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SCREENING TESTS, CRITERIA & INDICATORS. SCREENING PROGRAMMES IN COMMUNITY HEALTH ��DR ROSELIN. V�ASSOCIATE PROFESSOR

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Definition Screening

“The search for unrecognized disease or defect by means of rapidly applied tests, examinations or other procedures in apparently healthy individuals”

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Points considered before screening programme

  • Applied to people most likely to benefit from it.
  • Selection – Age, Sex, Medical History, Occupation, Family History etc.
  • Choice of test – Based on compromise.
  • Not done in isolation – Integrated into health services.
  • Risks, Benefits – Explained to participants.

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Aims and Objectives

Individuals or population not seeking health care

  • HIV – Blood donors.
  • Premarital syphilis screening.
  • Neonatal screening.

Case finding - Use of clinical or laboratory test

  • VDRL in pregnant women.

Diagnostic test – patients with signs & symptoms

  • VDRL in patients with lesions on genitals.

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Uses

Case detection

  • “Prescriptive screening” – Presumptive identification of unrecognised disease not arising from patients request like, Neonatal screening.

Control of disease

  • “Prospective screening” for benefits of others – e.g. immigrants.

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Research Purposes

  • Chronic diseases – cancers, hypertension, initial screening for prevalence, next screening for incidence
  • No followup therapy available.

Educational opportunities

  • Public awareness
  • Educating health professionals.

Conserving physicians time.

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Types

Mass screening

  • Whole population.
  • Backed by treatment.

High risk (Selective screening)

  • Productive, effective life,
    • Diabetes, Hypertension – Accumulate in population subgroups.
    • Diabetes in 40 and above.
    • Prostrate screening in 60 and above.

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  • Screening for risk factors – Preventive measures applied before actual disease. like,
    • Serum cholesterol - coronary artery disease

Multiphasic screening

  • Two or more screening tests are applied.
  • Questionnaires, clinical examination, investigation, measurement.

Opportunistic screening

  • Restricted to patients consulting doctor.

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Advantages

  • Improved prognosis – Elimination, postponment of death from disease.
  • Non fatal conditions – Improved quality of life style.
  • Resources for treatment and followup – Less consumption.
  • Correct negative test – Reassures those without disease.

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Disadvantages

  • Prolonged period of morbidity – e.g. cancer.
  • Diagnosis of a pseudo disease – over treatment of healthy screening (False positive).
  • False negatives not diagnosing underlying disease.
  • Test itself risky – mammography for breast cancer.
  • Expensive technology – Increased financial cost for health services.

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Model for early detection programmes

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Screening and incidious profile of disease

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Apparently healthy (Screening tests)

  • Apparently normal (Periodic re-screening)
  • Apparently abnormal
  • Normal periodic- screening
  • Intermediate- surveillance
  • Abnormal - treatment

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Difference from Periodic health examination

  • Capable of wider application.
  • Relatively inexpensive.
  • Requires little physician time.

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Screening test

Diagnostic test

Done on apparently healthy

Done on those with indications or sick

Applied to groups

Single patient and all diseases considered

Test results final

Diagnosis not final sum of all evidences

Based on criteria or cut-off point like DM

Based on number of symptoms, signs and laboratory findings

Less accurate

More accurate

Less expensive

More expensive

Not basis for treatment

Basis for treatment

Initiative comes from investigator

Initiative comes from patient

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Criteria

Disease to be screened

  • Important health problem – high prevalence.
  • Recognize latent or early asymptomatic stage.
  • Natural history – latent phase – declared disease.
  • Effective tests to detect disease.
  • Facilities – confirm diagnosis.
  • Effective treatment.
  • Agreed on policy – whom to treat as diseases like borderline diabetes – cut off levels.
  • Evidence – early detection, treatment reduces morbidity, mortality.
  • Expected benefits greater than risk and cost of screening.

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Screening tests

Acceptability

  • Co-operation – vaginal examination, rectal examination.

