Fecal Immunochemical Test Research Articles

Efficient organized colorectal cancer screening in Shenzhen: a microsimulation modelling study

BackgroundColorectal cancer (CRC) is a global health issue with noticeably high incidence and mortality. Microsimulation models offer a time-efficient method to dynamically analyze multiple screening strategies. The study aimed to identify the efficient organized CRC screening strategies for Shenzhen City.MethodsA microsimulation model named CMOST was employed to simulate CRC screening among 1 million people without migration in Shenzhen, with two CRC developing pathways and real-world participation rates. Initial screening included the National Colorectal Polyp Care score (NCPCS), fecal immunochemical test (FIT), and risk-stratification model (RS model), followed by diagnostic colonoscopy for positive results. Several start-ages (40, 45, 50 years), stop-ages (70, 75, 80 years), and screening intervals (annual, biennial, triennial) were assessed for each strategy. The efficiency of CRC screening was assessed by number of colonoscopies versus life-years gained (LYG).ResultsThe screening strategies reduced CRC lifetime incidence by 14–27 cases (30.9–59.0%) and mortality by 7–12 deaths (41.5–71.3%), yielded 83–155 LYG, while requiring 920 to 5901 colonoscopies per 1000 individuals. Out of 81 screening, 23 strategies were estimated efficient. Most of the efficient screening strategies started at age 40 (17 out of 23 strategies) and stopped at age 70 (13 out of 23 strategies). Predominant screening intervals identified were annual for NCPCS, biennial for FIT, and triennial for RS models. The incremental colonoscopies to LYG ratios of efficient screening increased with shorter intervals within the same test category. Compared with no screening, when screening at the same start-to-stop age and interval, the additional colonoscopies per LYG increased progressively for FIT, NCPCS and RS model.ConclusionThis study identifies efficient CRC screening strategies for the average-risk population in Shenzhen. Most efficient screening strategies indeed start at age 40, but the optimal starting age depends on the chosen willingness-to-pay threshold. Within insufficient colonoscopy resources, efficient FIT and NCPCS screening strategies might be CRC initial screening strategies. We acknowledged the age-dependency bias of the results with NCPCS and RS.

Detection of Upper Gastrointestinal Disorders in Patients with Positive Fecal Immunochemical Test (FIT) and Normal Colonoscopy: A Cross-Sectional Study

Abstract Introduction Colorectal cancer (CRC) is the second most prevalent cancer in the world, and the fecal immunochemical test (FIT) can be mentioned among the CRC screening methods based on the detection of occult blood in the feces, which may indicate upper gastrointestinal (UGI) malignancies; therefore, patients with a positive FIT but normal colonoscopy may be considered for a UGI endoscopy. Materials and Methods The present study was conducted on patients with a positive FIT who were submitted to colonoscopy with normal results. They subsequently underwent endoscopy for the detection of UGI disorders. Results We included 121 patients (64.5% of women and 35.5% of men; average age: 58.85 ± 12.93 years), 72.7% of whom were positive for Helicobacter pylori. The predominant result of the UGI endoscopy was normal, followed by erythema of the gastric mucosa, and anemia and dyspepsia were the most common clinical findings. The most common pathological result was chronic gastritis, followed by acute gastritis. Only one patient presented stomach cancer (adenocarcinoma). Conclusion Considering the small prevalence of cancer in the UGI endoscopies of patients with positive FIT and normal colonoscopy, to the performance of UGI endoscopy in these patients may not be necessary.

Engaging with Rural Communities for Colorectal Cancer Screening Outreach Using Modified Boot Camp Translation

Abstract: Background: Colorectal cancer (CRC) incidence and mortality are disproportionately high among rural residents and Medicaid enrollees. Objectives: To address disparities, we used a modified community engagement approach, Boot Camp Translation (BCT). Research partners, an advisory board, and the rural community informed messaging about CRC outreach and a mailed fecal immunochemical test program. Methods: Eligible rural patients (English-speaking and ages 50–74) and clinic staff involved in patient outreach participated in a BCT conducted virtually over two months. We applied qualitative analysis to BCT transcripts and field notes. Results: Key themes included: the importance of directly communicating about the seriousness of cancer, leveraging close clinic-patient relationships, and communicating the test safety, ease, and low cost. Conclusions: Using a modified version of BCT delivered in a virtual format, we were able to successfully capture community input to adapt a CRC outreach program for use in rural settings. Program materials will be tested during a pragmatic trial to address rural CRC screening disparities.

Do risk scores improve use of faecal immunochemical testing for haemoglobin in symptomatic patients in primary care?

