Executive Summary

The outlook for women with breast cancer has improved significantly since 1989 as the mortality rate has declined steadily, a decline attributed both to earlier detection through wider use of mammography screening and to improved treatments. Yet breast cancer remains a major problem, second only to lung cancer as a leading cause of death from cancer for women. This year over 200,000 new cases will be diagnosed and about 40,000 women—most diagnosed in earlier years—will die from the disease.

As their basic understanding has improved, researchers have discovered that breast cancer is far from simple. The disease has many forms that follow many pathways. Some are swift and lethal while others may never progress. Unfortunately, the tools available today cannot distinguish between the small pre-invasive lesions that will become lethal and those that will not. Consequently, most breast cancers are treated as if they were destined to be lethal and many women undergo difficult treatments, such as mastectomy, radiation, and chemotherapy, that might never have been needed.

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. None of these treatments, however, is guaranteed to save a woman’s life, and, because so little is understood about the cellular mechanisms and processes that gov-



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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Executive Summary The outlook for women with breast cancer has improved significantly since 1989 as the mortality rate has declined steadily, a decline attributed both to earlier detection through wider use of mammography screening and to improved treatments. Yet breast cancer remains a major problem, second only to lung cancer as a leading cause of death from cancer for women. This year over 200,000 new cases will be diagnosed and about 40,000 women—most diagnosed in earlier years—will die from the disease. As their basic understanding has improved, researchers have discovered that breast cancer is far from simple. The disease has many forms that follow many pathways. Some are swift and lethal while others may never progress. Unfortunately, the tools available today cannot distinguish between the small pre-invasive lesions that will become lethal and those that will not. Consequently, most breast cancers are treated as if they were destined to be lethal and many women undergo difficult treatments, such as mastectomy, radiation, and chemotherapy, that might never have been needed. 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. None of these treatments, however, is guaranteed to save a woman’s life, and, because so little is understood about the cellular mechanisms and processes that gov-

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis ern cancer progression, no one can predict with certainty which patients will be “cancer survivors” after treatment. To date, no way to prevent breast cancer has been discovered and experience has shown that treatments are most effective when a cancer is detected early, while still small and contained and before it has spread to other tissues. Those two facts suggest that, at the present time, improving early detection and diagnosis is the most effective way to continue reducing the toll from breast cancer. Several years ago an Institute of Medicine (IOM) and National Research Council (NRC) committee examined the array of promising detection and diagnostic technologies then in various stages of development, and concluded that mammography, while far from perfect, was still the best choice for screening the general population to detect breast cancer at early and treatable stages. Their findings and recommendations were published in 2001 in Mammography and Beyond: Developing Technologies for Early Detection of Breast Cancer. For a variety of reasons, many women do not undergo regular screening. 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. Others find the procedure painful. The fact that mammography does not work equally well for all women, especially those with dense breast tissue, is a further complication. In addition, the potential for false-positive and false-negative results remains high. Studies suggest that, due to a lack of sensitivity leading to false-negative findings, mammography screening may miss as many as 1 in 6 tumors. At the other extreme, the risk of a false-positive result is about 1 in 10, meaning that about 1 in 10 suspicious findings on a screening mammogram are false alarms. About three-quarters of suspicious areas biopsied as a result of a mammogram turn out to be benign—though only after a woman has endured the fear that she has breast cancer and borne the costs and discomfort of additional medical procedures. In 2002, the IOM and NRC named a second committee to examine which of the approaches identified in Mammography and Beyond held the greatest promise for improving early detection and diagnosis. In addition, this group was asked to both identify and recommend ways to overcome and/or circumvent barriers to the development, evaluation, and, finally, incorporation into clinical practice of those strategies with the greatest potential. Charged with developing a rational and workable framework for the early detection and diagnosis of breast cancer, the committee was also given the broader, and in some ways more formidable, challenge of improving the

