Faecal immunochemical test for suspected colorectal cancer symptoms: patient survey of usability and acceptability

BackgroundRecent evidence suggests that the Faecal Immunochemical Test (FIT) can rule out colorectal cancer (CRC) in symptomatic patients. To date, there is no research on usability and perception of FIT for these patients.AimTo measure variation in attitudes and perception of FIT in patients with suspected CRC symptoms.Design & settingCross sectional survey of a sub-set of participants of the NICE FIT study.MethodA questionnaire was co-developed with patients covering four themes: FIT feasibility, faecal aversion, patient knowledge and future intentions, on a Likert scale. Questionnaire and FIT kits were sent to patients with suspected CRC symptoms participating in the NICE FIT study. Logistic regression explored differences in patients’ test perception by ethnicity, language, age, location, deprivation, FIT use and previous experience.Results1151 questionnaires were analysed; 90.2% of patients found faecal collection straightforward, (95% CI 88.3%–91.8%), 76.3% disagreed FIT was unhygienic (95% CI 73.7%–78.6%), 78.1% preferred FIT to colonoscopy (95% CI 75.6%–80.4%). Preference for FIT over colonoscopy was weaker in patients aged 40–64 than those over 65 years (OR 0.60; 95% CI 0.43–0.84). Intention to use FIT again was stronger in patients who successfully used FIT than those unsuccessful (OR 11.08; 95% CI 2.74–44.75) and white compared to non-white patients (OR 3.20; 95% CI 1.32–7.75).ConclusionsWhile most patients found FIT practical and hygienic, perception differences were found. Strategies to engage patients with more negative FIT perception should underpin symptomatic FIT pathways.

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Public preferences for using quantitative faecal immunochemical test versus colonoscopy as diagnostic test for colorectal cancer: evidence from an online survey

BJGP Open ◽

10.3399/bjgpopen20x101007 ◽

2020 ◽

Vol 4 (1) ◽

pp. bjgpopen20X101007 ◽

Cited By ~ 1

Author(s):

Christian von Wagner ◽

Wouter Verstraete ◽

Yasemin Hirst ◽

Brian D Nicholson ◽

Sandro T Stoffel ◽

...

Keyword(s):

Colorectal Cancer ◽

Diagnostic Test ◽

Online Survey ◽

False Negative ◽

Test Results ◽

Cross Sectional ◽

Public Preferences ◽

Faecal Immunochemical Test ◽

Home Based ◽

Immunochemical Test

BackgroundThere has been interest in using the non-invasive, home-based quantitative faecal immunochemical test (FIT) to rule out colorectal cancer (CRC) in high-risk symptomatic patients.AimTo elicit public preferences for FIT versus colonoscopy (CC) and its delivery in primary care.Design & settingA cross-sectional online survey in England.MethodA total of 1057 adults (without CRC symptoms and diagnosis) aged 40–59 years were invited from an English online survey panel. Responders were asked to imagine they had been experiencing CRC symptoms that would qualify them for a diagnostic test. Participants were presented with choices between CC and FIT in ascending order of number of CRCs missed by FIT (from 1–10%). It was measured at what number of missed CRCs responders preferred CC over FIT.ResultsWhile 150 participants did not want either of the tests when both missed 1% CRCs, the majority (n = 741, 70.0%) preferred FIT to CC at that level of accuracy. However, this preference reduced to 427 (40.4%) when FIT missed one additional cancer. Women were more likely to tolerate missing CRC when using FIT. Having lower numeracy and perceiving a higher level of risk meant participants were less likely to tolerate a false negative test. Most of those who chose FIT preferred to return it by mail (62.2%), to be informed about normal test results by letter (42.1%), and about abnormal test results face to face (32.5%).ConclusionWhile the majority of participants preferred FIT over CC when both tests had the same sensitivity, tolerance for missed CRCs was low.

