Fecal Immunochemical Test Research Articles

Cost effectiveness of colorectal cancer screening in the Dominican Republic.

e23033 Background: Colorectal cancer (CRC) incidence in the Dominican Republic (DR) is increasing, and CRC now ranks as the third-most prevalent cancer in the DR. There are no national CRC screening guidelines in the DR, and CRC screening is not routinely performed. We evaluated the impact of nationwide CRC screening by comparing the cost-effectiveness of four CRC screening strategies to the current practice of no screening. Methods: We developed a Markov model comparing four CRC screening strategies to the current practice of no screening, or natural history (NH): colonoscopy every ten years (Colo); sigmoidoscopy every five years (Sig); fecal immunochemical test biennially (FIT); and fecal occult blood test biennially (FOBT). Model inputs for screening arms were derived from international randomized controlled trials whenever possible. Data from The Rosa Emilia Sánchez Pérez de Tavares National Cancer Institute in the DR was used to estimate baseline CRC incidence, stage distribution and mortality. Screening was implemented from age 45 to 75. We assumed a 60.6% adherence rate for each screening arm. The model was cross validated by comparing the estimated lifetime impact of each screening arm on CRC incidence and mortality to estimates derived from the MIcrosimulation SCreening Analysis (MISCAN) Colorectal Cancer Model in the US. The primary outcome was the incremental cost-effectiveness ratio (ICER) of each screening strategy. Secondary outcomes included life expectancy, total cost, CRC incidence and CRC-related mortality. The willingness to pay threshold (WTP) was set to the 2022 DR gross domestic product per person ($10,111.20/life year gained). Results: In the NH strategy, 2.3% of the population developed CRC, and 1.2% died from CRC, with a lifetime cost of 203.47 per person. Compared to NH, FIT prevented 27% of CRCs and 37% of CRC deaths, with a lifetime cost of 244.76 per person. Colo was more effective than FIT, preventing 33% and 43% of CRC cases and deaths, respectively, compared to NH. However, the ICER for Colo exceeded the WTP threshold. One-way sensitivity analyses showed that the model is most sensitive to test performance characteristics and test costs. Conclusions: Among the evaluated CRC screening strategies, FIT is the cost-effective option, averting a significant number of CRC cases and deaths, at an incremental cost that is well within the WTP threshold for the DR. Inclusion of local data on the effectiveness and acceptability of the tested CRC screening modalities would improve this model, and strengthen the credibility of our findings. [Table: see text]

Lowering Fecal Immunochemical Test Positivity Threshold vs Multitarget Stool RNA Testing for Colorectal Cancer Screening

This analysis uses data from 2 studies to explore whether lowering the threshold for fecal immunochemical test positivity can achieve comparable levels of sensitivity and specificity as multitarget stool RNA testing for colorectal cancer screening.

Faecal Immunochemical Test (FIT) Sensitivity; A Five Year Audit.

Introduction: Colorectal cancer has a high prevalence and mortality rate in the United Kingdom. Cancerous colorectal lesions often bleed into the gastrointestinal lumen. The faecal immunochemical test (FIT) detects haemoglobin (Hb) in the faeces of patients and is used as a first line test in the diagnosis of colorectal cancer. Materials and Methods: A retrospective audit of all FIT performed and all colorectal cancers diagnosed in the Hull and East Riding of Yorkshire counties of the United Kingdom (population approximately 609,300) between 2018 and 2022 was conducted. FIT were performed using a HM-JACKarc analyser from Kyowa medical. The predominant symptom suggestive of colorectal cancer which prompted the FIT was recorded. Colorectal cancer was diagnosed using the gold standard of histological biopsy following colonoscopy. Results: Between 2018 and 2022, 56,202 FIT were performed on symptomatic patients. Follow on testing identified 1,511 with colorectal cancer. Of these people, only 450 people with a confirmed colorectal cancer had a FIT within the 12months preceding their diagnosis. Of these 450 FIT results, 36 had a concentration of <10μg/g and may be considered to be a false negative. The sensitivity of FIT in the patients identified was 92.00%. The most common reason stated by the clinician for a FIT being performed in patients with colorectal cancer was a change in bowel habits, followed by iron deficient anaemia. The number of patients diagnosed with colorectal cancer decreased in 2020, but increased significantly in 2021. Discussion: This study shows that 8.00% of people diagnosed with colorectal cancer in the Hull and East Riding of Yorkshire regions had a negative FIT. This study also shows that the SARS-CoV-2 pandemic affected the number of people diagnosed with colorectal cancer, and therefore skews the prevalence and pre-test probability of a positive test. There are many reasons why a FIT could produce a false negative result, the most likely being biological factors affecting the stability of haemoglobin within the gastrointestinal tract, or pre-analytical factors influencing faecal sampling preventing the detection of haemoglobin. Some colorectal lesions do not protrude into the gastrointestinal lumen and are less likely to bleed. Conclusion: This is the first study showing data from outside of a structured clinical trial and provides the largest study to date showing the sensitivity of FIT in a routine clinical setting. This study also provides evidence for the impact COVID-19 had on the rate of colorectal cancer diagnosis.

