Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: study protocol.
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ABSTRACT: Background
There are nearly 50,000 colorectal cancer (CRC) deaths in the United States each year. CRC is curable if detected in its early stages. Fecal immunochemical tests (FITs) can detect precursor lesions and many can be analyzed at the point-of-care (POC) in physician offices. However, there are few data to guide test selection. Broader use of FITs could make CRC screening more accessible, especially in resource-poor settings.Methods
A total of 3600 racially and ethnically diverse individuals aged 50 to 85 years having either a screening or surveillance colonoscopy will be recruited. Each participant will complete five FITs on a single stool sample. Test characteristics for each FIT for advanced colorectal neoplasia (ACN) will be calculated using colonoscopy as the gold standard.Results
We have complete data from a total of 2990 individuals. Thirty percent are Latino and 5.3% are black/African American. We will present full results once the study is completed.Conclusions
Our focus in this study is how well FITs detect ACN, using colonoscopy as the gold standard. Four of the five FITs being used are POC tests. Although FITs have been shown to have acceptable performance, there is little data to guide which ones have the best test characteristics and colonoscopy is the main CRC screening test used in the United States. Use of FITs will allow broader segments of the population to access CRC screening because these tests require no preparation, are inexpensive, and can be collected in the privacy of one's home. Increasing CRC screening uptake will reduce the burden of advanced adenomas and colorectal cancer.
SUBMITTER: Levy BT
PROVIDER: S-EPMC8227954 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveThis study aimed to evaluate the cost-effectiveness of the colorectal cancer screening in China, and that when the screening was implemented in a specific region.MethodsA 13-state Markov model was established to compare four screening protocols, including annual fecal immunochemical testing (FIT1), biennial fecal immunochemical testing (FIT2), electronic colonoscopy every 10 years (e-CSPY10), and electronic colonoscopy every 5 years (e-CSPY5), with no screening from the perspective of Chinese healthcare system. The model simulated the health states of a cohort of 100,000 average-risk individuals aging from 50 to 75. Additionally, scenarios including the implementation in a specific region, starting from 40, and incompletely successful treatment of cancer were also analyzed.ResultsAnnual and biennial FIT could save 8.13USD (US Dollar) and 44.96USD per person, and increase 0.0705QALYs (Quality-Adjusted Life Years) and 0.2341 QALYs compared with no screening, respectively. Annual FIT could decrease costs by 36.81USD per person and increase 0.1637 QALYs in comparison to biennial FIT. The results showed that both annual and biennial FIT for screening were dominant over no screening, and annual FIT was dominant over biennial FIT. The ICER (Incremental Cost-Effectiveness Ratio) for e-CSPY10 were 1183.51USD/QALY and 536.66USD/QALY compared with FIT1 and FIT2. The ICER for e-CSPY5 were 1158.16USD/QALY and 770.85USD/QALY compared with FIT1 and FIT2. And the ICER for e-CSPY5 relative to e-CSPY10 was 358.71USD/QALY. All the ICER values were lower than the economic threshold of 2021 Chinese GDP (Gross Domestic Product) per capita in 2021(12554.42USD).ConclusionsIt is worthwhile to popularize CRC screening in mainland China, as FIT always saving costs and colonoscopy is cost-effective. Regions with high income can take electronic colonoscopy every 10 years, or even every 5 years into consideration when determining the specific strategies.
