Purpose: American College of Gastroenterology guidelines suggest that colonoscopy is the preferred screening strategy with fecal immunochemical test as the first alternative to colonoscopy. We assessed the cross-over rate to colonoscopy among study participants randomized to annual fecal occult blood test (FOBT) in a randomized controlled trial (RCT) comparing colonoscopy and annual (sensitive) FOBT. High cross-over rates would indicate that additional colonoscopy capacity will be required in a screening program of FOBT beyond that required for evaluating positive FOBTs if annual FOBT is not readily accepted as the screening modality. Methods: The National Colonoscopy Study is a feasibility study comparing screening colonoscopy to a program of annual FOBT conducted at 3 clinical centers: University of Minnesota (predominantly private insurance setting dominated by managed care organizations), Group Health Cooperative (integrated health plan setting), and Louisiana State University at Shreveport (minority-serving institution). Use of colonoscopy in the study period among those assigned to FOBT who had only negative or uncompleted FOBTs during the study period was the endpoint of this analysis. Subjects submitting a positive FOBT were censored at the time of their test. The cumulative percent crossing over to colonoscopy up to 4 years after randomization, overall and by center, was estimated using Kaplan-Meier curves. Results: Of 1765 randomized to a program of annual FOBT, the cross-over rate varied by clinical site with the highest cross-over rate in the private-insurance site (29% over 4 years) and with lower rates for the managed care plan (16%) and the minority serving institution (5%) (Figure). Conclusion: Colonoscopy use was observed for a substantial subset of subjects assigned to annual FOBT screening. This happened more frequently in patient populations with some fee-for-service insurance compared to the settings of an integrated health plan or a minority-serving institution. This phenomenon should be recognized in planning for a screening FOBT program and in clinical practice using FOBT.Figure
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