Quality Monitoring of a FIT-Based Colorectal Cancer Screening Program

Abstract BACKGROUND Quality assessment is crucial for consistent program performance of colorectal cancer (CRC) screening programs using fecal immunochemical test for hemoglobin (FIT). However, literature on the consistency of FIT performance in laboratory medicine was lacking. This study examined the consistency of FIT in testing positive or detecting advanced neoplasia (AN) for different specimen collection devices, lot reagents, and laboratories. METHODS All participants with a FIT sample with a cutoff concentration of 47 μg Hb/g feces in the Dutch CRC screening program in 2014 and 2015 were included in the analyses. Multivariable logistic regression analyses were performed to estimate the odds ratios of collection devices, reagents, and laboratories on testing positive or detecting AN and positive predictive value (PPV). RESULTS In total, 87519 (6.4%) of the 1371169 participants tested positive. Positivity rates and detection rates of AN differed between collection devices and reagents (all P < 0.01). In contrast, PPVs were not found to vary between collection devices, reagents, or laboratories (all P > 0.05). Positivity rates showed a small difference for laboratories (P = 0.004) but not for detection rates of AN. Size of the population affected by the deviating positivity rates was small (0.1% of the total tested population). CONCLUSIONS Variations were observed in positivity and detection rates between collection devices and reagents, but there was no detected variation in PPV. Although the overall population effect of these variations on the screened population is expected to be modest, there is room for improvement.

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Colorectal cancer after negative colonoscopy in fecal immunochemical test-positive participants from a colorectal cancer screening program

Endoscopy International Open ◽

10.1055/a-0650-4296 ◽

2018 ◽

Vol 06 (09) ◽

pp. E1140-E1148 ◽

Cited By ~ 4

Author(s):

Liseth Rivero-Sánchez ◽

Jaume Grau ◽

Josep María Augé ◽

Lorena Moreno ◽

Angels Pozo ◽

...

Keyword(s):

Colorectal Cancer ◽

Screening Program ◽

Fecal Immunochemical Test ◽

Colorectal Adenomas ◽

Crc Screening ◽

Cancer Screening Program ◽

Screening Strategies ◽

Immunochemical Test ◽

Low Incidence

Abstract Background and study aims Colorectal cancer (CRC) risk after a positive fecal immunochemical test (FIT) and negative colonoscopy is unknown. We aimed to ascertain the cumulative incidence of post-colonoscopy colorectal cancer (PCCRC) and the manifestation of other lesions that could explain the test positivity in individuals with a negative colonoscopy in a population screening program. Patients and method Observational study in participants from the first round of a CRC screening program (2010 – 2012) with positive-FIT (≥ 20 μg/g of feces) and negative colonoscopy (without neoplasia). A 42- to 76-month follow-up was performed searching in the National Health Service database and by a brief structured telephonic interview. Results Of 2659 FIT-positive individuals who underwent colonoscopy, 811 (30.5 %) had a negative colonoscopy. Three PCCRC (0.4 %) were detected within 11 – 28 months and accelerated carcinogenesis was ruled out. Among those with normal colonoscopy, 32 (5 %) relevant lesions were detected at follow-up. One-third of them (11/32) were significant neoplasias: a gastric cancer, a small-bowel lymphoma, six advanced colorectal adenomas, and the three PCCRC. The 21 remaining lesions were inflammatory, vascular disorders, or non-advanced colorectal adenomas. Conclusions The vast majority (95 %) of individuals did not present any subsequent lesion that could explain the FIT positivity. The very low incidence (0.4 %) and characteristics of PCCRC observed in our cohort reinforce the concept that, although a positive FIT preselects high risk individuals, a high quality colonoscopy is the paramount factor in preventing PCCRC. Improving quality standards of colonoscopy are required to strengthen the current CRC screening strategies.

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S1129 Equal Advanced Neoplasia Detection Rates in First and Second Round of an Fecal Immunochemical Test Based Colorectal Cancer Screening Program

Gastroenterology ◽

10.1016/s0016-5085(10)60845-1 ◽

2010 ◽

Vol 138 (5) ◽

pp. S-186 ◽

Cited By ~ 1

Author(s):

Maaike Denters ◽

Marije Deutekom ◽

Patrick M. Bossuyt ◽

Paul Fockens ◽

Evelien Dekker

Keyword(s):

Colorectal Cancer ◽

Cancer Screening ◽

Colorectal Cancer Screening ◽

Screening Program ◽

Fecal Immunochemical Test ◽

Detection Rates ◽

Advanced Neoplasia ◽

Cancer Screening Program ◽

Immunochemical Test

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Management of large polyps in a colorectal cancer screening program with fecal immunochemical test: a community- and population-based observational study

