Apples to Apples: ISPO Proposes Model for Research Participant Data

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Ask any business owner: Attempting to set standards that are consistently adhered to in a single company can be tough. In an entire industry, the process can be rife with pitfalls. But what about setting standards on a worldwide basis, where cultural, language, and political differences-just to name a few-come into play?

Impossible?

Maybe not. The International Society for Prosthetics and Orthotics (ISPO) is tackling just such a monster task in its effort to set clear P&O research guidelines, with an eye toward improving "the quality and consistency of research participant data that is presented in the literature" and, by extension, patient care around the world.

"Knowledge transfer from the scientific community to the clinic is essential for improving prosthetic care," says Ed Lemaire, PhD, president of ISPO Canada, ISPO Scientific Committee member, and clinical researcher for the Centre for Rehabilitation and Development, Ottawa Hospital Research Institute, Ontario, Canada. "These guidelines will improve how the population involved in an O&P research project are defined, thereby helping clinicians decide how the study of outcomes can be applied to their clinical practice."

Lemaire, who is also an associate professor at the University of Ottawa, explains how the guidelines will benefit researchers. "Better and more consistent identification of the people involved in a research project will help researchers when they evaluate multiple projects or perform meta-analyses to draw knowledge from many related studies," he says.

Setting the Stage

Evidence-based research (EBR) is nothing new. It's the foundation of science, the root from which many of the world's discoveries emanate. It's also a big revenue generator for some industries, providing evidentiary proof of the medical value of new pharmaceutical drugs, for example. New medical treatments and surgical techniques also must pass muster of EBR.

Following in the footsteps of the medical industry in general, EBR is equally essential, Lemaire says, for moving beyond the current state of care in prosthetics. Indeed, the quality of scientific evidence in prosthetics has skyrocketed over the past decade, setting the stage for its integration into everyday clinical care.

Lemaire goes on to explain that peer-reviewed research and evidence is a foundational aspect of modern O&P clinician education programs around the world, leaving in its wake "a generation of practitioners...that consider EBP [evidence-based practice] to be a natural part of their clinical practice."

Though the idea of implementing EBR has been knocking around for years within certain corners of the O&P community, the impetus for the initiative to establish a worldwide standard for participant data as it relates to O&P research and its presentation in the literature came from discussions in the scientific sessions at the 2010 ISPO World Congress in Leipzig, Germany.

The consensus from delegates, Lemaire says, "was that many prosthetic studies provided insufficient information to understand the study participants or the prosthetic technology that could affect the research outcomes."

From this consensus, the ISPO Scientific Committee was born. Officially formed in 2010, the committee is "an ideal structure within which to develop a set of guidelines that can help these deficiencies," Lemaire says.

The initiative is still in the early stages. In August 2012, the ISPO Scientific Committee issued a set of "Draft Recommendations for Defining Participants in Prosthetics Research" for open review, during which comments and recommendations were sought from the international prosthetics community.

The comment period closed as this issue was going to press. The committee is using the feedback it has received to improve the draft guidelines and plans to present the revised guidelines next month at the ISPO World Congress in Hyderabad, India.

While Lemaire says the timeline could change depending on the response from the open review, so far the draft guidelines have been well received. The main challenge was holding the data set to a minimum while assuring that it was still relevant because of the limited space in scientific publications. "Collaboration and multidisciplinary input was essential for working through this challenge, which is one advantage of working with the multidisciplinary ISPO community," he explains.

Far-Reaching Impact

If adopted, these guidelines could have far-reaching impact. Beyond the direct implications for O&P research and patient care, these guidelines may have indirect implications for innovations in prosthetic technology, Lemaire says. For example, prosthetic manufacturers might find it easier to link research outcomes from independent studies with their product lines. A clearer, more defined study population "may also help developers recognize technological deficiencies related to specific characteristics and then innovate to address these gaps," he adds.

M. S. Wong, CPO (HK), PhD, associate professor of prosthetics and orthotics at The Hong Kong Polytechnic University, People's Republic of China, says that the new guidelines will rectify a void within the O&P world. "A homogenous baseline for comparison of clinical studies in the orthotic and prosthetic community is of paramount importance for [the] assessment of intervention efficacy and planning for future developments, but this was not available in the past," says Wong, who is also a member of the ISPO Scientific Committee and an incoming member of the organization's board. "With the proposed study criteria, it would be easier or more feasible to assess and compare the results of different clinical studies."

This first attempt to set such guidelines, however, won't occur quickly or necessarily easily, he says. "It is not a short-term process, and a number of discussions are expected that can further facilitate the O&P community to think more and deeper. I do hope it would not take too long to reach a consensus and implement the guidelines."

While there are O&P-specific clinical studies available in the literature, Wong says that without a foundation, comparison is not feasible "because they have different inclusion and exclusion criteria, and the relevant confounding factors were not well defined and documented." These guidelines would create a platform for comparison of different clinical studies. "This is vital and important for the future development of O&P services," worldwide, he says.

