The validation of cervical cytology. Sensitivity, specificity and predictive values.

Statistics and methods for the validation of the results of cytologic screening for cervical cancer and its precursors were examined. Many of the methods commonly used, including the calculation of sensitivity and specificity on raw data, contain flaws that undermine their conclusions. Using a large computerized database of 748,871 cytologic screenings of 277,842 women over a ten-year period, the value of screening was examined. Only subsequent histologic examinations within one year were accepted to validate positive initial cytologic diagnoses; only two subsequent cytologic screenings within the next three years were accepted to validate negative initial cytologic diagnoses that had not been followed by a histologic examination. Cases not meeting these criteria were excluded from the initial analysis. From these data, the predictive value of a negative cytologic examination was determined to be 99.8%; the predictive value of a positive cytologic examination was 73.4% for an initial diagnosis of mild-to-moderate dysplasia, 90.6% for a diagnosis of severe dysplasia/carcinoma in situ, 94.5% for a diagnosis of carcinoma in situ or microinvasive carcinoma and 95.5% for an initial diagnosis of invasive carcinoma. Cases with an initial "questionable" cytologic diagnosis had a positive predictive value of only 64.0%. Extrapolation from the validated cases to the entire screened population showed an overall sensitivity of 80% and a specificity of 99.4% for cytologic screening for cervical cancer. The sensitivity was slightly lower for mild and moderate dysplasia (78.1%) and slightly higher for carcinoma in situ and severe dysplasia (81.4%) and invasive carcinoma (82.3%).