FECAL IMMUNOCHEMICAL TEST, FECAL CALPROTECTIN, AND SERUM C-REACTIVE PROTEIN IN ASSESSMENT OF PATIENTS PRESENTING WITH CHRONIC LOWER BOWEL SYMPTOMS

Background: Health status and expected mortality are important considerations in assessing the benefits of colorectal cancer (CRC) screening, particularly for older adults given that CRC screening is recommended for adults with life expectancy ≥10 years. We analyzed past-year CRC screening according to a 10-year mortality index among community-dwelling adults aged 65-84 years.
Methods: We estimated 10-year mortality risk using a validated index comprising age, sex, body mass index, smoking history, comorbidities (diabetes, cancer, chronic obstructive pulmonary disease), number of overnight admissions, perceived health status, and functional limitations (difficulty walking several blocks, instrumental activities of daily life dependency) among 40,842 adults aged 65-84 years in the nationwide National Health Interview Survey in survey years 2000, 2003, 2005, 2008, 2010, 2013, 2015, and 2018. The 10-year predicted mortality risk from the lowest to highest quintiles of risk index were 12%, 24%, 39%, 58%, and 79%, respectively. We assessed the receipt of past-year CRC screening, including invasive (colonoscopy and sigmoidoscopy) and non-invasive (CT colonography and stool-based tests) tests, within 12 months according to quintiles of mortality risk.
Results: Among adults aged 65-84 years, prevalence of past-year CRC screening did not differ by quintile of mortality risk index (23.7%, 25.0%, 24.1%, 22.8%, and 22.5%, respectively, from the lowest to highest quintile, p >0.05, Figure 1). Compared to adults in the lowest quintile of mortality index, adults in the highest quintile had similar odds of past-year screening (OR 0.94, 95% CI: 0.85-1.03, p >0.05). About one-quarter (27.9%) of past-year CRC screening occurred in those with 10-year mortality risk >50%. There were some differences in past-year CRC screening by quintiles of mortality risk across strata of age. For example, adults aged 75-79 years in the lowest mortality quintile had lower past-year CRC screening compared to adults aged 70-74 years in the highest mortality quintiles (18.1% vs. 26.5%, p <0.001). This pattern was consistent for invasive and non-invasive screening tests.
Conclusion: Past-year CRC screening does not differ according to expected 10-year mortality risk. Current age-based approaches to CRC screening may result in under-screening for older, healthier adults but over-screening for younger adults with comorbidities. These data have implications for optimal use of limited endoscopic capacity, as well as possible overdiagnosis. Personalized screening with incorporation of individual factors such as life expectancy should be considered when recommending CRC screening.

Background: Colorectal cancer (CRC) incidence and mortality are higher in rural compared to urban areas, partly due to lower rural CRC screening rates. Racial and ethnic disparities also exist in CRC incidence and mortality. To reach the National Colorectal Cancer Roundtable goal of 80% screening in every community, we need to better understand the impact of both race/ethnicity and geographic location on CRC screening disparities.
Aim: To examine racial/ethnic and geographic variation in CRC screening across primary care clinics in Wisconsin (WI) utilizing a novel six-category rural-urban geodisparity model.
Methods: EHR data from 1/1/2008 to 12/31/2018 were reviewed from 14 WI health systems. Data included CRC screening test completion and multiple patient, provider, clinic, and health system characteristics. Adults aged 50-75 yrs who have not had a total colectomy and are currently served by one of the health systems were included. Completed CRC screening was defined as: (1) FOBT/FIT within 1 yr, (2) multi-target stool DNA within 3 yrs, (3) sigmoidoscopy or CT colonography within 5 yrs, or (4) colonoscopy within 10 yrs. Race/ethnicity was self-identified by the patient. Clinic location was defined by a novel geodisparity model that incorporates information on regional healthcare capacity and health needs in WI ZIP Code Tabulation Areas. Average predicted screening rates were calculated for the 12 groups of race/ethnicity (White, Non-white) combined with geolocation (urban advantaged, urban, urban underserved, rural advantaged, rural, rural underserved) from a hierarchical model accounting for patient-, provider-, and clinic-level characteristics, as well as interactions between race/ethnicity and geolocation.
Results: 462,742 patients eligible for CRC screening, served by 2,334 providers in 271 clinics across 14 health systems were included. Overall, Non-White patients had lower screening rates compared to Whites (70% vs 80%) and patients living in underserved areas had lower screening rates (rural, 70%; urban, 62%) than other geolocations [Table 1]. Non-White patients in all three categories of rural communities had predicted screening rates ≤62%. Both White and Non-White patients living in urban underserved communities had predicted screening rates ≤65% [Table 2].
Conclusions: When considering the impact of race/ethnicity alone or geolocation alone, Non-White patients and patients in underserved areas (both rural and urban) are less likely to complete CRC screening. The interaction of race/ethnicity and geolocation shows that Non-White patients living in a rural area are even less likely to complete CRC screening than their White counterparts, as well as compared to Non-White patients in urban advantaged and urban areas. Interventions to increase CRC screening in racial/ethnic minorities should also address barriers specific to their geolocations.

