The value of hypersensitivity quantitative fecal immunochemical test in early colorectal cancer detection.

At present, both the incidence and mortality rates of colorectal cancer are on the rise, making early screening a crucial tool in reducing the fatality rate. Although colonoscopy is the recommended method according to the guidelines, compliance tends to be poor. The fecal immunochemical test (FIT), a new technology that uses latex immunoturbidimetry to detect fecal blood, offers high specificity and sensitivity. Additionally, it is low-cost, easy to operate, and less likely to be affected by food and drugs, thus improving the compliance rate for population screening. Compared to other screening techniques, FIT represents a safer and more accurate option. This article reviews the application of FIT in early colorectal cancer screening.

Factors associated with interval colorectal cancer after negative FIT: Results of two screening rounds in the Dutch FIT-based CRC screening program.

The interval colorectal cancer (CRC) rate after negative fecal immunochemical testing (FIT) is an important quality indicator of CRC screening programs. We analyzed the outcomes of two rounds of the FIT-based CRC screening program in the Netherlands, using data from individuals who participated in FIT-screening from 2014 to 2017. Data of individuals with one prior negative FIT (first round) or two prior negative FITs (first and second round) were included. Outcomes included the incidence of interval CRC in FIT-negative participants (<47 µg Hb/g feces [µg/g]), FIT-sensitivity, and the probability of detecting an interval CRC by fecal hemoglobin concentration (f-Hb). FIT-sensitivity was estimated using the detection method and the proportional incidence method (based on expected CRC incidence). Logistic regression analysis was performed to estimate whether f-Hb affects probability of detecting interval CRC, adjusted for sex- and age-differences. Incidence of interval CRC was 10.4 per 10 000 participants after the first and 9.6 after the second screening round. FIT-sensitivity based on the detection method was 84.4% (95%CI 83.8-85.0) in the first and 73.5% (95% CI 71.8-75.2) in the second screening round. The proportional incidence method resulted in a FIT-sensitivity of 76.4% (95%CI 73.3-79.6) in the first and 79.1% (95%CI 73.7-85.3) in the second screening round. After one negative FIT, participants with f-Hb just below the cut-off (>40-46.9 µg/g) had a higher probability of detecting an interval CRC (OR 16.9; 95%CI: 14.0-20.4) than had participants with unmeasurable f-Hb (0-2.6 µg/g). After two screening rounds, the odds ratio for interval CRC was 12.0 (95%CI: 7.8-17.6) for participants with f-Hb just below the cut-off compared with participants with unmeasurable f-Hb. After both screening rounds, the Dutch CRC screening program had a low incidence of interval CRC and an associated high FIT-sensitivity. Our findings suggest there is a potential for further optimizing CRC screening programs with the use of risk-stratified CRC screening based on prior f-Hb.

Making colonoscopy-based screening more efficient: A "gateopener" approach.

Screening colonoscopy for early detection and prevention of colorectal cancer (CRC) is mostly used inefficiently. Here, we assessed the potential of an innovative approach to colonoscopy-based screening, by use of a single, low threshold fecal immunochemical test (FIT) as a "gateopener" for screening colonoscopy. Using COSIMO, a validated simulation model, we modeled scenarios including either direct invitation to screening colonoscopy or an alternative approach involving mailing a single ("gateopener") FIT along with an invitation to colonoscopy contingent on a FIT value above a low threshold yielding a 50% positivity rate (ie, every other pretest will be positive). Under plausible assumptions on screening offer adherence, we found that such "gateopener screening" (use of screening colonoscopy contingent on a positive, low threshold gateopener FIT) approximately doubled cancer detection rates vs conventional screening. In those spared from screening colonoscopy due to a negative gateopener FIT pretest, numbers needed to screen were 10-times higher vs those for individuals with a positive FIT, peaking in >2000 and >3800 (hypothetically) needed colonoscopies to detect one case of cancer in men and women, respectively. Gateopener screening resulted in 42%-51% and 59%-65% more prevented CRC cases and deaths, respectively. In summary, by directing colonoscopy capacities to those most likely to benefit, offering screening colonoscopy contingent on a "gateopener" low-threshold FIT would substantially enhance efficiency of colonoscopy screening.