Faecal immunochemical testing (FIT) is used in the detection of colorectal cancer (CRC). FIT is invariably used at a single faecal haemoglobin (f-Hb) concentration threshold. The aim of this observational study was to explore risk scoring models (RSMs) with f-Hb and other risk factors for CRC in symptomatic patients attending primary care, potentially speeding diagnosis and saving endoscopy resources. Records of patients completing FIT were linked with The Scottish Cancer Registry and with other databases with symptoms, full blood count and demographic variables, and randomized into derivation and validation cohorts. Stepwise multivariable logistic regression created RSMs assessed in the validation cohort. Of 18 805 unique patients, 9374 and 9431 were in the derivation and validation cohorts, respectively: f-Hb, male sex, increasing age, iron deficiency anaemia and raised systemic immune inflammation index created the final RSM. A risk score threshold of ≥2.363, generating the same number of colonoscopies as a f-Hb threshold of ≥10 μg Hb/g gave improved sensitivity for CRC in both cohorts. A RSM which excluded f-Hb was used to investigate the effect of raising the f-Hb threshold from ≥10 to ≥20 μg Hb/g in those with a low risk score. This approach would have generated 234 fewer colonoscopies but missed four CRCs. The RSM conferred no significant benefit to patients with very low f-Hb and CRC. Alternative strategies combining FIT with other variables may be more appropriate for safety-netting of symptomatic patients. Further work to develop and investigate the value of RSM for significant bowel disease other than CRC may also be beneficial.

Performance of the Asia-Pacific Colorectal Screening score in stratifying the risk of advanced colorectal neoplasia: A meta-analysis and systematic review.

This study systematically reviewed and meta-analyzed the performance of the Asia-Pacific Colorectal Screening (APCS) score and its incorporation with the fecal immunochemical test (FIT) in stratifying the risk of advanced colorectal neoplasia (ACN). We systematically searched for relevant articles in 12 electronic databases and registers on October 20, 2021, and updated the search to September 1, 2023. Random-effect models were used to obtain the pooled performance statistics of the APCS score for ACN risk. From the 101 records screened, 13 eligible studies in the Asia-Pacific region involving 69762 subjects who had undergone colonoscopy were enrolled. The pooled prevalences of ACN in the average-risk (AR) tier (APCS 0-1), moderate-risk (MR) tier (APCS 2-3), and high-risk (HR) tier (APCS≥4) groups were 0.9%, 3.1%, and 8.1%, respectively. Compared with the combined AR-MR group, the HR group was significantly associated with a higher ACN risk (pooled diagnostic odds ratio: 2.84, 95% confidence interval [CI]: 2.35-3.45, P<0.001). The APCS score showed a sensitivity of 0.42 (95% CI: 0.40-0.44) and a specificity of 0.86 (95% CI: 0.85-0.86) for predicting the ACN risk, with a weighted area under the curve of 0.642 (95% CI: 0.610-0.657). The combination of the APCS score and FIT substantially improved ACN risk identification, demonstrating pooled diagnostic odds ratios of 4.02 (95% CI: 2.50-6.49) in the AR-MR groups and 5.44 (95% CI: 1.89-15.63) in the MR-HR groups. The APCS score could effectively stratify the ACN risk in the Asia-Pacific population. Incorporating FIT further improves its performance in identifying high-risk subjects who should be prioritized for colonoscopy screenings.

Exploring the gut DNA virome in fecal immunochemical test stool samples reveals associations with lifestyle in a large population-based study

Stool samples for fecal immunochemical tests (FIT) are collected in large numbers worldwide as part of colorectal cancer screening programs. Employing FIT samples from 1034 CRCbiome participants, recruited from a Norwegian colorectal cancer screening study, we identify, annotate and characterize more than 18000 DNA viruses, using shotgun metagenome sequencing. Only six percent of them are assigned to a known taxonomic family, with Microviridae being the most prevalent viral family. Linking individual profiles to comprehensive lifestyle and demographic data shows 17/25 of the variables to be associated with the gut virome. Physical activity, smoking, and dietary fiber consumption exhibit strong and consistent associations with both diversity and relative abundance of individual viruses, as well as with enrichment for auxiliary metabolic genes. We demonstrate the suitability of FIT samples for virome analysis, opening an opportunity for large-scale studies of this enigmatic part of the gut microbiome. The diverse viral populations and their connections to the individual lifestyle uncovered herein paves the way for further exploration of the role of the gut virome in health and disease.

