Colorectal Cancer Screening in Familiar-Risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
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ABSTRACT:
DISEASE(S): Colorectal Cancer,Colorectal Neoplasms
PROVIDER: 2085460 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Aims:
1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population.
2. To determine the compliance and complications associated with both strategies.
Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).
Study groups:
* Group I: iFOBT (OC Sensor) in one stool sample, followed by colonoscopy when a positive result.
* Group II: colonoscopy.
Sample-size calculation: 27,749 subjects in each study group (total: 55,498).
| 2072705 | ecrin-mdr-crc
Project description:BackgroundThe ColonCancerCheck screening program for colorectal cancer (CRC) in Ontario, Canada, is considering switching from biennial guaiac fecal occult blood test (gFOBT) screening between age 50-74 years to the more sensitive, but also less specific fecal immunochemical test (FIT). The aim of this study is to estimate whether the additional benefits of FIT screening compared to gFOBT outweigh the additional costs and harms.MethodsWe used microsimulation modeling to estimate quality adjusted life years (QALYs) gained and costs of gFOBT and FIT, compared to no screening, in a cohort of screening participants. We compared strategies with various age ranges, screening intervals, and cut-off levels for FIT. Cost-efficient strategies were determined for various levels of available colonoscopy capacity.ResultsCompared to no screening, biennial gFOBT screening between age 50-74 years provided 20 QALYs at a cost of CAN$200,900 per 1,000 participants, and required 17 colonoscopies per 1,000 participants per year. FIT screening was more effective and less costly. For the same level of colonoscopy requirement, biennial FIT (with a high cut-off level of 200 ng Hb/ml) between age 50-74 years provided 11 extra QALYs gained while saving CAN$333,300 per 1000 participants, compared to gFOBT. Without restrictions in colonoscopy capacity, FIT (with a low cut-off level of 50 ng Hb/ml) every year between age 45-80 years was the most cost-effective strategy providing 27 extra QALYs gained per 1000 participants, while saving CAN$448,300.InterpretationCompared to gFOBT screening, switching to FIT at a high cut-off level could increase the health benefits of a CRC screening program without considerably increasing colonoscopy demand.
| S-EPMC5351837 | biostudies-literature
Project description:The aim of this study is to compare the outcome of three (3) quantitative immunochemical faecal occult blood test in symptomatic patients.
| 2193653 | ecrin-mdr-crc
Project description:BackgroundSeveral colorectal cancer-screening tests are available, but it is uncertain which provides the best balance of risks and benefits within a screening programme. We evaluated cost-effectiveness of a population-based screening programme in Ireland based on (i) biennial guaiac-based faecal occult blood testing (gFOBT) at ages 55-74, with reflex faecal immunochemical testing (FIT); (ii) biennial FIT at ages 55-74; and (iii) once-only flexible sigmoidoscopy (FSIG) at age 60.MethodsA state-transition model was used to estimate costs and outcomes for each screening scenario vs no screening. A third party payer perspective was adopted. Probabilistic sensitivity analyses were undertaken.ResultsAll scenarios would be considered highly cost-effective compared with no screening. The lowest incremental cost-effectiveness ratio (ICER vs no screening euro 589 per quality-adjusted life-year (QALY) gained) was found for FSIG, followed by FIT euro 1696) and gFOBT (euro 4428); gFOBT was dominated. Compared with FSIG, FIT was associated with greater gains in QALYs and reductions in lifetime cancer incidence and mortality, but was more costly, required considerably more colonoscopies and resulted in more complications. Results were robust to variations in parameter estimates.ConclusionPopulation-based screening based on FIT is expected to result in greater health gains than a policy of gFOBT (with reflex FIT) or once-only FSIG, but would require significantly more colonoscopy resources and result in more individuals experiencing adverse effects. Weighing these advantages and disadvantages presents a considerable challenge to policy makers.
| S-EPMC3305953 | biostudies-literature
Project description:Blood that can be detected in stool via faecal immunochemical testing is a recognised risk factor for the presence of colorectal cancer.
