Fecal Immunochemical Test Test Research Articles

A Health Equity Study on Access by Ethnicity to Fecal Immunochemical Testing for Colorectal Cancer Screening at a Veteran Affairs Medical Center

Abstract Introduction/Objective It has been documented in the literature that significant ethnic and racial disparities in access to healthcare exist. Additionally, it has also been shown that these disparities can be corrected. Integrated health care systems such as the Veterans’ Administration health care system have previously been demonstrated to lead to more equitable care delivery and improved outcomes with lower racial and ethnic differences in access to care. Standard of care guidelines issued by the U.S. Preventive Services Task Force (USPSTF) exist recommending screening for colorectal cancer in adults, of which one of the screening methods involves the convenient fecal immunochemical test (FIT). FIT is a noninvasive simple screening test compared to alternatives such as colonoscopy. Given FIT’s benefits, the authors explored the accessibility by ethnicity for this important test at a Veteran Affairs Medical Center (VAMC). Methods/Case Report A search of all FIT testing performed at a regional VAMC from 10/1/2018 to 6/4/2022 was performed to determine the patient demographics including age, gender, and ethnicity. The ethnic distribution of all tested patients was compared to the local census population demographics of the county (Philadelphia) in which the VAMC is located (updated July 1, 2021). Results (if a Case Study enter NA) There were a total of 10,110 FIT tests conducted during the study period. From these 10,110 FIT tests, the ethnic composition of the test population is as follows: 5,164 or 51% (5,164/10,110) were African American, 4,389 or 43% (4,389/10,110) were Caucasian American, 65 or 0.6% (65/10,110) were Asian American, 48 or 0.5% were American Indian or Alaska Native American, 111 or 1% (111/10,110) were Native Hawaiian or other Pacific Islander Americans, and 333 or 3.2% (333/10,110) were unknown or declined to state in the medical record. Per the local county census, 44.8% of the local population was Caucasian American and 43.6% were African American. Conclusion The VAMC, being an integrated health care system, provides equitable access to FIT to screen for colorectal cancer.

Addressing Barriers to Colorectal Cancer Screening by Implementing a Colorectal Cancer Screening Program on a Mobile Health Unit

INTRODUCTION: Several barriers to healthcare access contribute to disparity in colorectal cancer screening. We developed a program to address structural and financial barriers to colorectal cancer screening in our community using an established mobile health unit. METHODS: This mobile health team aims to improve health and prevent chronic disease by providing wellness education and taking physiological measurements such as glucose and blood pressure. In partnership with this unit, we began providing fecal immunochemical test (FIT) tests to English- and Spanish-speaking patients aged 45 years and older during their visits to the mobile unit for other health examinations. Participants complete the FIT at home and return it via postal mail. A patient navigator follows up with participants. If the FIT is positive, the participant undergoes a colonoscopy. If the participant is uninsured, cost of colonoscopy and/or cancer care are covered by our institution. Participants complete surveys at baseline, test completion, and upon receiving their results. RESULTS: We have enrolled 34 participants, 65% women, median age: 55 years (interquartile range = 12). The majority (90%) of patients did not have health insurance, and 76% were Spanish-speaking. Most (88%) knew they were due for colorectal cancer screening, but 85% had never been screened for various reasons (Table). To date, 71% of participants have completed FIT testing, and 100% of completion survey respondents plan to repeat FIT testing next year. CONCLUSION: Our preliminary results demonstrate the feasibility of addressing structural and financial barriers to colorectal cancer screening by initiating FIT testing programs on existing mobile community health units. Table. - Enrollee-Reported Primary Past Barriers to Colorectal Cancer Screening Barrier Percentage I’ve never had the opportunity 26% I don’t have insurance 19% I didn’t think it was necessary 14% Testing is too expensive 11% I don’t know 11% Other 19%

