7
Translating New Technologies into Improved Patient Outcomes

In health care, invention is hard, but dissemination is even harder.

Donald Berwick

JAMA 2003

The development of new technologies for breast cancer detection and diagnosis is important in improving patient outcomes, but is not sufficient on its own.a In fact, the translation of a new technology into improved patient outcomes involves at least three overlapping processes: (1) decisions by healthcare delivery organizations to adopt these new technologies that are based on assessment of the efficacy and cost-effectiveness of the technologies, (2) deployment of these technologies within the complex organizational structure of healthcare providers, and (3) monitoring the use of these new technologies. Clearly, new technologies must be adopted by healthcare providers in order to affect patient outcomes. However, it may be less obvious that these technologies must be deployed in a manner that takes into account the frequent need for healthcare delivery organizations to adapt their organizational structures to deliver the full benefit of the new technologies. Furthermore, the use of new technologies by healthcare practitioners must be monitored to ensure and improve the quality of care. All too often, in the view of this Committee, analyses of healthcare technology have emphasized the development and assessment of new technologies and paid less attention to the process by which clinicians deploy new technologies into routine medical practice. The distance between efficacy and effectiveness is long and not always bridged (Box 7-1).

a  

As is the case throughout the report, “technology” is used in its broadest sense to include imaging devices, biologically based approaches (such as gene or protein biomarkers), detection software, and new procedures.