Growing Recognition, Need

The need for EBR and EBP is gaining recognition through multiple O&P organizations in the United States, and indeed there has been a steady upswing in its use. Running parallel with U.S. trends, "the link between EBP, clinical outcomes data, and prosthetic device funding is becoming more important in many European countries," Lemaire says.

"In Asia, the importance of evidence-based practice in the O&P field is also increasing," Wong says. "With limited resources and keen competition among different healthcare disciplines, evidence-based practice could be the only way to justify the value or even the existence of O&P professional services in the healthcare system."

O&P services are particularly critical in China, where demand is growing rapidly but O&P services are in an "embryonic stage," Wong says.

According to the 2011 Report on the Work of the Chinese Government, as of 2011, there were 83.7 million people with disabilities in China. Of that number, 24.6 million need prosthetic limbs or mobility aids.

However, Wong says that there are only three institutions in China that house O&P education programs-one is a technician education program and the other two are undergraduate practitioner education programs-and "the number of qualified O&P practitioners is less than 500."

The Money Factor

While the worldwide tide seems to be turning toward an evidence-based approach to O&P patient care, there are some barriers. In a cross-sectional Internet survey of 300 prosthetists and orthotists in Canada, Jan Andrysek, PhD, PEng, a scientist at Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, found that while clinicians value research as a way to improve their practice, time constraints, workload and system demands, limited relevant evidence, and gaps in the skills and knowledge required to perform EBP were hindering its use. The results of Andrysek's study were published in the March 2011 issue of Prosthetics and Orthotics International.

"The concept of EBP is simple: basically the more knowledgeable you are and the more information that you have, the more likely you are to make better decisions," he says. For O&P rehabilitation, the information relates to the technologies and treatments that are likely to be most effective.

"In other words," Andrysek explains, "the potential benefit of EBP is a more effective utilization of healthcare resources to improve patient outcomes, including lessening the burden of the patient's impairment, facilitating a higher level of physical function, and improving the well-being of the patient."

A well-rehabilitated patient is likely to be less reliant on the healthcare system, need fewer prosthetic follow-ups, "and more importantly…[experience] fewer long-term health issues such as joint or back problems, which are often associated with prosthetic rehabilitation." Improved patient outcomes can also lead to societal and economic benefits because well-rehabilitated patients are more likely to seek and maintain employment.

While patients will benefit as EBP takes hold, he continues, revenue for practitioners could, at least initially, decline.

"It all comes down to money," he says. Prosthetic rehabilitation doesn't come cheap, and costs for O&P care and services have skyrocketed in the past few years. "There are evermore of these increasingly sophisticated technologies that are available, costing many times more but claiming to provide better patient outcomes than their less-sophisticated predecessors," Andrysek says. "But do they really? The truth is that these technological advancements likely do improve the outcomes for many patients; the difficulty is that there is limited evidence to inform the decisions about which ones are best, under what circumstances, and for whom."

That's important as the ISPO initiative to more clearly define research participant data moves forward because healthcare resources are finite, Andrysek says, and the funders-including government sources and insurance providers-"that have to dip into their wallets to pay these skyrocketing bills, want and need to know that in fact they are getting the biggest bang for the healthcare dollar.

"This is the reason for a stronger-than-ever motivation for the EBP movement," he continues, "a movement that [involves] building evidence about the effectiveness of different treatment options and utilizing this information to inform clinical practice."

EBP also adds an element of risk for the manufacturer. Research is expensive, and if manufacturers need to conduct high-quality research studies to prove product efficacy, it could take years to bring new technologies to market and generate revenues, Andrysek says. As a result, fewer products may be introduced.

"This may not be a bad thing, given that in many areas of the P&O practice there are presently...so many similar products that it is often difficult for practitioners to make decisions about which to use," he adds. "There may ultimately be fewer technologies on the market, but ideally there will be more information about their effectiveness."

"While EBP may be a strain on P&O manufacturers, at least in the beginning, the P&O field as a whole is likely to benefit in the long term," Andrysek concludes. For practitioners who are successful at EBP, "the end result should be happier, healthier, and better-served patients, an element that not only drives a business to thrive, but one that also needs to remain the key focus of the P&O industry."

Simple Concept, Huge Potential

When it gets right down to it, the concept of EBP is fairly simple, says Bengt Soderberg, CPO, gait lab manager and managing director of the Scandinavian Orthopedic Laboratory, Helsingborg, Sweden, and incoming ISPO president. It's a matter of keeping track of what you do [and] how you do it, so you can do it again. And for those who handle reimbursement, it's a move in the right direction.

"The payer needs to know what they pay for is okay," he says. "If you buy a car, you need to know that there is an engine in that car and what kind of engine it is. You can call it research, but it isn't actually just research. The main thing is that you follow up on what you do and you follow up in a systematic way. You can call it research or whatever you want, but it is merely a matter of making sure that you can do the same thing another time so it's not trial and error every time."

