Population-Based Colonoscopy Screening for Colorectal Cancer: A Randomized Clinical Trial.
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ABSTRACT:
SUBMITTER: Bretthauer M
PROVIDER: S-EPMC5333856 | biostudies-literature | 2016 Jul
REPOSITORIES: biostudies-literature
Publications
Population-Based Colonoscopy Screening for Colorectal Cancer: A Randomized Clinical Trial.
Bretthauer Michael M Kaminski Michal F MF Løberg Magnus M Zauber Ann G AG Regula Jaroslaw J Kuipers Ernst J EJ Hernán Miguel A MA McFadden Eleanor E Sunde Annike A Kalager Mette M Dekker Evelien E Lansdorp-Vogelaar Iris I Garborg Kjetil K Rupinski Maciej M Spaander Manon C W MC Bugajski Marek M Høie Ole O Stefansson Tryggvi T Hoff Geir G Adami Hans-Olov HO
JAMA internal medicine 20160701 7
<h4>Importance</h4>Although some countries have implemented widespread colonoscopy screening, most European countries have not introduced it because of uncertainty regarding participation rates, procedure-related pain and discomfort, endoscopist performance, and effectiveness. To our knowledge, no randomized trials on colonoscopy screening currently exist.<h4>Objective</h4>To investigate participation rate, adenoma yield, performance, and adverse events of population-based colonoscopy screening ...[more]
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Project description:IntroductionColonoscopy is considered the gold standard for colorectal cancer screening. Panoramic colonoscopy offers better visualization to decrease the adenoma miss rate.AimTo assess the influence of 330° panoramic view colonoscopy on adenoma and polyp detection rate, cecal intubation time, and examiner's comfort.Material and methodsThe study enrolled 421 patients aged 18-80 years who were eligible for colonoscopy screening. Patients with prior abdominal surgery, inflammatory bowel disease or after colorectal resections were excluded from the study. Patients were randomized to either standard frontal view (SFV) (Olympus Evis Exera III 190 CF-HQ190L) or the panoramic view colonoscopy (PVC) (FUSE CDVL slim c38). The study was approved by the local bioethics committee and registered at ClinicalTrial.gov (NCT02929381).ResultsThere were 214 patients examined with SFV and 207 with PVC. The mean age of patients was 64 ±12.26 years. The two groups were comparable. The median cecal intubation time was 234 s with SFV vs. 311 s with PVC (p < 0.001). There were no significant differences in CIR or withdrawal time. PVC made it possible to discover more diverticula in the ascending colon (p = 0.009). PDR with SFV was 34.6% and 40.1% with PVC (p = 0.242). A higher number of polyps was found in the transverse colon in the PVC group (p = 0.006). ADR and advanced ADR (aADR) in both groups were similar (26.4% vs. 27.1% and 14, 2% vs. 13.9%).ConclusionsColonoscopy with wide-angle endoscopes lasts longer and allows for the detection of more polyps and diverticula without affecting ADR and aADR. Our study did not reveal the superiority of wide-angle colonoscopy in colorectal cancer screening.
| S-EPMC8193743 | biostudies-literature
Project description:BackgroundScreening colonoscopy (SC) for colorectal cancer (CRC) is underused by Latino individuals. The current randomized clinical trial examined the impact of 3 interventions: 1) patient navigation; 2) patient navigation plus standard Centers for Disease Control and Prevention print materials; and 3) patient navigation plus culturally targeted print materials for Latinos referred for SC. Demographic, personal and health history, and psychometric factors associated with SC also were examined.MethodsA total of 344 urban Latino individuals aged 50 to 85 years with no personal and/or immediate family history of CRC diagnosed before age 60 years, no personal history of a gastrointestinal disorder, no colonoscopy within the past 5 years, with insurance coverage, and with a referral for SC were consented. Participants were randomized to patient navigation (20%), patient navigation plus standard Centers for Disease Control and Prevention print materials (40%), and patient navigation plus culturally targeted print materials (40%). The completion of SC was assessed at 12 months.ResultsThe interventions had an overall SC rate of 82%. Counterintuitively, patients with an average income of <$10,000 were found to have higher SC rates (87%) than those with a greater income (75%).ConclusionsThe addition of standard or culturally targeted print materials did not appear to increase SC rates above those for patient navigation. Indeed, after controlling for other variables, culturally targeted print materials were found to be associated with lower SC rates among Puerto Rican individuals.
