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In this randomized trial involving 84,585 participants in Poland, Norway, and Sweden, the risk of colorectal cancer at 10 years was lower among those invited to undergo screening colonoscopy than among those assigned to no screening.

BackgroundColonoscopy is among the standard tests for colorectal cancer (CRC) screening. However, uptake varies, and alternatives such as colon capsule endoscopy (CCE) are available. The uptake and detection rate of clinically significant neoplasia with CCE, compared with colonoscopy, remain unclear in this setting.ObjectiveThe primary objective of this study was to compare the detection rates of advanced neoplasia between CCE and colonoscopy, using a pathway in which the study group could choose between the two procedures, while the control group was offered only colonoscopy.DesignA randomised, intention-to-treat trial was conducted among Danish CRC screening participants who tested positive with a faecal immunochemical test (FIT). The trial compared the detection rate of advanced neoplasia (primary outcome) and the uptake rate of both approaches between the two arms.ResultsA total of 473 684 invitations were sent to 396 676 individuals, with 62.6% returning the test. Among them, 11 075 tests were positive (4.5%), with no significant differences between the two study groups. Among FIT-positive cases, the uptake for colonoscopy was 91.1% in the control arm and 91.7% in the study arm, where participants had a choice of methods. In the study arm, 45.8% preferred CCE, 11.4% preferred colonoscopy and 42.8% had no preference and underwent colonoscopy. Ultimately, 69.9% of patients who initially opted for CCE were later referred for colonoscopy. The rate of advanced neoplasia detection was similar between the groups: 0.67% in the study arm versus 0.64% in the control arm.ConclusionOffering CCE as an alternative to colonoscopy did not significantly alter the detection rate of advanced neoplasia, nor did it increase uptake in a screening programme with high adherence to colonoscopy following a positive FIT test. Instead, it led to a very high rate of secondary colonoscopies. Therefore, CCE cannot be recommended in this setting.Trial registration number NCT04049357 (ClinicalTrials.gov)

Offering financial incentives to promote or \"nudge\" participation in cancer screening programs, particularly among vulnerable populations who traditionally have lower rates of screening, has been suggested as a strategy to enhance screening uptake. However, effectiveness of such practices has not been established. Our aim was to determine whether offering small financial incentives would increase colorectal cancer (CRC) screening completion in a low-income, uninsured population. We conducted a randomized, comparative effectiveness trial among primary care patients, aged 50-64 years, not up-to-date with CRC screening served by a large, safety net health system in Fort Worth, Texas. Patients were randomly assigned to mailed fecal immunochemical test (FIT) outreach (n=6,565), outreach plus a $5 incentive (n=1,000), or outreach plus a $10 incentive (n=1,000). Outreach included reminder phone calls and navigation to promote diagnostic colonoscopy completion for patients with abnormal FIT. Primary outcome was FIT completion within 1 year, assessed using an intent-to-screen analysis. FIT completion was 36.9% with vs. 36.2% without any financial incentive (P=0.60) and was also not statistically different for the $10 incentive (34.6%, P=0.32 vs. no incentive) or $5 incentive (39.2%, P=0.07 vs. no incentive) groups. Results did not differ substantially when stratified by age, sex, race/ethnicity, or neighborhood poverty rate. Median time to FIT return also did not differ across groups. Financial incentives, in the amount of $5 or $10 offered in exchange for responding to mailed invitation to complete FIT, do not impact CRC screening completion.