S2246 FIT or Unfit: Advanced Colon Cancer Screening

Introduction: Colorectal cancer (CRC) is the third leading cause of cancer related mortality worldwide. The U.S. Preventative Services Task Force guidelines recommend screening for average risk patients at age 45, and modalities include stool-based or direct visualization tests. We report a presentation of Stage IV colorectal adenocarcinoma in the setting of 3 annual negative fecal immunochemical testing (FIT) tests. Case Description/Methods: A 67-year-old woman presented with shortness of breath, unintentional weight loss, and abdominal pain. She denied hematochezia or melena. Physical exam was notable for pallor and right upper quadrant pain. Initial laboratory data showed normocytic anemia with a hemoglobin 10.1 g/dL, alkaline phosphatase 610 U/L, aspartate aminotransaminase 116 U/L, alanine aminotransaminase 67 U/L. Computed tomography of the chest, abdomen, and pelvis revealed a normal colon and extensive metastatic disease in the liver and lungs with bilateral subsegmental pulmonary emboli. Chart review was notable for negative FIT tests in 2017, 2018, and 2020, performed within a year of this presentation. Further workup was significant for elevated carcinogenic embryonic antigen 1470 ng/mL, and normal alpha-fetoprotein and cancer antigen 19-9 levels. Colonoscopy revealed an infiltrating, ulcerated, semi-circumferential mass at the ileo-cecal valve and ascending colon (Figure). Pathology demonstrated moderately differentiated invasive colonic adenocarcinoma with malignant glands infiltrating a desmoplastic stroma. Immunohistochemistry did not show any microsatellite instability changes. Discussion: One study showed FIT testing was 73.8% sensitive for detecting Stage I-III CRC, however, sensitivities dropped with advanced precancerous lesions and sessile serrated polyps to 23.8% and 5.1% respectively. Another retrospective cohort looking at 6 consecutive rounds of FIT testing demonstrated lower accuracy of detecting proximal colon cancers compared to distal cancers (0.45 vs 0.73; P< 0.001). Lower cut off values of qualitative FIT correlated with better sensitivities, however, specificity declined. Although FIT testing is able to detect the majority of colorectal cancers, it has decreased accuracy and sensitivity in advanced precancerous lesions, sessile serrated polyps, and proximal (right) colon lesions. Colonoscopy is considered gold standard and further guidelines should recommend a standardized cut off value to help improve screening efficacy.Figure 1.: Large fungating mass in the ascending colon and ileo-cecal valve.

S295 Preliminary Observations of FIT Testing for Colorectal Cancer (CRC) Prevention in Two Public Hospitals in New York City

Introduction: Expanding colorectal cancer screening (CRC) on a population level is essential in decreasing CRC mortality. Fecal immunochemical test (FIT) has an important role in improving screening rates. Currently, CRC guidelines recommend annual fecal immunochemical test (FIT) with follow up colonoscopy for all positive tests. We reviewed our experience with FIT testing for CRC screening at our institutions between July 2019 and December 2021. Methods: Eligible primary care clinic patients were given FIT kits with information on how to perform and submit the samples either during face-to-face visits or by mail. Eligible patients were identified as those aged 50-75 due for CRC screening, defined as those without a colonoscopy in the prior 10 years or FIT kit in the prior one year. Among patients who received FIT kits by mail, no standard education was provided about CRC, its screening, or the role of colonoscopy in prevention. A de-identified database was constructed containing demographic variables, process measures, colonoscopy quality measures and outcome measures in FIT+ patients. Results: One hundred seventy-six patients had positive FIT with a positivity rate of 7.2%. Mean age was 60+/-12 years and 52% were female. Follow up colonoscopies were ordered in 73% and performed in 52% of those ordered, representing only 38% of all positive FIT requiring a follow up colonoscopy. Mean and median intervals between +FIT and colonoscopy was 4 months. Of colonoscopies not performed, the patient refused in 54% while system issues were responsible in 21%. Quality metrics, including cecal intubation rates, withdrawal times, and adenoma detection rates (ADR) all met or exceeded benchmarks. The ADR was 58%, almost twice the benchmark, and the detection rate for advanced adenomas was 21%. Eight patients had cancers (11.9%) of which 6 had signs or symptoms and 4 were advanced. There were no interval cancers detected and no complications occurred. Conclusion: Among primary care clinic patients with positive FITs, we found that a low percentage completed their follow up colonoscopies. Among those who did complete colonoscopy, there were high detection rates for both adenomas and advanced adenomas. This highlights the importance of colonoscopy and demonstrates that enhanced pre-FIT educational efforts may be needed to increase adherence to colonoscopy follow up in patients with positive FIT results.

S337 Colonoscopy Quality Metrics After a Multi-Target Stool DNA or Fecal Immunochemical Test: A Systematic Review and Meta-Analysis