A pragmatic randomized trial of mailed fecal immunochemical testing to increase colorectal cancer screening among low-income and minoritized populations.

Colorectal cancer (CRC) screening is underused, particularly among low-income and minoritized populations, for whom the coronavirus disease 2019 (COVID-19) pandemic has challenged progress in achieving equity. A hub-and-spoke model was used. The hub was a nonacademic organization and the spokes were three community health center (CHC) systems overseeing numerous clinic sites. Via a cluster-randomized trial design, nine clinic sites were randomized to intervention and 16 clinic sites were randomized to usual care. Patient-level interventions included invitation letters, mailed fecal immunochemical tests (FITs), and call/text-based reminders. Year 1 intervention impact, which took place during the COVID-19 pandemic, was assessed as the proportion completing screening among individuals not up to date at baseline, which compared intervention and nonintervention clinics accounting for intraclinic cluster variation; confidence intervals (CIs) around differences not including 0 were interpreted as statistically significant. Among 26,736 patients who met eligibility criteria, approximately 58% were female, 55% were Hispanic individuals, and 44% were Spanish speaking. The proportion completing screening was 11.5 percentage points (ppts) (95% CI, 6.1-16.9 ppts) higher in intervention versus usual care clinics. Variation in differences between intervention and usual care clinics was observed by sex (12.6 ppts [95% CI, 7.2-18.0 ppts] for females; 8.8 ppts [95% CI, 4.7-13.9 ppts] for males) and by racial and ethnic group (13.8 ppts [95% CI, 7.0-20.6 ppts] for Hispanic individuals; 13.0 ppts [95% CI, 3.6-22.4 ppts] for Asian individuals; 11.3 ppts [95% CI, 5.8-16.8 ppts] for non-Hispanic White individuals; 6.1 ppts [95% CI, 0.8-10.4 ppts] for Black individuals). A regional mailed FIT intervention was effective for increasing CRC screening rates across CHC systems serving diverse, low-income populations.

Is annual screening by fecal immunochemical test necessary after a recent colonoscopy?

The population-based colorectal cancer screening guidelines in Japan recommend an annual fecal immunochemical test (FIT). However, there is no consensus on the need for annual FIT screening for patients who recently performed a total colonoscopy (TCS). Therefore, we evaluated the repeated TCS results for patients with positive FIT after a recent TCS to assess the necessity of an annual FIT. We reviewed patients with positive FIT in opportunistic screening from April 2017 to March 2022. The patients were divided into two groups: those who had undergone TCS within the previous 5 years (previous TCS group) and those who had not (non-previous TCS group). We compared the detection rates of advanced neoplasia and colorectal cancer between the two groups. Of 671 patients, 151 had received TCS within 5 years and 520 had not. The detection rates of advanced neoplasia in the previous TCS and non-previous TCS groups were 4.6% and 12.1%, respectively (p < 0.01), and the colorectal cancer detection rates were 0.7% and 1.5%, respectively (no significant difference). The adenoma detection rates were 33.8% in the previous TCS group and 40.0% in the non-previous TCS group (no significant difference). Only a few patients were diagnosed with advanced neoplasia among the patients with FIT positive after a recent TCS. For patients with adenomatous lesions on previous TCS, repeated TCS should be performed according to the surveillance program without an annual FIT. The need for an annual FIT for patients without adenomatous lesions on previous TCS should be prospectively assessed in the future.

Understanding Patient Perspectives to Improve Colorectal Cancer Screening Following the COVID-19 Pandemic: Assessment of a Mailed Fecal Immunochemical Testing Program.

Understanding Patient Perspectives to Improve Colorectal Cancer Screening Following the COVID-19 Pandemic: Assessment of a Mailed Fecal Immunochemical Testing Program.