AGA Clinical Practice Update on Approach to the Use of Noninvasive Colorectal Cancer Screening Options: Commentary.

The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update Commentary is to review the available evidence and provide expert advice regarding the approach to using noninvasive colorectal cancer (CRC) screening options, including evidence for their effectiveness, selection of individuals for whom these tests are appropriate, implications of a positive non-colonoscopy screening test, and opportunities to enhance the quality of noninvasive CRC screening programs. This Clinical Practice Update was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Gastroenterology. This expert commentary reflects recently published studies in this field, as well as the experiences of the authors who are gastroenterologists with high-level expertise in CRC screening and prevention.

Equitable Implementation of Mailed Stool Test-Based Colorectal Cancer Screening and Patient Navigation in a Safety Net Health System.

BACKGROUND: Mailed stool testing programs increase colorectal cancer (CRC) screening in diverse settings, but whether uptake differs by key demographic characteristics is not well-studied and has health equity implications. OBJECTIVE: To examine the uptake and equity of the first cycle of a mailed stool test program implemented over a 3-year period in a Central Texas Federally Qualified Health Center (FQHC) system. DESIGN: Retrospective cohort study within a single-arm intervention. PARTICIPANTS: Patients in an FQHC aged 50-75 at average CRC risk identified through electronic health records (EHR) as not being up to date with screening. INTERVENTIONS: Mailed outreach in English/Spanish included an introductory letter, free-of-charge fecal immunochemical test (FIT), and lab requisition with postage-paid mailer, simple instructions, and a medical records update postcard. Patients were asked to complete the FIT or postcard reporting recent screening. One text and one letter reminded non-responders. A bilingual patient navigator guided those with positive FIT toward colonoscopy. MAIN MEASURES: Proportions of patients completing mailed FIT in response to initial cycle of outreach and proportion of those with positive FIT completing colonoscopy; comparison of whether proportions varied by demographics and insurance status obtained from the EHR. KEY RESULTS: Over 3 years, 33,606 patients received an initial cycle of outreach. Overall, 19.9% (n = 6672) completed at least one mailed FIT, 5.6% (n = 374) tested positive during that initial cycle, and 72.5% (n = 271 of 374) of those with positive FIT completed a colonoscopy. Hispanic/Latinx, Spanish-speaking, and uninsured patients were more likely to complete mailed FIT compared with white, English-speaking, and commercially insured patients. Spanish-speaking patients were more likely to complete colonoscopy after positive FIT compared with English-speaking patients. CONCLUSIONS: Mailed FIT outreach with patient navigation implemented in an FQHC system was effective in equitably reaching patients not up to date for CRC screening.

Personalized colorectal cancer screening: study protocol of a mixed-methods study on the effectiveness of tailored intervals based on prior f-Hb concentration in a fit-based colorectal cancer screening program (PERFECT-FIT).

BACKGROUND: In 2014, the national population-based colorectal cancer (CRC) screening program was implemented in the Netherlands. Biennial fecal immunochemical testing (FIT) for hemoglobin (Hb) is used at a cut-off of 47 µg Hb per gram feces. The CRC screening program successfully started, with high participation rates and yield of screening. Now that the program has reached a steady state, there is potential to further optimize the program. Previous studies showed that prior fecal Hb (f-Hb) concentrations just below the FIT cut-off are associated with a higher risk for detection of advanced neoplasia (AN) at subsequent screening rounds. We aim to achieve a better balance between the harms and benefits of CRC screening by offering participants tailored invitation intervals based on prior f-Hb concentrations after negative FIT. METHODS: This mixed-methods study will be performed within the Dutch national CRC screening program and will consist of: (1) a randomized controlled trial (RCT), (2) focus group studies, and (3) decision modelling. The primary outcome is the yield of AN per screened individual in personalized screening vs. uniform screening. Secondary outcomes are perspectives on, acceptability of and adherence to personalized screening, as well as long-term outcomes of personalized vs. uniform screening. The RCT will include 20,000 participants of the Dutch CRC screening program; 10,000 in the intervention and 10,000 in the control arm. The intervention arm will receive a personalized screening interval based on the prior f-Hb concentration (1, 2 or 3 years). The control arm will receive a screening interval according to current practice (2 years). The focus group studies are designed to understand individuals' perspectives on and acceptability of personalized CRC screening. Results of the RCT will be incorporated into the MISCAN-Colon model to determine long-term benefits, harms, and costs of personalized vs. uniform CRC screening. DISCUSSION: The aim of this study is to evaluate the yield, feasibility, acceptability and (cost-) effectiveness of personalized CRC screening through tailored invitation intervals based on prior f-Hb concentrations. This knowledge may be of guidance for health policy makers and may provide evidence for implementing personalized CRC screening in The Netherlands and/or other countries using FIT as screening modality. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05423886, June 21, 2022, https://clinicaltrials.gov/ct2/show/NCT05423886.

