Definition of the Gold Standard

The often reported miss rate for CC of 6% for polyps 1 cm or larger, is based on a single small study of back-to-back CCs (Rex et al. 1997). CTC studies suggest the CC miss rate may be 12% (Pickhardt et al. 2004a). Several strategies are being employed by some multicenter trials to address this issue, including the segmental unblinding of the colonoscopist during the removal of the endoscope (Pickhardt et al. 2003). In this method, CTC results are reported segment by segment, after the endoscopist has made his/her own independent evaluation of a segment of colon. If there is a discrepancy between the reported CTC finding and CC, the endoscopist is able to re-advance the scope in attempt to find and confirm the presence or absence of a polyp. This comparison is particularly important to reduce the false positive rate for CTC that may be due to true lesions that are not initially detected by endoscopy. Clearly, CC is our best arbitrary "standard", but it is important that we recognize its limitations. When possible, all follow up data should be used for comparison of lesion matching, including surgical findings and follow up endoscopy.

When a follow up exam such as a second colonoscopy, flexible sigmoidoscopy, barium enema or surgical resection of colon changes the "truth", the by-patient data should be presented both with and without this follow up data.

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