Accuracy, Acceptability, and Application: Fecal Immunochemical Tests for Early Detection of Advanced Neoplasia in Colonoscopy-Based Surveillance

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.

Reimagining Colorectal Cancer Screening: Innovations and Challenges with Dr. Aasma Shaukat.

Colorectal cancer (CRC) currently ranks as the third most common cancer and the second leading cause of cancer-related deaths worldwide, posing a significant global health burden to the population. Recent studies have reported the emergence of a new clinical picture of the disease, with a notable increase in CRC rates in younger populations of <50 years of age. The American Cancer Society (ACS) now recommends CRC screening starting at age 45 for average-risk individuals. Dr. Aasma Shaukat's Keynote Conference highlights the critical need for updated screening strategies, with an emphasis on addressing the suboptimal adherence rates and the effective management of the growing burden of CRC. Lowering the adenoma detection screening age can facilitate early identification of adenomas in younger asymptomatic patients, altering the epidemiologic landscape. However, its implications may not be as profound unless a drastic shift in the age distribution of CRC is observed. Currently, various screening options are available in practice, including stool-based tests like multitarget stool DNA (mtDNA) tests, fecal immunochemical testing (FIT), and imaging-based tests. In addition to existing screening methods, blood-based tests are now emerging as promising tools for early CRC detection. These tests leverage innovative techniques along with AI and machine learning algorithms, aiding in tumor detection at a significantly earlier stage, which was not possible before. Medicare mandates specific criteria for national coverage of blood-based tests, including sensitivity ≥ 74%, specificity ≥ 90%, FDA approval, and inclusion in professional society guidelines. Ongoing clinical trials, such as Freenome, Guardant, and CancerSEEK, offer hope for further advancements in blood-based CRC screening. The development of multicancer early detection tests like GRAIL demonstrates a tremendous potential for detecting various solid tumors and hematologic malignancies. Despite these breakthroughs, the question of accessibility and affordability still stands. The ever-evolving landscape of CRC screening reflects the strength of the scientific field in light of an altered disease epidemiology. Lowering screening age along with the integration of blood-based tests with existing screening methods holds great potential in reducing the CRC-related burden. At the same time, it is increasingly important to address the challenges of adaptation of the healthcare system to this change in the epidemiologic paradigm.

Stable hemoglobin concentration with fecal immunochemical test at high temperatures in a Caribbean colorectal cancer screening program

Background and aimsHigh temperatures may reduce fecal immunochemical test (FIT) positivity and colorectal cancer (CRC) detection sensitivity. We investigated the effect of temperature on hemoglobin concentration [Hb], in the FOB Gold®. Additionally, we examined FIT pick-up, storage, return times and specimen collection. Materials and MethodsIn vitro experiments with buffer containing FIT devices, inoculated with Hb-spiked stool. For 7 days, 144 samples were stored in groups of 36 at 4 °C, 22 °C, 30 °C, and 50 °C. Additionally, 54 samples were stored in groups of 18 at 34 °C, 42 °C and 50 °C for 20 h. Paired t-tests and repeated measure ANOVA assessed [Hb] change. Sixty-five screening participants completed a FIT-handling questionnaire. ResultsAfter 7 days, mean [Hb] was stable at 30 °C (0.8 µg Hb/g;95 %CI: −1.5 to 3.1;p = 0.50). For 50 °C, mean [Hb] decreased within 2 days (−21.3 µg Hb/g;95 %CI: −30.2 to −12.5;p < 0.001) and after 20 h (−63.0 µg Hb/g;95 %CI: −88.7 to −37.3;p < 0.001), respectively. All other temperature categories showed significant mean [Hb] increase. Same-day FIT return was reported by 80 %. Eighty-seven percent experienced specimen collection as easy and 33 % kept the FIT refrigerated after collection. ConclusionsThe FOB Gold® is suitable for CRC screening in tropical climates. Although most respondents indicated same-day sample return, we recommend avoiding FIT storage above 30 °C for longer than7 days.

Association of Endoscopist Colonoscopy Quality Measures With Follow-Up Colonoscopy Outcomes After Positive Stool Tests (Multitarget Stool DNA or Fecal Immunochemical Test): Retrospective Cross-Sectional Analysis of Data From the New Hampshire Colonoscopy Registry.

