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2011 Summit Report

On Oct. 12-13, 2011, members of the musculoskeletal care community met in Washington, D.C., to discuss the development of a USBJI consensus statement designed to define the value of musculoskeletal care.

Kimberly Templeton, M.D., president of the U.S. Bone and Joint Initiative, told the audience that the concept of the summit arose during the strategic planning that occurred during the transition from the U.S. Bone and Joint Decade to the U.S. Bone and Joint Initiative.

"One of the goals from that discussion was to have more frequent meetings of the leadership of the various participating organizations to discuss areas of common interest so that we can hopefully move forward the agendas in research, advocacy and education in the musculoskeletal realm," she said.
After welcome messages from summit co-chairs Gunnar Andersson, M.D., Ph.D., Steve Gnatz, M.D., M.H.A., and David Pisetsky, M.D., Ph.D., keynote speaker E. Andrew Balas, M.D., Ph.D., dean and professor at Georgia Health Sciences University, opened the meeting by emphasizing the need for healthcare innovation and for better cooperation and collaboration between universities and industry leaders.  "Promoting innovation is an essential leadership function," Dr. Balas told the group. "Our current healthcare system often does not appreciate innovation, but stresses only policies and compliance."

Defining value in healthcare is elusive because the concept of value is very complex and surrounded by mystery, he said. He noted that there are many "big reasons" for better value, especially in the United States, where healthcare expenditures were higher than many other developed countries ($7538 per capita healthcare spending in 2008 vs. $2729 in Japan and $3470 in Sweden), but life expectancy is lower (78.3 years in the U.S. vs. 82.6 years in Japan and 80.9 years in Sweden).

With regard to musculoskeletal disease, Dr. Balas cited the Medical Expenditures Panel Survey (MEPS), which reported that an estimated 89.7 million persons had a musculoskeletal disease as a primary health concern during the period from 2004 to 2006. The annual estimated direct and indirect cost of musculoskeletal disease is $287 billion, and 10% of all persons reporting musculoskeletal diseases are under the age of 18.

Dr. Balas said quality improvement efforts are hampered in part by the fact that there is a great variation among practices, the causes of which he said are not entirely clear. These variations can result in significant funding cuts, he added, pointing to one recent cut of 1.4% in Medicare payments to nursing homes which affects reimbursement fees for "post-acute care" (such as hip fractures and multiple chronic physical problems) for seniors at skilled nursing facilities. These cuts were based, in part, on the variations that exist among nursing care facilities.

Dr. Balas also pointed to an overuse of clinical trials, and noted that while trials provide the foundation for evidence-based medicine by linking processes to outcomes and intervention to effects, overreliance on trials can make healthcare quality measurement misleading and narrowly focused. "If quality means only compliance with process expectation, there will be no incentive for innovation and better outcomes," he said. "We don't focus on outcomes as much as we should, and that creates a problem and introduces a bias into improvement efforts, because we stress only narrow compliance and not broader outcomes."

Although the Institute of Medicine (IOM) has tackled the issue of value in healthcare, equating it with excellence in quality, outcomes, safety, cost and innovation, the IOM concurs that there is no uniform definition. "That is not entirely surprising," Dr. Balas said. "In even something as relatively simple as defining the value of a car, the value for an individual will depend on the type of car, the model and make, as well as the reason for purchasing the car in the first place; the definition of value even in this case can be very tricky."

To enhance the value of healthcare, researchers and clinicians must set ambitious goals, some of which may be unattainable. Setting ambitious goals creates challenges which in turn spur innovation, which is essential to creating value in healthcare, he said.

Dr. Balas characterized commercialization as "the next frontier" to introduce and promote healthcare innovation, and added that collaboration between industry and academia is essential for encouraging innovation. Building bridges between academia and industry allows for the development of better, more efficient models of care, and also enables industry to directly channel industry questions to researchers, he said.

"It is very striking how much more we need to do to develop an understanding of industry realities among researchers so research can be more practical and relevant, and how much industry needs to improve its understanding of the research process," he said.

Innovation is the "unknown energy" of the healthcare system, he said, representing a huge opportunity to improve healthcare. For innovation and innovators to thrive and be successful, Dr. Balas said healthcare research should understand its ultimate outcomes, commercialization and public health improvement. Researchers should be trained to create intellectual property, and to collaborate successfully with industry, he said. "If researchers knew more about IP creation, the entire research process could be better targeted and more productive," he said.

Dr. Balas concluded with a call to action to clinicians to improve the value of healthcare by identifying major groups of patients based on health care needs; defining health care value ambitiously; identifying key resources and controlling costs; promoting sustainable innovation; and measuring and reporting health outcomes.

The morning sessions, chaired by Dr. Andersson, considered the question of how the value of musculoskeletal care is defined, and featured presentations from multiple stakeholder groups.

Debra Lappin, J.D., senior vice president of B&D Consulting, a Washington, D.C.-based advisory and advocacy firm, and former Chair of the Arthritis Foundation, began the session by sharing observations from the patient perspective.  She has dealt with ankylosing spondylitis, a debilitating musculoskeletal disease that causes inflammation, and in most cases, fusing, of the spine, for over 30 years. Ms. Lappin also has osteoarthritis. Understanding and communicating the value of a healthcare intervention is largely about telling the patient's story, to understand the impact on function, well-being and quality of life that can result when an intervention is successfully used, she said.

For Ms. Lappin, her story began with low back pain in 1978, when she was diagnosed with sciatica. After doing her own research and consulting with physicians, Ms. Lappin learned she actually had ankylosing spondylitis. In 1984 after an 18-day hospital stay, Ms. Lappin's pain forced her to stop practicing law with a major national law firm and to go on disability. 

In 1999, Ms. Lappin began taking Enbrel and her recovery process began. "It really was a kind of miracle," she said. "My family could see, before their eyes, a mother coming back, a wife coming back, and I was finally able to go back to work."

Ms. Lappin referred to efforts now occurring on multiple fronts to express the "value" of medical interventions in terms that can be captured and translated into policy responses. For example, she noted that in a recent article in the Harvard Business Review, Michael Porter et al suggested that a value equation might include the following components:  

Ms. Lappin also cited another recent example, a value equation for medical devices, focused on "value-driven engineering":   

How to understand "value" in the terms of an equation or a set of metrics, with particular focus on the first equation by Michael Porter, became a centerpiece of speaker presentations and panel discussions later in the day.

