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, 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

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00002540.

Figures

Figure 1.
Figure 1.
Study population selection.
Figure 2.
Figure 2.
Cumulative probability of a false-positive result for a multimodal cancer screening regimen.
Figure 2.
Figure 2.
Cumulative probability of a false-positive result for a multimodal cancer screening regimen.
Figure 3.
Figure 3.
Cumulative probability of receiving an invasive diagnostic procedurea as a direct result of a false-positive test in a multimodal cancer screening regimen.
Figure 3.
Figure 3.
Cumulative probability of receiving an invasive diagnostic procedurea as a direct result of a false-positive test in a multimodal cancer screening regimen.

Source: PubMed

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