FIT was performed with a single fecal sample. One of 2 separate FIT kits (Eiken OC-SENSOR or Kyowa HM-JACK) was selected by each municipality according to its own purchasing process. The hemoglobin cutoff points for the 2 tests were 100 (Eiken) and 8 ng/mL (Kyowa); they were both equivalent to 20 μg of hemoglobin per gram of feces. The rationale for this cutoff was based on the results of our previous community-based pilot study.16 (link) All samples were submitted to qualified laboratories in each municipality for testing. A positive test was defined as a test result that was above the defined cutoff for the given test. Test results were reported to all participants by mail and telephone. Participants with positive tests were referred for either total colonoscopy or sigmoidoscopy plus a barium enema for a confirmatory diagnosis. These confirmatory examinations were reimbursed by National Health Insurance, which has a coverage rate of 99.9% for the entire population.
All municipalities were asked to report the results of all confirmatory examination findings and pathological results. The histopathology of colon neoplasms was classified according to the World Health Organization criteria.17 Cancers were staged with the 6th edition of the American Joint Committee on Cancer staging system.
Data relevant to this screening program, including the demographics of screened subjects, the results of FIT, endoscopic findings, and the results of histopathology, were all stored in a central database. This database was linked to the National Death Registry of Taiwan and the Taiwan Cancer Registry, from which the causes of death (either cancerous or noncancerous codes) could be obtained. In this death registry, the causes of death in the government computer files were coded according to International Classification of Diseases, Ninth Revision. The cancer registry is a nationwide program with a coverage rate of 98.6% and an accuracy greater than 99%, but the delay in reporting is typically approximately 2 to 3 years.18 The date of diagnosis and the date and cause of death of a subject could be obtained via the matching of the computerized data file of the screening program and the aforementioned registry database with a unique identification number. We ascertained data regarding the incidence of CRC and CRC deaths from these 2 databases.