Negative colonoscopies following positive stool tests could result from stool test characteristics or from the quality of endoscopist performance. We used New Hampshire Colonoscopy Registry data to examine the association between endoscopist detection rates and polyp yield in colonoscopies performed for positive fecal immunochemical test (FIT) or multitarget stool DNA (mt-sDNA) test to evaluate the degree to which positive stool tests followed by negative colonoscopy ("false positives") vary with endoscopist quality. In addition, we investigated the frequency of significant polyps in the subgroup of highest quality colonoscopies following positive stool tests. We compared the frequencies of negative colonoscopies and of specific polyps following positive stool tests across quartiles of endoscopist adenoma detection rate (ADR) and clinically significant serrated polyp detection rate (CSSDR). Our sample included 864 mt-sDNA+ and 497 FIT+ patients. We found a significantly lower frequency of negative colonoscopies following positive stool tests among endoscopists with higher ADR and CSSDR, particularly in the 2 highest quartiles. In addition, detection of any adenoma after a positive stool test for endoscopists in the fourth ADR quartile was 63.3% (FIT+) and 62.8% (mt-sDNA+). Among endoscopists in the fourth CSSDR quartile, sessile serrated lesions were found in 29.2% of examinations following a positive mt-sDNA and in 13.5% following FIT+ examinations. The frequency of negative colonoscopies after positive stool tests was significantly higher in examinations performed by endoscopists with low ADR and CSSDR. Our results also suggest a benchmark target of at least 40% for ADR in patients with mt-sDNA+ or FIT+ tests and 20% for sessile serrated lesions in mt-sDNA+ patients.

Population-level impact of the BMJ Rapid Recommendation for colorectal cancer screening: a microsimulation analysis

ObjectiveIn 2019, a BMJ Rapid Recommendation advised against colorectal cancer (CRC) screening for adults with a predicted 15-year CRC risk below 3%. Using Switzerland as a case study, we estimated...

Improving Fecal Immunochemical Test Collection for Colorectal Cancer Screening During the COVID-19 Pandemic.

Colonoscopy is a first-line method for colorectal cancer (CRC) screening. However, cost-effective noninvasive tests, such as high-sensitivity guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT), are also used. The COVID-19 pandemic had a substantial negative impact on CRC screening rates. The James A. Haley Veterans Affairs Hospital (JAHVAH) continued socially distant CRC screening using FITs, but encountered inefficiencies due to high rates of incorrectly collected FIT samples. A quality improvement (QI) project was conducted to increase correctly collected and testable FIT kits upon initial laboratory submission. The ambulatory QI project sought out root causes for incorrectly returned FITs and proposed Plan-Do-Study-Act (PDSA) cycles based on a series of approved action plans. A multidisciplinary team of laboratory, nursing, administrative, and primary care staff worked together to discover 6 major root causes. Our multipronged PDSA cycle attempted to set up redundant patient reminders, centralize the FIT dispersal process, and make the patient-FIT interface more user-friendly. All PDSA solutions were implemented over 4 months. Lack of collection date was the most common reason for incorrectly returned FIT kits and the focus of PDSA improvements. The rate of FITs with missing collection dates dropped from 24% prior to PDSA to 14% in April 2021. The rate of correctly returned FIT kits rose from 38% before the project to 72% afterwards, surpassing the 20% improvement goal. FIT is a useful method for CRC screening that can be particularly helpful when in-person visits are limited, as seen during the COVID-19 pandemic. The increase in demand for FITs during the pandemic revealed process deficiencies and gave JAHVAH an opportunity to improve workflow.

Colorectal cancer screening knowledge among community pharmacists: A national survey

BackgroundColorectal cancer (CRC) screening can reduce CRC morbidity and mortality. Community pharmacies could be a viable option for delivering home-based CRC screening tests such as fecal immunochemical tests (FITs). However, little is known about community pharmacists' knowledge about CRC screening guidelines. ObjectiveWe assessed community pharmacists' knowledge about CRC screening to identify education and training needs for a pharmacy-based CRC screening program. MethodsBetween September 2022 and January 2023, we conducted an online national survey of community pharmacists practicing in the United States. Responders were eligible if they were currently-licensed community pharmacists and currently practiced in the United States. The survey assessed knowledge of national CRC screening guidelines, including recommended starting age, frequency of screening, different screening modalities, and follow-up care. Using multiple linear regression, we evaluated correlates of community pharmacists' level of CRC screening knowledge, defined as the total number of knowledge questions answered correctly from "0" (no questions correct) to "5" (all questions correct). ResultsA total of 578 eligible community pharmacists completed the survey, with a response rate of 59%. Most community pharmacists correctly answered the question about the next steps following a positive FIT (87%) and the question about where a FIT can be done (84%). A minority of community pharmacists responded correctly to questions about the age to start screening with FIT (34%) and how often a FIT should be repeated (28%). Only 5% of pharmacists answered all knowledge questions correctly. Community pharmacists answered more CRC screening knowledge questions correctly as their years in practice increased. Board-certified community pharmacists answered more CRC screening knowledge questions correctly compared to those who were not board-certified. ConclusionTo ensure the successful implementation of a pharmacy-based CRC screening program, community pharmacists need to be educated about CRC screening and trained to ensure comprehensive patient counseling and preventive service delivery.