Background
In May 2018, the American Cancer Society (ACS) recommended lowering the age for colorectal cancer (CRC) screening from 50 years to 45 years for average-risk individuals after evaluation of literature, data models, and increased evidence of changes in CRC incidence. In May 2021, the US Preventive Services Task Force (USPSTF) amended their guidelines to include adults aged 45-49 years. Guidelines include options screening with either a high-sensitivity stool-based test such as a fecal immunochemical (FIT) test or a structural (visual) examination. In May 2021, the eligibility criteria for a large mailed-FIT outreach program were adjusted to include adults aged 45-49 years to align with the updated guidelines from ACS and USPSTF. After the first year of expanded guidelines, we reviewed the data to compare those newly eligible to those age 50 and older.
Methods
Adults ages 45-74 who are not current with CRC screening were eligible for participation. Patients have been identified through various outreach modalities, including clinical partnerships and patient self-referrals. Patients were mailed an invitation to screening, along with a FIT kit with simplified instructions and paid return postage. All mailed outreach is provided in both English and Spanish. Patients received informational automated calls one week prior and at time of invitation. Live reminder calls occurred two weeks post invitation. Guideline-based navigation began once a patient returned the FIT kit. FIT negative patients were mailed results and re-invited for annual screening. Patients with abnormal results were navigated to a no-cost diagnostic colonoscopy.
Results
In the first year with new guidelines, we invited more than 550 individuals ages 45-49 to screen using FIT and more than 3,100 individuals over 50. The proportion of individuals completing FIT kits was higher for ages 45-49 (38.78%) than for individuals over 50 (32.80%; p = 0.005). The populations also differed by sex (p=0.001), race (p=0.004), ethnicity (p<.001), and preferred language (p= 0.023). Among participants, the proportion of individuals with abnormal results were similar when compared by age group (p=0.093), as was colonoscopy follow-up after abnormal FIT (p=0. 671).
Conclusions
This data demonstrates that people ages 45-49 are willing to participate in mailed FIT outreach for CRC screening at a higher rate than those ages 50+ and that mailed FIT outreach is a useful tool to reach this population, with nearly 40% of the population invited participating in screening. The younger age cohort had a similarly high proportion of those willing to complete colonoscopy after abnormal, with over 80% following up after abnormal FIT. More research is needed on effective strategies tailored to those ages 45-49 to increase screening participation using mailed FIT.

BACKGROUND
The ACG 2021 Clinical Guidelines for colorectal cancer (CRC) screening suggest using patient navigators to improve adherence to screening (“conditional recommendation, very low-quality evidence”). A dedicated patient navigator increases completion and return rates for fecal immunochemical testing (FIT) kits, allowing FIT to become an accurate and reliable screening tool. While FIT's ability to prioritize patients for diagnostic colonoscopies ultimately leads to earlier detection and treatment of CRC, an analysis of cost effectiveness has yet to be explored. We will show that the implementation of a patient navigator is an effective intervention to improve CRC screening using FIT.

METHODS
We recorded results from FIT testing for 3544 individuals aged 45 and older at a single internal medicine clinic, ordered from 01/2017 through 12/2021. In 01/2021 we implemented a dedicated patient navigator, and compared the average cost of CRC screening per patient before and after this intervention. Costs taken into consideration included the FIT kit, FIT testing, patient navigator, and colonoscopy. We performed chi-square and Student’s t-tests for descriptive analyses on demographics and cost components. Multivariable Cox hazard model was used to compare FIT kit drop off and colonoscopy rates pre- and post-intervention, and we performed multivariable linear regression analysis to compare the average total costs associated with CRC screening between the two study groups.