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis understanding of both the media and the general public of the public health issues that both underlie and impede the development of new approaches, including the role of regulatory policies and insurance coverage. With Mammography and Beyond as a starting point, the committee identified several potential approaches: broader access to and use of mammography, better quality mammography, or the development of new technologies. They concluded that for the immediate future, broader and better use of mammography holds the greatest potential to save lives. Even the most promising of the new technologies, committee members determined, will probably lead only to incremental improvements in existing technologies, and will not replace them. Indeed, finding ways to ensure those incremental advances are integrated into existing systems holds more immediate promise for improving outcomes for breast cancer patients than attempts to isolate a single new technology that might replace mammography. Important avenues of research and development for exciting technologies, such as biological markers of cancer and molecular profiling, although still in their infancy, are especially promising as diagnostic tools. 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. As the committee reminded, breast cancer is a complex disease that passes through numerous critical stages, each requiring different tools for detection and diagnosis, and demanding different sets of decisions. The first decision, of course, is whether a woman decides to be screened for breast cancer, a decision that depends, in part, on a woman’s perception of her own breast cancer risk, which is often distorted. For many women, the very topic of breast cancer provokes confusion and dread. Many women overestimate their risk of getting and dying of breast cancer before the age of 50, a finding mirrored in the many magazine articles that suggest a significant risk of breast cancer in younger women. Much of their information comes from news reports and advertisements in the mass media, and more recently the Internet, which tend to emphasize dramatic, unusual, and extreme examples rather than balanced and factual presentations. Extensive, and sometimes inaccurate, media coverage of recent controversies about the effectiveness of screening mammography has contributed to public confusion about the value of mammography, its role in breast cancer detection, and the ages at which it is most likely to be beneficial.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Also, glowing reports of “medical breakthroughs” and “promising” technologies that have not been submitted for approval or even tested in patients add another layer of confusion and uncertainty. Physicians face different kinds of decisions. When confronted with an abnormal mammogram, they must decide which technology will provide the most expedient and reliable result and, then, how much faith to put in that result. At present, they receive little research-based guidance about emerging technologies, which combinations of technologies, and which approaches would be most effective for certain groups of patients. The committee included clinicians involved in breast cancer screening, detection, and treatment; experts in cancer and molecular biology; those with expertise in clinical studies, as well as those involved with the development, evaluation, and adoption of medical technology and with experience in health care administration. To supplement their own considerable expertise, members held a number of background workshops and heard from a range of technology developers, researchers, and leaders of clinical studies designed to improve systems for early detection and diagnosis. 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. The detailed rationale and supporting data for each category are in the body of the report. A brief summary of pertinent findings, together with the recommendations, follows (recommendations are also listed separately in the box at the end of this summary). IMPROVE CURRENT APPLICATION OF SCREENING MAMMOGRAPHY A growing shortage of radiologists who specialize in reading mammograms, coupled with an imbalance between the closures and openings of screening facilities, has created unacceptable delays in some parts of the country. At the same time the number of false-positive readings appears to be increasing, possibly due to increasing defensive medicine in reaction to the frequency of malpractice litigation. Improving screening practices to reduce the number of false positives could reduce the costs of additional testing by an estimated $100 million

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis per year, in addition to eliminating the mental anguish and the possible need for a biopsy for thousands of women and also cutting unnecessary waiting time. Though no one knows the actual costs of settling malpractice suits, since so many are settled out of court, these settlements are thought to contribute to the ever-escalating costs of malpractice insurance for radiologists who read mammograms, a trend that discourages physicians from entering the profession. Given these, and other, factors, the committee sought ways to optimize the productivity of radiologists who interpret mammograms and, at the same time, improve their accuracy. They looked toward the experience of other countries, notably the United Kingdom, and their organization of screening services. 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. Also, the British National Breast Cancer Screening Program invites every woman for a screening mammogram, which is paid for through the National Health Service—but only at three-year intervals. In the United States, the recommended screening interval is one year, which is likely to detect more cancers, but women do not get screened unless they are referred by health care providers or refer themselves. Many women are never screened because they lack adequate, if any, insurance coverage. That group tends to include underserved women in lower socioeconomic groups in whom breast cancer may not be detected at an early stage when still treatable. A program that might be adapted by health care providers in the United States is the European Code Against Cancer which stresses that screening should be done within integrated breast care centers that have quality assurance programs. Another model is Britain’s National Health Service Breast Screening Program, which has developed national quality assurance standards and a quality assurance network though which programs are regularly monitored, with results measured against established targets. In the United States no organization collects or monitors data to promote high performance levels and guidelines are only voluntary. (The Mammography Quality Standards Act [MQSA] requires facilities in the United States to collect quality data for internal use, but does not require the facilities to use the data in any specific or documented approach for quality improvement.) In Sweden and the Netherlands, which both report low rates of false positives, screening takes place in outlying centers and diagnosis and

