Prosthetic care for persons who have had a lower-limb amputation or for those who were born with a limb difference has proven to be one of the most rehabilitative technologies in medicine. Many people having received lower-limb prosthetic care are living lives we might reasonably consider to range from completely ordinary to highly extraordinary.
Consider, for example, the stories of many persons with limb loss that are paralympic athletes. Although considered to have a disability, these individuals have qualified to compete with the world’s best able-bodied athletes. Even more amazing are those with less than four complete limbs who are mostly unnoticed as they simply do their jobs, play their sports, care for their families, and live their lives well with limb loss. The key ingredient in each success story is the individual care that each of these persons receives.
There are countless stories of success in prosthetics, and these inspiring stories and the hope they aroused were once all that was needed to justify the cost of prosthetic care and technology. This is no longer true, as health care costs have increased (3.2 trillion in 2015 or 17.8% of GDP compared with 5% of GDP in 1960) and are expected to grow to 20% by 2020. Aging populations and increased longevity, coupled with chronic health problems, have put huge financial demands and constraints on the health care system in the United States.1
As technology in prosthetics has increased, so has the average cost of an artificial limb. Although prosthetics are still a very small portion of the overall national health costs, the single line item price tag has made them a target for cost-cutting measures. Evidence, in the form of documentation and empirical measures to justify the expenditure, has become an absolute requirement. Unfortunately the measurement tools and data that provide the level of evidence required by payers often lags behind the initial technological advancements.
In 1987, at the age of 31 years, I had an accident at work and became one of the estimated 2 million persons with amputation living in the United States. My foot was crushed by a forklift, and 6 days later after surgery to reconstruct my foot, infection set in, making transtibial amputation the only option. I went to work one morning and came home from the hospital 2 weeks later—not something I expected or was prepared to deal with. Fortunately, there was a team of professionals trained to help me get my life back, including my surgeon, a physical therapist, and my prosthetist, all on my team to ensure I had everything I needed to be successful after the amputation.
I returned to work 2 months after my accident and began to get back to life. Not back to normal, but progress toward the new normal—of living with amputation. My daughter was 2 months old when the accident happened. My wife and I had been married for 2 years, and we had just bought a new house. My family was my emotional support team and my motivation as I went through the loss and recovery.
Before the accident, I had been an avid cyclist for many years. Midweek training rides and weekend events were a big part of my life. Cycling was my connection to my friends. When I lost my limb and my ability to cycle, I lost a big part of my social life, and along with it, my self-identity and confidence. I wanted more than just a leg that would enable me to go back to work. What I wanted was a way to get back to what I loved, my family, friends, work, and life. I think that’s what we all want after limb loss—a way back to what we love and a way forward in life with the technology that will take us there.
When I lost my leg in 1987, no one questioned if a prosthesis was a medical necessity for me. I was young, healthy, and motivated to return to work after the accident. That was all the insurance company needed to know. Things have changed over the last 30 years, and now “medical necessity” is an ever-changing, inconsistent standard that must be proven before prosthetic care is provided.
THE PATIENT’S RISING COSTS OF HEALTH CARE
As consumers of health care, we understand that the skyrocketing cost of health care must be contained. Every year, we pay more for health care and take home less money. Take-home wages have stagnated for more than 40 years, in part due to the rising costs of worker health insurance. Real, or inflation-adjusted, compensation has risen 61% since 1970; wages, on the other hand, have increased less than 3% in real terms in that period.2 The chart in Figure 1 illustrates the rise in health care cost since just 2005, and the result has been less take-home pay for the average worker in the United States. Health care costs for a family of four with PPO coverage rose to just under $27,000 in 2017. In the average group health plan, this is made up of 43% employee contribution and 57% employer.3
Value is defined by the dictionary as “the regard that something is held to deserve; the importance, worth, or usefulness of something.” Michael E. Porter, PhD, writing in the New England Journal of Medicine, described value in health care this way: “Value, neither an abstract ideal nor a code word for cost reduction, should define the framework for performance improvement in health care. Rigorous, disciplined measurement and improvement of value is the best way to drive system progress.”4
Again, quoting Michael Porter, “Value should always be defined around the customer, and in a well-functioning health care system, the creation of value for patients should determine the rewards for all other actors in the system. Since value depends on results, not inputs, value in health care is measured by the outcomes achieved, not the volume of services delivered, and shifting focus from volume to value is a challenge. Outcomes, the numerator of the value equation, are inherently condition specific and multidimensional. For any medical condition, no single outcome captures the results of care. Cost, the equation’s denominator, refers to the total costs of the full cycle of care for the patient’s medical condition, not the cost of individual services. To reduce cost, the best approach is often to spend more on some services to reduce the need for others.”4
This is especially important when we look at the current payment model for prosthetic care where initial investments in improved technologies may reduce long-term health care spending to treat comorbid health conditions. Reimbursement is based on the delivery of individual items billed with several L-codes, each often needing its own proof of medical necessity.