| S-EPMC9412186 | biostudies-literature
Project description:BackgroundThe fecal immunochemical test (FIT) is widely used in colorectal cancer (CRC) screening, but limited data exist for its application in individuals at above-average risk for CRC who complete surveillance colonoscopies.AimTo assess the accuracy, acceptability, and effectiveness of FIT in the interval between surveillance colonoscopies, for predicting advanced neoplasia (advanced adenoma or CRC) at the next colonoscopy.MethodsIndividuals enrolled in an Australian surveillance program were included. Diagnostic accuracy was determined for 614 individuals completing a two-sample FIT (OC-Sensor) ≤ 3 months preceding surveillance colonoscopy. 386 Individuals were surveyed to assess acceptability of interval FIT. Additionally, a retrospective analysis was performed on 7331 individuals offered interval FIT between colonoscopies, where a positive FIT (≥ 20 µg hemoglobin/g feces) triggered an early colonoscopy. Associations between interval FIT results and advanced neoplasia were determined using regression analysis.ResultsFIT detected CRC and advanced adenoma with sensitivities of 60.0% (3/5) and 27.1% (35/129), respectively. Most (89.1%, 344/386) survey respondents preferred completing interval FIT every 1-2 years. The detection rate of interval FIT for advanced neoplasia decreased with increasing FIT completion. Individuals returning a positive FIT had a higher risk of advanced neoplasia than those who did not complete FIT. Positive interval FIT reduced time-to-diagnosis for CRC and advanced adenoma by a median of 30 and 20 months, respectively.ConclusionInterval FIT was well accepted and enabled earlier detection of advanced neoplasia in individuals at above-average risk of CRC. Given that interval FIT predicts advanced neoplasia, it may be used to personalize surveillance colonoscopy intervals.
| S-EPMC11258152 | biostudies-literature
Project description:IMPORTANCE:Colorectal cancer (CRC) screening saves lives, but participation rates are low among underserved populations. Knowledge on effective approaches for screening the underserved, including best test type to offer, is limited. OBJECTIVE:To determine (1) if organized mailed outreach boosts CRC screening compared with usual care and (2) if FIT is superior to colonoscopy outreach for CRC screening participation in an underserved population. DESIGN, SETTING, AND PARTICIPANTS:We identified uninsured patients, not up to date with CRC screening, age 54 to 64 years, served by the John Peter Smith Health Network, Fort Worth and Tarrant County, Texas, a safety net health system. INTERVENTIONS:Patients were assigned randomly to 1 of 3 groups. One group was assigned to fecal immunochemical test (FIT) outreach, consisting of mailed invitation to use and return an enclosed no-cost FIT (n?=?1593). A second was assigned to colonoscopy outreach, consisting of mailed invitation to schedule a no-cost colonoscopy (n?=?479). The third group was assigned to usual care, consisting of opportunistic primary care visit–based screening (n?=?3898). In addition, FIT and colonoscopy outreach groups received telephone follow-up to promote test completion. MAIN OUTCOME MEASURES:Screening participation in any CRC test within 1 year after randomization. RESULTS:Mean patient age was 59 years; 64% of patients were women. The sample was 41% white, 24% black, 29% Hispanic, and 7% other race/ethnicity. Screening participation was significantly higher for both FIT (40.7%) and colonoscopy outreach (24.6%) than for usual care (12.1%) (P?<?.001 for both comparisons with usual care). Screening was significantly higher for FIT than for colonoscopy outreach (P?<?.001). In stratified analyses, screening was higher for FIT and colonoscopy outreach than for usual care, and higher for FIT than for colonoscopy outreach among whites, blacks, and Hispanics (P?<?.005 for all comparisons). Rates of CRC identification and advanced adenoma detection were 0.4% and 0.8% for FIT outreach, 0.4% and 1.3% for colonoscopy outreach, and 0.2% and 0.4% for usual care, respectively (P?<?.05 for colonoscopy vs usual care advanced adenoma comparison; P?>?.05 for all other comparisons). Eleven of 60 patients with abnormal FIT results did not complete colonoscopy. CONCLUSIONS AND REVELANCE: Among underserved patients whose CRC screening was not up to date, mailed outreach invitations resulted in markedly higher CRC screening compared with usual care. Outreach was more effective with FIT than with colonoscopy invitation. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01191411.
