An analysis published in the Journal of Breast Imaging argues that the initial results of the WISDOM trial do not support the conclusion that screening based on individual risk is as safe as annual screening starting at age 40. The authors review the trial design, its endpoints and adherence to the protocol to explain why, in their view, the trial’s conclusion goes beyond what its data show.
What was known
Widespread mammography screening has significantly reduced breast cancer mortality, but it is resource intensive. The WISDOM (Women Informed to Screen Depending on Measures of Risk) trial set out to assess an alternative based on individual risk rather than age, where the conventional arm consists of annual mammography starting at age 40. In their initial report, the trial investigators concluded that risk-based screening is safe and acceptable to women.
What this work adds
This is a critical analysis of that initial report, not a new patient study. The authors examine what the trial measured, the margin it allowed and how closely the planned protocols were followed in each arm, and they contrast those methodological choices with the non-inferiority conclusion for risk-based screening.
Main results
The first primary endpoint tested non-inferiority of risk-based screening using the proportion of stage IIB or higher tumours. The authors note that many of these cancers would be apparent on physical examination, which removes part of the advantage of early detection and ignores shortcomings of the risk-based approach. They add that the non-inferiority margin was set very loosely and that the details of mammography and MRI use reflect poor compliance with the screening protocols in both arms: non-compliance and imaging performed outside the study made the two groups nearly identical rather than comparing two different strategies. The second primary endpoint, whether risk-based screening produced fewer biopsies than annual screening, was not met. The risk-based protocol is also labour intensive and would be challenging to implement in a typical primary care practice.
What it means
According to this analysis, the vast majority of breast cancers occur in average-risk women, who could be missed in a risk-based system, especially below age 50 and among minority women. The text does not call for abandoning research into personalised screening; rather, it warns that the trial’s conclusions are not enough to change practice, and that the substantial non-compliance with the risk-based protocol makes it difficult to argue that this strategy is acceptable to women.
Reading from the breast unit
For a breast unit, the organisational message is twofold: any screening strategy rests on the real adherence of participants, and protocols that depend on calculating risk case by case require resources and pathways that are not guaranteed today in routine practice.
Reference: Monticciolo DL, Hendrick RE. Is Risk-based Screening Justified by the WISDOM Trial?. Journal of Breast Imaging, 2026. DOI 10.1093/jbi/wbag048
