Research to Clinical Practice: O&P Builds the Bridge
March 2011 Issue
Orthotics and prosthetics-related research is currently enjoying a vibrant, supportive atmosphere. And while advances have been made, challenges remain. Metaphorically speaking, O&P research is in its adolescence, growing into adulthood.
The heightened recognition of the vital role O&P research has on patient care has translated into increased funding and research support within the O&P community, heightened integration of evidence-based practice in clinical care, efforts to make clinically relevant research findings more quickly and efficiently accessible to clinicians, and advances in O&P education. These developments are helping to forward O&P research and overcome the barriers that remain in its widespread implementation and use.
Brian J. Hafner, PhD, assistant professor, Department of Rehabilitation Medicine, University of Washington, Seattle, and Orthotic and Prosthetic Education and Research Foundation (OPERF) board member and research committee chair, comments on this dynamic picture: "In these past few years, I have witnessed professionals across O&P change the way that they perceive and use research. Research is slowly but surely becoming an integral part of our practices, our educational programs, and our provision of patient care."
The experts interviewed for this article—all of whom are participating in aspects of research within their universities or companies and are involved in national O&P organizations' research initiatives—identified the following challenges to O&P research:
- The need for more persons within O&P who have academic credentials and research expertise to be involved in O&P-specific, clinically relevant research.
- Higher-quality research and study design, with the related challenges of finding sufficient numbers of study subjects for valid sample sizes, building information databanks to draw on, developing and applying validated outcomes measures and scales for accurate results, and connecting academic researchers with O&P clinicians.
- The need for clinically relevant information from current literature to be made available to practitioners in formats that can be widely disseminated and quickly read, assimilated, and applied in clinical practice.
- Obtaining adequate research funding.
Advances in O&P education and increased support from the O&P community are contributing to a growing number of O&P professionals who are earning advanced degrees. These individuals are more qualified to participate in research initiatives and are more educated consumers of research, according to interviewees.
Christopher Hovorka, MS, CPO, FAAOP, director of the master of science in prosthetics and orthotics (MSPO) program, Georgia Institute of Technology (Georgia Tech), Atlanta, cites such developments as the elevation of the clinical entry-level degree from a bachelor's to a master's degree, the development of doctoral programs that include an O&P focus, and the emergence of O&P community support via OPERF and the Center for Orthotics and Prosthetics Learning and Outcomes/Evidence-Based Practice (COPL).
OPERF seeks to raise O&P education and research standards and supports research at all levels from student to resident to experienced researcher. "This 'top-down, bottom-up' approach allows us to grow from within, encourage research of all kinds, and support those that have the most potential to contribute to our growing body of knowledge," Hafner says.
COPL is dedicated to advancing the development of, and education about, outcomes and evidence-based O&P research projects. COPL President William J. Barringer, CO, FAAOP, stresses the importance of evidenced-based practice research and disseminating results quickly to payers. "This not only improves the lives of our patients but also allows clinicians to provide the best available care." (Author's note: For more information about OPERF, visit www.operf.org. For more information about COPL, visit www.centerforoandp.org)
Scott Cummings, PT, CPO, FAAOP, president of the American Academy of Orthotists and Prosthetists (the Academy) and OPERF chairperson, notes the increasing sophistication of National Commission on Orthotic and Prosthetic (NCOPE) residency-directed studies and the Academy's Research Council, along with OPERF and COPL as factors contributing to the brighter research picture.
The efforts of OPERF and COPL are also helping the profession to meet the need for adequate research funding, our experts noted.
Outcomes measures and other research relevant to evidence-based practice emerged as a top priority for most of the interviewees. "The thinking in the field is that specific priorities need to focus on outcomes and clinically relevant research," comments Michelle Hall, CPO, FAAOP, the Academy's Research Council chair. She referenced a survey and forum conducted as part of a 2006 State-of-the-Science Report on Addressing Clinically Relevant Problems. For prosthetics respondents, outcomes measures and socket/interface were the most important research topics; for orthotics respondents, the top-ranked topic was outcomes measures. (Author's note: For more information, see www.nupoc.northwestern.edu/news-publications/papers/sos_reports/SOS_2006report.pdf)
Hafner adds, "There is no doubt we need outcomes research to better understand how the interventions we provide impact the health of our patients." He notes that other important priorities include research and development to advance technologies and their use in improving patients' lives, observational research to better understand the medical conditions O&P patients experience, and experimental research to better understand how O&P interventions work and impact patients' lives.