Implementing Mailed Colorectal Cancer Fecal Screening Tests in Real-World Primary Care Settings: Promising Implementation Practices and Opportunities for Improvement.

Colorectal cancer (CRC) screening reduces morbidity and mortality, but screening rates in the USA remain suboptimal. The Colorectal Cancer Control Program (CRCCP) was established in 2009 to increase screening among groups disproportionately affected. The CRCCP utilizes implementation science to support health system change as a strategy to reduce disparities in CRC screening by directing resources to primary care clinics to implement evidence-based interventions (EBIs) proven to increase CRC screening. As COVID-19 continues to impede in-person healthcare visits and compel the unpredictable redirection of clinic priorities, understanding clinics' adoption and implementation of EBIs into routine care is crucial. Mailed fecal testing is an evidence-based screening approach that offers an alternative to in-person screening tests and represents a promising approach to reduce CRC screening disparities. However, little is known about how mailed fecal testing is implemented in real-world settings. In this retrospective, cross-sectional analysis, we assessed practices around mailed fecal testing implementation in 185 clinics across 62 US health systems. We sought to (1) determine whether clinics that do and do not implement mailed fecal testing differ with respect to characteristics (e.g., type, location, and proportion of uninsured patients) and (2) identify implementation practices among clinics that offer mailed fecal testing. Our findings revealed that over half (58%) of clinics implemented mailed fecal testing. These clinics were more likely to have a CRC screening policy than clinics that did not implement mailed fecal testing (p = 0.007) and to serve a larger patient population (p = 0.004), but less likely to have a large proportion of uninsured patients (p = 0.01). Clinics that implemented mailed fecal testing offered it in combination with EBIs, including patient reminders (92%), provider reminders (94%), and other activities to reduce structural barriers (95%). However, fewer clinics reported having the leadership support (58%) or funding stability (29%) to sustain mailed fecal testing. Mailed fecal testing was widely implemented alongside other EBIs in primary care clinics participating in the CRCCP, but multiple opportunities for enhancing its implementation exist. These include increasing the proportion of community health centers/federally qualified health centers offering mailed screening; increasing the proportion that provide pre-paid return mail supplies with the screening kit; increasing the proportion of clinics monitoring both screening kit distribution and return; ensuring patients with abnormal tests can obtain colonoscopy; and increasing sustainability planning and support.

Model based evaluation of long-term efficacy of existing and alternative colorectal cancer screening offers: A case study for Germany.

For individuals willing to minimize their lifetime risk of colorectal cancer (CRC), the most effective screening approach remains unclear. Here, we sought to compare the long-term performance of existing and alternative CRC screening offers in a case study for Germany. Applying the perspective of a perfectly adhering man or woman at average risk, we used COSIMO, a validated Markov-based multistate model, to simulate the effects of current CRC screening offers in Germany. These include age- and sex-dependent offers for fecal immunochemical testing (FIT) or screening colonoscopy, which may be used twice starting at age 50 in men and age 55 in women. For comparison, we modeled screening colonoscopies at ages 50, 60 and 70, screening colonoscopies at ages 50 and 60, followed by biennial FITs and conventional FIT-based strategies at varying intervals. We found that the highest reductions in lifetime risks of developing (76%-84%) and dying from CRC (82%-90%) were achieved by three colonoscopies, followed by annual FIT screening and strategies combining both modalities. In men, additional screening from age 70 onwards reduced the risk of dying from CRC by another 9% units and resulted in 32 to 39 additional life-years-gained per 1000 individuals. Among women, three colonoscopies outperformed current screening offers in all outcomes, at little risk of screening-related complications. In summary, several FIT- and colonoscopy-based offers yield comparably high CRC risk reductions, including approaches combining both modalities. German screening offers may be optimized by lowering the eligibility age for screening colonoscopy for women, along with additional offers for the elderly.

