Ball, A.J., Aziz, I. orcid.org/0000-0003-4313-0553, Parker, S. et al. (3 more authors) (2022) Fecal immunochemical testing in patients with low-risk symptoms of colorectal cancer: a diagnostic accuracy study. Journal of the National Comprehensive Cancer Network, 20 (9). 989-996.e1. ISSN 1540-1405
Abstract
Background: The fecal immunochemical test (FIT) is recommended for triaging primary care patients in England with low-risk symptoms of colorectal cancer (CRC). The evidence underpinning recommendations by the National Institute for Health and Care Excellence had limitations, with a paucity of primary care evidence. This study examines the diagnostic accuracy of FIT in a defined low-risk symptom primary care population. Patients and Methods: Consecutive symptomatic adult patients referred for a FIT between October and December 2019 were included. Patients were derived from 225 primary care practices in England. Serious colorectal diseases (CRC, high-risk polyps, and inflammatory bowel disease [IBD]) were identified through patient follow-up over 18 months, using both primary and secondary healthcare records. Performance characteristics of FIT are reported according to differing thresholds, including the currently recommended threshold of ≥10 μg hemoglobin per gram of feces (μg/g). Results: A total of 3,506 patients were included in the final analysis. Of these, 708 had a positive FIT result (≥10 μg/g). The prevalence of CRC was 1.3%. FIT positivity declined from 20.2% to 5.8% and 4.5% at cutoffs of 10, 80, and 120 μg/g, respectively. The sensitivity of FIT at ≥10 μg/g to detect CRC was 91.1% (95% CI, 77.9%–97.1%); its specificity was 80.7% (95% CI, 79.3%–82.0%); the positive predictive value (PPV) was 5.8% (95% CI, 4.2%–7.8%); and the negative predictive value (NPV) was 99.9% (95% CI, 99.6%–99.95%). The area under the receiver operating characteristic curve was 0.93 (0.91–0.96). PPV and specificity increased, whereas sensitivity and NPV decreased when serious colorectal diseases (CRC, high-risk polyps, and IBD) were combined. Age, sex, socioeconomic deprivation, and anemia did not significantly influence FIT sensitivity on subgroup analysis. Conclusions: Utilization of FIT at a threshold ≥10 μg/g can safely triage patients with low-risk symptoms in primary care, with negative results effectively ruling out CRC.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2022 by the National Comprehensive Cancer Network |
Keywords: | Adult; Colonoscopy; Colorectal Neoplasms; Early Detection of Cancer; Feces; Hemoglobins; Humans; Inflammatory Bowel Diseases; Occult Blood; Sensitivity and Specificity |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > Department of Infection and Immunity (Sheffield) |
Funding Information: | Funder Grant number SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST STH21340 SOUTH YORKSHIRE AND BASSETLAW INTEGRATED CARE SYSTEM UNSPECIFIED |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 21 Sep 2022 11:33 |
Last Modified: | 21 Sep 2022 13:42 |
Status: | Published |
Publisher: | Harborside Press, LLC |
Refereed: | Yes |
Identification Number: | 10.6004/jnccn.2022.7037 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:191205 |