The value of using the faecal immunochemical test in general practice on patients presenting with non-alarm symptoms of colorectal cancer.
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ABSTRACT: Background
Around 50% of individuals with colorectal cancer (CRC) initially present with non-alarm symptoms.Methods
We investigated the value of using the faecal immunochemical test (FIT) in the diagnostic process of CRC and other serious bowel disease in individuals presenting with non-alarm symptoms in general practice. The study was conducted in the Central Denmark Region from 1 September 2015 to 30 August 2016. The FIT was used as a rule-in test on patients aged ≥30 years with non-alarm symptoms of CRC. The cut-off value was set to 10 µg Hb/g faeces.Results
A total of 3462 valid FITs were performed. Of these, 540 (15.6%) were positive. Three months after FIT performance, 51 (PPV: 9.4% (95% CI: 7.0;11.9)) individuals with a positive FIT were diagnosed with CRC and 73 (PPV: 13.5% (95%CI: 10.6;16.4)) with other serious bowel disease. Of CRCs, 66.7% were diagnosed in UICC stage I & II and 19.6% in stage IV. The false negative rate for CRC was <0.1% for the initial 3 months after FIT performance.Conclusion
The FIT may be used as a supplementary diagnostic test in the diagnostic process of CRC and other serious bowel disease in individuals with non-alarm symptoms of CRC in general practice.
SUBMITTER: Juul JS
PROVIDER: S-EPMC6133998 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesThe faecal immunochemical test (FIT) was introduced to triage patients with lower-risk symptoms of colorectal cancer (CRC) in English primary care in 2018. While there is growing evidence on its utility to triage patients in this setting, evidence is still limited on how official FIT guidance is being used, for which patients and for what symptoms. We aimed to investigate the use of FIT in primary care practice for lower-risk patients who did not immediately meet criteria for urgent referral.DesignA prospective, descriptive study of symptomatic patients offered a FIT in primary care between January and June 2020.SettingEast of England general practices.ParticipantsConsenting patients (aged ≥40 years) who were seen by their general practitioners (GPs) with symptoms of possible CRC for whom a FIT was requested. We excluded patients receiving a FIT for asymptomatic screening purposes, or patients deemed by GPs as lacking capacity for informed consent. Data were obtained via patient questionnaire, medical and laboratory records.Primary and secondary outcome measuresFIT results (10 µg Hb/g faeces defined a positive result); patient sociodemographic and clinical characteristics; patient-reported and GP-recorded symptoms, symptom severity and symptom agreement between patient and GP (% and kappa statistics).ResultsComplete data were available for 310 patients, median age 70 (IQR 61-77) years, 53% female and 23% FIT positive. Patients most commonly reported change in bowel habit (69%) and fatigue (57%), while GPs most commonly recorded abdominal pain (25%) and change in bowel habit (24%). Symptom agreement ranged from 44% (fatigue) to 80% (unexplained weight loss). Kappa agreement was universally low across symptoms.ConclusionAlmost a quarter of this primary care cohort of symptomatic patients with FIT testing were found to be positive. However, there was low agreement between patient-reported and GP-recorded symptoms. This may impact cancer risk assessment and optimal patient management in primary care.
| S-EPMC9486301 | biostudies-literature
Project description:BackgroundIn middle-income countries, the burden of colorectal cancer (CRC) is increasing in parallel with resources for diagnosis and treatment. There is a potential benefit of CRC screening programs in Mexico.ObjectiveSince there are no organized screening programs in the country, we explored the willingness of individuals to complete a faecal immunochemical testing (FIT) based CRC screening program and its potential benefit in Mexico.MethodsWe conducted a CRC screening program pilot in Veracruz, Mexico, during 2015-16 using FIT. Individuals with FIT results >100 ng of haemoglobin/ml buffer were referred for diagnostic colonoscopy.ResultsOf 473 FIT kits distributed to adults aged 50-75, 85.8% (406) were completed by participants and analysed in the laboratory. Of these, 5.9% (24/406) of test results showed >100 ng haemoglobin/ml. Twenty-one participants completed colonoscopy. The positive predictive value of FIT >100 ng haemoglobin/ml for premalignant lesions was 33%.ConclusionThese results provide preliminary evidence of the willingness of individuals to complete FIT-based CRC screening program in Mexico. However, further evaluation of health systems resources will be needed prior to large-scale implementation of CRC screening programs.