Introduction: Colorectal cancer (CRC) accounts for approximately 50,000 deaths or 14 deaths per 100,000 people yearly in the United States. Multi-target stool DNA (mt-sDNA) and fecal immunochemical test (FIT) are validated CRC screening strategies in average-risk asymptomatic individuals. This study aims to evaluate the colonoscopy quality metrics following a positive mt-sDNA test, FIT. Methods: We performed a comprehensive search in the databases of PubMed/MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from inception through May 2022. Meta-analysis was performed by standard methodology using the random-effects model and heterogeneity was assessed using the I2% statistics. Outcomes of interest were adenoma detection rate (ADR), colorectal cancer detection rate (CRCDR), withdrawal time (WT), and cecal intubation rate (CIR). Results: 27 high-quality studies (97825 patients) were included in the analysis. 94161 had a positive FIT test in 23 studies and 3664 had positive mt-sDNA in 4 studies. The pooled WT after positive mt-sDNA was 16.1 minutes (95% CI 9.4-22.8, I2=99%), whereas after positive FIT was 11.6 minutes (10.9-12.3, 99%). The corresponding WT in the negative tests was 13.2 minutes (12.7-13.7) for mt-sDNA and 10.2 minutes (9.3-11.2) for FIT. The pooled ADR was 73% (69.9-75.8) and CRCDR was 1.9% (0.9-4.2) in mt-sDNA positive. The pooled ADR was 54.2% (49.8-58.4) and pooled CRCDR was 4% (3.2-4.9) in FIT positive. Pooled CIR were excellent: 99% (98.6-99.3) in mt-sDNA positive, and 96.8% (95.8-97.6) in FIT positive. Pooled rates are summarized in Table. Conclusion: Our meta-analysis demonstrated that positive mt-sDNA or FIT patients had a higher WT and CIR when compared to negative or unknown tests. ADR and CRCDR were high, however, it is not known if it is secondary to positive stool test or to longer WT. Future studies are needed to validate our findings and determine the cost-effectiveness of these screening tests. Table 1. - Colonoscopy quality metrics including withdrawal time, cecal intubation rate, adenoma detection rate and colorectal cancer detection rate after positive and negative multi-target stool DNA and fecal immunochemical test testing Outcomes Multi-target stool DNA (mt-sDNA) Fecal Immunochemical Test (FIT) Withdrawal time (WT), mean (95%CI) Positive: 16.1 (9.4-22.8) (SE: 3.4);4 studiesNegative: 13.2 (12.7-13.7) (SE: 0.2)1 study Positive: 11.6 (10.9-12.3) (SE: 0.3);22 studiesNegative: 10.2 (9.3-11.2) (SE: 0.5)6 studies Cecal intubation Rate (CIR), pooled rate (95%CI) Positive: 99% (98.6-99.3)2 studies Positive: 96.8% (95.8-97.6, 94%)12 studies Adenoma Detection Rate (ADR), pooled rate (95%CI) Positive: 73% (69.9-75.8)1 studyNegative: NR Positive: 54.2% (49.8-58.4, 97%)20 studiesNegative: 35.1% (30.5-39.9, 95%)6 studies Colorectal Cancer Detection Rate (CRCDR), pooled rate (95%CI) Positive: 1.9% (0.9-4.2, 81%)3 studiesNegative: 7.9% (2.6-21.8)1 study Positive: 4% (3.2-4.9, 88%)17 studiesNegative: 0.5% (0.2-1.6, 85%)5 studies Abbreviations: NR: not reported, SE: standard error, CI: confidence interval.

Patterns of initial colorectal cancer screenings after turning 50 years old and follow-up rates of colonoscopy after positive stool-based testing among the average-risk population

Objectives Effective colorectal cancer (CRC) screening requires proper adherence beginning at the recommended screening age. For those with positive results on stool-based tests (SBTs), a follow-up colonoscopy is warranted. The objectives of this study were to 1) examine initial screening rates after turning 50 years old; and 2) assess rates of follow-up colonoscopy after a positive SBT. Methods This retrospective study used de-identified administrative claims data from 01/01/2006 to 06/30/2020 for commercially insured and Medicare Advantage enrollees. For objective 1, the index year was the year enrollees turned 50. Rates of CRC screening during and after the index year were captured. For objective 2, the index date was the claim date of a fecal immunochemical test (FIT) or multitarget stool DNA test (mt-sDNA) where linked lab data indicated a positive test result. Rates and time to follow-up colonoscopy after a positive SBT were assessed. Results Approximately 53% of enrollees initiated CRC screening within five years after turning 50 (50+ cohort N = 718,562). Among enrollees with an available lab result indicating a positive SBT (N = 7329; 2110 FIT and 5219 mt-sDNA), overall follow-up colonoscopy within 6 months of the positive result was less than optimal (65%) and varied by modality; 72% vs 46% (p < .001) among enrollees with a positive mt-sDNA test compared to FIT test, respectively. Conclusion There is potential for improving CRC screening among the eligible average-risk population, both to start screening once they reach the screening-eligible age, and to complete the CRC screening paradigm after a positive stool-based screen.

SA28 Systematic Review of Screening Interventions for Colon and Rectal Cancer, from the Point of View of the Instituto Mexicano Del Seguro Social

Evaluate the sensitivity and specificity of the fecal immunochemical test (FIT) for the diagnosis of adult patients with colorectal cancer (CRC) compared to the guaiac fecal occult blood test (gFOBT), Conventional colonoscopy (CC), and flexible sigmoidoscopy (FS), existing in the Instituto Mexicano del Seguro Social (IMSS). Methodology: We conducted a systematic review to evaluate the sensitivity and specificity of the FIT test compared to the screening options currently available at the IMSS to diagnose of adult patients with CRC.