| S-EPMC6992525 | biostudies-literature
Project description:ImportanceMailed fecal immunochemical test (FIT) outreach is more effective than colonoscopy outreach for increasing 1-time colorectal cancer (CRC) screening, but long-term effectiveness may need repeat testing and timely follow-up for abnormal results.ObjectiveCompare the effectiveness of FIT outreach and colonoscopy outreach to increase completion of the CRC screening process (screening initiation and follow-up) within 3 years.Design, setting, and participantsPragmatic randomized clinical trial from March 2013 to July 2016 among 5999 participants aged 50 to 64 years who were receiving primary care in Parkland Health and Hospital System and were not up to date with CRC screenings.InterventionsRandom assignment to mailed FIT outreach (n = 2400), mailed colonoscopy outreach (n = 2400), or usual care with clinic-based screening (n = 1199). Outreach included processes to promote repeat annual testing for individuals in the FIT outreach group with normal results and completion of diagnostic and screening colonoscopy for those with an abnormal FIT result or assigned to colonoscopy outreach.Main outcomes and measuresPrimary outcome was screening process completion, defined as adherence to colonoscopy completion, annual testing for a normal FIT result, diagnostic colonoscopy for an abnormal FIT result, or treatment evaluation if CRC was detected. Secondary outcomes included detection of any adenoma or advanced neoplasia (including CRC) and screening-related harms (including bleeding or perforation).ResultsAll 5999 participants (median age, 56 years; women, 61.9%) were included in the intention-to-screen analyses. Screening process completion was 38.4% in the colonoscopy outreach group, 28.0% in the FIT outreach group, and 10.7% in the usual care group. Compared with the usual care group, between-group differences for completion were higher for both outreach groups (27.7% [95% CI, 25.1% to 30.4%] for the colonoscopy outreach group; 17.3% [95% CI, 14.8% to 19.8%] for FIT outreach group), and highest in the colonoscopy outreach group (10.4% [95% CI, 7.8% to 13.1%] for the colonoscopy outreach group vs FIT outreach group; P < .001 for all comparisons). Compared with usual care, the between-group differences in adenoma and advanced neoplasia detection rates were higher for both outreach groups (colonoscopy outreach group: 10.3% [95% CI, 9.5% to 12.1%] for adenoma and 3.1% [95% CI, 2.0% to 4.1%] for advanced neoplasia, P < .001 for both comparisons; FIT outreach group: 1.3% [95% CI, -0.1% to 2.8%] for adenoma and 0.7% [95% CI, -0.2% to 1.6%] for advanced neoplasia, P < .08 and P < .13, respectively), and highest in the colonoscopy outreach group (colonoscopy outreach group vs FIT outreach group: 9.0% [95% CI, 7.3% to 10.7%] for adenoma and 2.4% [95% CI, 1.3% to 3.3%] for advanced neoplasia, P < .001 for both comparisons). There were no screening-related harms in any groups.Conclusions and relevanceAmong persons aged 50 to 64 years receiving primary care at a safety-net institution, mailed outreach invitations offering FIT or colonoscopy compared with usual care increased the proportion completing CRC screening process within 3 years. The rate of screening process completion was higher with colonoscopy than FIT outreach.Trial registrationclinicaltrials.gov Identifier: NCT01710215.
