Thomas F. Imperiale, MD; Rachel N. Gruber, MS; Timothy E. Stump, MA; Thomas W. Emmett, MD; Patrick O. Monahan, PhD
Financial Support: By the Department of Medicine and the Melvin and Bren Simon Cancer Center at the Indiana University School of Medicine and by the Regenstrief Institute.
Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-2390.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer, Johnson & Johnson, and Colgate-Palmolive. Christina C. Wee, MD, MPH, Deputy Editor, reports employment with Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Yu-Xiao Yang, MD, MSCE, Deputy Editor, reports that he has no financial relationships or interest to disclose.
Reproducible Research Statement:Study protocol: Not available. Statistical code and data set: Available to approved persons through written agreement with the authors (e-mail, firstname.lastname@example.org).
Corresponding Author: Thomas F. Imperiale, MD, Indiana University Medical Center, Regenstrief Institute, 1101 West 10th Street, Indianapolis, IN 46202; e-mail, email@example.com.
Current Author Addresses: Dr. Imperiale and Ms. Gruber: Indiana University Medical Center, Regenstrief Institute, 1101 West 10th Street, Indianapolis, IN 46202.
Mr. Stump and Dr. Monahan: Department of Biostatistics, Indiana University School of Medicine, 410 West 10th Street, HITS 3000, Indianapolis, IN 46202.
Dr. Emmett: Ruth Lilly Medical Library, 975 West Walnut Street, IB 100, Indianapolis, IN 46202-5121.
Author Contributions: Conception and design: T.F. Imperiale.
Analysis and interpretation of the data: T.F. Imperiale, T.E. Stump, P.O. Monahan.
Drafting of the article: T.F. Imperiale, R.N. Gruber, T.E. Stump, T.W. Emmett, P.O. Monahan.
Critical revision of the article for important intellectual content: T.F. Imperiale, R.N. Gruber, P.O. Monahan.
Final approval of the article: T.F. Imperiale, R.N. Gruber, T.E. Stump, T.W. Emmett, P.O. Monahan.
Provision of study materials or patients: T.F. Imperiale.
Statistical expertise: T.E. Stump, P.O. Monahan.
Administrative, technical, or logistic support: R.N. Gruber.
Collection and assembly of data: T.F. Imperiale, R.N. Gruber, T.W. Emmett.
Studies report inconsistent performance of fecal immunochemical tests (FITs) for colorectal cancer (CRC) and advanced adenomas.
To summarize performance characteristics of FITs for CRC and advanced adenomas in average-risk persons undergoing screening colonoscopy (reference standard) and to identify factors affecting these characteristics.
Ovid MEDLINE, PubMed, Embase, and the Cochrane Library from inception through October 2018; reference lists of studies and reviews.
Two reviewers independently screened records to identify published English-language prospective or retrospective observational studies that evaluated FIT sensitivity and specificity for colonoscopic findings in asymptomatic, average-risk adults.
Two authors independently extracted data and evaluated study quality.
Thirty-one studies (120 255 participants; 18 FITs) were included; all were judged to have low to moderate risk of bias. Performance characteristics depended on the threshold for a positive result. A threshold of 10 µg/g resulted in sensitivity of 0.91 (95% CI, 0.84 to 0.95) and a negative likelihood ratio of 0.10 (CI, 0.06 to 0.19) for CRC, whereas a threshold of greater than 20 µg/g resulted in specificity of 0.95 (CI, 0.94 to 0.96) and a positive likelihood ratio of 15.49 (CI, 9.82 to 22.39). For advanced adenomas, sensitivity was 0.40 (CI, 0.33 to 0.47) and the negative likelihood ratio was 0.67 (CI, 0.57 to 0.78) at 10 µg/g, and specificity was 0.95 (CI, 0.94 to 0.96) and the positive likelihood ratio was 5.86 (CI, 3.77 to 8.97) at greater than 20 µg/g. Studies had low to high heterogeneity, depending on the threshold. Although several FITs had adequate performance, sensitivity and specificity for CRC for 1 qualitative FIT were 0.90 and 0.91, respectively, at its single threshold of 10 µg/g; positive and negative likelihood ratios were 10.13 and 0.11, respectively. Comparison of 3 FITs at 3 thresholds was inconclusive: CIs overlapped, and the comparisons were across rather than within studies.
Only English-language studies were included. Incomplete reporting limited quality assessment of some evidence. Performance characteristics are for 1-time rather than serial testing.
Single-application FITs have moderate to high sensitivity and specificity for CRC, depending on the positivity threshold. Sensitivity of 1-time testing for advanced adenomas is low, regardless of the threshold.
Department of Medicine, Indiana University School of Medicine.
Imperiale TF, Gruber RN, Stump TE, et al. Performance Characteristics of Fecal Immunochemical Tests for Colorectal Cancer and Advanced Adenomatous Polyps: A Systematic Review and Meta-analysis. Ann Intern Med. 2019;170:319–329. [Epub ahead of print 26 February 2019]. doi: https://doi.org/10.7326/M18-2390
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Published: Ann Intern Med. 2019;170(5):319-329.
Published at www.annals.org on 26 February 2019
Cancer Screening/Prevention, Colorectal Cancer, Gastroenterology/Hepatology, Gastrointestinal Cancer, Hematology/Oncology.
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