Diagnostic Study Appraisal Worksheet

DIAGNOSTIC ACCURACY STUDIES

Performance of the Interferon Gamma 
Release Assays in Tuberculosis Disease 
in Children Five Years Old or Less 
P : Anak dibawah 5 tahun dengan TB
I : IGRA dan TST
C : Standart diagnosis (kultur dan radiologis)
O : positif TB

Step 1: Are the results of the study valid?

Was the diagnostic test evaluated in a Representative spectrum of patients (like

those in whom it would be used in practice)?
What is best? Where do I find the information?
It is ideal if the diagnostic test is applied to the The Methods section should tell you how
full spectrum of patients - those with mild, patients were enrolled and whether they were
severe, early and late cases of the target randomly selected or consecutive admissions. It
disorder. It is also best if the patients are should also tell you where patients came from
randomly selected or consecutive admissions and whether they are likely to be representative
so that selection bias is minimized. of the patients in whom the test is to be used.
This paper: Yes  No  Unclear 
Comment: Pada studi ini tidak dijelaskan secara jelas bagaimana sampling dari pasien ini. Namun
studi melibatkan berbagai derajat penyakit dari TB biasa sampai berat.

Was the reference standard applied regardless of the index test result?
What is best? Where do I find the information?
Ideally both the index test and the reference The Methods section should indicate whether
standard should be carried out on all or not the reference standard was applied to all
patients in the study. In some situations where patients or if an alternative reference standard
the reference standard is invasive or expensive (e.g., follow-up) was applied to those who tested
there may be reservations about subjecting negative on the index test.
patients with a negative index test result (and
thus a low probability of disease) to the
reference standard. An alternative reference
standard is to follow-up people for an
appropriate period of time (dependent on

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Diagnostic Study Appraisal Worksheet

disease in question) to see if they are truly

negative.
This paper: Yes  No  Unclear 
Comment: Pada studi ini dilakukan pemeriksaan pada keseluruhan pasien.

Was there an independent, blind comparison between the index test and an
appropriate reference ('gold') standard of diagnosis?
What is best? Where do I find the information?
There are two issues here. First the reference The Methods section should have a description
standard should be appropriate - as close to of the reference standard used and if you are
the 'truth' as possible. Sometimes there may unsure of whether or not this is an appropriate
not be a single reference test that is suitable reference standard you may need to do some
and a combination of tests may be used to background searching in the area.
indicate the presence of disease. The Methods section should also describe who
Second, the reference standard and the index conducted the two tests and whether each was
test being assessed should be applied to each conducted independently and blinded to the
patient independently and blindly. Those who results of the other.
interpreted the results of one test should not be
aware of the results of the other test.
This paper: Yes  No  Unclear 
Comment: Pada studi dilakukan dengan alat yang terstandarisasi namun tidak dijelaskan dokter
anak yang memeriksa dilakukan blinding atau tidak.

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Diagnostic Study Appraisal Worksheet

Step 2: What were the results?

Are test characteristics presented?

There are two types of results commonly reported in diagnostic test studies. One concerns the
accuracy of the test and is reflected in the sensitivity and specificity. The other concerns how the
test performs in the population being tested and is reflected in predictive values (also called post-
test probabilities). To explore the meaning of these terms, consider a study in which 1000 elderly
people with suspected dementia undergo an index test and a reference standard. The prevalence
of dementia in this group is 25%. 240 people tested positive on both the index test and the
reference standard and 600 people tested negative on both tests. The first step is to draw a 2 x 2
table as shown below. We are told that the prevalence of dementia is 25% therefore we can fill in
the last row of totals - 25% of 1000 people is 250 - so 250 people will have dementia and 750 will
be free of dementia. We also know the number of people testing positive and negative on both
tests and so we can fill in two more cells of the table.
Reference Standard
+ve -ve
Index test +ve 240
-ve 600
250 750 1000
By subtraction we can easily complete the table:
Reference Standard
+ve -ve
Index test +ve 240 150 390
-ve 10 600 610
250 750 1000
Now we are ready to calculate the various measures.

Pada IGRA dan TST 5 mm

Penyakit
+ -
IGRA-TST + 112 123 235
- 5 290 295
117 413 530

Pada IGRA dan TST 10 mm

Penyakit
+ -
IGRA-TST + 110 109 219
- 7 304 311
117 413 530

Pada IGRA dan TST 15 mm

Penyakit
+ -
IGRA-TST + 101 59 160
- 16 354 370
117 413 530

What is the measure? What does it mean?