Barriers and facilitators of implementing a multicomponent intervention to improve faecal immunochemical test (FIT) colorectal cancer screening in primary care clinics, Alberta

Background and objectiveColorectal cancer (CRC) screening is effective at reducing the incidence and mortality of CRC. To address suboptimal CRC screening rates, a faecal immunochemical test (FIT) multicomponent intervention was...

Potential Impact of USPS Mail Delivery Delays on Colorectal Cancer Screening Programs.

Colorectal cancer is the second-leading cause of cancer deaths in the United States. Fecal immunochemical tests (FITs) are a primary means of colorectal cancer screening at some health care institutions because of scheduling backlogs for screening, diagnostic, and surveillance endoscopies. However, delays in mail delivery can impact timely analysis of samples, possibly leading to false-negative results and the need for repeat tests. Some patients might be unwilling to submit another test when informed that an earlier sample cannot be reliably analyzed, resulting in a missed opportunity for screening. The Jesse Brown Veterans Affairs Medical Center has experienced some success through contacting the local US Postal Service (USPS) to avoid these delays; however, the problem often unpredictably recurs with USPS staff turnover. Laboratories and health systems experiencing delays should first ensure that prepaid envelopes have the correct postage and that their USPS accounts are properly funded, to confirm that insufficient funds are not contributing to the delayed deliveries. Adding additional language to the preprinted envelopes, such as "time-sensitive," may also be helpful. Asking patients to drop off test kits at the laboratory or using private letter carriers is not feasible in some communities. Other strategies include establishing a drop-off box at clinic offices or considering other screening methods, such as colonoscopies or flexible sigmoidoscopies. Clinicians who work in health care systems that use FIT kits need to be aware of the impact that local USPS delays can have on the reliability of FIT results. Health systems should be prepared to implement mitigation strategies if significant delays with mail delivery are encountered.

Colorectal Cancer Screening in Free Clinics: A Systematic Review

Abstract: Objective. There are significant inequities in colorectal cancer (CRC) screening and outcomes. Via literature review, we assessed CRC screening rates for the vulnerable populations served by free clinics. Methods. A systematic review was conducted for publications on CRC screening in free clinics. Outcomes included CRC screening characteristics, population demographics, and limitations. A methodological quality assessment was completed. Results. Out of 63 references, six studies were included, representing 8,844 participants. Black or Hispanic participants were the plurality in all but one study. All participants were uninsured. Median CRC screening rate was 48.4% (range 6.6–78.9%). Screening methods included colonoscopy, fecal occult blood test, flexible sigmoidoscopy, and fecal immunochemical test. Clinics offering only one screening method had a mean screening rate of 7.2% while those with multiple methods had a screening rate of 65.4%. Conclusion. Access to multiple CRC screening modalities correlates with higher screening rates in free clinics. More work is needed to increase CRC screening in free clinics.

Adherence to follow-up and resource use after abnormal FIT-screening: Evaluation of the Danish colorectal cancer screening program.

Background and study aims The effectiveness of colorectal cancer screening programs depends on adherence to surveillance protocols for screening-positive individuals. We evaluated adherence in the Danish population-based screening program and estimated the volume of diagnostic resources required to achieve this adherence. Patients and methods In this register- and population-based study, we included individuals with a positive fecal immunochemical test (FIT) screening from 2014 to 2017 and followed them until mid-2022. All endoscopic, imaging, and surgical procedures performed at public and private hospitals were identified. Adherence to national protocols was reported in terms of proportions and timeliness. Use of diagnostic and surveillance procedures was estimated during a 4-year post-screening period. Results Among 82,221 individuals with a positive FIT test, 84% had a baseline colonoscopy within 1 month. After removal of intermediate or high-risk adenomas, 12% and 6%, respectively, did not have any follow-up. Only ~50% had timely surveillance. Approximately 10% to 20%, depending on their referral diagnosis, did not have a second surveillance colonoscopy. In addition, 12% with a negative colonoscopy had a second colonoscopy within 4 years. Conclusions High adherence to baseline colonoscopy after positive FIT-screening is followed by lower adherence throughout the adenoma surveillance program. Better adherence to the guidelines could potentially improve the effectiveness and efficiency of the screening program.

