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© 2004 The Journal of Bone and Joint Surgery, Inc.
Health Care Technology AssessmentBasic Principles and Clinical Applications
1 Department of Orthopaedic Surgery (K.J.B.), School of Medicine (R.G.P.),
University of California, San Francisco, 500 Parnassus Avenue, MU 320W, San
Francisco, CA 94143-0728. E-mail address for K.J. Bozic:
bozick{at}orthosurg.ucsf.edu
Investigation performed at the Department of Orthopaedic Surgery,
School of Medicine, University of California, San Francisco, San Francisco,
California
Health care technology (defined as all drugs, devices, and medical and surgical procedures used in medical care as well as the organizational and supportive systems within which such care is provided) is widely regarded as an important driver of escalating health care spending in the United States. Many new health care technologies are adopted and used in clinical practice with little or no evidence that their use is associated with improved patient outcomes. Orthopaedic surgeons are facing increasing scrutiny from hospitals and payers regarding the adoption and use of new technology for the treatment of patients with musculoskeletal disease. Health care technology assessment is a growing field that is concerned with the multidisciplinary evaluation of clinical data on the basis of safety and efficacy as well as economic aspects of technology acquisition. Through an understanding of the relevant literature and the concepts of health care technology assessment, orthopaedic surgeons have an opportunity to participate in the assessment process and thus influence clinical and health policy decisions regarding the adoption and use of new and existing technologies in the field of orthopaedic surgery.
Over the past decade, orthopaedic surgeons have faced increasing scrutiny from hospitals, managed care organizations, and other third-party payers over issues related to the costs associated with the diagnosis and treatment of musculoskeletal illness. These pressures have at times led to miscommunication and mounting tensions among physicians, payers, and hospital administrators, often to the detriment of patient care. Physicians have frequently questioned the appropriateness of financial matters influencing clinical decision-making, pointing out their ethical responsibility to provide the best possible care for their patients, regardless of cost. Issues related to the cost of providing health care in the twenty-first century have been and will continue to be a source of great concern for anyone involved in the health care delivery process. Although there is controversy over whether health care technology is part of the problem or part of the solution, there is a growing body of literature suggesting that advances in medical technology are a major contributor to the growth in health care spending1-6. This has led to increased scrutiny on the part of health care policy makers and payers with respect to the adoption and use of new technology7. In order to understand the scope of the problem and to begin to find possible solutions, it is important to understand the rationale behind health policy as it relates to health care technology assessment and utilization. This article will present the basic principles of health care technology assessment and will review the relevant literature on the subject, with a specific focus on potential applications in orthopaedic surgery.
The cost of providing health care in industrialized nations, and in the United States in particular, continues to attract the attention of governments, third-party payers, patients, and health care providers. In the United States, health care costs have risen faster than the gross domestic product, often by a substantial margin, in all but three years since 19606. Whereas in 1960, roughly 5% of the gross domestic product of the United States was spent on medical care for its citizens, the most recent estimates from 2001 suggest that health care expenditures accounted for 13.9% of the gross domestic product2. Other Western industrialized nations also spend a substantial portion of national revenues on health care, but far less than is spent by the United States. In 2001, Britain and Japan spent 7.6% of the gross domestic product on health care; Sweden, 8.7%; Australia, 8.9%; Canada, 9.7%; and Germany 10.7%2. Policy experts and health care researchers have identified numerous factors that may contribute to rising costs. However, much recent analysis has focused on the role of medical technology, defined as all drugs, devices, and medical and surgical procedures used in medical care as well as the organizational and supportive systems within which such care is provided8. While the precise contributions of health care technology to rapidly expanding costs are poorly defined and are often contested by physicians, nearly every health care management article published in the 1990s pointed to technology acquisition and use as primary drivers responsible for the escalation in health care costs in the United States9. In a recent review on the subject of health care spending, Baker et al. stated: "It is commonly accepted that advances in technology have been one of the most important drivers of health care spending growth over the past several decades, if not the most important driver."1 References to an ongoing "medical arms race"—a competition for patients among managed care plans and physician groups that relies on continual acquisition of newer, costlier technologies as a means with which to signal superior quality of care—are widespread in the health policy literature10. Several health policy researchers have suggested that, while biomedical research has resulted in continuous improvements in the functionality of medical technology, advances in technology have "overshot" the needs of most patients. As Christensen et al. aptly noted, the