| S-EPMC7377340 | biostudies-literature
Project description:BackgroundColorectal cancer is a common malignancy and a leading cause of cancer-related death. Half of patients with colorectal cancer initially present with non-specific or vague symptoms. In the need for a safe low-cost test, the immunochemical faecal occult blood test (iFOBT) may be part of the evaluation of such patients in primary care. Currently, Danish general practitioners have limited access to this test. The aim of this article is to describe a study that will assess the uptake and clinical use of iFOBT in general practice. Furthermore, it will investigate the diagnostic value and the clinical implications of using iFOBT in general practice on patients presenting with non-alarm symptoms of colorectal cancer.Methods/designThe study uses a cluster-randomised stepped-wedge design and is conducted in the Central Denmark Region among 836 GPs in 381 general practices. The municipalities of the Region and their appertaining general practitioners will be included sequentially in the study during the first 7 months of the 1-year study period. The following intervention has been developed for the study: a mandatory intervention providing all general practitioners with a starting package of 10 iFOBTs, a clinical instruction on iFOBT use in general practice and online information material from the date of inclusion, and an optional intervention consisting of a continuous medical education on colorectal cancer diagnostics and use of iFOBT.DiscussionThis study is among the first and largest trials to investigate the diagnostic use and the clinical value of iFOBT on patients presenting with non-alarm symptoms of colorectal cancer. The findings will be of national and international importance for the future planning of colorectal cancer diagnostics, particularly for 'low-risk-but-not-no-risk' patients with non-alarm symptoms of colorectal cancer.Trial registrationA Trial of the Implementation of iFOBT in General Practice NCT02308384 . Date of registration: 26 November 2014.
| S-EPMC4940713 | biostudies-literature
Project description:BackgroundFaecal immunochemical test (FIT)-directed pathways based on a single test have been implemented for symptomatic patients. However, with a single test, the sensitivity is 87 per cent at 10 µg haemoglobin (Hb) per g faeces. This aims of this study were to define the diagnostic performance of a single FIT, compared with double FIT in symptomatic populations.MethodsTwo sequential prospective patient cohorts referred with symptoms from primary care were studied. Patients in cohort 1 were sent a single FIT, and those in cohort 2 received two tests in succession before investigation. All patients were investigated, regardless of having a positive or negative test (threshold 10 µg Hb per g).ResultsIn cohort 1, 2260 patients completed one FIT and investigation. The sensitivity of single FIT was 84.1 (95 per cent c.i. 73.3 to 91.8) per cent for colorectal cancer and 67.4 (61.0 to 73.4) per cent for significant bowel pathology. In cohort 2, 3426 patients completed at least one FIT, and 2637 completed both FITs and investigation. The sensitivity of double FIT was 96.6 (90.4 to 99.3) per cent for colorectal cancer and 83.0 (77.4 to 87.8) per cent for significant bowel pathology. The second FIT resulted in a 50.0 per cent reduction in cancers missed by the first FIT, and 30.0 per cent for significant bowel pathology. Correlation between faecal Hb level was only modest (rs = 0.58), and 16.8 per cent of double tests were discordant, 11.4 per cent in patients with colorectal cancer and 18.3 per cent in those with significant bowel pathology.ConclusionFIT in patients with high-risk symptoms twice in succession reduces missed significant colorectal pathology and has an acceptable workload impact.
