A renewed focus in O&P research has been talked about for decades. But a crucial meeting in Chicago 5 years ago may have been the spark that propelled the O&P industry into action. In late February 2006, the Rehabilitation Engineering Research Center (RERC) in O&P hosted a meeting at the Northwestern University Prosthetics and Orthotics Center on the 17th floor of the Rehabilitation Institute of Chicago. The meeting was established to critically assess research and investigate new directions in the O&P profession. The findings in the subsequent report, “Research in P&O: Are We Addressing Clinically-Relevant Problems?” were damning to a field fighting to gain legitimacy in the health care industry.
Time for action
According to the report, when study participants were asked if they believe that the amount and emphasis on current research in the O&P field was appropriate, 79.9% of the 224 responses indicated that the amount of research was lacking and 61.2% indicated the emphasis for research was lacking. Some of the specific areas the respondents deemed lacking were outcomes/evidence/efficacy measures, orthotics research, funding and statistically significant studies with strong design.
“Much of the evidence that practitioners rely on for making decisions about component selection, fitting and fabrication of prostheses and orthoses is anecdotal and undocumented,” Steven A. Gard, PhD, research associate professor, Northwestern University Feinberg School of Medicine, wrote. He wrote that the science of O&P is “severely immature and that much more work remains to be done.”
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The 2006 RERC report contained statistics and findings the profession could no longer ignore. Although it was assumed that this area of focus needed to improve, the time had come to finally act. It was time for the profession to rededicate itselves to research and outcomes measures.
Gradual improvements
Joan E. Sanders, PhD, professor of bioengineering, University of Washington, received her doctorate in bioengineering at the University of Washington in 1991. She began her career in prosthetics research at the university and as director of bioengineering research at the Prosthetics Research Study.
“There were no bioengineering researchers,” she said. “It was tough. Discussion is the lifeblood of science. Without other scientists doing research similar to us and familiar with the challenges, discussion was mainly within our own research group. We were productive and made good progress, but without a lot of outside criticism, it was not as fun as it might have been.”
As a result, Sanders started new research directions in areas related to prosthetics populated with more researchers, including skin adaptation and biomaterials.
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| Joan E. Sanders |
“As a profession, there are always areas in which we can grow and improve,” Brian Hafner, PhD, assistant professor, University of Washington Division of Prosthetics and Orthotics, said. “As producers of research, we can challenge ourselves to pursue meaningful and relevant research topics with methodologically sound and well-reasoned studies. As consumers of research, we can learn to apply the results of existing research and make specific requests for more.”
According to Hafner, clinically relevant research is best accomplished when clinicians and researchers are involved in the process together.
“I sometimes get the impression that people in the clinical community think that research should simple be used to justify the decisions made clinicians,” Hafner said. “Likewise, I get the impression that those in the research community are just interested in measuring the outcomes of clinical care without helping to promote changes in it. Neither of those situations is ideal. In my mind, the clinical community should be open to adopting change based on the results of the generated evidence through scientific research, just as the research community should be open to studying issues of importance to clinicians and patients. When we learn from each other in this way, we have the best potential to advance our profession.”
Maria Gerschutz, PhD, applied research engineer, WillowWood, began her career in O&P research 3 years ago. At that time, the research area in O&P was starting to move forward, becoming more active.
“I have seen the difference in the last few years on multiple levels,” Gerschutz said. “One of the levels is an emphasis on residents and student projects. The master’s program is heading in the right direction. I have seen an increase in submissions to journal publications. There has been a gradual movement toward that direction and helping the profession itself understand the importance of research.”
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| Maria Gerschutz |
Gerschutz also sees this movement as an opportunity to improve the technology, treatment methods and other areas that are in need of further development. But most importantly, improved research ultimately helps the patient.
“The most important impact is better patient treatment,” she said. “The practitioner will have more knowledge in treating their patient and achieving the maximum outcome that is possible.”
O&P research and the practitioner
The profession’s renewed dedication to O&P research was not lost on Sanders.
“For several years, we focused more on skin adaptation and biomaterials than prosthetics,” she said. “Then when prosthetics research nationally and internationally started to ramp up and so many scientists joined the field, we returned. Now, approximately 90% of our research is in prosthetics.”
Young and eager O&P researchers and investigators reinvigorated the field. The energy drew Sanders back in.
“I like the focus on clinical relevance,” she said. “I think the prosthetists are helping to convey certain questions to the researchers about a problem areas for patients. Having the practitioner so involved in the research and to provide feedback is great. It is quite valuable.”
The O&P research team relies heavily on the creativity and innovation of the practitioner. Unlike most allied health practitioners who often treat their patients within a certain conservative realm, the O&P practitioner has the freedom to tinker, test and experiment in order to get positive outcomes for the patient.
Sanders routinely works with practitioners at her facility in Seattle who often approach her with additional information or useful anecdotal data that she could apply to additional research.
“I would love for more feedback,” she said.
Like Sanders, Mark D. Geil, PhD, associate professor, graduate faculty, Georgia State University and O&P Business News Practitioner Advisory Council member, relishes the opportunity to communicate with practitioners about potential research projects.
“I have really noticed the value in the finished product when the research starts with an idea from a front-line clinician,” Geil told O&P Business News. “When I have ideas, they may be basic science and theoretical research, which is valuable, but they tend to be a few steps removed from practical application in the clinic. When the ideas start with the clinician, then as soon as we are published, it can have an impact on a patient’s day-to-day care. And that’s a gratifying thing.”
Geil works with a network of inquisitive clinicians. “They do not accept the status quo,” he said. “They think about how things can be done differently or about techniques, components or how certain aspects of a patient presentation are not well understood.”