| S-EPMC5228201 | biostudies-literature
Project description:BACKGROUND & AIMS:Biomarker assays could increase the accuracy of noninvasive detection of colorectal cancer (CRC); fecal immunochemical tests (FITs) are estimated to miss 27%-47% of CRCs and 70%-80% of advanced adenomas per round of screening. We investigated the conditions under which biomarker screens would be cost-effective compared with FIT screens of average-risk individuals. METHODS:We used the MISCAN-Colon microsimulation model to estimate the effects of various CRC screening test characteristics on life-years gained (LYG) and; age-specific all-cause mortality was based on the 2010 Dutch life tables. Simulated CRC incidence rate and CRC stage distribution were calibrated to observed data in The Netherlands from 1999 through 2003 (before opportunities for screening). Survival rates after diagnosis of CRC at an age younger than 75 years were based on CRC relative survival data from 1985 through 2004; survival for individuals diagnosed at an age of 75 years or older was adjusted to fit the observed age-increasing mortality/incidence ratio. We modeled FIT along with hypothetical biomarker tests with different test performance levels. For each biomarker test we calculated the maximum unit cost for the test to be cost-effective compared with FIT, assuming a willingness-to-pay threshold of €50,000 ($56,000) per LYG. RESULTS:Biennial FIT screening of subjects 55-75 years old provided 84.9 LYG at a cost of €122,000 ($137,000) per 1000 participants. Considering a unit cost of €7 ($8) for FIT (including kit and analysis only, excluding organizational costs), a biomarker test that detects CRC with higher levels of specificity and sensitivity (100%) and advanced adenomas at a proportionally higher level of sensitivity (53%) should never exceed a cost of €51 ($57). The threshold cost could increase to more than €200 ($224) for high-performing biomarker tests in cases of limited colonoscopy capacity or higher uptake of this test. CONCLUSIONS:By using the MISCAN-Colon microsimulation model to estimate effects of CRC screening tests, we found that for a biomarker test with increased overall performance to be cost-effective, it should not exceed 7-fold the unit cost of FIT. This maximum would increase substantially if colonoscopy becomes more expensive or scarce, or if the new test has higher screening uptake. These values could be used to estimate the added value of new biomarkers compared with current FIT screening.
| S-EPMC5773413 | biostudies-other
Project description:IntroductionThe Veterans Health Administration introduced a clinical reminder system in 2018 to help address process gaps in colorectal cancer screening, including the diagnostic evaluation of positive fecal immunochemical test (FIT) results. We conducted a qualitative study to explore the differences between facilities who performed in the top vs bottom decile for follow-up colonoscopy.MethodsSeventeen semistructured interviews with gastroenterology (GI) providers and staff were conducted at 9 high-performing and 8 low-performing sites.ResultsWe identified 2 domains, current practices and perceived barriers, and most findings were described by both high- and low-performing sites. Findings exclusive to 1 group mainly pertained to current practices, especially arranging colonoscopy for FIT-positive patients. We observed only 1 difference in the perceived barriers domain, which pertained to primary care providers.DiscussionThese results suggest that what primarily distinguishes high- and low-performing sites is not a difference in barriers but rather in the GI clinical care process. Developing and disseminating patient education materials about the importance of diagnostic colonoscopy, eliminating in-person precolonoscopy visits when clinically appropriate, and involving GI in missed colonoscopy appointments and outside referrals should all be considered to increase follow-up colonoscopy rates. Our study illustrates the challenges of performing a timely colonoscopy after a positive FIT result and provides insights on improving the clinical care process for patients who are at substantially increased risk for colorectal cancer.