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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 7 Translating New Technologies into Improved Patient Outcomes In health care, invention is hard, but dissemination is even harder. Donald Berwick JAMA 2003 The development of new technologies for breast cancer detection and diagnosis is important in improving patient outcomes, but is not sufficient on its own.a In fact, the translation of a new technology into improved patient outcomes involves at least three overlapping processes: (1) decisions by healthcare delivery organizations to adopt these new technologies that are based on assessment of the efficacy and cost-effectiveness of the technologies, (2) deployment of these technologies within the complex organizational structure of healthcare providers, and (3) monitoring the use of these new technologies. Clearly, new technologies must be adopted by healthcare providers in order to affect patient outcomes. However, it may be less obvious that these technologies must be deployed in a manner that takes into account the frequent need for healthcare delivery organizations to adapt their organizational structures to deliver the full benefit of the new technologies. Furthermore, the use of new technologies by healthcare practitioners must be monitored to ensure and improve the quality of care. All too often, in the view of this Committee, analyses of healthcare technology have emphasized the development and assessment of new technologies and paid less attention to the process by which clinicians deploy new technologies into routine medical practice. The distance between efficacy and effectiveness is long and not always bridged (Box 7-1). a   As is the case throughout the report, “technology” is used in its broadest sense to include imaging devices, biologically based approaches (such as gene or protein biomarkers), detection software, and new procedures.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis BOX 7-1 Efficacy and Effectiveness Efficacy refers to the likelihood that a particular intervention will benefit patients when used under optimal or ideal experimental conditions. Such conditions are rarely met except in controlled clinical studies. An efficacious treatment is one whose effects have been shown to have a statistically significant improvement in health or well-being, typically in a randomized controlled trial (RCT). Effectiveness refers to the likelihood that a particular intervention will benefit patients when used under usual and routine clinical practice conditions. Such conditions are generally more complex than those used in RCTs. For example, many people have coexisting conditions that alter the effect of interventions; they may not consistently follow treatment instructions; or they might be much older or younger or of different ethnicity than the people with whom the RCT was conducted. The Committee believes that because technologies that completely replace mammography are unlikely to reach the market—at least within the next 10 years—organizations will be faced with the challenge of adopting technologies that will be used in conjunction with existing modalities. These new technologies will have to be integrated into current practice and will require the creation of new organizational routines for screening and diagnosis. Mammography creates a high standard for any new technology. The value of any new breast cancer detection technology will be determined largely in reference to mammography. If any new technology were shown to outperform mammography for any specific groups—for example, for women whose breast density exceeds a certain threshold—then it might be adopted. Our discussion in this chapter distinguishes among the activities of (1) technology assessment and adoption, (2) technology deployment, and (3) monitoring of technologies in use. This tripartite schema, however, is a description of best practice. Technology assessment leading up to the decision to adopt, or purchase and use, is covered in Chapter 6. In fact, many health care delivery organizations undertake technology assessment and adoption. But far fewer plan systematically for the organizational, technological, and other complementary requirements for the deployment of these technologies. Even fewer healthcare delivery organizations, in the judgment of this Committee, invest sufficiently in the monitoring of the use and effectiveness of these technologies as employed by healthcare practitioners. One of the central arguments of this chapter is the need for greater attention to these second and third activities in order to improve patient outcomes.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis PROCESS OF TECHNOLOGY ADOPTION The foregoing implies that following Food and Drug Administration (FDA) approval, the successful introduction into routine clinical practice of any new technology relies on three phases: assessment, deployment, and monitoring (Table 7-1). Although many discussions of technology adoption focus only on the decision to adopt technology, this report refers to these phases together as the adoption process, in which the decision to adopt is just one element. The assessment of a new technology relies on an evaluation of its efficacy and effectiveness, based on the results of clinical studies that often are carried out in academic medical centers or other centers of research. This activity is typically undertaken by regulators (such as the FDA), technology developers, academic clinicians, delivery organizations and insurers (for example, Blue Cross Blue Shield). Without assessment, patients are subject to ineffective, or even harmful, medical treatments. Medical history is rich with examples of technologies that were applied only on the basis of what seemed plausible at the time, but were later proven to be inappropriate. Even today, an estimated 80,000 unnecessary hysterectomies and 500,000 unnecessary cesarean deliveries are performed in this country every year.3,9 The clinical settings where the assessments of effectiveness and efficacy are conducted may differ in significant ways from the typical health delivery environment within many health care organizations. Practitioner exper- TABLE 7-1 The Three Phases of Technology Adoption Phase Definition/ Examples Technology assessment Evaluation of the results of scientific testing of a technology: Cost-benefit analysis* Efficacy Specification of the target population Technology deployment Putting technology into practice: Early experience and learning Development of new work routines Integration with existing technologies and work routines Technology monitoring Post-application monitoring: Evaluation of outcomes Detection of anomalies *In practice, cost is rarely considered at this stage.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis tise may be less highly developed, patients not involved in a clinical trial or evaluation may be less committed to following the guidelines for specific procedures, and equipment may be less well maintained or operated by less highly qualified practitioners. Therefore, some evaluation of the scope of the task of technology deployment is an important step in successful introduction of a new medical technology. Technology deployment includes the activities of implementing the technology in routine use, gaining early experience in using it, and then making its use routine. In other industries this phase often includes a review by technology users of their capacity to apply the technology in routine work and evaluates the system and organizational requirements needed to support the use of the technology, such as the number and types of staff, their training needs, and the facilities needed. In health care, few parties undertake such reviews of the technology prior to actual use. Not all technologies are the same. Some are easily integrated into clinical practice because they can be substituted for existing technologies without requiring significant changes in work routines. Others require substantial changes in order to fully realize their potential. In the latter case, patient outcomes are not only a function of the technology itself (efficacy), but of the way it is applied by users; therefore the success of the technology depends on the organizational and clinical skill of individual users and user organizations (effectiveness). Finally, technology monitoring is the surveillance of patient outcomes after the introduction of new technology, with the intent of identifying opportunities for improvement or failures of the technology or its use. Ideally, issues related to technology use, such as “ease of use,” are integrated into technology design, and user experience with a technology is an important piece of feedback for designers. But formal evaluations of technologies by practitioners and delivery organizations focus more on technology assessment than application, and therefore a highly desirable “feedback loop” is less effective than it should be. In addition, the organizational adaptations necessary to exploit new technologies effectively (especially those based on digital technologies that create high potential for greater cross-functional integration and interaction within the delivery system) are rarely codified or incorporated with new technologies for breast cancer detection and diagnosis. All but the first phases of technology adoption are typically undertaken by healthcare delivery organizations that are planning widespread use of a technology (although some provider organizations also conduct their own technology assessment in addition to those undertaken by the FDA and Centers for Medicare & Medicaid Services [CMS]). In conducting the assessment, however, users may not have access to well described models of service delivery and operational processes, or strategies for staff training.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Nor may users have the capability to experiment with different service models for placing a new technology into routine practice. These deficiencies will impede technology adoption and may produce less successful outcomes for those technologies that are adopted. Many of the technological possibilities for improving detection and diagnostic outcomes in the relatively near future will involve integrated “portfolios” of technologies or technologies spanning different functions within the health care delivery organization. Adoption of such technologies is likely to be a complex process and one for which evaluation of effectiveness and outcomes in the clinical setting, rather than in an academic research center, will be particularly important. The complexity of technology adoption is likely to be further increased by the reduction in size of patient populations as smaller risk groups are successfully identified, each possibly requiring a different screening strategy and suite of screening technologies. This approach could be less complicated when used by an integrated health care team that provides all aspects of a breast cancer diagnosis. Thus, the responsibility will remain with the physician, and not the patient, to ask the right questions and obtain the appropriate information to determine the most effective approach for each woman. The tasks of technology deployment and monitoring have become more complex and demanding. Multiple risk and morphology identification technologies need to be integrated with each other in a way that helps to guide clinicians in their selections of evaluation strategies for each individual patient. Head-to-head comparisons of the performance of technologies under both research conditions and conditions of routine use will be an essential component of the development of clinical strategies for screening subgroups of at-risk patients. Two excellent, but unfortunately rare, examples of head-to-head comparison trials are discussed in Chapter 6: the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial comparing different medications for hypertension and the Digital Mammography Imaging Screening Trial (DMIST) comparing digital with screen-film mammography. New technologies or portfolios of technologies also need to be integrated into practice through training, change in organizational structure, and the design of appropriate incentives. Research on the organizational determinants of an individual technology’s performance and the collation and dissemination of organizational “best practices” are needed to aid individual clinicians, delivery organizations, and systems of care in planning for the implementation of new screening technologies or portfolios of technology. The thesis of this chapter is that the scope of technology assessment must be expanded to include considerations of “value in use,” or whether the technology will deliver its promise of improving health outcomes. The