Endoscopy International Open ◽

10.1055/a-1551-3306 ◽

2021 ◽

Vol 09 (11) ◽

pp. E1649-E1657

Author(s):

Bernard Denis ◽

Isabelle Gendre ◽

Philippe Perrin ◽

Nicolas Tuzin ◽

Mathieu Pioche

Keyword(s):

Colorectal Cancer ◽

Observational Study ◽

Endoscopic Resection ◽

Screening Program ◽

Population Based ◽

Fecal Immunochemical Test ◽

Detection Rates ◽

Cancer Screening Program ◽

Adenoma Detection ◽

Immunochemical Test

Abstract Background and study aims The aim of this study was to analyze presentation, management, and outcomes of large polyps (LPs; ≥ 20 mm) detected in a colorectal cancer (CRC) screening program using a quantitative fecal immunochemical test (FIT). Patients and methods This was a retrospective community- and population-based observational study of all LPs detected in patients aged 50 to 74 years between 2015 and 2019 during FIT-positive colonoscopies within the screening program organized in Alsace (France). Results Among 13,633 FIT-positive colonoscopies, 1256 LPs (8.5 % malignant and 51.8 % nonpedunculated) were detected by 102 community gastroenterologists in 1164 patients (one in 12 colonoscopies). The sensitivity of optical diagnosis of malignancy was 54 % for nonpedunculated and 27 % for pedunculated T1 CRCs. The endoscopic resection rate was 82.7 % (95 % confidence interval [CI] 80.3–84.9) for benign LPs (70.2 % [95 % CI 66.4–74.1]) nonpedunculated, 95.2 % [95 % CI 93.4–97.1] pedunculated), varying from 0 to 100 % depending on the endoscopist. It was correlated with cecal intubation (Pearson r = 0.49, P < 0.01) and adenoma detection rates (r = 0.25, P = 0.01). Most endoscopists did not refer patients to more experienced endoscopists, and as a result, 60 % to 90 % of 183 surgeries for benign LPs were unwarranted. Endoscopic resection was curative for 4.3 % (95 % CI 0.9–12.0) of nonpedunculated and 37.8 % (95 % CI 22.5–55.2) of pedunculated T1 CRCs. Overall, 22 endoscopic submucosal dissections had to be performed to avoid one surgery. Conclusions Compared with current recommendations, there is tremendous room for improvement in community endoscopy practices in the diagnosis and management of LPs. Detection and polypectomy competencies are correlated and highly variable among endoscopists. Endoscopic resection is curative for 83 % of benign LPs and 16 % of T1 CRCs.

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Risk of Colonoscopy-related Complications in a Fecal Immunochemical Test-based Population Colorectal Cancer Screening Program

Endoscopy ◽

10.1055/a-1328-5126 ◽

2020 ◽

Author(s):

Wen-Feng Hsu ◽

Chi-Yang Chang ◽

Chun-Chao Chang ◽

Li-Chun Chang ◽

Chien-Hua Chen ◽

...

Keyword(s):

Colorectal Cancer ◽

Complication Rate ◽

Screening Program ◽

Fecal Immunochemical Test ◽

Research Database ◽

Complication Rates ◽

Related Complication ◽

Crc Screening ◽

Cancer Screening Program ◽

Immunochemical Test

Background and study aims: The likelihood of advanced or synchronous neoplasms is significantly higher in fecal immunochemical test (FIT)-positive subjects than in the general population. The magnitude of colonoscopy-related complication rate in FIT-positive subjects, however, remains unknown. This study aims to elucidate the colonoscopy-related complication rate after positive FIT and compared with colonoscopy performed for other purposes. Patients and methods: Information regarding colonoscopy after positive FIT (FIT-colonoscopy) and ordinary colonoscopy related severe complications during 2010-2014 was ascertained from the Taiwanese Colorectal Cancer (CRC) Screening Program Database and National Health Insurance Research Database (NHIRD). Severe complications included significant bleeding, perforation, and cardiopulmonary events <14 days of colonoscopy. The number of events per 1000 procedures was used to quantify complication rates. Multivariate analysis was conducted to assess the association of various factors with severe complications in comparison with ordinary colonoscopy. Results: A total of 319,114 FIT-colonoscopies (214,955 subjects) were identified. Of those, 51,242 (16.1%) underwent biopsy and 94,172 (29.5%) underwent polypectomy; 2,125 had significant bleeding (6.7‰) and 277 had perforation (0.9‰) <14 days after colonoscopy. Polypectomy, antiplatelet use, and anticoagulant use were associated with higher risk of complications [adjusted odds ratio (aOR)= 4.41 (95% Confidence Interval {CI}=4.05–4.81); 1.35 (95%CI=1.12–1.53); and 1.88 (95%CI=0.61–5.84), respectively]. Compared with ordinary colonoscopy, FIT-colonoscopy involved significantly higher risk of significant bleeding [aOR= 3.10 (95%CI=2.90–3.32)]. Conclusions: FIT-colonoscopy was associated with more than two-fold risk of significant bleeding, especially when polypectomy is performed.

