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Screening Tests
Screening Tests
Screening Tests
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How to Approach Fusion Sessions
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Fusion sessions are online learning activities followed by a live session where you will
translate the content into practice. These require completing learning content in Canvas
before attending live sessions. To encourage preparation, attendance, and participation,
recordings of fusion sessions will not be posted; prepare accordingly so that you can fully
participate. Remember: Learning from written materials is a critical professional and
personal skill that RUSM is helping you develop through these sessions.
Suggested Process
1. Work through the content on this page.
2. Contact faculty via email or office hours if you have questions about content to ensure
you are prepared for the session.
3. Take the quiz. (You have three attempts.)
4. Attend and participate in the live session.
5. Take the quiz again.
6. Study missed content.
7. Take the quiz for the final attempt.
Overview
In this session, we will review the properties of screening and diagnostic tests and practice putting
these concepts to use in a TBL-style workshop.
Case Connection
MC is a 50-year-old woman who comes in for routine healthcare. Following the most recent
prevention guidelines for breast cancer screening, you order a routine mammogram. The
final report describes dense breast tissue, fibrocystic breast disease, and a questionable
area of thickening. When you inform MC of the results, she is distraught. “Let’s not jump to
any conclusions,” you say. “We should biopsy the suspicious area,” you say. MC is
scheduled for a biopsy the following week and is relieved when she is told the results are
negative. “I’m so happy,” she says, “but didn’t the mammogram find cancer? How can that
test be wrong? Did the radiologist misread it?”
How will you answer MC’s question? Consider your answer as you read, and we’ll revisit MC
at the end of the fusion session.
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Content and images for this lecture are used with permission from ScholarRx. Click the following link for a direct link
to the page: Diagnostic Test Characteristics (https://exchange.scholarrx.com/brick/diagnostic-test-characteristics)
. CC BY-SA 4.0 (https://creativecommons.org/licenses/by-sa/4.0/)
Learning Objectives
By the end of this session, you will be able to meet the following learning objectives:
Diagnostic Tests Characteristics
One of the main tasks of physicians is recognizing a disease so that it can be treated
appropriately. In addition to performing high-quality histories and physical exams (which are forms
of tests), physicians use a variety of diagnostic tests to increase or decrease the likelihood of
specific diagnoses. They, therefore, need to understand the diagnostic value and limitations of the
tests they use as well as how a test result should affect the likelihood of disease.
To evaluate the utility of a diagnostic test, we use specific test characteristics such as positive and
negative predictive values, sensitivity, and specificity. These characteristics are the focus of this
discussion.
Use the test in a patient sample that would normally require evaluation for the outcome in
question.
Have everyone receive the diagnostic test as well as the gold-standard test (the best
possible test for a condition, which is used as a benchmark).
Compare the results of the diagnostic test against those of the gold-standard test.
Therefore, a good quality gold standard is imperative. The lack of a quality gold standard can
impair the evaluation of a test.
Click on the following tabs to learn more about potential test outcomes, sensitivity, and specificity.
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Test results can be positive or negative, and those results can be true or false, depending on
whether they accurately reflect the patient’s condition. These qualities are combined when
describing a test result, leading to four possible scenarios:
True positive (TP): Patient with the disease has a positive test result.
False positive (FP): Patient without the disease has a positive test result.
True negative (TN): Patient without the disease has a negative test result.
False negative (FN): Patient with the disease has a negative test result.
Now that we’ve covered each of the potential outcomes of a diagnostic test, we’ll go into the
characteristics used to describe the performance of a test.
Sensitivity
If our patient has the disease, what are the chances that they will have a positive test result?
Sensitivity is the proportion of individuals with the disease that are true positives (TPs).
In clinical practice, a test is considered sensitive when a large proportion of individuals with the
disease are expected to have a positive test result; if not, the test is considered insensitive. For
instance, an antinuclear antibody (ANA) titer is sensitive for the diagnosis of systemic lupus
erythematosus (SLE) because most people with SLE have positive ANA tests. Conversely, a
chest X-ray is insensitive for the diagnosis of pulmonary embolism (PE) because many people
with PE have normal chest X-rays. A very sensitive test is useful to rule out a disease if it is
negative, a patient with a negative ANA titer would be unlikely to have SLE. However, a PE
cannot be reliably ruled out in a patient with a negative chest X-ray.