Recently, results on colorectal cancer (CRC) incidence and mortality reduction by the offer of screening colonoscopy were reported for the first time from a randomized controlled trial (RCT), the Nordic-European Initiative on Colorectal Cancer (NordICC) trial. Despite randomization, there was a substantially lower proportion of postrandomization exclusions of CRC cases due to cancer registry-recorded date of diagnosis before recruitment in the invited group than in the usual-care group. We aimed to evaluate the impact of such differential exclusions on the trial's effect estimates on CRC risk. We compared reported postrandomization exclusions of CRC cases due to cancer registry-recorded date of diagnosis, and we derived adjusted effect estimates on CRC risk accounting for the reported differential postrandomization exclusion of CRC cases in the invited group and the usual-care group. Reported postrandomization exclusion proportions of CRC cases were originally reported as 52/31,472 (0.17%) and 159/63,133 (0.25%) in the invited and usual-care group, respectively, (P < .005) in an analysis, including participants from all four NordICCstudy countries and as 52/28,277 (0.20%) and 164/56,529 (0.29%) in the recent analysis of 10-year follow-up data from three of the countries (P = .018). Accounting for the differential exclusion proportions increased the estimated CRC risk reduction (95% CI) from originally reported 18% (7%–30%) to 25% (95% CI 13%–35%) in intention-to-screen analysis. Estimated reduction of CRC risk among screening attenders increased from originally reported 31% (17%–45%) to 50% (25%–69%) in adjusted per-protocol analysis. Accounting for differential postrandomization exclusions of CRC cases leads to stronger-than-reported effect estimates in the so far only RCT on long-term effects of screening colonoscopy. •We analysed the proportions of post-randomization exclusions in the NordICC trial.•They were significantly lower in the intervention group than in the control group.•Accounting for these differences in the analysis yielded stronger effect estimates.•Reported NordICC trial results likely underestimated screening colonoscopy effects.•Reasons and implications of the differential exclusions require further research.

Patient navigation improves colorectal cancer screening among underserved populations, but limited resources preclude widespread adoption in minority-serving institutions. We evaluated whether a patient's self-selected social contact person can effectively facilitate outpatient screening colonoscopy. From September 2014 to March 2017 in an urban tertiary center, 399 black participants scheduled for outpatient screening colonoscopy self-selected a social contact person to be a facilitator and provided the person's phone number. Of these, 201 participants (50.4%) were randomly assigned to the intervention arm for their social contact persons to be engaged by phone. The study was explained to the social contact person with details about colonoscopy screening and bowel preparation process. The social contacts were asked to assist the participants, provide support, and encourage compliance with the procedures. The social contact person was not contacted in the usual care arm, n = 198 (49.6%). We evaluated attendance to the scheduled outpatient colonoscopy and adequacy of bowel preparation. Analysis was performed by intention to treat. The social contact person was reached and agreed to be involved for 130 of the 201 participants (64.7%). No differences were found in the proportion of participants who underwent screening colonoscopy (77.3% vs 77.2%; relative risk = 1.01; 95% confidence interval: 0.91-1.12), but there was a modest increase in the proportion with adequate bowel preparation with social contact involvement (89.1% vs 80.9%; relative risk = 1.10; 95% confidence interval: 1.00-1.21). Engaging a patient's social network to serve in the role of a patient navigator did not improve compliance to outpatient screening colonoscopy but modestly improved the adequacy of bowel preparation.

Background We recently reported per-protocol estimates of colonoscopy screening on colorectal cancer incidence and mortality in NordICC, a large-scale randomized trial. Our results may be affected by residual confounding due to lack of detailed information on confounders. Here, we supplement our per-protocol analyses with instrumental variable (IV) estimates whose validity relies on an alternate set of assumptions but does not depend on the availability of confounder data. Individuals in the NordICC trial were randomized at a 1:2 ratio to receive either an invitation to a one-time screening colonoscopy (the invited group) or no invitation (the usual-care group). We used IV analyses to estimate bounds and point estimates of per-protocol effects of colonoscopy screening on colorectal cancer incidence and mortality after 10 years follow-up. Analyses included 28,220 participants in the invited group and 56,365 participants in the usual-care group. Participation in screening was 42%. In IV per-protocol analyses, the 10-year risk of colorectal cancer was 1.13% (95% confidence interval [CI]: 1.04, 1.23) with usual care and, depending on the assumptions, 0.66% (95% CI: 035, 0.95) to 0.74% (95% CI: 0.57, 0.95) in screened individuals (risk ratio of 0.59 [95% CI: 0.30, 0.98] to 0.65 [95% CI: 0.48, 0.87]). The risk of colorectal cancer mortality at 10 years was 0.29% (95% CI: 0.24, 0.33) in the usual-care group and 0.20 (95% CI: 0.09, 0.73) to 0.22% (95% CI: 0.08, 0.37) in the screened group (risk ratio of 0.71 [95% CI: 0.31, 2.89] to 0.79 [95% CI: 0.24, 1.42]). IV estimation of per-protocol effects suggests that colonoscopy screening reduces colorectal cancer incidence by 35 to 41% after 10 years.

