Evidence-Based Practice in O&P: Where are we now? Where are we going?

Evidence-based practice (EBP) is having an increasing impact on O&P clinical decision making and patient care. The gap between research and clinical application is being bridged. Funding dollars are being generated within and outside of the O&P profession for research that is relevant to clinicians and the patients they serve. Initiatives are under way to transfer knowledge gained from research to those who can put it to practical use. DEFINING EBP In any discussion of EBP, it's important to define the term, since there are misconceptions about what it includes. "Evidence-based practice has three components: scientific evidence, the clinician's knowledge and experience, and patient preferences," explains M. Jason Highsmith, PhD, DPT, PT, CP, FAAOP , an associate professor and codirector of the Center for Neuromusculoskeletal Research, University of South Florida, Tampa, drawing on a widely applied definition developed by David Sackett, OC, MD, FRSC, FRCP. Highsmith adds, "Scientific evidence is the one [component] almost everyone focuses on, and they forget about the other two elements." Sackett is a leading pioneer and proponent of evidence-based medicine (EBM) and EBP (principles of EBM applied to other professions). He defines EBM as, "the integration of clinical expertise, patient values, and the best research evidence into the decision-making process for patient care. Clinical expertise refers to the clinician's cumulated experience, education, and clinical skills. The patient brings to the encounter his or her own personal and unique concerns, expectations, and values. The best evidence is usually found in clinically relevant research that has been conducted using sound methodology." ( libguides.gwumc.edu/ebm ) "But in today's world," Highsmith points out, "when we synthesize these three components and develop a treatment plan, we also have to ask if insurance will cover this, since the average person's ability to self-pay is limited." IMPACT ON O&P PATIENT CARE Has EBP prompted changes in everyday O&P clinical practice? In some areas of practice, the answer is yes. Mark Geil, PhD, points out some examples in his article, "Assessing the State of Clinically Applicable Research for Evidence-Based Practice in Prosthetics and Orthotics" ( Journal of Rehabilitation & Research (JRRD) , vol. 46, num. 3, 2009). He includes a table in the article that summarizes these examples in more detail than is done here. One of the examples he includes is a 1984 case series study by Lonstein and Carlson that initiated changes in treatment plans for idiopathic scoliosis patients with small initial spinal curvatures. Other studies cited with clinical applications include the following: Research by Kaufman et al. and McMillan et al. in 1996 and 2004, respectively, contributed to design iterations in stance-controlled knee orthoses; research by Hittenberger in 1986 led to the design development of dynamic elastic response prosthetic feet; a controlled before-and-after trial by Flandry et al. (1989) provided CAT-CAM (contoured adducted trochanteric controlled alignment method) socket-design outcomes and alignment documentation; and cross-sectional studies by Kerrigan et al. (2000) and Gard and Childress (2001) challenged the classic concept of six determinants of gait. BARRIERS BETWEEN RESEARCH AND CLINICAL APPLICATION Although many barriers between research and clinical application to patient care are being eroded, some still remain. Researchers and clinicians interviewed by The O&P EDGE , as well as several articles on the subject, identified the following important barriers: Relevance to everyday clinical application and what clinicians want to know. "An issue is the divide between common research studies and what the clinician wants and needs to support practice," says Shane Wurdeman, PhD, MSPO, CP, FAAOP , a biomechanics research scientist at the University of Nebraska at Omaha and a prosthetist with Hanger Clinic's Omaha patient care office. "Secondarily there is often not enough literature in the research community on a specific O&P intervention to show its effectiveness or ineffectiveness," says Brian Kaluf, CP , a staff prosthetist with the Greenville, South Carolina, Ability Prosthetics & Orthotics patient care center, and a member of the American Academy of Orthotists and Prosthetists (the Academy) Research Council. Small sample sizes and significant variables among subjects in O&P research. These factors can impair the validity of research findings. Funding. Time constraints. Busy practitioners often have little time to search out and sift through research articles that apply to patient care or clinical questions they have. Access. "The typical clinician is not housed within a large university or institution where it is possible to get access to research articles [that are not open access] for no charge," Wurdeman points out. "Without this access, individuals are dependent upon secondary sources for the research. The clinician then must depend on the qualifications of others to accurately interpret the science to create secondary knowledge sources." Need for knowledge translation and secondary knowledge sources. "Another issue is understanding the application of many research findings to clinical practice," Wurdeman notes. "Often journal articles do not connect the dots as to how a piece of information within the study can be applied to practice; instead this is left to the [research] consumer." "The thinking is to reduce the volume of material that clinicians have to wade through to get to the morsel that applies to their practice," Highsmith says. DRIVING PROGRESS The O&P community and national organizations are making progress in overcoming these barriers. Awareness and application of research in clinical practice is increasing among students, residents, and practicing clinicians. Students completing O&P master's level programs and residencies are entering the profession as knowledgeable research consumers and participants in research activities. For instance, residency requirements include completing one research activity each quarter, such as creating a critically appraised topic (CAT), making a journal club presentation or case presentation, or giving a professional in-service. "The additional research curriculum at the master's level programs, as well as the research requirement in residency, will add value to not only the