What do the consumers of prosthetic care (patients) want? Patients and payers generally want appropriate care, not the most care and not the most expensive care. This naturally leads to a discussion of “What do patients expect?” First, from the patient’s perspective, a prosthesis is not a device, nor is it a collection of components, nor is it an item of “durable medical equipment” as payers continue to classify it. From a patient’s standpoint, our needs extend beyond the item, the prosthesis, to prosthetic care, the process of obtaining and maintaining a functional solution to our physical deficits from a professional that specializes in the care of those who have an amputation or a limb difference.
Second, I believe the expectations of persons with amputation change over the course of life. In the beginning, such expectations can be unrealistically high. I remember my first steps on a prosthesis. The first thought to go through my mind was, “This doesn’t feel anything like my other leg!” Of course, it didn’t, but that was my level of expectation—getting a leg back. High expectations are fueled by the Internet and the information-rich world we live in. A wise prosthetist once told me, “The best prosthesis I or anyone else will ever provide you with is nothing more than a tool that you learn how to use to get on with the rest of your life.” That statement implies a responsibility on the part of both the prosthetist and patient. The patient has the responsibility to learn how to use the prosthesis (tool) and the prosthetist and rehabilitation team have the responsibility to select the best tool for that individual and to assist the patient in learning how to use the tool.
My wife Laurie, who has a congenital transradial limb loss, and I were recently asked by a prosthetist to meet with someone who had recently experienced an upper-limb amputation. During our conversation and as we answered his questions, he said, “I love to write, and I can’t wait to get a prosthesis that will let me type with all 10 fingers again.” Laurie and I, knowing that such technology is not yet possible, looked at each other, not really knowing what to say. I asked him, “Where did you see that technology?”
Of course, he replied, “On the Internet.”
However, elevated expectations are not all bad and seeing the advanced technologies of the future can be encouraging. When someone loses a limb, much of their hope to return to the life they once knew lives in the device that will magically make that happen. But, at the end of the day, high expectations and the belief that anything is possible through some new technology can offer hope at a time when hope may be in short supply. Ultimately, a thoughtful middle ground of hope founded in realistic expectation is required.
What about the real advances in technology, are they making a difference? In the past 20 years, there have been many advances in prosthetic care that have changed the lives of persons with amputation and the way prosthetic care is provided. Robotics has become a part of everyday life, and in prosthetic care, robotic technology is increasingly a part of our bodies. The integration of new materials, electronics, hydraulics, and myoelectric and microprocessor controls have had a significant impact on the safety, function, performance, and energy efficiency of the components that make up a prosthetic device. Some technologies have even been proven to accelerate healing and prevent injury.5 These devices get people back to work and get them back to taking care of themselves and their families. These technologies improve their quality of life and let them, to a large extent, get back to living life.
Although these improvements in technology have been life-changing for persons with amputation, they also, like most advances in care and quality of life, cost more. Balancing the increased cost is the benefit of improved outcomes. I believe this investment in care and technology is worth the cost because I see the results of this technology every day in my life and that of my wife. She was fit with her first prosthesis when she was 13 months old. She used a conventional body-powered device for the first four decades of her life. About the time she started having neck, back, and shoulder issues from being a lifelong body-powered user, she was able to switch to an externally powered myoelectric prosthesis that reduced the daily loads placed upon her neck, upper back, and shoulder. Her story is not uncommon, with one study concluding that at least 50% of all persons with upper-limb amputation will experience overuse syndrome.6 Overuse syndrome causes some to abandon their prosthesis or have surgery to relieve a variety of complications.
Like Laurie, I require prosthetic care and technology that will enable me to stay healthy, take care of my home and family, and do my job without pain, discomfort, or damage to my body. What are the components of my prosthetic care that make that possible? A skilled prosthetist who can assess the condition and individual characteristics of my residual limb, develop a plan of care to meet my needs, and manage that plan. Some of the specific needs I have are a prosthetic socket that fits properly, a means to adjust or manage changes in volume within my socket, a way to securely suspend the prosthesis on my residual limb, and a foot/pylon system that simulates the function of my foot and ankle. I also need a proper alignment of these components that will accommodate my individual biomechanics, allowing me to walk, run, or ride safely and efficiently over a variety or surface types and terrains.
