Fecal Immunochemical Test Results Research Articles

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

The 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. To 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. Individuals enrolled in an Australian surveillance program were included. Diagnostic accuracy was determined for 614 individuals completing a two-sample FIT (OC-Sensor) ≤ 3months 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 (≥ 20µg hemoglobin/g feces) triggered an early colonoscopy. Associations between interval FIT results and advanced neoplasia were determined using regression analysis. FIT 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 1-2years. 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 20months, respectively. Interval 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.

Real-world data evaluating Guy’s rapid diagnostic clinic as an alternate pathway for patients with FIT levels below 10

ObjectiveTo analyse the effectiveness of rapid diagnostic clinics (RDCs) as an alternative pathway for patients with concerning symptoms and a faecal immunochemical test (FIT) result <10. Our primary endpoint was...

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 (CRC) 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 three years and compared risks between those with a positive versus those with a negative FIT. Data of Dutch CRC 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 three 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 three 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 FIT-positives versus FIT-negatives. 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<0.001). FIT-positives were older and more frequently male than FIT-negatives (p<0.001). Significantly more cancers proximal to the colon were detected among FIT-positives (p<0.001; hazard ratio 1.55, 95% CI: 1.44 to 1.67). FIT-positive screenees were at significantly increased risk of being diagnosed with a cancer proximal to the colon within three years after FIT, though the three-year cumulative incidence was still less than one percent.

The effect of antiplatelet therapy and oral anticoagulants on the accuracy of faecal immunochemical testing.

Faecal immunochemical testing (FIT) has been adopted to identify patients requiring further investigations on the colorectal cancer (CRC) referral pathway. We aimed to investigate the effect of antiplatelet and anticoagulant drugs on the accuracy of FIT results. This observational study categorised patients with suspected CRC symptoms, who completed both FIT and colonic investigations, into two groups (control and exposed) based on their use of antiplatelet and anticoagulant drugs. Two-by-two tables and receiver operating characteristic (ROC) curve analysis were used to determine accuracy. A total of 928 patients were divided into a control (n=683) and an exposed group (n=245). A nonsignificant higher proportion of patients tested positive in the exposed group (24.1% vs 18.4%, p=0.063). For detection of CRC, improved sensitivity of 87% vs 81.2%, specificity of 84.8% vs 79.9% and negative predictive value of 99.2% vs 98.3% was calculated in the control vs exposed groups, respectively. The positive predictive value was comparable between the two groups (21.4% vs 22% in the control and exposed groups, respectively). In ROC analysis, there was no difference between the groups (AUC 90% vs 87%, p=0.56). The use of antiplatelet and anticoagulant drugs did not increase the risk of positive FIT results on multivariate logistic regression analysis. FIT accuracy for CRC detection remained unaffected despite more patients testing positive in the exposed group. FIT should be considered a supplementary tool for triage. Antiplatelet and anticoagulant drugs do not need to be discontinued before collection of FIT.

Methods for scaling up an outreach intervention to increase colorectal cancer screening rates in rural areas

BackgroundMailed fecal immunochemical test (FIT) outreach and patient navigation are evidence-based practices shown to improve rates of colorectal cancer (CRC) and follow-up in various settings, yet these programs have not been broadly adopted by health systems and organizations that serve diverse populations. Reasons for low adoption rates are multifactorial, and little research explores approaches for scaling up a complex, multi-level CRC screening outreach intervention to advance equity in rural settings.MethodsSMARTER CRC, a National Cancer Institute Cancer Moonshot project, is a cluster-randomized controlled trial of a mailed FIT and patient navigation program involving 3 Medicaid health plans and 28 rural primary care practices in Oregon and Idaho followed by a national scale-up trial. The SMARTER CRC intervention combines mailed FIT outreach supported by clinics, health plans, and vendors and patient navigation for colonoscopy following an abnormal FIT result. We applied the framework from Perez and colleagues to identify the intervention’s components (including functions and forms) and scale-up dissemination strategies and worked with a national advisory board to support scale-up to additional organizations. The team is recruiting health plans, primary care clinics, and regional and national organizations in the USA that serve a rural population. To teach organizations about the intervention, activities include Extension for Community Healthcare Outcomes (ECHO) tele-mentoring learning collaboratives, a facilitation guide and other materials, a patient navigation workshop, webinars, and individualized technical assistance. Our primary outcome is program adoption (by component), measured 6 months after participation in an ECHO learning collaborative. We also assess engagement and adaptations (implemented and desired) to learn how the multicomponent intervention might be modified to best support broad scale-up.DiscussionFindings may inform approaches for adapting and scaling evidence-based approaches to promote CRC screening participation in underserved populations and settings.Trial registrationRegistered at ClinicalTrials.gov (NCT04890054) and at the NCI’s Clinical Trials Reporting Program (CTRP no.: NCI-2021–01032) on May 11, 2021.

