Health Care in 2005
We find ourselves working in a health-care system in which $1.9 trillion dollars are spent to have the United States rank thirty-seventh in world health4. Clearly, our health-care expenditures do not coincide with better outcomes. Physicians are beset by medical liability fears that cause a paradoxical situation: We are driven to use the newest technology and as many diagnostic tests as possible, for fear that we will be sued for not providing enough care. This is done regardless of whether the technologies or diagnostic tests have been proven to be effective by good studies providing solid evidence.
The real kicker is that we feel like Sisyphus, pushing our productivity up the hill as the reimbursements for our work roll us back down. But something that may blindside us, if it has not done so already, is the fact that much of our work is being done by other professionals. Only 4% of all musculoskeletal payments made by Medicare are to orthopaedists. That is surprising, but at the same time this situation presents an opportunity—an opportunity to take back our profession. We must think about the future of musculoskeletal disease and what the role of clinicians and scientists will be. Do we want to expand our training programs and, by necessity, our examination process to include more nonoperative care (e.g., osteoporosis management) and expand into percutaneous interventional procedures (e.g., vertebroplasty and kyphoplasty)? If we wish to be more than gifted surgeons, then we need to be leaders not only in thoughtful practice but also in the science supporting that practice and we need to expand our work beyond the traditional operating room.
Who Else Treats Musculoskeletal Conditions?
Not unlike the situation in cardiovascular surgery, many orthopaedic conditions are being treated by other specialists. The delivery of musculoskeletal health care is being diffused across many more disciplines, surgical and nonsurgical alike. As stated above, only 4% of Medicare reimbursements for musculoskeletal treatment goes to orthopaedic surgeons. There are several examples of others who are treating musculoskeletal ailments. Podiatrists perform the vast majority of bunion surgery5, and more are treating clubfoot deformities in children using the Ponseti technique6. The number of carpal tunnel releases doubled between 1997 and 2003, with treatment provided by the subspecialties of orthopaedics, neurosurgery, plastic surgery, and general surgery (Fig. 3)5. Having such an eclectic group of providers is, in and of itself, a cause for variation in the diagnosis and treatment of musculoskeletal conditions. Furthermore, we are challenged by the amount of enigmatic variation within our own profession. Likewise, there is a tremendous amount of variation in surgery, not just in who performs it, but in where it is done. In our health-care system, we definitely see a pattern best expressed as one in which “what you get depends on where you live and who you see.”7 In spine surgery, we see the same trend, with rates of procedures varying dramatically across the country (Fig. 4), and neurosurgeons are now doing more spine surgery in the Medicare population (Fig. 5) and more arthrodeses with greater use of spinal instrumentation5.
Physicians and Surgeons
The best treatment may not always be surgery. Many ailments of the musculoskeletal system—arthritis and chronic low-back, hip, knee, shoulder, and/or foot pain—may need treatment, but rarely surgery. We must ask ourselves, do we want to be strictly orthopaedic surgeons (i.e., technicians), concentrating our energies only on surgical interventions and leaving the rest to others, or do we want to be stewards of our profession, being expert in the treatment of relevant diseases and conditions, not just in the surgeries that may benefit a few? A classic example of the dilemma facing orthopaedics is the management and prevention of fragility fractures and osteoporosis. An in-depth look at our handling of this issue as a specialty may provide insight into an underlying threat to the specialty.
Fragility Fracture Care... Not I!
The release, in November 2004, of Bone Health and Osteoporosis: A Report of the Surgeon General8 focused national attention on fragility fractures, commonly defined as fractures resulting from a fall from a standing height or less. “Our hope is that Americans can live long and live well. Unfortunately, fractures—the most common and devastating consequence of bone disease—frequently make it difficult,” the report noted. It concluded that “much of the burden of bone disease can potentially be avoided if at-risk individuals are identified and appropriate interventions... are... timely.... Health care providers frequently fail to identify and treat individuals at high risk for osteoporosis or other disorders of bone.”
On the basis of these two citations, you might think that this discussion is about to focus on the importance of osteoporosis screening. But it is not. It cannot. There are shelves full of osteoporosis guidelines written by well-intentioned medical societies, including the American Academy of Orthopaedic Surgeons (AAOS)—almost no one follows them.
