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A novel hypothesis on the sensitivity of the fecal occult blood test†
Results of a joint analysis of 3 randomized controlled trials
Article first published online: 13 MAR 2009
Copyright © 2009 American Cancer Society
Volume 115, Issue 11, pages 2410–2419, 1 June 2009
How to Cite
Lansdorp-Vogelaar, I., van Ballegooijen, M., Boer, R., Zauber, A. and Habbema, J. D. F. (2009), A novel hypothesis on the sensitivity of the fecal occult blood test. Cancer, 115: 2410–2419. doi: 10.1002/cncr.24256
The authors are indebted to their collaborators in this study: Prof. O. Kronborg, Mrs. Dr. D. Gyrd-Hansen, Odense University Hospital; Prof. J. Faivre, Mrs. Dr. C. Lejeune, Burgundy Cancer Registry; Prof. J.D. Hardcastle, Prof. D.K. Whynes, University of Nottingham; Dr. N. Segnan, Dr. G. Castiglione, Dr. C. Senore, Centro Prevenzione Oncologica Regione Piemonte; Dr. G. Hoff, Telemark Central Hospital; Dr. E. Thiis-Evensen, Riskhospitalet; Dr. H. Brevinge, Sahlgrens Hospital; Dr. T. Church, University of Minnesota; Dr. F. Loeve and Dr. G. van Oortmarssen, Erasmus MC University Medical Center Rotterdam. Their cooperation was essential for the successful completion of the study.
- Issue published online: 20 MAY 2009
- Article first published online: 13 MAR 2009
- Manuscript Accepted: 4 NOV 2008
- Manuscript Received: 9 SEP 2008
- European Commission. Grant Number: 99/CAN/36,898
- National Cancer Institute. Grant Number: U01 CA97426
- colorectal neoplasms;
- occult blood;
- sensitivity and specificity;
- statistical models
Estimates of the fecal occult blood test (FOBT) (Hemoccult II) sensitivity differed widely between screening trials and led to divergent conclusions on the effects of FOBT screening. We used microsimulation modeling to estimate a preclinical colorectal cancer (CRC) duration and sensitivity for unrehydrated FOBT from the data of 3 randomized controlled trials of Minnesota, Nottingham, and Funen. In addition to 2 usual hypotheses on the sensitivity of FOBT, we tested a novel hypothesis where sensitivity is linked to the stage of clinical diagnosis in the situation without screening.
We used the MISCAN-Colon microsimulation model to estimate sensitivity and duration, accounting for differences between the trials in demography, background incidence, and trial design. We tested 3 hypotheses for FOBT sensitivity: sensitivity is the same for all preclinical CRC stages, sensitivity increases with each stage, and sensitivity is higher for the stage in which the cancer would have been diagnosed in the absence of screening than for earlier stages. Goodness-of-fit was evaluated by comparing expected and observed rates of screen-detected and interval CRC.
The hypothesis with a higher sensitivity in the stage of clinical diagnosis gave the best fit. Under this hypothesis, sensitivity of FOBT was 51% in the stage of clinical diagnosis and 19% in earlier stages. The average duration of preclinical CRC was estimated at 6.7 years.
Our analysis corroborated a long duration of preclinical CRC, with FOBT most sensitive in the stage of clinical diagnosis. Cancer 2009. © 2009 American Cancer Society.