Diagnostic Accuracy of Fecal Immunochemical Test in Patients at Increased Risk for Colorectal Cancer

Abstract

The potential role of the fecal immunochemical test (FIT) for screening patients at increased risk for colorectal cancer (CRC) has not yet been elucidated.OBJECTIVE To assess the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in asymptomatic patients at above-average risk.DATA SOURCES MEDLINE, EMBASE, Cochrane Library, and gray literature sources through August 2016.STUDY SELECTION Diagnostic studies evaluating the accuracy of FIT for CRC or AN in patients with a personal or familial history of CRC using colonoscopy as the reference standard.DATA EXTRACTION AND SYNTHESIS Two authors (A.K. and P.P.) independently extracted data and evaluated study quality using the Quality Assessment of Diagnostic Accuracy Studies-2 tool, and evaluated the quality of the body of evidence by means of GRADE (Grading of Recommendations Assessment, Development, and Evaluation). Hierarchical models were used to synthesize available evidence. MAIN OUTCOMES AND MEASURESThe primary outcome was the diagnostic performance of FIT for detecting CRC or AN. RESULTSWe included 12 studies (6204 participants). Seven studies were deemed at high or unclear risk of bias. The average sensitivity of FIT for CRC was 93% (95% CI, 53%-99%), and the average specificity was 91% (95% CI, 89%-92%), yielding a positive likelihood ratio (LR+) of 10.30 (CI 7.7-13.9) and a negative likelihood ratio (LR−) of 0.08 (95% CI, 0.01-0.75) (GRADE: very low). The average sensitivity of FIT for AN was 48% (95% CI, 39%-57%); and the average specificity was 93% (95% CI, 91%-94%), yielding an LR+ of 6.55 (95% CI, 5.0-8.5) and an LR− of 0.57 (95% CI, 0.48-0.67) (GRADE: very low). Subgroup analyses indicated that FIT cutoff values between 15-and 25-μg/g feces provided the best combination of sensitivity and specificity for the diagnosis of CRC (93% and 94%, respectively). Quantitative and 1-sample FIT showed adequate test performance, but data on other FIT brands and multiple samples were insufficient. CONCLUSIONS AND RELEVANCEThe FIT has high overall diagnostic accuracy for CRC but moderate accuracy for AN in patients at above-average personal or familial risk. Heterogeneity and wide confidence intervals limit the trustworthiness of our findings.

Performance Characteristics of Fecal Immunochemical Tests for Colorectal Cancer and Advanced Adenomatous Polyps

“…Our findings are consistent with two prior systematic reviews that informed our study methods (17,18), one of which quantified performance characteristics for CRC only and included studies with the less accurate and potentially biased surrogate reference standard of two-year follow-up without a CRC diagnosis (17). The other systematic review quantified performance characteristics for both CRC and advanced adenoma, but only included studies of high-risk persons (18). In addition, our searches identified a recent systematic review by Gies and colleagues that assessed seven FIT brands across 22 studies (60).…”

“…Rather than develop and register a new formal protocol, we used two prior systematic reviews as guides for our study methodology (17,18). We followed standard procedures for systematic reviews and reported results according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines (19,20).PLEASE USE THE 2009 ANNALS PRISMA STATEMENT article for this reference.…”

“…Searches were done using various combinations of the following terms: feces, occult blood, colon cancer, cancer screening, early diagnosis, immunochemistry, and FIT (See Appendix Table 1). We also reviewed reference lists of relevant systematic reviews and meta-analyses (17,18) and of articles that met selection criteria.…”

“…17 (hemeselect or heme select or hemoccultsensa or hemoccult sensa or immudia or magstream or bayer detect or flexsure or oc auto or (monohaem not cytochrome*) or oc sensor or hemodia or fobgold or sentifob).tw. 18 or/ (28) Not provided Not provided Cheng, 2002 (29) Not provided Not provided Sohn, 2004 (30) Nor provided Not provided Morikawa, 2005 (31) Not provided 1.8% Nakazato, 2006 (32) Not provided 1.4% Graser, 2009 (33) Not provided 0.64% Brenner, 2010 (34) Not provided Not provided Park, 2010 (35) Not provided 0.12% Parra-Blanco, 2010 (36) Not provided 4.1% Chiang, 2011 (37) Not provided 0.64% Haug, 2011 (38) 2.0% "without FOBT result" 5.5% Khalid-de Bakkar, 2011 (39) Not provided Not provided † Omata, 2011 (40) 7.1% "unavailable" 0.93% de Wijkerslooth, 2012 (41) Not provided Not provided Brenner, 2013 (42) Not provided Not provided Chiu, 2013 (43) Not provided 1.7% Ng, 2013 (44) Not provided Not provided Chen, 2014 (45) Not provided Not provided ‡ Cubiella, 2014 (46) Not provided Not provided Hernandez, 2014 (47) Not provided Not provided Imperiale, 2014 (48) 0.31% insufficient hemoglobin 1.76% Stegeman, 2014 (49) Not provided Not provided Aniwan, 2015 (50) Not provided 0.95% Chang, 2016 (51) Not provided 1.98% Chiu, 2016 (52) Not provided Not provided Siripongpreeda, 2016 (53) Not provided Not provided Aniwan, 2017 (54) Not provided 0.7% Brenner, 2017 (55) Not provided Not provided Kim, 2017 (56) Not provided 8.9% Shapiro, 2017 (57) Not provided Not provided Brenner, 2018 (58) Not provided 0.9%…”

H2FPEF score for predicting future heart failure in stable outpatients with cardiovascular risk factors

“…Some reports indicated that likelihood ratios above 10 provide strong evidence to make a definitive diagnosis in most circumstances. 31,32 Thus, we considered that an H 2 FPEF score of 7 points was a clinically meaningful cutoff point from the viewpoint of specificity and LR+ in the present study. This suggests that more careful observation and intensive risk reduction treatment could be needed to treat outpatients with a high H 2 FPEF score (≥7 points).…”