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Specificity
On the other hand, if our patient does not have the disease, what are the chances that they will
have a negative test result? Specificity (true negative rate) is the proportion of individuals
without the disease that are true negatives. It’s calculated as TN ÷ (TN + FP), also shown in
the image in the sensitivity accordion.
In clinical practice, a test is considered specific when only a small proportion of individuals
without the condition tested are expected to have a positive test result; if not, the test is
considered nonspecific. For instance, an anti–double–stranded DNA antibody (anti-dsDNA)
titer is specific for the diagnosis of SLE (i.e., mainly SLE patients have a positive test, not
others). An ANA titer is nonspecific for SLE, as it can be positive in healthy individuals and in
other diseases. A very specific test is useful to rule in a diagnosis when it is positive.
Accordingly, you can be confident that a patient with a positive anti-dsDNA titer most likely has
SLE, but this conclusion cannot be reached with a positive ANA titer (a sensitive, but not
specific test).
Clinical Correlation
Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder that has a wide
range of clinical manifestations, including various rashes, oral ulcers, arthralgia/arthritis,
cytopenias, and kidney disease.
Click through the following interactive to learn more about the SnOut and SpIn mnemonic.
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Turn
Card 1 of 2
Transcript
Card 1
Front:
Back:
Card 2
Front:
Which type of test is better to rule in a disease, and which one is better to rule out?
Back:
A specific test is good to rule in a disease when its results are positive, whereas a sensitive
test is good to rule out a disease when its results are negative.
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Now that our patient has a positive test, what are the chances that they have the disease?
The positive predictive value (PPV) is the proportion of positive tests that are true positives or
the proportion of individuals with the disease among positive tests.
The formula used to calculate PPV is TP ÷ (TP + FP) and is shown at the right of the image.
A test must have a high PPV if we’re to trust its positive result. For instance, a test with a PPV
of 30% would mean that even with a positive test, an individual would only have a 30% chance
of having the disease (and therefore a 70% chance of not having it).
Since FP is in the denominator of both specificity and PPV, they are often either both high or
low. In other words, if a test is very specific, few individuals without the disease will have a
positive test (low FP), so most positive tests will be true positives, and the PPV will be high.
In contrast, if our patient has a negative test result, what are the chances that they do not have
the disease? The negative predictive value (NPV) is the proportion of negative test results that
are true negatives or the proportion of individuals without the disease among negative tests.
The formula used to calculate NPV is TN ÷ (TN + FN) and is shown in the image above. A test
must have a high NPV if we’re to trust its negative result. For instance, a test with an NPV of
30% would mean that even with a negative test, an individual would only have a 30% chance
of not having the disease (and therefore a 70% chance of having it).
For the same reason PPV and specificity are related, NPV is related to sensitivity. If a test is
very sensitive, few individuals with the disease will have a negative test (low FN), so most
negative tests will be true negatives, and the NPV will be high.
Click through the following interactive to learn more about the patients' positive test result.
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p p
disease tested is 40%, what
Cardare the1 chances that they do not
1 of
have the disease?
Turn
Transcript
Front:
If a patient has a positive test result and the PPV for the disease tested is 40%, what are
the chances that they do not have the disease?
Back:
60% (chance of having the disease is 40%, so chance of not having the disease = 100% -
40%)
However, the PPV and NPV of a test depend on the prevalence of the disease in the population.
Recall that prevalence is the total number of cases in the population divided by the total
population. The best way to illustrate this is to study a disease, say disease X, with a test that has
a sensitivity of 90% and a specificity of 80%. The prevalence of disease X in population A is 10%,
while it is 30% in population B. Both populations have 1000 individuals. With this information, we
can draw the two tables seen in the image below.