functionality of today's healthcare technologies, although impressive, often exceeds the needs of most health care consumers11. In part as a result of the current economic climate in health care, health care technology assessment—defined as a multidisciplinary evaluation of clinical data based on efficacy and safety as well as economic aspects of technology acquisition5—has assumed an increasingly important role in the decision making of United States health care organizations. Contemporary health care managers often subscribe to the theory that optimal utilization of financial resources allocated to health care can be reasonably achieved by combining the scientific aspects of evidence-based medicine with cost-effectiveness, sociopolitical, and medicolegal analyses. Including the latter considerations in health care technology assessment allows decision-makers to move beyond the more traditional paradigm of ensuring favorable medical outcomes regardless of expense to a cost-based model that uses the tools of finance, economics, and health care law to set priorities for investment and practice in an era of limited health care resources7. The emphasis now placed on health care technology assessment marks a major change in how we think about health care delivery in the United States. The orthodox American medical ethic developed following the Second World War demands that everything possible be done for a patient, and this conviction remains central to the philosophy of many United States physicians12. Patients, the argument holds, go to their physicians expecting the best possible care, without consideration of costs13. Health care providers, therefore, have a moral and legal responsibility to patients that does not relate primarily to economic considerations, such as cost-effectiveness analyses of diagnostic tests ordered and therapeutic treatments prescribed12. This perspective often leads to disagreement and friction between physicians and other major players in health care delivery, including policy-makers, payers, and health care administrators. Policy-makers, charged with responsibility for the commonwealth, and managers of health care organizations, who oversee the mechanisms for connecting patients with providers and services, must contend with cost containment in their attempts to maintain and improve both access to and quality of health care. They often attempt to assert control through regulatory actions, peer review processes, reimbursement methods, or all three12. Many popular strategies for cost control at the present time involve limiting the use of medical technology—magnetic resonance imaging scans, surgical procedures, diagnostic tests, and so on—that many physicians deem essential for delivering appropriate and high-quality patient care (albeit sometimes with little if any evidence to support these claims). Disagreement occurs in part because physicians, as a group, remain largely unaware of the process and goals of health care technology assessment, which involves more than simply determining whether a given test or treatment, or the purchase of the latest technology (for example, computer-assisted surgical navigational tools), will be allowed in light of any given month's profit-and-loss statement. Rather, health care technology assessment deals more broadly with the reasons—scientific, economic, ethical, and social—for adopting a particular medical technology, practice, or system of care and how such adoption or non-adoption influences both the distribution of resources and the quality of services within the health care infrastructure14. Most physicians do not possess the necessary skills to participate in such assessment, adoption, and diffusion of health care technology in a systematic way, despite the substantial and increasing influence of health care technology assessment on current medical practice. As a result, physicians have felt increasingly marginalized in the decision-making process regarding which technologies will be adopted and how they should be used. In order to facilitate a better understanding of the health care technology assessment process, this article will first review the evolution of health care technology assessment, including the reasons for its rising popularity, and examine how health care providers currently approach technology appraisal and adoption.
Health technology assessment in the 1950s, 1960s, and 1970s developed primarily as a means for physicians and other providers to assess the clinical costs and benefits, such as outcomes and risks for patients, of current and future technologies. The methodology of technology assessment was largely the business of specialists who frequently worked in multidisciplinary teams within academic centers14. While policy-makers and other nonpractitioner groups might have taken an interest in the outcomes of health technology studies, those groups rarely participated in the design of the studies or in setting standards for evaluating the use of new technologies3,14-17. Two nationally directed mandates during this era laid the foundation for the involvement of parties outside of academic medicine. The first was the establishment of the Medicare program during the 1960s, which turned to the United States Public Health Service for advice regarding which medical technologies should be covered18. Medicare legislation requires that the program cover technology used in the provision of "reasonable and necessary" medical care, and in the beginning this proviso was interpreted to mean that a technology should be effective (efficacious), safe, and an accepted part of medical practice. Cost was not included as a formal consideration at that time19. Second, in 1977, the National Institutes of Health asked the Office of Medical Applications of Research to begin organizing conferences that would allow concerned parties, primarily health care providers, to seek consensus on the