AB065. SOH24AB_277. Enhancing early detection: the impact of faecal immunochemical test on identifying high-risk individuals at St Luke’s General Hospital Kilkenny

AB065. SOH24AB_277. Enhancing early detection: the impact of faecal immunochemical test on identifying high-risk individuals at St Luke’s General Hospital Kilkenny

Risk of Cancers Proximal to the Colon in Fecal Immunochemical Test Positive Screenees in a Colorectal Cancer Screening Program

In more than half of the colorectal cancer screening participants with a positive fecal immunochemical test (FIT) result, no advanced neoplasia (AN) is detected at colonoscopy. The positive FIT result could also be generated by cancers located proximal to the colon: upper gastrointestinal, oral cavity, nose, and throat cancers. We evaluated screenees' risk of being diagnosed with a cancer proximal to the colon within the 3 years and compared risks between those with a positive vs those with a negative FIT. Data of Dutch colorectal cancer screening participants who underwent biennial FIT-based screening 2014-2018 were collected from the national screening database and linked to the National Cancer Registry. Screenees were classified into 3 groups: FIT-positives with AN (FIT+/AN+), FIT-positives without AN (FIT+/AN-), and FIT-negatives (FIT-). We compared the cumulative incidence of cancers proximal to the colon in each group 3 years after FIT. A Cox regression analysis with left truncation and right censoring, using FIT positivity as time-dependent variable and stratified for sex, was performed to compare the hazard of cancers proximal to the colon in participants who were FIT-positive vs FIT-negative. Three-year cumulative incidence of cancers proximal to the colon in FIT+/AN+ (n= 65,767), FIT+/AN- (n= 50,661), and FIT- (n= 1,831,647) screenees was 0.7%, 0.6%, and 0.4%, respectively (P < .001). FIT-positives were older and more frequently male than FIT-negatives (P < .001). Significantly more cancers proximal to the colon were detected among FIT-positives (P < .001; hazard ratio, 1.55; 95% CI, 1.44-1.67). FIT-positive screenees were at significantly increased risk of being diagnosed witha cancer proximal to the colon within 3 years after FIT,although the 3-year cumulative incidence was still less than 1%.

A Randomized Trial of Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting

Mailed outreach for colorectal cancer (CRC) screening increases uptake but it is unclear how to offer the choice of testing. We evaluated if the active choice between colonoscopy and fecal immunochemical test (FIT), or FIT alone, increased response compared with colonoscopy alone. This pragmatic, randomized, controlled trial at a community health center included patients between ages 50 and 74 who were not up to date with CRC screening. Patients were randomized 1:1:1 to the following: (1) colonoscopy only, (2) active choice of colonoscopy or FIT, or (3) FIT only. Patients received an outreach letter with instructions for testing (colonoscopy referral and/or an enclosed FIT kit), a reminder letter at 2 months, and another reminder at 3 to 5 months via text message or automated voice recording. The primary outcome was CRC screening completion within 6 months. Among 738 patients in the final analysis, the mean age was 58.7 years (SD, 6.2 y); 48.6% were insured by Medicaid and 24.3% were insured by Medicare; and 71.7% were White, 16.9% were Black, and 7.3% were Hispanic/Latino. At 6 months, 5.6% (95% CI, 2.8-8.5) completed screening in the colonoscopy-only arm, 12.8% (95% CI, 8.6-17.0) in the active-choice arm, and 11.3% (95% CI, 7.4-15.3) in the FIT-only arm. Compared with colonoscopy only, there was a significant increase in screening in active choice (absolute difference, 7.1%; 95% CI, 2.0-12.2; P= .006) and FIT only (absolute difference, 5.7%; 95% CI, 0.8-10.6; P= .02). Both choice of testing and FIT alone increased response and may align with patient preferences. clinicaltrials.gov NCT04711473.