Implementing an Organized Colorectal Cancer Screening Program: Lessons Learned From an Academic–Community Practice

IntroductionThe effectiveness of mailed fecal immunochemical test (FIT) outreach might be enhanced through an organized colorectal cancer (CRC) screening program, yet published real-world experiences are limited. We synthesized the process of implementing a CRC screening program which used mailed FIT outreach in a large integrated academic-community practice. Materials and MethodsData from a pilot mailed FIT program were shared with healthcare system leadership which inspired the creation of a cross-institutional organized CRC Screening Program. In partnership with a centralized Population Health Team and Primary Care, we defined: 1) the institutional approach to CRC screening, 2) the target population and method for screening, 3) the team responsible for implementation, 4) the healthcare team responsible for decisions and care, 5) a quality assurance structure, and 6) a method for identifying cancer occurrence. ResultsThe Fred Hutch/UW Medicine Population Health CRC Screening Program began in September 2021. The workflow for mailed FIT outreach included a mailed postcard, a MyChart message from the patient's primary care provider (PCP), a FIT kit with a letter signed by the PCP and program director, and up to three bi-weekly reminders. Patients without a colonoscopy 3 months after an abnormal FIT result received navigation through the program. In the first program year, we identified 9,719 patients eligible for outreach and in an intention to treat analysis, 32% of patients completed CRC screening by FIT or colonoscopy. ConclusionsReal-world experiences detailing how to implement organized CRC screening programs might increase adoption. In our experience, broadly disseminating pilot data, early institutional support, robust data management and strong cross-departmental relationships were critical to successfully implementing a CRC screening program that benefits all patients.

Increasing bowel cancer screening using SMS in general practice: the SMARTscreen cluster randomised trial.

Australia has one of the highest incidences of colorectal cancer (CRC) worldwide. The Australian National Bowel Cancer Screening Program (NBCSP) is a best-practice, organised screening programme, but uptake is low (40.9%) and increasing participation could reduce morbidity and mortality associated with CRC. Endorsement by GPs is strongly associated with increasing screening uptake. This study (SMARTscreen) aimed to test whether a multi-intervention short message service (SMS) sent by general practices to 50-60-year-old patients who were due to receive the NBCSP kit would increase NBCSP uptake, by comparing it with usual care. A stratified cluster randomised controlled trial was undertaken, involving 21 Australian general practices in Western Victoria, Australia. For intervention practices, people due to receive the NBCSP kit within a 6-month study period were sent an SMS just before receiving the kit. The SMS included a personalised message from the person's general practice endorsing the kit, a motivational narrative video, an instructional video, and a link to more information. Control practices continued with usual care, comprising at-home testing with a faecal immunochemical test (FIT) through the NBCSP. The primary outcome was the between-arm percentage difference in uptake of FIT screening within 12 months from randomisation, which was estimated using generalised linear model regression. In total, 39.2% (1143/2914) of people in 11 intervention practices and 23.0% (583/2537) of people in 10 control practices had a FIT result in their electronic health records - a difference of 16.5% (95% confidence interval = 2.02 to 30.9). The SMS intervention increased NBCSP kit return in 50-60-year-old patients in general practice. This finding informed a larger trial - SMARTERscreen - to test this intervention in a broader Australian population.

Colonoscopic cancer detection rate: a new performance measure – is it FIT for purpose?

IntroductionGastrointestinal symptoms correlate poorly with cancer diagnosis. A faecal immunochemical test (FIT) result of ≥10 µg has high sensitivity and negative predictive value for colorectal cancer (CRC) detection. An FIT-based...

Interval colorectal cancers after negative faecal immunochemical test in the New Zealand Bowel Screening Pilot

ObjectiveEvaluate the diagnostic performance of faecal immunochemical test (FIT), identify risk factors for FIT-interval colorectal cancers (FIT-IC) and describe long-term outcomes of participants with colorectal cancers (CRC) in the New...

Associations between patient factors and successful colon capsule endoscopy - A prospective cohort study.