He points out one caveat, however: "It would be shortsighted to support focused research in only one area, such as outcomes research, and neglect other areas that are key to building our body of knowledge. It is the responsibility of a profession to grow its body of knowledge across the spectrum. We would be wise to appropriately allocate resources to all areas of O&P research and not limit ourselves to any single type of research."
For Hovorka, a major goal is developing critical pathways of care for persons needing various levels and types of O&P care. Critical pathways are structured healthcare plans that detail essential steps in the care of patients with a specific clinical problem, he explains, pointing out that other healthcare professions are implementing these pathways in order to improve the efficiency of patient care while maintaining or improving quality.
Stefania Fatone PhD, BPO (Hons), research assistant professor at the Northwestern University Prosthetics-Orthotics Center (NUPOC), Chicago, Illinois, identifies establishing the efficacy and effectiveness of O&P interventions as a top priority. She explains, '"Efficacy' in this context means that we demonstrate that devices do what they are designed to do, and 'effectiveness' means that they are beneficial in real-world situations." Fatone feels that this type of research has been almost shut out by emphasis on technology development.
Basic Research: Is It Needed?
Basic research, in the sense of research that adds to the knowledge base but does not have an immediate application to clinical practice or technology development, has a place in O&P research, according to some of the interviewees.
Fatone sees a need for more fundamental research. She gives examples of questions that need to be answered, such as "What is the effect of elevated vacuum on the soft tissue of the residual limb? By what mechanism does elevated vacuum assist with soft tissue health and wound healing?" Research to answer these questions could ensure that vacuum technology is applied in a safe, effective manner, she points out.
Hovorka agrees. "There needs to be more fundamental research conducted on the person's physiological systems' response to wearing certain features of an orthosis and/or prosthesis," he says. "Outcomes research for evidence-based practice requires a sound understanding of fundamental features of O&P care. We do not yet have a good understanding of some of the fundamental aspects of a person's response to wearing a prosthesis or orthosis. Before we proceed to evidence-based practice for the whole patient, we first need to examine fundamental principles of O&P.
"For example, we do not know whether achieving alignment of a lower-limb prosthesis to encourage the individual to walk with a gait pattern that is symmetrical or approximating that of an individual without limb loss is appropriate," he continues. "Some of the biomechanics and motor-control literature seems to indicate that asymmetrical gait is more natural, energy efficient, and empowers a more robust neuromuscular system, and that a robust system is better adapted to the environment [than one that emulates] symmetry, which may not create an optimal outcome."
Edward Neumann, PhD, PE, CP, FAAOP, professor and chair, Department of Civil and Environmental Engineering and director of the Center for Disability and Applied Biomechanics, University of Nevada, Las Vegas, distinguishes three levels of research: (1) basic research which might have application in many areas such as national defense or space exploration; (2) research that attempts to find applications for basic research in a given area; and (3) clinical research designed to assist the clinician to make decisions. "All three are necessary to make advancements in O&P," Neumann says. "Advancements in area three cannot occur without advancements in area two, and advancements in area two depend on research in area one."
The gap between "basic science" research and "applied science" research is not as wide in O&P as it is in many other fields, Geil points out. In other fields, basic science may involve working with animals in a laboratory, with any human applications decades away. "O&P researchers are testing some fairly fundamental theories on, say, gait or prosthetic alignment that could impact practice much sooner than later."
Knowledge into Action
Knowledge translation is a major priority in O&P research, according to Geil and Phillip Stevens, MEd, CPO, FAAOP, a member of the Academy's Board and Research Council. "Research is only as good as our ability to get the salient points into the minds of treating practitioners," Stevens stresses. "Otherwise, research is of no benefit in patient care."
Primary sources for disseminating research findings are papers published in academic journals. However, cost and accessibility are strong barriers to wide dissemination, since the majority of O&P clinicians do not have access to university or hospital libraries or an extensive company library. Subscription costs are formidable, and online access to full-text articles can run $25-30 each; thus, costs mount up quickly in searching several journals for relevant information. Plus, clinicians can spend much time and effort in extrapolating clinically applicable information from journal articles.
Translating this information into more widely disseminated secondary sources through which knowledge can be more easily accessed, assimilated, and applied clinically helps to overcome this barrier between research and clinical application in evidence-based practice.
Secondary sources currently disseminated online and in print to the O&P community include State-of-the-Science Conference (SSC) results and Evidence Notes and Literature Updates from the Academy. However, more is needed, according to Stevens and Geil. They are proponents of adopting successful secondary source formats from other healthcare disciplines, including formats with such memorable acronyms as CATs (critically appraised topics) and POEMs (patient-oriented evidence that matters).