Prevalence of Sessile Serrated Lesions in Individuals With Positive Fecal Immunochemical Test Undergoing Colonoscopy: Results From a Large Nationwide Veterans Affairs Database

Prevalence of Sessile Serrated Lesions in Individuals With Positive Fecal Immunochemical Test Undergoing Colonoscopy: Results From a Large Nationwide Veterans Affairs Database

Would initiating colorectal cancer screening from age of 45 be cost-effective in Germany? An individual-level simulation analysis.

Colorectal cancer (CRC) screening has been shown to be effective and cost-saving. However, the trend of rising incidence of early-onset CRC challenges the current national screening program solely for people ≥50 years in Germany, where extending the screening to those 45-49 years might be justified. This study aims to evaluate the cost-effectiveness of CRC screening strategies starting at 45 years in Germany. DECAS, an individual-level simulation model accounting for both adenoma and serrated pathways of CRC development and validated with German CRC epidemiology and screening effects, was used for the cost-effectiveness analysis. Four CRC screening strategies starting at age 45, including 10-yearly colonoscopy (COL), annual/biennial fecal immunochemical test (FIT), or the combination of the two, were compared with the current screening offer starting at age 50 years in Germany. Three adherence scenarios were considered: perfect adherence, current adherence, and high screening adherence. For each strategy, a cohort of 100,000 individuals with average CRC risk was simulated from age 20 until 90 or death. Outcomes included CRC cases averted, prevented death, quality-adjusted life-years gained (QALYG), and total incremental costs considering both CRC treatment and screening costs. A 3% discount rate was applied and costs were in 2023 Euro. Initiating 10-yearly colonoscopy-only or combined FIT + COL strategies at age 45 resulted in incremental gains of 7-28 QALYs with incremental costs of €28,360-€71,759 per 1,000 individuals, compared to the current strategy. The ICER varied from €1,029 to €9,763 per QALYG, and the additional number needed for colonoscopy ranged from 129 to 885 per 1,000 individuals. Among the alternatives, a three times colonoscopy strategy starting at 45 years of age proves to be the most effective, while the FIT-only strategy was dominated by the currently implemented strategy. The findings remained consistent across probabilistic sensitivity analyses. The cost-effectiveness findings support initiating CRC screening at age 45 with either colonoscopy alone or combined with FIT, demonstrating substantial gains in quality-adjusted life-years with a modest increase in costs. Our findings emphasize the importance of implementing CRC screening 5 years earlier than the current practice to achieve more significant health and economic benefits.

Effect of an E-learning resource on endoscopists' proximal serrated polyp detection rate: a randomized controlled trial.

Recent studies demonstrated that a higher proximal serrated polyp detection rate (PSPDR) among endoscopists is associated with a lower risk of post-colonoscopy colorectal cancer (PCCRC) incidence and death for their patients. Our objective was to evaluate the effect of an e-learning resource on PSPDR. We performed a multicenter randomized controlled trial within the Dutch fecal immunochemical test-based colorectal cancer screening program. Endoscopists were randomized using block randomization per center to either receive a 60-minute e-learning resource on serrated polyp detection or not. PSPDR was calculated based on all colonoscopies performed during a 27-month pre-intervention and a 17-month post-intervention period. The primary end point was difference in PSPDR between intervention and control arms (intention to treat) using mixed effect logistic regression modeling, with time (pre-intervention/post-intervention) and interaction between time and arm (intervention/control) as fixed effects, and endoscopists as random effects. 116 endoscopists (57 intervention, 59 controls) were included, and performed 27494 and 33888 colonoscopies, respectively. Median PSPDR pre-intervention was 13.6% (95%CI 13.0-14.1) in the intervention arm and 13.8% (95%CI 13.3-14.3) in controls. Post-intervention PSPDR was significantly higher over time in the intervention arm than in controls (17.1% vs. 15.4%, P=0.01). In an era of increased awareness and increasing PSPDRs, endoscopists who undertook a one-time e-learning course significantly accelerated the increase in PSPDR compared with endoscopists who did not undertake the e-learning. Widespread implementation might reduce PCCRC incidence.

Questionnaire as a stratification method in organizing colorectal cancer screening

