Saving Women's Lives Strategies for Improving Breast Cancer Detection and Diagnosis (2005) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-18
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Current treatments for breast cancer range from the relatively simple, but daunting, procedure known as lumpectomy, which removes cancerous and surrounding breast tissues, to the modified radical mastectomy in which an entire breast and the adjacent lymph nodes are excised. Both may be accompanied by chemotherapy and/or radiation therapy.
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These reasons include limited availability of screening in some areas, inadequate insurance coverage, and misunderstanding of the value of screening. Also, some women are so afraid of breast cancer they choose not to be screened.
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Simply identifying promising technologies, even those proven through extensive clinical trials, would have no value unless those technologies are suitable for and adopted in clinical practice so they become available to the women who might benefit. Because most clinical trials for cancer detection are designed to evaluate a single technology and do not provide information that might help physicians choose which competing approaches would most benefit patients, the questions asked of new technologies should be which should be used and when, not which is best.
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They also discussed the many issues involved in assessing new medical technologies with senior staff at the federal agencies and with representatives of private insurance groups, all the groups that act as gatekeepers for medical technology. Based on this information and their lengthy deliberations, the committee identified four major categories for recommendations aimed at improving early detection and diagnosis of breast cancer: improve current application of screening mammography; integrate biology, technology, and risk models to develop new screening strategies; improve the environment for research and development; and improve the implementation and use of new technologies.
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Although differences in the number of "excess" biopsies due to false-positive readings were difficult to assess, for even within the United States significant regional variations exist, committee members did identify elements in the programs of some European countries, as well as Canada and Australia, that could be useful in the United States, which has limited national or regional standards or programs for breast cancer screening. For instance, in the United Kingdom radiologic technologists, who are not physicians, are trained to meet national certification standards, and have proven comparable in accuracy and speed to radiologists.
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To improve services in the United States, the committee recommended: Health care providers and payers should consider adopting elements of successful breast cancer screening programs from other countries. Such programs involve centralized expert interpretation in regionalized pro grams, outcome analysis, and benchmarking.
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This suggestion that physician extenders could be enlisted to help read mammograms could thus offer women a more thorough examination than is currently typical of most mammography facilities where mammograms are viewed only by a single breast imager. The potential for alleviating the shortage prompted the committee to recommend: To expand the capacity of breast screening programs, mammography facilities should enlist specially trained nonphysician personnel to pre screen mammograms for abnormalities or double-read mammograms to expand the capacity of breast imaging specialists.
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Based on data from the Breast Cancer Detection Demonstration Project conducted in the 1970s and involving 200,000 women, the model has proven highly accurate at predicting the numbers of women within various age and risk groups who will develop cancer within the next five years, but it is only moderately accurate at predicting which individual women will develop the disease. Another limitation of the Gail model is that it does not include genetic risk factors.
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Considerable progress has been made in identifying biomarkers for cancer and developing aggregate profiles of breast cancer in specific genes and proteins. Already the theoretical promise of this progress is being realized in animal models.
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To address this, the committee recommends: Research funders, including the National Cancer Institute (NCI) and private foundations, should develop tools that facilitate communica tion regarding breast cancer risk to the public and to health care pro viders.
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These efforts ought to involve collaborative efforts among technology developers, not-for-profit organizations (including professional societies) , advocacy groups, private health care payers, and provider organizations working together toward such joint goals as adopting and setting standards for assessment and adoption of new technology.
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· A public education campaign should be undertaken to inform the public, particularly under-represented groups, of the merit of participation in research studies that require the involvement of healthy volunteers and the donation of biologic specimens for ge netic analysis. · Advocacy groups and women's health organizations should partici pate in design and execution of public education about clinical trials.
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Further addressing concerns about the unintended consequences of the HIPAA privacy rule, the committee called upon the Department of Health and Human Services to work with the private sector in efforts to monitor its impact on the pace of research progress. IMPROVE THE IMPLEMENTATION AND USE OF NEW TECHNOLOGIES Several disquieting facts suggest the urgent need to improve both the implementation and use of new technologies: many cancer detection technologies that have been proposed and developed have proved to be of no value to patients; approval by the Food and Drug Administration (FDA)
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· This will involve identification of optimal combinations and sequenc ing of breast cancer detection technologies. · Research funders and private foundations should model and assess changes in practice and organization change that would optimize the benefit of new technology (including risk assessment)
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EXECUTIVE SUMMARY 15 This recommendation includes the identification of optimal combinations and sequencing of breast cancer detection technologies as well as developing models for, and then assessing, changes in practice and organization that would optimize benefits from new technologies, including risk assessment. The committee further recommended: The NIH, the AHRQ, and other public and private research sponsors should collaborate with health systems, providers, and payers to sup port research that would monitor clinical use of technologies to identify potential failures, as well as opportunities for improvement, with par ticular attention to: (Recommendation D2)
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A3. To expand the capacity of breast screening programs, mammography facili ties should enlist specially trained nonphysician personnel to prescreen mam mograms for abnormalities or double-read mammograms to expand the ca pacity of breast imaging specialists.
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Breast cancer research funders, such as the NIH, DoD, and private founda tions, should support research on screening and detection technologies that encompasses each aspect of technology adoption from deployment to appli cation, and should include monitoring of use in practice. · This will involve identification of optimal combinations and sequencing of breast cancer detection technologies.
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