Nastazja Dagny Pilonis1, Marek Bugajski2, Paulina Wieszczy2, Maciej Rupinski2, Malgorzata Pisera2, Edyta Pawlak3, Jaroslaw Regula2, Michal Filip Kaminski4. 1. The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland; Medical Center for Postgraduate Education, Warsaw, Poland. Electronic address: nastazja@gmail.com. 2. The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland; Medical Center for Postgraduate Education, Warsaw, Poland. 3. The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland. 4. The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland; Medical Center for Postgraduate Education, Warsaw, Poland; Institute of Health and Society, University of Oslo, Oslo, Norway.
Abstract
BACKGROUND & AIMS:Primary colonoscopy and fecal immunochemical testing (FIT) are considered first-tier tests for colorectal cancer (CRC) screening. Although colonoscopy is considered the most efficacious test, FIT might achieve higher participation rates. It is uncertain what the best strategy is for offering population-wide CRC screening. METHODS: This was a multicenter randomized health services study performed within the framework of the Polish Colonoscopy Screening Programbetween January 2019 and March 2020 on screening-naïve individuals. Eligible candidates were randomly assigned in a 1:1:1 ratio to participate in 1 of 3 competing invitation strategies: control (invitation to screening colonoscopy only); sequential (invitation to primary colonoscopy and invitation for FIT for initial nonresponders); or choice (invitation offering a choice of colonoscopy or FIT). The primary outcome was participation in CRC screening within 18 weeks after enrollment into the study. The secondary outcome was diagnostic yield for advanced neoplasia. RESULTS: Overall, 12,485 individuals were randomized into the 3 study groups. The participation rate in the control group (17.5%) was significantly lower compared with the sequential (25.8%) and choice strategy (26.5%) groups (P < .001 for both comparisons). The colonoscopy rates for participants with positive FITs were 70.0% for the sequential group and 73.3% for the choice group, despite active call-recall efforts. In the intention-to-screen analysis, advanced neoplasia detection rates were comparable among the control (1.1%), sequential (1.0%), and choice groups (1.1%). CONCLUSIONS: Offering a combination of FIT and colonoscopy as a sequential or active choice strategy increases participation in CRC screening. Increased participation in strategies with FIT do not translate into higher detection of advanced neoplasia. ClinicalTrials.gov, Number NCT03790475.
RCT Entities:
BACKGROUND & AIMS: Primary colonoscopy and fecal immunochemical testing (FIT) are considered first-tier tests for colorectal cancer (CRC) screening. Although colonoscopy is considered the most efficacious test, FIT might achieve higher participation rates. It is uncertain what the best strategy is for offering population-wide CRC screening. METHODS: This was a multicenter randomized health services study performed within the framework of the Polish Colonoscopy Screening Program between January 2019 and March 2020 on screening-naïve individuals. Eligible candidates were randomly assigned in a 1:1:1 ratio to participate in 1 of 3 competing invitation strategies: control (invitation to screening colonoscopy only); sequential (invitation to primary colonoscopy and invitation for FIT for initial nonresponders); or choice (invitation offering a choice of colonoscopy or FIT). The primary outcome was participation in CRC screening within 18 weeks after enrollment into the study. The secondary outcome was diagnostic yield for advanced neoplasia. RESULTS: Overall, 12,485 individuals were randomized into the 3 study groups. The participation rate in the control group (17.5%) was significantly lower compared with the sequential (25.8%) and choice strategy (26.5%) groups (P < .001 for both comparisons). The colonoscopy rates for participants with positive FITs were 70.0% for the sequential group and 73.3% for the choice group, despite active call-recall efforts. In the intention-to-screen analysis, advanced neoplasia detection rates were comparable among the control (1.1%), sequential (1.0%), and choice groups (1.1%). CONCLUSIONS: Offering a combination of FIT and colonoscopy as a sequential or active choice strategy increases participation in CRC screening. Increased participation in strategies with FIT do not translate into higher detection of advanced neoplasia. ClinicalTrials.gov, Number NCT03790475.
Authors: U Strömberg; C Bonander; M Westerberg; L Å Levin; C Metcalfe; R Steele; L Holmberg; A Forsberg; R Hultcrantz Journal: EClinicalMedicine Date: 2022-04-16
Authors: Sebastian Heidenreich; Lila J Finney Rutten; Lesley-Ann Miller-Wilson; Cecilia Jimenez-Moreno; Gin Nie Chua; Deborah A Fisher Journal: Cancer Med Date: 2022-03-21 Impact factor: 4.711