Dataset Information

Prevalence of repeat faecal immunochemical testing in symptomatic patients attending primary care.

ABSTRACT:

Aim

The faecal immunochemical test (FIT) for faecal haemoglobin (f-Hb) helps determine the risk of colorectal cancer (CRC) and has been integrated into symptomatic referral pathways. 'Safety netting' advice includes considering referral for persistent symptoms, but no published data exists on repeated FITs. We aimed to examine the prevalence of serial FITs in primary care and CRC risk in these patients.

Method

A multicentre, retrospective, observational study was conducted of patients with two or more consecutive f-Hb results within a year from three Scottish Health Boards which utilize FIT in primary care. Cancer registry data ensured identification of CRC cases.

Results

Overall, 135 396 FIT results were reviewed, of which 12 359 were serial results reported within 12 months (9.1%), derived from 5761 patients. Of these, 42 (0.7%) were diagnosed with CRC. A total of 3487 (60.5%) patients had two f-Hb < 10 μg/g, 944 (16.4%) had f-Hb ≥ 10 μg/g followed by <10 μg/g, 704 (12.2%) f-Hb < 10 μg/g followed by ≥10 μg/g and 626 (10.9%) had two f-Hb ≥ 10 μg/g. The CRC rate in each group was 0.1%, 0.4%, 1.4% and 4.0%, respectively. Seven hundred and thirty four patients submitted more than two FITs within a year. The likelihood of one or more f-Hb ≥ 10 μg/g rose from 40.4% with two samples to 100% with six, while the CRC rate fell from 0.8% to 0%.

Conclusion

Serial FITs within a year account for 9.1% of all results in our Boards. CRC prevalence amongst symptomatic patients with serial FIT is lower than in single-FIT cohorts. Performing two FITs within a year for patients with persistent symptoms effectively acts as a safety net, while performing more than two within this timeframe is unlikely to be beneficial.

SUBMITTER: Johnstone MS

PROVIDER: S-EPMC10084108 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Prevalence of repeat faecal immunochemical testing in symptomatic patients attending primary care.

Johnstone Mark S MS MacLeod Campbell C Digby Jayne J Al-Azzawi Yassir Y Pang Grace G Watson Angus J M AJM Strachan Judith J Mowat Craig C McSorley Stephen T ST

Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland 20220718 12

<h4>Aim</h4>The faecal immunochemical test (FIT) for faecal haemoglobin (f-Hb) helps determine the risk of colorectal cancer (CRC) and has been integrated into symptomatic referral pathways. 'Safety netting' advice includes considering referral for persistent symptoms, but no published data exists on repeated FITs. We aimed to examine the prevalence of serial FITs in primary care and CRC risk in these patients.<h4>Method</h4>A multicentre, retrospective, observational study was conducted of pati ...[more]

PMID: 35776684

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Project description:BackgroundFaecal immunochemical testing (FIT) is widely used in bowel screening programmes and assessing symptomatic patients for suspected colorectal cancer (CRC). The evidence for single test performance of FIT in both settings is considerable; however, the use of a repeat test to increase sensitivity remains uncertain. We aimed to review what increase in test positivity would be generated by additional FITs, whether a repeated FIT detects previously missed CRC and advanced colorectal neoplasia (ACRN), and to estimate the sensitivity of double-FIT strategies to diagnose CRC and ACRN.MethodsA systematic search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) was performed using key search terms. Studies reporting the use of more than one FIT in the same screening round or planned assessment of a single symptomatic patient episode were included. Studies were categorised by the reported study population into asymptomatic, mixed (cohorts of combined asymptomatic, symptomatic, or high-risk surveillance), or symptomatic cohorts.ResultsA total of 68 studies were included for analysis (39 asymptomatic, 21 mixed, 7 symptomatic, and 1 study with discrete asymptomatic and symptomatic data). At a threshold of 10 µg Hb/g, the two-test positivity ranged between 8.1 and 34.5%, with an increase from the second test of 3-9.2 percentage points. Four out of five studies comparing one versus two tests for diagnosing CRC at 10 µg Hb/g identified additional cases with the second test, with a minimum of 50% reduction in missed CRC. At a threshold of 20 µg Hb/g, the second test increased the positivity by 1.3-6.7 percentage points, with a two-test positivity of between 5.1 and 25.0%. Using a threshold of 20 µg Hb/g, five out of seven studies had a 25% reduction in missed CRC. A meta-analysis estimated the double-FIT sensitivity at 10 µg Hb/g for CRC in mixed-risk and symptomatic cohorts to be 94% and 98%, respectively.ConclusionsRepeated use of FIT helps to diagnose more cases of CRC with a moderate increase in positivity. A double-FIT strategy at 10 µg Hb/g in mixed and symptomatic cohorts has a very high sensitivity for CRC.