| S-EPMC5648645 | biostudies-literature
Project description:BackgroundClinical guidelines recommend either a clear-liquid diet or a low-fiber diet for colonoscopy preparation. Participants in a screening program are usually motivated healthy individuals in which a good tolerability is important to improve adherence to potential surveillance colonoscopies.ObjectiveOur aim was to assess whether or not a normocaloric low-fiber diet followed the day before a screening colonoscopy compromises the efficacy of bowel cleansing and may improve the tolerability of bowel preparation.DesignThis is a randomized, endoscopist-blinded, noninferiority clinical trial.SettingsThe study was conducted at a tertiary care center.PatientsA total of 276 consecutive participants of the Barcelona colorectal cancer screening program were included.InterventionParticipants were randomly assigned to a clear-liquid diet or a normocaloric low-fiber diet the day before the colonoscopy. Both groups received 4 L of polyethylene glycol in a split-dose regimen.Main outcome measuresPrimary outcome was the adequate bowel preparation rate measured with the Boston bowel preparation scale. Secondary outcomes included tolerability, fluid-intake perception, hunger, side effects, and acceptability.ResultsParticipants in both groups were similar in baseline characteristics. Adequate bowel preparation was achieved in 89.1% vs 95.7% in clear-liquid diet and low-fiber diet groups, showing not only noninferiority, but also superiority (p = 0.04). Low-fiber diet participants reported less fluid-intake perception (p = 0.04) and less hunger (p = 0.006), with no differences in bloating or nausea.LimitationsThe single-center design of the study could limit the external validity of the results. The present findings may not be comparable to other clinical settings.ConclusionA normocaloric low-fiber diet the day before a screening colonoscopy achieved better results than a clear-liquid diet in terms of adequate colon preparation. Moreover, it also improved the perception of hunger and excessive fluid intake. Registered at clinicaltrials.gov: NCT02401802. See Video Abstract at http://links.lww.com/DCR/A829.
| S-EPMC6445600 | biostudies-literature
Project description:Background & aimsColonoscopy provides incomplete protection from colorectal cancer (CRC), but determinants of post-colonoscopy CRC are not well understood. We compared clinical features and molecular characteristics of CRCs diagnosed at different time intervals after a previous colonoscopy.MethodsWe performed a population-based, cross-sectional study of incident CRC cases in Denmark (2007-2011), categorized as post-colonoscopy or detected during diagnostic colonoscopy (in patients with no prior colonoscopy). We compared prevalence of proximal location and DNA mismatch repair deficiency (dMMR) in CRC tumors, relative to time since previous colonoscopy, using logistic regression and cubic splines to assess temporal variation.ResultsOf 10,365 incident CRCs, 725 occurred after colonoscopy examinations (7.0%). These were more often located in the proximal colon (odds ratio [OR], 2.34; 95% confidence interval [CI], 1.90-2.89) and were more likely to have dMMR (OR, 1.26; 95% CI, 1.00-1.59), but were less likely to be metastatic at presentation (OR, 0.65; 95% CI, 0.48-0.89) compared with CRCs diagnosed in patients with no prior colonoscopy. The highest proportions of proximal and/or dMMR tumors were observed in CRCs diagnosed 3-6 years after colonoscopy, but these features were still more frequent among cancers diagnosed up to 10 years after colonoscopy. The relative excess of dMMR tumors was most pronounced in distal cancers. In an analysis of 85 cases detected after colonoscopy, we found BRAF mutations in 23% of tumors and that 7% of cases had features of Lynch syndrome. Colonoscopy exams were incomplete in a higher proportion of cases diagnosed within <1 year (in 38%) than in those diagnosed within 1-10 years after colonoscopy (16%).ConclusionsIn a study of incident CRC cases in Denmark, we observed that tumors found in patients who have undergone colonoscopy are more often proximal and have dMMR compared to CRCs detected in patients without previous colonoscopies. The excess of right-sided tumors and the modest independent effects of dMMR reinforce the importance of proper colonoscopic examination of the proximal large bowel.
