OC-098 Faecal immunochemical testing for haemoglobin in symptomatic patients can help decide need for colonoscopy

Macdonald, LR; Smith, Laura; Godber, IM; Todd, LM; Fraser, Christophe; Downey, Martin; Mukherjee, Arijit; Younes, Hakim Ben

doi:10.1136/gutjnl-2015-309861.98

Cited by 2 publications

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“…A comparison of FIT to the NICE 2-week wait referral criteria was outside the scope of our study; however, two of the studies included in our systematic review did consider this issue [ 29 , 50 ]. These studies reported the development and validation of risk prediction models for CRC [ 48 ] and AN [ 29 ]; f-Hb was identified as an independent predictor in both, and in both cases the final model demonstrated improved rule-out performance compared to the NICE 2-week wait referral criteria. The score based on the AN model had an optimum sensitivity of 88.1% (95% CI 74.3–96.0%) compared to 38.3% (95% CI 30.0–47.2%) for the NICE criteria [ 29 ].…”

Section: Discussionmentioning

confidence: 99%

Faecal immunochemical tests (FIT) can help to rule out colorectal cancer in patients presenting in primary care with lower abdominal symptoms: a systematic review conducted to inform new NICE DG30 diagnostic guidance

Westwood

Lang

Armstrong

et al. 2017

BMC Med

128

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BackgroundThis study has attempted to assess the effectiveness of quantitative faecal immunochemical tests (FIT) for triage of people presenting with lower abdominal symptoms, where a referral to secondary care for investigation of suspected colorectal cancer (CRC) is being considered, particularly when the 2-week criteria are not met.MethodsWe conducted a systematic review following published guidelines for systematic reviews of diagnostic tests. Twenty-one resources were searched up until March 2016. Summary estimates were calculated using a bivariate model or a random-effects logistic regression model.ResultsNine studies are included in this review. One additional study, included in our systematic review, was provided as ‘academic in confidence’ and cannot be described herein.When FIT was based on a single faecal sample and a cut-off of 10 μg Hb/g faeces, sensitivity estimates indicated that a negative result using either the OC-Sensor or HM-JACKarc may be adequate to rule out nearly all CRC; the summary estimate of sensitivity for the OC-Sensor was 92.1% (95% confidence interval, CI 86.9–95.3%), based on four studies (n = 4091 participants, 176 with CRC), and the only study of HM-JACKarc to assess the 10 μg Hb/g faeces cut-off (n = 507 participants, 11 with CRC) reported a sensitivity of 100% (95% CI 71.5–100%). The corresponding specificity estimates were 85.8% (95% CI 78.3–91.0%) and 76.6% (95% CI 72.6–80.3%), respectively.When the diagnostic criterion was changed to include lower grades of neoplasia, i.e. the target condition included higher risk adenoma (HRA) as well as CRC, the rule-out performance of both FIT assays was reduced.ConclusionsThere is evidence to suggest that triage using FIT at a cut-off around 10 μg Hb/g faeces has the potential to correctly rule out CRC and avoid colonoscopy in 75–80% of symptomatic patients.Systematic review registrationPROSPERO 42016037723Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-017-0944-z) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Faecal immunochemical tests (FIT) can help to rule out colorectal cancer in patients presenting in primary care with lower abdominal symptoms: a systematic review conducted to inform new NICE DG30 diagnostic guidance

Westwood

Lang

Armstrong

et al. 2017

BMC Med

128

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“…After initial screening of titles and abstracts, 113 papers were considered to be potentially relevant and ordered for full-paper screening; of these, 21 papers 13,[52][53][54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70][71] were included in the review.…”

Section: Results Of the Assessment Of Clinical Effectiveness Assessmentmentioning

confidence: 99%

“…Three diagnostic cohort studies, 56,57,75 reported in seven publications, 56,57,65,66,71,72,75 provided data on the diagnostic performance of the HM-JACKarc FIT assay. Two studies 56,75 reported accuracy data, for which CRC was the specified target condition.…”

Section: Details Of Hm-jackarc Studiesmentioning

confidence: 99%

Faecal immunochemical tests to triage patients with lower abdominal symptoms for suspected colorectal cancer referrals in primary care: a systematic review and cost-effectiveness analysis

