Patient perspective: Is intensive screening of women at high risk of breast cancer evidence-based medicine or déjà vu?

In 2023, a breast cancer risk assessment and a subsequent positive test for the BRCA-2 genetic mutation brought me to the uncomfortable intersection of a longstanding career as an advocate for high-quality medical evidence to support shared patient-provider decision making and a new role as a high-risk patient. My search for studies of available risk-management options revealed that the most commonly recommended approach for women with a ⩾20% lifetime breast cancer risk, intensive screening including annual mammography and/or magnetic resonance imaging beginning at age 25-40 years, was supported only by cancer-detection statistics, with almost no evidence on patient-centered outcomes-mortality, physical and psychological morbidity, or quality of life-compared with standard screening or a surgical alternative, bilateral risk-reducing mastectomy. In this commentary, I explore parallels between the use of the intensive screening protocol and another longstanding women's health recommendation based on limited evidence, the use of hormone therapy (HT) for postmenopausal chronic disease prevention, which was sharply curtailed after the publication of the groundbreaking Women's Health Initiative trial in 2002. These declines in HT utilization were followed by marked decreases in breast cancer incidence, providing a compelling lesson on the critical importance of a solid evidentiary basis for women's health decisions. Known harms accompanying the benefits of breast screening-overdiagnosis, psychological effects, and mammography-associated radiation-exposure risks-make empirical measurement of patient-centered outcomes essential. Yet, published research on intensive screening of women at high breast cancer risk has largely ignored these outcomes, leaving patients, providers, and guideline developers lacking the evidence needed for best practice. Outcomes research is both feasible and urgently needed to inform care decisions and health policy for this patient population.