The wisdom trial is based on faulty reasoning and has major design and execution problems
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REVIEW
The wisdom trial is based on faulty reasoning and has major design and execution problems Daniel B. Kopans1 Received: 16 July 2020 / Accepted: 13 November 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020
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. Keywords Breast cancer · Screening · Screening trials
The wisdom trial WISDOM is a trial whose main goal is to evaluate mammography screening based on each woman’s risk of developing breast cancer. The trial is planning to recruit 100,000 women stating, “This study compares annual screening with a risk-based breast cancer screening schedule, based upon each woman’s personal risk of breast cancer” [1]. The rationale for the trial is that there is disagreement as to which women should participate in screening; at what age women should begin mammography screening; and how often they should be advised to participate. The trial is described in greater detail below, but “Within the Athena Breast Health Network, the study will compare comprehensive, patient-centered risk-based screening to annual screening for women starting at age 40.” “The study’s personalized approach will recommend an age to start and stop screening as well as a frequency based upon individual risk. Women of high* Daniel B. Kopans [email protected] 1
Radiology, Harvard Medical School, 20 Manitoba Road, Waban, MA 02468, USA
est risk will receive greater surveillance than those of lowest risk where the lower bound is the USPSTF-recommended guidelines. In this manner, the study will focus the most effort on those most likely to develop the disease.” “Type of Study This Wisdom Study is a preferencetolerant randomized controlled trial. This means that there are two study participation options: randomization or self-selection. If a woman elects to be randomized, she will be randomly assigned to either a personalized screening schedule or an annual screening schedule. If a woman prefers to choose her own screening schedule, she may choose to participate in either the personalized or annual screening group” [2].
Faulty trials are a dangerous problem There is a major problem when clinical trials are undertaken and their results reported, despite
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