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--> 8 Translating Research into Practical Applications Scientific discoveries must be translated into clinical practice to benefit humanity. Technology transfer is the transmittal of developed ideas, products, or techniques from a research environment to one of practical application, and thus is an important component of rehabilitation science and engineering. By disseminating the knowledge and products that researchers have developed, their science attracts more attention and success and has value to society by improving the health and quality of life of those who ultimately benefit from the knowledge. No topic is likely the focus of more discussion but less productive action than technology transfer. The reason is simple: technology transfer is difficult and problematic. Rogers (1983, p. 1), in Diffusion of Innovations, says, ''One reason why there is so much interest in the diffusion of innovations is because getting a new idea adopted, even when it has obvious advantages, is often very difficult." In the context of governmental agency support for research, the idea of technology transfer usually means moving the results of government-sponsored research and development (R&D) out of laboratories and into practical application. With companies, it means developing or obtaining new technologies for their business enterprises. The technology may be products or devices, procedures, techniques, processes, software, knowledge, concepts, and so forth. Once the technology or knowledge is available, the issue becomes how it should be diffused throughout society. For purposes of this discussion it is assumed that technology transfer represents positive action for society.
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--> The Current State of Technology Transfer in Rehabilitation This definition of technology transfer has application for rehabilitation science: the biomedical and engineering applications of rehabilitation research can follow some, but not all, of the traditional technology transfer mechanisms. Rehabilitation research does pose a new challenge that requires additional mechanisms for transfer, because much of the research results in therapeutic interventions that are applied in exercise techniques and educational strategies by professionals, not through the use of drugs or equipment. In traditional pharmaceutical clinical research, after a drug is synthesized in the laboratory and tested with animal models or after the device is developed and bench tested, it is subjected to clinical (phase I to IV) trials—research studies designed to address specific questions about the safety and effectiveness of new methods or tools in prevention or treatment—supervised by the U.S. Food and Drug Administration (FDA). Phase I trials focus on safety and usually involve small samples (20 to 100) of healthy volunteers. Phase II trials test the efficacy of the drug, usually in studies with dozens or hundreds of patients and often in randomized controlled trials. Phase III trials test the safety, efficacy, and possible adverse reactions, usually in multicenter, randomized, and blinded trials. Phase IV studies usually compare the new therapy with the available alternative interventions and determine its long-term effectiveness and side effects and the cost-effectiveness of the intervention(s) (Pocock, 1987). Most clinical research is funded by private industry (biotechnology or pharmaceutical companies) or the federal government (e.g., the National Institutes of Health [NIH], the National Science Foundation, the Centers for Disease Control and Prevention, or the National Institute on Disability and Rehabilitation Research [NIDRR]). The successful transfer of rehabilitation interventions such as therapeutic exercise and physical modalities from research to practice poses a different set of problems than the transfer of drugs. Drugs are discrete entities and are thus easily regulated by the federal government, but rehabilitation interventions are more generic and are less amenable to FDA regulation. Indeed, most such interventions would be "grandfathered" because despite subtle differences in approach, practice regimen, and other details, most rehabilitation interventions would still be "exercise" and thus not subject to regulation. Nonetheless, initiatives such as the stroke care guidelines of the Agency for Health Care Policy and Research provide valuable federal guidance to local practitioners (Gresham et al., 1995) by offering structure to the best and evidence-based practices that should result in comparable care for individuals following a stroke. Reha-
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--> bilitation relies at least in part on methods such as this for the dissemination of interventions proven to be effective by research. Those who require access to information generated from rehabilitation research include professionals in practice and in training, rehabilitation scientists, people with disabling conditions and their families, architects, and policy makers including elected officials, insurers, and administrators. Research findings should foster high-quality care and services for people with disabling conditions, enable better disability prevention, build community networks of care to guide the development of effective and efficient rehabilitation services, and stimulate further research efforts. No organized mechanism for the development of rehabilitation science exists, however, nor does a formal mechanism for distributing the findings of rehabilitation science to those providing services. Few journals focus on interdisciplinary research. Although the U.S. Department of Veterans Affairs (VA) publishes and distributes free for the asking The Journal of Rehabilitation Research and Development, VA does not presume that it publishes all the information that the federal government should disseminate. In part because the journal is chronically underfunded, the delay between the time of submission and the time of publication is, on average, longer