As the image shows, the PPV and NPV of a test are influenced by the prevalence of the disease
in the population. A higher prevalence means that more individuals will be true positives and that
fewer will be false positives, leading to a higher PPV. Conversely, the number of false negatives
will increase, and the NPV will decrease. The opposite effect is seen with a lower prevalence: the
PPV decreases, and the NPV increases. In summary, the following changes in diagnostic test
characteristics occur when the prevalence changes:
Click through the following interactive to learn more about the positive predictive value.
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Turn
Card 1 of 1
Transcript
Front:
If the positive predictive value of a test has increased in a population, does that mean the
prevalence has increased or decreased?
Back:
So far, we have determined that diagnostic tests can be either positive or negative. For some
types of tests, differentiating a positive from a negative result is easy: an abdominal ultrasound
can be either positive for gallstones if they are observed or negative if they are not. However,
this distinction is not as clear for numerical tests with continuous values, such as most blood
and serum tests.
Let’s start with two extremes. In the image below on the left, a test is chosen so that the true
negative population (blue) and the true positive population (red) are perfectly distinct.
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Point X is the test value that separates them, and all patients with a value greater than X have
the disease. All of those with a value under X will not have the disease. This symmetry is rare,
however.
In the image above on the right shows the opposite. In this test, the true positives and
negatives completely overlap, and no test result can separate them. This would be a
completely useless test, a flip of the coin, so to speak.
For most legitimate tests, the two populations overlap. For example, what should be the cutoff
for an ANA titer to be considered positive for SLE since the amount of the antibody exists in a
range of values in different patients? This decision influences the characteristics of the
diagnostic test. This concept can be visualized in the image below.
In the case of ANA titers in SLE, if a low cutoff value is chosen (e.g., cutoff point A in the image
above), the test will be more sensitive (a larger portion of the red curve in the image above is
correctly detected), as even individuals with SLE and a low ANA titer will be true positives
instead of false negatives (portion labeled as “FN” is correctly detected). The NPV will also
increase, as only very low ANA titers will be considered negative, which is more likely to occur
in patients without SLE. However, having a low ANA titer cutoff value will result in more
individuals without SLE having a positive test, resulting in decreased specificity (a larger
portion of the blue curve in the image above is falsely detected), more false positives (portion
labeled as “FP” is falsely detected), and a lower PPV.
In contrast, if a high cutoff value is chosen (cutoff point C), the test will be more specific (a
smaller area of the blue curve is falsely detected), as individuals with a moderately high ANA
titer without SLE will be true negatives instead of false positives (portion labeled as “FP” is
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correctly not detected). The PPV will increase, as only those with high ANA titers will be
considered positive, which is more likely to occur in SLE. However, having a high ANA titer
cutoff value will result in more individuals with SLE having a negative test, resulting in
decreased sensitivity (a larger area of the red curve is missed), more false negatives (portion
labeled as “FN” is missed), and a lower NPV.
Click through the following interactive to learn more about the cutoff value.
g
sensitive, what will
Cardbe the
1 ofeffect
1 on the PPV?
Turn
Transcript
Front:
If the cutoff value of a test is changed to make it more sensitive, what will be the effect on
the PPV?
Back:
The PPV will decrease; sensitivity has increased, meaning that the false positive value has
increased.
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Thus, sensitivity and specificity are interconnected when deciding on a cutoff value, and
they usually vary at the expense of each other (cutoff points A vs. C). In clinical practice,
the cutoff value is often a compromise that allows acceptable sensitivity and specificity
(cutoff point B).
Thus, sensitivity and specificity are interconnected when deciding on a cutoff value, and they
usually vary at the expense of each other (cutoff points A vs. C). In clinical practice, the cutoff
value is often a compromise that allows acceptable sensitivity and specificity (cutoff point B).
On a ROC for a given test, every possible cutoff value of the test is plotted; for each cutoff value,
the true positive rate (i.e., sensitivity) and false positive rate (1 – specificity) are both plotted.
The perfect cutoff is the top left corner. Here, the true positive rate is 100%, and the false positive
rate is 0%—the perfect test! That would be like point X in the How are test Cutoffs Chosen
section, left, above. It would completely separate the two populations.