Abstract Background CALM was a randomized phase 3 trial in patients with Crohn’s disease (CD) that demonstrated improved endoscopic outcomes when treatment was escalated based on cutoffs for inflammatory biomarkers, fecal calprotectin (FC), C-reactive protein (CRP), and CD Activity Index (CDAI) remission vs CDAI response alone. The purpose of this post hoc analysis of CALM was to identify drivers of treatment escalation and evaluate the association between biomarker cutoff concentrations and endoscopic end points. Methods The proportion of patients achieving CD Endoscopic Index of Severity (CDEIS) <4 and no deep ulcers 48 weeks after randomization was evaluated according to CRP <5 mg/L or ≥5 mg/L and FC <250 μg/g or ≥250 μg/g. Subgroup analyses were performed according to disease location, and sensitivity analyses were conducted in patients with elevated CRP and/or FC at baseline. The association between endoscopic end points and biomarker cutoffs was performed using χ 2 test. Results The proportion of patients who achieved the primary end point CDEIS <4 and no deep ulcers was significantly greater for those with FC <250 µg/g (74%; P < 0.001), with an additive effect for CRP <5 mg/L. The association of FC <250 µg/g with improved endoscopic outcomes was independent of disease location, although the greatest association was observed for ileocolonic disease. Fecal calprotectin <250 µg/g, CRP <5 mg/L, and CDAI <150 gave a sensitivity/specificity of 72%/63% and positive/negative predictive values of 86%/42% for CDEIS <4 and no deep ulcers 48 weeks after randomization. Conclusion This post hoc analysis of CALM demonstrated that a cutoff of FC <250 µg/g is a useful surrogate marker for mucosal healing in CD. A post hoc analysis of a phase 3 trial in Crohn’s disease showed that a fecal calprotectin cutoff of <250 μg/g accurately classified mucosal healing at week 48 after randomization in a majority of patients.

Background Colonoscopy as a common screening practice to prevent colorectal cancer lacks strong evidence. NordICC, the first randomized trial of colonoscopy screening, reported no clear clinical benefit for colonoscopy in the intention-to-screen population with suggested benefit in the risk of colorectal incidence and cancer-specific mortality in the per-protocol analyses. However, although the study was designed to perform survival analysis, no survival outcomes were reported since the underlying assumption for hazard ratio was not valid. We aimed to assess whether colonoscopy screening is associated with improved survival outcomes compared with usual care. Methods We reconstructed patient-level data from the Kaplan-Meier estimator of the primary endpoints reported in NordICC for the intention-to-screen and adjusted per-protocol populations. The restricted-mean survival time difference (RMST-D) and restricted-mean time loss ratio (RMTL-R), which are robust alternatives to the hazard ratio without specific model assumptions, were calculated for colorectal cancer incidence and death. Results In this study, no significant difference in colorectal cancer incidence over 10 years was found in the intention-to-screen population (RMST-D: -0.68 days, 95% CI -3.9–2.6; RMTL-R: 1.04, 95% CI 0.88–1.22) or in the per-protocol analysis population (RMST-D: -2.9 days, 95% CI -6.5–0.67; RMTL-R: 1.15, 95% CI 0.97–1.35). In the intention-to-screen population, inviting individuals to colonoscopy did not improve colorectal-cancer death (RMST-D: -0.29 days, 95% CI -1.6–1.0; RMTL-R: 1.07, 95% CI 0.78–1.48). Over 10 years, in the per-protocol analysis, individuals who underwent colonoscopy survived an average of 1.1 more days free of colorectal cancer, but this difference was not statistically significant (RMST-D: 95% CI -0.13–2.3; RMTL-R: 0.72, 95% CI 0.49–1.07). Conclusions In this reanalysis of the NordICC data, no evidence of improvement in survival outcomes for participants invited to undergo colonoscopy compared to usual care was identified, even when assuming that all invited participants did undergo colonoscopy. Thus, our results do not support the use of colonoscopy as a population-wide screening test as a mean to decrease colorectal cancer incidence or death. Registry Not applicable.