Osteoporosis is not, as some continue to claim, a “silent disease.” It is not a hidden disease. It is a denied disease. Many patients refuse to believe they have osteoporosis. In a recent study, Gardner et al. reported that 40% of patients lying in bed after a hip fracture declined the offer to participate in an osteoporosis follow-up study because they thought their fracture was not the result of osteoporosis9. Chevalley et al. reported that 73% of the patients who completed a questionnaire to determine their osteoporosis awareness within ten days after their fracture believed that that their injury was not related to osteoporosis10. Despite the seemingly endless public education campaigns by the National Osteoporosis Foundation and the AAOS, patients are not making the connection between fragility fractures and osteoporosis.
We need a paradigm shift. Rather than focusing on the prevention of fractures in all populations, we need to focus on the patients at highest risk: those who have already sustained a fragility fracture. This approach is in keeping with the report of the Surgeon General, which advised that “a number of red flags... signal potential problems with an individual's bone health at different ages. One of the most important flags is a previous fragility fracture.”8
Fragility fractures, together with osteoporosis, have long been considered “an inevitable and immutable consequence of aging.”11 Increasingly, we are recognizing that this is not necessarily the case. A fracture can be seen as a warning sign. According to Joan McGowan, PhD, coeditor of the Surgeon General's report, and recently quoted in The New York Times, any fracture is “really a sentinel event in any older person.”12
Patients who have had a fracture in the past and are not recognized are the ones who are likely to have multiple, difficult injuries in the future. Although there is debate about the value of osteoporosis screening and drug therapy for osteopenia, there is agreement on one point: fractures predict fracture. The risk of future fracture is increased by 1.5 to 9.5-fold following an initial fragility fracture13-18. In fact, a history of fragility fracture is more predictive of future fracture than is bone density19.
Starting to heed these red flags, and paying attention to these sentinel events, is a tall order. The majority of orthopaedic surgeons only repair the fracture and do not identify, much less treat, the underlying osteoporosis that led to the fracture in the first place. Elliot-Gibson et al. reviewed thirty-seven studies performed between 1994 and 200314. They found that dual-energy x-ray absorptiometry was performed in 0.5% to 32% of all patients; the average was 11%. The percentage of patients for whom bisphosphonates were prescribed ranged from 0.5% to 38%; only six studies found that >10% of the patients were treated with these medications.
This is unfortunate because fractures offer the ultimate in teachable moments. No one who has had a fracture ever wants another. We must concentrate on getting to people when they hurt. These patients may be in denial that they have osteoporosis, as the study by Gardner et al.9 illustrated, but there will never be a more powerful moment to persuade them of the error of their thinking. No one is better equipped to point this out than the individual trying to repair the injury with his or her own hands: the orthopaedic surgeon. Fragility fractures offer our profession an unparalleled opportunity to assert leadership in an important area of public health and, in so doing, rightfully reclaim our time-honored “ownership of the bone.”
The failure to intervene early is doubly problematic because, with the use of bone mineral density testing and additional diagnostic studies, it is becoming easier to help patients to understand how important the risk of refracture actually is. Thus, we can point out that the presence of both low bone density and previous fracture dramatically increases the risk of future fracture—more so than either risk factor alone. For example, in an eighty-year-old woman with a history of a fragility fracture and low bone density, the absolute risk of another fracture in ten years is 36%. However, if bone turnover markers found in that patient's urine are also elevated, the absolute risk of another fracture increases to approximately 55%20.
In addition, once a patient has been identified, we now have compelling evidence that treatment works. Current medications can substantially reduce the risk of repeat fractures. The most pronounced fracture-reduction effect—a reduction in absolute risk—has been shown in patients with a preexisting vertebral fracture (and, in most cases, a low bone mineral density). In these individuals, reported reductions in the prevalence of repeat fracture have ranged from 70% to 90%20. Because the rate of refracture is substantially increased in the year after the fracture has occurred21, the assessment and, if appropriate, treatment must take place as soon as possible after a fracture occurs.
