Christopher D. Jensen, PhD, MPH; Douglas A. Corley, MD, PhD; Virginia P. Quinn, PhD, MPH; Chyke A. Doubeni, MD, MPH; Ann G. Zauber, PhD; Jeffrey K. Lee, MD, MAS; Wei K. Zhao, MPH; Amy R. Marks, MPH; Joanne E. Schottinger, MD; Nirupa R. Ghai, PhD; Alexander T. Lee, MD; Richard Contreras, MS; Carrie N. Klabunde, PhD; Charles P. Quesenberry, PhD; Theodore R. Levin, MD; Pauline A. Mysliwiec, MD
Grant Support: The study was conducted through the National Cancer Institute–funded Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) consortium (U54 CA163262 [Dr. Corley]).
Disclosures: Drs. Jensen, Corley, Quesenberry, and Levin report grant support from the National Cancer Institute during the conduct of the study. Dr. Quinn reports grant support from the National Institutes of Health during the conduct of the study. Dr. Doubeni reports compensation for 1-time consultancy (Exact Sciences) outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0983.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy 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. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Reproducible Research Statement:Study protocol and data set: Not available. Statistical code: Available from Dr. Corley (e-mail, firstname.lastname@example.org).
Corresponding Author: Douglas A. Corley, MD, PhD, Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612; e-mail, email@example.com.
Current Author Addresses: Drs. Jensen, Corley, and Quesenberry; Ms. Zhao; and Ms. Marks: Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612.
Drs. Ghai and Quinn and Mr. Contreras: Department of Research & Evaluation, Kaiser Permanente Southern California, 100 South Los Robles, 2nd Floor, Pasadena, CA 91101.
Dr. Doubeni: Department of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, 3400 Spruce Street, Gate 2, Philadelphia, PA 19104.
Dr. Zauber: Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2063A, New York, NY 10017.
Dr. Lee: Division of Gastroenterology, University of California, San Francisco, 1701 Divisadero Street, Suite 120, San Francisco, CA 94115.
Dr. Schottinger: Kaiser Permanente Southern California Permanente Medical Group, 393 East Walnut Street, Pasadena, CA 91188.
Dr. Lee: Kaiser Permanente Southern California Permanente Medical Group, Woodland Hills Medical Center, 5601 De Soto Avenue, Woodland Hills, CA 91365.
Dr. Klabunde: Office of Disease Prevention, National Institutes of Health, 6100 Executive Boulevard, Suite 2B03, Rockville, MD 20852.
Dr. Levin: Kaiser Permanente Medical Center, 1425 South Main Street, Walnut Creek, CA 94596.
Dr. Mysliwiec: The Permanente Medical Group, 975 Sereno Drive, Vallejo, CA 94589.
Author Contributions: Conception and design: C.D. Jensen, D.A. Corley, V.P. Quinn, C.A. Doubeni, J.K. Lee, A.R. Marks, A.T. Lee, C.N. Klabunde, T.R. Levin, P.A. Mysliwiec.
Analysis and interpretation of the data: C.D. Jensen, D.A. Corley, V.P. Quinn, C.A. Doubeni, A.G. Zauber, J.K. Lee, W.K. Zhao, C.N. Klabunde, C.P. Quesenberry, T.R. Levin, P.A. Mysliwiec.
Drafting of the article: C.D. Jensen, D.A. Corley, V.P. Quinn, A.R. Marks, J.E. Schottinger, N.R. Ghai, P.A. Mysliwiec.
Critical revision of the article for important intellectual content: C.D. Jensen, D.A. Corley, V.P. Quinn, C.A. Doubeni, A.G. Zauber, J.K. Lee, N.R. Ghai, A.T. Lee, C.N. Klabunde, T.R. Levin, P.A. Mysliwiec.
Final approval of the article: C.D. Jensen, D.A. Corley, V.P. Quinn, C.A. Doubeni, A.G. Zauber, J.K. Lee, J.E. Schottinger, N.R. Ghai, A.T. Lee, C.N. Klabunde, C.P. Quesenberry, T.R. Levin, P.A. Mysliwiec.
Provision of study materials or patients: D.A. Corley, V.P. Quinn, A.T. Lee.
Statistical expertise: D.A. Corley, A.G. Zauber, A.R. Marks, C.P. Quesenberry.
Obtaining of funding: D.A. Corley, V.P. Quinn, C.A. Doubeni, C.P. Quesenberry, T.R. Levin,
Administrative, technical, or logistic support: D.A. Corley, V.P. Quinn, C.A. Doubeni, J.K. Lee, A.R. Marks, P.A. Mysliwiec.
Collection and assembly of data: C.D. Jensen, D.A. Corley, V.P. Quinn, C.A. Doubeni, R. Contreras, T.R. Levin, P.A. Mysliwiec.
Jensen CD, Corley DA, Quinn VP, Doubeni CA, Zauber AG, Lee JK, et al. Fecal Immunochemical Test Program Performance Over 4 Rounds of Annual Screening: A Retrospective Cohort Study. Ann Intern Med. 2016;164:456-463. doi: 10.7326/M15-0983
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Published: Ann Intern Med. 2016;164(7):456-463.
Published at www.annals.org on 26 January 2016
The fecal immunochemical test (FIT) is a common method for colorectal cancer (CRC) screening, yet its acceptability and performance over several rounds of annual testing are largely unknown.
To assess FIT performance characteristics over 4 rounds of annual screening.
Retrospective cohort study.
Kaiser Permanente Northern and Southern California.
323 349 health plan members aged 50 to 70 years on their FIT mailing date in 2007 or 2008 who completed the first round of FIT and were followed for up to 4 screening rounds.
Screening participation, FIT positivity (≥20 µg of hemoglobin/g), positive predictive values for adenoma and CRC, and FIT sensitivity for detecting CRC obtained from Kaiser Permanente electronic databases and cancer registries.
Of the patients invited for screening, 48.2% participated in round 1. Of those who remained eligible, 75.3% to 86.1% participated in subsequent rounds. Median follow-up was 4.0 years, and 32% of round 1 participants crossed over to endoscopy over 4 screening rounds—7.0% due to a positive FIT result. The FIT positivity rate (5.0%) and positive predictive values (adenoma, 51.5%; CRC, 3.4%) were highest in round 1. Overall, programmatic FIT screening detected 80.4% of patients with CRC diagnosed within 1 year of testing, including 84.5% in round 1 and 73.4% to 78.0% in subsequent rounds.
Screening detection, rather than long-term cancer prevention, was evaluated.
Annual FIT screening was associated with high sensitivity for CRC, with high adherence to annual follow-up screening among initial participants. The findings indicate that annual programmatic FIT screening is feasible and effective for population-level CRC screening.
National Institutes of Health.
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Cancer Screening/Prevention, Colorectal Cancer, Gastroenterology/Hepatology, Gastrointestinal Cancer, Hematology/Oncology.
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