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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 Rizny F. Saldi,
Yupitri Pitoyo, Widyaningsih

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 Freud’s 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 Broca’s 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 Diagnostic
profile, what the patient’s illness? knowledge
2. Explanation of illness: why did this illness occur in Etiologic
this patient at this time? knowledge
3. Prediction of course: given the patient’s illness, it’s Prognostic
aetiology, the clinical and non-clinical profile, etc., knowledge
what will be the future course of the illness,
depending on (absence of) treatment
4. Treatment decision Prognostic &
5. Treatment execution 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 Formulate


answerable
evidence clinical questions

Critical Search the


appraisal evidence

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Case Presentation

‘Old fashion’ EBCR

• Clinical problem is not • PICO


formulated • Critical appraisal (basic
• Critical appraisal (-) procedure in EBM)
• Broad discussion • Focused discussion
• No explicit conclusion • Conclusion

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Karagöz 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.
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

 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

• Introduction, justification: management problem


Clinical question
• Clinical question

• Search strategy/selection
Methods
• Critical appraisals

• Search results (table, flowchart)


• Appraisal results
Results
• Level of evidence
• Study results
• Interpretation of the results
Discussion • Strong and weak points of the selected articles
• Formulate recommendation

Conclusion • Answer question about patient

References • Relevant references in appropriate format


Case Clinical
Methods Results Discussion Conclusion
Description Questions

 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 Clinical
Methods Results Discussion Conclusion
Description Questions

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 Diagnostic
profile, what the patient’s illness? knowledge
2. Explanation of illness: why did this illness occur Etiologic
in this patient at this time? knowledge
3. Prediction of course: given the patient’s illness, Prognostic
it’s aetiology, the clinical and non-clinical knowledge
profile, etc., what will be the future course of
the illness, depending on (absence of)
treatment
4. Treatment decision Prognostic &
5. Treatment execution Decision
analysis skill

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Case Clinical
Methods Results Discussion Conclusion
Description Questions

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 Clinical
Methods Results Discussion Conclusion
Description Questions

 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
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
the patients RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Case Clinical
Methods Results Discussion Conclusion
Description Questions

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 Clinical
Methods Results Discussion Conclusion
Description Questions

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 Clinical
Methods Results Discussion Conclusion
Description Questions

Select
 Article selection:
 Reduction number titles
 Prior definition of exclusion and inclusion criteria
 study type (design)
 Refer to PICO
 Screening title/abstract
 All decisions are made by consensus of at least 2 reviewers
Make it transparent!

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Case Clinical
Methods Results Discussion Conclusion
Description Questions

Critical appraisals

Methods
V was the study Valid?
(and Results)

Your clinical
I were the results clinically Important?
judgement

were the valid and important results Your patient 


A can be Applied to my patients? study domain

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Case Clinical
Methods Results Discussion Conclusion
Description Questions

 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 Clinical
Methods Results Discussion Conclusion
Description Questions

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 Clinical
Methods Results Discussion Conclusion
Description Questions

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 Clinical
Methods Results Discussion Conclusion
Description Questions

1a. Search strategy (Table 1)


 Source files searched (internet)
 Combination of search terms (OR, AND)
 Numbers
Database Search strategy Hits Selected articles
PubMed/ ((“magnetic resonance imaging” 57 6
Medline [MeSH]) AND (mammography) AND
(“breast neoplasms” [MeSH])) AND
(specificity[Title/ Abstract])

Embase (breast cancer) AND (MR) AND 2 1


(premenopausal)
Cochrane Breast neoplasms AND Magnetic 3 0
Resonance Imaging
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Case Clinical
Methods Results Discussion Conclusion
Description Questions

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
Search terms Search terms
Identification Number of records Number of additional
identified through database records identified through
searching other database/sources

Screening Number of records after duplicates removed


the abstract
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

## article found by
Included Number of studies included screening references
(useful articles) ## articles
useful/not useful
Search date: dd/mm/yyyy
children AND (pneumococcal meningitis) AND
(cerebrospinal fluid) AND mortality
Identification
PubMed/MEDLINE EMBASE
N = 79 N = 51

Screening 55 records after duplicates removed


the abstract
37 records excluded:
Animals (N=5); Neonates (N=7);
Adults (N=10); Therapeutic study
Inclusion criteria: 18 records screened (N=12); CSF composition
Prognostic study;
Mortality as not specified (N=3)
outcome; CSF
composition as
prognostic factor
13 full-text articles
assessed for eligibility 3 records excluded:
Insufficient outcome (mortality)
(N=1); Experimental, non-
comparable CSF measurement
Eligibility (N=1); Therapeutic study (N=1)

