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Middle East Fertility Society Journal

Vol. 12, No. 1, 2007

Copyright Middle East Fertility Society

EVIDENCE-BASED MEDICINE CORNER

Evidence-based diagnosis: II. Sensitivity and specificity


Abdelhamid Attia, M.D.
Prof. of Obstetrics & Gynecology - Cairo University; President of the Arab Federation of Evidence-Based Medicine

Practicing EBM requires certain steps which


are: 1) to assess the patient, 2) to phrase a question,
3) to search the literature for evidence, 4) to
appraise the evidence, and 5) to apply the evidence
to patient care.

now know, from the first part of this article, you


have to calculate a pre test probability of having
the disease then calculate the posttest probability
of having (or not having) it. This needs a search for
articles that evaluated the accuracy of HSG in
diagnosing or excluding tubal obstruction.

Clinical Scenario
The search
You are working at your clinic when 2 patients
who complain of infertility (Mrs. A and Mrs. B)
came to you with their hysterosalpingography
(HSG)
results.
Looking
into
their
hysterosalpingograms you find that Mrs. A has a
negative result (tubes patent) and Mrs. B has a
positive result (tubes obstructed). Knowing that
the results of semen analysis of both partners and
midluteal serum progesterone of both women are
normal; you decide to start treatment for Mrs. A
and plan for laparoscopy for Mrs. B. But you were
stopped by a question from Mrs. A saying
Doctor! What is the probability that this test result
is wrong and that I am going to start treatment that
will not work for me? and from Mrs. B saying:
What is the probability that this result is wrong
and that laparoscopy would be unnecessary?

You know correctly that any test result is never


certain. This means that a positive test result does
not necessarily mean that the patient is having the
disease and vice versa. Thus, you need to know
exactly the probabilities of having or not having
the disease or disorder in question and to answer
the questions of your patients properly. As you

Unlike therapy in which randomized controlled


trials give the highest evidence, for diagnosis
research the cross sectional double blind
comparison with a gold standard is the best study
design to answer questions about diagnosis. When
searching for evidence we first search for a
systematic review that addressed the problem at
hand and in absence of systematic reviews we
search for original primary studies. The gold
standard for the diagnosis of tubal disease in
comparison with HSG is laparoscopy. So you would
like to have a systematic review or a meta-analysis
for articles that studied the accuracy of HSG
compared with laparoscopy for the diagnosis of
tubal disease.
Searching the PubMed using hysterosalpingography as a key word and limiting the search to
meta-analysis retrieved 5 articles only (Fig. 1).
You read the abstracts and find that only one of
them addresses your query (1).
This meta-analysis has analyzed 20 studies with
4197 patients for whom both HSG and laparoscopy
had been performed for comparison. In this metaanalysis the sensitivity of HSG was found to be
65% and the specificity 83%.
Now given these data about HSG; how are you

Vol. 12, No. 1, 2007

Attia

The problem

Evidence-based medicine

69

Figure 1. Studies Retrieved In the Search

going to answer your patients?


Sensitivity and Specificity?
Sensitivity is the probability of a positive test
among those who have the disease. It equals
number of diseased individuals who tested
positive divided by the total number of diseased
individuals. For example if you tested 100
diseased individuals with a new test that gave you
92 positive results (which are true positive here)
and 8 negative results (which are false negative
here) this test has a sensitivity of 92/100 = 92%.
Thus it is important to emphasize that there are
always false negative results whose probability
equals 100 minus sensitivity (%) which mean in
this example that 8% of the real patients who
would be tested would have a negative test result

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Attia

Evidence-based medicine

i.e. diagnosed wrongly by the test as free from the


disease.
Specificity is the probability of a negative test
among those who are free from the disease. It
equals number of disease-free persons who tested
negative divided by the total number of diseasefree individuals For example if you tested a 100
free individuals (not having the disease) with a
new test that gave you 88 negative results (which
are true negative here) and 12 positive results
(which are false positive here) this test has a
specificity of 88/100 = 88%. Thus it is important to
emphasize that there are always false positive
results whose probability equals 100 minus
specificity (%) which mean in this example that
12% of the free individuals who would be tested
would have a +ve test result and would be
diagnosed wrongly as having the disease.

MEFSJ

Table 1. Results of HSG In 200 Women When Sensitivity is 65% and Specificity Is 83% and 50% of study population has tubal
obstruction.