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Faecal immunochemical test is superior to symptoms in predicting pathology in patients with suspected colorectal cancer symptoms referred on a 2WW pathway: a diagnostic accuracy study

Gut ◽

10.1136/gutjnl-2020-321956 ◽

2020 ◽

pp. gutjnl-2020-321956 ◽

Cited By ~ 2

Author(s):

Nigel D'Souza ◽

Theo Georgiou Delisle ◽

Michelle Chen ◽

Sally Benton ◽

Muti Abulafi

Keyword(s):

Colorectal Cancer ◽

Diagnostic Accuracy ◽

Characteristic Curve ◽

Final Analysis ◽

Diagnostic Accuracy Study ◽

Predictive Values ◽

Cancer Symptoms ◽

Faecal Immunochemical Test ◽

Accuracy Study ◽

Immunochemical Test

ObjectiveTo assess whether a faecal immunochemical test (FIT) could be used to select patients with suspected colorectal cancer (CRC) symptoms for urgent investigation.DesignMulticentre, double-blinded diagnostic accuracy study in 50 National Health Service (NHS) hospitals across England between October 2017 and December 2019. Patients referred to secondary care with suspected CRC symptoms meeting NHS England criteria for urgent 2 weeks wait referral and triaged to investigation with colonoscopy were invited to perform a quantitative FIT. The sensitivity of FIT for CRC, and effect of relevant variables on its diagnostic accuracy was assessed.Results9822 patients were included in the final analysis. The prevalence of CRC at colonoscopy was 3.3%. The FIT positivity decreased from 37.2% to 19.0% and 7.6%, respectively, at cut-offs of 2, 10 and 150 µg haemoglobin/g faeces (µg/g). The positive predictive values of FIT for CRC at these cut-offs were 8.7% (95% CI, 7.8% to 9.7%), 16.1% (95% CI 14.4% to 17.8%) and 31.1% (95% CI 27.8% to 34.6%), respectively, and the negative predictive values were 99.8% (95% CI 99.7% to 99.9%), 99.6% (95% CI 99.5% to 99.7%) and 98.9% (95% CI 98.7% to 99.1%), respectively. The sensitivity of FIT for CRC decreased at the same cut-offs from 97.0% (95% CI 94.5% to 98.5%) to 90.9% (95% CI 87.2% to 93.8%) and 70.8% (95% CI 65.6% to 75.7%), respectively, while the specificity increased from 64.9% (95% CI 63.9% to 65.8%) to 83.5% (95% CI 82.8% to 84.3%) and 94.6% (95% CI 94.1% to 95.0%), respectively. The area under the receiver operating characteristic curve was 0.93 (95% CI 0.92 to 0.95).ConclusionFIT sensitivity is maximised to 97.0% at the lowest cut-off (2 µg/g); a negative FIT result at this cut-off can effectively rule out CRC and a positive FIT result is better than symptoms to select patients for urgent investigations.Trial registration numberISRCTN49676259.

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The diagnostic accuracy of the faecal immunochemical test for colorectal cancer in risk-stratified symptomatic patients

Annals of The Royal College of Surgeons of England ◽

10.1308/rcsann.2019.0144 ◽

2020 ◽

Vol 102 (3) ◽

pp. 174-179 ◽

Cited By ~ 5

Author(s):

N D’Souza ◽

G Hicks ◽

SC Benton ◽

M Abulafi

Keyword(s):

Colorectal Cancer ◽

Pilot Study ◽

Diagnostic Accuracy ◽

Significant Variation ◽

Detection Rate ◽

Low Risk ◽

Faecal Immunochemical Test ◽

Risk Patients ◽

Immunochemical Test ◽

Rule Out

Introduction The faecal immunochemical test detects blood in the faeces, reporting faecal haemoglobin quantitatively in micrograms of haemoglobin per gram of faeces. The aim of this pilot study was to determine the feasibility of using the faecal immunochemical test as a rule-out test in symptomatic patients at low and high risk of colorectal cancer. Material and methods Between November 2016 and October 2017, consecutive symptomatic patients within a multicultural part of London were recruited to perform a faecal immunochemical test prior to colonoscopy. Analysis was performed on the HM-JACKarc analyser. Results Faecal immunochemical test samples were returned by 298 patients who underwent colonoscopy. There was no significant variation in faecal haemoglobin levels by age, sex, ethnicity or deprivation. The overall detection rate for colorectal cancer was 100% at 2 µg/g and 92% at 10 µg/g. If a faecal haemoglobin threshold for investigation of 2 µg/g (ie detectable) or 10 µg/g had been employed, the number of colonoscopies would have been reduced by 70% and 84%, respectively, in all symptomatic patients. For low-risk patients, the sensitivity of the faecal immunochemical test for colorectal cancer at both thresholds of 2 µg/g or 10 µg/g remained 100%, with the number of colonoscopies reduced by 80% and 91%, respectively. Conclusion This study shows that the faecal immunochemical test is a promising technology that detected colorectal cancer in all high- or low-risk symptomatic patients in our cohort at a threshold of detectable faecal haemoglobin. Data from adequately powered cohort studies will elucidate the true diagnostic accuracy of the test and the rate and patterns of undetected colorectal cancer.

