Verification bias in pediatric studies evaluating diagnostic tests.

Improperly designed evaluations of diagnostic tests may lead to inaccurate conclusions about a test's accuracy. One problem, verification bias, occurs if subjects are not equally likely to have the diagnosis verified by a gold-standard evaluation and if selection for further evaluation is dependent on the diagnostic test result. To determine whether verification bias is a problem in pediatric studies of diagnostic tests, we conducted a critical appraisal of all studies evaluating diagnostic tests published in three pediatric journals during a 3-year period. Thirty-six percent were subject to verification bias. The most prevalent cause was restriction of the patient sample to those whose diagnosis had been verified by a gold standard evaluation, when the decision to obtain the gold standard was influenced by the diagnostic test result. Verification bias may have serious effects on the estimated sensitivity and specificity of a test. Improved awareness of the potential for verification bias may help physicians improve their selection and interpretation of diagnostic tests and thereby improve the quality and efficiency of patient care.