Repeatability

  • Reliability, precision or reproducibility.
  • Consistency.
  • Depends on 3 major factors
    • Observer variation.
    • Biological variation.
    • Errors relating to technical methods.

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Observer variation

  • Intra observer.
  • Inter observer.
  • Common in – X-rays, ECG, BP readings, histopathological specimens etc.

Minimisation

  • Standardising procedures for measurements classification - Calibration.
  • Training observers.
  • Two or more observers for independent assessment.
  • Repetition of observations and taking average.

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Biological variation

  • Physiological variables – BP, Blood sugar, serum cholesterol etc.

Reasons

  • Change in parameter observed – frequent in clinical presentation like cervical smears, MI.
  • Way patient perceives symptoms and answer – questionnaire, past events.
  • Regression to mean – ulcerative colitis, rheumatoid arthritis.

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Errors - technical method

  • Defective instruments.
  • Errors in calibration.
  • Faulty reagents.
  • Test itself may be innappropriate or unreliable.

Validity (Accuracy)

  • Def – ability of a test to distinguish those who have disease from those who do not – glycosuria, GTT.
  • Two components – Specificity and sensitivity (expressed in percentages)

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Screening result by diagnsosis

Screening test results

Diagnosis

Total

Present

Absent

Positive

a (True positive)

b (False positive)

a + b

Negative

c (False negative)

d (True negative)

c + d

Total

a + c

b + d

a+b+c+d

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Screening indicators

  • Sensitivity = TP / (TP+FN) X 100
  • Specificity = TN / (TN+FP) X 100
  • Predictive value
    • Positive test = TP / (TP+FP) X 100
    • Negative test = TN / (FN+TN) X 100
  • Percentages
    • False negative = FN / (TP+FN) X 100
    • Positive = FP / (FP+TN) X 100

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Sensitivity

  • Ability of a test to identify correctly all those who have disease – true positives.

Specificity

  • Ability of a test to identify correctly those not having disease – True negative.

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Diagnosis of brain tumors by EEG

EEG results

Brain tumor

Present

Absent

Positive

36

54

Negative

4

306

40

360

  • Sensitivity = 36 / 40 X 100 = 90%
  • Specificity = 306 / 360 X 100 = 85%

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Diagnosis of brain tumors by Computer assisted tomography

CAT results

Brain tumor

Present

Absent

Positive

39

18

Negative

1

342

40

360

  • Sensitivity = 39 / 40 X 100 = 97.5%
  • Specificity = 342 / 360 X 100 = 95.0%

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Others

  • Yield – Amount of previous unrecognised disease diagnosed as a result of screening effort.
  • Depends on
    • Sensitivity, specificity.
    • Prevalence of disease.
    • Participation of individuals.
  • High risk populations selected for screening – 40 yrs above adults for diabetes.

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Predictive accuracy

  • Diagnostic power of test.
  • Depends on
    • Sensitivity
    • Specificity
    • Disease prevalence
  • Prevalence directly proportional to predictive accuracy.

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Predictive value of positive gram stained cervical smear test (with constant sensitivity of 50% and specificity of 90%) at three levels of prevalence

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False negatives

  • Harmful in serious diseases, time for rescreening.
  • Sensitivity indirectly proportional to false negatives.

False positives

  • Subjected to further diagnostic tests.
  • Anxiety, inconvenience.
  • Specificity is inversely proportional to false positives

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Problem of borderline

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Cut-off point - factors

Disease prevalence

  • When high screening, set at a lower level.
  • Increases sensitivity.

Disease

  • Very lethal like cancer – greater sensitivity is desired.
  • Proportion of false positives tolerable but not false negatives.
  • False positives ruled out by further diagnostic test.
  • Diabetes Mellitus – high specificity is desired, false positives decreased.
  • Useful index – predictive value of positive test.

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References

  • Oxford textbook of public health by Walter W. Holland, Rager Deteb and George Knox, 4th Edition.
  • Textbook of Community Medicine by Sundar Lal, Adarsh, Pankaj 1st Ed.
  • Textbook of preventive and social medicine by K. Park, 19th Edition, 2007.