Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial

Abstract Annual fecal immunochemical testing (FIT) is cost‐effective for colorectal cancer (CRC) screening. However, FIT positivity rates and positive predictive value (PPV) can vary substantially, with false‐positive (FP) results adding to colonoscopy burden without improving cancer detection. Our...

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Main Authors: Carrie M. Nielson, Amanda F. Petrik, Lorie Jacob, William M. Vollmer, Erin M. Keast, Jennifer L. Schneider, Jennifer S. Rivelli, Tanya J. Kapka, Richard T. Meenan, Rajasekhara R. Mummadi, Beverly B. Green, Gloria D. Coronado
Format: Article
Language:English
Published: Wiley 2018-09-01
Series:Cancer Medicine
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Online Access:https://doi.org/10.1002/cam4.1727
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author Carrie M. Nielson
Amanda F. Petrik
Lorie Jacob
William M. Vollmer
Erin M. Keast
Jennifer L. Schneider
Jennifer S. Rivelli
Tanya J. Kapka
Richard T. Meenan
Rajasekhara R. Mummadi
Beverly B. Green
Gloria D. Coronado
author_facet Carrie M. Nielson
Amanda F. Petrik
Lorie Jacob
William M. Vollmer
Erin M. Keast
Jennifer L. Schneider
Jennifer S. Rivelli
Tanya J. Kapka
Richard T. Meenan
Rajasekhara R. Mummadi
Beverly B. Green
Gloria D. Coronado
author_sort Carrie M. Nielson
collection DOAJ
description Abstract Annual fecal immunochemical testing (FIT) is cost‐effective for colorectal cancer (CRC) screening. However, FIT positivity rates and positive predictive value (PPV) can vary substantially, with false‐positive (FP) results adding to colonoscopy burden without improving cancer detection. Our objective was to describe FIT PPV and the factors associated with FP results among patients undergoing CRC screening. In an ongoing pragmatic clinical trial of mailed‐FIT outreach, clinics delivered one of three FIT brands (InSure, OC‐Micro, and Hemosure). Patients who had a positive FIT result and a follow‐up colonoscopy were included in this analysis (N = 1130). Patients’ demographic and medical histories were abstracted from electronic health records (EHR). Associations with a FP result (ie, a positive FIT result with no evidence of advanced neoplasia during follow‐up colonoscopy) were evaluated for FIT brand and patient factors using mixed‐effects multivariable logistic regression. The mean proportion of FIT‐positive results ranged from 8% in centers using the OC‐Micro test to 21% for Hemosure. PPVs for advanced neoplasia were 0.30 to 0.17, respectively (P for χ2 = 0.08). In multivariable‐adjusted models, use of Hemosure was associated with greater odds of a FP result than OC‐Micro (OR = 2.00, 95% CI: 0.47‐8.56) or InSure (OR = 1.72, 95% CI: 0.44‐6.68). However, only female sex (OR = 1.58, 95% CI: 1.19‐2.10) and history of a colorectal condition (OR = 2.17, 95% CI: 1.13‐4.15) were significantly associated with FP. In conclusion, FIT positivity varied by brand, and FP results differed by patient factors available through the EHR. These results can be used to minimize the frequency of FP results, reducing patient distress and colonoscopy burden.
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spelling doaj-art-be2b83896d2c46afad26fb1581a31e8f2025-08-20T03:04:30ZengWileyCancer Medicine2045-76342018-09-01794781479010.1002/cam4.1727Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trialCarrie M. Nielson0Amanda F. Petrik1Lorie Jacob2William M. Vollmer3Erin M. Keast4Jennifer L. Schneider5Jennifer S. Rivelli6Tanya J. Kapka7Richard T. Meenan8Rajasekhara R. Mummadi9Beverly B. Green10Gloria D. Coronado11Kaiser Permanente Center for Health Research Portland OregonKaiser Permanente Center for Health Research Portland OregonOCHIN Portland OregonKaiser Permanente Center for Health Research Portland OregonKaiser Permanente Center for Health Research Portland OregonKaiser Permanente Center for Health Research Portland OregonKaiser Permanente Center for Health Research Portland OregonKaiser Permanente Center for Health Research Portland OregonKaiser Permanente Center for Health Research Portland OregonKaiser Permanente Center for Health Research Portland OregonKaiser Permanente Washington Health Research Institute Seattle WashingtonKaiser Permanente Center for Health Research Portland OregonAbstract Annual fecal immunochemical testing (FIT) is cost‐effective for colorectal cancer (CRC) screening. However, FIT positivity rates and positive predictive value (PPV) can vary substantially, with false‐positive (FP) results adding to colonoscopy burden without improving cancer detection. Our objective was to describe FIT PPV and the factors associated with FP results among patients undergoing CRC screening. In an ongoing pragmatic clinical trial of mailed‐FIT outreach, clinics delivered one of three FIT brands (InSure, OC‐Micro, and Hemosure). Patients who had a positive FIT result and a follow‐up colonoscopy were included in this analysis (N = 1130). Patients’ demographic and medical histories were abstracted from electronic health records (EHR). Associations with a FP result (ie, a positive FIT result with no evidence of advanced neoplasia during follow‐up colonoscopy) were evaluated for FIT brand and patient factors using mixed‐effects multivariable logistic regression. The mean proportion of FIT‐positive results ranged from 8% in centers using the OC‐Micro test to 21% for Hemosure. PPVs for advanced neoplasia were 0.30 to 0.17, respectively (P for χ2 = 0.08). In multivariable‐adjusted models, use of Hemosure was associated with greater odds of a FP result than OC‐Micro (OR = 2.00, 95% CI: 0.47‐8.56) or InSure (OR = 1.72, 95% CI: 0.44‐6.68). However, only female sex (OR = 1.58, 95% CI: 1.19‐2.10) and history of a colorectal condition (OR = 2.17, 95% CI: 1.13‐4.15) were significantly associated with FP. In conclusion, FIT positivity varied by brand, and FP results differed by patient factors available through the EHR. These results can be used to minimize the frequency of FP results, reducing patient distress and colonoscopy burden.https://doi.org/10.1002/cam4.1727cancercolorectalfecal immunochemical testneoplasiascreening
spellingShingle Carrie M. Nielson
Amanda F. Petrik
Lorie Jacob
William M. Vollmer
Erin M. Keast
Jennifer L. Schneider
Jennifer S. Rivelli
Tanya J. Kapka
Richard T. Meenan
Rajasekhara R. Mummadi
Beverly B. Green
Gloria D. Coronado
Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial
Cancer Medicine
cancer
colorectal
fecal immunochemical test
neoplasia
screening
title Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial
title_full Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial
title_fullStr Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial
title_full_unstemmed Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial
title_short Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial
title_sort positive predictive values of fecal immunochemical tests used in the stop crc pragmatic trial
topic cancer
colorectal
fecal immunochemical test
neoplasia
screening
url https://doi.org/10.1002/cam4.1727
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