Purpose: In recent years, colorectal cancer (CRC) screening rates have increased steadily in the USA, though racial and ethnic disparities persist. In a community-based randomized controlled trial, we investigated the effect of patient navigation on increasing CRC screening adherence among older African Americans. Methods: Participants in the Cancer Prevention and Treatment Demonstration were randomized to either the control group, receiving only printed educational materials (PEM), or the intervention arm where they were assigned a patient navigator in addition to PEM. Navigators assisted participants with identifying and overcoming screening barriers. Logistic regression analyses were used to assess the effect of patient navigation on CRC screening adherence. Up-to-date with screening was defined as self-reported receipt of colonoscopy/sigmoidoscopy in the previous 10 years or fecal occult blood testing (FOBT) in the year prior to the exit interview. Results: Compared with controls, the intervention group was more likely to report being up-to-date with CRC screening at the exit interview (OR 1.55, 95 % CI 1.07–2.23), after adjusting for select demographics. When examining the screening modalities separately, the patient navigator increased screening for colonoscopy/sigmoidoscopy (OR 1.53, 95 % CI 1.07–2.19), but not FOBT screening. Analyses of moderation revealed stronger effects of navigation among participants 65–69 years and those with an adequate health literacy level. Conclusions: In a population of older African Americans adults, patient navigation was effective in increasing the likelihood of CRC screening. However, more intensive navigation may be necessary for adults over 70 years and individuals with low literacy levels.

ObjectiveTo assess the safety and quality of baseline screening colonoscopy in a randomised controlled trial (RCT).MethodsA population-based RCT with an explanatory design is ongoing to evaluate the efficacy of colonoscopy screening in 9751 men and women aged 40–74 years at average risk of colorectal cancer (CRC) in Japan. Screening colonoscopies for the intervention group were performed from June 2009 to June 2017.ResultsOf the 4861 participants in the intervention group, 4495 (92.5%) underwent screening colonoscopy. The quality of bowel preparation was excellent (34.8%) or good (45.6%) in 80.4% of cases. The caecal intubation rate was 99.7% (4483/4495), and the mean (±SD) withdrawal time was 9.7 (±5.3) min. The adenoma detection rate (ADR) was 39.4% (1770/4495). A total of 27 participants (0.6%) were diagnosed with CRC, and 266 (5.9%) were diagnosed with advanced neoplasia (AN). In women, adenomas were more frequently detected in the proximal colon than in the distal colon (proximal: 18.9% vs distal: 16.4%, p=0.024), and a similar trend was observed for AN (proximal: 2.4% vs distal: 1.5%, p=0.045). No serious adverse events related to screening colonoscopy were reported, and minor adverse events were observed in two participants (0.04%).ConclusionsAdequate performance in compliance, ADR, and safety was confirmed in the intervention arm of the RCT evaluating the efficacy of screening colonoscopy. The high quality of screening colonoscopy observed in the trial suggests its feasibility as a population-based screening approach.Trial registration numberUMIN000001980.