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National Colorectal Cancer Screening Program in Lithuania: Description of the 5-Year Performance on Population Level

Cancers ◽

10.3390/cancers13051129 ◽

2021 ◽

Vol 13 (5) ◽

pp. 1129

Author(s):

Audrius Dulskas ◽

Tomas Poskus ◽

Inga Kildusiene ◽

Ausvydas Patasius ◽

Rokas Stulpinas ◽

...

Keyword(s):

Colorectal Cancer ◽

Quality Assurance ◽

Cancer Screening ◽

Colorectal Cancer Screening ◽

Screening Program ◽

Histopathological Examination ◽

Insurance Fund ◽

Crc Screening ◽

Cancer Screening Program ◽

The Impact

We aimed to report the results of the implementation of the National Colorectal Cancer (CRC) Screening Program covering all the country. The National Health Insurance Fund (NHIF) reimburses the institutions for performing each service; each procedure within the program has its own administrative code. Information about services provided within the program was retrieved from the database of NHIF starting from the 1 January 2014 to the 31 December 2018. Exact date and type of all provided services, test results, date and results of biopsy and histopathological examination were extracted together with the vital status at the end of follow-up, date of death and date of emigration when applicable for all men and women born between 1935 and 1968. Results were compared with the guidelines of the European Union for quality assurance in CRC screening and diagnosis. The screening uptake was 49.5% (754,061 patients) during study period. Participation rate varied from 16% to 18.1% per year and was higher among women than among men. Proportion of test-positive and test-negative results was similar during all the study period—8.7% and 91.3% annually. Between 9.2% and 13.5% of test-positive patients received a biopsy of which 52.3–61.8% were positive for colorectal adenoma and 4.6–7.3% for colorectal carcinoma. CRC detection rate among test-positive individuals varied between 0.93% and 1.28%. The colorectal cancer screening program in Lithuania coverage must be improved. A screening database is needed to systematically evaluate the impact and performance of the national CRC screening program and quality assurance within the program.

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To do or not to do – a survey study on factors associated with participating in the Danish screening program for colorectal cancer

BMC Health Services Research ◽

10.1186/s12913-020-06023-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Jesper Bo Nielsen ◽

Gabriele Berg-Beckhoff ◽

Anja Leppin

Keyword(s):

Colorectal Cancer ◽

Screening Program ◽

Demographic Data ◽

Survey Study ◽

Stepwise Logistic Regression ◽

Willingness To Participate ◽

Cross Sectional Survey ◽

Screening Programs ◽

Crc Screening ◽

Screening Participation

Abstract Background Screening programs for colorectal cancer (CRC) exist in many countries, and with varying participation rates. The present study aimed at identifying socio-demographic factors for accepting a cost-free screening offer for CRC in Denmark, and to study if more people would accept the screening offer if the present fecal test was replaced by a blood test. Methods We used a cross-sectional survey design based on a representative group of 6807 Danish citizens aged 50–80 years returning a fully answered web-based questionnaire with socio-demographic data added from national registries. Data were analyzed in STATA and based on bivariate analyses followed by regression models. Results Danes in general have a high level of lifetime participation (+ 80%) in the national CRC screening program. The results of the stepwise logistic regression model to predict CRC screening participation demonstrated that female gender, higher age, higher income, and moderate alcohol intake were positively associated with screening participation, whereas a negative association was observed for higher educational attainment, obesity, being a smoker, and higher willingness to take health risks. Of the 1026 respondents not accepting the screening offer, 61% were willing to reconsider their initial negative response if the fecal sampling procedure were replaced by blood sampling. Conclusion The CRC screening program intends to include the entire population within a certain at-risk age group. However, individual factors (e.g. sex, age obesity, smoking, risk aversity) appear to significantly affect willingness to participate in the screening program. From a preventive perspective, our findings indicate the need for a more targeted approach trying to reach these groups.