Participation in Competing Strategies for Colorectal Cancer Screening: A Randomized Health Services Study (PICCOLINO Study).

BACKGROUND & AIMS: Primary colonoscopy and fecal immunochemical testing (FIT) are considered first-tier tests for colorectal cancer (CRC) screening. Although colonoscopy is considered the most efficacious test, FIT might achieve higher participation rates. It is uncertain what the best strategy is for offering population-wide CRC screening. METHODS: This was a multicenter randomized health services study performed within the framework of the Polish Colonoscopy Screening Program between January 2019 and March 2020 on screening-naïve individuals. Eligible candidates were randomly assigned in a 1:1:1 ratio to participate in 1 of 3 competing invitation strategies: control (invitation to screening colonoscopy only); sequential (invitation to primary colonoscopy and invitation for FIT for initial nonresponders); or choice (invitation offering a choice of colonoscopy or FIT). The primary outcome was participation in CRC screening within 18 weeks after enrollment into the study. The secondary outcome was diagnostic yield for advanced neoplasia. RESULTS: Overall, 12,485 individuals were randomized into the 3 study groups. The participation rate in the control group (17.5%) was significantly lower compared with the sequential (25.8%) and choice strategy (26.5%) groups (P < .001 for both comparisons). The colonoscopy rates for participants with positive FITs were 70.0% for the sequential group and 73.3% for the choice group, despite active call-recall efforts. In the intention-to-screen analysis, advanced neoplasia detection rates were comparable among the control (1.1%), sequential (1.0%), and choice groups (1.1%). CONCLUSIONS: Offering a combination of FIT and colonoscopy as a sequential or active choice strategy increases participation in CRC screening. Increased participation in strategies with FIT do not translate into higher detection of advanced neoplasia. ClinicalTrials.gov, Number NCT03790475.

Clinic Factors Associated With Mailed Fecal Immunochemical Test (FIT) Completion: The Difference-Making Role of Support Staff.

PURPOSE: Mailed fecal immunochemical test (FIT) programs can facilitate colorectal cancer (CRC) screening. We sought to identify modifiable, clinic-level factors that distinguish primary care clinics with higher vs lower FIT completion rates in response to a centralized mailed FIT program. METHODS: We used baseline observational data from 15 clinics within a single urban federally qualified health center participating in a pragmatic trial to optimize a mailed FIT program. Clinic-level data included interviews with leadership using a guide informed by the Consolidated Framework for Implementation Research (CFIR) and FIT completion rates. We used template analysis to identify explanatory factors and configurational comparative methods to identify specific combinations of clinic-level conditions that uniquely distinguished clinics with higher and lower FIT completion rates. RESULTS: We interviewed 39 clinic leaders and identified 58 potential explanatory factors representing clinic workflows and the CFIR inner setting domain. Clinic-level FIT completion rates ranged from 30% to 56%. The configurational model for clinics with higher rates (≥37%) featured any 1 of the following 3 factors related to support staff: (1) adding back- or front-office staff in past 12 months, (2) having staff help patients resolve barriers to CRC screening, and (3) having staff hand out FITs/educate patients. The model for clinics with lower rates involved the combined absence of these same 3 factors. CONCLUSIONS: Three factors related to support staff differentiated clinics with higher and lower FIT completion rates. Adding nonphysician support staff and having those staff provide enabling services might help clinics optimize mailed FIT screening programs.

Source matters: a survey of cost variation for fecal immunochemical tests in primary care.