than 1 year, and the journal is not widely distributed, so it lacks the prestige of major journals. More funding would help to improve the turnaround time for articles in this journal and to improve the prestige of this journal and others like it. An additional dissemination problem results from the fact that rehabilitation professionals are taught according to an individual profession's criteria and traditions; few opportunities for cross-disciplinary interaction are available and the professions are not knowledgeable about the science of the other professions. Models are needed to increase cross-disciplinary communication. Rehabilitation is an interdisciplinary field and ultimately patients will only benefit when professionals have access to information that will support their patients through their recovery and re-entry to their family, work, and community lives. One such model for rehabilitation science and engineering to consider for dissemination is the extension model used by the U.S. Department of Agriculture (USDA). This model allows physicians, farmers, homemakers, and scientists alike to obtain state-of-the-art information from USDA county extension agents, pamphlets, and from USDA-sponsored information services. The Administration on Disability and Rehabilitation Research could facilitate transfer of information among (See Chapter 10), to give nurses, therapists and physicians access to information that would support organizations, professions, consumer groups, providers, and others access to accurate, evidence-based rehabilitation information. Just as USDA's sponsorship of home economics classes
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--> encouraged better nutrition nationwide, similar encouragement related to disability prevention and the adaptation of a healthy lifestyle could be provided if information were readily available. Perhaps the proposed Administration on Disability and Rehabilitation Research could foster the development of dissemination centers to address the regional needs of rehabilitation providers. A model such as the Dartmouth Atlas of Health Care (Center for the Evaluative Clinical Sciences, Dartmouth Medical School, 1996) documents a substantial nationwide variability in many health care interventions and there is no reason to believe that rehabilitation interventions would be more homogeneous nationwide. Therefore, the federal government through the ADRR could facilitate the provision of information on scientifically based practices to all locales to prevent the selective implementation on the basis of the specific characteristics of a locale. Presuppositions for Technology Transfer Technology transfer presupposes several conditions; otherwise, it cannot come about. Some of the presuppositions are described in the following sections. A Technology Must Exist Technologies must exist to be transferred. This seems obvious, but technologies do not appear de novo. Someone must bring them into existence. Usually, new technologies come from R&D programs, although a limited number of technologies may result from innovation or invention processes that may not be strictly classified as R&D. For much technology transfer to come about, sponsored R&D projects, public or private, need to exist. There will not be much technology transfer if there is not strong, productive research, and funds must be available for R&D efforts. A supply of competent and creative researchers must also exist. The existence of productive scientists and engineers in laboratories presupposes that good educational programs exist. The preparation of people for careers in R&D is fundamental to new technology development. In short, a strong R&D effort and infrastructure for technological development must exist before technology can be transferred. Organizational Structures and Mechanisms Organizational structures and mechanisms that can foster technology transfer need to exist. A structured method or mechanism is needed to promote the process of technology transfer and to help eliminate barriers
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--> to the transfer process. People involved in R&D frequently do not want or have the skills required for technology transfer. Technology transfer officers facilitate the process in some research organizations. Unless someone or some group accepts responsibility for the transfer process, it is likely to wither and stop. Even if assistance is available, the process often halts after the demonstration of concept. Even if transfer to commercialization takes place, the technology still needs to be diffused into society. Rogers (1983, p. 5) says, "Diffusion is the process by which an innovation is communicated through certain channels over time among the members of a social system." For example, VA has a Technology Transfer Section within its Rehabilitation Research and Development Program that attempts to transfer technology developed through VA-sponsored rehabilitation research. This unit has the capacity to fund technology transfer by soliciting the manufacture of prototype devices from manufacturers and by evaluating the prototypes in VA medical centers. Positive evaluation leads to VA approval of the technology for purchase. This process stimulates the commercialization of the product. The Small Business Innovative Research (SBIR) process is a mechanism that the U.S. Congress set up to stimulate technology transfer by providing start-up funding to small companies that develop technologies that may come out of agency-funded research. NIDRR funds a center that has the mission of fostering technology transfer. From about 1950 to 1975 the Committee on Prosthetics Research and Development of the National Research Council coordinated prosthetics research efforts and conducted evaluation studies, which often resulted in technology transfer. Private companies encourage technology transfer by two primary means. First, some of them conduct in-house R&D and transfer the technology directly. Second, large companies often purchase small companies to obtain the technologies that