| S-EPMC8865517 | biostudies-literature
Project description:OBJECTIVE:The English Bowel Cancer Screening Programme (BCSP) recommends 3?yearly colonoscopy surveillance for patients at intermediate risk of colorectal cancer (CRC) postpolypectomy (those with three to four small adenomas or one ?10?mm). We investigated whether faecal immunochemical tests (FITs) could reduce surveillance burden on patients and endoscopy services. DESIGN:Intermediate-risk patients (60-72 years) recommended 3?yearly surveillance were recruited within the BCSP (January 2012-December 2013). FITs were offered at 1, 2 and 3?years postpolypectomy. Invitees consenting and returning a year 1 FIT were included. Participants testing positive (haemoglobin ?40?µg/g) at years one or two were offered colonoscopy early; all others were offered colonoscopy at 3?years. Diagnostic accuracy for CRC and advanced adenomas (AAs) was estimated considering multiple tests and thresholds. We calculated incremental costs per additional AA and CRC detected by colonoscopy versus FIT surveillance. RESULTS:74% (5938/8009) of invitees were included in our study having participated at year 1. Of these, 97% returned FITs at years 2 and 3. Three-year cumulative positivity was 13% at the 40?µg/g haemoglobin threshold and 29% at 10?µg/g. 29 participants were diagnosed with CRC and 446 with AAs. Three-year programme sensitivities for CRC and AAs were, respectively, 59% and 33% at 40?µg/g, and 72% and 57% at 10?µg/g. Incremental costs per additional AA and CRC detected by colonoscopy versus FIT (40?µg/g) surveillance were £7354 and £180 778, respectively. CONCLUSIONS:Replacing 3?yearly colonoscopy surveillance in intermediate-risk patients with annual FIT could reduce colonoscopies by 71%, significantly cut costs but could miss 30%-40% of CRCs and 40%-70% of AAs. TRIAL REGISTRATION NUMBER:ISRCTN18040196; Results.
| S-EPMC6709777 | biostudies-literature
Project description:BACKGROUND & AIMS:The fecal immunochemical test (FIT) is widely used in colorectal cancer (CRC) screening. The OC-Light FIT is 1 of 2 FITs recommended for CRC screening by the Preventive Services Task Force guidelines. However, little is known about its ability to detect CRC in large average-risk populations. METHODS:We performed a retrospective cohort study of patients (50-75 years old) in the San Francisco Health Network who were screened for CRC by OC-Light FIT from August 2010 through June 2015. Patients with a positive result were referred for colonoscopy. We used electronic health records to identify participants with positive FIT results, and collected results from subsequent colonoscopies and pathology analyses. The FIT positive rate was calculated by dividing the number of positive FIT results by the total number of FIT tests completed. The primary outcome was the positive rate from OC-Light FIT and yield of neoplasms at colonoscopy. Secondary outcomes were findings from first vs subsequent rounds of testing, and how these varied by sex and race. RESULTS:We collected result from 35,318 FITs, performed on 20,886 patients; 2930 patients (8.3%) had a positive result, and 1558 patients completed the follow-up colonoscopy. A positive result from the FIT identified patients with CRC with a positive predictive value of 3.0%, and patients with advanced adenoma with a positive predictive value of 20.8%. The FIT positive rate was higher during the first round of testing (9.4%) compared to subsequent rounds (7.4%) (P < .01). The yield of CRC in patients with a positive result from the first round of the FIT was 3.7%, and decreased to 1.8% for subsequent rounds (P = .02). CONCLUSIONS:In a retrospective analysis of patients in a diverse safety-net population who underwent OC-Light FIT for CRC screening, we found that approximately 3% of patients with a positive result from a FIT to have CRC and approximately 21% to have advanced adenoma.