Left behind
Hafner described research and development as a moving target. No matter how big the profession’s body of knowledge becomes, there will always be a need for better and more research. This is true for all allied health professions. The O&P profession has often been considered behind in terms of volumes of research documents and clinically relevant research. But who is the profession behind? Who or what are they really chasing?
“It may not be appropriate to compare ourselves to other professions,” Hafner said. “I do not think of research as a race with other fields. In my mind, it is more of a challenge to ourselves.”
One of the mistakes Hafner commonly sees in O&P is that practitioners and researchers often try to reinvent the wheel when it comes to promoting and building research. He recommended examining how other professions successfully developed their research programs and bodies of literature. Find the similarities between O&P and other allied health professions, determine what worked for them and steer clear of what did not.
“Then we can avoid the same growing pains,” he said. “Our needs are different from their needs. But there are similarities and we should learn from those situations.”
Like Hafner, Geil agreed that the comparison between the allied health profession and O&P is an unfair one due to the nature of the evidence.
“The nature of the best evidence tends to be randomized controlled trials appropriate for a pharmacology study, but not appropriate for O&P, he said. “The nature of our field is such that you can not give someone a component and a placebo. A lot of what we do in O&P research may be viewed as a lesser hierarchy of research. When I review articles, I tend to not compare the best research design but rather was this design appropriate for the specific question.”
Funding
According to Geil, the biggest challenge facing O&P research is no longer the lack of research projects being conducted; rather, gathering enough subjects for the project is the biggest hurdle.
“That is our biggest hurdle in any project, particularly in prosthetics,” Geil said. “I have Master’s students proposing projects and for one project in particular, it looks at a fairly simple population — adult unilateral transtibial amputees. For the question we are asking and for the effect sizes we are interested in, the analysis recommends we have 60 subjects.”
Based in Atlanta, Geil could probably spend most of his days recruiting 60 subjects that fit his criteria. But it would be incredibly expensive.
“Anything you want to do in terms of changing alignment or remaining consistent in sockets adds to the clinical expenses,” he admitted. “Then you have to multiply that by 60 patients. You need serious funding to accomplish that.”
Because significant funding is often not there, Geil conducts research while producing samples of convenience or recruiting as many as subjects as he can afford.
“If money is a hurdle then it’s incumbent on us to scratch and claw to raise that money,” he said.
Volume of research
When submitting a proposal for funding to a federal agency such as the National Institute of Health (NIH) or the National Institute on Disability and Rehabilitation Research (NIDRR), standing out in the crowd is not necessarily a good thing. The traditional allied health professions routinely win out in the competitive research proposal game. To combat this, Orthotic and Prosthetic Education and Research Foundation (OPERF), Center for O&P Learning and Evidence Based Practice (COPL) and most recently, American Orthotic and Prosthetic Association (AOPA) have awarded grant money to O&P researchers, investigators, students and residents, accumulating a large volume of data and clinically relevant research for the profession.
In 2009, Sanders was the recipient of a $25,000 small grant award from OPERF for her research paper, “How Does Socket Volume Affect Limb Volume in Transtibial Amputee Patients?” Sanders then used the OPERF money to generate data which showed that her idea was promising.
“The nature of our research was a new idea,” she said. “It was a new way to measure the fluid volume changes in a patient’s limb non-invasively in the socket and pretty much in real time. If we had just gone to the federal funding agencies and said we have this idea, without the data, they likely would have said no. By generating this initial data with money we got from OPERF, we put a proposal into the federal agencies that was very strong and they funded it.”
Sanders’ research was sent to and accepted for funding by the Department of Defense. She received a $3 million grant for 4 years. The project is ongoing.
The research portfolio
A strategically diversified funding strategy for research and development will promote long-term growth for a profession often considered a step behind. Building a large amount of research and a body of literature for the O&P profession is much like building a financial portfolio, according to Hafner. A financial advisor probably would not recommend allocating all of your attention and resources to just one specific area in the stock market.
“Instead, you try to create a reasoned, well-balanced portfolio that may be strategically weighted in a few areas, but distributed to net the best possible long-term outcome for your money,” Hafner said. “The research portfolio should be thought of the same way. Just like the careful investor, we only have so much money to invest. We have to be wise in how we do it. We should create a portfolio of research opportunities so we grow the profession as a whole, not just in one area.”
In Hafner’s view, the profession has to consider today’s challenges but pay heed to challenges and potential obstacles that will arise in the coming decades.
“This is a long-term race, not a sprint,” he said.
According to Geil, the decision was made at Georgia State University to invest in specific areas of research, linking faculty with specific topics.
“Not everyone agrees with the school’s decision,” Geil said. “The O&P field is broad and with relatively limited resources. At this point it makes sense to keep that diversified approach until we find a pressing need that the majority would agree to invest in. I do not see that special need right now.”
Prioritize projects
While it is unclear if the O&P profession has enough resources to reach each O&P research area, Hafner does not believe that any particular O&P research should go unfunded, but projects should be prioritized.
“As a profession, we have not yet had the opportunity to come together and identify the research priorities,” he said. “I would like to see that happen. Not everyone or every organization inside of O&P has the same priorities, so we must all agree to disagree to some extent. But just as a solid financial portfolio is built by constantly investing, we must all continually invest in the research portfolio. That can be through donations, collaboration or participation in research activities.” — by Anthony Calabro
For more information:
Fatone S, Gard SA, editors. 2007. P&O Research: Are We Addressing Clinically-Relevant Problems? Report on the State-of-the-Science Meeting in Prosthetics and Orthotics, February 28, 2006. Chicago: Northwestern University.
