EBM - Diagnostic

Evidence-Based Medicine

See a
patient

Monitor the change

Ask a question Seek the best

evidence

Apply the evidence Appraise that eviden

Critical Appraisal
- Worksheet for
critical appraisal
- Software : CAT Maker
Main area of clinical objectives:
1. Diagnosis
2. Prognosis
3. Therapy/Treatment
4. Risk/Harm

Others:
Systematic Review and Meta-analysis
Clinical Guidelines
Clinical Decision Making etc.

Untuk menegakkan diagnosis

diperlukan uji diagnosis:
Pemeriksaan klinis
Pemeriksaan lab sederhana
Pemeriksaan lain yg lbh canggih

Uji diagnostik bisa dilakukan scr

bertahap (serial): mis test tuberkulin
dahulu baru foto thorak
Paralel: bbrp pemeriksaan dilaksanakan
sekaligus.

Uji diagnostik yg ideal: uji yg

memberi hasil positif pd semua
subjek yg sakit dan memberikan
hasil negatif pd semua subjek yg
tidak sakit.

Tetapi ada kemungkinan diperoleh

hasil uji positif pd subjek yg sehat
(false posititive) dan hasil negatif pd
subjek yg sakit (false negative).

Tujuan:
Utk menegakkan diagnosis penyakit atau
menyingkirkan penyakit (sensitif :
kemungkinan negatif semu kecil; spesifik :
kemungkinan positif semu kecil)
Utk keperluan screening (mencari subjek
yg asimptomatik)
Utk pengobatan pasien memantau
perjalanan penyakit, mengidentifikasi
komplikasi, mengetahui kadar terapi suatu
obat, menetapkan prognosis dan
mengkonfirmasi suatu hasil pemeriksaan
yg tak diduga
Utk studi epidemiologis

Prinsip dasar uji diagnostik:

Uji diagnostik baru hrs memberi manfaat yg
lebih dibanding uji diagnostik yg sdh ada.

Lebih sederhana/mudah, murah dan tidak invasif

Dpt mendiagnosa pd fase lebih dini

Uji diagnostik bbtk tabel 2x2:

Hasil
uji

Penyakit
Ya
Tidak
PB
PS

Jlh
Ya
PB+P
S
Tidak
NS
NB
NB+N
S
PB=positif benar ; PS = positif semu ; NS = negatif semu ; NB =
negatif benar
Jlh
PB+NS PS+NB
total

Pd uji diagnostik kita menentukan

bagaimana suatu uji dpt memisahkan
antara subjek yg sakit dgn yg tdk sakit.
Cth
Suatu uji diagnostik thd 100 pasien limfoma
malignum yg dibuktikan dgn biopsi, 65
menunjukkan hasil positif; sdgkan uji
diagnostik yg sama thd 100 pasien dgn
pembesaran kelenjar non-limfoma, hanya 30
yg menunjukkan hasil uji positif. Bila
dilakukan uji hipotesis dgn X2, tdpt hubungan
yg bermakna (p<0,001) antara hasil uji
positif dgn tdptnya limfoma malignum.

Hasil
uji

Penyakit
Limfom
Non
Jlh
a
limfoma
Positif
PB
PS
PB+P
S
65
30
Negatif
NS
NB
NB+N
S
35
70
Jlh
PB+NS PS+NB Total
100
100
200

SENSITIVITAS dan SPESIFISITAS

BAKU EMAS
UJI
Positif Negati
Jlh
f
Positif
A
B
A+B
Negatif
C
D
C+D
Jlh
A+C
B+D A+B+C+
TABEL 2X2 HASIL UJI DIAGNOSTIK YAITU HASIL YG DIPEROLEH DGN UJI
D
YG DITELITI DAN DGN HASIL PD PEMERIKSAAN DGN BAKU EMAS.
Sensitivitas = A : (A+C)
Spesifisitas = D : (B+D)
Nilai prediksi positif (Positive Predictive Value ) = A :
(A+B)

PRE-TEST PROBABILITY = PREVALENCE = (A+C )

/ (A+B+C+D)

LR = LIKELIHOOD RATIO
LR+ = SENSITIVITY/(1-SPESIFICITY)
LR- = (1- SENSITIVITY)/SPESIFICITY

PRE TEST ODDS = PREVALENCE : ( 1PREVALENCE)

POST TEST ODDS = PRE TEST ODDS X LR
POST TEST PROBABILITY = POST TEST ODDS :
(1 + POST TEST ODDS)

Sensitivitas:
memperlihatkan kemampuan alat
diagnostik utk mendeteksi penyakit.
Kemungkinan bahwa hasil uji diagnostik
akan positif bila dilakukan pd sekelompok
subjek yg sakit.

Spesifisitas
Menunjukkan kemampuan alat diagnostik
utk menentukan bahwa subjek tidak sakit
Kemungkinan bahwa hasil uji diagnostik
akan negatif bila dilakukan pd sekelompok
subjek yg sehat.

Positive Predictive Value:

Probabilitas seseorang menderita
penyakit apabila uji diagnostiknya
positif.
= A : (A+B)

Negative Predictive Value:

Probabilitas seseorang tidak menderita
penyakit apabila uji diagnostiknya
negatif.
= D : (C+D)

Likelihood ratio:

Probabilitas dari hasil test pad orang yang

menderita penyakit dibandingkan dengan
probabilitas dari hasil test pada orang
yang tidak menderita penyakit.