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis workup takes place in centralized facilities. Great Britain has developed a quality assurance self-assessment program, the only one of its kind in the world, which, while voluntary, is used by 90 percent of that nation’s radiologists to identify weaknesses and improve interpretive skills. By contrast, in the United States screening services are rarely integrated within a comprehensive breast cancer center, and typically separated from treatment, counseling, and support services. The MQSA addressed the technical quality of mammograms, but does not require standards to improve delivery of services and quality of interpretation, or quality assurance and a continuing education program intended to enhance the accuracy of interpretation. 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 programs, outcome analysis, and benchmarking. (Recommendation A1) At this time, one of the few regulations directly relating to the quality of interpretation in the United States requires physicians who interpret mammograms to read a minimum of 960 exams in a 24-month period, which averages out to 480 per year. By comparison, breast imaging specialists in the United Kingdom are required to read at least 5,000 each year. A number of technologies under development have potential to improve the quality and accuracy of mammography interpretation. These include such technologies as computer-aided detection (CAD), which does not replace interpretation by a radiologist but can highlight areas of concern for further review by the radiologist. The greatest value of CAD may prove to be its potential to increase the performance level of general radiologists to that of those who specialize in breast imaging. Too, the shortage of mammography personnel may actually impede the kinds of innovation that would improve their efficiency for experts are needed to both assess and properly use these new technologies. To address these issues the committee recommended: Breast imagers and technology developers should work in collaboration with health care providers and payers to improve the overall quality of mammographic interpretation by: (Recommendation A2) adopting and further developing practices that promote self-improvement of breast imagers, but that do not jeopardize the workforce; and developing technologies, such as CAD, that have the potential to improve quality, and expanding their use once they have been validated.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis In addition to the inconsistent quality of mammographic interpretation, some experts believe the growing shortage of breast imagers might soon create a crisis in access to high-quality mammography services. This shortage, coupled with an imbalance between the closures and openings of screening facilities, has created delays of several months in some parts of the country. One approach to address this shortage would be to train physician assistants, or physician extenders, a practice that has helped to alleviate shortages and reduce the workload for physicians in other medical specialties. The judicious use of physician extenders could raise the productivity of the limited number of radiologists who interpret screening mammograms. The committee does not suggest that physician extenders should interpret diagnostic mammograms or that screening mammograms should be interpreted solely by a physician extender, rather they would work to expand the capacity of radiologists. The MQSA stipulates that mammograms are to be interpreted only by a physician specifically certified in mammography. The Act does not, however, preclude other personnel from examining the mammograms that are also interpreted by certified physicians. Although not widely appreciated and rarely practiced, it would in fact be permissible within the provisions of the MQSA to have nonphysician personnel examine mammograms—as long as a certified physician signed the mammogram report indicating that he or she had interpreted it. 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 prescreen mammograms for abnormalities or double-read mammograms to expand the capacity of breast imaging specialists. (Recommendation A3) INTEGRATE BIOLOGY, TECHNOLOGY, AND RISK MODELS TO DEVELOP NEW SCREENING STRATEGIES The wide-ranging levels of risk for breast cancer have important implications for screening and detection. Most guidelines in the United States now recommend annual mammograms for every woman over the age of 40, but the ability to better classify women according to their risk levels—whether high, normal, or low—could allow a more individualized approach to screening. For example, most women would gain no medical benefit

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis from screening before the age of 40 or from twice-yearly screening, though a small minority of women might benefit. Finding techniques that permit such classification will demand a better and more precise understanding of risk factors. To date, the most significant risk factors are age and gender. The widely used “Gail model” identified five risk factors: age, age at menarche, age at first live birth, number of prior breast biopsies, and the number of first degree relatives with breast cancer. 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. Risk assessments for women with BRCA genetic mutations have been developed from retrospective analyses of risks in the relatives of carriers from high-risk families. The accuracy of these analyses has been questioned as population-based studies indicate the risk may be substantially lower. Also risk assessments for carriers have not taken into account the other risk factors used in the Gail model. The committee believes that individual screening strategies are crucial to improving the early detection of breast cancer and that accurate risk assessment is an essential step toward the eventual development of individualized screening strategies. Therefore: Researchers and technology developers should focus their efforts on developing tools to identify those women who would benefit most from breast cancer screening. Such tools should be based on individually tailored risk prediction techniques that integrate biologic and other risk factors. (Recommendation B1) The combination of established risk factors with more comprehensive genetic risk profiles will require the development of mathematical models to relate genetic predictors, biological expression, natural course of disease, and responses to treatment in order to: Elucidate the natural course of disease progression and identify disease subgroups with distinctive risk profiles and treatment susceptibilities; Identify aspects of the models where further research and data collection are needed;