To establish patient factors associated with a successful colon capsule endoscopy (CCE) test. This prospective cohort study used data collected from patients who underwent CCE as part of the ScotCap evaluation prior to April 2020. A CCE was defined as successful if the capsule visualized the whole colon and rectum (complete test) with sufficient bowel cleansing to permit assessment of the colonic mucosa (adequate bowel preparation). Factors from patients in symptomatic and surveillance groups were analysed for associations with a successful test, complete test, adequate bowel preparation and requirement for further procedure using univariate, multivariate logistic, least absolute shrinkage and selection operator regression. Data from 263 symptomatic and 137 surveillance patients were analysed. There was an association between a symptomatic patient's age and a successful test (OR = 0.97, 95% CI: 0.95-0.99), adequate bowel preparation (OR = 0.97, 95% CI: 0.94-1.00) and further procedure requirement (OR = 1.04, 95% CI: 1.02-1.06). An association was found, for symptomatic patients, between a faecal immunochemical test result in the range 10-399 μg/g and a further procedure (OR = 2.32, 95% CI: 1.23-4.48). In patients undergoing surveillance for previous colorectal cancer (OR = 0.42, 95% CI: 0.18-0.97), had previous bowel resection surgery (OR = 0.43, 95% CI: 0.19-0.98) or took a beta blocker medication (OR = 0.32, 95% CI: 0.11-0.88), an association was found with further procedure requirement. Among symptomatic patients, younger age was associated with obtaining a successful CCE test. Clinicians could consider patient selection based on these results to improve the rate of successful testing in clinical practice.

S388 Patient Navigation Increases Follow-Up After Abnormal Fecal Immunochemical Test Results but Reveals Persistent Barriers to Colonoscopy

S388 Patient Navigation Increases Follow-Up After Abnormal Fecal Immunochemical Test Results but Reveals Persistent Barriers to Colonoscopy

Performance of OC-Auto Micro 80 Fecal Immunochemical Test in an Integrated Academic-Community Health System.

We aimed to determine the performance of the OC-Auto Micro 80 fecal immunochemical test (FIT) in an average-risk population receiving care in an integrated, academic-community health system. The FIT is the most used colorectal cancer (CRC) screening test worldwide. However, many Food and Drug Administration-cleared FIT products have not been evaluated in clinical settings. We performed a retrospective cohort study of patients (50 to 75y old) in the University of Washington Medicine health care system who were screened for CRC by OC-Auto Micro 80 FIT between March 2016 and September 2021. We used electronic health records to extract patient-level and clinic-level factors, FIT use, colonoscopy, and pathology findings. The primary outcomes were the FIT positivity rate and neoplasms detected at colonoscopy. Secondary outcomes were FIT positivity by sex and safety-net versus non-safety-net clinical settings. We identified 39,984 FITs completed by 26,384 patients; 2411 (6.0%) had a positive FIT result (>100 ng/mL of hemoglobin in buffer), and 1246 (51.7%) completed a follow-up colonoscopy. The FIT positive rate was 7.0% in men and 5.2% in women (P <0.01). Among those who completed a colonoscopy after an abnormal FIT result, the positive predictive value for CRC, advanced adenoma, and advanced neoplasia was 3.0%, 20.9%, and 23.9%, respectively. In a retrospective analysis of a large heterogeneous population, the OC-Auto Micro 80 FIT for CRC screening demonstrated a positivity rate of 6.0% and a positive predictive value for CRC of 3.0%.

Applying the healthcare failure mode and effects analysis approach to improve the quality of an organised colorectal cancer screening programme.

The first level of a colorectal cancer (CRC) screening process was systematically analysed using the Healthcare Failure Mode and Effects Analysis (HFMEA) approach by a multidisciplinary team aiming to improve the programme quality. The study was conducted at the Local Health Authority of Bologna, Northern Italy. Seven brainstorming sessions were conducted and all the activities performed were recorded on a FMEA worksheet consisting of individual records reporting the specific phases of the analysed process along with associated activities, possible failure modes, their causes and effects, the obtained risk priority numbers (RPNs) and the control measures to plan. Twenty-three failure modes, 14 effects and 12 possible causes were identified. Nine failure modes were prioritised according to the RPN obtained; most resulted in possible false-negative faecal immunochemical test (FIT) results (66.7%), followed by sample loss (22.2%) and not reaching the entire target population (11.1%). This leads to 66.7% of corrective/preventive actions being applied to the phase of returning the stool sample by the citizen. For this phase reorganisation, the local pharmacies were involved not only as FIT kit delivery points but also as specimen collection and sending points to the laboratory. These organisational changes allowed the introduction of complete traceability of kits and specimens flow, as well as temperature control. A re-evaluation of the prioritised failure modes 6 months after launching the implemented screening process showed that HFMEA application decreased the risk of potential errors by 75.9%. HFMEA application in CRC screening programme is a useful tool to reduce potential errors.