Likelihood ratio ini menunjukkan berapa

kali kemungkinan suatu hasil test dijumpai
pada orang yang menderita penyakit
diabndingkan dengan orang normal.

POSITIVE LIKELIHOOD RATIO (LR+)

Menunjukkan berapa besar kemungkinan
suatu test memberikan hasil positif pada
orang yang sakit dibandingkan pada orang
sehat.
= { a/(a+c)} / {b/(b+d)}
= SENSITIVITY / (1- SPECIFICITY)

NEGATIVE LIKELIHOOD RATIO (LR-)

Menunjukkan berapa besar kemungkinan
suatu test memberikan hasil negatif pada
orang yang sakit dibandingkan pada orang
sehat.
= { c/(a+c)} / {d/(b+d)}
= (1- SENSITIVITY ) / SPECIFICITY

Kemampuan suatu test yang valid, bila

dapat merubah pendapat kita dari apa
yang kita pikirkan sebelum test (pretest
probability) ke apa yang kita pikirkan
setelah test (postest probability)

Test diagnostic akan lebih berguna bila

test tsb menghasilkan perubahan yang
besar (big changes) dari pretest
probability ke postest probability.

Cth 1:

Hasil
uji

Positif
Negatif
Jlh

Penyakit
Limfom
Non
a
limfoma
65
30
35
100

70
100

Jlh
95
105
200

Sensitivitas = A : (A+C) = 65 : 100

= 65%
Spesifisitas = D : (B+D) = 70 : 100
= 70%

Cth 2:

Positif
Mammog Negati
rafi
f
Jlh
SENSITIVITY:
A/(A+C)
(13/16)X100
%
= 81,25%

SPESIFICITY:
D/(B+D)

(28/32)X100
%
=87,5%

Histopatologi
Ca
Non Ca
13
4
3
28

Jlh
17
31

16

48

LR+:
SENS/
(1-SPEC)

(13/16)
/(1-28/32)
=6,5

32
LR-:
(1-SENS)
/SPEC

PRE-TEST
PROBABILITY
= PREVALENCE:
(A+C ) /
(A+B+C+D)

1-(13/16)
/(28/32)

16/48

=0,21

= 33,3%

PRE TEST ODDS=

PREVALENCE:
(1-PREVALENCE)

POST TEST ODDS=

PRE TEST ODDS X
LR+

POST-TEST PROBABILITY=
POST TEST ODDS:
(1+POST TEST ODDS)

0,5 X 6,5

3,25 : (1+3,25)
= 0.764
= 76,4%

(16/48) : (1-16/48)
= 0,5

Pretest probability
probability
33.3%

= 3,25

Post test
76.4%

Diagnostic tests that produce big changes from pretest to

post-test probabilities are important and likely to be useful to us
in our practice

Worksheet for

Diagnosi
s

DIAGNOSIS WORKSHEET
Citation:
Are the results of this diagnostic study valid?
Was there an independent, blind comparison with a
reference (gold) standard of diagnosis?
Was the diagnostic test evaluated in an appropriate
spectrum of patients (like those in whom it would be
used in practice)?
Was the reference standard applied regardless of the
diagnostic test result?
Was the test (or cluster of tests) validated in a second,
independent group of patients?

Are the valid results of this diagnostic study important?

SAMPLE CALCULATIONS
Target disorder
(iron deficiency anemia)
Present
Diagnostic
Positive
test result (< 65 mmol/L)
(serum
Negative
ferritin)
( 65 mmol/L)

Totals

Absent

731
a

270
b

1001
a+b

78
c

1500
d

1578
c+d

1770
b+d

2579
a+b+c+d

Totals
809= 90%
Sensitivity = a/(a+c) = 731/809
a+c = 85%
Specificity = d/(b+d) = 1500/1770

Likelihood ratio for a positive test result = LR+ = sens/(1-spec)

= 90%/15% = 6
Likelihood ratio for a negative test result = LR - = (1-sens)/spec
= 10%/85% = 0.12
Positive Predictive Value = a/(a+b) = 731/1001 = 73%
Negative Predictive Value = d/(c+d) = 1500/1578 = 95%
Pre-test probability (prevalence) = (a+c)/(a+b+c+d) = 809/2579
= 32%
Pre-test odds = prevalence/(1-prevalence) = 31%/69% = 0.45
Post-test odds = pre-test odds LR

Can you apply this valid, important evidence about

a diagnostic test in caring for your patient?
Is the diagnostic test available, affordable, accurate, and precise in your
setting?
Can you generate a clinically sensible estimate of your patients pre-test
probability (from personal experience, prevalence statistics, practice
databases, or primary studies)?
Are the study patients similar to your own?
Is it unlikely that the disease possibilities or probabilities have changed
since the evidence was gathered?
Will the resulting post-test probabilities affect your management and help
your patient?
Could it move you across a test-treatment threshold?
Would your patient be a willing partner in carrying it out?
Would the consequences of the test help your patient?

Additional notes:

Software:

CAT Maker

Thank
you..