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Annals of Family Medicine 7:212-222 (2009)
© 2009 Annals of Family Medicine, Inc.
doi: 10.1370/afm.942
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Cumulative Incidence of False-Positive Results in Repeated, Multimodal Cancer Screening

Jennifer Miller Croswell, MD*, Barnett S. Kramer, MD, MPH*, Aimee R. Kreimer, PhD, Phil C. Prorok, PhD, Jian-Lun Xu, PhD, Stuart G. Baker, ScD, Richard Fagerstrom, PhD, Thomas L. Riley, Jonathan D. Clapp, Christine D. Berg, MD, John K. Gohagan, PhD, Gerald L. Andriole, MD, David Chia, PhD, Timothy R. Church, PhD, E. David Crawford, MD, Mona N. Fouad, MD, MPH, Edward P. Gelmann, MD, Lois Lamerato, PhD, MS, Douglas J. Reding, MD, MPH and Robert E. Schoen, MD, MPH

National Institutes of Health, Office of the Director, Office of Disease Prevention, Bethesda, Maryland (Croswell, Kramer); National Institutes of Health, National Cancer Institute, Division of Cancer Prevention, Bethesda, Maryland (Kreimer, Xu, Baker, Fagerstrom, Berg, Gohagan); IMS, Incorporated, Washington, DC (Riley, Clapp); Washington University School of Medicine, St. Louis, Missouri (Andriole); UCLA School of Medicine, Los Angeles, California (Chia); University of Minnesota School of Public Health, Minneapolis, Minnesota (Church); University of Colorado Health Sciences Center, Aurora, Colorado (Crawford); University of Alabama at Birmingham, Birmingham, Alabama (Fouad); Herbert Irving Comprehensive Cancer Center, Columbia University, New York, New York (Gelmann); Henry Ford Health System, Detroit, Michigan (Lamerato); Marshfield Clinic Research Foundation, Marshfield, Wisconsin (Reding); University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (Schoen).

CORRESPONDING AUTHOR: Jennifer M. Croswell, MD, Office of the Director, Office of Disease Prevention, National Institutes of Health, 6100 Executive Blvd, Suite 2B-03, Bethesda, MD 20892, croswellj{at}od.nih.gov

Annals Journal Club selection—see inside back cover or http://www.annfammed.org/AJC/.

PURPOSE Multiple cancer screening tests have been advocated for the general population; however, clinicians and patients are not always well-informed of screening burdens. We sought to determine the cumulative risk of a false-positive screening result and the resulting risk of a diagnostic procedure for an individual participating in a multimodal cancer screening program.

METHODS Data were analyzed from the intervention arm of the ongoing Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, a randomized controlled trial to determine the effects of prostate, lung, colorectal, and ovarian cancer screening on disease-specific mortality. The 68,436 participants, aged 55 to 74 years, were randomized to screening or usual care. Women received serial serum tests to detect cancer antigen 125 (CA-125), transvaginal sonograms, posteroanterior-view chest radiographs, and flexible sigmoidoscopies. Men received serial chest radiographs, flexible sigmoidoscopies, digital rectal examinations, and serum prostate-specific antigen tests. Fourteen screening examinations for each sex were possible during the 3-year screening period.

RESULTS After 14 tests, the cumulative risk of having at least 1 false-positive screening test is 60.4% (95% CI, 59.8%–61.0%) for men, and 48.8% (95% CI, 48.1%–49.4%) for women. The cumulative risk after 14 tests of undergoing an invasive diagnostic procedure prompted by a false-positive test is 28.5% (CI, 27.8%–29.3%) for men and 22.1% (95% CI, 21.4%–22.7%) for women.

CONCLUSIONS For an individual in a multimodal cancer screening trial, the risk of a false-positive finding is about 50% or greater by the 14th test. Physicians should educate patients about the likelihood of false positives and resulting diagnostic interventions when counseling about cancer screening.

Key Words: Mass screening • neoplasms • false positive reactions • randomized controlled trial




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TRACK Comments:

Read all TRACK Comments

Towards an accurate estimate of false positive screens
Stephen H Taplin
Annals of Family Medicine, 26 May 2009 [Full text]
Authors' Reply
Jennifer M Croswell, et al.
Annals of Family Medicine, 29 May 2009 [Full text]
Multiple Cancer Screening Tests - What’s a Practicing Clinician to Do?
Jennifer T. Loud, et al.
Annals of Family Medicine, 8 Jul 2009 [Full text]
Authors' Reply
Jennifer M. Croswell, et al.
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Finding Meaning in Multiple Screening
William R. Phillips, MD, MPH
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