The WISDOM Personalized Breast Cancer Screening Trial: Simulation Study to Assess Potential Bias and Analytic Approaches

JNCI Cancer Spectrum
Martin EklundLaura J Esserman

Abstract

WISDOM (Women Informed to Screen Depending on Measures of Risk) is a randomized trial to assess whether personalized breast cancer screening-where women are screened biannually, annually, biennially, or not at all depending on risk and age-can prevent as many advanced (stage IIB or higher) cancers as annual screening in women ages 40-74 years across 5 years of trial time. The short study time in combination with design choices of not requiring study entry and exit mammograms for all participants may introduce different sources of bias in favor of either the personalized or the annual arm. We designed a simulation model and performed 5000 virtual WISDOM trials to assess potential biases. Each virtual trial simulated 65 000 randomly assigned participants who were each assigned a risk stratum and a time to stage of at least IIB cancer sampled from an exponential distribution with the hazard rate based on the risk stratum. Results from the virtual trials were used to evaluate two candidate analysis strategies with respect to susceptibility for introducing bias: 1) difference between arms in total number of events over total trial time, and 2) difference in number of events within complete screening cycles. Based on the simulations,...Continue Reading

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Citations

May 7, 2020·JNCI Cancer Spectrum·Martin EklundLaura J Esserman
Jun 25, 2021·Cancer Prevention Research·Anne S QuanteRuth M Pfeiffer
Sep 17, 2021·Breast Cancer Research and Treatment·Laura EssermanMichael Plaza
Sep 18, 2021·The Medical Journal of Australia·John L Hopper, Tuong Linh Nguyen

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Methods Mentioned

BETA
biopsies

Clinical Trials Mentioned

NCT02620852

Software Mentioned

Confluence Stat
WISDOM

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