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

ObjectiveImplementation of faecal immunochemical tests (FIT) as a triage test in primary healthcare may improve the efficiency of referrals without missing cases of colorectal cancer (CRC). We aim to summarise the performance characteristics of FITs for CRC in symptomatic patients presenting to primary healthcare.DesignWe performed a systematic literature review of Medline and EMBASE databases from May 2018 to November 2020. Previous related systematic searches were also adapted to this aim and completed with reference screening. We identified studies performed on adult patients consulting for abdominal symptoms in primary care which reported data such that the FIT diagnostic performance parameters for CRC could be obtained. Bivariate models were used to synthesise available evidence. Meta-regression analysis was performed to evaluate the causes of heterogeneity.ResultsTwenty-three studies (69 536 participants) were included (CRC prevalence 0.3%–6.2%). Six studies (n=34 691) assessed FIT as rule in test (threshold of ≥150 µg Hb/g faeces) showing a sensitivity of 64.1% (95% CI 57.8% to 69.9%) and a specificity of 95.0% (95% CI 91.2% to 97.2%). A threshold of 10 µg/g (15 studies; n=48 872) resulted in a sensitivity of 87.2% (95% CI 81.0% to 91.6%) and a specificity of 84.4% (95% CI 79.4% to 88.3%) for CRC. At a 20 µg Hb/g faeces threshold (five studies; n=24 187) less than one additional CRC would be missed per 1000 patients investigated compared with 10 µg Hb/g faeces threshold (CRC prevalence 2%).ConclusionFIT is the test of choice to evaluate patients with new-onset lower gastrointestinal symptoms in primary healthcare.

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Development, validation and effectiveness of diagnostic prediction tools for colorectal cancer in primary care: a systematic review

BMC Cancer ◽

10.1186/s12885-020-07572-z ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Bogdan Grigore ◽

Ruth Lewis ◽

Jaime Peters ◽

Sophie Robinson ◽

Christopher J. Hyde

Keyword(s):

Colorectal Cancer ◽

Systematic Review ◽

Primary Care ◽

Cost Effectiveness ◽

Prediction Model ◽

Prediction Models ◽

Diagnostic Tools ◽

Inclusion Criteria ◽

Impact Studies ◽

The Impact

Abstract Background Tools based on diagnostic prediction models are available to help general practitioners (GP) diagnose colorectal cancer. It is unclear how well they perform and whether they lead to increased or quicker diagnoses and ultimately impact on patient quality of life and/or survival. The aim of this systematic review is to evaluate the development, validation, effectiveness, and cost-effectiveness, of cancer diagnostic tools for colorectal cancer in primary care. Methods Electronic databases including Medline and Web of Science were searched in May 2017 (updated October 2019). Two reviewers independently screened titles, abstracts and full-texts. Studies were included if they reported the development, validation or accuracy of a prediction model, or assessed the effectiveness or cost-effectiveness of diagnostic tools based on prediction models to aid GP decision-making for symptomatic patients presenting with features potentially indicative of colorectal cancer. Data extraction and risk of bias were completed by one reviewer and checked by a second. A narrative synthesis was conducted. Results Eleven thousand one hundred thirteen records were screened and 23 studies met the inclusion criteria. Twenty-studies reported on the development, validation and/or accuracy of 13 prediction models: eight for colorectal cancer, five for cancer areas/types that include colorectal cancer. The Qcancer models were generally the best performing. Three impact studies met the inclusion criteria. Two (an RCT and a pre-post study) assessed tools based on the RAT prediction model. The third study looked at the impact of GP practices having access to RAT or Qcancer. Although the pre-post study reported a positive impact of the tools on outcomes, the results of the RCT and cross-sectional survey found no evidence that use of, or access to, the tools was associated with better outcomes. No study evaluated cost effectiveness. Conclusions Many prediction models have been developed but none have been fully validated. Evidence demonstrating improved patient outcome of introducing the tools is the main deficiency and is essential given the imperfect classification achieved by all tools. This need is emphasised by the equivocal results of the small number of impact studies done so far.