safety, efficacy, and appropriate conditions for use of various medical technologies20. Known as consensus conferences, these gatherings relied on attendance from clinical experts—still mostly physicians —and used scientific evidence regarding medical outcomes as the gold standard for evaluation. Questions regarding expense, resource distribution, or any metric aside from decreased morbidity and mortality were rarely considered19. The popularity of the consensus conference model rapidly spread to other Western nations, including Sweden, Denmark, The Netherlands, Norway, France, Canada, and the United Kingdom. To date, the National Institutes of Health has released about seventy-five such reports based on consensus conference assessments, including a recent National Institutes of Health consensus statement on total knee replacement7,19,21. However, in most countries, including the United States, consensus development programs established, at best, weak links to health care policy and did little to coordinate nationwide systems for rational investment in health care technology19. The confinement of health care technology assessment to clinical efficacy, with continued exclusion of economic, social, and political considerations, continued into the 1980s. In 1985, Feeny noted that numerous factors influenced the adoption and utilization of new medical technologies, including the severity and urgency of the medical problem, the availability of alternatives, financial advantages (i.e., the potential for the new technology to increase hospital and/or physician revenue), compatibility with current practice style, the prestige and reputation of the advocates for the technology, channels of communication, patient preferences, physician attitudes, regulation, and the prevailing climate of litigation22. In short, the paradigm for health care technology assessment still centered largely on physician priorities—i.e., effective care of the patient and compatibility with successful and well-accepted clinical practice. Even as late as 1991, a study of 1100 scientific papers presented at the Annual Meeting of the American Society of Anesthesiologists demonstrated that <10% of the clinical investigations published in Anesthesiology that year mentioned costs, and only 1% contained any data related to cost-effectiveness6. In a recent review of economic evaluative studies related to total hip arthroplasty, one of us (K.J.B.) and colleagues reported that only eighty-one studies related to cost-effectiveness had been published in the total hip arthroplasty literature since 1966, and only 8% of those studies adhered to accepted methodological guidelines for health care economic studies23. Yet, despite physicians' avoidance of cost as an important variable in evaluating technology, important economic factors have been moving to the forefront of discussions about health care. Data from the Organisation for Economic Co-operation and Development on health care expenditures in the United States since 1970 reveal a striking escalation in medical costs and spending. In 1970, the United States devoted 7.4% of its gross domestic product to health care, whereas five years later it devoted 8.4%. In 1980, 1985, and 1990, health care expenditures totaled 9.2%, 10.5%, and 12.4% of the gross domestic product, respectively24. Health care expenditures for Germany (the second highest spender for health care in the world in 2001) over the same period rose in a more controlled fashion, with expenditures of 5.9%, 8.1%, 8.4%, 8.7%, and 8.3% of the gross domestic product at five-year intervals from 1970 to 1990. Rapidly rising costs in health care became the most important health policy issue in many countries during that period, especially in the United States, because these costs were perceived as threatening the prospects for providing higher-quality services to broader populations25. There are many reasons for the cost escalation, including demographic drivers such as the aging of the population, but a critical factor became and continues to be the rate at which technological resources are used in health care1,6,26-31. In a 1994 article in Health Policy, Banta argued that such resource consumption is closely linked with the rapidity of technological change and that nations seeking to control these costs must control the processes by which health care technologies are developed, evaluated, adopted, and used25. In a recent study of the relationship between the supply of new technologies and health care utilization and spending, Baker et al. reported that increases in the supply of medical technology correlate with higher utilization and spending on the service in question1. Numerous other articles on health care management and policy have suggested that technology is the largest driver of health care inflation3,6,10,29,31,32. As a result, health care technology assessment has quickly moved to integrate cost-effectiveness analysis as a primary consideration and has become an increasingly visible process in many countries7,25,33-36. As a result of a greater understanding of the role of health care technology assessment in the evaluation of new medical technologies, the definition of clinical excellence as "doing more"—leaving no stone unturned in the search for a diagnosis and denying no treatment no matter how expensive—has been challenged by theories about providing patient populations with better value for their health care dollars37-40. Concerns about costs first increased the demand for scientific evidence, in the form of evidence-based practice guidelines, to demonstrate the effectiveness of diagnostic tests and therapeutic interventions37. Royal argued: "In the past, technology assessment focused on diagnostic accuracy.... In the future, technology assessment will be focused on whether use of diagnostic [tools] improve patients' outcomes and/or lower costs."37 Many of the stakeholders in the