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis first stage of technology assessment, clinical trials, was addressed in Chapter 6. This chapter continues with consideration of the subsequent stages through which new technologies are incorporated into clinical practice, and how their potential value can be delivered once they are adopted. THE MANY DRIVERS OF TECHNOLOGY ADOPTION The study of diffusion of innovation has a long history in social science, although much of that history focuses on the decision to adopt innovations. Individuals who adopt specific innovations have been classified into five groups based on their rates of adoption of new technologies and students of innovation have identified distinctive personalities and social roles that are linked to adoption (Box 7-2).20 In addition to the characteristics of the people who adopt innovations, perceptions of an innovation are a major determinant of how quickly and extensively that innovation will be adopted. The belief that an innovation is both beneficial and compatible with the values and needs of individuals is particularly influential—as it should be. Another important factor that is particularly relevant to breast cancer detection technologies is complexity. BOX 7-2 Typology of Technology Adopters The fastest individuals or groups to adopt new technologies are the innovators who tend to be wealthier than average or otherwise able to accept the risks and costs inherent in innovation. They are not opinion leaders; in fact, they may be thought of as mavericks or may appear to be heavily invested personally in a specialized topic. The next group is the early adopters. They are opinion leaders who do not tend to search as widely as the innovators, but do seek out the innovators. Such people are generally testing several innovations at once. Early adopters are often elected as leaders of professional groups, and they are the likeliest targets of pharmaceutical or device company detailing. The next third of the distribution is the early majority, who tend to learn mainly from people they know well. They tend to travel less and interact less with the innovators than do the early adopters. The next group, another third of the population, is more conservative: the late majority. They will adopt an innovation when it appears to be the new standard of practice, but not before. Members of the final group are termed “laggards,” although traditionalists is perhaps a better term. They are the physicians who swear by the tried and true. SOURCE: Text quoted from Donald Berwick. Disseminating Innovations in Health Care (JAMA 2004) based on typology developed by Everett Rogers (Diffusion of Innovations).

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Generally, simple technologies are adopted faster than complicated ones.4 Complicated technologies almost always change as they spread, and local adaptation is nearly always necessary for successful adoption. Approval from both the FDA and health care payers is usually a necessary step for technology adoption, but neither can ensure that the “right” technologies will find their way into widespread clinical use. There is no guarantee that a technology that receives a favorable review during the technology assessment process will be used in routine practice. In addition to the general patterns that drive technology adoption, idiosyncratic aspects of particular technologies can influence the likelihood that they will be adopted into clinical practices. Finally, clear evidence of efficacy and effectiveness should be, but is not always, the basis for a decision to adopt a new technology. FDA Approval Only Partly Predicts the Adoption of Technology FDA approval is a critical step in the development of most new medical technologies. When a fledgling company obtains FDA approval for its product, its ability to raise capital soars, which in turn enables the company to continue developing the product. Likewise, the label “FDA approved” is commonly used as a marketing tool. Although FDA approval enables a new technology to enter the marketplace, it does not guarantee success. For example, the T-Scan™ device that measures electrical impedance in breast tissue was approved by the FDA in 1999 as an adjunct to mammography, but 4 years later the manufacturer had not sold a single machine in the United States (see Box 7-3). Another example is the case of thermography, first approved by the FDA in 1982 for use as an adjunct to mammography. Definitive clinical trials of thermography have never been conducted to determine its effectiveness in detection breast cancer and no thermographic devices have gained widespread clinical acceptance. Therefore, it should not be surprising that FDA approval is no guarantee that a technology will be widely adopted. Even so, thermography service centers are currently open for business and promoting the use of thermography for breast cancer detection. The FDA approval process focuses primarily on assessing whether the technology is safe and effective and uses data drawn exclusively from highly structured experimental settings in order to make this determination. FDA approval implies nothing about the likelihood of realizing these optimal outcomes in the setting of routine practice, nor does the FDA provide guidance on what structures or activities might be necessary in order to realize optimal outcomes. Importantly, FDA approval says nothing about how a new technology might be practically used in concert with other technologies already in use, which is an especially important issue when a

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis BOX 7-3 T-Scan: FDA Approval, but No Market In 1999, the FDA approved the T-Scanv 2000, which is based on a technique known as electrical impedance scanning, as an adjunct to mammography. The T-Scan, developed by TransScan Medical, Inc., works by creating a map of the breast using a small electrical current. Unlike mammography, electrical impedance spectroscopy measures do not require compression of the breast. Images are made at the time of testing and are simple to interpret, which reduces the waiting time for results. It is also much less expensive than magnetic resonance imaging (MRI) or ultrasound. The first models cost about $70,000; the second generation models are expected to cost about $30,000. Individual exams could cost as little as $10 to $20. Comparatively, screen-film mammography devices cost approximately $70,000 and individual exams are reimbursed approximately $80 by CMS. Limitations. Although a website sponsored by Siemens (the international distributor of T-Scan) describes T-Scan as “diagnostically accurate” and “cost-effective to own and operate,” there are limitations to the device in breast cancer detection. The accuracy, as defined by sensitivity and specificity, is lower than either mammography or current biopsy techniques. It is also less sensitive than any of the current technologies used to investigate the results of suspicious mammograms—either ultrasound or surgical biopsy—and it cannot detect microcalcifications, often associated with early stage breast cancers. In the event of a suspicious mammogram, the premium on specificity is very high. No Sales in the United States. As of January 2003, 125 devices had been sold outside the United States. Sixty-five of them had been sold in Europe, 50 in Asia, and 10 in Latin America. However, no units have been sold in the United States. The company decided not to market in the United States because they did not think it would be accepted, and they were probably right, because the fear of malpractice litigation exerts strong pressure to avoid false negatives. In addition, some cancers detectable by mammography will be missed if this technology is used in its place. new technology complements existing technologies, as opposed to replacing them. In certain cases, such as for BRCA testing or other “home-brew” tests, FDA approval is not even necessary. The FDA does not regulate the BRCA test, because the test kits are not marketed to consumers and do not claim to produce a beneficial clinical outcome. The test is certified only by the CMS under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and lacks any other regulation within the United States. CLIA requires only that the laboratories demonstrate accuracy and reliability in measuring the substances that they claim to be assaying. BRCA testing also illustrates another issue that crops up regularly, which is the potential for patents to impede the development and dissemi-