Project description:BackgroundThere is increasing evidence supporting the use of faecal immunochemical tests (FIT) in patients reporting symptoms associated with colorectal cancer (CRC), but most studies until now have focused on selected subjects already referred for investigation. We therefore set out to determine the accuracy and predictive values of FIT in a primary care population.MethodA prospective, multicentre, single-gated comparative diagnostic study on quantitative FIT in patients aged 40 years and above presenting in primary care with symptoms associated with CRC will be conducted. Patients representing the whole spectrum of severity of such symptoms met with in primary care will be eligible and identified by GPs. Participants will answer a short form on symptoms during the last month. They will provide two faecal samples from two separate days. Analyses will be performed within 5 days (QuikRead go®, Aidian Oy). The analytical working range is 10-200 μg Hb/g faeces. Reference test will be linked to the Swedish Colorectal Cancer Registry up to 2 years after inclusion. Accuracy, area under ROC curves, and predictive values will be calculated for one FIT compared to the highest value of two FIT and at cutoff < 10, 10-14.9, 15-19.9 and ≥ 20 μg Hb/g faeces. Subgroup analyses will be conducted for patients with anaemia and those reporting rectal bleeding. A model-based cost-effectiveness analysis based on the clinical accuracy study will be performed. Based on previous literature, we hypothesized that the sensitivity of the highest value of two FIT at cutoff 10 μg Hb/g faeces will be 95% (95% CI + / - 15%). The prevalence of CRC in the study population was estimated to be 2%, and the rate of non-responders to be 1/6. In all, 3000 patients will be invited at 30 primary care centres.DiscussionThis study will generate important clinical real-life structured data on accuracy and predictive values of FIT in the most critical population for work-up of CRC, i.e. patients presenting with at times ambiguous symptoms in primary care. It will help establish the role of FIT in this large group.Trial registrationNCT05156307 . Registered on 14 December 2021-retrospectively registered.

Project description:BackgroundThis study aimed to describe the faecal immunochemical test non-return rate of those referred with high-risk symptoms of colorectal cancer from primary care, and the clinical outcomes of the 'non-returners'.MethodsFrom January 2019 to July 2021, patients referred to secondary care with symptoms suspicious of colorectal cancer and a referral priority of urgent or urgent suspicion of cancer were sent a faecal immunochemical test. All patients were investigated regardless of faecal immunochemical test return or result. Demographics and clinical outcomes such as colorectal cancer prevalence were compared between those who returned a faecal immunochemical test and non-returners.ResultsOf 7345 patients included in the study, 874 (11.9%) did not return a faecal immunochemical test. Non-returner characteristics included male sex (P = 0.040), younger age (median age 57 versus 65 years, P < 0.001), per rectal bleeding (P < 0.001) and lower socioeconomic status (median Scottish Index of Multiple Deprivation, 6 versus 7, P < 0.001) compared with those who returned a faecal immunochemical test. Of 6294 patients undergoing colorectal investigation, there was a greater prevalence of colorectal cancer (5.4% versus 3.6% P = 0.032) and significant bowel pathology than in the non-returners (15.3% versus 9.8%, P < 0.001). With a median follow-up of 25 months, the colorectal cancer prevalence for the entire 7345 cohort was equal between those who returned and did not return a faecal immunochemical test (3.2% versus 3.8%, P = 0.108). Of note, the non-returners diagnosed with colorectal cancer were younger (median age 64 versus 73 years, P < 0.001) and from a lower socioeconomic area (median Scottish Index of Multiple Deprivation 4 versus 7, P = 0.015) than faecal immunochemical test returners.ConclusionPatients referred to secondary care, with symptoms suspicious of colorectal cancer, that did not return a faecal immunochemical test had a similar colorectal cancer prevalence to those that returned the test.

Dataset Information

Prevalence of repeat faecal immunochemical testing in symptomatic patients attending primary care.

Aim

Method

Results

Conclusion

Publications

Prevalence of repeat faecal immunochemical testing in symptomatic patients attending primary care.

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