The purpose of the study: to compare the efficacy of questionnaires and fecal immunochemical tests in stratification of risk groups during colorectal cancer screening. A non-randomized comparative study was conducted to evaluate the effectiveness of two stratification methods for colorectal cancer screening as part of pilot projects in the regions of the Central Federal District of the Russian Federation. In the first group, the stratification method was the original questionnaire, and in the second group — the fecal immunochemical test (FIT). All participants included in the first and second groups underwent colonoscopy at the second stage of screening. A total of 250 respondents participated in the study, 128 in the questionnaire group and 122 in the FIT group. In the questionnaire group, a high risk of colorectal cancer was found in 91 (71.1 %) individuals, while 37 (28.9 %) respondents had a low risk. Based on colonoscopy results, colorectal cancer and colorectal polyps were diagnosed in 65 (50.8 %) participants, and no significant pathology was found in 63 (49.2 %). In the FIT group, 102 (83.6 %) participants tested positive (FIT+) and 20 (16.4 %) tested negative (FIT-). According to the results of the performed colonoscopy, colorectal cancer and colon polyps were diagnosed in 75 (61.5 %) individuals, while no significant pathology was detected in 47 (38.5 %) participants. The sensitivity of the questionnaire was 86.2 % (95 % CI 75.3–93.5 %) and specificity was 44.4 % (95 % CI 31.9–57.5 %); the predictive value of a positive result was 61.5 % (95 % CI 50.7–71.6 %), and the predictive value of a negative result was 75.7 % (95 % CI 58.8–88.2 %). The FIT sensitivity was 86.7 % (95 % CI 76.8–93.4 %), the specificity was 21.3 % (95 % CI 10.7–35.7 %), the predictive value of a positive result was 63.7 % (95 % CI 53.6–73.0 %), and the predictive value of a negative result was 50.0 % (95 % CI 27.2–72.8 %). In conclusion, the questionnaire method in the colorectal cancer screening model is comparable in sensitivity and specificity to those of the FIT. It is essential to emphasize that questionnaires, along with ease of implementation, do not entail significant economic costs.

Value of combined serum CEA, CA72-4, and CA19-9 marker detection in diagnosis of colorectal cancer.

The aim of this study was to examine whether the combination of serum tumor markers (carcinoembryonic antigen [CEA], carbohydrate antigen [CA]72-4, CA19-9) improves sensitivity and accuracy in the diagnosis of colorectal cancer and precancerous lesion tubular adenoma. An automatic electrochemiluminescence immunoassay with matched kits (ECLIA) was performed on a Roche Cobas e411 analyzer to determine the levels of serum CEA, CA72-4, and CA19-9 in 35 patients with early colorectal cancer, 87 patients with tubular adenoma, and 58healthy people undergoing colonoscopy after positive fecal immunochemical test (FIT) in a colorectal cancer screening program 2021 January to April. The values of these three tumor markers in the diagnosis of colorectal cancer and tubular adenoma were analyzed. 180 patients (92 female and 88 male) were included into the study. We compared serum CEA, CA72-4 and CA19-9 markers among 3 groups: healthy people (mean age 64,0 ±8,6), patients with tubular adenoma (mean age 62,7 ± 6,4) and colorectal cancer (mean age 59,2 ±6,2). The levels of serum CEA, CA72-4, and CA19-9 were higher in the colorectal cancer group than in the tubular adenoma group and healthy subjects, and these differences were significant (p < 0.05). The combination of CEA, CA72-4, and CA19-9had a higher diagnostic value for colorectal cancer compared to single markers, and the positive detection rate was 54.3%. The diagnostic power when using all three markers was the best, and applied for colorectal cancer and tubular adenoma. The combination of CA72-4, CEA, and CA19-9 markers increases the sensitivity and accuracy in the diagnosis of colorectal cancer and can thus be considered an important tool for early colorectal diagnosis.

Multilevel Interventions to Improve Colorectal Cancer Screening in an Urban Native American Community: A Pilot Randomized Clinical Trial

Native Americans have the highest burden of colorectal cancer (CRC) and the lowest rates of CRC screening across the United States.1 The disparities in CRC screening were made worse during the pandemic, creating an unmet need to implement evidence-based, multilevel interventions to improve CRC screening uptake. This can be achieved through an organized outreach program with identification of screen-eligible individuals using health records from the clinic; and a screening program with the following: (1) a mailed invitation, (2) a package of materials so patients can complete a fecal immunochemical test (FIT) kit from their homes, (3) reminder calls and a letter, and (4) navigation to a diagnostic colonoscopy.2-5 We conducted a pilot randomized controlled trial of a program of outreach vs usual care for completion of CRC screening at an urban clinic serving the Native American community. Applying the Consolidated Framework for Implementation Research (CFIR),6 we also conducted patient and provider interviews to understand barriers and facilitators to the organized program and CRC screening in general.