health care delivery process have come to realize that health care technology assessment studies and other health care economic evaluations can help them make ethically sound clinical and policy decisions regarding which interventions provide the maximum health benefit for a given cost. Similar references to cost control appeared throughout the literature during this period, revealing an evolving trend toward applying stringent cost-containment measures to nearly all aspects of medical care; these measures include the application of economic methods (cost-benefit, cost-utility, cost-effectiveness, and cost-minimization analyses) to decisions regarding whether and when to use high-tech, high-cost interventions6. A 1988 article in Health Policy by Glasser and Chrzanowski identified the four main concepts in health care technology assessment as need, safety, effectiveness, and cost14. A 1993 article by Tuman and Ivankovich proposed a model that is much more familiar to current practitioners: "Intelligent cost containment measures must include application of disciplined logic to the decision making process of when to use high-tech, high-cost interventions. Such decision making depends upon knowledge of the basic concepts of economic and cost-benefit analyses, outcome (benefit) studies, and some principles of decision-threshold analysis."6
This rapid shift in priorities for health care technology assessment has not been simply an intellectual or administrative one. Although managed care organizations, third-party payers, and federal programs, including Medicare, have recently placed greater emphasis on the use of a cost-control paradigm when evaluating, adopting, and utilizing health care technologies than have clinicians, health care providers have been involved in this process as well. Almost every effort to decrease health care spending in the last two decades has affected the patient-physician encounter, resulting in shorter office visits, more cumbersome payment mechanisms, and increased barriers to the use of high-tech, high-cost diagnostic tests and therapeutic modalities. A backlash has naturally ensued as physicians have felt increasingly marginalized from their historically central place in decision-making about the adoption and use of medical technologies38. Clinicians in general and orthopaedic surgeons in particular have criticized this new health care technology assessment model, arguing that it exaggerates the contribution made by expensive technology to the total cost of health care and undermines the professional approach to the definition of priorities and the delivery of care in an effort to implement "specious forms of managerial control."29 Physicians have widely challenged the new solutions to escalating medical expenditures, solutions that encourage an emphasis on costs, a shift away from the traditional dominance of the medical profession, and hierarchical rather than consensual management38. Providers have disparaged health care managers for concentrating on the process of delivering care instead of on clinical outcomes, and they have noted the often bizarre effects of "managed care": beds emptied and wards closed to reduce expense, but at the real cost of diminishing services to patients, and patients sometimes detained in the hospital to maintain "bed-occupancy" while at other times pushed out to increase turnover29. The medical profession is not alone in making these observations and formulating these critiques. As mentioned at the beginning of this article, the ostensible definition of health care technology assessment at a theoretical level is broad: it is a method for examining medical, societal, economic, and ethical aspects of the adoption and use of health care technology, and therefore it serves as a comprehensive form of research examining the long-term and short-term consequences of technology application with regard to the health of patients9,39,41,42. However, numerous researchers in health care administration and technology assessment have noted that health care technology assessment in its present form is often myopically focused on cost control, dealing primarily with the short-term benefits (i.e., clinical efficacy), risks, and financial expenses while often neglecting questions about unintended, indirect, or delayed effects on health care delivery and society19,43,44. This is contrary to the recommendations of the Panel on Cost-Effectiveness in Health and Medicine, which suggested that, in a well-designed health care economic evaluation, the investigators should make every effort to include information about both direct medical costs and nonmedical costs (e.g., time and lost productivity) as well as consider costs and benefits that accrue both now and in the future45. It has been noted in the health care technology assessment literature that efforts in technology assessment remain fragmented and poorly funded, with little or no coordination between public or private-sector groups to deliberately address the diffusion of technologies and the related national implications for quality of care or resource distribution19,46,47. The Institute of Medicine Committee for Evaluating Medical Technologies in Clinical Use noted that, in 1984, despite estimates that health care technology accounted for a substantial portion of health care spending in the United States, <0.3% of all health care dollars were spent on technology assessment48. Similarly, information garnered from health care technology assessment studies is not efficiently shared among medical organizations, health care systems, or policy makers12. The response has been a demand for broad regional and national health care technology assessment programs that would study the effects of health care technology more systematically and involve providers, policy-makers, patient advocacy groups, and government in decisions about adoption and utilization of technology5,48.