| S-EPMC5159224 | biostudies-literature
Project description:BackgroundNo head-to-head randomized controlled trials have demonstrated the superiority of one colorectal screening modality over another in reducing colorectal cancer mortality. We conducted a pilot randomized controlled trial of fecal occult blood testing (FOBT), optical colonoscopy (OC), and virtual colonoscopy (VC), to inform the planning of a larger evaluative trial.MethodsEligible patients (aged 50 to 70) were recruited from five primary care practices in Hamilton, ON, Canada, between March 23, 2010 and August 11, 2010, and randomized 1:1:1 in a parallel design using an automated, centralized telephone service to either FOBT, OC, or VC. To reflect conventional practice, patients received no additional reminders to complete their allocated screening test beyond those received in usual practice. The primary outcome was completion of the assigned screening procedure. Results of the index test and any follow-up investigations were ascertained at 6 months. Participants, caregivers, and outcome assessors were not blinded to group assignment. The trial was stopped early due to lack of ongoing funding.ResultsA total of 198 participants were enrolled, of whom 67 were allocated to FOBT, 66 to OC, and 65 to VC. The allocated screening procedure was completed by 43 (64%) subjects allocated to FOBT (95% confidence interval [CI], 52-75%), 53 (80%) subjects allocated to OC (95% CI, 69-88%), and 50 (77%) subjects allocated to VC (95% CI, 65-85%); because the trial stopped early, we had insufficient statistical power to detect clinically relevant differences in completion rates. During 6 months follow-up, colorectal adenomas were detected in 0 (0%) subjects allocated to FOBT, 12 (18%) subjects allocated to OC, and 2 (3%) subjects allocated to VC. One subject in the OC arm had histological evidence of high-grade dysplasia. No subjects were diagnosed with colorectal cancer.ConclusionsIn this pilot randomized controlled trial of colorectal cancer screening in a primary care setting, 64-80% of subjects completed their allocated screening test. These findings may be of value to investigators planning clinical trials to evaluate the effectiveness of colorectal cancer screening.Trial registrationClinicalTrials.gov NCT00865527. https://clinicaltrials.gov/ct2/show/NCT00865527.
| S-EPMC4499903 | biostudies-literature
Project description:BackgroundOrganised programmes for colorectal cancer screening demand a high burden of medical and economic resources. The preferred methods are the faecal immunochemical test and primary colonoscopy.ObjectiveThe purpose of this study was to perform an economic analysis and comparison between these tests in Europe.MethodsWe used a Markov cost-utility analysis from a societal perspective comparing biennial faecal immunochemical test or colonoscopy every 10 years screening versus non-screening in Portugal. The population was screened, aged from 50-74 years, and efficacy was evaluated in quality-adjusted life years. For the base-case scenario, the faecal immunochemical test cost was €3 with 50% acceptance and colonoscopy cost was €397 with 38% acceptance. The threshold was set at €39,760/quality-adjusted life years and the primary outcome was the incremental cost-effectiveness ratio.ResultsScreening by biennial faecal immunochemical test and primary colonoscopy every 10 years resulted in incremental utilities of 0.00151 quality-adjusted life years and 0.00185 quality-adjusted life years at additional costs of €4 and €191, respectively. The faecal immunochemical test was the most cost-effective option providing an incremental cost-effectiveness ratio of €2694/quality-adjusted life years versus €103,633/quality-adjusted life years for colonoscopy. Colonoscopy capacity would have to increase 1.3% for a faecal immunochemical test programme or 31% for colonoscopy.ConclusionBiennial faecal immunochemical test screening is better than colonoscopy as it is cost-effective, allows more individuals to get screened, and provides a more rational use of the endoscopic capacity available.
