Objective Limited data exist on attendance and additional yield of 2-sample faecal immunochemical testing (FIT) screening during multiple rounds. We therefore conducted a population-based colorectal cancer screening trial comparing attendance and yield of repeated 1-sample and 2-sample FIT screenings.
Design Two randomly selected groups of average-risk subjects aged 50–74 years were invited for two rounds of either 1-sample (n=5007) or 2-sample (n=3197) FIT (OC-sensor Micro) screening. The test was considered positive if at least one sample was positive (cut-off 50 ng/mL; 10 µg haemoglobin/g).
Results The cumulative attendance rate was similar for repeated 1-sample and 2-sample FIT screenings (1-sample FIT: 68.1%; 2-sample FIT: 67.1%, p=0.368). The positivity rate in the second round was lower for 1-sample FIT (6.2%, 95% CI 5.4% to 7.2%) than for 2-sample FIT (8.4%, 95% CI 7.1% to 9.8%, p=0.007), whereas the detection rate of advanced neoplasia (AN, 1-sample FIT: 1.9%, 95% CI 1.2% to 2.2%; 2-sample FIT: 1.7%, 95% CI 1.2% to 2.5%, p=0.861) and the positive predictive value (1-sample FIT: 32%, 95% CI 24% to 40%; 2-sample FIT: 21%, 95% CI 15% to 29%, p=0.075) did not differ. After two rounds of screening, the cumulative diagnostic yield of AN for 1-sample FIT was 29.3 per 1000 invitees, compared with 34.0 for 2-sample FIT (p=0.241).
Conclusions Using 2-sample FIT instead of 1-sample FIT does not result in a higher detection rate of AN in the second round of repeated FIT screening. Furthermore, both strategies lead to a similar yield of AN over two rounds. These findings imply that 1-sample FIT screening is preferred over 2-sample FIT screening.
- COLORECTAL CARCINOMA
- COLORECTAL CANCER SCREENING
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Contributors EJK, MvB and MEvL: study concept; EJK, MvB and MEvL: study design; EJK: supervised the execution of the study; LH, AHCvR and AK: performed the retrieval of the population sample and the randomisation in collaboration with the Regional Organisation for Population Screening South-West Netherlands, Rotterdam and Tenalea, Amsterdam; J.C.I.Y. Reijerink and H. ‘t Mannetje: retrieval of the target population from the municipal registries and all mailings; AJvV, J. Francke, M. Ouwendijk, A. Heijens and N. Nagtzaam: analysis of all FIT samples; MEvL, LH and AHCvR: the database design; AHCvR and AK: data entry; A.C.M. van der Togt, and J.C.I.Y. Reijerink: coordinated the daily process; AK: drafted the report; LH, AHCvR, MvB, IL-V, WS, KI, MEvL and EJK: critical revision of the manuscript for important intellectual content; AK and C.W.N. Looman: performed the statistical analyses. All co-authors read and approved the final version of the paper.
Funding This trial was funded by the Dutch Cancer Society (EMCR 2006-3673), the Dutch Ministry of Health, Health Care Prevention Program—Implementation (ZonMw 63300022 and ZonMw 120720011), Olympus Medical Systems Europe GmbH, Hamburg, Germany, the Jacoba Foundation, and Eiken Chemical Co, Tokyo, Japan. None of them was involved in the study design, collection, analysis, and interpretation of the data and in the writing of the report.
Competing interests None declared.
Patient consent Obtained
Ethics approval The study was approved by the Dutch Ministry of Health (PG/ZP 2.727.071 and PG/ZP 2.823.158). The study letters and information brochures were approved by the Institutional Review Board at the Erasmus University Medical Centre (MEC-2005-264 and MEC-2008-029).
Provenance and peer review Not commissioned; externally peer reviewed.