The influences of cost-containment approaches to health care in general and to the adoption and use of technology in particular are familiar to most orthopaedic surgeons practicing in the United States. Managed care organizations have attempted to limit the implementation and utilization of medical technologies through various methods. By decreasing payments for acquisition and use of technology, payers and management groups can alter the profit expectations of health care providers and reduce their cash reserves, thereby diminishing incentives for rapid adoption and producing financial uncertainty that engenders conservatism toward investment in new technology. Health care plans can also strategically award contracts to lower-tech, lower-cost providers, thereby devaluing the reputation of clinicians and groups that utilize expensive technology and limiting patient access to such high-tech care49. However, physicians themselves can and do play an important role in the choice of the technologies that they use. These choices are not simply related to constraints placed on them by external organizations. Rather, a variety of well-studied factors influence physicians' thinking and behavior regarding adoption of technology15. Personal characteristics play an important role; on the whole, advanced professional training, increased specialization, and a scientific orientation positively correlate with earlier adoption of a new technology50. Access to information about the clinical value and profitability of technology also shapes physicians' attitudes and behaviors regarding acquisition and utilization46,51. Physicians with many journal subscriptions, close ties to medical organizations beyond their local region, and a high degree of social integration within the medical community are more likely to adopt new technologies than are their peers who have fewer subscriptions and looser ties with professional organizations22. Interestingly, impersonal sources of information on technology, such as journals, professional conferences, and industry representatives, may be most important when physicians first become aware of an innovation38. However, discussions with colleagues and thought leaders in the field are often the most influential source of evaluative information later on, when physicians are considering whether to adopt a new technology51. The desire for professional advancement, including an enhanced reputation for providing high-quality care and financial gain, also influences physicians' thinking and behavior. Hospitals frequently decide to adopt a new technology because it will permit the hospital to improve patient care, recruit and retain high-quality staff, attract new patients, conduct research, or augment revenue through billing for the new service4,22,33,41. This last category—financial incentives—has a particularly strong correlation with adoption and utilization of technologies by hospitals and providers in the present era of fluctuating reimbursements for services22. When reimbursement rates are high, physicians and hospitals move quickly to acquire and utilize technologies. The frequent use of spinal arthrodesis for the treatment of low-back pain is a telling example: evidence suggesting that the procedure is overused for low-back pain has done little to curb its use because reimbursements have remained high52,53. Competition among physician groups and hospitals for patients and related revenue—a kind of medical turf war—also drives technology adoption. A convincing commentary by Barros et al., published in 1999, argued that providers of care invest in technology, often excessively, as a way to "signal" their intrinsic (and unobservable) quality to patients, who conjecture that providers displaying newer technology are of higher quality than their peers10. Those who purchase impressive, state-of-the-art technology early can then establish themselves as experts within their region or community, thereby increasing market share and their own prestige, but also increasing the pace of investment in technology44,50. The recent increase in the acquisition and marketing to patients of computer-assisted surgical navigation tools is one example of this phenomenon in orthopaedics54. The list of factors enumerated thus far creates an impression that the foremost driver behind technology utilization by physicians is financial gain, through improved reimbursements for services and/or increased patient demand. However, clinical efficacy, which many would argue should be the most important determinant of technology acquisition and use among physicians, has little to do with economics, cost, or income, but rather has to do with patient care. The goal of medical care and research, at its core, is to improve the treatment of disease, and physicians therefore seek new technologies and apply them with the hope of providing better care for their patients. However, the lack of published results from randomized clinical trials or other well-designed clinical outcome studies in orthopaedics makes it difficult, and at times impossible, to judge efficacy in every instance. Nevertheless, patients and society believe that potentially curative technologies should be made available rapidly for the public's benefit4,32,46. Caught between imperfect data—clinical as well as economic, sociopolitical, and ethical—and enormous patient demand, physicians must make choices about technology and, when doing so, they tend to overlook cost considerations because efficacy is more important to them3,28,38. From a broader health care technology assessment perspective, this choice creates a gap between the provider's private valuation of technology and its true social value, at times leading to an inefficient use of health care resources, which has, in part, given rise to efforts at cost containment in American medicine10. Over the past decade, there has been a dramatic increase in the amount of money spent on direct consumer marketing by the pharmaceutical and medical device industry. This type of marketing has been shown to be effective in convincing patients that higher-cost technologies are associated with better health outcomes55. At the same time, the percentage of health care costs for which Americans pay "out of pocket" has fallen dramatically, from 88.4% in 1929 to 20.1% in 199355. As a result, many health care consumers in today's market demand the highest-quality care and most advanced technologies, regardless of cost. These trends may change in the future as consumer-driven health plans, which shift both the decision-making and the financial burden of health care delivery to the patient, become more widespread56.