Despite the documented efficacy of treatment, the majority of patients who have a fragility fracture do not receive these treatments14. Fragility fractures are rarely associated with osteoporosis, rarely evaluated, and rarely treated. The State of Health Care Quality: 2004, published by the National Committee for Quality Assurance, documented the percentage of women sixty-seven years of age or older who are diagnosed with a fracture and receive either a bone mineral density test or prescription treatment for osteoporosis within six months after the fracture with use of one of its newest measures entitled “Osteoporosis Management in Women Who Have Had a Fracture.”22 Compliance was demonstrated in only 18% of the patients.
Need for Musculoskeletal Education
Why have treatment patterns not improved? Most authors have cited the cost, time, concerns about the safety and effectiveness of the medication, the lack of useful guidelines, and the difficulty in keeping abreast of new developments as barriers to change11. Interviews with orthopaedists have underscored their view that the investigation and treatment of osteoporosis should be the responsibility of the primary care physicians. But primary care doctors are overwhelmed, and, more important, they do not “know bone.” In his introduction to the Surgeon General's report8, Dr. Richard Carmona noted that osteoporosis was not part of his medical school training. It was simply considered a natural part of aging.
The comment by Surgeon General Carmona actually spoke to a much larger problem. DiCaprio et al. recently reported that only fifty-one (41.8%) of 122 United States medical schools offered a required preclinical module or block of instruction focused on musculoskeletal medicine23. In addition, only twenty-five (20.5%) of the schools required a musculoskeletal clerkship during the clinical years. Fifty-seven schools, or nearly half of their sample, had no required instruction in musculoskeletal medicine whatsoever. Similarly, Freedman and Bernstein addressed the woeful inadequacy of the musculoskeletal knowledge base of most graduating medical students24. This is true despite the fact that the National Ambulatory Medical Care Survey consistently ranks symptoms referable to the musculoskeletal system as either the first or second most-common reason why patients visit a physician25.
Patient Education and Advocacy: “Own the Bone”
The fact that patients are not getting the necessary care and that medical students are not trained in common diagnoses is no longer tolerable. The federal government is concerned that hundreds of millions of dollars are spent on unnecessary and ineffective care and yet the necessary care is often omitted. The Institute of Medicine report, Crossing the Quality Chasm: A New Health Care System for the 21st Century, speaks to the urgent need to improve health-care delivery and urges the creation of “an environment that fosters and rewards improvement by 1) creating an infrastructure to support evidence-based practice, 2) facilitating the use of information technology, 3) aligning payment incentives, and 4) preparing the workforce to better serve patients in a world of expanding knowledge and rapid change.”26 In an effort to try to change behaviors, the Centers for Medicare and Medicaid Services have already begun pilot projects that focus on pay-for-performance measures in the hospital setting.
Most of us are not ready to have the government become the arbiter of care. Fortunately, the American Orthopaedic Association (AOA) has stepped up to the plate. Using fragility fractures as a rallying point, the AOA has taken the first steps to develop a national effort to improve the management of fragility fractures with the “Own the Bone” program27.
The program is modeled after the American Heart Association (AHA) program called “Get With The Guidelines.”28 Ten years ago, the AHA faced a situation similar to ours. When a patient presented with a myocardial infarction, the heart attack was treated aggressively, but no efforts were undertaken to prevent future myocardial infarctions. Recognizing that patients recovering from the infarction were in a teachable moment, the AHA initiated an aggressive program to improve medication compliance and behavioral change. The results have been extremely positive as evidenced by the report in The State of Health Care Quality: 2004 that, in 2003, 92.9% of Medicare recipients received beta-blocker treatment following a heart attack22.
The AOA “Own the Bone” program will adopt a number of the strategies that have been successfully used by cardiologists and the ideas that have been recommended in the Institute of Medicine report26. Like the AHA, the AOA has designed a program that is focused on hospital care. This is an excellent place to start because the patient and the family are focused on an event so serious that it requires hospitalization and likely an operation. In addition, hospitals already have a quality-improvement infrastructure that can provide an enthusiastic partner.