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis BOX 7-4 Myriad Problems in International Gene Patenting Through several patents, Myriad Genetics, Inc., legally owns a DNA sequence associated with an increased risk of developing breast cancer. The Salt Lake City, Utah-based company was awarded “composition of matter” and “method-of-use” patents on the BRCA1 and BRCA2 breast cancer susceptibility genes from the U.S., European, and Canadian Patent Offices. However, as of this writing, Myriad has granted only a few limited licenses to other companies, effectively making Myriad the only legal source for BRCA testing in Europe and North America. This business strategy has created international controversy, because it restricts others from testing for BRCA mutations even with superior methods. For example, several cheaper tests with similar effectiveness have been developed, yet the broad scope of Myriad’s patent prevents health care systems worldwide from adopting other technologies.21 For instance, a faster and cheaper genetic test cannot be offered locally within a system of care that is linked to genetic counseling services and the other testing services offered by the system, thus restricting access to care.25 Testing begun in the Canadian province of Ontario for a third of the cost of Myriad’s test and with results available eight weeks sooner, was threatened with legal action by Myriad against the province of Ontario in late 2002. However, under the direction of Ontario’s Health Minister Tony Clement, regional hospitals have disregarded the patent and continue to offer BRCA gene testing services. Clement opposes Myriad’s patent saying, “We do not accept their claim and we are disregarding that claim.” In response to threats from Myriad Genetics to enforce their patent, Clement stated that he was willing to take the issue to the highest court.16 However, care may be affected by the cost of the test, the length of time it takes for samples to be mailed and processed, and the inability of Myriad to test for every possible breast cancer mutation, resulting in false negatives. Only 10 to 20 percent of the potential BRCA1 mutations are tested by Myriad, and their testing has missed mutations.11 nation of new technologies. Although the patent system was designed to “promote the useful arts,” the ability of patent holders to restrict access to their technologies can create obstacles, as has been the case for BRCA testing7 (Box 7-4). Coverage Matters More for Some Technologies Than Others As with FDA approval, the decision by health care payers (insurance companies, health maintenance organizations, and Medicare) to reimburse health care providers is usually an important driver of technology adoption. Gaining coverage is still no guarantee of adoption, nor is it required for the successful adoption of an innovative technology into routine practice. For example, testing for BRCA mutations was widely done even in the absence

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis of coverage. Most insurance companies now cover BRCA testing. Even though MRI is not covered for screening, it has nonetheless been marketed for screening and is requested by consumers on a daily basis (see Box 1-3 in Chapter 1). Reimbursement policies will have their greatest effect on the adoption of more expensive technologies. Positron emission tomography (PET), computer-aided detection (CAD), and digital mammography all experienced a surge in usage after health care payers decided to cover them. Reimbursement procedures also influence technology adoption. Since CAD is a technology to improve interpretation of mammography, its reimbursement could have been bundled into a single payment for mammography. Instead, CAD is covered as a separate add-on payment, and that clarifies the economic implications of employing this technology and is more likely to encourage its diffusion. Frost & Sullivan, a leading market analyst firm for medical technology, reports “skyrocketing” sales for CAD, with 18 and 8 percent growth in 2002 and 2003, propelled by the increased reimbursement rates for mammography CAD screening.10 They also report that use of CAD has “boosted the confidence levels of both radiologist and patients.” As discussed in Chapter 3, the evidence that the use of CAD improves breast cancer detection is promising, but not definitive. Digital mammography is a different story. Although CMS will reimburse health care providers for the use of digital mammography for screening mammograms, many insurance companies will not. The Blue Cross Blue Shield Technology Evaluation Center and the Kaiser Foundation Health Plan have both decided not to cover digital mammography, because it has not been demonstrated that:5 It improves net health outcomes, It is as beneficial as screen-film mammography, and It improves outcomes outside investigational settings (i.e., in routine clinical practice). This conclusion was reached in July 2002 and was based on the data available up to that point, but could be revised if new evidence indicates clear advantages of digital over screen-film mammography, such as the results from the DMIST trial expected in 2005 (see Chapter 6). In the meantime, lack of reimbursement will limit the adoption of digital mammography. Digital mammography is an expensive technology when compared with conventional screen film, with digital systems ranging from $350,000 to $500,000 versus $80,000 to $90,000 for screen-film units.2 In general, decisions by healthcare payers to deny reimbursement puts a brake on the adoption of expensive and unproven technologies (at least for screening), including PET, MRI, laser tomography, and thermography.1 Although lack of validation and lack of coverage are strong deterrents, as noted