At the opposite extreme is any cutoff value on the diagonal (dotted blue line). For each of the
points on this line, true positive rate = false positive rate—a coinflip. This portrays the How are
test Cutoffs Chosen section, right, and the test is useless.
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Most tests fall in between, as the gray curve does in the image above. The closer the curve
comes to the upper left corner, the better the test. If you calculate the area under the curve (AUC),
which is the hatched area in the image above, this corresponds to the predictive value of the test.
As you can see, the ideal curve, including the top left corner, would have the greatest area (1) and
perfect predictive value. A useless test would have an AUC of 0.5 and, thus, no predictive value.
Clinical Correlation
Mammography is an excellent screening test, with sensitivity for breast cancer at 97%
but specificity of only 65% (many false positives, like benign cysts). A positive
mammograph, as occurred with patient MC, must be confirmed by a more specific
test. Screening tests should be easy and inexpensive, so they can be used in large
populations.
A positive screening test is, therefore, often not sufficient for diagnosis and requires a
confirmatory test. This type of test needs to be highly specific to ensure that those with a
positive result have a high likelihood of having the disease.
Clinical Correlation
A biopsy is the most specific test for breast cancer, with a very low false positive rate.
Its sensitivity as a screening test would not be good because it is invasive and
impractical to do on a large scale and because the pathologist may not pinpoint the
area, leading to a false negative.
Click through the following interactive to learn more about diagnostic test characteristics.
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Turn
Card 1 of 1
Transcript
Front:
What is the most important diagnostic test characteristic for a screening test, and what
is it for a confirmatory test?
Back:
What are Test Accuracy, Validity, and Precision?
We’ll finish up by discussing three additional properties of tests.
Accuracy is the ability of a diagnostic test to generate results that are true and free of systematic
error or bias.
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Validity often is used interchangeably with accuracy; however, it more specifically refers to
whether the test measures what it was intended to measure. Validity includes aspects beyond
accuracy, including methodology and study design.
As you can see, a test can be accurate without being precise or precise without being accurate.
An ideal test is both accurate and precise.
Click through the following interactive to learn more about forgetting to tare.
Turn
Card 1 of 1
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Transcript
Front:
If you forget to tare (i.e., reset to zero) a scale after placing a container on it and then weigh
the same thing on it multiple times, which measure will be affected: precision or accuracy?
Back:
If you forget to tare (i.e., reset to zero) a scale after placing a container on it and then weigh
the same thing on it multiple times, accuracy will be affected, as all your measurements will
have the same systematic error (the weight of the container), whereas precision should not be
affected.
Case Connection
You explain to MC that mammograms are highly sensitive tests meant to not miss any cases
of breast cancer. Because of the high sensitivity, the mammogram may pick up even minor
breast abnormalities and interpret them as cancer. To make the distinction between cancer
and, for example, cysts or normal breast tissue, you tell MC that a biopsy is needed. You
explain that biopsies are highly specific, meaning that a positive result would indicate breast
cancer. “I’m glad the biopsy was negative, and I understand the importance of not missing
any case of breast cancer, but I can tell you that my anxiety level was through the roof while I
waited for the results of the biopsy,” said MC.
Summary of Screening Tests
Sensitivity (true positive rate) is the proportion of true positives among all the individuals
with the disease.
Specificity (true negative rate) is the proportion of true negatives among all individuals
without the disease.
A highly sensitive test, when negative, is good to rule out a disease.
A highly specific test, when positive, is good to rule in a disease.
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The positive predictive value (PPV) is the proportion of true positives among all positive
tests.
The negative predictive value (NPV) is the proportion of true negatives among all negative
tests.
Increasing the sensitivity of a test increases its NPV.
Increasing the specificity of a test increases its PPV.
The prevalence of the condition tested has no influence on the sensitivity or specificity of a
diagnostic test.
An increase in the prevalence of the condition tested increases the test’s PPV and
decreases its NPV.
A decrease in the prevalence of the condition tested increases the test’s NPV and
decreases its PPV.