All data will be gathered with use of a web-based tool that protects patient privacy and is designed by the same team that developed the tools for the AHA program “Get With The Guidelines.” The tool will collect basic information about the patient and will provide a letter and teaching tools both for the primary care physician as well as the patient. Most importantly, because the data collection will be web-based, data feedback can be almost instantaneous, thus allowing for easier support of clinical improvement efforts.
If the pilot program is successful, the AOA will seek to rally other orthopaedic societies to join this cause. The AOA is keenly aware that, in order to have maximum impact, it would be wise to involve a wide range of professionals interested in fragility fracture care. The AOA sees this as an orthopaedic initiative, not solely an AOA initiative. Societies whose mission it is to effect resident education, advocacy, public awareness, and physician education are needed to achieve change.
Defining the Unique Role of the Orthopaedic Surgeon in Today's Health-Care System
Orthopaedic surgery traces its roots back to the care of the deformed child and fracture care. Many hospitals had a fracture service before they had an orthopaedic department. But we are ceding our roots to others who frequently do not always grasp the need for good bone health. We are part of a larger trend in which neurosurgeons place spinal hardware, podiatrists care for the foot, plastic surgery shares in the treatment of the hand, chiropractors treat back pain, and radiologists do vertebroplasty and spinal injections. Now, general surgeons are seeking to provide fracture care as part of the delivery of emergency services, yet they have limited training in biomechanics and little understanding of how to manage complications of fracture-healing.
Follow-up care after a fragility fracture offers an unparalleled opportunity for orthopaedics to assert its leadership and reclaim ownership of the bone. Fragility fractures (1) speak to the need of the national health-care system to decrease morbidity and improve the health of the nation, (2) provide a rationale for insisting on orthopaedic involvement in musculoskeletal education in medical schools and orthopaedic residency programs, (3) provide a thoughtful message with which to reach out to the American public about the importance of orthopaedic care, and (4) provide a compelling case to take to Congress on why more monies are needed for musculoskeletal research.
Approximately 1.5 million osteoporotic fractures occur in the United States annually8. If we can convince these individuals that their injury is not a natural part of aging and enlist them and their families as advocates for fragility fracture prevention, we can make a difference. Now is the time to begin to “Own the Bone.” Osteoporosis is but one example of how the impact of technology and new treatments can prompt the need for changes in the definition of a specialty.
The Impact of Biotechnology on Orthopaedic Surgery
The lack of aggressive diagnosis and management of osteoporosis by orthopaedic surgeons is one warning sign visible today that indicates that we are not achieving the status of “keeper of the musculoskeletal system” and, rather, are being perceived by other specialties as surgical technicians. Are there other warning signs and/or opportunities? Most orthopaedic surgeons choose their careers because they like fixing things with their hands and seeing immediate results. Although the majority of operations require several months before musculoskeletal function is completely restored, few orthopaedic surgeons have an interest in chronic conditions, particularly those that are not managed by operative treatment. When a patient has a chronic musculoskeletal condition, such as metabolic bone disease, degenerative or inflammatory arthritis, or chronic infection, orthopaedists prefer to transfer care to a nonsurgical colleague. Thus far, this approach has not negatively impacted the orthopaedic surgeon's role in the global spectrum of musculoskeletal care. However, as technology advances such that diseases previously corrected by operative intervention can be prevented or managed by nonoperative strategies, or when robotic technologies enable tissue manipulation by means of a keyboard and monitor from a remote location, it may be possible for nonsurgeon physicians to take on the treatment of certain problems currently managed by orthopaedic surgeons. This raises the central question of whether orthopaedic surgeons should continue to be proceduralists or should evolve into “keepers” of the musculoskeletal system.
The role of biotechnology in human health and disease is in its infancy. While molecular diagnostics and recombinant protein growth factors and cytokines have already impacted orthopaedics29,30, it is anticipated that, within the next ten years, the development of synthetic small molecules31, adult stem-cell therapy, and gene therapy will lead to further advances (Table I)32. The ability to stimulate the healing of a delayed union or a nonunion by a percutaneous injection of recombinant growth factor or naked DNA encoding an osteoinductive gene is just one example33.