Applying the equation to her own case, Ms. Lappin said the value of medical care can be estimated, at least in part, by looking at the costs she endured before the drug Enbrel (etanercept) was available.

"In my own life, there were extreme costs of care, both to health insurers and to the public good, as well as out-of-pocket expenses, including copays and child care for our young children," she said. "In addition, there was a loss of productivity and a loss of opportunity; my illness resulted in a significant loss of income for my family."

"But to reconstruct it, here I stand today, no longer on any disability insurance and employed, and while I used to see my rheumatologist every week, I now find myself visiting only out of necessity when I must in order to get my prescription refilled. Imagine that difference," she said.
Ms. Lappin said her return to the life she enjoys today was due to her astute rheumatologist, extremely integrated care, physical therapy and the innovation that led to the development of Enbrel.

"If we don't create the value story that describes what it means to have a return to health, we may lose the funding that we need for basic research," she said. "The decline in U.S. patents filed by U.S. developers as opposed to our global competitors, is only one stirring measure of how we are beginning to lose this race for innovation that will change peoples' lives."

"Finally, it's all about access," she said. "If I had not had access to Enbrel, if I had not had access to insurance coverage, if I had not had access to payment across multiple systems, this story would never have been written. Any value equation is wholly dependent upon the assumption that once value is designed and delivered, our society and patients such as I will have access."

Mary Crow, M.D., physician-in-chief and chair of rheumatology at the Hospital for Special Surgery in New York and past president of the American College of Rheumatology, offered a perspective of how rheumatologists can play a role in defining value in healthcare. Dr. Crow identified four key questions in defining value: Can the conditions that provide the greatest opportunities for achieving value be identified? How are the most relevant outcomes defined? How can health care resources be allocated to provide the greatest value? And how can the providers and their professional organizations contribute to achieving value?

Defining the most relevant outcomes should focus on making patients better or maintaining stable health, considering what is most relevant to both the patient and society, she noted. Issues like relief of pain, improved function, time required to achieve an independent lifestyle and time to resume work are all important considerations that may be weighted differently among patients.

Importantly, rather than focusing solely on measuring and defining predictors of negative outcomes, Dr. Crow said researchers should also focus on predictors that define a positive outcome or response, since it is easier to identify patients who will gain the most value from a specific procedure when that value is based on positive outcomes: for instance, looking at results of studies focused on positive outcomes can help a physician determine which patient will benefit from anti-TNF biologic therapy and which will benefit from a traditional disease-modifying anti-rheumatic drug (DMARD), she said.

Dr. Crow also discussed "flat of the curve" medicine, where the goal is to focus on interventions which provide excellent or good quality-of-life for relatively low to moderate cost, versus interventions that offer little improvement of quality-of-life and involve significant cost.

Rheumatologists and their professional organizations are committed to educating the public on the significance, prevention and mechanisms of rheumatoid arthritis, as well as the appropriate evaluation and treatment methods for musculoskeletal, automimmune and inflammatory diseases, she added. The professional organizations, including the American College of Rheumatology and the Arthritis Foundation, are also dedicated to promoting basic, translational and clinical research - particularly outcomes research - to identify patients who are most likely to benefit from treatment.

Perhaps most significantly for the USBJI, Crow reiterated the value of collegial and collaborative relationships with orthopaedic surgeons and other professionals to ensure optimal outcomes for patients. Rheumatologists should take the lead in developing pathways of care for patients with arthritis and related diseases, and incorporate leading-edge information technology and patient workflow solutions, as well as patient satisfaction data, to optimize practice systems.

Allan Korn, M.D., FACP, who serves as both chief medical officer and senior vice president in the office of clinical affairs for the Blue Cross and Blue Shield Association, discussed the role of commercial insurance in defining healthcare value, describing the company's Blue Distinction Program.
The program defines quality as being outcomes-based, patient-centered, objectively measured, publically reported, trended over time, continually improved and addressing appropriateness of treatment, and uses self-reported data from hospitals to rank medical facilities according to a grade-based system. Those receiving As and Bs under the system are designated as Blue Distinction Centers.

Using their system, the Blue Cross and Blue Shield Association has identified centers across the country in all geographical areas, and will be releasing data to employers in 2012 to aid them in establishing health care packages for their employees. In addition to data about specific procedures and outcomes, data about procedure costs will also be included, Dr. Korn said. Under this program, employers "set the bar" for the hospitals they want to include, based on grade and cost level.

"The reason we devised this system is because we were under enormous pressures from employers to fix the cost problem," Dr. Korn noted.  "What's more, in another few years, many families will begin to write checks for their own healthcare, and as more Americans write checks, cost considerations become even more important."

"What we've done is create a marketplace," Dr. Korn said. "It's based on quality and outcome as defined by medical practitioners. We took our own data and found out what was being charged for procedures, and now we are offering employers and, in the future as necessary, families, an opportunity to buy value.  We want purchasers to have an opportunity to share not only in the information we have, but more importantly, to share the opportunity to realize value."

While cost is one component of value, quality is an equally important consideration. Michael Rapp, M.D., J.D., director of the  Quality Measurement and Health Assessment Group at the Centers for Medicare & Medicaid Services (CMS), noted that although the U.S. spends more per capita on healthcare than any other country in the world, the quality of that healthcare is often inferior to that of other nations. There is significant variation in quality and cost by geographic location, as well as serious disparities in the quality of healthcare by race, and socioeconomic status. In the current Medicare system, Dr. Rapp said patients do not pay for value, but rather pay for services. "We have a fee-for-service structure - the fee is paid for the service, but the patient is not asked how good or effective the treatment was," he said. "The effort now for CMS is to move more toward a value-based payment system, to ensure that patients are receiving the best value they can."

CMS has established a national quality strategy with a "three-part aim" focusing on better care for individuals, better health for the population and lower cost through improvement. The strategy was designed to make care safer by reducing harm caused in the delivery of care; ensure that each person and family are engaged as partners in their care; and to promote effective communication and coordination of care, as well as the most effective prevention and treatment practices for the leading causes of mortality.

The National Quality Strategy is also intended to promote wide use of best practices to enable healthy living within communities, and to make quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care delivery models.
Value-based purchasing, he said, will hold healthcare providers accountable for quality and cost, and will link payments to better quality and lower cost. The introduction of physician programs, including feedback and incentive programs, also will help CMS move toward the system of value-based purchasing.