Different information needs-The major reasons for calling the helpline when invited to colorectal cancer screening.

IntroductionThis study pertains to the design of a decision aid (DA) to shed light on information and support needs in colorectal cancer screening, with the aim to explore the calling patterns to the Screening of Swedish Colons (SCREESCO) study's helpline.MethodsA cross‐sectional study was conducted with data from documented telephone calls to the SCREESCO study, including individuals, 59–60 years, randomized to colonoscopy or high sensitive faecal immunochemical test (FIT).ResultsMore than 2000 calls (women 58.5%; colonoscopy 59%) were analysed. Calling patterns: unsubscribing from screening, confirmation of participation, logistical concerns about the screening procedure, counselling, and FIT screening difficulties or in need of a new FIT test. Comorbidity was the most frequent reason for unsubscribing and most of the counselling calls included questions about the FIT test or the colonoscopy.ConclusionMost of the calls to the helpline seemed to be related to individuals' lack of understanding about the organization of the screening programme and the screening procedure. Therefore, we find it important to further stress the tailoring part in our DA developing process, that is, provide limited information initially, with the possibility of access to more, if desired by the individual, still with respect to the individual's needs, health and digital literacy.Patient and Public ContributionIndividuals representing the public and invited to SCREESCO participated since we analysed their calls to the helpline. The findings will contribute to our continued work with the DA where the public will contribute and participate.

Colorectal two-week wait service and quantitative FIT: it's not just about colon cancer.

The aim of this study was to assess faecal immunochemical test (FIT) negativity in terms of its effect on cancer risk in the local symptomatic two-week wait (2WW) population. FIT was introduced to the colorectal 2WW pathway at the start of the pandemic. This study analyses the FIT-negative (<10µg Hb/g) cohort and calculates the relative risk and odds ratio associated with a negative FIT test. FIT tests were sent to symptomatic 2WW patients without rectal bleeding, iron-deficient anaemia or palpable mass. Where FIT was <10µg Hb/g investigations were moved to a radiology protocol. The test return rate was 91% with a FIT-negative (<10µg Hb/g) rate of 82%. The FIT-negative group in the symptomatic referral pathway in Cornwall have a low (1.4%) risk of colon cancer but a significant risk (6.6%) when all cancer types are considered. The impact of a negative quantitative FIT changes the odds ratio of a patient having a luminal cancer by 0.26. The odds ratio for 'all cancer' risk was affected by 0.83. A negative FIT test within the local NG12 symptomatic patient group signifies a low risk of colon cancer and identifies patients who can be initially investigated with cross-sectional imaging. However, when all cancer types are considered, cancer prevalence in this group remains above 6%. In relative risk terms a negative FIT represents a small change in overall risk and this patient group still qualify for investigation through 2WW pathways.

The use of the faecal immunochemical test during the COVID-19 pandemic to triage urgent colorectal cancer referrals.

AimDuring the first wave of the COVID‐19 pandemic in 2020, elective gastrointestinal endoscopy services were abbreviated for fear of viral transmission. However, urgent suspected colorectal cancer (CRC) referrals continued. Serendipitously, a national study suggested that a new faecal immunochemical test (FIT) might be helpful in triaging patients with colorectal alarm symptoms.MethodsThis was a single centre observational study of patients referred using NG12 criteria between March and August 2020. Patients were triaged to the urgent cancer pathway for FIT ≥ 10 μg/g and investigated using the latest National Health Service England guidance. Demographic data, method of investigations, cancer and polyp detection rates were compared to patients referred in the 6 months prior to the use of FIT as a triage tool.ResultsIn all, 1192 patients (median age 70) were referred using NG12 guidelines during the pandemic period, compared with 1592 patients (median age 72) in the previous 6 months. CRC detection was similar in both groups (n = 45, 2.8% vs. n = 38, 3.5%; P = 0.248). Two patients with a negative FIT (0.36%) had CRC. Using FIT as a triage tool resulted in a significant reduction in the use of endoscopy (n = 477, 43.6% vs. n = 1186, 74.5%; P > 0.001) with a significant increase in CT scanning (n = 696, 63.6% vs. n = 750, 47.1%; P < 0.001).ConclusionThe use of FIT in NG12 patients triaged during the first wave of the COVID‐19 pandemic reduced endoscopy but not CT scanning and did not compromise CRC detection rates. It is a safe method that aids in reducing the burden on services greatly. A negative FIT test does not absolutely exclude CRC.

Colorectal cancer screening preferences among physicians and individuals at average risk: A discrete choice experiment.