A107 ANALYSIS OF THE EFFICACY IN TRANSITIONING FROM FOBT TO FIT FOR COLORECTAL CANCER SCREENING AT A SINGLE CENTRE IN ONTARIO

Abstract Background Colonoscopy is the gold standard for detecting colorectal cancer (CRC) and advanced lesions, but is an invasive and carries some risks, with limited availability and accessibility. Alternatively, the fecal occult blood test (FOBT) and fecal immunochemical test (FIT) are both non-invasive, cost-effective screening tests that can also be used to detect CRC, advanced lesions, and polyps, identifying individuals to be prioritized to undergo colonoscopy. FOBT screens for small amounts of blood in stool by detecting heme through a chemical reaction. FIT confirms the presence of blood in stool by using antibodies to detect hemoglobin. Prior to 2019, Ontario employed FOBT as the preferred method for CRC screening in eligible individuals. In early 2019, Ontario transitioned to FIT as the preferred screening test, due its established superior test performance for identifying patients with high risk lesions for colon cancer. Aims This single-centre retrospective study analyzed the change in efficacy of detecting advanced lesions, when transitioning from FOBT to FIT, as identified on subsequent colonoscopy Methods A retrospective chart review was conducted of approximately 1000 patients undergoing colonoscopy for FOBT or FIT at Cambridge Memorial Hospital, covering the period of transition from FOBT to FIT. Colonoscopies were performed by 10 endoscopists. Patients were stratified into 2 groups based on fecal test type, FOBT (N = 344) and FIT (N = 572). Overall and individual proportions of cancer, polyps, adenomas, advanced adenomas (AA), and sessile serrated adenomas (SSA) detection in the subsequent colonoscopies were calculated for both groups. The efficacy of both tests was then assessed using statistical analysis. Results In total, 344 patients were included for FOBT analysis and results included: cancer (5.52%), any polyp (56.69%), adenoma (43.6%), AA (20.64), and SSA (6.1%). In contrast, 572 patients were included for analysis of FIT group and results included: cancer (3.85%), any polyp (83.22%), adenoma (76.92%), AA (43.01), and SSA (12.94%). Cancer detection was similar in the 2 groups. There was significant improvement in polyp, adenoma, advanced adenoma, and sessile serrated adenoma detection with FIT compared to FOBT. This improvement was consistent in all endoscopists, but more pronounced in endoscopists with lower detection rates in FOBT cases. Conclusions The use of FIT as a screening stool test, as compared to FOBT, was associated with a significantly improved detection for polyps, adenomas, AA, and SSA, confirming greater accuracy and sensitivity of FIT as a screening tool. This result confirms the premise, at least at a single institution, that by switching to FIT, Ontario has improved colon cancer screening and prevention with more efficient and higher yield utilization of a limited and costly health care resource Funding Agencies None

A151 THRESHOLD TRANSFERABILITY STUDY FOR 3 QUANTITATIVE FITS IN AN ACTIVE COLORECTAL CANCER SCREENING PROGRAM (CRCSP)

Abstract Background Three quantitative fecal immunochemical tests (FITs) were evaluated in the context of a possible supplier transition of the Quebec CRCSP. FITs from different suppliers have different sensitivities, specificities and positivity rates at preset thresholds (PT) which impacts the number of colonoscopies generated. Our hypothesis was that the determination of an equivalent threshold (ET) by a positivity rate equivalent strategy (PRES) or with regression analysis would lead to similar clinical performances. Aims Determine if ETs can be obtained and what their impact is on the sensitivity and specificity of each supplier Methods Kits containing a collection tube for each supplier were distributed to 6600 patients. Sampling was done on a fresh stool by patients with specific instructions for each supplier. Patients with FIT results ≥35 ug/g of stool hemoglobin were considered positive and referred for a colonoscopy within the CRCSP and those between 20 and 35 ug/g were invited to consent to a colonoscopy. Colonoscopy results were considered positive if advanced neoplasia (AN) was found. ETs were determined by PRES and regression analysis comparing each pair of suppliers. Median sensitivity and specificities were computed for each supplier at current and ETs. Results Kits from 5513 patients were included in the study. Colonoscopy results were obtained for 262/342 FIT positive patients and 65/155 patients with results between 20 and 35 ug/g who consented to a colonoscopy. 69 patients were positive for AN at colonoscopy. ETs were obtained for the PRES but not for the regression method due to failed linearity tests. The ETs yielding the same positivity rate as Eiken’s 35.0 ug/g were determined to be 21.6 ug/g and 37.4 ug/g for Sentinel and Alfresa respectively. At the PT, the sensitivities of Alfresa (0.71, CI :0.58-0.80) and Eiken (0.71, CI:0.58-0.80) did not differ significantly but were higher than Sentinel (0.52, CI:0,39-0,64, p= 0.0059 and 0.016). The specificity for Sentinel (0.64, CI: 0.57-0.69) was significantly higher than Alfresa (0.45, CI: 0.38-0.50, p= 3.3E-6) and Eiken (0.54, CI: 0.47-0.59, p= 0.0059), as was the one from Eiken when compared to Alfresa (p =0.038). After adjustment using PRES, no significant differences for sensitivity (Alfresa (0.68, CI:0.55-0.77), Eiken (0.71, CI :0.58-0.80), Sentinel (0.52, CI:0.46-0.70)) and specificity (Alfresa (0.51 CI: 0.45-0.57), Eiken (0.54, CI: 0.47-0.59), Sentinel (0.57, CI: 0.50-0.62)) were observed between suppliers. Conclusions Our study demonstrates that a PRES can be used to adjust the threshold in a supplier transition in order to achieve similar clinical performances. To our knowledge this is the first study to evaluate this in a real life active CRCSP setting where the stool is sampled by the patient and non-homogenized. Funding Agencies Ministère de la Santé et des Services Sociaux du Québec and private funds (Somagen-Eiken, Quidel-Sentinel, Abbott-Alfresa)