Dr. Rapp said the CMS recognizes musculoskeletal conditions and care are "important priorities," and the agency encourages partnership and active engagement with physicians to achieve the dual goals of high quality care and effective implementation.

The concept of value is especially difficult to determine when the major players - especially patients and their caregivers - have widely divergent views of what constitutes value. In her role as director of the Center for Outcomes and Evidence of the Agency for Healthcare Research and Quality (AHRQ), a division of the U.S. Department of Health and Human Services (HSS), Jean Slutsky, P.A., M.S.P.H., said learning what patients really want from their healthcare experiences can aid tremendously in understanding how to measure value effectively.

Although caregivers often do not talk with patients about issue of quality of care, Ms. Slutsky said the results of focus groups conducted by AHRQ show that patients absolutely have specific ideas of what value means to them, and need to be included in discussions of creating and defining value within the healthcare system. As an example, she noted the results of a focus group designed to compare the experiences of patients who were included in a study of two procedures for unstable angina. Although the physicians involved in the initial study felt it was imperative to include mortality as a primary endpoint, Ms. Slutsky said the patients had a different goal in mind.

"There was a tsunami of anger among the patients we interviewed, because for them, the primary endpoint actually was angina and how they could carry on their daily activities," she said. "Being able to interact with their grandkids on a daily basis was much more important to them than if they had a couple more years of life. So one of the keys to understanding value is to begin by understanding that what value may mean to me may not be what it means to the next person."

Ms. Slutsky said AHRQ and HHS are in the unique position of being able to create an infrastructure to understand the national course of illness over time, replacing traditional and sometimes inaccurate surrogate measures of value.

Despite a difference in how value is defined, Ms. Slutsky also noted that group meetings like the USBJI summit allow all stakeholders to discuss their individual goals while also sharing common goals, like improving the quality, safety, efficiency and effectiveness of care for patients.
"Clearly, there are issues that we are facing now regarding a concern about the value of science and the role of evidence in the decision process, and whether or not this country should continue to invest in supporting evidence generation and evidence use," she said. "But I think we are able to have a much healthier discussion today about the important role of evidence in determining and upholding the value of care."

Sherine E. Gabriel, M.D., M.Sc., professor of medicine and epidemiology at the Mayo Clinic offered summit attendees insight into the Patient-Centered Outcomes Research Institute (PCORI), which was created by the 2010 Patient Protection and Affordable Care Act (PPACA). Dr. Gabriel is the chair of PCORI's Methodology Committee.

PCORI is an independent organization created to help people make informed healthcare decisions and improve healthcare delivery, by commissioning research that is guided by patients, caregivers and the broader health care community. The goal of PCORI is to focus on determining how to effectively incorporate the patient's "voice" throughout the entire research process, from selecting questions to the final distribution of data, and is committed to ensuring that patients play a pivotal role in assessing the value of healthcare options.

Being able to define value in healthcare is becoming especially important as the world population ages, Dr. Gabriel noted. "People are living longer, and that means people will be experiencing more comorbidities and a greater need for healthcare, and to be able to deliver healthcare in a more efficient manner is very important," she said.

Dr. Gabriel said PCORI will help guide the debate over healthcare value by commissioning research that will answer patient-focused questions, like "Given my personal characteristics, conditions and preferences, what should I expect will happen to me?" and "How can the health care system improve my chances of achieving the outcomes I prefer?"

"We are not getting value for the money we're spending when you look at healthcare expenditures and the outcomes we're getting in the U.S., compared to other developed countries," she said. "Healthcare spending is growing faster than the economy, and payment reform alone will not solve our problems. Looking at how we deliver care and how we can improve outcomes is extremely important."

With regard to musculoskeletal care, Dr. Gabriel noted that more than 30% of the U.S. population has a musculoskeletal condition requiring medical care, and learning how to accurately define value and effectively deliver care is therefore crucial. The annual estimated direct and indirect cost attributable to individuals with musculoskeletal disease is $287 billion.

Considering knee osteoarthritis alone, 13% of men and women who are older than 65 have symptoms of OA, which globally is the fourth leading cause of years lost due to disease. The risk of mobility disability - that is, needing help walking or climbing stairs - is greater than any other medical condition in people who are over 65 years of age.

Despite this burden, there are significant challenges in defining outcomes:  available evidence is often incomplete, confusing and conflicting, and is generally not patient-centered. Using the osteoarthritis example, Dr. Gabriel noted that while patients often report fatigue as being an important aspect of their disease, fatigue usually is not considered as a measurable outcome by most research.

Methodological standards are also lacking, and where evidence does exist, clinical practice does not reflect recommendations, and there are barriers in implementation and dissemination.

"There is a gap which suggests that we haven't been able to make system-wide changes, even when evidence is known," she said.
Improving the value of healthcare is perhaps one of the most powerful tools available for transforming healthcare, she added, and the prevalence and impact of musculoskeletal diseases makes it a "critically important target population for value enhancement."

Following the presentations on defining the value of musculoskeletal care, summit co-chair Dr. Gnatz led panelists in a discussion of how the value of musculoskeletal care is measured. For decades, outcomes measurements have been used to determine value of specific healthcare modalities.  More than 300 such measures have been described. Most measurements define a good outcome by criteria that include being able to live independently in the community; having minimal pain, being able to work and pursue hobbies and other interests; and having an overall good quality of life. Dr. Gnatz reviewed some of the more common outcome measures used in musculoskeletal care and their relative usefulness.

The SF-36 is one of the more ubiquitous outcome measures in use today. Based on a 36-question health survey form, the SF-36 is a broad, generic measure of functional health and well-being, as well as psychometrically-based physical and mental health summary measures. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments. Because it uses a brief survey format, the SF-36 has good patient compliance and is easy to administer. However, it lacks details regarding specific diseases or target populations, and may not reveal small but important treatment effects.

The ICF is based on the ICD-10 coding system and was established by the World Health Organization with the aim of putting human ability and disability on a spectrum. The ICF includes two parts: function and disability, which includes bodily functions and structures, and activities and participation; and contextual factors, including both the environment and personal factors. The change in ICF score over time can be used to measure rehabilitation outcomes as well as the effectiveness of treatments.

"In America, we are not very familiar with ICF because it's based on ICD-10, which we are not using in this country yet," Dr. Gnatz noted. "But ICF appears to offer a good opportunity to have an agreed upon international classification of function and disability in addition to disease."