Combined serum albumin, fecal immunochemical test, and leucine-rich alpha-2 glycoprotein levels for predicting prognosis in remitting patients with ulcerative colitis

This study investigated the usefulness of serum leucine-rich alpha-2 glycoprotein (LRG) and fecal immunochemical tests (FIT) for predicting relapse in patients with ulcerative colitis (UC). Data of 194 patients tested for LRG between January 2020 and June 2022 were retrospectively collected and clinical characteristics were recorded. LRG was strongly correlated with CRP levels and it had a moderately negative correlation with albumin levels, whereas FIT was not significantly correlated with either CRP or albumin levels. Furthermore, the median serum albumin and FIT were significantly different between patients with or without clinical relapse; while the LRG level was not associated with clinical relapse. Although LRG is not an independent factor for predicting clinical relapse, the cumulative remission rate was significantly higher in patients with higher albumin than in those with lower albumin. Furthermore, the combination of FIT and albumin was useful for predicting for relapse, patients with higher FIT and lower albumin tended to have higher relapse rates than those with both lower FIT and albumin and those with lower FIT and higher albumin. Our study indicated that serum albumin level is useful for predicting relapse, even in remitting outpatients. Although LRG is not an independent factor for predicting clinical relapse, it is useful for identifying patients that are likely to relapse when combined serum albumin or FIT results.

Nonadherence to Referral Colonoscopy After Positive Fecal Immunochemical Test Results Increases the Risk of Distal Colorectal Cancer Mortality

Nonadherence to Referral Colonoscopy After Positive Fecal Immunochemical Test Results Increases the Risk of Distal Colorectal Cancer Mortality

The accuracy of the FIT in detecting advanced neoplasm is highest in young people aged 40 to 49 years: an analysis based on sex and age

BackgroundColorectal cancer (CRC) is one of the most common cancers and is associated with high incidence and mortality rates worldwide. CRC has caused a tremendous loss of human health and wealth. The incidence and mortality of colorectal carcinoma are increasing in young adults. Early cancer detection and prevention are made possible through screening. At present, the faecal immunochemical test (FIT) is a noninvasive method that can be used for the large-scale clinical screening of CRC status. Therefore, this study, based on CRC screening results in Tianjin from 2012 to 2020, was conducted to analyse the major differences in diagnostic performance parameters according to sex and age.MethodsThis study was based on 39,991 colonoscopies performed for individuals in the Tianjin CRC screening program from 2012 to 2020. Of these individuals, they had complete FIT and colonoscopy results. The differences in FIT results were analysed by sex and age.ResultsAccording to this study, males were generally more likely to develop advanced neoplasms (ANs) than females, and the prevalence increased with age. Males with negative FIT results were more likely to have advanced neoplasms than females with positive results. The accuracy of the FIT in detecting ANs in each age group was 54.9%, 45.5%, 48.6% and 49.5% in the 40–49, 50–59, 60–69, and ≥ 70 age groups, respectively.ConclusionsThe FIT detected ANs with highest accuracy in the 40–49 age group. Our research can provide guidance to formulate CRC screening strategies.

Mental disorders, participation, and trajectories in the Danish colorectal cancer screening programme: a population-based cohort study

People with mental disorders exhibit increased mortality due to colorectal cancer, despite having a similar incidence to the general population. We aimed to evaluate the extent to which people with mental disorders participate in organised colorectal cancer screening. We conducted a population-based cohort study of all Danish residents aged 50-74 years who were invited to undergo biennial faecal immunochemical testing between March 1, 2014, and Sept 30, 2018. We used national registry data from all first-time invitees. The primary endpoint was participation within 90 days of invitation. We calculated the proportion who participated and assessed their screening results and adherence to and completeness of follow-up colonoscopy according to their history of mental disorders, classified as none, mild or moderate, or severe. We computed crude and adjusted participation differences in percentage points and participation ratios using the pseudo-observations method. Of 2 036 704 people who were invited, we included 2 036 352 in the final cohort, of whom 1 008 045 (49·5%) were men and 1 028 307 (50·5%) were women, with a mean age of 60·7 years (SD 8·3, range 49-78). Data on ethnicity were not collected. Compared with people with no mental disorders, the adjusted analysis showed lower participation among people with mild or moderate mental disorders (men: participation difference -4·4 percentage points [95% CI -4·7 to -4·1]; women: -3·8 percentage points [-4·1 to -3·6]) and severe mental disorders (men: participation difference -13·8 percentage points [-14·3 to -13·3]; women: -15·4 percentage points [-15·8 to -14·9]). People with mental disorders had a higher proportion of positive faecal immunochemical test results, lower adherence to colonoscopy, and more incomplete colonoscopies than people without mental disorders. People with mental disorders were less likely to participate in colorectal cancer screening than those without these disorders. Patients with mental disorders could benefit from support or encouragement from their general practitioner or mental health-care facility to participate in cancer screening. Potential interventions should consider type of mental disorder, as needs might differ. Danish Cancer Society, Danish Health Foundation.