In parallel with the advances in biotechnology are the advances that are, for the present time, even more visible to orthopaedic surgeons. These include advanced instrumentation and operating-room imaging tools for the performance of minimally invasive surgery and the development of navigation systems that help surgeons to reach inaccessible anatomic sites with approaches guided by percutaneous or minimally invasive techniques (Table II). When these advances converge with those taking place in the biotechnology sector, the only thing that will limit advanced orthopaedic care will be our own ingenuity and imagination.
As all of these advances take place, surgeons may ask, “Will there be less surgery to do in the future? Will operative treatments be replaced by disease prevention, minimal tissue manipulation, and biotechnology?” Certainly, some diseases will become things of the past such as those in which gene mutations are identified and corrected by gene therapies31. Similarly, for the musculoskeletal diseases that are at least partially dependent on genetic background, knowledge of the human genome will at least provide the ability to predict disease occurrence or response to treatment and thereby guide therapy30. As a result, musculoskeletal care will improve and fewer patients will require the kinds of operative interventions that are commonly performed today, but many of these operative interventions will be converted into smaller, less invasive therapies, and, importantly, advances in biotechnology and surgical technology will lead orthopaedic surgeons to develop new operative treatments that are not yet possible. The net effect will most likely be no decrease in the amount of surgery performed; however, operative interventions will be very different from those performed today.
Examples of the Potential Impact of Recombinant Proteins and Adult Stem-Cell Therapy
Recombinant gene technology uses the information contained in human DNA to engineer the production of protein products from nonhuman cells in a laboratory. For example, recombinant human (rh) bone morphogenetic protein (BMP)-2, rhBMP-7 and parathyroid hormone (rhPTH) are currently in use for musculoskeletal applications and have been produced by inserting human DNA into Escherichia coli or Chinese hamster ovary cells. This is an expensive and laborious process, but it conceivably permits the production of unlimited quantities of therapeutic material. Early results with implantation of rhBMPs have demonstrated their efficacy in the treatment of nonunions and fresh open tibial fractures34. As these recombinant proteins and their delivery systems become better optimized, and as injectable formulations become available, it may soon be possible to treat delayed unions with a percutaneous injection into the fracture site in an outpatient setting. This could reduce the number of operative treatments needed for delayed unions and nonunions.
Another example of a future advance with recombinant protein therapy is the use of a percutaneous injection of a chondrogenic morphogen to enhance cartilage repair or to regenerate cartilage tissue. Again, patients may undergo outpatient procedures involving percutaneous joint injections in which recombinant protein is used to stimulate cartilage repair. This might obviate the need for arthroscopic treatment or other cartilage repair procedures such as autologous chondrocyte implantation, mosaicplasty, or microfracture. Alternatively, the ability to inject a tissue morphogen may lead to the development of new types of operative interventions, not decreasing the number of operations performed but, rather, changing the way we accomplish them. For example, it is currently possible to perform percutaneous microdiscectomy with use of laser dissolution of the disc35. If this could be followed with a percutaneous injection of a bone morphogen such as a rhBMP, it may be possible to turn a disc removal and arthrodesis operation into a percutaneous procedure in an outpatient setting.
As has been suggested, these technologies may reduce the number of operative procedures or eliminate the need for certain interventions because the conditions may be managed in an outpatient setting. On the other hand, they could lead to the development of new types of operative procedures and advance orthopaedic surgical care. However, the ability to intervene with the use of these technologies would still most likely remain within the purview of the orthopaedic surgeon. The question for the future is “Will this hold true for other advances soon to impact the field of musculoskeletal care?”
Use of New Pharmocologics in the Treatment of Musculoskeletal Disease
Over the past decade, the use of potent nitrogen-containing bisphosphonates, such as alendronate, risedronate, ibandronate, and zoledronate, has led to a substantial reduction in the prevalence of osteoporosis-associated fractures36. The impact of this advance on the number of orthopaedic procedures performed for the fixation of these fractures has not been captured by statistically grounded studies. However, as the control and management of age-associated and osteoporosis-associated fractures evolves, a reduction in operative interventions may be predicted. This raises the question of whether orthopaedists should assume, or at least coordinate and/or initiate, the preventive and nonoperative care of these patients even though operative intervention may be reduced.