BackgroundGuidelines include several options for average‐risk colorectal cancer (CRC) screening that vary in aspects such as invasiveness, recommended frequency, and precision. Thus, patient and provider preferences can help identify an appropriate screening strategy. This study elicited CRC screening preferences of physicians and individuals at average risk for CRC (IAR).MethodsIAR aged 45–75 years and licensed physicians (primary care or gastroenterology) completed an online discrete choice experiment (DCE). Participants were recruited from representative access panels in the US. Within the DCE, participants traded off preferences between screening type, screening frequency, true‐positive, true‐negative, and adenoma true positive (physicians only). A mixed logit model was used to obtain predicted choice probabilities for colonoscopy, multi‐target stool DNA (mt‐sDNA), fecal immunochemical test (FIT), and methylated septin 9 (mSEPT9) blood test.ResultsPreferences of IAR and physicians were affected by screening precision and screening type. IAR also valued more regular screening. Physicians preferred colonoscopy (96.8%) over mt‐sDNA (2.8%; p < 0.001), FIT (0.3%; p < 0.001) and mSEPT9 blood test (0.1%; p < 0.01). IAR preferred mt‐sDNA (38.8%) over colonoscopy (32.5%; p < 0.001), FIT (19.2%; p < 0.001), and mSEPT9 blood test (9.4%; p < 0.001). IAR naïve to screening preferred non‐invasive screening (p < 0.001), while the opposite was found for those who previously underwent colonoscopy or sigmoidoscopy.ConclusionsWhile physicians overwhelmingly preferred colonoscopy, preferences of IAR were heterogenous, with mt‐sDNA being most frequently preferred on average. Offering choices in addition to colonoscopy could improve CRC screening uptake among IAR.This study used a discrete choice experiment in the US to elicit preferences of physicians and individuals at average risk for colorectal cancer screening modalities and their characteristics.

Cross-cultural validation of stool Based Colorectal cancer screening methods in the North West of Iran

BackgroundGlobally, colorectal cancer (CRC) is the third most common cancer and the second leading cause of death from cancer. Incidence and mortality from CRCboth can be reduced and prevented using screening and early detection programs. The current study aimed to assess the feasibility of the colorectal cancer screening program in Northwest of Iran. MethodsThe study designed as a cross-cultural analytic study, to evaluate the diagnostic accuracy of stool-based tests compared with colonoscopy, during 2016–2020. All individuals first were assessed with our CRC risk assessment tool, then eligible volunteers entered the study. Colonoscopy was performed on all participants, also stool-based tests including traditional guaiac, high-sensitivity guaiac-based, fecal immunochemical test (FIT), and multitarget stool DNA (Mt-sDNA) panel tests were performed. ResultsMt-sDNA test panel had a sensitivity of 77.8% (95% CI: 40–97.2)for detecting colorectal cancer with a specificity of 91.2% (95% CI:85.4–95.2). The FIT test alone had a lower sensitivity (66.7%; 95% CI:29.9–92.5) and almost the same specificity of 93.9% (95% CI: 88.7–97.2) for cancer detection. Mt-sDNA test had better diagnostic accuracy than the FIT (AUC = 0.85 vs 0.80), and is a more useful screening test. Positive and negative predictive values for cancer detection for both Mt-sDNA and FIT tests were almost the same results, however Mt-sDNA test had better NPV results than the FIT test alone. ConclusionOur results showed that both Mt-sDNA panel and the FIT test had acceptable cut-off points for cancer detection, however, Mt-sDNA test had better diagnostic accuracy.

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

BackgroundColorectal 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.MethodsWe 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).ResultsAmong 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).ConclusionsOur 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.

Abstract PO-247: Is colorectal cancer screening in West Africa worthwhile? A prospective multi-institutional study of 2,330 average-risk Nigerians using fecal immunochemical testing (FIT)