A72 THE ENDOSCOPIC YIELD OF PRIORITIZED INDICATIONS USING A PROVINCIAL-WIDE COLONOSCOPY REFERRAL FORM

Abstract Background The widespread use of a standardized and validated province-wide colonoscopy referral form (PCRF), regrouping mutually exclusive indications into suggested priority wait time categories, has allowed for a more comprehensive assessment of routine colonoscopy practice Aims To validate the Quebec PCRF by better characterizing endoscopic finding yields according to specific clinical indications. Methods This retrospective cohort study includes consecutive adult patients with available data from the PCRF from two tertiary hospitals. The primary outcome was the diagnostic rates of colorectal cancer (CRC). Secondary outcomes assessed incidences of clinically significant lesions (CSL) on endoscopy and confirmed at pathology. These are CRC, advanced adenomas, sessile serrated polyps, polyps ≥ 5mm, colitis, colonic strictures, and miscellaneous other findings excluding hemorrhoids and diverticulosis. Descriptive and inferential statistics, and multivariable regression predictive modeling are reported. Results Overall, 14,657 patients (mean age 59.2 ± 14.0 years, 50.9% female) were included from September 2018 to August 2022. The most frequent indications for colonoscopy were polyp surveillance (IN13, 20.8%), recent change in bowel habits (IN7, 11.9%), a positive fecal immunochemical test (IN5, 8.3%), a family history of CRC or polyps (first-degree relative) (IN8, 6.4%), and suspected active inflammatory bowel disease (IBD) (IN3, 5.8%). Overall, 40.6% had CSL, including CRCs in 0.8%. CRCs were found more frequently for IN2 (19.7% vs 2.0%, pampersand:003C0.01), IN5 (29.9% vs 8.2%, pampersand:003C0.01), and an unexplained documented iron deficiency anemia (IN6) (11.8% vs 5.2%, pampersand:003C0.01). CSLs were more frequent for IN3 (1.6% vs 5.8%, p=0.04), IN7 (4.7% vs 12.0%, p=0.01), IN8 (0.8% vs 6.5%, p=0.01), IN13 (7.1% vs 20.9%, pampersand:003C0.01), IBD surveillance (IN15, 0.0% vs 4.0%, p=0.02), and surveillance for a significant family history (IN21, 0.0% vs 3.7%, p=0.02). On multivariable analysis, CRC was significantly associated with IN2 OR=31.8 (4.86; 208.7), IN5 OR=19.2 (3.86; 95.7), and IN6 OR=15.7 (2.37; 78.0) - (all are high priority PCRF referrals with a suggested shorter wait time than for most other indications). CSLs were significantly associated with age (OR=1.03 (1.02; 1.03)), IN2 (OR=2.32 (1.35; 3.99)), IN5 (OR=2.37 (1.74; 3.22)), and IN13 (OR= 1.66 (1.36; 2.02)). Conclusions This large cohort study confirms the validity of indications and corresponding prioritization of wait times of a PCRF. Funding Agencies CPAC and MSSS

Cost-effectiveness analysis of single colonoscopy versus single fecal test for colorectal cancer diagnosis and treatment.