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis BOX 7-5 Drug-Eluting Stents Coronary stents are metallic mesh devices that are often placed at the site of angioplasty to keep the artery open. In some patients, scar tissue grows at the site of the stent, thereby creating a new blockage or narrowing in the artery. Drugeluting stents are coated with a polymer containing a drug that is released into the surrounding tissue to prevent scar tissue formation. earlier, there are many drivers to technology adoption, including patients who pay out of pocket for new technologies. Indeed, leading market analysts predict that digital mammography will slowly replace traditional screen-film mammography—anticipating, in part, that evidence will eventually shift in favor of digital mammography. (Other factors such as increased efficiency in processing and handling of images are also likely to influence the rate of adoption.) Even without clear evidence and without widespread coverage, digital mammography generated about $70 million in revenues, and is predicted to be 70 percent of overall mammography revenues.19 (By comparison, the mammography market in North America generated $203 million in 2002.) Delays in coverage decisions are frequently cited as a major source of delay in the diffusion of medical innovations. In 2001 the Lewin Group reported that Medicare can take 15 months to 5 years or more to make policy decisions on new blood tests like those for colon cancer, breast cancer, and prostate cancer.13 But in some cases, such as the use of drugeluting stents in cardiac surgery, the superiority of the technology is so immediately clear that coverage decisions are made quickly (Box 7-5). The use of drug-eluting stents in cardiac surgery spread more rapidly than any recent innovation in medical technology and in that sense represents the extremely rare “magic bullet.” Perhaps even more important to the rapid dissemination of drug-eluting stents was that effective use of them required minimal learning on the part of surgical teams and did not require significant adaptation of conventional procedures. Consumer Demand Can Override Lack of Data In many cases, widespread technology adoption occurs in the absence of strong evidence that it delivers any measurable benefit to consumer health. Sometimes this adds up only to wasted time and money, but other times the outcomes—as in the treatment of breast cancer patients with high-dose chemotherapy—can be fatal.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Such cases are generally propelled by consumer demand, sometimes to the point of being enshrined in legal mandates. In 1997, Congress passed a law mandating reimbursement of bone densitometry for osteoporosis screening and for prostate serum antigen testing for prostate cancer, despite the lack of data indicating that those tests reduced mortality for either condition. The case of treatment of breast cancer with high-dose chemotherapy combined with bone marrow transplants (HDC/BMT) is a particularly grim example, because the treatment itself carried a significant risk of mortality, about 20 percent in the early years. In the mid-1980s a few preliminary studies indicated that HDC/BMT might be beneficial, and belief in the treatment spread like wildfire. Health care payers initially denied coverage on the grounds that the treatment was unproven, but patients took their insurers to court and won.23,b Ten states passed laws mandating coverage for HDC/BMT. The Office of Personnel Management, which provides health insurance coverage for more than 9 million federal employees through the Federal Employees Benefits Program, required all participating health insurers to cover HDC/BMT. Most private insurers followed their lead. In spite of the lack of evidence for the procedure, insurers were strongly influenced by the threat of litigation (in which the insurers were usually unsuccessful), public relations concerns, and the government mandates.24 Definitive clinical trials that eventually showed the treatment to be generally ineffective were delayed for many years because so many women believed the treatment had already been proven and were not willing to enroll in trials. Many patients with advanced disease had been told at cancer centers that this treatment had shown promise.23 In the meantime, more than 15,000 women with invasive breast cancer had been treated with HDC/BMT, a grueling treatment that involved weeks of isolation in extreme pain.15 Void-Filling Technologies Are Adopted More Readily When mammography was introduced, it was a “void-filling” technology and thus had no competition during the adoption process. New imaging technologies for breast cancer detection face a different scenario. Not only must they be as effective as mammography, but they must offer enough added value to justify the cost of substituting the new technology for the old. b   The precedent-setting case was Fox v. Health Net of California in 1993, a highly publicized case in which a jury awarded $89 million in damages to the family of Nelene Fox whose insurance company had denied coverage of HDC/BMT. (Fox’s local community raised the money for treatment, but she died soon after it; Case no. 219692 California Supreme Court.)

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis As a rule, technologies that fill a void are adopted more rapidly than those that perform the same functions as technologies already in use. If history had been reversed and electrical impedance scanning (EIS) had been well established as a life-saving technology before the advent of mammography, it likely would have found a strong market in the United States. But if mammography had come along with better sensitivity and specificity than EIS, it is likely that EIS would have been replaced. Furthermore, if mammography had followed EIS, then it might have been welcomed more skeptically in the face of an existing technology that did not carry with it the discomfort and exposure to radiation associated with mammography. For now, the combination of sensitivity, specificity, and relatively low cost of mammography set a high bar for the entry of new breast cancer detection technologies. In general, anatomically based technologies that rely on nonspecific aspects of cancer-associated changes (such as temperature, water content, or conductivity) are unlikely to be widely adopted because mammography already occupies that niche. For widespread adoption, new technologies will have to be demonstrably superior to mammography. This would include technologies where increased efficiency or reduced costs permit increased access or treatment quality. In contrast, other technologies such as blood tests that could reliably and accurately identify breast cancer risk or that could distinguish among potentially invasive and noninvasive cancer would be void-filling technologies and would be expected to be readily adopted. BRCA testing and protein profiling based on microarray analysis are both examples of void-filling technologies. TECHNOLOGY AND ORGANIZATIONAL CHANGE In innovation, new concepts usually must come from outside the current system, but new processes—the things that make the concepts live—must come from inside or they will not work. Donald Berwick, JAMA 2003 One of the most robust findings of more than two decades of research on the adoption of new technologies, especially technologies that rely heavily on digital transmission or storage of information, is the need for complementary organizational changes to fully realize the economic, efficiency, or productivity benefits of these technologies. For example, an analysis of 1,000 drug approvals since 1987 revealed that several drug development companies consistently outperformed the others in drug development times, developing their drugs as much as 50 percent faster than other companies. The top performers tended to be those that invested in new technologies to speed the routing of documents—a seemingly small aspect of a