There are a number of point of care faecal immunochemical testing devices available. This study is to trial one of these machines into the clinical setting to see if the results are safe and accurate as a ‘rule out’ test for colorectal cancer. We will be investigating patients that present with symptoms or anaemia to their GP and are referred on the two-week rule pathway to our hospital.
It has also been advocated that digital rectal examination (which is part of the routine assessment for a patient presenting to colorectal clinic) provides an opportunity to use a small sample of stool from a gloved finger to perform faecal immunochemical testing. We will be comparing a patient provided sample with a DRE sample on a standard laboratory-based machine.
| 2340309 | ecrin-mdr-crc
Project description:Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths in the United States. Randomized controlled trials have shown that annual screening fecal occult blood testing (FOBT) reduces CRC mortality and incidence. However, patient compliance with FOBT is low.To determine whether a mailed educational reminder increases FOBT card return rates and to examine predictors of FOBT compliance.Blinded, randomized, controlled trial at the Veteran Affairs Medical Center, San Diego, California.Seven hundred and seventy-five consecutive patients > or =50 years of age referred by their primary care physicians for FOBT.Patients were randomly assigned to the usual care group or the intervention group. Ten days after picking up the FOBT cards, a 1-page reminder with information related to CRC screening was mailed to the intervention group only.The primary outcome was proportion of returned FOBT cards after 6 months. Patient demographic, clinical characteristics and prior FOBT completed were collected for multivariate regression analysis.At 6 months after card distribution, 64.6% of patients in the intervention group returned cards compared with 48.4% in the control group (P < 0.001). Patients who received a mailed reminder (OR 2.02; 95% CI: 1.48-2.74) or have a prior history of returning the FOBT cards (OR 1.87; 95% CI: 1.29-2.70) were more likely to return the FOBT cards. Patients with current or recent illicit drug use were less likely to return the FOBT cards (OR 0.26; 95% CI: 0.13-0.50).A simple mailed educational reminder significantly increases compliance with FOBT for CRC screening.
| S-EPMC2771232 | biostudies-literature
Project description:Interventions: Immunochemical fecal occult blood test (FIT) using OC sensor io (Eiken co)
Primary outcome(s): Diagnostic sensitivity of immunochemical fecal occult blood test (FIT) for colorectal cancers based on the location, staging, tumor size and macroscopic types.
Study Design: Single arm Non-randomized
| 2624966 | ecrin-mdr-crc
Project description:BackgroundFecal immunochemical test (FIT) is an effective colorectal cancer screening modality. Little is known about prevalence, reasons, and testing after unsatisfactory FIT, or a FIT that cannot be processed by the laboratory due to inadequate stool specimen or incomplete labeling.MethodsOur retrospective cohort study examined unsatisfactory FIT among average-risk individuals aged 50-74 years in a large, integrated, safety-net health system who completed an index FIT from 2010 to 2019. We determined prevalence of unsatisfactory FIT and categorized reasons hierarchically. We used multivariable logistic regression models to identify factors associated with: (i) unsatisfactory FIT; and (ii) subsequent testing within 15 months of the unsatisfactory FIT.ResultsOf 56,980 individuals completing an index FIT, 10.2% had an unsatisfactory FIT. Reasons included inadequate specimen (51%), incomplete labeling (27%), old specimen (13%), and broken/leaking container (8%). Unsatisfactory FIT was associated with being male [OR, 1.10; confidence interval (CI), 1.03-1.16], Black (OR, 1.46; CI, 1.33-1.61), Spanish speaking (OR, 1.12; CI, 1.01-1.24), on Medicaid (OR, 1.42; CI, 1.28-1.58), and received FIT by mail (OR, 2.66; CI, 2.35-3.01). Among those with an unsatisfactory FIT, fewer than half (41%) completed a subsequent test within 15 months (median, 4.4 months). Adults aged 50-54 years (OR, 1.16; CI, 1.01-1.39) and those who received FIT by mail (OR, 1.92; CI, 1.49-2.09) were more likely to complete a subsequent test.ConclusionsOne in ten returned a FIT that could not be processed, mostly due to patient-related reasons. Fewer than half completed a subsequent test after unsatisfactory FIT.ImpactScreening programs should address these breakdowns such as specimen collection and labeling to improve real-world effectiveness. See related In the Spotlight, p. 183.
