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!
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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?

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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)

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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).

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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


Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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.

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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?)
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

Case
Description

Clinical
Questions

Methods

Results

Discussion

Conclusion

Overall conclusion is the answer of your previous

clinical question.
Evidence-based recommendations for your

patient.

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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?
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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)

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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]

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia

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)

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo Fakultas Kedokteran Universitas Indonesia