The FIM® (functional independence measure) is designed to evaluate inpatient rehabilitation patients, and is based on a seven-point scale, with zero being completely dependent and seven being independent. The FIM considers six areas, or domains, including self-care, communication, cognition and movement (locomotion), and offers huge databases of results with very good benchmarking, and can be used to accurately measure changes in patient function and to determine caregiver burden.  However, because it is used primarily in an inpatient setting, its scope is limited and it requires special training to be used correctly. The FIM also does not address the critical issues of quality of life. Benchmarking data also are only available at a cost.

Dr. Gnatz noted that despite the wide number of available measures, there is no single perfect tool, and none of the available measures are especially effective in defining what a person can do (maximal functional status) as compared to what they choose to do (optimal functional status). With regard to rehabilitation outcomes, even when those outcomes can be measured, Dr. Gnatz said there is still disagreement over the medical necessity of rehabilitation; who should pay for rehabilitation; and how much rehabilitation is "enough."

"In health care economics, we often talk about the curve, or benefits associated with expense, as flattening out at some point, when the outcomes achieved level off despite expenditures going up," Dr. Gnatz said. "I think we can even agree that quality may at times go down as resources are increased; that is, as more and more tests are performed, perhaps inappropriately, the benefit to the patient will actually go down as the resources utilized goes up. Many people would argue that that is the point where we are in American medicine today."

However, that is not the case with rehabilitation, he noted. "In rehabilitation, the more that is done in helping a patient recover and improve function, the more benefit that patient experiences. What happens then, is that value becomes a societal judgment regarding how much is sufficient with regard to the provision of rehabilitative services."

Sigurd Berven, M.D., associate professor in residence at the University of California in San Francisco, discussed the need for economic analysis in a market-driven healthcare delivery system, and the challenges that analysis presents in determining value.

"Musculoskeletal conditions have an impact on health status that is more significant than other common medical conditions," Dr. Berven noted. "Demonstrating value in musculoskeletal interventions will be necessary to preserve coverage, funding levels, and access to care in a healthcare economy with limited resources."

One of the most difficult and complex challenges facing physicians and others charged with defining the value of musculoskeletal care is the lack of consensus on the measures that encompass the relevant components of the value equation - namely quality (or outcomes) and cost.  Because the perspectives of the stakeholders involved in reaching consensus, including hospitals, patients, pharmaceutical companies and others, can vary widely, establishing a system of measurement that all parties can agree on is essential.

Traditional outcome measures are limited, and make it difficult if not impossible to compare results across different healthcare disciplines. To overcome these challenges, Dr. Berven said utility measures like QALYs (quality adjusted life years) permit a unit of measure of health status that is translatable across healthcare alternatives. Utility scores can be used to measure quality of life, disease burden and the value of new technology.

"Utility measures permit calculations of value and engagement in healthcare economics discussions," Dr. Berven said. "Even without explicit thresholds for coverage, QALYs may guide priority for interventions that offer the most health care benefit for the least cost."

Dr. Berven noted that transparency of cost and outcomes are important in guiding a market-driven healthcare system.  Direct and indirect costs of care are difficult to determine, and may add significant opacity to the accurate estimations of healthcare costs.  Measures of cost are also complex, involving direct and indirect costs, as well as social and opportunity costs, and traditional outcome measures in orthopaedics do not adequately quantify value of the healthcare experience to the patient.

In the value equation, the concept of value merges cost considerations with clinical effectiveness to determine high or low value services. In environments with limited resources, cost alone may direct the allocation of resources and drive healthcare policy, and this scenario is especially short-sighted and prone to perverse incentives in care provision.

"Cost considerations are already implicitly included in coverage decisions," Dr. Berven noted. "Including cost in comparative effectiveness studies will improve transparency to patients and providers, and offer more transparency in decision-making regarding an evidence-based approach to care."

Determining cost is not without controversy, and there are specific situations in which issues of quality and outcomes should be considered independent of cost, he added, including setting priorities for research and reducing medical uncertainty between alternatives. Cost-effectiveness evaluations are based upon population considerations rather than individual cases, and an inherent lack of transparency in cost considerations makes it especially difficult to include them in an effective analysis.

Following Dr. Berven's presentation, some audience members expressed concerns that QALYs may not be well understood by the public, and so implementing them as a measurement tool may involve some challenges.

Vibeke Strand, M.D., a biopharmaceutical consultant and an adjunct clinical professor at Stanford University, told summit attendees about the role of clinical trials in helping to identify and define value, discussing some of the changes that have occurred in the treatment of rheumatoid arthritis during the past two decades. Since 1998, 10 new DMARDs have gained approval, and there have been a significant number of studies using different outcome measures to determine safety, efficacy and other factors of each new agent.

Dr. Strand said OMERACT (Outcome Measures in Rheumatoid Arthritis Clinical Trials), an international effort to improve outcome measurement in rheumatology, has played a critical role in reporting and measuring outcomes of patients with RA. Response criteria established by both the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) have helped ensure consistency among trial measurements. The ACR response criteria now are used as the primary outcome for the FDA to evaluate new treatments, and involve seven components, including the swollen joint count, tender joint count, and several patient-reported assessments. EULAR uses disease activity scores (DAS) to identify a baseline score as well as changes in activity. Both ACR and EULAR responses are closely correlated, she said.

In addition to the Health Assessment Questionnaire (HAQ), the generic health related quality of life measure, SF-36 has also proved useful in measuring outcomes in RA studies, demonstrating that all of the new DMARDs are very effective from a patient point of view, Dr. Strand said. "It's an important outcome measurement that is patient-oriented and is a good measure of many domains of HRQOL, in addition to physical function.  It can also be used to derive a health utility score, SF-6D, which has been shown to correlate well with direct queries of patient utility measures in a clinical trial, thus offering an accurate measure of "value".

Dr. Strand said one of the most important clinical assessments in RA practice is the RAPID3, composed of the 3 patient reported outcomes included in the ACR response criteria, which is becoming widely used in clinical practice and is "probably one of the best ways to ask a patient how they are doing with RA."

**Anna Tosteson, Sc.D., professor of medicine, of community and family medicine and of The Dartmouth Institute, talked about economic outcome measures and their usefulness in determining value.  Cost-benefit analysis measures benefit in monetary terms, whereas cost-effectiveness analysis does not require that health benefits be monetized.  Instead, cost-effectiveness analysis estimates cost per unit of effectiveness as a key outcome with QALYs being the recommended effectiveness measure in the United States.