An associated question with respect to the treatment of patients with osteoporosis is the role of the orthopaedic surgeon in the use of new procedures and the management of musculoskeletal pain and function. For example, about ten years ago, vertebroplasty and kyphoplasty were introduced. Orthopaedic surgeons had already turned over the care of osteoporosis-associated spinal fractures to endocrinologists, rheumatologists, and primary care physicians. Then, when this operative intervention became available, instead of capturing the majority of these patients, they were referred to interventional radiologists in greater numbers than to orthopaedic surgeons37 even though the role of vertebroplasty and kyphoplasty in the management of patients with osteoporosis is still a matter of debate. While reimbursement issues continue to affect the medical economics associated with this condition, this is an example of how orthopaedic surgeons can potentially “lose out” on the type of care in which they would like to be involved if they do not assume comprehensive management of patients with skeletal disorders.
The Impact of Advanced Imaging and Diagnostics on Orthopaedic Surgery
New methods for making diagnoses in musculoskeletal conditions may also impact operative treatment. A good example of this occurred approximately twenty years ago with the advent of magnetic resonance imaging. In the mid-1980s, orthopaedic surgeons had enjoyed a period of approximately ten years during which the diagnosis of intra-articular abnormalities was made with a combination of arthrography and diagnostic arthroscopy. Once magnetic resonance imaging technology was introduced, most intra-articular abnormalities became diagnosed with use of this new nonoperative modality. This did not negatively impact orthopaedic surgery, as it better identified intra-articular conditions that required orthopaedic management. However, it did remove the diagnostic aspect of patient care and transferred it to the nonoperative physician.
New imaging modalities are being developed all of the time. As radiologists find new ways to identify musculoskeletal conditions, and as navigation systems and robotic technologies make it possible to intervene from remote workstations, there is a concern that direct tissue manipulation and operative treatment could be accomplished by these “new interventionalists.” The example of vertebroplasty noted above supports this concern.
The care of musculoskeletal conditions continues to be driven by technology with advances in implantable devices, new local and systemic pharmacologic agents, and the prospects of gene therapy for tissue repair and regeneration. As we reflect on the future of orthopaedic surgery as a specialty and the orthopaedic surgeon as a healer, we must take heed of the history of specialties that remained focused only on surgical procedures, such as cardiothoracic surgery and general surgery. It seems clear that if orthopaedic surgeons relegate the nonoperative management of their patients to primary care physicians or other health-care providers, referrals directly to nonorthopaedic intervention-alists may occur before orthopaedic surgeons have the opportunity to become involved in patient care. Focusing only on surgical procedures will ensure that orthopaedists of the future are no longer keepers of the musculoskeletal system but, rather, technicians available for the ever-shrinking list of invasive “salvage” operations used only when newer methods of disease prevention and treatment have failed.
Although it is not yet too late, many forces that require us as a discipline to make the conscious determination of what we want our future role to be in the world of musculoskeletal care are already in motion. At the Annual Meeting of the American Orthopaedic Association in 2005, although 88% of the orthopaedic surgeons who attended agreed that the diagnosis and treatment of osteoporosis should be part of the orthopaedic surgeon's repertoire, >60% of that group did not order dual-energy x-ray absorptiometry or an osteoporosis screening consultation on at least half of the patients they had recently treated for a hip fracture. Moreover, 25% believed that nonoperative management of the musculoskeletal system should be left to other specialties. Alternatively, many believe that the orthopaedic surgeon is uniquely and best suited to be the quarterback and/or general manager of the musculoskeletal team. This would require a major shift in the current practice and training paradigm. If one agrees, then it is paramount for the orthopaedic surgeon to maintain control of the entire spectrum of musculoskeletal disorders by coordinating primary, secondary, and tertiary care. One model that is becoming increasingly popular involves creative collaborations with nonoperative specialists that are seamlessly integrated into the orthopaedic practice38. There is likely no one solution, but a failure to embrace change and drive the future of our specialty will surely result in an outcome that may not be best for orthopaedic surgery or for patients with musculoskeletal disorders.
The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.
* This report is based on a symposium presented at the Annual Meeting of the American Orthopaedic Association on June 23, 2005, in Huntington Beach, California. Cited Here...
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