| S-EPMC10364540 | biostudies-literature
Project description:BackgroundFaecal immunochemical tests (FITs) are used to triage primary care patients with symptoms that could be caused by colorectal cancer for referral to colonoscopy. The aim of this study was to determine whether combining FIT with routine blood test results could improve the performance of FIT in the primary care setting.MethodsResults of all consecutive FITs requested by primary care providers between March 2017 and December 2020 were retrieved from the Oxford University Hospitals NHS Foundation Trust. Demographic factors (age, sex), reason for referral, and results of blood tests within 90 days were also retrieved. Patients were followed up for incident colorectal cancer in linked hospital records. The sensitivity, specificity, positive and negative predictive values of FIT alone, FIT paired with blood test results, and several multivariable FIT models, were compared.ResultsOne hundred thirty-nine colorectal cancers were diagnosed (0.8%). Sensitivity and specificity of FIT alone at a threshold of 10 μg Hb/g were 92.1 and 91.5% respectively. Compared to FIT alone, blood test results did not improve the performance of FIT. Pairing blood test results with FIT increased specificity but decreased sensitivity. Multivariable models including blood tests performed similarly to FIT alone.ConclusionsFIT is a highly sensitive tool for identifying higher risk individuals presenting to primary care with lower risk symptoms. Combining blood test results with FIT does not appear to lead to better discrimination for colorectal cancer than using FIT alone.
| S-EPMC8920746 | biostudies-literature
Project description:BACKGROUND: The cutoff of semi-quantitative immunochemical faecal occult blood tests (iFOBTs) influences colonoscopy referrals and detection rates. We studied the performance of an iFOBT (OC-Sensor) in colorectal cancer (CRC) screening at different cutoffs. METHODS: Dutch screening participants, 50-75 years of age, with average CRC risk and an iFOBT value >or=50 ng ml(-1) were offered colonoscopy. The detection rate was the percentage of participants with CRC or advanced adenomas (>or=10 mm, >or=20% villous, high-grade dysplasia). The number needed to scope (NNTScope) was the number of colonoscopies to be carried out to find one person with CRC or advanced adenomas. RESULTS: iFOBT values >or=50 ng ml(-1) were detected in 526 of 6157 participants (8.5%) and 428 (81%) underwent colonoscopy. The detection rate for advanced lesions (28 CRC and 161 with advanced adenomas) was 3.1% (95% confidence interval: 2.6-3.5%) and the NNTScope was 2.3. At 75 ng ml(-1), the detection rate was 2.7%, the NNTScope was 2.0 and the CRC miss rate compared with 50 ng ml(-1) was <5% (N=1). At 100 ng ml(-1), the detection rate was 2.4% and the NNTScope was <2. Compared with 50 ng ml(-1), up to 200 ng ml(-1) CRC miss rates remained at 16% (N=4). CONCLUSIONS: Cutoffs below the standard 100 ng ml(-1) resulted in not only higher detection rates of advanced lesions but also more colonoscopies. With sufficient capacity, 75 ng ml(-1) might be advised; if not, up to 200 ng ml(-1) CRC miss rates are acceptable compared with the decrease in performed colonoscopies.
| S-EPMC2768446 | biostudies-other
Project description:BackgroundRecently, faecal immunochemical tests (FITs) have been introduced for investigation of primary care patients with low-risk symptoms of colorectal cancer (CRC), but recommendations vary across the world. This systematic review of clinical practice guidelines aimed to determine how FITs are used in symptomatic primary care patients and the underpinning evidence for these guidelines.MethodsMEDLINE, Embase and TRIP databases were systematically searched, from 1 November 2008 to 1 November 2018 for guidelines on the assessment of patients with symptoms suggestive of CRC. Known guideline databases, websites and references of related literature were searched. The following questions were addressed: (i) which countries use FIT for symptomatic primary care patients; (ii) in which populations is FIT used; (iii) what is the cut-off level used for haemoglobin in the faeces (FIT) and (iv) on what evidence are FIT recommendations based.ResultsThe search yielded 2433 publications; 25 covered initial diagnostic assessment of patients with symptoms of CRC in 15 countries (Asia, n = 1; Europe, n = 13; Oceania, n = 4; North America, n = 5; and South America, n = 2). In three countries (Australia, Spain and the UK), FIT was recommended for patients with abdominal symptoms, unexplained weight loss, change in bowel habit or anaemia despite a low level of evidence in the symptomatic primary care patient population.ConclusionsFew countries recommend FITs in symptomatic patients in primary care either because of limited evidence or because symptomatic patients are directly referred to secondary care without triage. These results demonstrate a clear need for research on FIT in the symptomatic primary care population.