education and residency experience, but long term to the field as a whole," says Arlene Gillis, MEd, CP, LPO, FAAOP , National Commission on Orthotic and Prosthetic Education (NCOPE) board chair and program director of the J. E. Hanger College of Orthotics and Prosthetics, St. Petersburg College, St. Petersburg College/Florida State University Consortium, Master of Science in Industrial Engineering, Engineering Management of Orthotics and Prosthetics program. This research background and experience "will prepare our future clinicians to not just be more knowledgeable consumers of research, but also to make better decisions as clinicians and potentially contribute to the body of research themselves," she adds. "The students that are graduating now are learning to be consumers of research," Wurdeman says. "They aren't satisfied with doing things 'because that's how it's been done,' and this mentality has spread to the more veteran clinicians." Although Wurdeman says that clinicians are making a stronger effort than ever before to use research, he cautions: "It's not entirely clear whether a percentage of the utilization of research application in patient care and decision making is reactive versus proactive. In other words, how much is used to justify what is being done as opposed to how much is being utilized to guide decision making?" Payers are also becoming somewhat more aware of EBP research, Kaluf says. "In my experience, private insurers are often actually good consumers of published literature because many insurance medical coverage policies actually reference literature by researchers in our field." MORE CLINICALLY RELEVANT RESEARCH, FUNDING Doors are opening in clinically relevant research and funding. The Academy and the American Orthotic & Prosthetic Association (AOPA) have been working with other stakeholders over the years to discuss research priorities and needs and how to address them. Meetings and conferences have included O&P clinicians, doctoral-level scientists, engineers, other experts, consumers, funding sources, and others, with initiatives continuing, Highsmith notes. For example, a multistakeholder focus-group workshop held in 2009 in Seattle aimed to assess the needs of individuals with lower-limb amputations and identify differences between those with diabetic dysvascular amputations and those with traumatic amputations. The meeting and results are described in an article by Glenn K. Klute, PhD, research health scientist, U.S. Department of Veterans Affairs Rehabilitation Research and Development Center of Excellence for Limb Loss Prevention and Prosthetic Engineering, Seattle, and colleagues ("Lower-Limb Amputee Needs Assessment using Multistakeholder Focus-Group Approach," JRRD , vol. 46, num. 3, 2009). A table therein summarizes the research needs expressed by prosthetic users, clinicians, researchers, and manufacturers in each of four categories: technical goals, education, communication and collaboration, and system of care. The results provide an insightful look into the varying perspectives on research priorities. For example, with respect to technical goals, prosthetic users want an adaptable socket and suspension system that adjusts to heat, activity, and variation in limb shape; improvements in alignment systems; and more functional feet and ankles to accommodate greater varieties of terrain, activity, and footwear. Clinicians want evidence on relationships between outcomes, alignment, prosthetic components, and amputation level. Researchers' technical goals closely matched prosthetic users: adaptive socket technology, liner materials, cooling and evaporation systems, actuators and sensors, and alignment measuring systems. Manufacturers' goals were meaningful outcome measures for new innovations and technologies. Since research needs funding, these two issues go hand-in-hand. The $1.1 trillion combined continuing resolution and omnibus appropriations ("cromnibus") bill enacted in December 2014 includes a U.S. Department of Defense section with an additional $10 million for O&P outcomes research funding, an AOPA press release announced. "This is another good win for AOPA and its members," the release stated. The Orthotic and Prosthetic Education and Research Foundation (OPERF) and the Center for Orthotic and Prosthetic Learning and Outcomes/Evidence-Based Practice (COPL) generate funding within the profession. For O&P researchers interested in pursuing grants, the OPERF website lists potential funding sources that include federal government organizations, departments, and agencies; private foundations; and other resources, along with resources for preparing and writing grant applications. A search engine, www.grants.gov , provides a mechanism for locating and applying for grants from various federal agencies. The easiest and most effective way clinicians can support research is to recruit subjects for studies, Wurdeman says. "Recruiting research subjects can be very frustrating for researchers, and simply hanging a recruitment flyer in a lobby is not an effective strategy. But when clinicians talk with patients and give them a brief overview of the study, patients can understand the importance and altruistic value of the study. The easier studies are to conduct, the more research that can be conducted." SECONDARY KNOWLEDGE SOURCES CER, PCOR, EBP, and Policy Comparative effectiveness research (CER) and patient-centered outcomes research (PCOR) are aspects of evidence-based practice (EBP) that are being used to shape healthcare policies, legislation, and government programs, as well as by clinicians, patients, and insurance companies. The Medicare Modernization Act of 2003 expanded the role of the U.S. Department of Health and Human Services Agency for Healthcare Research and Quality (AHRQ) in generating and disseminating evidence about the comparative effectiveness of medications, devices, diagnostic tools, and other interventions, according to the American Academy of Orthopaedic Surgeons. More recently, the American Recovery and Reinvestment Act of 2009 and the Patient Protection and Affordable Care Act of 2010 dedicated significant funds to establish and support a national infrastructure for programs that directly compare the effectiveness of different treatments and care settings on health outcomes, per the Aspen Institute. CER CER is defined by the Institute of Medicine of the National Academy of Sciences as "the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policymakers to make informed decisions that will improve healthcare at both the individual and population levels." CER is an AHRQ focus area. PCOR PCOR is patient-centered comparative clinical effectiveness research with more emphasis on patients' values, healthcare questions, and preferences. According to the Patient-Centered Outcomes Research Institute, a nonprofit, nongovernmental organization established under the ACA, PCOR "helps people and their caregivers communicate and make informed healthcare decisions, allowing their voices to be heard in assessing the value of healthcare options." ( www.pcori.org ) Quantitative, Qualitative Research Quantitative research has been defined as "a systematic process used to gather and statistically analyze information that has been measured by an instrument.... It studies only quantifiable concepts...