Participation and Ease of Use in Colorectal Cancer Screening: A Comparison of 2 Fecal Immunochemical Tests.

INTRODUCTION: The impact of fecal immunochemical test (FIT)-based colorectal cancer (CRC) screening on disease incidence and mortality is affected by participation, which might be influenced by ease of use of the FIT. We compared the participation rates and ease of use of 2 different FITs in a CRC screening program. METHODS: There were two study designs within the Dutch CRC screening program. In a paired cohort study, all invitees received 2 FITs (OC-Sensor, Eiken, Japan, and FOB-Gold, Sentinel, Italy) and were asked to sample both from the same stool. Ease of use of both FITs was evaluated by a questionnaire. In a randomized controlled trial, invitees were randomly allocated to receive one of the 2 FITs to compare participation and analyzability. RESULTS: Of 42,179 invitees in the paired cohort study, 21,078 (50%) completed 2 tests and 20,727 (98%) returned the questionnaire. FOB-Gold was reported significantly easier to use. More participants preferred FOB-Gold (36%) than OC-Sensor (5%), yet most had no preference (59%; P < 0.001). In the randomized trial, 936 of 1,923 invitees (48.7%) returned the FOB-Gold and 940 of 1,923 invitees (48.9%) returned the OC-Sensor, a difference of -0.2% (confidence interval, -3.4% to 3.0%), well within the pre-specified 5% noninferiority margin (P = 0.001). Only one FOB-Gold (0.1%) and 4 OC-Sensors (0.4%) were not analyzable (P = 0.18). CONCLUSIONS: Although FOB-Gold was significantly but marginally considered easier to use than OC-Sensor, the number of analyzable tests and the participation rates in organized CRC screening are not affected when either of the FITs is implemented as a primary screening test.

Equivalent Accuracy of 2 Quantitative Fecal Immunochemical Tests in Detecting Advanced Neoplasia in an Organized Colorectal Cancer Screening Program.

BACKGROUND & AIMS: Although different brands of fecal immunochemical tests (FITs) are used for colorectal cancer (CRC) screening, few studies have compared their accuracy in detecting advanced neoplasia. METHODS: We performed a large prospective cohort study within the Dutch national CRC screening program to evaluate 2 quantitative FITs: FOB-Gold (Sentinel, Milan, Italy) and OC-Sensor (Eiken Chemical, Tokyo Japan), from May 2016 through March 2017. We randomly selected 42,179 screening-naïve individuals (55-75 years old), who were asked to perform both FITs themselves using the same bowel movement. Participants with positive results from 1 or both FITs (≥15 µg hemoglobin/gram feces) were invited for colonoscopy examination (reference standard). Equivalence in detection of advanced neoplasia was evaluated with a predefined margin of 0.15%. RESULTS: Of 42,179 invitees, 22,064 (52%) participated and FITs were completed for 21,078 participants. Of 2112 participants (9.6%) with 1 or 2 positive results from FITs, 1778 (84%) underwent a colonoscopy. Of all invitees, the FOB-Gold test detected advanced neoplasia (confirmed by colonoscopy) in 610 participants (1.45%) and the OC-Sensor detected advanced neoplasia (confirmed by colonoscopy) in 606 participants (1.44%)-an absolute difference of 0.01% (95% confidence interval [CI], -0.06% to 0.08%). Of the 21,078 participants who completed both FITs, 1582 (7.5%) had a positive result from the FOB-Gold test and 1627 (7.7%) a positive result from the OC-Sensor test (P = .140). The relative true-positive rate of FOB-Gold vs OC-Sensor in detecting advanced neoplasia was 0.97 (95% CI, 0.92-1.01) and 0.95 (95% CI, 0.87-1.03) for CRC. The relative false-positive rate of the FOB-Gold test vs the OC-Sensor test in detecting advanced neoplasia was 0.99 (95% CI, 0.93-1.05). CONCLUSIONS: In a large prospective study of individuals invited for CRC screening in The Netherlands, we found equivalent accuracy of the FOB-Gold FIT vs the OC-Sensor FIT in detecting advanced neoplasia. These results are relevant for selecting FITs for CRC screening programs worldwide. Dutch National Trial Registry: NTR5874.

Breast cancer screening halves the risk of breast cancer death: a case-referent study.

Large-scale epidemiologic studies have consistently demonstrated the effectiveness of mammographic screening programs, however the benefits are still subject to debate. We estimated the effect of the Dutch screening program on breast cancer mortality. In a large multi-region case-referent study, we identified all breast cancer deaths in 2004 and 2005 in women aged 50-75 who had been invited for screening (cases). Cases were individually matched to referents from the population invited to screening. Conditional logistic regression was used to estimate the odds ratio (OR) of breast cancer death according to individual screening history. The OR was adjusted for self-selection bias using regional correction factors for the difference in baseline risk for breast cancer death between screened and unscreened women. A total of 1233 cases and 2090 referents were included in this study. We found a 58% reduction in breast cancer mortality in screened versus unscreened women (adjusted OR = 0.42, 95% CI 0.33-0.53). Screening, i.e. early detection and treatment, has resulted in a substantial reduction in breast cancer mortality, indicating that the Dutch breast cancer screening program is highly effective.

Do women make an informed choice about participating in breast cancer screening? A survey among women invited for a first mammography screening examination.

OBJECTIVE: To determine the level of informed choice in women invited for breast cancer screening for the first time. METHODS: To determine the content of decision-relevant knowledge, 16 experts were asked to judge whether each of 51 topics represented essential information to enable informed choices. To assess the level of informed choices, a questionnaire was then sent to all 460 invited women in the south-western part of the Netherlands who turned 50 in August 2008. RESULTS: Of all 229 respondents, 95% were deemed to have sufficient knowledge as they answered at least 8 out of 13 items correctly. In 90% there was consistency between intention (not) to participate and attitude. As a result, 88% made an informed choice. Sixty-eight percent of women responded correctly on the item of over-diagnosis. Even if all non-respondents were assumed to have no knowledge, 50% of the total group invited to participate still had sufficient knowledge. CONCLUSIONS: Women were deemed to have sufficient relevant knowledge of the benefits and harms if they answered at least half of the items correctly. PRACTICE IMPLICATIONS: To further increase informed choices in breast cancer screening, information on some of the possible harms merits further attention.