Screening

Screening
• What is screening?
• It is the early detection
– of disease,
– precursors to disease, or
– susceptibility to disease
in individuals who do not show any signs of the
disease
 A type of secondary prevention
 Screening

• Screening is the search for unrecognized

disease or defect by means of rapidly applied
tests, examination or other procedures in
apparently healthy individuals.
 What does screening mean?
• The application of a medical procedure or test to people who as yet
have no symptoms of a particular disease, for the purpose of
determining their likelihood of having the disease.

• Early detection of disease (earlier than would usually occur in clinical

practice) that is carried out in the hope of improving diagnosis

• The screening procedure itself does not diagnose the illness.

• Those who have a positive result from the screening test will need
further evaluation with subsequent diagnostic tests or procedures.
 The goal of screening

• To reduce morbidity or mortality from the disease

by detecting diseases in their earliest stages, when
treatment is usually more successful.
 Examples of Screening Tests

• Pap smear
• Mammogram
• Clinical breast exam
• Blood pressure determination
• Cholesterol level
• Eye examination/vision test
• Urinalysis
 Criteria for Screening
• The criteria relate to
– Characteristics of the disorder or disease
– Treatment of the disease
– Characters of the screening test

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Criteria for Instituting a Screening Program
Disease
• Must be serious
• Important (common; severe)
• Recognizable early state
• Natural history is known
• Long period between first signs and overt disease
Diagnostic test
• Sensitive and specific
• Simple and Cheap
• Safe and Acceptable
• Reliable
Treatment
• Available, acceptable, effective
• Early treatment improves prognosis
 Criteria for effective screening program
• Does the significance of the disease or disorder warrant its
consideration as a community problem?? (prevalence and
severity - congenital hypothyroidism, breast cancer)
• Natural history is known
• Treatment of diseases at their earlier stages should be
more effective than treatment begun after the
development of symptoms.
• Suitable screening test must be available.
• There must also be appropriate follow-up of those
individuals with positive screening results to ensure
thorough diagnostic testing occurs
• Psychological/Physical Harm is low
• Interval for repeat screening agreed
• Cost Effective
 Diagnostic and Screening tests
• Diagnostic and screening tests are useful for a
decision to initiate or continue a therapeutic
(preventive) intervention.
Screening tests
• are tests done in individuals with no such
symptoms or sign.
Diagnostic tests
• are tests performed in persons with a
symptom or a sign of an illness.
 Diagnostic and screening tests
• May be based on
– Standardized interviews,
– Physical examinations,
– Laboratory tests,
– More sophisticated measurements
• radiography,
• electro-cardiograph,
• slit-lamp examination.
 Types of Screening
• Mass screening
– On a population
• Multiple/ multi-phasic screening
– Multiple: Many tests at a time )(for employment)
• Targetted screening
– Often used in occupational and environmental
health
• Case finding or opportunistic screening

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 Clinical aim of Screening
• To reduce morbidity and mortality through
early detection and treatment
• To reverse, halt, or slow the progression of a
disease to its sever form
 Public Health aim of Screening
• Protect society from contagious disease
• Reduce mortality
• Rational allocation of resources
• Research: study on natural history of disease…

Other Use:
• Selection of healthy individuals: employment,
military, driving license, immigrants, food handler, …
 Screening tests
 One screening test is evaluated by the ff
1. Validity (accuracy) of test
– Sensitivity
– Specificity
2. Performance of screening test
– Predictive Value Positive (PV+)
– Predictive Value Negative (PV-)
3 Reliability
– Percentage of Correct Classification
– Cohune's Kappa
• Reliability (precision) of test is one that gives
consistent result when the test is performed
more than once on the same individual under
the same condition.
– Affected by
• Variation inherent in the method / biological
• Observer variation(error)- Intra and inter-
observer bias
• Validity (accuracy) of test: is the ability of the
test to differentiate accurately those who
have the disease and those who do not.
– Sensitivity
– Specificity
• For screening to be successful a suitable screening
test must be available.

• A screening test should be ideally, inexpensive,

easy to administer, and impose minimum
discomfort on the patient.