RESULTS
Of the 3544 patients in our study, 1084 (30.6%) were in the post-intervention group. A dedicated patient navigator improved FIT kit drop off rates by 37.7% (HR 1.38 [1.25-1.51]). The pre-intervention group had about a 4-fold increased chance of undergoing colonoscopy (HR 3.6 [2.28-5.73]), and a higher average number of exams per patient (1.5±0.96 vs. 1.06±0.24, p<0.0001). The total cost of CRC screening per patient was decreased by $874.18 in the post-intervention group ($72.0±383.3 vs. $946.1±1873.5, p<0.0001).

CONCLUSION
FIT is a sensitive and specific CRC screening modality which can be used to reach and risk-stratify patients to increase the yield for detecting advanced neoplasia and cancer. By prioritizing patients for colonoscopy, FIT decreases the burden on endoscopy centers, particularly in resource-limited settings, and improves efficiency of colonoscopy in the average-risk screening population. A dedicated patient navigator is a simple intervention that improves completion rates. Despite an upfront cost of hiring a navigator, the savings to the healthcare system are significant. The prioritization of positive FIT will reduce the detrimental delay in performance of colonoscopies, delayed diagnosis of CRC, and total healthcare cost. Our findings suggest that implementation of patient navigators can be a cost-effective intervention improving the efficiency of CRC screening.

Background
In patients with chronic lower bowel symptoms (LBS), including mid to lower abdominal pain, diarrhea, constipation, bloating, or bleeding per rectum, identifying those harboring significant diseases is important. The presence of alarm features is generally utilized; however, its accuracy is limited. Immunochemical fecal occult blood test (iFOBT), fecal calprotectin (FC), and C-reactive protein (CRP) might help improve diagnostic accuracy.
Objective
To examine the performance of iFOBT, FC, and CRP in distinguishing patients with significant ileocolonic lesions (colon cancer, advanced adenoma, and ileitis/colitis) from those without significant lesions in patients presenting with chronic LBS.
Materials and Methods
From December 2019 to July 2022, patients who presented with at least 1-month of LBS and had scheduled for colonoscopy were prospectively enrolled. Clinical findings, blood tests, and stool samples were obtained within a month prior to the colonoscopies. The performance of the presence of alarm features (bleeding per rectum, anemia, or weight loss), quantitative iFOBT (EIKEN OC-Sensor io), FC (EliA Calprotectin 2), and CRP in distinguishing patients with- from those without significant lesions detected on colonoscopy were analyzed. The cutoff value of 10 ng/ml for iFOBT, 50 mg/kg for FC, and 5 mg/L for CRP were used.
Results
Of 1007 participants, 922 had complete blood and stool tests and were included in analyses. The mean age was 62.3 years, and 38% were male. One hundred thirty patients (14.1%) had significant lesions, including 50 colon cancers, 49 advanced adenomas, and 31 ileitis/colitis. The Area under the receiver operating characteristic (AUROC) in predicting significant lesions was 0.630 (95% confident interval 0.589 – 0.671) for the presence of any alarm features, 0.781 (0.732 – 0.830) for iFOBT, 0.667 (0.612-0.722) for FC, and 0.643 (0.586 – 0.699) for CRP (Figure 1). Only iFOBT had significantly higher AUROC than alarm features (p<0.001). The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each diagnostic tool are shown in Table 1. Overall, the positivity of either iFOBT or FC had the highest sensitivity (89.2%) and NPV (95%), while the positivity of both tests had the high specificity (80.9%) and highest PPV (31.6%). When subgrouping in patients without alarm features, the negative results of iFOBT and FC generated an NPV of 96.1%. Furthermore, among patients with alarm features, the positivity of both iFOBT and FC generated a PPV of 39.9%.
Conclusion
Fecal occult blood tests and fecal calprotectin could help assess patients with LBS. In colonoscopy-limited countries, negative both tests in patients without alarming features could defer colonoscopy, while positive both tests enhanced the need for colonoscopy, particularly in patients with alarm features.