Laurie’s externally powered device allows her to continue using a prosthesis, work full time, and live her life without pain. In my case, technology and great prosthetic care allowed me to return to my job 2 months after the accident, get back into cycling, learn to run again, complete five marathons, and still be running for fitness 30 years later. There are many thousands of stories of successes like ours, but in a world of rapidly increasing health care costs and a system focused on the justification of every dollar spent, they fall short of justifying the expense for most payers.
This brings me back to the question, “What do patients want?” In the end, they want what the payers want: proven positive outcomes. So then how do we define a positive outcome? Not just great stories and promises, but proven results. But first we need to define the “desired result.” A term that seems to resonate with all the stakeholders in health care is value. Much time has been spent defining and designing value in health care because it means different things to each of the multiple stakeholders. Patients want improved usability and clinical outcomes, providers want increased reputation for sound clinical outcomes and reduced financial risk, and payers want controlled health care costs with an increased bottom line and reduced financial risk (Figure 2). Ultimately, patients, providers, and payers all agree on improved patient outcomes. Future value models in health care emphasize patient-centric models as opposed to medical models. Some components of each model are compared in Table 1.
Currently, there are two schools of thought in the patient-centric model: one would put the patient at the center of all decisions made about the care of the individual, and the other empowers the patient to make decisions about his or her health. Education and information are the keys to success in this model. In prosthetic care, that would require patients to have reliable information on the results of several different treatment options. Although these may be available for heart disease and cancers, well-documented outcomes that would support decision making at the patient level are hard to find in prosthetic care.
For consumers, anticipated outcomes are the key to understanding patient-centric and value-based care. They support the reasoning behind decisions that are made not just in their individual case but more broadly in the system overall. Most importantly, outcome data will give them a better idea of what they can expect in their individual situation at each stage in the rehabilitation process. Outcome data will also help them along with their care providers to make sound decisions about which care options and technologies would be their best choice. In the end, when expectations are realistic and align with rehabilitation goals, they become true value for all in the health care system.
One framework for that value goal is put into a framework developed by the Institute for Healthcare Improvement (IHI) (Figure 3). The IHI believes that there three important targets to aim for in health care:
- Improving the patient experience of care (including quality and satisfaction);
- Improving the health of populations; and
- Reducing the per capita cost of health care.
The goals of the IHI “Triple Aim” of health care are more than just great goals for health care. They are goals that have to be achieved for our society as a whole. Society and its health care consumers are, after all, the ultimate bearers of the cost of health care.7
Some recent studies like the Rand’s “Economic Value of Advanced Transfemoral Prosthetics”8 and the Dobson-DaVanzo study on the “Economic Value of Prosthetic Services Among Medicare Beneficiaries”9 are examples of how empirical data can be used to achieve the triple aim in health care for the patients, providers and payors. These studies combined with a patient’s individual stories of add significant impact to the argument for access to care the they need.
As future research projects are planned, it is in the best interest of all those who seek to improve prosthetic care to take a patient-centric approach in designing and conducting these studies.
One of the challenges of research in the population of individuals with amputation is collecting large amounts of data in small clinical settings. Unlike care for heart or stroke patients, prosthetic care is provided in much smaller settings (clinics vs. large medical centers) and to a much smaller population. Adding to the challenge in collecting data is the diversity in age, reason for amputation, and amputation levels. The collection of patient outcomes information is currently very diverse across the clinical settings. From gait analysis with electronic data collection to the simple “timed up and go” type evaluations, the methods and timing are not consistent. Although most patients are willing to participate in research, most are not involved in research at any level.
Evidence-based practice (EBP) is using the best evidence available in making care decisions. Although efforts to incorporate EBP in practice in prosthetics are being made, many barriers still exist. EBP standards in the field of prosthetics and orthotics are still not as developed as in other medical fields.10 There is a gap between published research and resources that are clinically useful.11 The unique characteristics of each patient needing prosthetic care make it difficult to generate data in large enough numbers to draw definitive conclusions. Even so, Ramstrand and Brodtkorb in 2008 suggested that the use of EBP should be a combination of best available evidence and the prosthetist’s professional experience to achieve the best result.12
No matter how the data are collected or how small the data set, it is beneficial in the clinical setting for the care provider and the patient. Measurements give them both a baseline to work from in setting goals, achieving those goals and reaching higher levels of function. If the data could be collected across a large number of clinical settings and if it were consistent, it could yield greater knowledge of what is required to improve outcomes that matter. Patient-reported outcomes such as perception of balance, mobility, and function are in many ways more meaningful than shaving 0.2 second off of a 10-meter walk test. This information could also be a better indicator of overall improvements in a patient.