No debate about health care technology assessment would be complete without a discussion of the impact of the adoption and use of technology on the quality of care. As noted by Baker et al.: "Any attempts to address the issue of technology availability and rising costs could end up badly misguided if implications for quality were not considered."1 It is important to recognize that higher health care spending need not be purely negative for society if the spending yields greater benefits in terms of improved patient outcomes1. However, although few would argue with the contention that the use of certain technologies has improved patient outcomes, such as the discovery of penicillin and the widespread administration of the poliomyelitis vaccine, there is surprisingly little scientific or clinical evidence to support the use of many new or existing medical technologies. In fact, there is strong evidence that much of the regional variation in health care spending in the United States comes from the use of technologies and services for which guidelines based on clinical or cost-effectiveness research simply do not exist30,42. Furthermore, there is compelling evidence throughout the literature that suggests that higher-than-average health care spending in the United States compared with that of other developed countries does not buy better patient outcomes31,46. Generating the highest-quality evidence of the clinical benefits of these technologies, through randomized clinical trials when possible, is essential to justify the additional cost of the technology, particularly in a limited-resource environment.
As noted by the Institute of Medicine Committee for Evaluating Medical Technologies in Clinical Use in their book Assessing Medical Technologies: "Technology assessment offers the essential bridge between basic research and development and prudent practical application of medical technology."48 Numerous clinical and health economic research methodologies have been applied to assess the effectiveness and appropriate use of various health care technologies. However, as with any research-driven field, the usefulness of the conclusions that can be drawn from these studies is directly proportional to the quality of the research methods and inputs that are used to derive those conclusions. The prospective, randomized clinical trial is widely regarded as the most powerful and sensitive tool for the comparison of therapies, diagnostic procedures, and regimens of care48. Few would argue with the proposition that a well-designed and well-executed randomized clinical trial that includes a large number of subjects from diverse geographic and socioeconomic backgrounds, random assignment to treatment regimens, comparison of a new treatment with an existing "gold standard," blinding of both subjects and reviewers, quality-control measures to ensure appropriate follow-up and data collection, and appropriate statistical analysis will provide extremely valuable data on which to base decisions regarding the adoption and use of new health care technologies. However, many issues often conspire to make randomized clinical trials difficult or impractical for the evaluation of certain interventions, particularly in surgical fields such as orthopaedics. For instance, a randomized clinical trial to compare the rates of wear and osteolysis associated with newer, so-called alternative bearing surfaces with those associated with conventional ultra-high molecular weight polyethylenes in total hip arthroplasty would necessitate randomizing large numbers of patients to each treatment group and following these patients for decades in order to detect small differences in wear rates that could prove to be clinically relevant. Practical considerations of sample size, time, and cost make these types of studies difficult to execute. Furthermore, ethical considerations centered around the physician-patient relationship, difficulty with blinding, physician and patient bias, medicolegal concerns, and issues related to the generalizability and external validity of the results make randomized clinical trials sometimes not feasible for answering certain questions in orthopaedics. Despite these limitations, policy-makers will continue to look to well-designed randomized clinical trials when evaluating and comparing health care technologies in many fields. When appropriate, randomized clinical trials comparing various orthopaedic treatments and technologies are greatly needed in order to improve the quality of evidence on which policy-makers and payers base decisions about the adoption and use of technology in orthopaedics. Given the difficulties associated with randomized clinical trials described above, other methodologies can also be useful for assessing health care technologies. Case series and cohort studies can provide insight into decision-making regarding a new technology, such as intraoperative surgical navigation tools and their effect on the accuracy of pedicle screw placement in spinal surgery57. The contributions of case studies are greatly enhanced when they incorporate findings from other forms of evaluation, including randomized clinical trials, epidemiological surveys, and economic analyses48. Clinical databases and registries, such as the Swedish National Total Hip Arthroplasty Register58, can provide useful information for generating and evaluating research hypotheses regarding the effectiveness of certain treatments and technologies. As pointed out by the Institute of Medicine Committee for Evaluating Medical Technologies in Clinical Use, registries work best when they are incorporated into the clinical care program rather than as separate entities, especially given the well-documented problems with retrospective chart abstraction48. Epidemiological and surveillance studies are useful for identifying rare events that may be caused by the adverse effects of a technology, such as the potential association between malignant tumors and metal wear debris generated by metal-on-metal bearing surfaces in total hip arthroplasty59,60. Quantitative synthesis (e.g., meta-analysis) is a valuable method with which to summarize current states of knowledge and bridge the gaps among research findings48. The results of such studies can lead to further investigations of a technology for which there is no conclusive evidence regarding its clinical and/or cost-effectiveness, such as studies of the efficacy and safety of various treatment modalities for prophylaxis against thromboembolism following orthopaedic surgical procedures61. In addition to clinical research methodologies, health economic evaluations provide a useful tool with which