• It must be valid and reliable

 Two-by-Two Table for
Evaluation of Screening
• False negative rate (1-sensitivity)
FN/(FN+TP)
• False positive rate = (1-specificity)
FP/(FP+TN)
• The more sensitive a test, the less likely it is that an
individual with a negative test will have the disease and
thus the greater the PVN
• The more specific the test, the less likely that an
individual with a positive test will be free from the
disease and the greater predicative value positive.
• Predictive value is the ability of the test to predict the
presence or absence of disease from the test result.
Depends on
– specificity and sensitivity of the test
– Prevalence of disease (PV is not property of test alone)
• PV is also called posterior (post test) probability
• Obviously, it would be desirable to have a
screening test that has both high sensitive and
high specific which usually is not possible.
• sensitivity = specificity
• A decision regarding specific criteria for
acceptable level of sensitivity and specificty in
a given situation involves weighting the
consequence of leaving cases undetected (FN)
against erroneously classifying healthy persons
as disease (FP).
Conditions when sensitivity should be
increased
• Penalty associated with missing a case is high,
such as
– When the disease is serious and definitive exist
– When the disease can be spread (Syphilis …)
– When the subsequent diagnostic evaluations of
positive screening tests are associated with
minimal cost and risk. (such as-BP)
 Conditions when specificity should be increased
• When the cost or risks associated with further
diagnostic techniques are substantial, such as
• Breast cancer  biopsy (definitive treatment)
• Be aware that negative is not guarantee of being
disease free but low probability than those positive for
the time being.
• One way of addressing the tradeoff (balance) between
sensitivity and specificity is to use the result of several
screening test together, which can be
• – Parallel
- series
Sensitivity and specificity can also be affected by the cut-off
value of measure at which a test is defined as positive
 Parallel test
• When screening tests are in parallel, all are
administered at the same time, and person with
positive results on any test are considered positive.
• It needs positive result in atleast one
• No necessity all to be +ve to declare positive.
• In general, parallel testing results in increased
sensitivity compared with that of each individual
test, since disease is less likely to be missed, but
lower specificity b/c false positive diagnosis are
more likely.
 Series
• When screening tests are given in series, an
initial screening test is administered, and only
persons with a positive test are reevaluated
with additional screening procedure
• In general, serial testing results in an increase
in specificity compared with a single test, b/c
a positive care is more likely to represent true
diseases.
• As sensitivity increases
– Specificity decreases
– FP increases
– FN decreases
– PPV decreases
– NPV increases
• As Specificity increases
– Sensitivity decreases
– FP decreases
– FN increases
– PPV increases
– NPV decreases
• Sensitive test are important when the
probability of the disease is relatively low and
the purpose of the test is to detect possible
cases
• A sensitive test, is therefore, most helpful
when the test result is negative.
• Specific test on other hand is are important
when the test result is positive
• Are used to confirm diagnosis suggested by
the others.
 Case definition
• Use sensitive test if the case is rare but
potentially severe; communicable disease.
• Use specific test to determine cause of out
break: to ascertain the patient really have the
disease.
Effect of cutoff point
• Cut of point A
– Highly sensitive
– Greater false positive
– Lower specificity
• Cut of point B
– Lower sensitivity
– Higher specificity
– Greater false negative rate
 Effect of altering the cut off point for serum cholesterol
levels in a test for the classification of individuals who
are at high risk for developing coronary heart disease
G H
E F
Disease -VE Disease +VE
C D
A X B
• Cut of point set too low? Too high?
• Greater sensitivity? Greater specificity?
• True positive for cut off point X? true P & N for X?
• TN for X? TN and FN for X?
• FP for cut of point A?
• FN for cut of point B
PPV
Calculate PPV and NPV
 Reliability
The yield (number of cases detected by the screening
program).
Persons with the disease
Yield = detected by the test
X 100
Total screened
 
TP
Yield = X 100
TP + FN + TN + FP
 D+ D- Total
+ve e1 T2
-Ve e2 T3
Total T1 T4

e1= T1 x T2/T
e2= T3 x T4/T
• K= Po – Pe
1-Pe

• K= (a+d)/T- (e1+e2)/T
1-(e1+e2)/T
• The value of К ranges between -1 and +1, similar to Karl
Pearson’s co-efficient of correlation ‘r’. In fact, Kappa
and r assume similar values if they are calculated for
the same set of dichotomous ratings for two raters.
• A value of kappa equal to +1 implies perfect agreement
between the two raters, while that of -1 implies perfect
disagreement. If kappa assumes the value 0, then this
implies that there is no relationship between the
ratings of the two raters, and any agreement or
disagreement is due to chance alone. A kappa value of
0.70 is generally considered to be satisfactory.
However, the desired reliability level varies depending
on the purpose for which kappa is being calculated.
 Effectiveness
• evaluation of effectiveness of a screening program must be based on
measures that reflect the impact of a program on the course of a
disease.
• An effective screening program should result in reduction of
morbidity, mortality and disability.
• The most definitive measure of the efficacy of a screening program is
a comparison of the cause-specific mortality rates among those
whose disease was picked up by screening and those whose
diagnosis was related to the development of symptoms.
 Effectiveness cont…
• In determining the efficacy of screening , the groups must be
comparable with regard to all factors affecting the end point
under evaluation.
• Each of these sources may result in an erroneous
appraisal of the mortality experience of screened
as compared with symptom-diagnosed cases.
 Effectiveness cont…
• In general, volunteers tend to have better health and lower
mortality rates than the general population and are more
likely to adhere to prescribed medical regimens.
• On the other hand, those who volunteer for a screening
program may represent the “worried well,” that is,
asymptomatic individuals who are at higher risk of
developing the disease because of medical or family history,
or life-style characteristics.
 Effectiveness cont…

• Such individuals might have an increased risk mortality

regardless of the efficacy of the screening program.
• The direction of the potential patient selection bias may
be difficult to predict and the magnitude of such effects
even more difficult to quantify.
 2. Lead time bias
• It is defined as the interval b/n the diagnosis of a
disease at screening and when it would have been
detected due to development of symptoms.
• It represents the amount of time by which the
diagnosis has been advanced as a result of screening.
• Can be affected by
– Duration of pathogenesis of the disease
– Time of screening; how soon is the screening made
• Ways to decrease the effects of lead bias
– Adjusted survival data for estimated lead time
– Stage disease and compare morbidity/mortality with stage
 Length bias
• It refers to the variation in the speed of
progression of disease.
– cases picked up by screening may be less sever,
slow progressive compared with others.
 Exercise
• Assume we have 100 HIV positive and 200 HIV negative
confirmed with PCR. If we discover a test kit for HIV,
called PH bach04, and want to test the above group of
people, it might give us 120 HIV positive from the total
and 20 negative from the real positives.
• Calculate
• Sensitivity?
• Specificity?
• PPV? NPV?
• Yield?
• Accuracy rate?
• Reliability?