Regular endoscopy or fecal immunochemical test (FIT) is ideal for screening colorectal cancer. However, only a limited number of individuals undergo regular screening. This study aimed to compare the cost-effectiveness of a single colonoscopy with a single FIT performed for colorectal cancer screening. A microsimulation model was constructed based on real-world observational data collected from three institutions between 2019 and 2022 that compared colonoscopy-based screening with FIT-based screening. The total costs of diagnosis and treatment of the detected lesions using the two strategies were calculated. The incremental cost-effectiveness ratio (ICER) per life year gained (LYG) of the colonoscopy-based strategy was calculated. Data from 11 407 patients undergoing colonoscopies and 59 176 patients undergoing FITs were used to establish a model. In the base case analysis of screening strategies, colonoscopy was more cost-effective than FIT (ICER 415 193 yen/LYG). The ICER of the colonoscopy-based strategy among 60- to 69-year-old patients was lowest at 394 200 yen/LYG, whereas that in 20- to 29-year-old patients was highest. Monte Carlo simulations showed that the colonoscopy-based strategy was more cost-effective than the FIT-based strategy (net monetary benefit [NMB]: 5 695 957 yen vs 5 348 253 yen). When the adenoma detection rate in the colonoscopy was over 30% or the positive FIT rate was lower than 8.6% in the FIT-based strategy, the NMB of the colonoscopy-based strategy exceeded that of the FIT-based strategy. In the microsimulation model, colonoscopy is recommended as a one-time screening procedure in patients aged >60years with >30% ADR or <8.6% positive FIT rate.

Feasibility and Colonoscopy Yield Using the Fecal Immunochemical Test (FIT)-Based Colorectal Cancer Screening in a Latin America Country

Background and aimsOrganized colorectal cancer (CRC) is not widely practiced in Latin America and the results of regional studies may help overcome barriers for implementation of national screening programs. We aimed to describe the implementation and findings of a fecal immunochemical test (FIT)-based program in Brazil. MethodsIn a prospective population-based study, asymptomatic individuals (50 to 75 years-old) from Sao Paulo city were invited to undergo FIT for CRC screening. Participants with positive FIT (>10 μg Hb/g feces) were referred for colonoscopy. Subjects were classified into groups according to the presence of CRC, precursor lesions, and other benign findings, possibly related to bleeding. ResultsOf a total of 9,881 subjects, 7.8% had positive FIT and colonoscopy compliance was 68.9% (n=535). Boston scale was considered adequate in 99% and cecal intubation rate was 99.4%. CRC was diagnosed in 5.9% of the cases, adenoma in 63.2%, advanced adenoma (AA) in 31.4%, and advanced neoplasia (AN) in 33.0%. Age was positively associated with CRC (p=0.03). Higher FIT concentrations were associated with increased detection of CRC (p<0.008), AA (p<0.001), and AN (p<0.001). ConclusionImplementation of a FIT-based CRC screening program was feasible in a low-resource setting, and there was a high yield for neoplasia in individuals with a positive FIT. This approach could be used as a model to plan and disseminate organized CRC screening more broadly in Brazil and Latin America.

The multitarget faecal immunochemical test for improving stool-based colorectal cancer screening programmes: a Dutch population-based, paired-design, intervention study

The faecal immunochemical test (FIT) is widely employed for colorectal cancer screening. However, its sensitivity for advanced precursor lesions remains suboptimal. The multitarget FIT (mtFIT), measuring haemoglobin, calprotectin, and serpin family F member 2, has demonstrated enhanced sensitivity for advanced neoplasia, especially advanced adenomas, at equal specificity to FIT. This study aimed to prospectively validate and investigate the clinical utlitity of mtFIT versus FIT in a setting of population-based colorectal cancer screening. Individuals aged 55-75 years and who were eligible for the Dutch national FIT-based colorectal cancer screening programme were invited to submit both a FIT and mtFIT sample collected from the same bowel movement. Positive FIT (47 μg/g haemoglobin cutoff) or mtFIT (based on decision-tree algorithm) led to a colonoscopy referral. The primary outcome was the relative detection rate of mtFIT versus FIT for all advanced neoplasia. Secondary outcomes were the relative detection rates of colorectal cancer, advanced adenoma, and advanced serrated polyps individually and the long-term effect of mtFIT-based versus FIT-based programmatic screening on colorectal cancer incidence, mortality, and cost, determined with microsimulation modelling. The study has been registered in ClinicalTrials.gov, NCT05314309, and is complete. Between March 25 and Dec 7, 2022, 35 786 individuals were invited to participate in the study, of whom 15 283 (42·7%) consented, and 13 187 (86·3%) of 15 283 provided both mtFIT and FIT samples with valid results. Of the 13 187 participants, 6637 (50·3%) were male and 6550 (49·7%) were female. mtFIT showed a 9·11% (95% CI 8·62-9·61) positivity rate and 2·27% (95% CI 2·02-2·54) detection rate for advanced neoplasia, compared with a positivity rate of 4·08% (3·75-4·43) and a detection rate of 1·21% (1·03-1·41) for FIT. Detection rates of mtFIT versus FIT were 0·20% (95% CI 0·13-0·29) versus 0·17% (0·11-0·27) for colorectal cancer; 1·64% (1·43-1·87) versus 0·86% (0·72-1·04) for advanced adenoma, and 0·43% (0·33-0·56) versus 0·17% (0·11-0·26) for advanced serrated polyps. Modelling demonstrated that mtFIT-based screening could reduce colorectal cancer incidence by 21% and associated mortality by 18% compared with the current Dutch colorectal cancer screening programme, at feasible costs. Furthermore, at equal positivity rates, mtFIT outperformed FIT in terms of diagnostic yield. At an equally low positivity rate, mtFIT-based screening was predicted to further decrease colorectal cancer incidence by 5% and associated mortality by 4% compared with FIT-based screening. The higher detection rate of mtFIT for advanced adenoma compared with FIT holds the potential to translate into additional and clinically meaningful long-term colorectal cancer incidence and associated mortality reductions in programmatic colorectal cancer screening. Stand Up to Cancer, Dutch Cancer Society, Dutch Digestive Foundation, and Health~Holland.

