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DSL on Screening 1
Learning outcomes
The students would be able to:
●​ Compare and contrast screening and diagnostic test
●​ Correlate favorable characteristics of a disease that make screening useful and relevant
for the disease.
●​ Select an ideal screening test on the basis of its characteristics and ethics.
●​ Interpret calculated values of the Sensitivity, Specificity, PPV, NPV, False positive and
False negative rate and accuracy of the test​

The iceberg phenomenon describes a situation in which a large percentage of a problem is

subclinical, unreported, or otherwise hidden from view. Thus, only the "tip of the iceberg" is
apparent to the epidemiologist. Uncovering disease that might otherwise be below "sea-level" by
screening and early detection often allows for better disease control. According to the iceberg
phenomenon of disease, submerged portion of the iceberg represents the hidden mass of the
disease (e.g. sub clinical cases, carriers, undiagnosed cases), while the floating tip is what the
physician sees in his practice.
Screening may be defined as “The presumptive identification of unrecognized diseases or defect
by the application of tests, examinations or other procedures which can be applied rapidly to
sort out apparently well persons who probably have a disease from those who probably do not.”

The screening test itself does not necessarily diagnose illness, those who test positive are
evaluated by a subsequent diagnostic procedure to determine whether they in fact do or do not
have the disease.
Comparison of screening and diagnostic test.

Screening test Diagnostic test

1 Done on apparently healthy Done on those with indications or sick
2 Applied to groups Applied to single patients, all diseases are
considered
3 Test result are arbitrary and final Diagnosis is not final but modified in light of
new evidence, diagnosis is the sum of all
evidence
4 Based on one criterion or cut-off point Based on evaluation of a number of
(e.g, diabetes) symptoms, signs and laboratory findings
5 Less accurate More accurate
6 Less expensive More expensive
7 Not a basis for treatment Used as a basis for treatment
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8 The initiative comes from the The initiative comes from a patient with a
investigator or agency providing care complaint
Aims & Objectives of Screening
It is carried out in a hope that earlier diagnosis and subsequent treatment favorably alters the
natural history of the disease in a significant proportion of those who are identified
CRITERIA FOR SCREENING (Wilson’s Criteria)
Before a screening program is initiated, a decision must be made whether it is worthwhile,
which requires ethical, scientific, and, if possible financial justification. The criteria for
screening are based on two considerations: the DISEASE to be screened, and the TEST to be
applied.
Disease
The disease to be screened should fulfill the following criteria before it is considered suitable
for screening:
1.​ The condition sought should be an important health problem (in general, prevalence
should be high);
2.​ There should be a recognizable latent or early asymptomatic stage;
3.​ The natural history of the condition, including development from latent to declared
disease, should be adequately understood (so that we can know at what stage the
process ceases to be reversible);
4.​ There is a test that can detect the disease prior to the onset of signs and symptoms;
5.​ Facilities should be available for confirmation of the diagnosis;
6.​ There is an effective treatment;
7.​ There should be an agreed-on policy concerning whom to treat as patients (e.g., lower
ranges of blood pressure; border-line diabetes);
8.​ There is good evidence that early detection and treatment reduces morbidity and
mortality;
9.​ The expected benefits (e.g., the number of lives saved) of early detection exceed the
risks and costs.
When the above criteria are satisfied, then only, it would be appropriate to consider a suitable
screening test.
Screening Test Criteria: -
General Specific characteristics: pertaining to functions
characteristics
Simple 1. Validity: Sensitivity and Specificity
Safe, usually 2. Yield: Positive predictive value/Negative predictive value
non-invasive
Rapid 3. Reliability or precision or reproducibility
Feasible
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Low cost
Easy to administration
Acceptable

Validity
Validity of a screening test is measured by its ability to do what it is supposed to do i.e., provides
a good preliminary indication of which individuals actually have the disease and which do not.​
Validity has two components:​
1. Sensitivity (true positive rate)​
2. Specificity (true negative rate)
Sensitivity of a test is the ability of the test to detect disease in all those who actually have the
disease (i.e., correctly identify all those who have the disease)​
Specificity of a test is the ability of the test to rule out disease in all those in whom the disease is
actually absent (i.e., correctly identify all those who do not have the disease).
An ideal screening test is one that is 100% sensitive and 100% specific. If disease is present an
ideal, or truly accurate, test will always give a positive result. If disease is not present, the test
will always give a negative result. In practice this does not occur.