Cost-effectiveness analysis aims to determine if the benefits, or health outcomes, of musculoskeletal care are large enough to justify the associated costs. Dr. Tosteson said the rationale behind CEA is straightforward: with available limited resources, every healthcare expenditure should provide a benefit worth its additional cost. Since musculoskeletal care competes with other health interventions, CEA can be an effective tool for comparing the value of specific interventions.

The use of any economic outcome measure presents specific challenges. One of the primary challenges is reckoning with varying perspectives: for instance, Dr. Tosteson noted that the societal perspective may have limited relevance to individual insurers. Offering alternative model-based analyses may provide insight into varying perspectives, she added.

A second challenge lies in determining value for a specific "target" population.
"Randomized clinical trials rarely address the full spectrum of clinical applications for which a technology is marketed or ultimately used," she said.
Moreover, cost-effectiveness for one indication does not necessarily ensure value for another indication, and policymakers may be concerned about "indication creep" - using a treatment alternative for more conditions than for which it is customarily used or approved.

Finally, Dr. Tosteson noted that the value of specific interventions may also vary widely regionally due to differences in the populations receiving treatment in each region. "According to data from the Dartmouth Atlas, in the United States alone, there is nearly a six-fold variation in rates of spine surgery. Ideally, practice objectives should be aimed at avoiding flat-of-the-curve healthcare. Instead, positive health outcomes are carefully balanced against the cost of the intervention. In the end, determining value-based outcomes of musculoskeletal care requires diverse data sources and methodologies, including randomized clinical trials, healthcare registries, administrative claims data, disease modeling, cost-effectiveness analysis," she said.
In a discussion of population health measures, Edward Yelin, Ph.D., a professor of medicine and health policy, University of California, San Francisco, described the medical and economic model approaches in determining the value of medical care costs.

The medical model includes a traditional approach, in which an individual provider decides whether a service is worthwhile for a patient, and the modern approach, which argues that inappropriate and equivocal care as revealed by well-done studies in the literature should be eliminated. One of the problems with this approach, Dr. Yelin noted, is that there is no compelling evidence that the high costs associated with musculoskeletal diseases are inappropriate, and in fact, there is evidence that expenditures may be too low in certain underserved populations. 

"In general health studies, there is an argument that the money saved from reducing the use of inappropriate services can be used to redistribute appropriate and necessary care to the underserved," he said. "But in musculoskeletal disease, there is not much evidence of inappropriate care. There is, however, strong evidence that that there is an underprovision of effective care in musculoskeletal diseases, which is related to race/ethnicity, language, immigration status and socioeconomic status."

The economic model operates on the basis that the ratio of expenditure to benefit should be the guide to decision-making. Dr. Yelin said that while currently, the rule of thumb is that $150,000 per quality adjusted life year (QALY) gained is reasonable, societies may differ in how this information is applied.
"The major issue in musculoskeletal care is distributional," Dr. Yelin said. "While healthcare reform should help, there will likely be residual effects due to the use of inexperienced providers, health systems that do not include the highest quality providers, and providers who do not provide culturally appropriate care."

A more detailed examination of the role and importance of the patient experience and patient goals was provided by international patient advocate and author, Amye Leong, M.B.A., president and CEO of Healthy Motivation in Santa Barbara. Ms. Leong was diagnosed with rheumatoid arthritis at age 18; by age 26 she was completely wheelchair-bound and subsequently experienced 16 surgeries and 12 joint replacements to regain function and mobility.
"I could not walk 10 feet nor raise my hands to my face to eat," she said. "And I had to figure out how to get the care I needed in the system of musculoskeletal care. Patients are not trained to deal with a potentially crippling disease, let alone an elusive healthcare system."

Ms. Leong said that in addition to learning to understand the healthcare process she and her family faced an additional obstacle due to culture, ethnicity and gender differences reflective of her Asian heritage. "Because of my background, I was very reluctant to talk about the pain, fear and symptoms of rheumatoid arthritis in order to get the kind of help that I needed. My Chinese culture told me it was inappropriate to talk about bad things, especially to strangers," she said. "If I could not understand it for myself how was I going to talk about it to my healthcare providers?"

After being confined to a wheelchair for more than five years, Ms. Leong said she finally found the strength and understanding to ask her own questions to figure out what she needed to get the care that would help her overcome its disabling effects. During the tedious 20-year process to regain function, Ms. Leong said she was compelled to become an outspoken advocate for patients.

In order for patients and healthcare professionals to move forward as a coordinated care team and to achieve specific beneficial patient goals, Ms. Leong said it is essential to reduce the silos that exist between stakeholder groups. "The patient is the center of the care paradigm," she noted. "Patients are people who happen to have a diagnosis. Patient education is critical. When patients understand why things are done the way they are and become engaged in the details of decision making in musculoskeletal care, they are more likely to adhere to the treatment program because they have been a part of the decision process."

"It is critical that the patient experience become a priority for all stakeholders," she continued. "The federal government is realizing this benefit by promoting patient-centered care paths and patient-reported outcomes research. By dangling available funds in these areas, we can only hope to see important changes in health care provider actions."

Communication between patients and providers is one area where there is significant room for improvement, she added, and offers a "real opportunity to ensure that both groups are on the same page" when discussing care and expectations. Understanding ethnic, cultural and even gender differences in communicating care and treatment options are important factors to reduce disparities in healthcare. "We know that lifestyle and early access to care decisions made by patients can reduce pain, deformity and severity of bone and joint disorders," Ms. Leong said. "I am a living example of the worst effect of the impact of these differences. But luckily through perseverance and determination, people like me can regain function and mobility through patient education, advocacy, and excellent communication and understanding with their healthcare team."

Registries can be a tool in collecting data about the treatment process and its outcomes, and one which should be used to answer the value question, said Matthew Liang, M.D., M.P.H., a professor of medicine at Harvard Medical School and a professor of health policy and management at Harvard School of Public Health, and a study director for the Veterans Administration Cooperative Studies Program.

Speaking about the importance of registries in outcomes management and research, Dr. Liang defined registries as places where data, records, or laboratory samples are kept and made available for research or comparative effectiveness study. A registry for patient-oriented research can be an assembly of people with a medical condition, or who have had a surgical procedure, who are systematically followed over time.