Abstract Objective: The estimated incidence of CRC is rising in many African countries. In Nigeria, it is the fourth most common cause of cancer death. More than half of CRC patients in Nigeria present with metastatic disease. Early detection and screening for CRC is a goal of the Nigerian National Cancer Control Plan. This study assessed the performance of the fecal immunochemical test (FIT) as a CRC screening modality in an average-risk population in Nigeria. Methods: A population-based, cross-sectional study of FIT-based CRC screening was undertaken. Asymptomatic average-risk participants aged 45-75 years in three states in Southwest Nigeria were screened using a qualitative (50ng/mL) FIT test. Participants were invited to enroll using age- and sex-stratified convenience sampling following community outreach. Participants with positive test results underwent colonoscopy and the positive predictive value (PPV) of FIT-based CRC screening for CRC and advanced adenomas (tubulovillous, villous or high grade dysplasia) was calculated. Information on demographics, cancer knowledge, and acceptability of the FIT test and colonoscopy were also collected. Results: Between January-April 2021, 2330 participants in 3 states (Osun, Kwara, Lagos) were enrolled in the study. The median age was 57 years. 68% had at least secondary level education. Participants were evenly spread across wealth quintiles. Baseline knowledge of CRC symptoms among participants was low, especially outside of Lagos. The test return rate was 90.6%, and FIT positivity rate was 20.5% overall (n=432); 11.2% in Lagos, 20.4% in Osun, and 27.8% in Kwara states. Among the FIT positive patients who completed colonoscopy (n=285; 66.0%), the positive predictive value (PPV) for invasive adenocarcinoma was 1.1%, and for advanced adenoma was 1.8%.[KTP1] [AD2] The acceptability of fecal-based CRC screening among participants was very high. Conclusions: CRC screening with qualitative FIT testing in Southwest Nigeria is feasible and acceptable to average-risk asymptomatic participants. The high false-positive rates and low PPV for advanced neoplasia, however, suggest it is not an optimal screening tool in this environment, particularly given the health resources required for endoscopic evaluation. Citation Format: Olusegun I. Alatise, Anna J. Dare, Patrick A. Akinyemi, Fatima B. Abdulkareem, Samuel A. Olatoke, Gregg C. Knapp, Peter T. Kingham. Is colorectal cancer screening in West Africa worthwhile? A prospective multi-institutional study of 2,330 average-risk Nigerians using fecal immunochemical testing (FIT) [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-247.

Abstract PO-025: Implementing evidence-based interventions (EBI) to increase uptake of fecal immunochemical test (FIT) colorectal cancer (CRC) screening in Vulnerable Populations

Abstract Purpose: We partnered with a local Federally Qualified Health Center (FQHC) to test implementation of evidence-based interventions (EBI) promoting Fecal Immunochemical Test (FIT) CRC screening in an environment in which colonoscopy has been the prevailing screening strategy. We report on implementation adaptations and preliminary results. Background: Sociocultural and medical concerns are barriers to colonoscopy uptake in some populations. An additional barrier to CRC screening is system level capacity for colonoscopy that results in a back log of cases and long wait times. With Covid-19, the additional backlog in overdue CRC screening has underscored the need to expand FIT testing capacity to address screening needs and to pre-empt further racial/ethnic and SES disparities in CRC outcomes. This trial tests the unique and additive value of multiple EBIs for increasing CRC screening (primarily through FIT testing, but also colonoscopy when indicated) while evaluating the success of implementing these approaches. EBIs include the use of medical reminders, addressing the structural barriers (social determinants of health [SDOH]), and assistance from community health workers. Methods: Participants (3500), ages 45-75, were identified from a large FQHC in New Haven, CT and determined to be overdue for CRC screening. Participants were randomly assigned to one of the four arms of the study: 1) Provider reminder (overdue for CRC screening) only; 2) Provider Reminder + SDOH short message and one-size-fits all link to resources; 3) Provider Reminder + SDOH short message and offer for individualized navigation (trained navigators from local community) to address SDOH and other barriers; 4) Provider Reminder + offer to participate in a CRC educational program as phase 2 of the NCI's Screen to Save program (not an EBI). Preliminary data on uptake of CRC screening will be presented. Results: With input from stakeholders, we have: 1) lowered age eligibility from 50 to 45 to align with new guidelines; 2) expanded the target population to 2 additional satellite clinics, more than doubling the proposed study enrollment; 3) incorporated design changes in the patient reminders. The collaboration between research team and clinician stakeholders has been critical in minimizing disruptions to clinical workflow while assuring fidelity to the evidence-based interventions. Preliminary outcomes (within one month of intervention) on uptake of intervention across the 4 arms of the study, i.e., referral for CRC screening and test completion will be presented. Conclusion: The unique challenges of this urban community of primarily African American/Black, Hispanic/Latinx and/or low socioeconomic status individuals stem from the disproportionate burden of SDOH barriers. Findings will inform primary care setting implementation of EBIs to address the anticipated increase in disparities in CRC screening, exacerbated by COVID-19 changes in health care access and utilization, as well as the increased demand associated with the change in guidelines. Citation Format: Beth A. Jones, Sakinah C. Suttiratana, Sally A. DeGiovanni, Levita Y. Robinson, Michael J. Couturie, Denise Stevens, Monique K. Stefanou, Jose DeJesus, Eduardo Reyes, Jonathan Colon, Maryanne Cosgrove, Steven J. Parra. Implementing evidence-based interventions (EBI) to increase uptake of fecal immunochemical test (FIT) colorectal cancer (CRC) screening in Vulnerable Populations [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-025.