Bundling Colorectal Cancer Screening Outreach with Screening for Social Risk in Federally Qualified Health Centers: A Stepped-Wedge Implementation-Effectiveness Study

BackgroundBundling is combining individual interventions to meet quality metrics. Bundling offers of cancer screening with screening for social determinants of health (SDOH) may enable health centers to assist patients with social risks and yield efficiencies.ObjectiveTo measure effects of bundling fecal immunochemical testing (FIT) and SDOH screening in federally qualified health centers (FQHCs).DesignClustered stepped-wedge trial.ParticipantsFour Massachusetts FQHCs randomized to implement bundled FIT-SDOH over 8-week “steps.”InterventionOutreach to 50–75-year-olds overdue for CRC screening to offer FIT with SDOH screening. The implementation strategy used facilitation and training for data monitoring and reporting.Main MeasuresImplementation process descriptions, data from facilitation meetings, and CRC and SDOH screening rates. Rates were compared between implementation and control FQHCs in each “step” by fitting generalized linear mixed-effects models with random intercepts for FQHCs, patients, and “step” by FQHC.Key ResultsFQHCs tailored implementation processes to their infrastructure, workflows, and staffing and prioritized different groups for outreach. Two FQHCs used population health outreach, and two integrated FIT-SDOH within established programs, such as pre-visit planning. Of 34,588 patients overdue for CRC screening, 54% were female; 20% Black, 11% Latino, 10% Asian, and 47% white; 32% had Medicaid, 16% Medicare, 32% private insurance, and 11% uninsured. Odds of CRC screening completion in implementation “steps” compared to controls were higher overall and among groups prioritized for outreach (overall: adjusted odds ratio (aOR) 2.41, p = 0.005; prioritized: aOR 2.88, p = 0.002). Odds of SDOH screening did not differ across “steps.”ConclusionsAs healthcare systems are required to conduct more screenings, it is notable that outreach for a long-standing cancer screening requirement increased screening, even when bundled with a newer screening requirement. This outreach was feasible in a real-world safety-net clinical population and may conserve resources, especially compared to more complex or intensive outreach strategies.Clinical Trials RegistrationNCT04585919

The Reach of Calls and Text Messages for Mailed FIT Outreach in the PROMPT Stepped-Wedge Colorectal Cancer Screening Trial.

Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening participation. We assessed the reach and effectiveness of adding notifications to mailed FIT programs. We conducted secondary analyses of a stepped-wedge evaluation of an enhanced mailed FIT program (n = 15 clinics). Patients were stratified by prior FIT completion. Those with prior FIT were sent a text message (Group 1); those without were randomized 1:1 to receive a text message (Group 2) or live phone call (Group 3). All groups were sent automated phone call reminders. In stratified analysis, we measured reach and effectiveness (FIT completion within 6 months) and assessed patient-level associations using generalized estimating equations. Patients (n = 16,934; 83% Latino; 72% completed prior FIT) were reached most often by text messages (78%), followed by live phone calls (71%), then automated phone calls (56%). FIT completion was higher in patients with prior FIT completion versus without [44% (Group 1) vs. 19% (Group 2 + Group 3); P < 0.01]. For patients without prior FIT, effectiveness was higher in those allocated to a live phone call [20% (Group 3) vs. 18% (Group 2) for text message; P = 0.04] and in those who personally answered the live call (28% vs. 9% no call completed; P < 0.01). Text messages reached the most patients, yet effectiveness was highest in those who personally answered the live phone call. Despite the broad reach and low cost of text messages, personalized approaches may more successfully boost FIT completion.