| S-EPMC6151285 | biostudies-literature
Project description:BACKGROUND:The Community Preventive Services Task Force recommends multi-component interventions, including patient reminders, to improve uptake of colorectal cancer screening. OBJECTIVE:We sought to compare the effectiveness of different forms of reminders for a direct-mail fecal immunochemical test (FIT) program. DESIGN:Patient-randomized controlled trial. PARTICIPANTS:2772 adults aged 50-75, not up to date with colorectal cancer screening recommendations, with a clinic visit in the previous year at any of four participating health center clinics. INTERVENTION:Participants were mailed an introductory letter and FIT. Those who did not complete their FIT within 3 weeks were randomized to receive (1) a reminder letter, (2) two automated phone calls, (3) two text messages, (4) a live phone call, (5) a reminder letter and a live phone call, (6) two automated phone calls and a live phone call, or (7) two text messages and a live phone call. Patients with a patient portal account were sent two email reminders, but were not randomized. MAIN MEASURES:FIT return rates for each group, 6 months following randomization. KEY RESULTS:A total of 255 (10%) participants returned their FIT within 3 weeks of the mailing. Among randomized participants (n = 2010), an additional 25.5% returned their FITs after reminders were delivered (estimated overall return rate = 32.7%). In intention-to-treat analysis, compared to the group allocated to receive a reminder letter, return rates were higher for the group assigned to receive the live phone call (OR = 1.51 [1.03-2.21]) and lower for the group assigned to receive text messages (OR = 0.66 [0.43-0.99]). Reminder effectiveness differed by language preference. CONCLUSIONS:Our data suggest that FIT reminders that included a live call were more effective than reminders that relied solely on written communication (a text message or letter). TRIAL REGISTRATION:ClinicalTrials.gov/ctc2/show/NCT01742065 .
| S-EPMC5756165 | biostudies-literature
Project description:Colorectal cancer (CRC) is a common but largely preventable cancer. Although fecal immunochemical tests (FITs) detect the majority of CRCs, they miss some of the cancers and most advanced adenomas (AAs). The potential of blood tests in complementing FITs for the detection of CRC or AA has not yet been systematically investigated.We conducted a systematic review of performance of FIT combined with an additional blood test for CRC and AA detection versus FIT alone. PubMed and Web of Science were searched until June 9, 2017.Some markers substantially increased sensitivity for CRC when combined with FIT, albeit typically at a major loss of specificity. For AA, no relevant increase in sensitivity could be achieved.Combining FIT and blood tests might be a promising approach to enhance sensitivity of CRC screening, but comprehensive evaluation of promising marker combinations in screening populations is needed.
| S-EPMC5802681 | biostudies-literature
Project description:BackgroundPerformance characteristics of fecal immunochemical tests (FITs) to screen for colorectal cancer (CRC) have been inconsistent.PurposeTo synthesize data about the diagnostic accuracy of FITs for CRC and identify factors affecting its performance characteristics.Data sourcesOnline databases, including MEDLINE and EMBASE, and bibliographies of included studies from 1996 to 2013.Study selectionAll studies evaluating the diagnostic accuracy of FITs for CRC in asymptomatic, average-risk adults.Data extractionTwo reviewers independently extracted data and critiqued study quality.Data synthesisNineteen eligible studies were included and meta-analyzed. The pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of FITs for CRC were 0.79 (95% CI, 0.69 to 0.86), 0.94 (CI, 0.92 to 0.95), 13.10 (CI, 10.49 to 16.35), 0.23 (CI, 0.15 to 0.33), respectively, with an overall diagnostic accuracy of 95% (CI, 93% to 97%). There was substantial heterogeneity between studies in both the pooled sensitivity and specificity estimates. Stratifying by cutoff value for a positive test result or removal of discontinued FIT brands resulted in homogeneous sensitivity estimates. Sensitivity for CRC improved with lower assay cutoff values for a positive test result (for example, 0.89 [CI, 0.80 to 0.95] at a cutoff value less than 20 µg/g vs. 0.70 [CI, 0.55 to 0.81] at cutoff values of 20 to 50 µg/g) but with a corresponding decrease in specificity. A single-sample FIT had similar sensitivity and specificity as several samples, independent of FIT brand.LimitationsOnly English-language articles were included. Lack of data prevented complete subgroup analyses by FIT brand.ConclusionFecal immunochemical tests are moderately sensitive, are highly specific, and have high overall diagnostic accuracy for detecting CRC. Diagnostic performance of FITs depends on the cutoff value for a positive test result.Primary funding sourceNational Institute of Diabetes and Digestive and Kidney Diseases and National Cancer Institute.
| S-EPMC4189821 | biostudies-literature