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Provide guidance to technology developers as to the types of technologies that will be most useful, including the required performance characteristics. The current biological revolution has introduced a new era in cancer detection. 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. Yet the novel diagnostic tests of genomics and proteomics, despite their tantalizing potential, must be developed with a goal of clinical usefulness and, ultimately, value to the patient. These tests may prove much too complex for routine screening if they provide too much information, not too little. It is difficult, for instance, to validate tests that provide hundreds of thousands of results for each specimen, as opposed to single-result tests, but without such validation the tests will be of limited value. Another possible drawback to these tests may be their lack of specificity; they may be able to detect cancer, but not be able to identify the type of cancer or location. Because of this, their first useful clinical applications may be to monitor therapeutic response and recurrence, and not as screening tools. Even as individual biomarkers for cancer are identified, blood tests to screen women who are symptom free and at normal risk may be meaningless based on a one-time measurement. Further in the future, there exists the potential for individualized management of each case based on specific molecular characteristics. The development of a profile of deranged cellular circuitry in each cancer patient may allow the tailoring of therapy to meet the individual molecular profile, the microenvironment of the specific tumor and the cancer. Instead of single targets and single therapeutic agents, multiple targets may be used. Instead of waiting for a therapeutic response or signs of recurrence, those targets can be monitored, through the use of molecular imaging or serum proteomics. Fulfilling the promise of molecular imaging and the potential of biological markers for breast cancers and other cancers will require substantial funding as well as collaborations between molecular biologists and scientists from many disciplines. Their joint goal must be to achieve the rational design of new diagnostic tools, establish their importance and utility, and adopt them for clinical use. These tools must meet safety and effectiveness criteria as well as evidence-based standards. Assistance from all parts of the system, from payers, providers, and patients, will be needed to ensure that innovative technology becomes integrated as part of the existing system.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis To achieve maximum potential from innovative technologies, the committee further recommended: Technology innovators, including basic scientists, should work with clinicians, health systems experts, and epidemiologists from the earliest stages of development in order to increase the likelihood of creating clinically useful tools for the early detection of breast cancer. (Recommendation B2) Because understanding the implications of risk plays an important role in breast cancer, the committee gave considerable attention to the problems involved with risk communication. Their concerns included finding better ways to communicate the notions of absolute and relative risk—no easy task, at best—both to individual women and to members of the public, including the news media. Better tools are needed for communicating risk to help health care providers—the physicians, nurses, and counselors who work directly with patients—communicate more effectively with patients. Conversely, better tools are needed for patients and the public, specifically including the media, so they will have greater understanding of the material. Many physicians do not communicate risk effectively and far too often patients either fail to recognize or are reluctant to admit their confusion. As more accurate predictive tools are identified and as individual risk profiles are developed, the need for such tools will become even more pressing. To address this, the committee recommends: Research funders, including the National Cancer Institute (NCI) and private foundations, should develop tools that facilitate communication regarding breast cancer risk to the public and to health care providers. (Recommendation B3) IMPROVE THE ENVIRONMENT FOR RESEARCH AND DEVELOPMENT A number of groups, including the IOM and NRC’s Mammography and Beyond committee and the NCI’s Breast Cancer Research Progress Group have established priorities for breast cancer research. These include the identification of biomarkers, molecular analysis of the transition from pre-invasive to invasive disease, and the need for extensive databases so data can be assimilated and exploited for maximum benefit. These priorities, which the committee believes are appropriate, are reflected in the research portfolios of NCI, Department of Defense (DOD), and private funders. In addition, the committee members concluded that the “discovery research” that lays the foundation for innovative technologies is pro-