1 article found by
Included 3 studies included screening references
(useful articles) not useful (domain:
adults also included)
Search date: 30 Nov 2005
Case Clinical
Methods Results Discussion Conclusion
Description Questions

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
Case Clinical
Methods Results Discussion Conclusion
Description Questions

intervention/ indicators
Similarity determinant/
2b. Criteria relevance:

Similarity outcomes
Similarity domain/
similar PICO

population
 Specific for patient’s case
 Own simply applied
system Study A yyyy + + +
Study B, 2010 - +/- +
 Never forget legends
Study C, 2006 - - +
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
Inference Presence/ Course of Result of Relation of a
absence disease treatment risk (etiology)
disease factor
Domain (Patient) Patient Patient with Patient with Population at
suspected of diagnosis and diagnosis and risk
disease probability probability
endpoint endpoint
Determinant As in practice As in practice Manipulated As in practice
(Indicator/Compar (exposure/risk
ator) factors)
Outcome reference test Mortality, Mortality, Mortality,
or -criterium morbidity, morbidity, morbidity, QoL
QoL QoL
Type of study Cross sectional Follow up (time Follow up (time Follow up, case-
until outcome) until outcome) control
Design study Descriptive Descriptive Causal Causal
Outcome measure AR AR RR/RD RR
Case Clinical
Methods Results Discussion Conclusion
Description Questions

The evidence
 Briefly describe the evidence and its strength
 Look through the structure of the paper and think
about each element of the study
 Was the study design a strong one?

 Were the outcomes clinically significant?

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Case Clinical
Methods Results Discussion Conclusion
Description Questions

 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 Clinical
Methods Results Discussion Conclusion
Description Questions

 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 Clinical
Methods Results Discussion Conclusion
Description Questions

Early primary repair of TOF is comparable to later


repair, with several retrospective reviews concluding
that there is no increase in mortality and re-
intervention 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
c
c

c
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

• Introduction, justification: management problem


Clinical question
• Clinical question

• Search strategy/selection
Methods
• Critical appraisals

• Search results (table, flowchart)


• Appraisal results
Results
• Level of evidence
• Study results
• Interpretation of the results
Discussion • Strong and weak points of the selected articles
• Formulate recommendation

Conclusion • Answer question about patient

References • Relevant references in appropriate format


Tugas Evidence-Based Case Reports
Modul Evidence-Based Medicine
Semester Genap 2018/2019

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Minggu

Diskusi
ke-

ke-
Luaran/Target Tugas Peserta Didik

I 1 • Menetapkan skenario klinis. Tugas diserahkan dengan


• Memformulasikan pertanyaan klinis dan PICO. mengisi formulir topik EBCR
yang tersedia di SCeLE pada
bagian ‘Tugas minggu ke-1’.
II 2 • Menetapkan metode untuk: Tugas diserahkan dengan
 Penelusuran literatur (resources, search mengisi bagian yang relevan
strategy, selection criteria). dalam draft Laporan EBCR
 Telaah kritis. dan mengunggahnya di SCeLE
• Melakukan penelusuran dan seleksi literatur pada bagian ‘Tugas minggu
secara sistematis dan melaporkan hasilnya ke-2’.
dalam bentuk narasi dan Tabel 1 (resources &
search strategy), Gambar 1 (PRISMA flow chart)
dan Tabel 2 (karateristik literatur).
3 Melakukan telaah kritis untuk setiap artikel hasil
pencarian yang terseleksi dan melaporkan hasilnya
dalam bentuk narasi dan tabel.
III 4 • Mendiskusikan kembali hasil telaah kritis. Menyelesaikan laporan EBCR
• Menyusun diskusi serta kesimpulan. lengkap sesuai format dan
• Menyelesaikan laporan EBCR lengkap mengunggahnya di SCeLE
pada bagian ‘Tugas minggu
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
ke-3’.
RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Scroll ke
bawah

ce-ebm

Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit


RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
Tenggat waktu pengumpulan tugas: setiap hari Minggu jam 23:55 WIB melalui SCeLE
Clinical Epidemiology and Evidence-Based Medicine (CEEBM) Unit
RSUPN Dr. Cipto Mangunkusumo – Fakultas Kedokteran Universitas Indonesia
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


yupitrimd@yahoo.co.id

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

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