to assess the benefits of new and existing medical technologies. Cost-minimization, cost-effectiveness, cost-utility, and cost-benefit analyses all have useful applications for the evaluation of the relative merits of many orthopaedic technologies62. Cost-utility and cost-benefit studies are particularly helpful for comparing the relative values of treatments across disciplines, since outcomes are measured in common utility or monetary units63. Economic modeling techniques offer a useful alternative to long, complicated, and expensive clinical or economic trials by simulating future outcomes and incorporating complicated variables to reveal what parameters and variables seem to produce the most substantial effects. When combined with sensitivity analyses and backed by strong empirical investigations, these techniques may add important depth and breadth to the technology assessment process48. All of the research methodologies described above provide valuable information for clinicians, payers, governments, and policy-makers who are evaluating the potential risks and benefits of a new health care technology. However, as noted by the Institute of Medicine, the challenge lies in assembling information from a variety of sources and integrating the results48. As consumers of health care technology assessment, we need to improve and expand on the application of techniques, such as meta-analysis, that can combine information from a number of studies intended to answer common questions regarding the safety and efficacy of a clinical practice or technology. Furthermore, economic variables need to be considered when designing clinical trials in order to properly evaluate the clinical benefits along with the economic and social consequences of health care interventions. In the long run, the more effort we put into improving the quality of evidence obtained from clinical and economic outcome studies, the more benefit we will derive when applying this evidence to evaluate new and existing health care technologies.
Given the rapid growth in the rates of relatively resource-intensive orthopaedic interventions being performed each year in the United States and abroad, it is not surprising that many payers and government agencies are beginning to focus their health care technology assessment efforts on orthopaedics. However, the literature contains few well-designed research investigations related to health care technology assessment in orthopaedics. Wild et al. offered an illustrative example of the health care technology assessment process with their review of the effectiveness of extracorporeal shock wave therapy in orthopaedics64. The investigators examined the impact of published clinical and economic research on the effectiveness of that treatment on the health care policy-making process in Germany, Austria, and Switzerland. They reported that, despite widespread utilization of extracorporeal shock wave therapy in those countries, most of the clinical evidence supporting its use came from poorly designed clinical studies from which no reasonable conclusions regarding the efficacy of the treatment could be derived. The authors warned that "a pragmatic approach is recommended to controll the diffusion of [this] uncertain health technology," and they recommended additional clinical and economic research to allow a more comprehensive appraisal of it64. Regional variations in the rate of spine surgery have been well documented in the literature60,65,66. In a study comparing the rates of spine surgery in eleven developed countries, Cherkin et al.66 reported that the rate in the United States was at least 40% higher than that in any other country and was more than five times the rate in the United Kingdom. They also found that spine surgery rates increased almost linearly with the per capita supply of orthopaedic surgeons and neurosurgeons in the country and that countries with high spine surgery rates also had high rates of other discretionary procedures. The authors concluded that differences in health care systems can have a large impact on the use of health care technologies and that better outcome studies are needed to determine the appropriate use of spine surgery66. Another form of health care technology assessment that has been applied to orthopaedic technologies is threshold analysis, which can be used to determine the minimum gain in clinical effectiveness that would have to be achieved to justify the additional cost associated with a new technology. Gillespie et al. provided a useful example of this technique by employing published survival data from Sweden and cost and demographic data from Australia in a sophisticated economic model to compare the cost-effectiveness of various new and existing cemented prosthetic designs for total hip arthroplasty67. They found that, in young active patients, a new prosthetic design would have to guarantee a 90% improvement in survivorship over fifteen years and a 15% reduction in the cost of revision surgery in order to justify a price two to 2.5 times that of "conventional" cemented components, such as the Charnley low-friction replacement. In older patients, only a very small increase in the cost of a prosthesis could be justified because of the shorter life expectancy of the patient and the high survivorship of the implant67. This study also demonstrated one of the limitations of cost-effectiveness analysis—namely, the ceiling effects that are encountered when new technologies are used in an older patient population with limited life expectancy. Deyo recently provided an interesting commentary on the "cascade effects" of medical technology68. Using the example of what he referred to as "irrelevant abnormalities" on spinal imaging, he described how an unnecessary test, an unexpected result, or patient or physician anxiety can lead to a chain of events that results in additional ill-advised tests or treatments that may cause avoidable adverse effects and/or morbidity. He identified common triggers to this process as a failure to understand the likelihood of false-positive results, errors in data interpretation, overestimation of benefits or underestimation of risks, and low tolerance of ambiguity. He went on to note that excess capacity and perverse financial incentives, which can often lead to unindicated spinal surgery in patients with incidental findings on spinal imaging, may contribute to these cascade effects. He concluded that, in order to avoid such cascade effects, issues related to excess capacity in health care systems should be addressed and physicians and patients should be better educated on the natural history of mild diagnostic abnormalities68.