[examining] phenomenon through the numerical representation of observations and statistical analysis." Qualitative research "implies a focus on qualities of a process or entity and meanings that are not examined or measured in terms of quantity, amount, frequency, or intensity. Qualitative research can mean the analysis of open-ended questions that respondents are asked to write on a survey.... It also can refer to...naturalistic research, a general label for qualitative research methods that involve the researcher going to a natural setting, that is, to where the phenomenon being studied is taking place." ( www.oandp.com/link/302 ) Mixed Methods Mixed methods "refers to an emergent methodology of research that advances the systematic integration, or 'mixing,' of quantitative and qualitative data within a single investigation or sustained program of inquiry. The basic premise of this methodology is that such integration permits a more complete and synergistic utilization of data than do separate quantitative and qualitative data collection and analysis." ( www.pcmh.ahrq.gov ) Work is also ongoing to increase access to published literature through reviews by knowledgeable sources. "The Academy and AOPA are working and communicating together to commission and publish systematic reviews," says Academy Board President Phil Stevens, MEd, CPO, FAAOP, practice manager, Hanger Clinic, Salt Lake City. How important are such reviews? "An understanding of systematic reviews and how to implement them in practice is becoming mandatory for all professionals involved in the delivery of healthcare," states the U.S. Department of Health and Human Services (HHS) Agency for Healthcare Research and Quality (AHRQ). Systematic reviews are conducted to appraise, select, and synthesize all high-quality research relevant to the question being considered, AHRQ notes. "The Academy's state-of-the-science conferences (SSCs) are being transitioned to a state-of-the-science program," Stevens says. "The state of the science conferences were large projects that consumed a lot of resources and were confined to topics with well-established evidence bases," he explains. "They began with exhaustive, time-consuming literature reviews and culminated with a face-to-face meeting and subsequent conference proceedings. Under the state of the science program, the literature review/conference/proceedings model will still be one possible option, but there will be alternate delivery tracks that aren't as demanding with respect to time and resources." He adds, "Literature will be collected, synthesized, and distributed in a number of different ways according to the strength of the available evidence. The end result should be an increase in the evidence resources made available to clinicians. This is a broader initiative where we're looking at ways to disseminate the information and get it into the hands of individual practitioners." "The Academy will be increasing the output from those bodies of work," Kaluf adds. A state-of-the-science program on a clinical subject typically includes a systematic literature review that summarizes the research findings, he explains. "Disseminating that information to clinicians will include secondary knowledge formats such as Academy webinars, presentations at Academy meetings, or shorter versions in publications such as The Academy TODAY or Evidence Notes." Other knowledge translation work includes a CAT development project. The Academy Research Council's Secondary Knowledge Sources Committee, chaired by Leigh Davis, MSPO, CPO, FAAOP, is creating a model for developing CATs and banking them for access on the Academy's website. Some secondary knowledge sources, such as the Academy's Literature Updates, also include O&P-relevant findings from journals outside the O&P profession that ordinarily wouldn't be read by clinicians. Stevens and Kaluf suggest other aids to locating pertinent EBP information on a clinical question. For example, Google Scholar ( www.scholar.google.com ) enables a searcher to quickly access pages of relevant references, click through to the article or abstract, and even store selections in a personal online library. Kaluf mentions using the PICO (patient problem or population, intervention, comparison, and outcomes) model to create an outline and then research literature on that subject to aid clinical decision making. "Asking the right question is a difficult skill to learn, yet it is fundamental to the evidence-based decision-making process," notes the University of Southern California website. (Author's note: For more information, visit www.oandp.com/link/303 .) RESEARCH'S ROLE IN DEFINING O&P AS A PROFESSION "A profession's body of knowledge is a major part of what defines it..., and research is a large component of the body of knowledge," Highsmith points out. "Much of a profession's experiential history, chronicled in textbooks, and emerging research, are included [in that]. A body of knowledge including within education and clinical training is a large element helping to define a profession." Gillis adds, "With orthotic and prosthetic technology growing exponentially, it is more important now than ever before to ensure that orthotists and prosthetists, the people with their hands on the patients, are involved in, if not driving, the research process. Better understanding and increased involvement in research is how we ensure our patients receive the best quality of care." Miki Fairley is a freelance writer based in southwest Colorado. She can be contacted via e-mail at miki.fairley@gmail.com .

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