| S-EPMC7571772 | biostudies-literature
Project description:The risk of having colorectal cancer (CRC) or its precursors vary with age and sex. Yet, most CRC screening programs using the quantitative faecal immunochemical test (FIT) use a uniform FIT cut-off. We aimed to calculate individualized FIT cut-offs based on age and sex. Data from a study of 1,112 asymptomatic average-risk screening participants undergoing colonoscopy without preselection were used to build a logistic regression model to calculate the risk of having advanced neoplasia (AN) at colonoscopy using age, sex, and FIT concentration as variables. We calculated age- and sex-adjusted FIT cut-off concentrations based on a uniform risk threshold. In a total of 101 of the 1,112 participants AN was detected at colonoscopy. We selected a risk threshold that would produce a specificity of 96.9% in the study group, matching the specificity of FIT at a cut-off of 20 µg Hb/g faeces. At this threshold, age- and sex-adjusted FIT cut-off concentrations ranged from 36.9 µg Hb/g faeces for 50-year-old women to 9.5 µg Hb/g faeces for 75-year old men. At this level of specificity, the risk-based model reached a sensitivity for AN of 28.7% (95%CI: 20.8 to 38.2) versus 27.7% (95%CI: 19.9 to 37.1) for FIT only. Using a risk threshold instead of a uniform FIT-based threshold for inviting screening participants to follow-up colonoscopy ensures that everyone has a comparable risk of AN prior to colonoscopy and may improve the detection of advanced neoplasia, although the absolute magnitude of the increase is likely to be limited.
| S-EPMC8209662 | biostudies-literature
Project description:Introduction: The colorectal cancer prognosis depends on the stage of the neoplasm; therefore, its early detection plays an important role. The aim of the study is evaluation of the sensitivity, specificity, and clinical effectiveness of the faecal immunochemical test in the early colorectal cancer detection. Methods: The clinical analysis was based on the results of the studies included in a systematic review conducted in accordance with the Cochrane Collaboration guidelines. The following medical information sources were searched: Medline (via PubMed), Embase (via Ovid), The Cochrane Library. Results: From 241 citations, 13 studies were included in this review. All included studies had a low risk of bias. The faecal immunochemical test is highly specific in all analysed populations ranging from 85% to 97%. In most of the found studies, sensitivity is over 75%. The faecal immunochemical test screening also determines a reduction in death (10-59%) due to colorectal cancer. Conclusions: The faecal immunochemical test is an effective and cost-effective method of conducting population-wide colorectal cancer screening. It is an alternative or complementary to other screening tests, including colonoscopy.
| S-EPMC9496929 | biostudies-literature
Project description:BackgroundOrganised programmes for colorectal cancer screening demand a high burden of medical and economic resources. The preferred methods are the faecal immunochemical test and primary colonoscopy.ObjectiveThe purpose of this study was to perform an economic analysis and comparison between these tests in Europe.MethodsWe used a Markov cost-utility analysis from a societal perspective comparing biennial faecal immunochemical test or colonoscopy every 10 years screening versus non-screening in Portugal. The population was screened, aged from 50-74 years, and efficacy was evaluated in quality-adjusted life years. For the base-case scenario, the faecal immunochemical test cost was €3 with 50% acceptance and colonoscopy cost was €397 with 38% acceptance. The threshold was set at €39,760/quality-adjusted life years and the primary outcome was the incremental cost-effectiveness ratio.ResultsScreening by biennial faecal immunochemical test and primary colonoscopy every 10 years resulted in incremental utilities of 0.00151 quality-adjusted life years and 0.00185 quality-adjusted life years at additional costs of €4 and €191, respectively. The faecal immunochemical test was the most cost-effective option providing an incremental cost-effectiveness ratio of €2694/quality-adjusted life years versus €103,633/quality-adjusted life years for colonoscopy. Colonoscopy capacity would have to increase 1.3% for a faecal immunochemical test programme or 31% for colonoscopy.ConclusionBiennial faecal immunochemical test screening is better than colonoscopy as it is cost-effective, allows more individuals to get screened, and provides a more rational use of the endoscopic capacity available.
| S-EPMC6374854 | biostudies-literature