they want. This purchasing technique is an efficient means of obtaining technologies that are desirable, and it has become a prevalent method as companies have decreased their own involvement in R&D. Because rehabilitation is generally a service rather than a product, the purchasing method is not a viable option unless health systems have an incentive to develop the service as a product. Wherever technology transfer occurs, it often involves the patent process, trade secrets, licensing arrangements, and other legal matters. A number of laws concerning technology transfer have been passed by Congress. Many believe that the Technology Transfer Act of 1986 (Public Law 99-502), which amends the Stevenson-Wydler Act of 1980, is the most significant, particularly with respect to government laboratories and private organizations. Rogers (1983, p. 159) believes that the agricultural extension model, which involves a research system, county extension agents, and state ex-
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--> tension specialists, has been the most successful federal agency model in securing users' adoption of research results, although not everyone shares his viewpoint. He points out that the extension program spends about the same amount on technology transfer that is spent on agricultural research. Most federal agencies apparently spend only about 4 to 5 percent of their research funding on transfer and diffusion activities, which is nowhere near the amount spent in the agricultural extension model. Several government agencies, such as the National Cancer Institute's Community Clinical Oncology Program, have tried to copy the agricultural extension model with mixed success. It is clear that dissemination requires a commitment of resources that must be built into the mission of the agency and must be funded. Promoters and Champions of Technology Intelligent decision makers and promoters need to exist. It appears that few technologies are ever transferred without a person or groups of people to champion their cause, sometimes over a long period of time (see Box 8-1). This person may be a technology transfer officer, the developer(s), or some other interested party. It is clear that considerable effort and perseverance are needed by this advocate if the technology transfer is to come about. The supporter often is someone who has a vision of what the technology can become. In this respect, champions for technology transfers are like good scientists; they have intuition concerning what technologies should be pushed for transfer and what should be left alone. They may have administrative acumen, and good administrators may know how to cut through red tape and bureaucratic delay. Few experts on technology transfer exist, however, and the field is not systematized. Market research can help, but it is not a complete answer. Consumers do not always know what they need or what they would purchase. Marketing managers in companies regularly launch new products, some of which have gone through extensive marketing surveys, but according to Rogers (1983, p. 74), only 1 of every 540 ideas results in a successful product and only 8 percent of the approximately 6,000 new consumer items introduced each year have a life expectancy of 1 year or longer. Although intelligence and experience are needed in the technology transfer process, they do not ensure success. Even products or ideas that are clearly superior to those that already exist are not always successful. For example, from an ergonomic viewpoint, the Dvorak keyboard for typewriters and computers is clearly advantageous over the commonly used QWERTY arrangement. Nevertheless, even though a conversion would be technically very simple today
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--> BOX 8-1 Technology Transfer: A Sometimes Lengthy Process Although success stories in research and development and in technology transfer abound, one seldom knows about the tortuous path, effort, and time associated with a transfer. Likewise, one is seldom aware of the research and development work that does not pan out or that for some reason does not reach users. Only a small amount of research and development work is successful all the way to technology transfer. That does not mean that most research and development is not vital. It is as important to find out what does not work as to find what does, and even perhaps more so. In the long run, negative results may help science and engineering more than positive results, because research—whether it results in positive or negative results—advances knowledge and knowledge is the foundation on which all further advances are based. For example, blood substitutes that can be stored for long periods of time, that do not have to be Rh matched to recipients, and that can be made free of pathogens will soon be available for clinical use. This new product of research and development is predicted to save thousands of lives annually in trauma management alone. By the time commercial production begins and the product is available in the United States, probably in 1998, 14 years will have elapsed since the substitute's active components, stitched hemoglobin molecules, were demonstrated in a University of Iowa laboratory. This example illustrates that even discoveries of great medical importance and high potential profit often take a long time to be transferred from the bench to the bedside Technology transfer is seldom rapid and often takes longer than the research itself. Therefore, the research team that made the discovery usually moves on to other important research work, and rightly so. Only when the product or technique has someone who serves as its champion or when there are excellent possibilities for financial profits does the technology have much chance of being transferred. Technology transfer out of federal agency-backed research programs is arduous, but similar difficulties exist even when the product is developed by a private company's own research laboratories. For example, it is well known that scientists and engineers at