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10 Screening (2)

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Screening in disease

control
Learning objective
Upon successful completion of this module, students
will be able to:
• Define screening and describe the basic concepts of
screening
• Describe criteria for diseases screening
• Describe types of screening
• Define validity and reliability of a screening test
• Compare measures of validity (sensitivity and
specificity)
• Describe factors affecting reliability of screening
test
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Brain storming

• Define screening and natural history of disease?


• Mention stages of natural history of disease and
which stage is appropriate time of do screening?
• What is the difference between screening and
diagnostic test?
Screening Definition

• Is the presumptive identification of unrecognized disease or


defect by the application of tests, examinations or other
procedures which can be applied rapidly in apparently
healthy individuals
• Screening tests sort out those who may have a disease from
apparently healthy people
• Screening is not usually diagnostic and it requires
appropriate investigative follow up and treatment
• Screening is an initial examination only, and positive
responders require a second, diagnostic examination
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Diagnosis Screening
Screening Diagnosing
• Healthy non patients •Sick patients
• No diagnostic intent •Diagnostic intent
• Very low to low •Low to high disease
disease prevalence prevalence

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Natural History of Disease
Detectable subclinical disease

Susceptible Subclinical Clinical Disease Stage of Recovery,


Host Disease Disability, or Death

Diagnosis
Point of Exposure sought

Onset of
symptoms

Screening
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Screening Process

Population (target population)

Screening
Test negative Test positive
Clinical
Exam

Unaffected Affected

Re-screen Intervene

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Purpose of Screening
• Aims to reduce morbidity and mortality from
disease among persons being screened
– To reverse, halt, or slow the progression of
disease more effectively than would probably
normally happen
– To alter the natural course of disease for a
better outcome for individuals affected
• Rational allocation of resources
• Selection of healthy individuals: employment,
military…
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Research; study on natural history of diseases 8
Diseases Appropriate for
Screening
To be appropriate for screening:
• A disease should be serious and have important
consequences
• The disease must progressive and treatment given
before symptoms develop should be more beneficial in
terms of reducing morbidity or mortality than that
given after they develop
• The prevalence of preclinical disease should be high
among the population screened
Criteria for establishing screening
program
1. The problem to be detected should be important
enough to be worth detecting.
2. There should be an acceptable intervention
which is effective.
3. The intervention should be feasible and
available.
4. There should be a recognizable latent or early
"asymptomatic "stage.
5. There should be a suitable test.
6. The test should be acceptable to the population
to be tested.

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Criteria…

7. The natural history of the condition, should be


adequately understood
8. There should be an agreed policy regarding
when the intervention is appropriate.
9. The cost of detecting the problem and its remedy
should be reasonable.
10. The screening program should be ongoing, and
not a "one-time“ effort.
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Characteristics of a good screening

• Simple: the screening should be easy to learn


and perform
– One that can be administered by non physician
medical personnel will necessary cost less than
one that requires years of medical training
• Rapid: the test should not take long to
administer, and the results should be available
soon
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Inexpensive: the lower the cost of a test, the
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Types of screening

There are different types of screening, each with specific aims


A. Mass screening – involves screening of a whole
population
B. Multiple or multiphasic screening – involves a variety
of screening tests on the same occasion
C. Targeted screening of groups with specific exposures – is
often used in environmental and occupational health
D. Case-finding or opportunistic screening – is restricted
to patients who consult a health practitioner for some other
purpose
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Screening Tests
• For screening to be successful, the screening test
must be:
 Economical (inexpensive),
 Convenient (easy to administer),
 Relatively free of risk and discomfort,
 Acceptable to a large number of individuals, and
 Highly valid and reliable.
• E.g., -Serology test for HIV, HBV, TB
-mammography for breast cancer & Pap
smear for cervical cancer
- HTN &DM

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Validity and Reliability
• How can we determine the extent to which a particular
indicator represents a given theoretical concept?
• There are 2 basic properties of empirical
measurements; Validity and Reliability
• The two are desirable qualities of any measuring
procedure or instrument

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Validity of a Screening Test

• Validity of a test is the ability to differentiate accurately


between those who have the disease and those who do not
• The validity of a screening test is how well the given
screening test reflects another test of known greater
accuracy
• Validity assumes that there is a gold standard to which a
test can be compared
• Sensitivity and Specificity are two measures of the
validity of a screening test

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Two by two table for calculation of
validity
Test result Result for a Gold
Standard test
Screening Diseased Non Total
Test Diseased
Positive TP(a) FP(b) TP+FP (a + b)

FN(c) TN(d) FN+TN (c +


Negative d)
TP+FN(a TN+FP(b + TP+FP+TN+F
Total + c) d) N
(a + b + c+ d)