EP.WE.844Two-week bowel cancer referrals during the COVID pandemic

AimsThe aims were to assess the impact of the COVID-19 pandemic on the waiting times for patients referred via the two-week pathway for suspected colorectal cancer. We also examined the use of Faecal Immunochemical Test (FIT) alongside the presenting complaints in triaging/prioritising patients for further imaging and/or endoscopic investigations appropriately.MethodsA list of all patients referred via the two-week pathway to the West Suffolk Hospital for suspected colorectal cancers from 30/01/2020 to 19/07/2020 was compiled. The main four red flag symptoms were change in bowel habit (CIBH), anorectal bleeding, anaemia and weight loss. A subset of 235 patients were closely examined regarding their presenting complaints, FIT, imaging and endoscopy results with analysis of outcomes.Results127 male versus 108 female patients were included. 59.61% of patients who were eligible for the FIT test received one. Mean waiting time for FIT positive patients was 42.39 (95% CI) versus 61.10 (95% CI) for FIT negative patients. Patients with one or two red flags symptoms had a mean waiting time of 44.81 days (95% CI 35.79-53.82) and 47.91 days (95% CI 38.07-57.75) respectively. Patients with three red flag symptoms had a mean waiting time of 28.2 days (95% CI 17.94-38.39). There was a statistically significant difference in mean waiting time between patients having 1-2 symptoms and patients with three symptoms (p < 0.005).ConclusionsDespite delays during the COVID pandemic particularly for endoscopy, high risk and FIT positive patients were prioritised. Waiting times were still higher than advised national guidelines.

S182 Cost-Effectiveness of Outreach Strategies for Stool-Based Colorectal Cancer Screening in a Medicaid Population

Introduction: Outreach, including patient navigation, has been shown to increase the uptake of colorectal cancer (CRC) screening in underserved populations. This analysis evaluates the cost-effectiveness of triennial multi-target stool DNA (mt-sDNA), where each test includes centralized patient navigation support, versus outreach, with or without a mailed annual fecal immunochemical test (FIT), in a simulated Medicaid population. Methods: A microsimulation model was used to estimate the incremental cost-effectiveness ratio using quality-adjusted life years (QALY), direct costs and clinical outcomes in a cohort of Medicaid beneficiaries aged 50 – 64 over a lifetime time horizon. For annual FIT screening, we modeled two outreach scenarios: a mailed letter encouraging CRC screening completion along with instructions about how to obtain a FIT test (with no actual FIT test provided); and outreach via a mailed letter encouraging CRC screening completion along with a FIT test. The base case model explored scenarios of either 100% adherence or real-world reported adherence (51.3% for mt-sDNA, 21.1% for outreach with FIT and 12.3% for outreach without FIT) with or without real-world adherence for follow-up colonoscopy (66.7% for all). Costs and outcomes were discounted at 3.0%. Results: When 100% adherence is assumed for both the screening test and follow-up colonoscopy, outreach with or without FIT results in higher incidence reduction and higher mortality reduction compared to mt-sDNA (Table 1); mt-sDNA also cost more and was less effective compared to outreach with or without FIT at 100% adherence to both screening tests and follow-up colonoscopy (Figure 1). When real-world adherence rates were considered for screening strategies (with 100% adherence for follow-up colonoscopy), mt-sDNA resulted in the greatest reduction in incidence and mortality from CRC compared to outreach with or without FIT for incidence and mortality (Table 1); mt-sDNA was also cost-effective versus outreach with and without FIT ($32,150/QALY and $22,707/QALY, respectively) (Figure 1). mt-sDNA remained cost-effective versus FIT, with or without outreach, under real-world adherence rates for follow-up colonoscopy (Figure 1). Conclusion: Patient outreach/navigation interventions and associated real-world adherence rates to screening tests should be considered when evaluating the cost effectiveness of CRC screening strategies in underserved populations.Table 1.: Clinical and cost outcomes.Figure 1.: Incremental cost-effectiveness plane (A) mt-sDNA versus outreach + FIT (B) mt-sDNA versus outreach alone.

S307 The FIT Initiative: A VA Quality Improvement Initiative to Improve Colorectal Cancer Screening