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Selection of patients for large mailed fecal immunochemical test colorectal cancer screening outreach programs: A systematic review

Journal of Medical Screening ◽

10.1177/0969141321997482 ◽

2021 ◽

pp. 096914132199748

Author(s):

Andrew Wang ◽

Briton Lee ◽

Shreya Patel ◽

Evans Whitaker ◽

Rachel B Issaka ◽

...

Keyword(s):

Colorectal Cancer ◽

Systematic Review ◽

Health Care ◽

Cancer Screening ◽

Patient Selection ◽

Implementation Strategies ◽

Screening Programs ◽

Crc Screening ◽

Key Informant ◽

Immunochemical Test

Objective Digital health care offers an opportunity to scale and personalize cancer screening programs, such as mailed outreach for colorectal cancer (CRC) screening. However, studies that describe the patient selection strategy and process for CRC screening are limited. Our objective was to evaluate implementation strategies for selecting patients for CRC screening programs in large health care systems. Methods We conducted a systematic review of 30 studies along with key informant surveys and interviews to describe programmatic implementation strategies for selecting patients for CRC screening. PubMed and Embase were searched since inception through December 2018, and hand searches were performed of the retrieved reference lists but none were incorporated ( n = 0). No language exclusions were applied. Results Common criteria for outreach exclusion included: being up-to-date with routine CRC screening ( n = 22), comorbidities ( n = 20), and personal history ( n = 22) or family history of cancer ( n = 9). Key informant surveys and interviews were performed ( n = 28) to understand data sources and practices for patient outreach selection, and found that 13 studies leveraged electronic medical care records, 10 studies leveraged a population registry (national, municipal, community, health), 4 studies required patient opt-in, and 1 study required primary care provider referral. Broad ranges in fecal immunochemical test completion were observed in community clinic ( n = 8, 31.0–59.6%), integrated health system ( n = 5, 21.2–82.7%), and national regional CRC screening programs ( n = 17, 23.0–64.7%). Six studies used technical codes, and four studies required patient self-reporting from a questionnaire to participate. Conclusion This systematic review provides health systems with the diverse outreach practices and technical tools to support efforts to automate patient selection for CRC screening outreach.

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Choice of faecal immunochemical test matters: comparison of OC-Sensor and HM-JACKarc, in the assessment of patients at high risk of colorectal cancer

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2020-1170 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Caroline J. Chapman ◽

Ayan Banerjea ◽

David J Humes ◽

Jaren Allen ◽

Simon Oliver ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Decision Making ◽

Full Range ◽

Clinical Decision ◽

Detection Rates ◽

Faecal Immunochemical Test ◽

Specimen Collection ◽

Increased Risk ◽

Immunochemical Test

AbstractObjectivesCurrently, NICE recommends the use of faecal immunochemical test (FIT) at faecal haemoglobin concentrations (f-Hb) of 10 μg Hb/g faeces to stratify for colorectal cancer (CRC) risk in symptomatic populations. This f-Hb cut-off is advised across all analysers, despite the fact that a direct comparison of analyser performance, in a clinical setting, has not been performed.MethodsTwo specimen collection devices (OC-Sensor, OC-S; HM-JACKarc, HM-J) were sent to 914 consecutive individuals referred for follow up due to their increased risk of CRC. Agreement of f-Hb around cut-offs of 4, 10 and 150 µg Hb/g faeces and CRC detection rates were assessed. Two OC-S devices were sent to a further 114 individuals, for within test comparisons.ResultsA total of 732 (80.1%) individuals correctly completed and returned two different FIT devices, with 38 (5.2%) CRCs detected. Median f-Hb for individuals diagnosed with and without CRC were 258.5 and 1.8 µg Hb/g faeces for OC-S and 318.1 and 1.0 µg Hb/g faeces for HM-J respectively. Correlation of f-Hb results between OC-S/HM-J over the full range was rho=0.74, p<0.001. Using a f-Hb of 4 µg Hb/g faeces for both tests found an agreement of 88.1%, at 10 µg Hb/g faeces 91.7% and at 150 µg Hb/g faeces 96.3%. A total of 114 individuals completed and returned two OC-S devices; correlation across the full range was rho=0.98, p<0.001.ConclusionsWe found large variations in f-Hb when different FIT devices were used, but a smaller variation when the same FIT device was used. Our data suggest that analyser-specific f-Hb cut-offs are applied with regard to clinical decision making, especially at lower f-Hb.

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