BACKGROUND: Colorectal cancer (CRC) screening can improve health outcomes, but screening rates remain low across the US. Mailed fecal immunochemical tests (FIT) are an effective way to increase CRC screening rates, but is still underutilized. In particular, cost of FIT has not been explored in relation to practice characteristics, FIT selection, and screening outreach approaches. METHODS: We administered a cross-sectional survey drawing from prior validated measures to 252 primary care practices to assess characteristics and context that could affect the implementation of direct mail fecal testing programs, including the cost, source of test, and types of FIT used. We analyzed the range of costs for the tests, and identified practice and test procurement factors. We examined the distributions of practice characteristics for FIT use and costs answers using the non-parametric Wilcoxon rank-sum test. We used Pearson's chi-squared test of association and interpreted a low p-value (e.g. < 0.05) as evidence of association between a given practice characteristic and knowing the cost of FIT or fecal occult blood test (FOBT). RESULTS: Among the 84 viable practice survey responses, more than 10 different types of FIT/FOBTs were in use; 76% of practices used one of the five most common FIT types. Only 40 practices (48%) provided information on FIT costs. Thirteen (32%) of these practices received the tests for free while 27 (68%) paid for their tests; median reported cost of a FIT was $3.04, with a range from $0.83 to $6.41 per test. Costs were not statistically significantly different by FIT type. However, practices who received FITs from manufacturer's vendors were more likely to know the cost (p = 0.0002) and, if known, report a higher cost (p = 0.0002). CONCLUSIONS: Our findings indicate that most practices without lab or health system supplied FITs are spending more to procure tests. Cost of FIT may impact the willingness of practices to distribute FITs through population outreach strategies, such as mailed FIT. Differences in the ability to obtain FIT tests in a cost-effective manner could have consequences for implementation of outreach programs that address colorectal cancer screening disparities in primary care practices.

Measures of longitudinal adherence to fecal-based colorectal cancer screening: Literature review and recommended approaches.

The success of fecal occult blood-based colorectal cancer screening programs is dependent on repeating screening at short intervals (ie, every 1-2 years). We conducted a literature review to assess measures that have been used to assess longitudinal adherence to fecal-based screening. Among 46 citations identified and included in this review, six broad classifications of longitudinal adherence were identified: (a) stratified single-round attendance, (b) all possible adherence permutations, (c) consistent/inconsistent/never attendance, (d) number of times attended, (e) program adherence and (f) proportion of time covered. Advantages and disadvantages of these measures are described, and recommendations on which measures to use based on data availability and scientific question are also given. Stratified single round attendance is particularly useful for describing the yield of screening, while programmatic adherence measures are best suited to evaluating screening efficacy. We recommend that screening programs collect detailed longitudinal, individual-level data, not only for the screening tests themselves but additionally for diagnostic follow-up and surveillance exams, to allow for maximum flexibility in reporting adherence patterns using the measure of choice.

Effectiveness and Cost-effectiveness of Mailed FIT in a Safety Net Clinic Population.

BACKGROUND: Mailed fecal immunochemical testing (FIT) can increase colorectal cancer (CRC) screening rates, including for vulnerable patients, but its cost-effectiveness is unclear. OBJECTIVE: We sought to examine the effectiveness and cost-effectiveness of the initial cycle of our mailed FIT program from November 2017 to July 2019 in a federally qualified health center (FQHC) system in Central Texas. DESIGN: Single group intervention and economic analysis PARTICIPANTS: Eligible patients were those ages 50-75 who had been seen recently in a system practice and were not up to date with screening. INTERVENTION: The program mailing packet included an introductory letter in plain language, the FIT itself, easy to read instructions, and a postage-paid lab mailer, supplemented with written and text messaging reminders. MAIN MEASURES: We measured effectiveness based on completion of mailed FIT and cost-effectiveness in terms of cost per person screened. Costs were measured using detailed micro-costing techniques from the perspective of a third-party payer and expressed in 2019 US dollars. Direct costs were based on material supply costs and detailed observations of labor required, valued at the wage rate. KEY RESULTS: Of the 22,838 eligible patients who received program materials, mean age was 59.0, 51.5% were female, and 43.9% were Latino. FIT were successfully completed by 19.2% (4395/22,838) patients at an average direct cost of $5275.70 per 500-patient mailing. Assuming completed tests from the mailed intervention represent incremental screening, the direct cost per patient screened, compared with no intervention, was $54.83. Incorporating start-up and indirect costs increases total costs to $7014.45 and cost per patient screened to $72.90. Alternately, assuming 2.5% and 5% screening without the intervention increased the direct (total) cost per patient screened to $60.03 ($80.80) and $67.05 ($91.47), respectively. CONCLUSIONS: Mailed FIT is an effective and cost-effective population health strategy for CRC screening in vulnerable patients.

