Dataset Information

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 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 ?2 = 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.

SUBMITTER: Nielson CM

PROVIDER: S-EPMC6144161 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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

Nielson Carrie M CM Petrik Amanda F AF Jacob Lorie L Vollmer William M WM Keast Erin M EM Schneider Jennifer L JL Rivelli Jennifer S JS Kapka Tanya J TJ Meenan Richard T RT Mummadi Rajasekhara R RR Green Beverly B BB Coronado Gloria D GD

Cancer medicine 20180813 9

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 thr ...[more]

PMID: 30101513

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Project description:Challenges of recruiting participants into pragmatic trials, particularly at the level of the health system, remain largely unexplored. As part of Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), we recruited eight separate community health centers (consisting of 26 individual safety net clinics) into a large comparative effectiveness pragmatic study to evaluate methods of raising the rates of colorectal cancer screening.In partnership with STOP CRC's advisory board, we defined criteria to identify eligible health centers and applied these criteria to a list of health centers in Washington, Oregon, and California affiliated with Oregon Community Health Information Network, a 16-state practice-based research network of federally sponsored health centers. Project staff contacted centers that met eligibility criteria and arranged in-person meetings of key study investigators with health center leadership teams. We used the Consolidated Framework for Implementation Research to thematically analyze the content of discussions during these meetings to identify major facilitators of and barriers to health center participation.From an initial list of 41 health centers, 11 met the initial inclusion criteria. Of these, leaders at three centers declined and at eight centers (26 clinic sites) agreed to participate (73%). Participating and nonparticipating health centers were similar with respect to clinic size, percent Hispanic patients, and percent uninsured patients. Participating health centers had higher proportions of Medicaid patients and higher baseline colorectal cancer screening rates. Common facilitators of participation were perception by center leadership that the project was an opportunity to increase colorectal cancer screening rates and to use electronic health record tools for population management. Barriers to participation were concerns of center leaders about ability to provide fecal testing to and assure follow-up of uninsured patients, limited clinic capacity to prepare mailings required by the study protocol, discomfort with randomization, and concerns about delaying program implementation at some clinics due to the research requirements.Our findings address an important research gap and may inform future efforts to recruit community health centers into pragmatic research.

Project description:BackgroundPerformance characteristics of fecal immunochemical tests (FITs) to screen for colorectal cancer (CRC) have been inconsistent.PurposeTo synthesize data about the diagnostic accuracy of FITs for CRC and identify factors affecting its performance characteristics.Data sourcesOnline databases, including MEDLINE and EMBASE, and bibliographies of included studies from 1996 to 2013.Study selectionAll studies evaluating the diagnostic accuracy of FITs for CRC in asymptomatic, average-risk adults.Data extractionTwo reviewers independently extracted data and critiqued study quality.Data synthesisNineteen eligible studies were included and meta-analyzed. The pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of FITs for CRC were 0.79 (95% CI, 0.69 to 0.86), 0.94 (CI, 0.92 to 0.95), 13.10 (CI, 10.49 to 16.35), 0.23 (CI, 0.15 to 0.33), respectively, with an overall diagnostic accuracy of 95% (CI, 93% to 97%). There was substantial heterogeneity between studies in both the pooled sensitivity and specificity estimates. Stratifying by cutoff value for a positive test result or removal of discontinued FIT brands resulted in homogeneous sensitivity estimates. Sensitivity for CRC improved with lower assay cutoff values for a positive test result (for example, 0.89 [CI, 0.80 to 0.95] at a cutoff value less than 20 µg/g vs. 0.70 [CI, 0.55 to 0.81] at cutoff values of 20 to 50 µg/g) but with a corresponding decrease in specificity. A single-sample FIT had similar sensitivity and specificity as several samples, independent of FIT brand.LimitationsOnly English-language articles were included. Lack of data prevented complete subgroup analyses by FIT brand.ConclusionFecal immunochemical tests are moderately sensitive, are highly specific, and have high overall diagnostic accuracy for detecting CRC. Diagnostic performance of FITs depends on the cutoff value for a positive test result.Primary funding sourceNational Institute of Diabetes and Digestive and Kidney Diseases and National Cancer Institute.

Dataset Information

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

Publications

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

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