He described a milestone study in which he and others developed and validated patient-oriented burn outcomes questionnaires for Shriners Hospitals for Children to gather information about the treatment of infants and children with burns, with the goal of identifying factors which affected outcomes and for which healthcare could be held realistically accountable. The project gained even more significance over its 17 years as burn care in the Shriners Hospitals was cost-free until very recently. The benchmarks established by the study allowed analyses to see which interventions had value.
"We took a pragmatic approach, developing a patient-oriented questionnaire that could be completed easily during one brief sitting with a parent or child," he said. "We boiled down the sea in a sense, to reduce the number of items but still remain as sensitive as possible. Those questionnaires have been translated into multiple languages and used globally."

Using the data collected from burn victims, normal expected recovery curves for symptoms and function after burns were documented, for the first time.
"These curves are the equivalent of growth and development curves used in pediatrics," Dr. Liang said. "By outcomes measurement, we can look and see where that patient is on the curve in terms of the recovery process."

Registries can take considerable time to establish, he added, but that time could be dramatically shortened with a directed, pragmatic approach and with adequate funding. In today's funding climate, registries are "starved for resources," despite their value in developing new treatments and providing value. "We can, and should, do better," he said.

During a lunchtime presentation, Dr. Liang coached summit attendees to ensure success in reaching a consensus on the definition of value in musculoskeletal care. A consensus serves multiple purposes, including acting as a point of reference for studies and clinical trials; to help determine clinical guidelines; and as a point of discussion. Although developing a consensus may be intended for the broader good, Dr. Liang cautioned that it often also involves unintended consequences, including serving as a rallying cry for opposing influences or "naysayers." To be effective, a consensus should be initiated by a credible organization, with plans to revise periodically. A variety of consensus-building techniques can be used, but all should have the goals of ensuring the equity of all stakeholders, eliminating status and politics and calming emotions. To ensure success, Dr. Liang said those attempting to reach consensus should understand that it is less important for members to be correct than to agree, and to invite help when needed.

Summit attendees returned in the afternoon for a series of presentations on the role of industry in providing value in musculoskeletal care, led by summit co-chair Dr. Pisetsky. Gregory Keenan, M.D., vice president of medical affairs for Human Genome Sciences, offered the pharmaceutical industry's perspective in determining the value of specific drugs, and talked about the pharmaceutical industry's responsibility in considering patient needs when considering the question of value during a product's lifecycle. 

Dr. Keenan said that for industry, the goal is about creating value that can be used by practitioners to help patients. "If patients benefit in important ways relative to what is currently available, that is value," he said.

"Musculoskeletal care does not get as much attention or respect as more 'dramatic' conditions, such as cancer or cardiovascular conditions," noted Dr. Keenan, who jokingly likened musculoskeletal care to the "Rodney Dangerfield of healthcare": "It doesn't get the respect it deserves, but it is very important."

Some of the specific indications considered in determining whether or not to bring a drug to market include establishing that the new drug would satisfy an unmet need, the time it would take to bring the drug to market, and the revenue potential represented by marketing the drug. The cost of bringing one new drug to market is about $1 billion, Dr. Keenan said, including the costs of multiple trials required to establish the drug's efficacy and safety, and to meet regulatory requirements.

Pharmaceutical companies must consider strategic environment issues, like growth potential, intellectual property and royalty burdens, he noted. In some cases, even though a drug may have potential, the royalty and patent costs are so substantial that development of the drug is not feasible, he said.
Additional issues for consideration include whether there are similar products currently available, or whether the drug represents a completely new therapeutic category, and whether there is the potential for label expansion and long-term growth. Disease progression and damage to the body's systems and structures are important components for consideration, but so are quality of life issues, which may include objective measures, like changes in work and school attendance or other activities, comorbidities and increased use of healthcare facilities, as well as patient-reported measures, such as feelings of fatigue, malaise and well-being, he said.

Dr. Keenan said pharmaceutical companies use these criteria to determine a relative score, based on market size, the challenges of completing the necessary clinical trials, and the regulatory pathway involved in bringing a drug to market.
"It isn't always the case that the product with the highest score is the one that is pursued," he noted. "In some cases, for instance, a drug with a lower score may have a much clearer regulatory path, and so that is the one that will be pursued."

Determining value involves both art and science elements, both of which must consider the patient's needs.
"When it comes to value determination, there is a science-based methodology involved, but there is also no question that there is also a value judgment involved," Dr. Keenan said. "Getting a drug to market is by no means a simple process, and in many cases can take several years to go from an idea to an available drug. At the end of the day, if you remember the patients and the patients' needs relative to all the other factors, good things are going to happen and be advanced."

Patient-centered care was also the focus of a presentation by Shamiram Feinglass, M.D., M.P.H., vice president of global medical and regulatory affairs for Zimmer, Inc., and representing the Advanced Medical Technology Association. Dr. Feinglass said her own experiences as a young physician led her to understand the value of musculoskeletal care as she watched her own joint replacement patients regain mobility following treatment, and also recover from the depression they felt in not being able to accomplish their everyday tasks.

Watching her patients recover "helped me understand that when people can't walk or do the things they want to do in their lives, there is a huge impact, not only because they can't walk, but because they become dispirited, sometimes even depressed, because they can't do the things they want to do, can't contribute to their communities as they used to, and, in some cases, can't even care for themselves as they were used to," she said. "Because of these issues, we consider patients and their well-being in everything we do at Zimmer."

Dr. Feinglass said that industry's role is to develop and deliver innovative technologies, tools and training that support better health outcomes. "When we deliver quality, innovative devices that are needed for better patient care that's a winning situation; when this results in patients being able to return to active lifestyles and the things that they love, then we have stayed true to our mission of quality, innovative devices that, in skilled hands, help to improve people's lives," she said.

The relationship between industry and the academic research community is essential. Dr. Feinglass noted that without industry's backing, many of the procedures and treatments that are possible today would not be available for the care of patients. Echoing Dr. Balas' presentation from the morning session, Dr. Feinglass said collaboration between industry and academic institutions is at the heart of a successful healthcare system.

The success of joint replacement procedures is a clear example of where industry and providers - nurses, physician assistants, academic researchers and surgeons - have developed a collaboration to develop a technique and product that significantly improves quality of life for patients, she noted.
"In addition to spurring and supporting innovation, industry must also prove value for their products, assuring people that when they pay for a service or product, they are receiving value, she added. In industry, we must create products and treatments that improve patients' lives, and we must do that within the constraint of controlling costs."

