Screening Epidemiology

Ansariadi, PhD
Chapter 5
 Learning Objectives
¨Understand the concept of screening

¨Understand the characteristics of health-related

events suitable for screening

¨Recognize the characteristics of a screening

program
 Screening
Screening is the process to detect among healthy
people disorders or risk factors of which they are
unaware
 Population screening
Immediate objective of a screening test – to
classify people as being likely or unlikely of
having the disease
• Ultimate objective: to reduce mortality and
morbidity

5
 Natural history is central to screening

Detectable, Disability
Pre-detectable Clinical
preclinical or death

Age: 35 45 55 65 75

Possible detection Clinical

via screening detection

6
Factors appropriate
for screening

¨Important health problem

¨High prevalence
¨Natural history understood
¨Long latent period
¨Early detection improves prognosis
Evaluation of
a screening program

¨Reliability
¨Feasibility
¨Validity
¨Performance
¨Effectiveness
Reliability
¨Biological variation
¨Program method
¨Intraobserver variability
¨Interobserver variability
 Feasibility
¨Acceptability ¨Cost effectiveness
·Quick ·Screening
·Easy ·Diagnosis
·Safe ·Follow-up
·Intervention
 Validity
¨Sensitivity:
Probability to test positive among
truly affected
¨Specificity:
Probability to test negative
among truly unaffected
 Performance
¨PV+:- Probability to be affected
among test positives
¨PV-:- Probability to be unaffected
among test negatives
¨PCC:- Probability to be correctly
classified
Effectiveness
¨Outcome measures:
·Morbidity
·Disability
·Mortality
Effectiveness
¨Bias
·Patient self-selection
·Lead time
·Length
 True Disease Status
Cases Non-cases
True False
Positive positive positive a+b
Screening
a b
Test c d
Results False True
Negative c+d
negative negative

a+c b+d
True positives a
Sensitivity = =
All cases a+c
True negatives d
Specificity = =
All non-cases b+d
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 True Disease Status
Cases Non-cases

Positive 140 1,000 1,140

Screening
a b
Test c d
Results 19,000 19,060
Negative 60

200 20,000
True positives 140
Sensitivity = = = 70%
All cases 200
Specificity = True negatives = 19,000 = 95%
All non-cases 20,000
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Interpreting test results: predictive value

Probability (proportion) of those tested who

are correctly classified

/
Cases identified all positive tests

/
Noncases identified all negative tests

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 True Disease Status
Cases Non-cases
True False
Positive positive positive a+b
Screening
a b
Test c d
Results False True
Negative c+d
negative negative

a+c b+d
True positives a
PPV = =
All positives a+b
True negatives d
NPV = =
All negatives c+d
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 True Disease Status
Cases Non-cases

Positive 140 1,000 1,140

Screening
a b
Test c d
Results 19,000 19,060
Negative 60

200 20,000
True positives 140
PPV = = = 12.3%
All positives 1,140
True negatives 19,000
NPV = = = 99.7%
All negatives 19,060
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 Positive predictive value,
Sensitivity, specificity, and prevalence
Prevalence (%) PV+ (%) Se (%) Sp (%)
0.1 1.4 70 95
1.0 12.3 70 95
5.0 42.4 70 95
50.0 93.3 70 95

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Example: Mammography screening of unselected women

Disease status
Cancer No cancer Total
Positive 132 985 1,117
Negative 47 62,295 62,342
Total 179 63,280 63,459
Prevalence = 0.3% (179 / 63,459)
Se = 73.7% Sp = 98.4% PV+ = 11.8% PV– = 99.9%

Source: Shapiro S et al., Periodic Screening for Breast Cancer

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 Effect of Prevalence on Positive Predictive Value
Sensitivity = 93%, Specificity = 92%
Surgical biopsy (“gold standard”)
Cancer No cancer Prev.
Without palpable mass in breast
Fine needle Positive 14 8 13%
aspiration Negative 1 91 PV+ = 64%
With palpable mass in breast
Fine needle Positive 113 15 38%
aspiration Negative 8 181 PV+ = 88%
See http://www.meddean.luc.edu/lumen/MedEd/ipm/IPM1/Biostats/diagnostic_test_example1_Solutions1011.pdf

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 What is used as a “gold standard”
1. Most definitive diagnostic procedure
e.g. microscopic examination of a tissue
specimen
2. Best available laboratory test
e.g. polymerase chain reaction (PCR)
for HIV virus
3. Comprehensive clinical evaluation
e.g. clinical assessment of arthritis
9/10/2002 Natural history; population screening 23
 Main concepts
1. Requirements for a screening program
2. Concept of natural history – possible biases include
lead time, “length”, over-diagnosis
3. Reliability (repeatable) – can occur by chance
4. Validity (correct) – sensitivity, specificity
5. Sensitivity and specificity relate to the detectable
pre-clinical stage of the disease
6. Predictive value – the population perspective on
disease detection

9/16/2003 Natural history; population screening 24

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