Incidence of Interval Colorectal Cancer After Negative Results From First-Round Fecal Immunochemical Screening Tests, by Cutoff Value and Participant Sex and Age.

BACKGROUND & AIMS: We evaluated the incidence of interval cancers between the first and second rounds of colorectal cancer (CRC) screening with the FOB-Gold fecal immunochemical test (FIT), and the effects of different cutoff values and patient sex and age. METHODS: We collected data from participants in a population-based CRC screening program in the Netherlands who had a negative result from a first-round of FIT screening. We calculated the cumulative incidence of interval cancer after a negative result from a FIT and the sensitivity of the FIT for detection of CRC at a low (15 µg Hb/g feces) and high (47 µg Hb/g feces) cutoff value. RESULTS: Among the 485,112 participants with a negative result from a FIT, 544 interval cancers were detected; 126 were in the 111,800 participants with negative results from a FIT with the low cutoff value and 418 were in the 373,312 FIT participants with negative results from a FIT with the high cutoff value. The mean age of participants tested with the low cutoff value was 72.0 years and the mean age of participants tested the high cutoff value was 66.7 years. The age-adjusted 2-year cumulative incidence of interval cancer after a negative result from a FIT were 9.5 per 10,000 persons at the low cutoff value vs 13.8 per 10,000 persons at the high cutoff value (P < .005). The age-adjusted sensitivity of the FIT for CRC were 90.5% for the low cutoff value vs 82.9% for the high cutoff (P < .0001). The FIT identified men with CRC with 87.4% sensitivity and women with CRC with 82.6% sensitivity (P < .001). CONCLUSIONS: In an analysis of data from a FIT population-based screening program in the Netherlands, we found that incidence of interval CRC after a negative result from a FIT to be low. Although the sensitivity of detection of CRC decreased with a higher FIT cutoff value, it remained above 80%.

Premature Fecal Immunochemical Testing in British Columbia Canada: a Retrospective Review of Physician and Screening Participant Characteristics.

BACKGROUND: Colorectal cancer (CRC) screening is an evidence-based strategy to reduce CRC-related mortality. OBJECTIVE: This study identifies physician and participant characteristics, as well as previous FIT values associated with premature FIT usage. DESIGN: This is a retrospective review of all FITs ordered from January 1, 2016, until June 30, 2017. For each ordered FIT, the participant's chart was reviewed to identify if a previous FIT had occurred in the prior 21 months. A premature FIT was defined as an ordered test with a negative FIT in the preceding 21 months. PARTICIPANTS: Screening participants were average risk for CRC, aged 50-74, and had a FIT ordered by their primary care provider in British Columbia, Canada. MAIN MEASURES: The BC College of Physicians and Surgeons' database was used to identify the location of referring physician, date of graduation from medical school, and gender. The participant's age, gender, and value of previous FIT were recorded. Physician and participant variables and previous FIT value were examined with logistic regression to identify associations with premature FIT ordering. KEY RESULTS: In total, 385,375 FITs were ordered during this period with 116,727 representing participants returning following a previous negative FIT. In total, 35,148 (30.1%) returned early for screening. Men were more likely to return early than women (OR 1.14; 95% CI 1.11-1.17; p < 0.0001). Male physicians were more likely to order premature FITs (OR 1.15; 95% CI 1.06-1.24; p < 0.0001). A higher quantitative FIT value (ng/mL) of the previous FIT was also associated with early screening (OR 1.11; 95% CI 1.09-1.14; < 0.0001). CONCLUSIONS: This study found that approximately 30% of FIT tests, ordered for CRC screening, were ordered before they were due. This may lead to wasted resources, unnecessary participant stress, and unwarranted patient risk.

First-year implementation of mailed FIT colorectal cancer screening programs in two Medicaid/Medicare health insurance plans: qualitative learnings from health plan quality improvement staff and leaders.