Xerox Corporation's Palo Alto Research Center developed the precursors of today's personal computers, with mice and graphical user interfaces, 10 to 12 years before the Apple Corporation introduced the Macintosh and more than 20 years ahead of Windows 95. The technology was there, but its importance was initially not understood or acted upon. Consequently, technology transfer did not occur. This kind of difficulty with technology transfer is more common than might be expected by those who have not had experience with the process. with computers, involving only some software changes, there has yet been no movement to the Dvorak system. Goal-directed R&D is effective if knowledge concerning what is needed exists and if the technology to produce what is needed exists In rehabilitation research, the application must be of use to people with disabling conditions Thus, the research process requires consumer in-
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--> volvement in the design and implementation of studies if the results are to have wide applicability. Basic research often creates the knowledge concerning what needs to be done. It also often creates the knowledge necessary to produce the needed technology. Basic research and goal-directed research are both important. Technology transfer withers if either is missing for a period of time. The Market A market must exist for innovations. Technology transfer and diffusion cannot proceed without customers. Even though there are millions of people with disabling conditions, their problems are individual and their resources for technology are limited, so markets are generally small and the products needed are extremely varied. There is no mass market, but the needs are nevertheless great. Some of the markets are similar to "orphan drug" markets and might be called "orphan product" markets. Societal assistance may be necessary to meet some needs for orphan products in rehabilitation. Other needs are frequently met by small companies that can be effective in niche markets. Mass-produced products of major companies can often be modified to effectively meet rehabilitation needs, and rehabilitation engineers have taken the lead with such modifications. The concept of universal design is generally a good one for the design of products. Often, small modifications can make major products accessible to almost everyone. Design of this nature can come about naturally through communications with companies about the need for universal design; however, laws concerning access can also be effective in bringing about design that permits access by as many people as reasonably possible. The Role of Federal Agencies Agencies must want the innovations that they research to be transferred. Most universities have technology transfer officers and incubation facilities for small companies, some started with SBIR funding. In rehabilitation, the Committee on Prosthetics Research and Development of the National Research Council was effective in research coordination and technology transfer during a previous era. Whether the R&D milieu in Washington, D.C., permits such action today is questionable. The SBIR process apparently seems to be working well in some areas of medicine, but its influence on rehabilitation product transfer remains undetermined. The Technology Transfer Section of the Rehabilitation R&D Program in VA has been successful in technology transfer, and although it is limited to developments made by VA medical centers, its organizational and functional structure can be
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--> applauded. The NIDRR model, which uses a center to advance technology transfer matters, has yet to be scientifically evaluated. NIH has the Office of Technology Transfer (OTT), but it apparently does not involve rehabilitation science and engineering. Each of the institutes, centers, and divisions within NIH conducts its own dissemination and technology transfer activities. NIH as a whole uses OTT as a focal point for coordinated technology transfer in the planning stages of the research process. This office uses Cooperative Research and Development Agreements to forge joint government-industry research projects and Material Transfer Agreements to facilitate the exchange of research materials. OTT also handles the intellectual property portfolio, which includes patenting, for NIH scientists and research. The National Cancer Institute (NCI), through its Community Clinical Oncology Program (CCOP), has been particularly successful at technology transfer by providing patients access to state-of-the-art care. Established in 1983, the program focuses on clinical trials as its primary vehicle for dissemination. Central to the success of this program is the linkage of patients and providers, each with their own incentives. By increasing the number of patients and physicians who can participate in clinical trials, CCOP hopes to bring the latest techniques and technologies to a larger number of people at the community level while increasing the knowledge base of cancer treatment research as a whole. Because, as noted earlier, most rehabilitation interventions do not require FDA approval, the federal control exerted in a program such as CCOP alone cannot work in transfer of rehabilitation technology. Controlling access to powerful anticancer drugs gives the government a lever to encourage patients to enroll in clinical trials; only in trials involving a medical device (e.g., prosthetic and orthotic) would this encouragement be apt. To be done properly, strong federal support is required, but occasionally, innovative individuals can generate important new contributions to the science. Therefore, the committee does not recommend that a restrictive system such as CCOP be adopted to enhance rehabilitation technology transfer. The CCOP system could, however, be adapted to the rehabilitation science and engineering environment to encourage multicenter trials. As such, a system coordinated by the ADRR would need to be developed with the expressed mission to: improve quality of care; serve as continuing education for physicians and other health professionals; support a diversified research agenda spanning many scientific disciplines and foster interdisciplinary efforts;