| S-EPMC6374854 | biostudies-literature
Project description:BackgroundChildhood cancer survivors (CCS) are at increased risk of developing colorectal cancer (CRC) compared to the general population, especially those previously exposed to abdominal or pelvic radiation therapy (APRT). However, the benefits and costs of CRC screening in CCS are unclear. In this study, we evaluated the cost-effectiveness of early-initiated colonoscopy screening in CCS.MethodsWe adjusted a previously validated model of CRC screening in the US population (MISCAN-Colon) to reflect CRC and other-cause mortality risk in CCS. We evaluated 91 colonoscopy screening strategies varying in screening interval, age to start, and age to stop screening for all CCS combined and for those treated with or without APRT. Primary outcomes were CRC deaths averted (compared to no screening) and incremental cost-effectiveness ratios (ICERs). A willingness-to-pay threshold of $100 000 per life-years gained (LYG) was used to determine the optimal screening strategy.ResultsCompared to no screening, the US Preventive Services Task Force's average risk screening schedule prevented up to 73.2% of CRC deaths in CCS. The optimal strategy of screening every 10 years from age 40 to 60 years averted 79.2% of deaths, with ICER of $67 000/LYG. Among CCS treated with APRT, colonoscopy every 10 years from age 35 to 65 years was optimal (CRC deaths averted: 82.3%; ICER: $92 000/LYG), whereas among those not previously treated with APRT, screening from age 45 to 55 years every 10 years was optimal (CRC deaths averted: 72.7%; ICER: $57 000/LYG).ConclusionsEarly initiation of colonoscopy screening for CCS is cost-effective, especially among those treated with APRT.
| S-EPMC6855986 | biostudies-literature
Project description:Colorectal cancer screening has clear benefits in terms of mortality reduction; however, it is still underutilized and especially among medically underserved populations, including African Americans, who also suffer a disproportionate colorectal cancer burden. This study consisted of a theory-driven (health belief model) spiritually based intervention aimed at increasing screening among African Americans through a community health advisor-led educational series in 16 churches. Using a randomized design, churches were assigned to receive either the spiritually based intervention or a nonspiritual comparison, which was the same in every way except that it did not contain spiritual/religious content and themes. Trained and certified peer community health advisors in each church led a series of two group educational sessions on colorectal cancer and screening. Study enrollees completed a baseline, 1-month, and 12-month follow-up survey at their churches. The interventions had significant pre-post impact on awareness of all four screening modalities, and self-report receipt of fecal occult blood test, flexible sigmoidoscopy, and colonoscopy. There were no significant study group differences in study outcomes, with the exception of fecal occult blood test utilization, whereas those in the nonspiritual intervention reported significantly greater pre-post change. Both of these community-engaged, theory-driven, culturally relevant approaches to increasing colorectal cancer awareness and screening appeared to have an impact on study outcomes. Although adding spiritual/religious themes to the intervention was appealing to the audience, it may not result in increased intervention efficacy.
| S-EPMC5568036 | biostudies-other
Project description:BackgroundMany trials have tested different strategies to increase colorectal cancer (CRC) screening. Few describe whether participants are representative of the population from which they are recruited.PurposeTo determine risk factors related to nonparticipation among patients enrolled in an integrated health plan and not up to date for CRC testing, in a trial to increase screening rates.MethodsBetween July 2008 and October 2009, a total of 15,000 adults aged 50-74 years from 21 clinics in Washington State who were due for CRC screening were contacted. Nonparticipants were defined as English-speaking patients who did not engage in the call or refused participation while still potentially eligible. Log-binomial regression models were used to estimate the relative risk of nonparticipation. Analyses were completed between October 2010 and June 2011.ResultsPatients who were nonwhite, had less education, used tobacco, had less continuity of care, and had lower rates of preventive care and cancer screening were more likely to be nonparticipants. Patients reporting never having received any type of CRC testing or screening were also more likely not to participate (62% of nonparticipants vs 46% of participants; adjusted RR=1.58, 95% CI=1.47, 1.70). Reasons for refusal included costs, risks of procedures, and not wanting their medical records reviewed.ConclusionsPatients eligible for but not participating in the trial were more likely to be from minority socioeconomic and racial groups and had behaviors that can negatively affect cancer outcomes. Additional efforts are needed to recruit patients who need CRC screening the most.Trial registrationThis trial is registered at clinicaltrials.gov NCT 00697047.
| S-EPMC3549634 | biostudies-literature