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis complex scientific process that was nonetheless identified as a critical strategic step.6 Technologies that affect the transmission or storage of information have particularly significant implications for organizational structure, precisely because organizational hierarchies often are based on differential access to various types of data or information. But when a new technology involves a significant change in procedures or the costs of those procedures, the most efficient roles for different team members are likely to change. This may also require changing organizational hierarchies, which is, by definition, disruptive. Many of the important new technologies in breast cancer detection and diagnosis rely on improvements in information handling, and therefore have significant implications for organizational structure. Moreover, as Maanen and Barley14 and Edmondson and colleagues8 have shown, the adoption of many other types of new medical technologies has followed this pattern. Significant organizational change is necessary in order to exploit the potential of these technologies for improvements in patient care and patient outcomes. An important part of the “technology deployment” task, therefore, is the instigation and management of the organizational changes necessary to accommodate new medical technologies. Organizational capabilities are what determine the difference between technology potential and technology yield. Adopting new technology requires a high degree of organizational adaptation.12 As a rule, once research has established the efficacy and safety of a device and it has obtained regulatory approval (if needed), the factors that should be considered in the decision to acquire a particular technology include: How it fits into the culture or operational style of a health organization or practices, How it affects workflow and work processes, What other technologies it displaces or changes, How easy it is to master and set up, How easy it is to maintain, Whether it is reimbursable (more important for relatively expensive technologies), Whether there is recognition or demand for it, and Promotional initiatives. For example, a study that compared the ability of different surgical teams to adopt minimally invasive procedure for cardiac surgery found that their proficiency was linked to their ability to adopt new work routines and relationships among surgical team members (Box 7-6).8,18

