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<p>The Women Informed to Screen Depending on Measures of risk (WISDOM) Study (clinicaltrials.gov NCT02620852, 2016-08-31) is pragmatic randomized controlled trial evaluating risk assessment to inform the age to start, frequency and modality of breast cancer screening and risk reduction. The WISDOM Study uses a preference-tolerant design, enabling women who decline randomization to self-select their screening arm. The risk-based arm included comprehensive breast cancer risk assessment using the Breast Cancer Surveillance Consortium (BCSC) model and genetics. From August 2016 to February 2023, WISDOM enrolled a large, diverse, nationwide cohort of 46,403 participants - 77% non-Hispanic (NH) White, 9% Hispanic, 6% (NH) Black, and 5% (NH) Asian; demographic diversity increased over time. Mean age at baseline was 54 years. 28,372 (61%) were randomized, while 89% of those who self-selected their screening arm chose risk-based screening. The preference-tolerant design captured real-world screening preferences while maintaining scientific rigor and demonstrated strong preference for risk-based screening.</p>

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WISDOM randomized trial comparing risk-based versus annual breast cancer screening: study cohort characteristics and design

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月24日

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  • Allison Fiscalini,
  • Kelly Blum,
  • Kirkpatrick Fergus,
  • Robert A. Hiatt,
  • Arash Naeim,
  • Andrea Kaster,
  • Maren T. Scheuner,
  • Laura J. van ‘t Veer,
  • Andrea Z. LaCroix,
  • Alexander D. Borowsky,
  • Olufunmilayo I. Olopade,
  • Hannah L. Park,
  • James Esserman,
  • Rachael Lancaster,
  • Diane Heditsian,
  • Susie Brain,
  • Vivian Lee,
  • Deborah L. Goodman,
  • Katherine S. Ross,
  • Neil Wenger,
  • Barbara A. Parker,
  • Lisa Madlensky,
  • Jeffrey A. Tice,
  • Yiwey Shieh,
  • Elad Ziv,
  • Vignesh A. Arasu,
  • Hoda Anton-Culver,
  • Celia P. Kaplan,
  • Kim F. Rhoads,
  • Kimberly Badal,
  • Michael Hogarth,
  • Antonia Petruse,
  • Irene A. Soto,
  • Katherine Leggat-Barr,
  • Steffanie Goodman,
  • Jennifer Atamer,
  • Rita Ryu,
  • Kelly Adduci,
  • Jeffrey B. Matthews,
  • Martin Eklund,
  • Leah P. Sabacan,
  • Laura Esserman

摘要

The Women Informed to Screen Depending on Measures of risk (WISDOM) Study (clinicaltrials.gov NCT02620852, 2016-08-31) is pragmatic randomized controlled trial evaluating risk assessment to inform the age to start, frequency and modality of breast cancer screening and risk reduction. The WISDOM Study uses a preference-tolerant design, enabling women who decline randomization to self-select their screening arm. The risk-based arm included comprehensive breast cancer risk assessment using the Breast Cancer Surveillance Consortium (BCSC) model and genetics. From August 2016 to February 2023, WISDOM enrolled a large, diverse, nationwide cohort of 46,403 participants - 77% non-Hispanic (NH) White, 9% Hispanic, 6% (NH) Black, and 5% (NH) Asian; demographic diversity increased over time. Mean age at baseline was 54 years. 28,372 (61%) were randomized, while 89% of those who self-selected their screening arm chose risk-based screening. The preference-tolerant design captured real-world screening preferences while maintaining scientific rigor and demonstrated strong preference for risk-based screening.