Clinical Area:

Validity • Independent blind comparison with a gold standard or follow-up of those not receiving the gold standard test? Yes, the cone biopsy was the gold standard. • Was “normal” defined? Yes, according to the Bethesda system. • Appropriate spectrum of disease? Not to assess technology for screening. This was a high-risk sample, and the sensitivity and specificity likely differs from a screening population. • Consecutive patients? Yes. • Methods described in enough detail to enable you to replicate the test? Yes. • Reproducible results? Yes.