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis BOX 7-6 Minimally Invasive Cardiac Surgery: A Case Study in Technology Deployment The effective adoption of most new medical technologies, including those described in this report, is likely to require changes in clinical practice. A study of the adoption of minimally invasive cardiac surgery indicates that the success of this procedure depends as much on organizational factors as on the efficacy of the technology in question. When first introduced, minimally invasive cardiac surgery was expected to be a significant improvement over conventional cardiac surgery, because it was so much less traumatic for patients. Recovery from the surgery was much faster and less painful. The most obvious difference between the two approaches is that a surgeon performing a minimally invasive procedure accessed the heart through a small incision between the ribs, rather than by splitting the breastbone apart. But minimally invasive cardiac surgery also differs from conventional cardiac surgery in a number of more subtle ways that affect how efficiently the procedure is implemented. During minimally invasive surgery, heart function cannot be gauged by seeing and touching the organ, as in conventional surgery, but instead is indicated by sensors that measure blood pressure and other vital signs. This information is displayed on monitors that hang from the ceiling of the operating room and are monitored not by the surgeon, but by other surgical team members: the anesthesiologist, the perfusionist (the technician who controls the pump that substitutes for the heart during the procedure), and the nurse. Although the equipment or techniques used to perform minimally invasive cardiac surgery were not novel, the organization of the procedure represented a major departure from convention. The successful adoption of this approach required members of the surgical team to learn new tasks, establish new routines, and—most importantly—develop ways of working together that differed considerably from their experience in performing conventional cardiac surgery. A Harvard research team compared the adoption of the minimally invasive procedure among 16 different cardiac surgical units, using the amount of time taken to complete a coronary artery bypass graft (CABG) as an indicator of efficiency. All of the surgical teams received the same standardized training in this procedure, and all performed it in their early cases with much the same efficiency, taking about 3 times as long as the typical 3- to 6-hour conventional CABG. As the surgical teams gained experience, their procedure times decreased. However, the rate by which different teams achieved improvement varied significantly. Several factors were associated with the rapid learning and successful adoption of the minimally invasive procedure: careful selection of the team members, preparations such as practice sessions before the first case; choosing uncomplicated early cases, and holding debriefing sessions after every early case to review what went well and what could be done better. The teams that were most successful were those that fostered an environment where team members were willing to acknowledge errors, received criticism, or were warned of an impending error by another team member. Interestingly, neither the type of hospital (academic or community) nor the surgeon’s seniority appeared to influence success in adopting the new procedure. The worst performing teams tended to be those that followed entrenched clinical routines and status relationships among professional disciplines.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Conventional wisdom holds that institutions with the same amount of experience with a new technology will be similarly successful in applying it (the so-called “volume-outcome hypothesis”). By contrast, the results of the study on adoption of minimally invasive surgery suggest that experience with a new technology is necessary but not sufficient to ensure its successful adoption. To fully realize a new technology’s potential, the adopting team needs to develop and optimize work routines and relationships. In fact, although many studies have found a positive association between hospitals’ volume of cardiac artery bypass surgery (CABG) and patient outcome, the effect is modest.17 Most low-volume hospitals achieve excellent outcomes, suggesting that superior processes rather than volume per se is important in high performance.22 However, variation in outcomes is higher among small-volume hospitals. After adjusting for case variation among hospitals, rates of operative mortality decrease only 0.07 percent for every additional CABG procedure conducted. Organizational changes are as important in improving the application of current technology as they are for the integration of new technologies into existing systems. Technology monitoring is integral to recognizing the need for improvement, as well as for achieving improvement. Benefits of Organizational Change: The Colorado Mammography Project The mammography project at the Colorado Permanente Medical Group (CPMG) illustrates the value of attention to organizational design, quality improvement, and performance management, as well as the benefit to patients. The project was started in 1996 in response to quality assessments indicating that detectable breast cancers were being misdiagnosed by several radiologists. It incorporated many innovations in healthcare delivery, including patient safety, continuous quality improvement, and development of practice focus within the specialty of radiology specific to mammography. The project entailed a series of fundamental changes in the radiology department: In 1996, a comprehensive quality assessment program for mammography interpretation was established, with multiple continuous monitors of quality (Table 7-2). In 1998, the radiology department consolidated multiple medical office practices into a single central reading facility and instituted standardized practices with respect to every facet of the interpretation of mammograms.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis TABLE 7-2 Quality Measures Used in Colorado Mammography Project Indicator Project Goals Benchmarks Established in Other Studies or by Law Proportion of stage 0 or 1 diagnosed by mammography 80% in 1998 85% by 2003 80% Sensitivity 80% 73% Cancers per 1,000 mammograms > 6 6 Recall rate for screening mammograms ≤ 7% 8.3% Number of mammograms read per radiologist 4,000/year 480/year Prior to 1998, each of the 21 radiologists in the region interpreted mammograms, some as few as 40 per month, the minimum requirement of the Mammography Quality Standards Act. By the end of 1998, the radiologists had specialized, limiting the interpretation of mammograms to a subgroup with proven high performance, and who read, on average, 6,000 to 7,000 studies annually. From the inception of the comprehensive quality monitoring process, individual and group results have been fed back to the radiologists. Data are compared to published benchmarks, goals of group performance and individual variation are defined, performance gaps analyzed, specific interventions applied, and the results of interventions measured. Where persistent gaps exist, additional improvement activities are instituted. In 1998, project leaders established a mammography self-assessment exercise that is mandatory for each of the subspecialists. This exercise consists of a blinded evaluation of a mix of normal and known, subtle breast cancers. The exercise challenges the radiologist to continually assess and improve his/her mammography interpretation skills. Although the quality improvement activities have concentrated on systems improvement and self-learning, certain intractable performance issues have been encountered, necessitating withdrawal of privileges for four radiologists over 8 years.