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Diagnostic accuracy of follow‐up tests for detecting colorectal cancer recurrences in primary care: A systematic review and meta‐analysis

European Journal of Cancer Care ◽

10.1111/ecc.13432 ◽

2021 ◽

Author(s):

Geertje B. Liemburg ◽

Daan Brandenbarg ◽

Marjolein Y. Berger ◽

Saskia F.A. Duijts ◽

Gea A. Holtman ◽

...

Keyword(s):

Colorectal Cancer ◽

Systematic Review ◽

Primary Care ◽

Diagnostic Accuracy ◽

Meta Analysis

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Attitudes towards faecal immunochemical testing in patients at increased risk of colorectal cancer: an online survey of GPs in England

British Journal of General Practice ◽

10.3399/bjgp18x699413 ◽

2018 ◽

Vol 68 (676) ◽

pp. e757-e764 ◽

Cited By ~ 4

Author(s):

Christian von Wagner ◽

Sandro Stoffel ◽

Madeleine Freeman ◽

Helga Laszlo ◽

Brian D Nicholson ◽

...

Keyword(s):

Colorectal Cancer ◽

Primary Care ◽

High Risk ◽

Online Survey ◽

Educational Outreach ◽

Cross Sectional ◽

Logistic Regression Models ◽

Increased Risk ◽

Willingness To Use ◽

Rule Out

BackgroundThere is increasing interest in using a quantitative faecal immunochemical test (FIT) to rule out colorectal cancer (CRC) in patients with high-risk symptoms in primary care.AimThis study aimed to investigate GPs’ attitudes and willingness to use a FIT over an urgent 2-week wait (2WW) referral.Design and settingA cross-sectional online survey involving 1024 GPs working across England.MethodLogistic regression models were used to explore the likelihood of GPs using a FIT instead of a 2WW referral, and reported using odds ratios (ORs) and 95% confidence intervals (95% CIs).ResultsJust over one-third of GPs (n = 365) preferred to use a FIT as a rule-out test over a 2WW referral. GPs were more willing if they were: aged 36–45 years (OR 1.59 [95% CI = 1.04 to 2.44]); 46–55 years (OR 1.99 [95% CI = 1.14 to 3.47]); thought a FIT was highly accurate (OR 1.63 [95% CI = 1.16 to 2.29]); thought patients would benefit compared with having a colonoscopy (OR 2.02 [95% CI = 1.46 to 2.79]); and were highly confident about discussing the benefits of a FIT (OR 2.14 [95% CI = 1.46 to 3.16]). GPs were less willing if they had had >10 urgent referrals in the past year (OR 0.62 [95% CI = 0.40 to 0.94]) and thought that longer consultations would be needed (OR 0.61 [95% CI = 0.44 to 0.83]).ConclusionThe study findings suggest that the acceptability of using a FIT as a rule-out test in primary care is currently low, with less than half of GPs who perceived the test to be accurate preferring it over colonoscopy. Any potential guideline changes recommending a FIT in patients with high-risk symptoms, instead of urgent referral to rule out CRC, are likely to require intensive supporting educational outreach to increase GP confidence in the accuracy and application of a FIT in this context.

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The diagnostic value of symptoms for colorectal cancer in primary care: a systematic review

British Journal of General Practice ◽

10.3399/bjgp11x572427 ◽

2011 ◽

Vol 61 (586) ◽

pp. e231-e243 ◽

Cited By ~ 114

Author(s):

Margaret Astin ◽

Tom Griffin ◽

Richard D Neal ◽

Peter Rose ◽

William Hamilton

Keyword(s):

Colorectal Cancer ◽

Systematic Review ◽

Primary Care ◽

Diagnostic Value

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Value of symptoms and additional diagnostic tests for colorectal cancer in primary care: systematic review and meta-analysis

BMJ ◽

10.1136/bmj.c1269 ◽

2010 ◽

Vol 340 (mar31 3) ◽

pp. c1269-c1269 ◽

Cited By ~ 114

Author(s):

P. Jellema ◽

D. A. W. M. van der Windt ◽

D. J. Bruinvels ◽

C. D. Mallen ◽

S. J. B. van Weyenberg ◽

...