Yield
Yield of a screening test is the number of persons detected by a screening program. It is an
important measure for determining the usefulness of a test under field conditions. It is estimated
by assessing:​
• Positive Predictive Value​
• Negative Predictive Value
Yield of the test depends on prevalence of disease, specificity and sensitivity of the test and
participation of individuals in the detection program. Tests most likely to fulfil one condition
may however, be least likely to fulfil another - for example, tests with greater accuracy may be
more expensive and time consuming. The choice of the test must therefore often be based on
compromise.

Positive predictive value (PV+) the probability that the disease is present when the test is
positive and expressed as a percentage​
Negative predictive value (PV-) is the probability that the disease is not present when the test is
negative and expressed as a percentage.

Cross tabulation of data

The simplest cross tabulation is a 2 x2 table. A 2 x 2 table is one which has only two rows and
two columns
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Disease Disease Total

confirmed Not confirmed
Screening (True (False a+b
+ve Positive) a Positive ) b Apparently diseased

Screening-ve (False (True c+d

Negative) c Negative) d Apparently non – diseased

a=
Total a+c b+d
The
Total Total
diseased non-diseased a+b+c+d
Grand
total
number of individuals for whom the screening test is positive and they actually have the disease
(True positives)​
b= The number of individuals for whom the screening test is positive but they do not have the
disease (False positives)​
c= The number of individuals for whom the screening test is negative but they actually have the
disease (False negatives)​
d= The number of individuals for whom the screening test is negative and they actually do not
have the disease (True negatives)
So, interpreting the cells​
• a+c = All those who actually have the disease.​
• b+d = All those who actually do not have the disease.​
• a+b = All those who test positive on the screening test.​
• c+d = All those who test negative on the screening test.
Sensitivity = a/(a+c) x100​
Specificity = d/(b+d) x100​
Positive predictive value= a/(a+b) x100​
Negative predictive value= d/(c+d) x100
False positive rate= b/b+d x100
False negative rate= c/a+c x100
Accuracy= a+d/n x100
3. Repeatability
An attribute of an ideal screening test or any measurement (e.g., height, weight) is its
repeatability (sometimes called reliability, precision or reproducibility). That is, the test must
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give consistent results when repeated more than once on the same individual or material, under
the same conditions. The repeatability of the test depends upon three major factors, namely
observer variation, biological (or subject) variation and errors relating to technical methods. For
example, the measurement of blood pressure is poorly reproducible because it is subjected to all
these three major factors.

A. Observer variation
All observations are subjected to variation (or error). These may be of two types:
​ a. Intra-observer variation
If a single observer takes two measurements (e.g., blood pressure, chest expansion) in the
same subject, at the same time and each time, he obtains a different result, this is termed as
intra-observer or within-observer variation. This is variation between repeated observations by
the same observer on the same subject or material at the same time. Intra-observer variation
may often be minimized by taking the average of several replicate measurements at the same
time.
b. Inter-observer variation
This is variation between different observers on the same subject or material, also known
as between-observer variation. Inter-observer variation has occurred if one observer examines
a blood-smear and finds malaria parasite, while a second observer examines the same slide and
finds it normal.
Observational errors are common in the interpretation of X-rays, ECG tracings, readings of
blood pressure and studies of histopathological specimens. Observer errors can be minimized by
(a) standardization of procedures for obtaining measurements and classifications (b) intensive
training of all the observers (c) making use of two or more observers for independent assessment,
etc. It is probable that these errors can never be eliminated absolutely.

B. Biological (subject) variation

There is a biological variability associated with many physiological variables such as blood
pressure, blood sugar, serum cholesterol, etc. The fluctuation in the variate measured in the same
individual may be due to: (a) Changes in the parameters observed: This is a frequent
phenomenon in clinical presentation. For example, Myocardial infarction may occur without
pain and variations in blood pressure throughout the day. (b) variations in the way patients
perceive their symptoms and answers. (c) regression to the mean: there is a tendency for
values at the extreme of a distribution either very high or low, to regress towards the mean or
average on repeat measurements.
Whereas observer variation may be checked by repeat measurements at the same time, biological
variation is tested by repeat measurements over time. This is due to the fact that measurement is
done only on a tiny sample of the normal distribution of the physiological variable.

C. Errors relating to technical methods:

For example, defective instruments, erroneous calibration, faulty reagents.