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Individualized Faecal Immunochemical Test Cut-off based on Age and Sex in Colorectal Cancer Screening

Preventive Medicine Reports ◽

10.1016/j.pmedr.2021.101447 ◽

2021 ◽

pp. 101447

Author(s):

Tim L. Kortlever ◽

Manon van der Vlugt ◽

Evelien Dekker ◽

Patrick M.M. Bossuyt

Keyword(s):

Colorectal Cancer ◽

Cancer Screening ◽

Colorectal Cancer Screening ◽

Faecal Immunochemical Test ◽

Immunochemical Test ◽

Age And Sex

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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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Finding the needle in the haystack; the diagnostic accuracy of the faecal immunochemical test for colorectal cancer in younger symptomatic patients

Colorectal Disease ◽

10.1111/codi.15786 ◽

2021 ◽

Author(s):

Nigel D’Souza ◽

Kevin Monahan ◽

Sally C. Benton ◽

Lisa Wilde ◽

Muti Abulafi ◽

...

Keyword(s):

Colorectal Cancer ◽

Diagnostic Accuracy ◽

Faecal Immunochemical Test ◽

Immunochemical Test

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Impact of screening programme using the faecal immunochemical test on stage of colorectal cancer: Results from the IMPATTO study

International Journal of Cancer ◽

10.1002/ijc.32089 ◽

2019 ◽

Vol 145 (1) ◽

pp. 110-121 ◽

Cited By ~ 6

Author(s):

Massimo Vicentini ◽

Manuel Zorzi ◽

Emanuela Bovo ◽

Pamela Mancuso ◽

Marco Zappa ◽

...

Keyword(s):

Colorectal Cancer ◽

Screening Programme ◽

Faecal Immunochemical Test ◽

Immunochemical Test

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What is associated with increased side effects and lower perceived efficacy following switching to a generic medicine? A New Zealand cross-sectional patient survey

BMJ Open ◽

10.1136/bmjopen-2018-023667 ◽

2018 ◽

Vol 8 (10) ◽

pp. e023667 ◽

Cited By ~ 9

Author(s):

Kate MacKrill ◽

Keith J Petrie

Keyword(s):

New Zealand ◽

Side Effects ◽

Generic Version ◽

Drug Efficacy ◽

Patient Survey ◽

Generic Medicine ◽

Cross Sectional Survey ◽

Online Questionnaire ◽

Cross Sectional ◽

Perceived Efficacy

ObjectiveFollowing a switch from either a generic or branded antidepressant (venlafaxine) to a new generic, we investigated the factors associated with a preference for branded medicines, side effects reported following switching and efficacy ratings of the new generic drug.DesignA cross-sectional survey of patients switched to a new generic.SettingPatients accessing venlafaxine information online from the New Zealand government pharmaceuticals funding website.Participants310 patients, comprising 205 originally on branded venlafaxine and 105 previously taking a generic version.Main outcome measuresAn online questionnaire assessing demographic factors, perceived sensitivity to medicines, trust in pharmaceutical agencies, sources of switch information, preference for branded medicine, new medicine perceptions, side effects and efficacy ratings.ResultsPreference for branded medicine was significantly stronger in older patients (OR=1.04, 95% CI 1.01 to 1.05), those taking branded venlafaxine (OR=2.02, 95% CI 1.13 to 3.64) and patients with a higher perceived sensitivity to medicine (OR=1.23, 95% CI 1.06 to 1.19). Different factors predicted side effects in those switching from the branded and those switching from the generic venlafaxine. Trust in pharmaceutical agencies and the number of side effects were significant predictors of efficacy ratings of the new generic in both patients switching from a branded and those switching from a generic version of venlafaxine.ConclusionsIn patients switching from a branded medicine and those already taking a generic, different demographic and psychological factors are associated with preference for branded medicine, side effect reporting and perceived efficacy of the new drug. When switching to new generic, there appears to be a close bidirectional relationship between the experience of side effects and perceived drug efficacy. Trust in pharmaceutical agencies impacts directly on perceived efficacy and increasing such trust could reduce the nocebo response following a generic switch.

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