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis ceeding well, with promising developments that reflect these priorities on the horizon. But a frustrating and considerable time lag occurs between the identification and development of a promising technology and the testing and experience that shows whether the promise will be achieved and the technology will prove useful. The fact that no system exists for the assessment of new technologies—aside from post-marketing surveillance which only detects product failures and does not assess performance once in use—means that there is no way to compare or evaluate the clinical effectiveness of technologies once they are on the market, a process that would require either long-term clinical studies or the collection, evaluation, and comparison of data. Because so many more new technologies make it to the market than prove clinically useful, the committee sought ways to identify technologies that are not only feasible but will actually improve health or the delivery of health care services. 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. To achieve this goal, the committee recommended: The National Institutes of Health, Agency for Healthcare Research and Quality (AHRQ), and Centers for Medicaid and Medicare Services (CMS) should collaborate to establish programs and centers (which may be virtual) that bring together expertise and funding to enable a more comprehensive approach to technology assessment and adoption. (Recommendation C1) These efforts should involve collaboration with technology developers, not-for-profit organizations (including professional societies), advocacy groups, private health care payers, and provider organizations. Experimentation with innovative organizational structures for the centers should be encouraged. Adoption of standards for collecting and sharing data should be a priority. Clinical studies are expensive, typically costing millions of dollars in addition to the time and effort of participating patients, physicians, and nurses, but such studies are essential to the successful evaluation and adoption of new treatments and technologies. Too many clinical studies fail to provide useful data or to answer the basic question of whether a new technology improves health outcomes. That reflects an underlying problem

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis with study design. Because of the costs involved, considerable attention should be given to avoiding poor study design, eliminating unintentional bias, and standardizing data collection. These studies depend on the willing participation of the public and many researchers have noted a growing reluctance to participate, especially in studies that involve genetic testing and the collection of biological materials. Some of this reluctance has been attributed to fears that results of these tests could be misused by employers and by health and life insurance companies to discriminate against those with existing or potential problems. With implementation of regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), other problems have emerged. The act was created for many reasons, among them to ensure the privacy and confidentiality of health information and make the transfer of health data more efficient. While the law was not intended to hinder research, it has changed the way health plans, clearinghouses, and providers handle personal health information and the way researchers share information. The potential impact on research may prove far-reaching, especially on population-based research that requires broad and unbiased access to the medical records of health providers. The law also threatens the establishment of large databanks and makes it difficult to link data gathered in different institutions or to do studies that require long-term follow-up, which will be virtually impossible if all data have to be deidentified. While the Association of American Medical Colleges has established a network and database to monitor and document the impact of the law on research, uncertainty about the impact and interpretation of this very complex and lengthy law has already led to delays in research and has complicated the grant and contract process. The concerns of committee members about the impact of this law, with its potential to impede efforts to improve the detection and diagnosis of breast cancer, led them to recommend that: Professional societies should work together with women’s health organizations to identify barriers to participation in studies (especially those that require provision of biologic specimens) and ways in which those barriers might be overcome. (Recommendation C2) 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 genetic analysis. Advocacy groups and women’s health organizations should participate in design and execution of public education about clinical trials.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis This could be a collaborative effort, and might include the NCI and the American Cancer Society (ACS). The Department of Health and Human Services (CHHS) should join with private entities in monitoring the effect of the HIPAA Privacy Rule on the pace of research progress. Breast cancer advocacy groups and women’s health organizations have played very important roles in raising public awareness and generating support for efforts to reduce the toll from breast cancer. They could work with other groups such as NCI and ACS on a campaign to educate the public about the merit of participating in research studies that depend on healthy volunteers and the donation of biological materials for genetic analysis. They should also particularly target under-represented groups whose participation in such research is essential to reducing health care disparities based on race and ethnicity. 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), which evaluates a technology for safety and effectiveness, is no guarantee the technology will be used. Perhaps most important, though, is the pivotal role of insurance coverage, which poses a classic “Catch 22” dilemma for most new technologies. Federal and private insurers do not pay for new procedures and technologies until their role in improving outcomes for patients has been documented, but until these same procedures and technologies have been widely used outside of a research setting—which generally means someone must pay for their use—it is almost impossible to demonstrate how well a technology does, or does not, perform in actual use. Contrary to public perceptions, only about 10 percent of new technologies that do make it to the market have undergone the kinds of clinical testing that demonstrate safety and effectiveness. Others have been approved because they have been judged to be similar to technologies already on the market and certain kinds of genetic and diagnostic tests, especially

