1. What is Screening? Basic Public Health Concepts Sheila West, Ph.D. El Maghraby Professor of Ophthalmology Wilmer Eye Institute Johns Hopkins University

2. SCREENING: DEFINITION “The PRESUMPTIVE identification of UNRECOGNIZED disease or defect by the application of tests, exams 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”* Key Elements: disease/disorder/defect screening test population *Commission on Chronic Illness, 1957

4. Issues in Screening Disease -Disease/disorder should be an important public health problem High prevalence Serious outcome -Early Detection in asymptomatic (pre-clinical) individuals is possible -Early detection and treatment can affect the course of disease (or affect the public health problem?)

5. Screening Test Concerned with a Functional Definition of Normality versus Abnormality Screening Test Normal Abnormal

6. Criteria for Evaluating a Screening Test Validity : provide a good indication of who does and does not have disease -Sensitivity of the test -Specificity of the test Reliability : (precision): gives consistent results when given to sameperson under the same conditions Yield : Amount of disease detected in the population, relative to the effort -Prevalence of disease/predictive value

7. Validity of Screening Test (Accuracy) - Sensitivity: Is the test detecting true cases of disease? (Ideal is 100%: 100% of cases are detected) -Specificity: Is the test excluding those without disease? (Ideal is 100%: 100% of non-cases are negative)

9. True Cases of Glaucoma YesNo IOP > 22:Yes50100 No501900 (total)1002000 Sensitivity = 50% (50/100) False Negative=50% Specificity = 95% (1900/2000) False Positive=5% Screening for Glaucoma using IOP

10. Consider: -The impact of high number of false positives: anxiety, cost of further testing -Importance of not missing a case: seriousness of disease, likelihood of re-screening Where do we set the cut-off for a screening test?

11. Reliability (reproducibility) Agreement within and between examiners ________________________________________________ Inter-Observer Agreement in Grading Severity of Cataract Examiner<1 1-<2 2-<3 3-<4 4 2 <110 2 10 0 1-<21 20 20 0 2-<30 1 201 0 3-<40 0 110 2 40 0 02 5 % Agreement = 81.3% Kappa = 0.76 Examiner 1: Grade

12. Validity versus Reliability of Screening Test Examiner 1Examiner 2Examiner 3 True cases Good Reliability Low Validity

13. Yield from a Screening Test for Disease X Predictive Value X X Screening Test Negatives Positives X X X X

14. Yield from the Screening Test: Predictive Value Relationship between Sensitivity, Specificity, and Prevalence of Disease Prevalence is low, even a highly specific test will give large numbers of False Positives Predictive Value of a Positive Test (PPV): Likelihood that a person with a positive test has the disease Predictive Value of a Negative Test (NPV): Likelihood that a person with a negative test does not have the disease

15. True Cases of Glaucoma YesNo IOP > 22:Yes50100 No501900 (total)1002000 Specificity = 95% (1900/2000) False Positive=5% Positive Predictive Value =33% Screening for Glaucoma using IOP

16. How Good does a Screening Test have to be? IT DEPENDS - Seriousness of disease, consequences of high false positivity rate: - Rapid HIV test should have >90% sensitivity, 99.9% specificity -Screen for nearsighted children proposes 80% sensitivity, >95% specificity -Pre-natal genetic questionnaire could be 99% sensitive, 80% specific

17. Principles for Screening Programs 1.Condition should be an important health problem 2.There should be a recognizable early or latent stage 3.There should be an accepted treatment for persons with condition 4.The screening test is valid, reliable, with acceptable yield 5.The test should be acceptable to the population to be screened 6. The cost of screening and case finding should be economically balanced in relation to medical care as a whole