Keyword(s):

Colorectal Cancer ◽

Systematic Review ◽

Primary Care ◽

Diagnostic Tests ◽

Meta Analysis

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Faecal immunochemical test to triage patients with abdominal symptoms for suspected colorectal cancer in primary care: review of international use and guidelines

Family Practice ◽

10.1093/fampra/cmaa043 ◽

2020 ◽

Vol 37 (5) ◽

pp. 606-615 ◽

Cited By ~ 2

Author(s):

Marije van Melle ◽

Samir I S Yep Manzano ◽

Hugh Wilson ◽

Willie Hamilton ◽

Fiona M Walter ◽

...

Keyword(s):

Colorectal Cancer ◽

Primary Care ◽

Primary Care Patient ◽

Care Patient ◽

Bowel Habit ◽

Level Of Evidence ◽

Primary Care Population ◽

Abdominal Symptoms ◽

Primary Care Patients ◽

The Uk

Abstract Background Recently, 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. Methods MEDLINE, 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. Results The 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. Conclusions Few 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.

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Symptoms and signs of colorectal cancer, with differences between proximal and distal colon cancer: a prospective cohort study of diagnostic accuracy in primary care

BMC Family Practice ◽

10.1186/s12875-021-01452-6 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Knut Holtedahl ◽

Lars Borgquist ◽

Gé A. Donker ◽

Frank Buntinx ◽

David Weller ◽

...

Keyword(s):

Colorectal Cancer ◽

Primary Care ◽

Rectal Bleeding ◽

Occult Blood ◽

Distal Colon ◽

Supplementary Information ◽

Free Text ◽

Persistent Symptoms ◽

Abdominal Symptoms ◽

Symptoms And Signs

Abstract Background In an abdominal symptom study in primary care in six European countries, 511 cases of cancer were recorded prospectively among 61,802 patients 16 years and older in Norway, Denmark, Sweden, Netherlands, Belgium and Scotland. Colorectal cancer is one of the main types of cancer associated with abdominal symptoms; hence, an in-depth subgroup analysis of the 94 colorectal cancers was carried out in order to study variation in symptom presentation among cancers in different anatomical locations. Method Initial data capture was by completion of standardised forms containing closed questions about symptoms recorded during the consultation. Follow-up data were provided by the GP after diagnosis, based on medical record data made after the consultation. GPs also provided free text comments about the diagnostic procedure for individual patients. Fisher’s exact test was used to analyse differences between groups. Results Almost all symptoms recorded could indicate colorectal cancer. ‘Rectal bleeding’ had a specificity of 99.4% and a PPV of 4.0%. Faecal occult blood in stool (FOBT) or anaemia may indicate gastrointestinal bleeding: when these symptoms and signs were combined, sensitivity reached 57.5%, with 69.2% for cancer in the distal colon. For proximal colon cancers, none of 18 patients had ‘Rectal bleeding’ at the initial consultation, but three of the 18 did so at a later consultation. ‘Abdominal pain, lower part’, ‘Constipation’ and ‘Distended abdomen, bloating’ were less specific and also less sensitive than ‘Rectal bleeding’, and with PPV between 0.7% and 1.9%. Conclusions Apart from rectal bleeding, single symptoms did not reach the PPV 3% NICE threshold. However, supplementary information such as a positive FOBT or persistent symptoms may revise the PPV upwards. If a colorectal cancer is suspected by the GP despite few symptoms, the total clinical picture may still reach the NICE PPV threshold of 3% and justify a specific referral.

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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

Health Technology Assessment ◽

10.3310/hta21330 ◽

2017 ◽

Vol 21 (33) ◽

pp. 1-234 ◽

Cited By ~ 24

Author(s):

Marie Westwood ◽

Isaac Corro Ramos ◽

Shona Lang ◽

Marianne Luyendijk ◽

Remziye Zaim ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Cost Effective ◽

Occult Blood ◽

Base Case ◽

Faecal Occult Blood ◽

Abdominal Symptoms ◽

Faecal Occult ◽

Rule Out

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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