Introduction: The fecal immunochemical test (FIT) is a validated test for colorectal cancer screening for average risk individuals over the age of 45 as per the latest guidelines from the United States Preventative Task Force1. Using antibody-hemoglobin complexes, the test identifies human hemoglobin in a stool sample with a sensitivity of 74% and specificity of 94%1,2. A positive FIT test requires a follow-up colonoscopy for the detection and removal of pre-cancerous lesions. During the fiscal year (FY) 2020, 62% of returned FIT kits at the Veterans Administration Hospital were sent back incorrectly. This inefficiency led to increased cost/wasted product, delay in cancer detection, and dissatisfaction for patients and providers alike. Furthermore, the COVID-19 pandemic urged social distancing measures, which increase FIT kit usage since in-person colonoscopies were deferred. Methods: The ambulatory quality improvement project sought out root causes for the incorrectly returned FITs and proposed PDSA cycles based on a series of approved action plans. The multidepartment team composed of individuals from lab, nursing, administrative staff, and primary care came together virtually and discovered 6 major root causes. The 80/20 rule was applied to our pareto chart of root concerns and a frequency vs risk chart was made to highlight our major problems. Our assessment showed that lack of written collection date was the biggest issue and thus a PICK chart was assembled to prioritize our future solutions. Our multi-pronged PDSA (Plan, Do, Study, Act) cycle attempted to set up redundant patient reminders, centralize the FIT dispersal process and make the patient-FIT interface more user-friendly. All our PDSA solutions were implemented over the course of 4 months. Results: Preliminary data has shown that the average percentage of incorrectly returned FITs due to lack of written collection date has decreased by 38.56% as of May 2021. Conclusion: As with any quality improvement process, an overhaul in process can bring up new issues. Due to frequent assessments through this project, we were able to troubleshoot a number of human factor engineering issues that arose between staff and FIT kits. Our aim is to continue these efforts throughout FY 2021 and attempt to improve our FIT screening capability at the VA.

S250 Increasing Fecal Immunochemical Test Return Rates by Patient Reminders: A Quality Improvement Study

Introduction: The incidence of colorectal cancer (CRC) in the United States is increasing, and it remains the second leading cause of cancer death in the United States for men and women combined. The American Cancer Society now recommends that adults aged 45 years and older with an average risk of CRC undergo regular screening with either a high sensitivity stool-based test or structural (visual) examination, depending on patient preference and test availability. The primary objective of this quality improvement project was to determine if reminder methods, such as telephone or letter reminders, increased the return rate of fecal immunochemical tests (FIT) for colorectal cancer screening. Methods: At public outreach events and daily clinics in the West Texas Panhandle area, participants in the GET FIT program were provided with FIT kits after completing the education on colorectal cancer. Participants who fit the inclusion criteria and had received a FIT kit from the program were included. They were instructed on how to perform the test and mail it back. Participants that did not return the completed kits within two weeks were reminded either by 1) through a reminder letter or 2) by telephone every 2 weeks (+/- 3 days) for 60 days or 5 attempts to contact. We de-identified and analyzed the FIT kit return data from June-November 2019 before instituting these reminder methods. We then calculated the change in return rates from December 2019 to February 2020. Our goal was to increase the FIT return rates by 25% over the baseline return rate. Results: The pre-intervention return rate of kits for June-November 2019 was 67.58%, and the postintervention return rate for December 2019-February 2020 was 81.87%. This rate was equal to an approximately 21% increase in return rates. The average return rate of FIT kits overall was 72.34%. The average rate of returned new patient kits was 69%, and the average % of new patient return kits was 68.51%. We also noticed a significant increase in return of FIT tests after a community cancer screening in October 2019. Conclusion: Fecal immunohistochemical test (FIT) remains one of the primary options for colorectal cancer screening. Due to its lower cost and noninvasiveness, FIT was offered to patients at average risk.We did achieve a significant increase in return rates, although we did not meet our target goal for this project. Our project was limited to studying 3 months post-intervention due to the COVID pandemic and barrier in returning tests. (Table Presented).

Improving Adenoma Detection Rates: The Role of the Fecal Immunochemical Test.

BackgroundThere is limited knowledge about adenoma detection rates (ADRs) in patients with a positive fecal immunochemical test (FIT). We hypothesized that colonoscopy performed after FIT would result in higher ADRs.MethodsWe reviewed ADRs for colonoscopies performed after a positive FIT test and compared them to ADR rates for routine colonoscopy performed without an initial FIT test between November 2014 and March 2017 at multiple endoscopy sites.ResultsA total of 979 patients underwent a FIT testing in the Texas panhandle, of whom 12.1% (n=119) tested positive. Also, 32.8% (n=39) were found to have one or more tubular adenomatous polyps on final pathological examination. Among these patients, the majority were female (64.1%; n=25). Of the patients, 15.9% (n=19) had a hyperplastic polyp, 1.7% (n=2) had findings consistent with ulcerative colitis, and 0.8% (n=1) were positive for an adenocarcinoma. In the control group of 2,603 patients in whom routine colonoscopy was performed as the initial tool for screening, 719 were found to have one or more tubular adenomas, with an ADR rate of 27.5%. In this group, the cancer rate was found to be 1%.ConclusionsThere was a significant increase in the ADR when colonoscopy is conducted after a positive FIT test. Recommending colonoscopies after a positive FIT test will not only improve ADRs significantly but also lower the overall healthcare cost for screening colon cancer in this era of escalating healthcare costs.