The result could be a worldwide database of information that any manufacturer, prosthetist, or researcher can tap into.

"I think the way forward is to be able to share knowledge and to share it in a common database," Soderberg says. "We have databases now supported by the Swedish government-84 different types of them containing different pathologies. It's not worldwide now, but that would be fantastic if it would be possible."

Garrison Wells is an award-winning freelance writer and author based in Colorado Springs, Colorado. He has written for newspapers and magazines nationwide and authored five books on martial arts. He can be reached at

Presidential Retrospective

Jan Geertzen reflects on his tenure as ISPO president.

Jan Geertzen, MD, PhD, Center for Rehabilitation, University Medical Center Groningen, the Netherlands, cites the establishment of the Scientific Committee and advances in evidence-based practice among the top accomplishments during his tenure as president of the International Society for Prosthetics and Orthotics (ISPO).

Evidenced-based medicine and evidence-based guidelines, he says, "will be more and more prominent in daily [patient] care. "We have just developed this in the Netherlands concerning surgery, rehabilitation, and prosthetics for lower extremities, and this will form the basis for the ISPO international guidelines [for consistent research participant data]."

"This collaboration will be good for everyone involved in patient care," he says.

He is also proud of the steps ISPO has taken to make its organizational structure more transparent and the restructuring of the ISPO Education Committee.

"We now have everything documented," he says. "Descriptions for EB [executive board] members' roles and responsibilities, short courses, application forms…[are] now all on the new ISPO website."

The new website, he adds, is more informative and easier to navigate. Even the organization's financial structure is more transparent, he says.

Geertzen also notes the ratification of the new ISPO constitution in Leipzig, Germany, in May 2010, as one of the organization's top accomplishments during his presidential tenure.

However, Geertzen does not leave his post without a few lingering concerns, one of which is the decline in the number of ISPO members as a result of economic crises around the world. He says that he'd also like to see more collaboration and coordination in the future, particularly in regard to the ISPO World Congress.

"I am very worried about the concurrency in organizing the World Congress," he says. "There is a lack of coordination, and some congresses that were locally organized were turned into a world congress. There are too many players in the field."

He adds that there should be more effort to get the orthopedic industry involved with the exhibitions.

Bengt Soderberg sets goals for his term as ISPO president.

There are three primary goals floating around in the organized mind of Bengt Soderberg, CPO, as he considers his role as incoming president of the International Society for Prosthetics and Orthotics (ISPO).

He wants to continue the work that ISPO has already started, include more input from patients and the industry, and define what the organization can do to meet specific needs in different parts of the world.

"The base is really good," says Soderberg, gait lab manager and managing director of the Scandinavian Orthopedic Laboratory, Helsingborg, Sweden. "We're in more than 100 countries and have national member societies in more than 50 countries, so it's quite a strong organization. The foundation put down by other people is really solid. You follow what other people have done before because they have laid the path."

Maintaining that foundation and making it stronger requires a team approach. "We are just part of the total obligation for patients, and if we don't have the whole team, we can't do much," he says. "We need the whole multidisciplinary team-surgeons, physiotherapists, prosthetists, and orthotists. Because this is such a narrow field, if we all work together we become stronger."

Patients, however, lead the way, he says. "It's the patients who will describe what they need, and if we don't have them on the team, we won't know what they want." Indeed, Soderberg points out that patient expectations may be different from those of the care team.

He goes on to say that when it comes to affecting change at the national level, patients can be quite powerful. For instance, if a patient seeks help from the government, there is some assurance he or she will be heard. But if the industry approaches government or politicians, they are more likely to be dismissed.

"That is why I find it quite important to involve patient organizations around the world," Soderberg says. "They are the ones who can change thing.... Our position is more to support them and to help them to do that."

Soderberg says that in the coming years, ISPO will also work more closely with all branches of the O&P industry, including manufacturers. He says there is a need for more commingling and interaction at industry events to break the tradition of the manufacturers primarily congregating in the exhibit hall while practitioners attend educational presentations.

Perhaps the largest and yet most difficult-to-define challenge Soderberg faces is maintaining cohesion in a worldwide organization that must navigate among diverse opinions and differing needs every day.

"Traditionally, ISPO has worked in a lot of developed countries and used knowledge from those countries in the undeveloped countries," he says. "Now we need to identify and reach out to each part of the world...and learn both ways. There are [areas] that have massive needs for prosthetics and orthotics, like Asia."

Finally, Soderberg says he'd like to see an increase in social acceptance of disability around the world. The United States "was probably one of the first countries where amputees walk around in shorts," he says. "Now they walk around in these shorts in Sweden, which was once very unusual. People looked at them in the town and thought, 'Wow, they are walking with one leg.' That is now very common to do in our countries, but we need to do this in other parts of the world."