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Validity cont…
• Sensitivity: The ability of a test to correctly identify
those who have the disease
• The percentage of those who have the disease and are
proven to have the disease as demonstrated by a test
• Is the probability of a positive test in people with the
disease
• More sensitive tests tend to identify cases earlier

Sensitivity = a/ (a + c)*100 i.e. TP/ (TP + FN)*100

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Validity cont…
• Specificity: the ability of a test to correctly identify those
who do not have the disease from peoples without the
disease
• The probability of a negative test in people without the
disease
• High specificity minimizes the number of false-positive
tests and their adverse consequences that must be
followed up
Specificity = d/ ( b + d)*100 i.e. TN/ (TN + FP)*100

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Predictive value of a test
• Predictive value is the ability of a test to predict
the presence or absence of disease from test
results

• Positive predictive value of a screening test is


the probability that the person tested positive by
this specific test truly has the disease
 PPV = (a/ a + b)*100 i.e. (TP/ TP + FP)*100

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Predictive value of a test...

• Predictive value negative of a screening test is


the probability that a subject does not have the
disease, given that the subject has a negative
screening test result
• Shows the degree of confidence the disease can be
ruled out by using this specific test
 NPV = (d/ c + d)*100 i.e. (TN/ TN + FN)*100

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Validity cont…
• False-positive rate: the proportion of non-
diseased persons the test classifies incorrectly as
positive (b/ (b + d))*100
– False positive rate = 1-specificity
• False-negative rate: the proportion of diseased
people the test classifies (incorrectly) as negative
(c/ (a + c))*100
– False negative rate = 1-sensitivity

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Validity cont…

• The yield (number of cases detected by the


screening program)
Persons with the
disease detected by the
Yield = test X 100
Total screened

TP
Yield = X 100
TP + FN + TN + FP

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Example
Sensitivity and specificity of breast cancer screening
examination (Health Insurance Plan of Great New York
(HIP Program)

Breast cancer
Yes No Total
Screening test
Positive 132 983 1115
Negative 45 63,650
63,695
Total 177 64,633 64,810

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Example…

Sensitivity = TP/ TP+FN *100


= 132/177 *100 = 74.6%

Specificity = TN/ TN+FP *100


= 63,650/64,633 *100 = 98.5%

PV+ = TP/ TP+FP *100


= 132/1115 = 11.8 %

PV- = TN/ TN+FN *100


= 63,650/63,695 *100 = 99.9%

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Example…

• False positive rate = FP/ FP+TN = 1- specificity


= 983/ 64633
= 1- 0.985 = 0.015 *100
= 1.5%
• False negative rate = FN/ FN+TP = 1- sensitivity
= 45/ 177
= 1- 0.746 = 0.254 *100
= 25.4%

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Validity cont…
• Sensitivity 74.6% means that of those diagnosed with
breast cancer during the study period, approximately
75% tested positive on the screening procedure
• Specificity 98.5% indicates that virtually all women
who did not have the disease tested negative
• It would be desirable to have a screening test that was
both highly sensitive and highly specific
• PPV = 11.8 % means the probability that a woman who
tested positive on the screen actually had breast cancer
is 11.8%
• NPV = 99.9% means the probability that a woman who
tested negative truly did not have breast cancer is
99.9%
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Reliability (Precision)

• Reliability refers to the consistency of results


when repeat examinations are performed on the
same persons under the same condition
• There are 4 sources of variability that can affect
the reproducibility of results of screening test:

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Reliability cont…

1. Biological variation

– Inherent in the actual manifestation being measured


such as BP
– Which varies considerably for a given individual with
time and other circumstances

2. Variation due to the test method or measurement


– Which relates to the reliability of the instrument itself,
such as standard mercury sphygmomanometer for BP

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Reliability cont…

3. Intra observer variability which refers to


differences in repeated measurements by the
same screener
4. Inter observer variation which refers to
inconsistencies attributable to differences in the
way different screeners apply or interpret test
results

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Reliability cont…

These variations can usually be reduced by:


1. Careful standardization of procedures
2. An intensive training period for all observers
(or interviewers)
3. The use of two or more observers making
independent observations
4. Periodic checks on their work

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Exercise
• Suppose that 100,000 men were screened for
prostate cancer for the first time. Of these, 4000
men had a positive result on the screening blood
test; of those who tested positive, 800 had a
biopsy indicating a diagnosis of prostate cancer.
Among the remaining 96,000 men who screened
negative, 100 developed prostate cancer within
the following year and were assumed to be false
negatives to the screen.
A. Set up the two-by-two table for these data.
B. What is the prevalence of prostate cancer in this
population?
C. Calculate and interpret the sensitivity of this
screening test.
D. Calculate and interpret the specificity of this
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THANK YOU

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