HSG Positive (Tubes Blocked In HSG)


HSG Negative (Tubes Patent In HSG)

Women with known blocked tubes by


laparoscopy (100 women)

Women with known patent tubes by


laparoscopy (100 women)

65 (True +ve)
35 (False ve)

17 (False +ve)
83 (True ve)

Sensitivity and specificity are not helpful to


clinicians as they only tell us how the test works in
the population but not whether a specific patient
has the disease or not. Thus given the above
sensitivity and specificity for HSG in diagnosing
tubal obstruction we can only conclude that HSG
correctly diagnoses 65% of patients with tubal
obstruction meanwhile 35% would be falsely
diagnosed as having patent tubes. While it
correctly identifies 83% of women with patent
tubes meanwhile 17% would be falsely diagnosed
as having tubal obstruction.
This can be illustrated more by studying a
population of 200 women in which 100 women
have tubal obstruction and the other 100 have
patent tubes and see how does the test work in
them (Table 1).
SnNout
It is important to know that even a test with 100%
sensitivity, in which all diseased individuals would
test +ve, is not good for diagnosing or ruling in the
disease if it has a lower specificity. On the contrary
this test is used better to exclude or rule out the
disease rather than to diagnose its presence (Table 2).
From the above table we observe that when
sensitivity is 100% and specificity is 80% all
diseased individuals will test +ve but also 20% of
free individuals will test +ve. Thus, there are two
possibilities for a patient with a +ve test result. She
may have the disease if her result is a true +ve one
but she also might be diagnosed wrongly as having
the disease if her result is a false +ve one.
We can also observe that 80% of free
individuals will test ve and that none of the
diseased individuals will test ve. Thus there is
only one possibility for a patient with a ve test
result. She would be diagnosed correctly to be free
from the disease.

Vol. 12, No. 1, 2007

So the mnemonic snNout means that: when


Sensitivity is high a Negative test result rules out
the disease.
SpPin
It is also equally important to know that even a
test with 100% specificity, in which all disease-free
individuals would test -ve, is not good for excluding
or ruling out the disease if it has a lower sensitivity.
On the contrary this test is used better to diagnose or
rule in the disease (Table 3).
From table three we observe that when sensitivity is
90% and specificity is 100% all disease-free
individuals will test -ve but also 10% of diseased
individuals will test -ve. Thus, there are two
possibilities for a patient with a -ve test result. She
may be free of the disease if her result is a true -ve
one but she also might be diagnosed wrongly as free
of the disease if her result is a false -ve one.
We can also observe that 90% of diseased
individuals will test +ve and that none of those who
are free from the disease will test +ve. Thus there is
only one possibility for a patient with a +ve test result.
She would be diagnosed correctly to have the disease.
So the mnemonic SpPin means that: when
Specificity is high a Positive test result rules in the
disease.
Table 2. Results of a test when sensitivity is 100% and
specificity is 80%.
Diseased Subjects
(100)

Free Subjects
(100)

Test Positive

100
(True +ve)

20
(False +ve)

Test Negative

0
(False ve)

80
(True ve)

Attia

Evidence-based medicine

71

Table 3. Results of a test when sensitivity is 90% and


specificity is 100%.

Test Positive
Test Negative

Diseased Subjects
(100)

Free Subjects
(100)

90
(True +ve)
10
(False ve)

0
(False +ve)
100
(True ve)

What you really need to know is what is the


probability of a patient with a +ve test to have the
disease and what is the probability of a patient with
a ve test to be free from the disease. So, here it
looks that a better measure would be the +ve and
ve predictive values of the test that would be
covered in the coming article about diagnosis.

REFERENCES
Now back to Mrs. A and Mrs. B questions you
now know that knowing the sensitivity and
specificity of HSG can not help you, as such, to
answer their questions. You can only tell them at
this moment that HSG misses the correct diagnosis
of patent tubes in 17% of the cases and of
obstructed tubes in 35% of the cases.

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Evidence-based medicine

1.

Swart P, Mol BW, van der Veen F, van Beurden M,


Redekop WK, Bossuyt PM. The accuracy of
hysterosalpingography in the diagnosis of tubal
pathology: a meta-analysis Fertil Steril. 1995
Sep;64(3):486-91.

MEFSJ

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