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The wisdom trial is based on faulty reasoning and has major design and execution problems

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Abstract

Purpose

To evaluate the design and plan of execution of the “WISDOM” trial.

Methods

The rationale and reasoning behind the WISDOM Trial were reviewed and analyzed. The published parameters of the trial were reviewed.

Results

The study is based on a failed understanding of the available data about breast cancer screening and is based on faulty assumptions, false reasoning, a scientifically unsupportable study design, ignoring advances in screening, a questionable endpoint, the likely lacking of power to answer the primary question, and support by insurance companies whose primary goal is almost certainly to reduce their costs.

Conclusion

A major part of the premise is that there is a “debate” about the efficacy of screening. WISDOM ignores the fact that the “debate” has been manufactured and is not science-based. The results of the WISDOM Trial may be misleading.

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  1. Radiology, Harvard Medical School, 20 Manitoba Road, Waban, MA, 02468, USA

    Daniel B. Kopans

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  1. Daniel B. Kopans
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Correspondence to Daniel B. Kopans.

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Dr. Kopans is an advisor to DART Imaging Technology (https://cn.linkedin.com/in/tao-wu-50429715) and has a small interest in the company.

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Kopans, D.B. The wisdom trial is based on faulty reasoning and has major design and execution problems. Breast Cancer Res Treat 185, 549–556 (2021). https://doi.org/10.1007/s10549-020-06020-7

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