Consequences of false-positive screening mammograms.

importanceFalse-positive mammograms, a common occurrence in breast cancer screening programs, represent a potential screening harm that is currently being evaluated by the US Preventive Services Task Force.

objectiveTo measure the effect of false-positive mammograms on quality of life by measuring personal anxiety, health utility, and attitudes toward future screening. DESIGN, SETTING, AND

participantsThe Digital Mammographic Imaging Screening Trial (DMIST) quality-of-life substudy telephone survey was performed shortly after screening and 1 year later at 22 DMIST sites and included randomly selected DMIST participants with positive and negative mammograms. EXPOSURE: Mammogram requiring follow-up testing or referral without a cancer diagnosis. MAIN OUTCOMES AND MEASURES: The 6-question short form of the Spielberger State-Trait Anxiety Inventory state scale (STAI-6) and the EuroQol EQ-5D instrument with US scoring. Attitudes toward future screening as measured by women's self-report of future intention to undergo mammographic screening and willingness to travel and stay overnight to undergo a hypothetical new type of mammography that would identify as many cancers with half the false-positive results.

resultsAmong 1450 eligible women invited to participate, 1226 (84.6%) were enrolled, with follow-up interviews obtained in 1028 (83.8%). Anxiety was significantly higher for women with false-positive mammograms (STAI-6, 35.2 vs 32.7), but health utility scores did not differ and there were no significant differences between groups at 1 year. Future screening intentions differed by group (25.7% vs 14.2% more likely in false-positive vs negative groups); willingness to travel and stay overnight did not (9.9% vs 10.5% in false-positive vs negative groups). Future screening intention was significantly increased among women with false-positive mammograms (odds ratio, 2.12; 95% CI, 1.54-2.93), younger age (2.78; 1.5-5.0), and poorer health (1.63; 1.09-2.43). Women's anticipated high-level anxiety regarding future false-positive mammograms was associated with willingness to travel overnight (odds ratio, 1.94; 95% CI, 1.28-2.95). CONCLUSIONS AND RELEVANCE: False-positive mammograms were associated with increased short-term anxiety but not long-term anxiety, and there was no measurable health utility decrement. False-positive mammograms increased women's intention to undergo future breast cancer screening and did not increase their stated willingness to travel to avoid a false-positive result. Our finding of time-limited harm after false-positive screening mammograms is relevant for clinicians who counsel women on mammographic screening and for screening guideline development groups.