Westwood

Ramos

Lang

et al. 2017

Health Technol Assess

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BackgroundColorectal cancer (CRC) is the third most common cancer in the UK. Presenting symptoms that can be associated with CRC usually have another explanation. Faecal immunochemical tests (FITs) detect blood that is not visible to the naked eye and may help to select patients who are likely to benefit from further investigation.ObjectivesTo assess the effectiveness of FITs [OC-Sensor (Eiken Chemical Co./MAST Diagnostics, Tokyo, Japan), HM-JACKarc (Kyowa Medex/Alpha Laboratories Ltd, Tokyo, Japan), FOB Gold (Sentinel/Sysmex, Sentinel Diagnostics, Milan, Italy), RIDASCREEN Hb or RIDASCREEN Hb/Hp complex (R-Biopharm, Darmstadt, Germany)] for primary care triage of people with low-risk symptoms.MethodsTwenty-four resources were searched to March 2016. Review methods followed published guidelines. Summary estimates were calculated using a bivariate model or a random-effects logistic regression model. The cost-effectiveness analysis considered long-term costs and quality-adjusted life-years (QALYs) that were associated with different faecal occult blood tests and direct colonoscopy referral. Modelling comprised a diagnostic decision model, a Markov model for long-term costs and QALYs that were associated with CRC treatment and progression, and a Markov model for QALYs that were associated with no CRC.ResultsWe included 10 studies. Using a single sample and 10 µg Hb/g faeces threshold, sensitivity estimates for OC-Sensor [92.1%, 95% confidence interval (CI) 86.9% to 95.3%] and HM-JACKarc (100%, 95% CI 71.5% to 100%) indicated that both may be useful to rule out CRC. Specificity estimates were 85.8% (95% CI 78.3% to 91.0%) and 76.6% (95% CI 72.6% to 80.3%). Triage using FITs could rule out CRC and avoid colonoscopy in approximately 75% of symptomatic patients. Data from our systematic review suggest that 22.5–93% of patients with a positive FIT and no CRC have other significant bowel pathologies. The results of the base-case analysis suggested minimal difference in QALYs between all of the strategies; no triage (referral straight to colonoscopy) is the most expensive. Faecal immunochemical testing was cost-effective (cheaper and more, or only slightly less, effective) compared with no triage. Faecal immunochemical testing was more effective and costly than guaiac faecal occult blood testing, but remained cost-effective at a threshold incremental cost-effectiveness ratio of £30,000. The results of scenario analyses did not differ substantively from the base-case. Results were better for faecal immunochemical testing when accuracy of the guaiac faecal occult blood test (gFOBT) was based on studies that were more representative of the correct population.LimitationsOnly one included study evaluated faecal immunochemical testing in primary care; however, all of the other studies evaluated faecal immunochemical testing at the point of referral. Further, validation data for the Faecal haemoglobin, Age and Sex Test (FAST) score, which includes faecal immunochemical testing, showed no significant difference in performance between primary and secondary care. There were insufficient data to adequately assess FOB Gold, RIDASCREEN Hb or RIDASCREEN Hb/Hp complex. No study compared FIT assays, or FIT assays versus gFOBT; all of the data included in this assessment refer to the clinical effectiveness of individual FIT methods andnottheir comparative effectiveness.ConclusionsFaecal immunochemical testing is likely to be a clinically effective and cost-effective strategy for triaging people who are presenting, in primary care settings, with lower abdominal symptoms and who are at low risk for CRC. Further research is required to confirm the effectiveness of faecal immunochemical testing in primary care practice and to compare the performance of different FIT assays.Study registrationThis study is registered as PROSPERO CRD42016037723.FundingThe National Institute for Health Research Health Technology Assessment programme.

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OC-098 Faecal immunochemical testing for haemoglobin in symptomatic patients can help decide need for colonoscopy

Cited by 2 publications

References 0 publications

Faecal immunochemical tests (FIT) can help to rule out colorectal cancer in patients presenting in primary care with lower abdominal symptoms: a systematic review conducted to inform new NICE DG30 diagnostic guidance

Faecal immunochemical tests (FIT) can help to rule out colorectal cancer in patients presenting in primary care with lower abdominal symptoms: a systematic review conducted to inform new NICE DG30 diagnostic guidance

Faecal immunochemical tests to triage patients with lower abdominal symptoms for suspected colorectal cancer referrals in primary care: a systematic review and cost-effectiveness analysis

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