BACKGROUND: Colorectal cancer screening rates remain low, especially among certain racial and ethnic groups and the uninsured and Medicaid insured. Clinics and health care systems have adopted population-based mailed fecal immunochemical testing (FIT) programs to increase screening, and now health insurance plans are beginning to implement mailed FIT programs. We report on challenges to and successes of mailed FIT programs during their first year of implementation in two health plans serving Medicaid and dual eligible Medicaid/Medicare enrollees. METHODS: This qualitative descriptive study gathered data through in-depth interviews with staff and leaders at each health plan (n = 10). The Consolidated Framework for Implementation Research, field notes from program planning meetings between the research team and the health plans, and internal research team debriefs informed interview guide development. Qualitative research staff used Atlas.ti to code the health plan interviews and develop summary themes through an iterative content analysis approach. RESULTS: We identified first-year implementation challenges in five thematic areas: 1) program design, 2) vendor experience, 3) engagement/communication, 4) reaction/satisfaction of stakeholders, and 5) processing/returning of mailed kits. Commonly experienced challenges by both health plans related to the time-consuming nature of the programs to set up, and complexities and delays in working with vendors. We found implementation successes in the same five thematic areas as well as four additional areas of: 1) leadership support, 2) compatibility with the health plan, 3) broader impacts, and 4) collaboration with researchers. Commonly experienced successes included the ability to adapt the mailed FIT program to the individual health plan culture and needs, and the synchronicity between the programs and their organizational missions and goals. CONCLUSIONS: Both health plans successfully adapted mailed FIT programs to their own culture and resources and used their strong quality management resources to maximize success in overcoming the time demands of setting up the program and working with their vendors. Mailed FIT programs administered by health plans, especially those serving Medicaid- and dual eligible Medicaid/Medicare-insured populations, may be an important resource to support closing gaps in colorectal cancer screening among traditionally underserved populations.

Comparative effectiveness of mailed reminders with and without fecal immunochemical tests for Medicaid beneficiaries at a large county health department: A randomized controlled trial.

BACKGROUND: Colorectal cancer (CRC) screening is effective but underused. Screening rates are lower among Medicaid beneficiaries versus other insured populations. No studies have examined mailed fecal immunochemical testing (FIT)-based outreach programs for Medicaid beneficiaries. METHODS: In a patient-level randomized controlled trial, a mailed CRC screening reminder plus FIT, sent from an urban health department to Medicaid beneficiaries, was compared with the same reminder without FIT. The reminder group could request FIT. Completed FIT kits were processed by the health department laboratory. Respondents were notified of normal results by mail. Abnormal results were given via phone by a patient navigator who provided counselling and assistance with follow-up care. The primary outcome was FIT return. RESULTS: In all, 2144 beneficiaries at average CRC risk were identified, and there was no evidence of screening with Medicaid claims data. To the reminder+FIT group, 1071 were randomized, and 1073 were randomized to the reminder group; 307 (28.7%) in the reminder+FIT group and 347 (32.3%) in the reminder group were unreachable or ineligible (previous screening). The FIT return rate was significantly higher in the reminder+FIT group than the reminder group (21.1% vs 12.3%; difference, 8.8%; 95% confidence interval, 3.7%-13.9%; P < .01). Eighteen individuals (7.2%) who completed FIT tests had abnormal results, and 15 were eligible for follow-up colonoscopy; 66.7% (n = 10) completed follow-up colonoscopy. CONCLUSIONS: A health department-based, mailed FIT program targeting Medicaid beneficiaries was feasible. Including a FIT kit resulted in greater screening completion than a reminder letter alone. Further research is needed to understand the comparative cost-effectiveness of these interventions.

Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program.

BACKGROUND: The effectiveness of fecal immunochemical testing (FIT) in reducing colorectal cancer (CRC) mortality has not yet been fully assessed in a large, population-based service screening program. METHODS: A prospective cohort study of the follow-up of approximately 5 million Taiwanese from 2004 to 2009 was conducted to compare CRC mortality for an exposed (screened) group and an unexposed (unscreened) group in a population-based CRC screening service targeting community residents of Taiwan who were 50 to 69 years old. Given clinical capacity, this nationwide screening program was first rolled out in 2004. In all, 1,160,895 eligible subjects who were 50 to 69 years old (ie, 21.4% of the 5,417,699 subjects of the underlying population) participated in the biennial nationwide screening program by 2009. RESULTS: The actual effectiveness in reducing CRC mortality attributed to the FIT screening was 62% (relative rate for the screened group vs the unscreened group, 0.38; 95% confidence interval, 0.35-0.42) with a maximum follow-up of 6 years. The 21.4% coverage of the population receiving FIT led to a significant 10% reduction in CRC mortality (relative rate, 0.90; 95% confidence interval, 0.84-0.95) after adjustments for a self-selection bias. CONCLUSIONS: This large, prospective Taiwanese cohort undergoing population-based FIT screening for CRC had the statistical power to demonstrate a significant CRC mortality reduction, although the follow-up time was short. Although such findings are informative for health decision makers, continued follow-up of this large cohort will be required to estimate the long-term impact of FIT screening if the covered population is expanded.