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Diagnostic Study Appraisal Worksheet
Sensitivity (Sn) = the proportion of people
with the condition who have a positive test
result.
Sensitivitas pada kelompok IGRA dan TST
5 mm adalah Sen = 112/117 = 95.7%.
Sensitivitas pada kelompok IGRA dan TST
10 mm adalah Sen = 110/117 = 94.01%.
Sensitivitas pada kelompok IGRA dan TST
15 mm adalah Sen = 101/117 = 86.3%.
Specificity (Sp) = the proportion of people
without the condition who have a negative
test result.
Spesifitas pada kelompok IGRA dan TST 5
mm adalah Spe = 290/413 = 70.2%.
Spesifitas pada kelompok IGRA dan TST
10 mm adalah Spe = 304/413 = 73.6%.
Spesifitas pada kelompok IGRA dan TST 5
mm adalah Spe = 354/413 = 85.7%.
Positive Predictive Value (PPV) = the
proportion of people with a positive test
who have the condition.
PPV pada kelompok IGRA dan TST 5 mm
adalah PPV = 112/235 = 47.6%.
PPV pada kelompok IGRA dan TST 10 mm
adalah PPV = 110/219 = 50.2%.
PPV pada kelompok IGRA dan TST 15 mm
adalah PPV = 101/160 = 63.1%.
Negative Predictive Value (NPV) = the
proportion of people with a negative test
who do not have the condition.
NPV pada kelompok IGRA dan TST 5 mm
adalah PPV = 290/295 = 98.3%.
NPV pada kelompok IGRA dan TST 10 mm
adalah PPV = 304/311 = 97.7%.
NPV pada kelompok IGRA dan TST 15 mm
adalah PPV = 354/370 = 95.6%.
The sensitivity tells us how well the test identifies
people with the condition. A highly sensitive test will
not miss many people.
Sebanyak 5% (5,58 ~ 6 anak) dengan TB dilakukan
kesalahan dalam identifikasi. Tes IGRA dan TST 5
mm baik dalam melakukan diagnosis pada pasien
TB.
Sebanyak 6% (7,02 ~ 7 anak) dengan TB dilakukan
kesalahan dalam identifikasi. Tes IGRA dan TST 10
mm baik dalam melakukan diagnosis pada pasien
TB.
Sebanyak 13.7% (16,02 ~ 16 anak) dengan TB
dilakukan kesalahan dalam identifikasi. Tes IGRA
dan TST 10 mm baik dalam melakukan diagnosis
pada pasien TB.
The specificity tells us how well the test identifies
people without the condition. A highly specific test
will not falsely identify many people as having the
condition.
Sebanyak 30% (123.9 ~ 124 anak) tanpa TB yang
salah terindentifikasi memiliki TB. Hasil ini
menunjukkan angka yang kurang baik.
Sebanyak 27% (111.5 ~ 112 anak) tanpa TB yang
salah terindentifikasi memiliki TB. Hasil ini
menunjukkan angka yang cukup baik.
Sebanyak 14% (57.8 ~ 58 anak) tanpa TB yang
salah terindentifikasi memiliki TB. Hasil ini
menunjukkan angka yang baik.
This measure tells us how well the test performs in
this population. It is dependent on the accuracy of
the test (primarily specificity) and the prevalence of
the condition.
Dari 235 pasien anak dengan hasil tes IGRA dan
TST 5 mm positif, maka 47.6% pasien terdiagnosis
TB.
Dari 219 pasien anak dengan hasil tes IGRA dan
TST 10 mm positif, maka 50.2% pasien terdiagnosis
TB.
Dari 160 pasien anak dengan hasil tes IGRA dan
TST 15 mm positif, maka 63.1% pasien terdiagnosis
TB.
This measure tells us how well the test performs in
this population. It is dependent on the accuracy of
the test and the prevalence of the condition.
Dari 295 pasien anak dengan hasil tes IGRA dan
TST 5 mm positif maka, 98.3% pasien tidak
terdiagnosis TB.
Dari 304 pasien anak dengan hasil tes IGRA dan
TST 10 mm positif maka, 97.7% pasien tidak
terdiagnosis TB.
Dari 370 pasien anak dengan hasil tes IGRA dan
TST 15 mm positif maka, 95.6% pasien tidak
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Diagnostic Study Appraisal Worksheet

terdiagnosis TB.

Step 3: Applicability of the results

Were the methods for performing the test described in sufficient detail to permit
replication?
What is best? Where do I find the information?
The article should have sufficient description of The Methods section should describe the test in
the test to allow its replication and also detail.
interpretation of the results.
This paper: Yes  No  Unclear 
Comment: Ya. Pada studi ini di bagian methods dijelaskan secara detail bagaimana cara
pemberian dan pengambilan test dilakukan