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis those performed in laboratories and not intended for direct sale, are not reviewed by FDA. The rising costs of product development and the expense of clinical trials, coupled with uncertainty about the outcome of FDA review, have become significant roadblocks to the development of innovative technologies, particularly by small and start-up companies with limited financial resources. Recently FDA has worked to help reduce costs and expedite the review process, trying to work more closely with those groups who have little experience with FDA. How effective this approach will prove is still uncertain. Based on their review, committee members concluded additional steps were needed, not only to expedite the assessment and to document the effectiveness of new procedures but also, once proven, to promote wider use in clinical practice. For instance, conditional coverage could help document which new technologies do improve the outlook for patients if data collection and evaluation are required. Then, if a technology failed to meet expectations, coverage could be withdrawn, but there is a caveat—experience has shown the near impossibility of eliminating coverage once it has been provided. Therefore, the committee does not recommend conditional coverage without careful analysis of feasible mechanisms for implementation. Promoting wide use of new technologies that do prove beneficial poses other challenges, as well. Private practitioners need to learn how to use these procedures and incorporate them into their practices effectively. Studies have shown that strategies such as lectures and distribution of reading materials do little to change the way physicians practice medicine. Current NIH efforts that include workforce training and efforts to translate research into practical applications and develop clinical research networks beyond academic settings address this problem. The committee’s strong conviction that basic research needs to be integrated with technology development and assessment prompted the following recommendation: Breast cancer research funders, such as the NIH, DOD, and private foundations, should support research on screening and detection technologies that encompasses each aspect of technology adoption from deployment to application, and should include monitoring of use in practice. (Recommendation D1) This will involve identification of optimal combinations and sequencing 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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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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 support research that would monitor clinical use of technologies to identify potential failures, as well as opportunities for improvement, with particular attention to: (Recommendation D2) how appropriately the technologies are being utilized, their impact on clinical decision making, and their impact on health outcomes.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Summary of Recommendations A. Improve Current Application of Screening Mammography A1. 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 programs, outcome analysis, and benchmarking. A2. Breast imagers and technology developers should work in collaboration with health care providers and payers to improve the overall quality of mammographic interpretation by:   • Adopting and further developing practices that promote self-improvement of breast imagers, but that do not jeopardize the workforce.   • Developing technologies, such as computer aided detection, that have the potential to improve quality, and expanding their use once they have been validated. A3. To expand the capacity of breast screening programs, mammography facilities should enlist specially trained nonphysician personnel to prescreen mammograms for abnormalities or double-read mammograms to expand the capacity of breast imaging specialists. B. Integrate Biology, Technology, and Risk Models to Develop New Screening Strategies for Breast Cancer B1. Researchers and technology developers should focus their efforts on developing tools to identify those women who would benefit most from breast cancer screening. Such tools should be based on individually tailored risk prediction techniques that integrate biologic and other risk factors. B2. Technology innovators, including basic scientists, should work with clinicians, health systems experts, and epidemiologists from the earliest stages of development in order to increase the likelihood of creating clinically useful tools for the early detection of breast cancer. B3. Research funders, including the NCI and private foundations, should develop tools that facilitate communication regarding breast cancer risk to the public and to health care providers. C. Improve the Environment for Research and Development of New Technologies for Breast Cancer Detection C1. The NIH, AHRQ, and CMS should collaborate to establish programs and centers (which may be virtual) that bring together expertise and funding to enable a more comprehensive approach to technology assessment and adoption.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis   • These efforts should involve collaboration with technology developers, not-for-profit organizations (including professional societies), advocacy groups, private health care payers, and provider organizations.   • Experimentation with innovative organizational structures for the centers should be encouraged.   • Adoption of standards for collecting and sharing data should be a priority. C2. Professional societies should work together with women’s health organizations to identify barriers to participation in studies (especially those that require provision of biologic specimens) and ways in which those barriers might be overcome.   • A public education campaign should be undertaken taken 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 genetic analysis.   • Advocacy groups and women’s health organizations should participate in design and execution of public education about clinical trials. This could be a collaborative effort, and might include the NCI and the ACS.   • The DHHS should join with private entities in monitoring the effect of the HIPAA Privacy Rule on the pace of research progress. D. Improve the Implementation and Use of New Technologies D1. Breast cancer research funders, such as the NIH, DoD, and private foundations, should support research on screening and detection technologies that encompasses each aspect of technology adoption from deployment to application, and should include monitoring of use in practice.   • This will involve identification of optimal combinations and sequencing 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). D2. The NIH, AHRQ, and other public and private research sponsors should collaborate with health systems, providers, and payers to support research that would monitor clinical use of technologies to identify potential failures, as well as opportunities for improvement, with particular attention to:   • how appropriately the technologies are being utilized,   • their impact on clinical decision making, and   • their impact on health outcomes.

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