| S-EPMC10873102 | biostudies-literature
Project description:BACKGROUND: Previous studies have suggested that the immunochemical fecal occult blood test has superior specificity for detecting bleeding in the lower gastrointestinal tract even if bleeding occurs in the upper tract. We conducted a large population-based study involving asymptomatic adults in Taiwan, a population with prevalent upper gastrointestinal lesions, to confirm this claim. METHODS: We conducted a prospective cohort study involving asymptomatic people aged 18 years or more in Taiwan recruited to undergo an immunochemical fecal occult blood test, colonoscopy and esophagogastroduodenoscopy between August 2007 and July 2009. We compared the prevalence of lesions in the lower and upper gastrointestinal tracts between patients with positive and negative fecal test results. We also identified risk factors associated with a false-positive fecal test result. RESULTS: Of the 2796 participants, 397 (14.2%) had a positive fecal test result. The sensitivity of the test for predicting lesions in the lower gastrointestinal tract was 24.3%, the specificity 89.0%, the positive predictive value 41.3%, the negative predictive value 78.7%, the positive likelihood ratio 2.22, the negative likelihood ratio 0.85 and the accuracy 73.4%. The prevalence of lesions in the lower gastrointestinal tract was higher among those with a positive fecal test result than among those with a negative result (41.3% v. 21.3%, p < 0.001). The prevalence of lesions in the upper gastrointestinal tract did not differ significantly between the two groups (20.7% v. 17.5%, p = 0.12). Almost all of the participants found to have colon cancer (27/28, 96.4%) had a positive fecal test result; in contrast, none of the three found to have esophageal or gastric cancer had a positive fecal test result (p < 0.001). Among those with a negative finding on colonoscopy, the risk factors associated with a false-positive fecal test result were use of antiplatelet drugs (adjusted odds ratio [OR] 2.46, 95% confidence interval [CI] 1.21-4.98) and a low hemoglobin concentration (adjusted OR 2.65, 95% CI 1.62-4.33). INTERPRETATION: The immunochemical fecal occult blood test was specific for predicting lesions in the lower gastrointestinal tract. However, the test did not adequately predict lesions in the upper gastrointestinal tract.
| S-EPMC3176840 | biostudies-other
Project description:BackgroundMailed reminders to promote colorectal cancer (CRC) screening by fecal immunochemical testing (FIT) have been shown to be effective in the Medicaid population, in which screening is underused. However, little is known regarding the cost-effectiveness of these interventions, with or without an included FIT kit.MethodsThe authors conducted a cost-effectiveness analysis of a randomized controlled trial that compared the effectiveness of a reminder + FIT intervention versus a reminder-only intervention in increasing FIT screening. The analysis compared the costs per person screened for CRC screening associated with the reminder + FIT versus the reminder-only alternative using a 1-year time horizon. Input data for a cohort of 35,000 unscreened North Carolina Medicaid enrollees ages 52 to 64 years were derived from the trial and microcosting. Inputs and outputs were estimated from 2 perspectives-the Medicaid/state perspective and the health clinic/facility perspective-using probabilistic sensitivity analysis to evaluate uncertainty.ResultsThe anticipated number of CRC screenings, including both FIT and screening colonoscopies, was higher for the reminder + FIT alternative (n = 8131; 23.2%) than for the reminder-only alternative (n = 5533; 15.8%). From the Medicaid/state perspective, the reminder + FIT alternative dominated the reminder-only alternative, with lower costs and higher screening rates. From the health clinic/facility perspective, the reminder + FIT versus the reminder-only alternative resulted in an incremental cost-effectiveness ratio of $116 per person screened.ConclusionsThe reminder + FIT alternative was cost saving per additional Medicaid enrollee screened compared with the reminder-only alternative from the Medicaid/state perspective and likely cost-effective from the health clinic/facility perspective. The results also demonstrate that health departments and state Medicaid programs can efficiently mail FIT kits to large numbers of Medicaid enrollees to increase CRC screening completion.
| S-EPMC10588542 | biostudies-literature