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis The project involves a comprehensive performance improvement process, the identification of opportunities at the system and the individual radiologist level, the implementation of plans, and significant and sustainable improvement in patient outcomes. Moreover, the catalyst for this process was a complete reorganization of the radiology department and a commitment to develop mammography as a legitimate subspecialty. Small improvements, such as a 4 percent improvement in sensitivity for detection of breast cancer, resulted from isolated performance interventions, but overall reorganization had much greater impact—for example, raising sensitivity by 11 percent. Because this process was oriented toward self-assessment and learning, there was little emphasis on applying the information to individual performance management. For example, the information was not used in the radiologist’s annual performance appraisal. Each set of cases was certified for 2 1/2 hours of American Medical Association Category 1 Continuing Medical Education (CME), and the exercise was available to radiologists from local private practice groups with intermittent participation. Radiologist satisfaction averaged 92 percent for the overall measures included on the CPMG survey. With the completion of mammography specialization by 1998, however, a sustained level of nearly 90 percent early stage cancer has been achieved. This represents statistically significant improvement and exceeds published benchmarks by 10 percent. Patients are commonly recalled for additional views when the screening mammogram is inconclusive or demonstrates findings potentially indicative of cancer. Such callbacks produce great patient anxiety, consume limited resources, and expose the patient to additional radiation. In Colorado, both group and individual performance are monitored relative to a goal of 7 percent. When a radiologist exceeds two standard deviations for any quarter, he or she must gain the concurrence of another physician for any proposed recall. Using this simple intervention, the group has experienced rapid normalization in every case. In addition, as a result of the improved “process efficiency” of mammogram interpretation, the program has generated net savings of greater than $3 million over the past seven years. During the study period the cost of the professional component relative value unit for each mammogram declined 45 percent, and is now approximately $28, which is 77 percent of the Medicare benchmark. Technology monitoring was integral to this project: first, in the recognition that there was room for improvement, and then throughout the project by establishing monitoring as a routine part of the organization. Finaly, the benefits for the women of Colorado are made clear through the results of monitoring.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis SUMMARY Most approaches to technology assessment imply that it is only the technology that needs assessing and do not address the capabilities of the provider in using the technology—that is, that the technology’s performance capabilities are a function of the technology, not the skill of the user. The Committee believes technology assessment should include more than an assessment of the efficacy of a new technology under ideal circumstances; assessment should also weigh the benefits and costs of the technology in relation to existing interventions and should include a review of the organizational capabilities (skills, resources, and processes) required to successfully utilize the technology in daily practice. This is critical to realizing the full potential the technology has to offer. Multiple technologies with utility for smaller subgroups of women will need to be integrated (1) with each other, and (2) into existing organization and clinical routines. In essence, the scope of technology assessment should be expanded to consider “value in use” in much the same way that nonmedical technologies are assessed. This entails the development of implementation plans and assessment of how it works in practice, with opportunities to make improvements. Technology assessment should thus take “adoptability” into account. The experiences of early adopters should be used to assess necessary adaptations for use of the technology. REFERENCES 1. Bankhead C. PET tests the waters of breast cancer monitoring. December 2002. Web Page. Available at: http://www.diagnosticimaging.com/communitypet/3.shtml. 2. Batchelor JS. 2003, November 21. Detours mark the road to U.S. adoption of digital mammo. Accessed December 1, 2003. Web Page. Available at: http://www.auntminnie.com/default.asp?Sec=sup&Sub=wom&Pag=dis&ItemId=60067. 3. Bernstein SJ, Fiske ME, McGlynn EA, Gifford DS. 1998. Hysterectomy: A Review of the Literature on Indications, Effectivenes, and Risks. Santa Monica, CA: RAND. 4. Berwick DM. 2003. Disseminating innovations in health care. JAMA 289(15):1969-1975. 5. Blue Cross Blue Shield Association. 2004. TEC Assessment Program Vol. 17(7) Full Field Digital Mammography. Accessed March 26, 2004. Web Page. Available at: http://www.bcbs.com/tec. 6. CenterWatch Clinical Trials Listing Service. 2002. Web Page. Available at: http://www.centerwatch.com. 7. Cho MK, Illangasekare S, Weaver MA, Leonard DG, Merz JF. 2003. Effects of patents and licenses on the provision of clinical genetic testing services. J Mol Diagn 5(1):3-8. 8. Edmondson AC, Bohmer R, Pisano G. 2001. Disrupted routines: team learning and new technology adoption. Admin Sci Quart 46:685-716.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 9. Flamm BL. 1997. Once a cesarean, always a controversy. Obstet Gynecol 90(2):312-315. 10. Frost & Sullivan. 2003. U.S. Computer Aided Detection (CAD) Markets—An Analysis of an Emerging Market. MC897194. New York: Frost & Sullivan. 11. Gad S, Scheuner MT, Pages-Berhouet S, Caux-Moncoutier V, Bensimon A, Aurias A, Pinto M, Stoppa-Lyonnet D. 2001. Identification of a large rearrangement of the BRCA1 gene using colour bar code on combed DNA in an American breast/ovarian cancer family previously studied by direct sequencing. J Med Genet 38(6):388-392. 12. Leonard-Barton DA. 1995. Wellsprings of Knowledge: Building and Sustaining the Sources of Innovation. Boston, MA: Harvard Business School Press. 13. Lewin Group. 2001. Outlook for Medical Technology: Will Patients Get the Care They Need? Falls Church, VA: Lewin Group. 14. Maanen JV, Barley S, Frost P, Moore L, Louis M, Lundberg C, Martin J. 1985. Organizational Culture. Beverly Hills, CA: Sage. Pp. 31-53. 15. National Cancer Institute. 2001, April 6. High Dose Chemotherapy for Breast Cancer: History. Accessed June 21, 2003. Web Page. Available at: http://www.nci.nih.gov/clinicaltrials/developments/high-dose-chemo-history0501. 16. Palmer K. 2003, January 7. Battle over gene test. Toronto Star. 17. Peterson ED, Coombs LP, DeLong ER, Haan CK, Ferguson TB. 2004. Procedural volume as a marker of quality for CABG surgery. JAMA 291(2):195-201. 18. Pisano GP, Bohmer RJM, Edmunson AC. 2001. Organizational differences in rates of learning: evidence from the adoption of minimally invasive cardiac surgery. Manag Sci 47(6):752-768. 19. Ridley EL. 2003, April 30. Shift to full-field digital units will spur mammography market. Accessed December 20, 2003. Web Page. Available at: http://www.auntminnie.com/default.asp?Sec=sup&Sub=wom&Pag=dis&ItemId=58036. 20. Rogers EM. 1995. Diffusion of Innovations. 4th ed. New York: Free Press. 21. Sevilla C, Julian-Reynier C, Eisinger F, Stoppa-Lyonnet D, Bressac-de Paillerets B, Sobol H, Moatti JP. 2003. Impact of gene patents on the cost-effective delivery of care: the case of BRCA1 genetic testing. Int J Technol Assess Health Care 19(2):287-300. 22. Shahian DM. 2004. Improving cardiac surgery quality—volume, outcome, process? JAMA 291(2):246-248. 23. Sharf BF. 2001. Out of the closet and into the legislature: breast cancer stories. Health Aff (Millwood) 20(1):213-218. 24. U.S. General Accounting Office. 1996. Health Insurance: Coverage of Autologous Bone Marrow Transplantation for Breast Cancer. Washington, DC: GAO. 25. Walpole IR, Dawkins HJ, Sinden PD, O’Leary PC. 2003. Human gene patents: the possible impacts on genetic services healthcare. Med J Aust 179(4):203.