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Diagnostic Tests Evaluation. Azita Kheiltash Social Medicine Specialist Tehran University of Medical Sciences. Diagnostic Tests.
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Diagnostic Tests Evaluation AzitaKheiltash Social Medicine Specialist Tehran University of Medical Sciences
Diagnostic Tests • The term ′diagnostic tests′ includes everything physicians do to diagnose disease. This includes assessing symptoms and signs, as well as what we conventionally refer to as tests: such as laboratory investigations, imaging, …
Gold Standard • The gold standard is the best single test (or a combination of tests) that is considered the current preferred method of diagnosing a particular disease (X). All other methods of diagnosing X, including any new test, need to be compared against this ′gold′ standard. The gold standard is different for different diseases.
Validity • It is the extent to which a test measures what it is supposed to measure; in other words, it is the accuracy of the test. Validity is measured by sensitivity and specificity. • The validity of a diagnostic test is the extent to which the results represent an unbiased estimate of the underlying truth (it is testing what it supposed to test)
Definitions Imagine a study evaluating a new test that screens people for a disease. The test results may be (comparing a new diagnostic test with the gold standard): • True positive: Sick people correctly diagnosed as sick • False positive: Healthy people incorrectly identified as sick • True negative: Healthy people correctly identified as healthy • False negative: Sick people incorrectly identified as healthy.
Sensitivity • Sensitivity: The capacity of the test to correctly identify diseased individuals in a population “TRUE POSITIVES”. The greater the sensitivity, the smaller the number of unidentified case “false negatives”. • Sensitivity relates to the test's ability to identify positive results. • If a test has high sensitivity then a negative result would suggest the absence of disease. • Sensitivity = TP/(TP + FN)
Specificity • Specificity: The capacity of the test to correctly exclude individuals who are free of the disease “TRUE NEGATIVES”. The greater the specificity, the fewer “false positives” will be included. • Specificity relates to the ability of the test to identify negative results. • If a test has high specificity, a positive result from the test means a high probability of the presence of disease. • Specificity = TN/(TN + FP)
Positive predictive value • Positive Predictive Value: The probability of the disease being present, among those with positive diagnostic test results. • The positive predictive value, or precision rate is the proportion of subjects with positive test results who are correctly diagnosed. It is a critical measure of the performance of a diagnostic method, as it reflects the probability that a positive test reflects the underlying condition being tested for. • Positive predictive value (PPV) = TP/(TP + FP)
Negative predictive value • Negative Predictive Value: The probability that the disease was absent, among those whose diagnostic test results were negative. • The negative predictive value (NPV) is a summary statistic used to describe the performance of a diagnostic testing procedure. It is defined as the proportion of subjects with a negative test result who are correctly diagnosed. A high NPV means that when the test yields a negative result, it is uncommon that the result should have been positive. • Negative predictive value (NPV) = TN/(TN + FN)
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Sensitivity 800 200 120 68 132 680 68 200 = 34%
Specificity 800 200 120 68 132 680 680 800 = 85%
Positive predictive value 120 68 132 680 68 68+120 = 36%
Negative predictive value 120 68 132 680 680 680+132 = 83.7%
References: • Hulley SB; Cummings SR, Browner WS, Grady DG, Newman TB. Designing Clinical Research, Lipincott, 2007 • Fischer JE, Bachman LM, Jaeschke R. A reader’s guide to the interpretation of diagnostic test properties: clinical example of sepsis. Intensive Care Med 2003; 29: 1043-1051 • Examining Diagnostic Tests: An Evidence-Based Perspective. Physical Therapy . Volume 81 . Number 9 . September 2001