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--> provide a mechanism for the linkage and participation of basic, clinical, behavioral, and social scientists; serve as an umbrella for fundamental as well as applied research, thus enhancing the activities of the investigators; create bridging mechanisms to link prevention and clinical studies with ongoing research activities; provide a mechanism to manage the explosion of new information and assimilate new information into clinically meaningful concepts for dissemination to practicing clinicians; support broad social policy to spread the benefits of treatment of the population to control research; create a spirit of cooperation both within the institution and among institutions working on the same disease or disorder; be cost-effective by reducing the need for repetitive samples, (studies at multiple centers allow for multiple analyses); and allow for the timely accomplishment of an effort. Two additional benefits could be achieved by having a technology transfer mechanism: individuals with disabling conditions can function as consultants to centers to bring validity to the questions and methods used to identify and study the constructs, and a registry of people involved in studies will bring together resources for long term follow-up and analysis. As noted at the beginning of this chapter, technology transfer is difficult and complicated. It is an important human process, however, that is chaotic, unstructured, and problematic. It is also full of promise, opportunity, and excitement. Barriers to Information Transfer The barriers to translating rehabilitation research into clinical practice are rooted in limited mechanisms to transfer the research. Clinical rehabilitation research is severely underfunded and thus is still in its early stage. Likewise, because several disciplines are involved, little formal theory has emerged across the disciplines and formal mechanisms for transferring knowledge are limited. More research in rehabilitation science and engineering would likely change this situation. However, more research requires formal mechanisms for transferring knowledge to multiple disciples. There currently is not a joint journal or conference to facilitate communication among the rehabilitation sciences like the Gerontol-
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--> ogy Society which has a medical science, behavioral science and social science division. Because few rehabilitation procedures have undergone rigorous clinical trials, treatments are based on theoretical rationale rather than data from tests with people with disabling conditions. Most rehabilitation research to date has been focused at the pathology and impairment levels and not at the levels that relate to functional limitation and how people with disabling conditions interact with the environment (see Chapter 4 of this report) (Jette, 1995). For example, no randomized prospective trials on even the most frequently used rehabilitation treatments, such as postcruciate ligament repair surgery, have been conducted. Few models exist that bring the patient, the physician(s), therapists, scientist, engineers, and communities together to solve problems that limit disabilities. One of the first issues that the federal effort in rehabilitation research needs to address is this shortage of knowledge. Limited funding for rehabilitation research also limits the number of trained and experienced researchers and artificially lowers the demand for training in clinical research. At this time, only a few universities offer formal degree-granting programs in clinical investigations. With increased funding, rehabilitation could develop a cadre of researchers who could establish formal theories that would drive future rehabilitation science and engineering. Finally, formal mechanisms of knowledge transfer are not well developed in rehabilitation science. The availability of as well as access to properly controlled outcomes research is very limited. To build the most effective mechanisms for the transfer of products of research, a partnership among the researchers, the government programs that fund the research, educators, health service providers, and consumers will be required. To increase the likelihood of successful technology transfer, rehabilitation research needs a market link. This involves tying the products of R&D to the market economy and increasing the knowledge available to the consumers of rehabilitation products to increase market demand. This will strengthen the interest of people with disabling conditions who have needs that can only be served by knowledgeable professional and private enterprise. The demands should invigorate research and technology transfer, similar to the relationship that research now has with drug companies, which fund the majority of clinical trials. Technology Transfer Mechanisms in the Practice Professions Traditional mechanisms intended to engender evidence-based clinical practice are largely untested. It is widely assumed that clinicians read
