Cumulative incidence of false-positive results in repeated, multimodal cancer screening

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

Research output: Contribution to journalArticlepeer-review

117 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)212-222
Number of pages11
JournalAnnals of family medicine
Issue number3
StatePublished - 2009

Bibliographical note

Funding Information:
Funding support: Funding for the overall Prostate, Lung, Colorectal, and Ovarian (PLOC) Cancer Screening Trial was provided by the US National Cancer Institute. No additional funding was provided for the design and conduct of this study.


  • False positive reactions
  • Mass screening
  • Neoplasms
  • Randomized controlled trial


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