Enabling a paradigm shift: A preference-tolerant RCT of personalized vs. annual screening for breast cancer.
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Le résumé fourni par la source
e18281 Background: For almost 30 years, annual mammography starting at age 40 has been a cornerstone of the US strategy to reduce breast cancer mortality. The 2009 USPSTF screening guidelines, despite having a sound evidence base, continue to spark debate. Scientific opinion remains divided. Methods: The Wisdom Study (Women Informed to Screen Depending on Measures of Risk) compares annual screening vs. risk-based screening (RBS). In RBS, a comprehensive risk model incorporates high-impact risk factors, including genetic mutations and common genetic variants (SNPs), mammographic density, family history, exposures, and co-morbidities. The goal is to determine if RBS, compared to annual screening, is as safe, is less morbid, enables prevention, and is preferred by women. Results: Funded by the new PCORI initiative ‘Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes’, the Wisdom Study is designed to determine safety in 5 years, demonstrating that Stage IIB or higher cancers are not increased in RBS. The study has an innovative preference-tolerant design in which participants who are not willing to be randomized to the risk-based or annual arm may join the observational cohort and choose their arm, thus allowing for greater representation and more widely applicable findings. RBS requires payor engagement and is expected to result in cost savings within five years. Since PCORI funds do not cover clinical services, the study has partnered with insurers to cover clinical services associated with the trial. One mechanism for reimbursement is Coverage with Evidence Development (CED). CED accelerates evaluation of value-enhancing clinical innovations to determine if they should be made permanently available to members. Conclusions: By design, the study engages and shares data with multiple stakeholders including participants, investigators, policy makers, technology partners, payors, and scientific granting agencies. Prior to the launch of the study, all stakeholders agree upon, and have access to, metrics for what constitutes the threshold for adoption. Payors will already cover services, so if the threshold for adoption is reached, implementation of RBS can become standard of care immediately. Clinical trial information: NCT02620852.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Enabling a paradigm shift: A preference-tolerant RCT of personalized vs. annual screening for breast cancer.
- Date Crossref
- 20/05/2016
- Éditeur
- American Society of Clinical Oncology (ASCO)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
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University of California pays non établi dans la noticeUniversité ou école supérieure
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University of California, Executive Office of the President et University of California Office of the President, avec 8 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.