What about quality of life, or in technical terms, the quality-adjusted life years (QALYs)? QALY is the measure of the impact of a particular plan of care on a patient’s length of life and his or her health-related quality of life (HRQoL). These measures are widely used in health economics as a summary measure of health outcomes, which can inform health care resource allocation decisions. Basically, these measures inform our health care system on the economic value of care and provide a guide for decision making based on value. If patients are at the center of our system, then quality of life measure is also at the center of our system. Mobility is part of life and most often this is what is taken from individuals with the loss of a limb. To a large extent mobility is freedom for them, and therefore great value is placed on mobility.
But how do patients measure value? Value is hard to put into dollars and cents when emotions and expectations are running high. What is the value of prosthetic function—walking, standing, grasping, bimanual function, returning to work, caring for your family, or just getting back to enjoying life after the loss of a limb?
My perspective as a consumer and someone who got his life back through prosthetic care and the incredible technology that is a part of that care drives me to advocate for access to prosthetic care for all who can derive value from it. Value is the key, value as defined by patients, providers, and payers. In a health care system driven by that value, decisions are based on outcome data rather than high expectations and emotions. If value is the key, then outcomes data is key to measuring that value.
Outcomes are how we measure success, but how can we define success across the spectrum of limb loss levels and causes of amputation? How can we determine if a particular plan of care or particular technology will help an individual with amputation reach that success? I believe the key is collecting large amounts of outcome data in a uniform way over time and that will generate information that will help us set expectations. Expected outcomes determine value and drive the decisions made by payers on medical necessity and appropriate technology. If prosthetic care and technologies are provided without regard to an expected outcome, it lowers the value of care for all. Value benefits everyone in our society: those that need the care, provide the care, and pay for the care. In the end, society bears the cost of providing or withholding care for that those who have experienced limb loss.
To define value, we need to answer patient-centric questions: Did the care provided help patients to reach their goals? Are they able to use their prosthesis as much as they need to every day? Has the prosthesis reduced their pain and prevented injury to the residual limb? Have they had fewer falls and have they improved their confidence? Are they taking a greater number of steps each day? Each of these data points and more need to be collected and fed back into a larger system that could analyze the results and compare protocols and devices across the spectrum of prosthetic care. The key is working together with patients, prosthetists, researchers, and payers to create these reporting standards.
From my viewpoint as a former provider, educated consumer, and advocate, this is not rocket science. It comes down to defining the best measurements, doing the arduous work of collecting the data, analyzing the results, and accepting the conclusions, even if they are not what we expected. I also recognize there are times when a practitioner will review the information available, combine it with his clinical experience, and with good judgment, decide to step outside the conclusions of the research. Prosthetic care, like other medical care, is an art, an art based on science. In our world where prosthetic patients, payers, and providers live, we could use a little more science.
1. National Health Expenditures Summary Including Share of GDP, CY 1960-2015, National Healthcare Expenditure Projections, 2010–2020. Centers for Medicare and Medicaid Services, Office of the Actuary.
2. Health-Care Costs Ate Your Pay Raises-By Barry Ritholtz- September 28, 2016.
4. Porter ME. What is value in health care?. N Engl J Med
5. Brunelli S, Averna T, Delusso S, Traballesi M. Vacuum assisted socket system in trans-tibial amputees: clinical report. Orthopädie-Technik Quarterly, English edition II
6. Jones LE, Davidson JH. Save that arm: a study of problems in the remaining arm of unilateral upper limb amputees. Prosthet Orthot Int
7. Stiefel M, Nolan K. A Guide to Measuring the Triple Aim: Population Health, Experience of Care, and Per Capita Cost. IHI Innovation Series white paper
. Cambridge: Institute for Healthcare Improvement; 2012: (Available on www.IHI.org
8. Economic Value of Advanced Transfemoral Prosthetics
by Harry H. Liu, Christine Chen, Mark Hanson, Ritika Chaturvedi, Soeren Mattke, Richard Hillestad. Santa Monica, CA: RAND Corporation; 2017:51.
9. Retrospective Cohort Study of the Economic Value of Orthotic and Prosthetic Services Among Medicare Beneficiaries Final Report -Dobson DaVanzo & Associates, LLC Vienna, VA 703.260.1760. Available at: www.dobsondavanzo.com
10. Andrysek J, Christensen J, Dupuis A. Factors influencing evidence-based practice in prosthetics
and orthotics. Prosthet Orthot Int
11. Geil MD. Assessing the state of clinically applicable research for evidence-based practice in prosthetics
and orthotics. J Rehabil Res Dev
12. Ramstrand N. Translating research into prosthetic and orthotic practice. Prosthet Orthot Int
Keywords:© 2019 by the American Academy of Orthotists and Prosthetists.
prosthetics; health economics; limb loss; amputation; patient-centric care