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Previous Volume 349:335-342 July 24, 2003 Number 4 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Schröder, F. H. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background The sensitivity and specificity of a screening test are biased when disease status is not verified in all subjects and when the likelihood of confirmation depends on the test result itself. We assessed the screening characteristics of the prostate-specific antigen (PSA) measurement after correction for verification bias.

Methods Between 1995 and 2001, 6691 men underwent PSA-based screening for prostate cancer. Of these men, 705 (11 percent) subsequently underwent biopsy of the prostate. Under the assumption that the chance of undergoing a biopsy depends only on the PSA-test result and other observed clinical variables, we used a mathematical model to estimate adjusted receiver-operating-characteristic (ROC) curves.

Results Adjusting for verification bias significantly increased the area under the ROC curve (i.e., the overall diagnostic performance) of the PSA test, as compared with an unadjusted analysis (0.86 vs. 0.69, P<0.001, for men less than 60 years of age; 0.72 vs. 0.62, P=0.008, for men 60 years of age or older). If the threshold PSA value for undergoing biopsy were set at 4.1 ng per milliliter, 82 percent of cancers in younger men and 65 percent of cancers in older men would be missed. A digital rectal examination that is abnormal but not suspicious for cancer does not affect the overall performance characteristics of the test.

Conclusions A lower threshold level of PSA for recommending prostate biopsy, particularly in younger men, may improve the clinical value of the PSA test.

Source Information

From the Joint Center for Radiation Therapy, Harvard Medical School, Boston (R.S.P.); the Department of Radiation Oncology, Brigham and Women's Hospital and the Dana–Farber Cancer Institute, Boston (A.V.D.); the Division of Urologic Surgery, Washington University School of Medicine, St. Louis (W.J.C., K.A.R.); the Department of Urology, Northwestern University, Fineberg School of Medicine, Chicago (W.J.C.); and the Department of Health Policy and Management, Harvard School of Public Health, Boston (K.M.K.).

Address reprint requests to Dr. Kuntz at the Center for Risk Analysis, Harvard School of Public Health, 718 Huntington Ave., Boston, MA 02115-5924, or at kmk{at}hsph.harvard.edu.

Full Text of this Article

Related Letters:

Verification Bias in Screening for Prostate Cancer
Leiner S., Chatterton H. T., Punglia R. S., Catalona W. J., Kuntz K. M.
Extract | Full Text | PDF  
N Engl J Med 2003; 349:1672-1673, Oct 23, 2003. Correspondence

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