Variability in Flexible Sigmoidoscopy Performance Among Examiners in a Screening Trial

Abstract

The efficacy of flexible sigmoidoscopy (FSG) in reducing colorectal cancer mortality is being evaluated in randomized trials. In 2 European trials, wide variability across examiners in FSG performance was noted. We report on the performance of examiners in the US randomized trial: the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Screening was performed at 10 geographically dispersed clinical centers. Patients with screens positive for a lesion or mass were referred to their private health care providers for endoscopic follow-up evaluation; lesions were not removed and a biopsy examination was not performed at screening. FSG performance among 64 examiners at these centers, each performing 100 or more baseline FSG examinations, with an aggregate of almost 50,000 examinations, was analyzed. Screen-positivity results among examiners ranged from 9%-58%, with a coefficient of variation (CV) of 36%. CVs were 29% for distal polyp detection and 21% for distal adenoma detection. Inadequate rates ranged from 1%-27% (CV, 52%). Examiners with higher screen-positivity rates had higher false-positive rates, defined as a positive screen with no distal lesion found on endoscopic follow-up evaluation. Considerable variability exists in the rates of positive screens and in polyp and adenoma detection rates among FSG examiners performing the procedures using a common protocol.