Can we do better? A qualitative study in the East of England investigating patient experience and acceptability of using the faecal immunochemical test in primary care

ObjectivesThe faecal immunochemical test (FIT) is increasingly used in UK primary care to triage patients presenting with symptoms and at different levels of colorectal cancer risk. Evidence is scarce on...

Performance of the Fecal Immunochemical Test in Detecting Advanced Colorectal Neoplasms and Colorectal Cancers in People Aged 40-49 Years: A Systematic Review and Meta-Analysis.

The incidence of early-onset colorectal cancer (CRC) is increasing. Many guidelines recommend initiating screening at 45 years. This study investigated the detection rate of advanced colorectal neoplasm (ACRN) by using fecal immunochemical tests (FITs) in individuals aged 40-49 years. PubMed, Embase, and Cochrane Library databases were searched from inception to May 2022. The primary outcomes were the detection rates and positive predictive values of FITs for ACRN and CRC in people aged 40-49 (younger age group) and ≥50 years (average risk group). Ten studies with 664,159 FITs were included. The FIT positivity rate was 4.9% and 7.3% for the younger age and average risk groups, respectively. Younger individuals with positive FIT results had significantly higher risks of ACRN (odds ratio [OR] 2.58, 95% confidence interval [CI] 1.79-3.73) or CRC (OR 2.86, 95% CI 1.59-5.13) than did individuals in the average-risk group, regardless of FIT results. Individuals aged 45-49 years with positive FIT results had a similar risk of ACRN (OR 0.80, 95% CI 0.49-1.29) to that of people aged 50-59 years with positive FIT results, although significant heterogeneity was observed. The positive predictive values of the FIT were 10-28.1% for ACRN and 2.7-6.8% for CRC in the younger age group. The detection rate of ACRN and CRC based on FITs in individuals aged 40-49 years is acceptable, and the yield of ACRN might be similar between individuals aged 45-49 and 50-59 years. Further prospective cohort and cost-effective analysis are warranted.

O136 An observational cohort study of replicate faecal immunochemical tests in symptomatic two-week wait patients

Abstract Introduction Triage of patients with suspected colorectal cancer (CRC) utilises a single faecal immunochemical test (FIT) at a defined threshold. Limited evidence exists regarding whether replicate FIT improves the positive and negative predictive value in symptomatic patients. This study examines two-week wait (TWW) patients undergoing replicate FIT. Primary aim is to assess two FITs and CRC/serious bowel disease. Secondary aims are to determine correlation and utility of replicate FIT. Methods TWW patients carried out one additional FIT during COVID-19 pandemic. FIT 1 and FIT 2 (the replicate sample) were analysed in relation to symptoms, diagnoses, investigations, future colonoscopy and missed CRC. Study period was 01/03/2020-31/07/2020. Three subgroups were compared; double positive (&amp;gt;10μg Hb/g faeces), double negative, and discordant FIT (one positive). Results 111 patients had replicate FIT (50 male, 61 female). 43 (38.7%) patients had double negative, 32 (28.8%) double positive and 36 (32.4%) had discordant FITs. Median time between FITs was 14 days (IQR=11 to 19). 83% of double positive patients underwent colonoscopy/virtual colonoscopy (61% in double negative patients). Six CRC and one high-risk polyp were in double positive patients (none in other groups). One discordant patient was not investigated and a CRC missed. Conclusion Replicate FIT as a triage strategy appears most effective where both FITs are negative. CRC risk is low when FIT results are discordant. Double negative FITs are reassuring given benign associated diagnoses, or for patients where endoscopic investigation is high-risk. Larger studies are required to evaluate discordant FITs, enabling refinement of urgent investigation pathways.