POEMs are summaries of research important to patients and doctors, Stephens explains in the article, "Barriers to Implementation of Evidence-Based Practice in Orthotics and Prosthetics," published in the January 2011 issue of the Journal of Prosthetics & Orthotics (JPO). POEMs must meet three criteria: they must (1) address a question that physicians encounter; (2) measure outcomes that physicians and patients care about; and (3) have the potential to change how physicians practice. (Editor's note: For more information about and examples of POEMs, see Stevens' article, "The Poetry of...Microprocessors,")
CATs are intended to be brief, literature-based answers to specific clinical questions, Stevens says. Authors, typically clinicians, search the best, most recent evidence before writing a concise, clinically focused summary. O&P clinicians, residents, and even students under an educator's guidance could participate in preparing these secondary knowledge sources, Stevens adds.
Journal clubs—groups that meet regularly to critically evaluate recent literature articles—are "a great way to help people keep current on the literature," Hall says. She created a journal club at Gillette Specialty Children's Healthcare, St. Paul, Minnesota, where she is a staff member. "We read the same article beforehand. When we meet, we discuss the article, including clinical implications—whether to apply it, how we would apply it, etc." Hall notes that the Academy's Gait Society has created an online journal club with an interactive format and encourages others to start journal clubs.
The Academy's Research Council recently created two new committees to help meet the need for knowledge translation: the Secondary Knowledge Committee and the Outcomes Research Committee, according to Hall. The Secondary Knowledge Committee, chaired by Stevens and M. Jason Highsmith, PT, DPT, CP, FAAOP, assistant professor, School of Physical Therapy & Rehabilitation Sciences, College of Medicine, University of South Florida, Tampa, will focus on developing CATs and other secondary knowledge sources.
The Outcomes Research Committee, co-chaired by Neumann and another chair, not yet named at the time of this writing, will help clinicians to more effectively understand and use outcome measures.
Meeting Other Challenges
O&P researchers also face the challenge of recruiting enough subjects for sufficient sample sizes and locating clinician partners to provide necessary expertise.
"There's a 'hierarchy' of evidence that starts with opinion and ends with randomized controlled trials," which are generally considered the gold standard, Geil explains. "Your progression up the hierarchy depends on your study design and number of subjects." State O&P associations, clinical partners, P&O schools, and patient support groups may offer avenues to connect with patients willing to assist in research, Geil suggests.
Neumann suggests that research entities create patient registries of willing volunteers.
"For researchers [who are] not affiliated with a P&O school and who don't have a clinical network, subject recruitment is a huge barrier," Geil says. Such researchers may have great ideas that cannot be implemented and thus just die on the vine.
However, there is another vital resource available. "The Amputee Coalition has a large database of amputees, perhaps the largest in the country not regulated by HIPAA [Health Insurance Portability and Accountability Act]," says Amputee Coalition President and CEO Kendra Calhoun. "We are currently working with ten organizations to recruit for their studies. The most exciting news is that we expect our database to reach 100,000 records by the end of the year, making us an excellent partner for research organizations." Amputees must agree to participate before inclusion, and confidentiality is protected, Calhoun adds.
Outcomes Measures and Database Resources
Regarding outcomes measures, Geil points out that O&P research needs more reliable outcomes measures and increased use of valid instruments that already exist. Geil calls attention to SSCs on outcomes measures for upper-limb prosthetics (2009) and lower-limb prosthetics (2008) and an outcomes toolkit available on the Academy's website. The toolkit is an interactive document that lists reliable outcomes measures and what they measure, what questions they might answer, what patient populations are appropriate for application, and where to find them and how to use them, Geil explains. (Author's note: For more information, visit the Academy's website: www.oandp.org) Efforts are under way to develop additional, O&P-specific measurement tools, Geil adds.
"Research lives and breathes on data," Geil continues, noting the need for a large information database, which would be especially helpful in research involving questions "we didn't know to ask at the time the data was collected."
Hafner sums up the thoughts of many in O&P research: "I would like to see our profession come together in unified support of research and take the steps necessary to build a body of knowledge that we can all use and appreciate. I would like to see collaborations among academic institutions, medical centers, device manufacturers, service providers, and the consumers we serve thrive and grow. I believe that if we continue to build a culture that recognizes and appreciates the value of growing and applying our body of knowledge, we can and will be successful. There is no doubt in my mind that we are taking steps in that direction every day. I look forward to seeing what the future holds for all of us in O&P."
Miki Fairley is a freelance writer based in southwest Colorado. She can be reached at