On the basis of the recommendations of health policy researchers19, implementation of a comprehensive health care technology assessment approach could help us to:
In addition, others have called for a health care technology assessment process that assesses the benefits, risks, and costs of technologies before they come into general use by physicians and then employs the results of that assessment to guide adoption and use of technology25. The recently introduced Centers for Medicare and Medicaid Services technology assessment program by the United States government is one such example of this type of health care technology assessment process70. Other authors, including Lehoux and Blume5 and Davies et al.32, have formulated similar models. Health care technology assessment of this form and magnitude would most likely fall under the auspices of political bodies, such as federal agencies and congressional committees, raising new questions about the relationship of physicians to technology assessment and adoption19. Faced with high drug expenditures in an environment of cost containment, many drug formulary committees currently consider the results of cost-effectiveness studies when evaluating new products71. As medical device and implant formularies become more widespread, this type of analysis will be increasingly important to physicians, payers, hospitals, and, particularly, medical device manufacturers. Moreover, as cost-effectiveness analyses continue to play a larger role in determining the prices of drugs and medical devices in the future, they could affect the decision-making process used by industry when evaluating potential research and development opportunities related to new technologies.
Orthopaedic surgeons are often faced with difficult decisions in the evaluation and treatment of patients with musculoskeletal disorders. The economic evaluations discussed in this paper may appear to have a very small role in the care provided by individual physicians on a daily basis. Patients seek the advice and treatment of physicians with the expectation that they will receive the best possible care, without consideration of costs. However, most orthopaedists make economic decisions in their practices daily when they budget their time (spending more of it with patients whom they think they can help) and select diagnostic tests or treatments (choosing the less expensive of equally useful ones)38. Also, in their administrative functions (as advisers to the government, medical chiefs of staff, or heads of departments), orthopaedists have been entrusted by society to ensure that the limited resources available for health care in general and musculoskeletal care in particular yield the maximum benefit. As health care technology assessment programs become more widespread, policy-makers and payers will continue to look to clinicians for leadership and scientific evidence to support the clinical efficacy and cost-effectiveness of new technologies. Orthopaedic surgeons have a unique opportunity to participate in the health care technology assessment process by supporting and performing high-quality clinical research, including randomized clinical trials when appropriate, and other well-designed clinical and economic outcome studies. Despite its deficiencies, health care technology assessment is likely to remain in the policy-making tool-kit for the foreseeable future. Rather than disappear, it is more likely to evolve, and present calls for improvement in health care technology assessment methodology are more common than demands for its termination. As noted by Harvard Business School Professor Clayton Christensen and colleagues in a recent Harvard Business Review article on the subject of disruptive innovation in health care, history has shown that successful innovation and progress will occur more quickly and far less painfully when individuals and institutions work together to embrace change rather than fight it11. The expanding gap between the health care that can be provided through the application of new technological innovations and the health care that can be provided with the available financial resources has made the health care technology assessment process increasingly important and visible in most developed societies. A general understanding of the basic principles of health care technology assessment is essential for clinicians who are interested in collaborating with hospital administrators, third-party payers, and policy-makers to ensure the responsible adoption and use of new medical technologies, with the goal of providing high-quality, cost-efficient patient care.
NOTE: The authors thank Jonathan Showstack, MD, MPH, for his help and guidance in the preparation of this manuscript.
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Abstract
Introduction