Lowering a test’s cutoff value will increase its sensitivity and NPV but decreases its
specificity and PPV.
Increasing a test’s cutoff value will increase its specificity and PPV but decreases its
sensitivity and NPV.
An ideal screening test needs to be highly sensitive to decrease the number of false
negatives.
An ideal confirmatory test needs to be highly specific to decrease the number of false
positives.
Accuracy is a test’s ability to generate results that are true and free of systematic error or
bias.
Validity often is used interchangeably with accuracy but also includes factors such as
methodology and study design.
The precision (reliability) of a test refers to its reproducibility, consistency, and extent of
random variation.
Check Your Knowledge
Click through the following interactive to check your knowledge.
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Decreased sensitivity
Increased specificity
Check
Transcript
1. If the prevalence of a disease increases in a population, which of the following changes will
occur to the diagnostic test characteristics?
Answer:
Other choices:
Explanation:
The correct answer is decreased negative predictive value (A). With increasing prevalence, a
larger proportion of negative tests will be false negatives, and the NPV will decrease.
Decreased positive predictive value (B) is incorrect because as prevalence increases, a larger
proportion of positive tests becomes true positives and the PPV will increase. Decreased
sensitivity (C) is incorrect because the sensitivity of a test does not change with prevalence.
Increased specificity (D) is incorrect because the specificity of a test does not vary with
prevalence. Increased true positive rate (E) is incorrect because the true positive rate
corresponds to the sensitivity of the test, which does not vary with prevalence.
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2. If the diagnostic cutoff of a test is increased, which of the following changes will occur to the
diagnostic test characteristics?
Answer:
Other choices:
Decreased prevalence
Decreased specificity
Increased negative predictive value
Increased sensitivity
Explanation:
The correct answer is increased positive predictive value (D). If the diagnostic cutoff is higher,
fewer false positives will be seen, and the PPV will increase. Decreased prevalence (A) is
incorrect because although fewer cases might be detected by raising the diagnostic cutoff, the
actual prevalence of the disease does not change. Decreased specificity (B) is incorrect
because raising the cutoff point will increase specificity. Increased negative predictive value (C)
is incorrect because raising the cutoff point will lead to a higher proportion of false negatives
and therefore a decreased NPV. Increased sensitivity (E) is incorrect because raising the cutoff
point will decrease sensitivity.
Other choices:
Explanation:
The correct answer is low false negative rate (C). The goal of a screening test is to detect as
many affected individuals as possible and minimize the number of false negatives (individuals
with the disease that are missed). High positive predictive value (A) is incorrect because a
highly sensitive test might result in a relatively high number of false positives and a reduced
PPV. A high PPV is more important for a confirmatory test. High specificity (B) is incorrect, as
this is a required characteristic of confirmatory tests. Low specificity (D) is incorrect. A highly
sensitive test might have a low cutoff value and be relatively nonspecific, but this is not a
requirement for a good screening test.
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4. When a blood sample glucose level is measured 10 times by five different glucometers, they
all give the same value: 102 ± 3 mg/dL. However, a sixth glucometer gives a value of 102 ± 12
mg/dL. Compared to the first five glucometers, what is the precision and accuracy of the sixth
one?
Answer:
Other choices:
Explanation:
The correct answer is no change in accuracy, decreased precision (C). The mean glucose
value is the same as the other glucometers, so the result is accurate. However, the higher
standard deviation indicates more variability between the measurements, meaning that
precision is lower. Decreased accuracy, decreased precision (A) is incorrect because the mean
glucose value is the same as other glucometers, so the result is accurate. Decreased
accuracy, no change in precision (B) is incorrect because a higher standard deviation means
lower precision, not lower accuracy. No change in accuracy, increased precision (D) is
incorrect because a higher standard deviation means lower (not higher) precision. No change
in accuracy, no change in precision (E) is incorrect because a higher standard deviation means
lower precision.
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Quiz
Quiz | Screening Test (https://rossmed.instructure.com/courses/3497/quizzes/21755)
Contact
Dr. Karie Gaska
Email: kgaska@rossu.edu
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