"I think musculoskeletal health is a key component to the economic, social and spiritual engine of this country," Dr. Feinglass concluded. "If you cannot move as you wish, you cannot perform your regular activities, and you probably don't have a good sense of well-being as a result.  Movement is life."
In her role as director of the FDA Center for Drug Evaluation and Research, Janet Woodcock, M.D., gave summit participants a glimpse into the regulator's idea of value in healthcare. Like the industry participants, Dr. Woodcock said that for the FDA, value is a patient-centered concept. The three criteria considered by the FDA definition of value include how the person feels, functions or survives, and the FDA expects an approved therapy to improve at least one of those areas.

One of the problems plaguing regulators today is a concern over the perceived relative incompleteness of data that exists when a drug or therapy is brought to market. "Products that go through the FDA review process have incomplete knowledge with regard to utility, and many people believe more outcome data are needed, including more long-term outcome data and comparative data, as well as data on effectiveness, which is not considered in randomized controlled trials," Dr. Woodcock said. "While the FDA agrees that a gap in knowledge does exist, there is a balance that has to be struck between how much information can or should be gathered and when the drug is ready to be released to the public; it's a question of how much burden the innovation machinery can absorb before just breaking down and not producing any new therapies at all."

Society is in deep disagreement about how this balance should be struck, she added, ranging from demanding much more information a few years ago to today's environment, when the prevailing view is that regulatory standards should be lowered to avoid threatening innovation.
The concept of value is not static, but changes as other therapeutics enter the marketplace, or as providers offer drugs as an off-label use for populations that were not studied in clinical trials, an act that can dilute that perceived value and increase the reported risks associated with the agent, Dr. Woodcock said. Efforts by the FDA to restrict distribution of certain therapeutics in an effort to hold value to the level demonstrated by clinical trials has been poorly received by the medical community.

Value can also vary based on the level of risk a patient is willing to receive, which in turn can vary significantly, based on the severity level of the patient's condition. Dr. Woodcock said the FDA is seeking funding for an initiative that would gather patient feedback about risk tolerance.
"This is patient-centered drug development, and we want to bring patients in and determine their own risk tolerance and the value of various benefits for their specific disease level," she said. "Once we have a better understanding of what level of risk, or what magnitude of harm, patients are willing to tolerate and accept, we can incorporate that data into the regulatory process."

The American Academy of Orthopaedic Surgeons is conducting its own analysis to help determine the value of orthopaedic care, and William Martin III, M.D., William Robb, M.D., and Lane Koenig, Ph.D., discussed the impetus for the study, as well as its progress.

Dr. Martin, the medical director of the AAOS, said the escalation in healthcare costs is due to many factors, including overutilization, inefficiencies in technology systems and malpractice lawsuits and the practice of defensive medicine. There is inherent administrative waste in dealing with the for-profit insurance industry, as well: $83,000 a year is attributed to physicians in the U.S. compared to physicians in Ontario, who pay only $22,000.
As a result of these soaring costs, annual health care spending for families of four with employer-sponsored coverage will grow from nearly $17,000 in 2009 to over $39,000 by 2019or from 19 percent of family income to 31 percent.

"Most American families depend on employer-sponsored insurance for their health coverage, yet premiums and out-of-pocket expenses for families with employer-sponsored plans are rising at an unprecedented pace," Dr. Martin noted. "Unless something is done, healthcare costs will continue to eat away at family budgets, compromising families' ability to pay their bills, buy a home, or save toward long-term goals such as their retirement or their children's education."

Dr. Robb, member of the AAOS Social and Economic Value of Orthopaedic Surgery Project Team, noted that the perception of healthcare value is being eroded by negative reports in the press, which may have an eventual impact on the availability of specialty care. Politically, value is being defined in terms of limited or defined services at minimized costs, and specialty care is equated with technology and an increase in both total costs and the rates of inflation, he added. As the perceived value of specialty care declines, the ability to obtain funding and support for that care will be much more difficult to secure.

"The Bone and Joint Decade was designed and dedicated in part to increase effective advocacy for musculoskeletal diseases, but despite a decade of dedicated activity, underfunding and biases persist," Dr. Robb said.

Although negative reports have bolstered the notion among lawmakers that life-threatening diseases deserve greater funding than diseases that cause pain and disability, in fact, bone and joint disorders are the number one source of disability according to a 2009 report from the Centers for Disease Control (CDC), accounting for 41.4% of disabilities, compared to heart conditions, which comprise 6.6% of disabilities. In 2004, the cost for treatment of patients with musculoskeletal disease was $849 billion, or 7.7% of the GDP, including $510 billion in direct costs and $339 billion in indirect costs. Musculoskeletal disease also accounted for the majority of lost work and bed days in 2005.

Faced with these challenges, Dr. Robb said the AAOS hired KNG Health Consulting to develop models for specific orthopaedic conditions, in order to more effectively demonstrate the value of orthopaedic treatment.

Dr. Koenig, president of KNG Health Consulting, said Phase I of the study involved the development of a white paper, which presented a framework for estimating the value of orthopaedic treatments after reviewing and identifying gaps in the clinical literature. Phase II, which has just begun, will focus on specific areas of orthopaedic care, relying on literature, data and expert opinion to address gaps with established economic modeling methodologies. Medical and non-medical costs, including social and work productivity, as will quality and length of life.

The study will evaluate OA of the knee, hip fracture, disc disorders, rotator cuff tears and anterior cruciate ligament tears, and attempt to answer the question, "What is the social and economic value of musculoskeletal care in the United States?"

The study will determine value by answering what the burden of musculoskeletal disease would be if musculoskeletal care were not available.  The key study question is then to understand what a dollar spent on musculoskeletal care can "buy" in terms of reduced burden.

Dr. Koenig said the study will use cost effectiveness analysis (CEA), a type of economic evaluation that examines both the costs and health outcomes of alternative intervention strategies, to develop value models for each of the four conditions being studied. CEA estimates the value of services and determines the most effective treatments according to maximum outcome at minimum cost.

"CEA compares the cost of an intervention to its effectiveness as measured in natural health outcomes - for instance, "cases prevented" or "years of life saved," Dr. Koenig said. "CEA results are presented in a cost-effectiveness ratio, which expresses cost per health outcome."
Dr. Robb also noted that the AAOS project is designed to create a resource for musculoskeletal care, and to provide a methodology that, once established, will be valuable for the entire musculoskeletal community, and will be especially valuable in advocacy efforts.