Two-year follow-up of the effectiveness of a multifaceted intervention to improve adherence to annual colorectal cancer screening in community health centers.

PURPOSE: We previously found that a multifaceted outreach intervention achieved 82 % annual adherence to colorectal cancer (CRC) screening with fecal occult blood testing (FOBT). This study assessed adherence to FOBT after a second outreach. METHODS: We followed 225 patients in community health centers in Chicago, Illinois, who were randomized to the intervention group. Our primary analysis focused on 124 patients who completed FOBT during the first outreach and were due again for annual FOBT; 90% were Latino, 87% preferred to speak Spanish, and 77% were uninsured. Second outreach consisted of (1) a mailed reminder letter, a free fecal immunochemical test (FIT) with postage-paid return envelope, (2) automated phone and text messages, (3) automated reminders 2 weeks later if the FIT was not returned, and (4) a telephone call after 3 months. Our main outcome was completion of FIT within 6 months of the due date. We also analyzed the proportion of the original 225 patients who were fully screened for CRC over the 2-year study period. RESULTS: A total of 88.7% of patients completed a FIT within 6 months of their second outreach. Over the 2 years since the first outreach, 71.6% of the 225 patients assigned to the intervention group were fully up to date on CRC screening, another 11.1% had been screened suboptimally, and 17.3% were inadequately screened or not screened. CONCLUSIONS: It is possible to achieve high rates of CRC screening over a 2-year period for vulnerable populations using outreach with FIT as a primary strategy.

Enhancing colorectal cancer screening in high-risk population through fecal immunochemical test surveillance: Results from a surveillance program.

BACKGROUND: Current guidelines recommend colonoscopy-based surveillance to decrease the risk of colorectal cancer (CRC) among these participants with above-average risk. The fecal immunochemical test (FIT) holds promise as a viable alternative surveillance tool, but the existing evidence regarding the use of settings remains limited. Therefore, our aim is to evaluate the CRC incidence rates in individuals with above-average CRC risk and the relationship between FIT surveillance and CRC incidence. METHODS: The retrospective cohort study was performed based on the CRC screening program between January 2012 and December 2022, in Tianjin, China. This cohort study included 12,515 participants aged 40-74 years with above-average risk. The primary outcomes were the incidence rates of CRC and advanced colorectal neoplasia which were expressed as the number of events per 100,000 person-years. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox proportional hazards models. RESULTS: We included 12,515 participants aged 40-74 years, of whom 4980 received subsequent FIT surveillance during the study period. Among these participants, 51 CRC cases occurred in the non-FIT surveillance group (incidence rate, 233.88 per 100,000 person-years) and there were 29 cases of CRC in the FIT surveillance group (incidence rate, 184.85 per 100,000 person-years), resulting in an incidence rate ratio (IRR) of 0.58 (95% CI, 0.37-0.91). Meanwhile, 428 advanced colorectal neoplasia cases were reported in the non-FIT surveillance group, while 269 cases occurred in the FIT surveillance group, with significantly lower incidence of advanced colorectal neoplasia in the FIT surveillance group (IRR: 0.64; 95% CI, 0.55-0.74). Compared with the non-FIT surveillance group, the FIT surveillance group had a 54% decreased risk of developing CRC (HR, 0.46; 95% CI, 0.29-0.74) and a 45% decreased risk of developing advanced colorectal neoplasia (HR, 0.55; 95% CI, 0.47-0.64). CONCLUSIONS: In this retrospective cohort study, above-average risk individuals who received subsequent FIT in the intervals between colonoscopies were associated with a reduction of CRC and advanced colorectal neoplasia incidence, which indicated the value and utility of FIT in the surveillance program.