During afternoon and early evening breakout groups, summit attendees grappled with the development of the value consensus statement, approaching the question from both disease-specific work groups and interdisciplinary work groups designed to address issues surrounding the definition and measurement of value, advocacy of the value of musculoskeletal care and treatment, and the role of professional organizations.

Disease-specific work sessions were divided into four groups, including arthritis and joint replacement, spine, bone disease, and trauma and injury. Each group considered four key areas: definition of value; measurement of value; advocacy; and the role of professional organizations. In these disease-specific groups, members had an opportunity to ensure the final concept of value would reflect the unique needs of their own specialty or condition areas. Although each group had slightly different approaches to defining value within the confines of their specific specialty area, all groups independently identified quality of life and patient-centered definitions of value as being important considerations in the overall question of value.

In the second session, members formed into interdisciplinary work groups which comprised members from each disease-specific work group. Interdisciplinary work groups allowed all of the members to come to a
broader consensus regarding the four key areas, ensuring that the objectives and needs of each disease-specific group were given consideration.
On Thursday morning, summit attendees reconvened to review the work group outcomes and develop the initial draft of the USBJI value consensus statement. Interdisciplinary work group results were presented to the group at-large by work group leaders. The work group on the definition of value, after some debate and discussion with members of the audience, agreed on the following statement: "The value in musculoskeletal care is the ability to maximize a person's ability to function in society while minimizing pain and other symptoms, and balancing both risk and cost over the entire life span of that person."

The work group on measurement issued the following statement with regard to the purpose of measurement: "To advocate for high-value care in the setting of clinical encounters through use of registries and longitudinal research. Including personalized assessment of both outcome and cost will substantially improve the quality of patient education and shared decision making tools for both patient and policy makers." This group also addressed issue of cost and outcomes.

The work group on advocacy began by recognizing the substantial effort that will be required of all stakeholders, including patients, caregivers, industry, policymakers, payers and academia, to disseminate and emphasize the value of musculoskeletal care to the individuals and organizations involved in health care reform. Messages related to advocacy must be clear and based on solid data regarding patient outcomes and cost estimates. The group identified several areas for advocacy, including the establishment of an integrated information and research network to provide information about patient care and outcomes, using measures that are suitable for use in registries. Advocacy efforts need to promote prioritization of funding and research according to the societal burden of disease with agencies such as the NIH and CDC, to help these agencies develop better models of funding and information collection and dissemination. The group recognized the need to maintain and increase funding for research conducted by other government agencies, including the Department of Defense, with regard to research in the area of musculoskeletal care and its long-term effects.  Medical schools need to improve the knowledge and skills of graduating students to ensure they understand the management of musculoskeletal conditions and care. Academic institutions need to develop a multidisciplinary model of care that is designed to improve patient outcomes and which is better suited to integrated health systems. The group also encouraged development of new care delivery models that can be adapted as demographics evolve, and which address underserved populations, including groups that are more susceptible to musculoskeletal disease and its comorbidities. Finally, the work group recognized a need to increase the musculoskeletal care workforce to address the growing needs of an aging population, and to encourage greater participation of women in the workforce.

In the final consensus statement, the USBJI recognized the need for an increased awareness of the burden of musculoskeletal diseases, as well as the establishment of the value and cost-effectiveness of musculoskeletal care, in promoting beneficial changes in health care systems. Ultimately, these challenges will meet several goals, including redirecting resources to control costs, funding research that is adequate for the burden of care that exists, developing more effective programs for prevention, treatment and rehabilitation, improving outcomes and reducing costs through integrated systems of care, and improving the quality of life by improving general health for all.

Finally, the work group on the role of professional organizations acknowledged the critical role these groups can play in improving musculoskeletal advocacy at the government level. The group identified a need for more collaborative efforts to improve the knowledge and skills of practitioners to enable them to deliver care of the highest caliber both to patients with musculoskeletal disease, and to those at risk for developing disease. The group also cited a need to develop consistent measures of value, and to monitor those measurements and improve them as necessary. Professional organizations should strive to develop longitudinal models, where care can be tracked over time to measure improvement and value of care; educate "medical home" and other caregivers about optimal care practices; prepare members to be leaders of innovation in their community; promote prevention and value tactics across disciplines; and to encourage and nurture a culture of professional collaborations that are focused on patient outcomes. The group also felt that organizations should develop and promote a common message when advocating for musculoskeletal health. In addition, the group called on the USBJI and its member organizations to provide visibility for patients with conditions that do not have a patient advocacy group, to increase understanding about diagnosis and management within the medical community, to help promote timely implementation of care.

Following the presentation of the consensus statement draft and closing remarks by Dr. Andersson, the formal meeting portion was adjourned and members attended a congressional luncheon briefing, examining the impact of musculoskeletal injury and trauma among America's veterans. The luncheon featured a presentation by retired marine Mike Jackson, who struggles with early onset osteoarthritis, and healthcare providers who serve members of the military. 

Considering the task set before the summit and its attendees, Dr. Templeton and the summit co-chairs noted that the work accomplished during the relatively brief time frame was notable.

"The summit provided an opportunity for the participating organizations to interact at a more in-depth level than is available during USBJI board of director meetings or at the meetings of the various organizations," Dr. Templeton said. "A future objective of the USBJI is to continue to provide a forum through which the participating organizations can discuss and interact on areas of common concern, using the strength of our united voices to improve the treatment of patients with musculoskeletal conditions."

Dr. Pisetsky and Dr. Andersson agreed that the summit was successful in meetings its objectives.

"The summit was very successful in identifying important issues about value and developing a framework to promote value as a goal in musculoskeletal care for all providers," Dr. Pisetsky said. "The consensus statement will be a valuable document for advocacy and programmatic planning at all levels.  It will also promote discussion among different organizations about the importance of value in the provision of care and instituting value measures in evaluating programs and developing new services."

"The single most important outcome of the summit in my opinion was the fact that we could reach consensus on definition and measurement issues as well as on the role of the professional organizations and how to promote value in musculoskeletal care," Dr. Andersson added.
Dr. Gnatz noted that the next step is to develop an action plan to implement the decisions and suggestions made during the summit.  
"The USBJI will take up the issues raised by the consensus statement and determine a working plan to accomplish goals suggested by it," he said. "A work plan would be a logical outcome of the consensus statement with USBJI setting priorities for tasks aimed at such goals."