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--> life-long management strategy. In addition, public education and increasing consumer demand for the clinical research product might provide market-driven incentives. To effect this shift in incentives, more federally funded model care centers (such as NIDRR's Rehabilitation Engineering Research Centers) should be funded to provide clinical research and transfer its findings to consumers by providing the best possible care. Models such as these could be coordinated by the proposed Administration on Disability and Rehabilitation Research. Finally, best practices should be widely disseminated through various public media, including television "health news" reports, the World Wide Web, and newspapers (such as the technique used by the Journal of the American Medical Association and the New England Journal of Medicine, which de facto requires that physicians read the latest research from those journals to be able to answer their patients' questions the next day). Lack of Training and Techniques to Transfer Existing Evidence to Practice Despite the importance of clinical investigations, current rehabilitation education opportunities for physicians and other clinicians are inadequate. There are only a few formal degree-granting programs in "Clinical Investigations." The Institute of Medicine has written persuasively that training in and support of clinical investigation is "fragmented, frequently undervalued, and potentially underfunded" (Kelley and Randolph, 1994). So few investigators with formal training exist that currently, most clinical investigators obtain their training via informal postdoctoral experiences or by apprenticing themselves to someone who also has no formal training as a clinical investigator. Formal training in clinical investigation should become a requisite for both doctorally prepared principal investigators and nondoctorally prepared study coordinators and other team members. The lack of funded mentors with training in clinical investigation is a great impediment to future rehabilitation treatment efficacy research. Because the federal government has neglected clinical investigations in rehabilitation for so long, some private foundations (e.g., the American Occupational Therapy Foundation) have developed mentored rehabilitation research funds and, indeed, NIH-like program project grants and clinical research centers (Foundation for Physical Therapy, 1994). The apparent motivation of these private foundations is to generate sufficient treatment outcomes evidence to prevent denial of services in an increasingly competitive environment. A more sagacious approach would be for the federal government, probably through NIDRR or NIH, to assemble disinterested parties to assess treatment outcomes as impartially as possible, but subjecting the treatments to usual standards of scientific in-
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--> quiry. Moreover, such an approach might be more likely to generate a new treatment paradigm rather than simply test the custom-based paradigms currently taught in rehabilitation. Incentives and Priorities Despite years of clinical research, federal incentives to change the practice habits of health care providers remain insufficient. Several mainstream-medically oriented examples exist: for two decades it has been clear the tourniquet applied to maintain a blood-free operative field during knee surgery causes 30 to 60 percent of the subjects to have frank neuropathy (Krebs, 1982, 1989); nonetheless tourniquets continue to be used in virtually all limb surgery, in part because the neuropathies usually resolve spontaneously (Krebs, 1982). Moreover, thirty percent of durable medical equipment used for rehabilitation is thrown out by the first month following its issue to the patient. (For further evidence, one need only think of all the walkers, canes, and crutches in one's own basement! The basements of persons with permanent functional limitations are often more stalwart silent sentinels to insufficient technology matching.) The former example clearly demonstrates the extraordinarily slow process of technology transfer (or the transfer of ideas in this case) from research to implementation in clinical practice; the latter demonstrates how better treatment guidelines could save money, which could help fund best practice guidelines research. Currently, MCOs' interests may seem to be best served by playing Old Maid (a children's card game whose objective is to entice the competition to take the unwanted card) with people with disabling conditions; MCOs can lower their short-term costs by reducing or denying care (Ware et al., 1996). If federal regulations required MCOs to provide the best care possible to people with disabling conditions, long-term MCO incentives would change to incorporate prevention and advances in health science at all levels (Rubin, 1996). Saving money alone cannot be an ethical health care goal. Indeed, efficiency is an institutional value; individuals, by contrast, value access to care, quality of care, health-related quality of life, and treatment effectiveness. The necessary tension between collective and individual goals in an MCO has led to some disability rights groups considering class-action suits to better balance the needs of corporations and individuals (Hadorn, 1992). Recent evidence indicates that at least some MCOs deny care to people with chronic illnesses, resulting in poorer outcomes than those for patients who have less restricted, fee-for-service access to care (Ware et al., 1996). Technology transfer incentives need federal attention not just among clinicians and patients but also among engineers, architects, and politicians. Until the 1990s building designers informally consulted friends
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--> who might be rehabilitation professionals or consumers to determine the widths of accessible ramps, restrooms, and doors to make buildings accessible to people with potentially disabling conditions. After passage of the Americans with Disabilities Act of 1990 (ADA), many architects established formal guidelines for acceptable barrier reduction. Such guidelines however, are not comprehensive, for example, retrofitting to make existing buildings accessible. It is the federal government's role to set national standards, which has begun in part because of the guidelines set forth in ADA. Much remains to be done, however, from the prosaic, such as ensuring that all city crosswalks have audible cues, curb cuts, and sufficiently long Walk/Don't Walk ratios, to the more exotic, such as determining Social Security Insurance disability standards that correctly separate "can't work" from "won't work." Transferring research findings into clinical and societal practice cannot occur if only the short-term cost to the builder or care provider is at stake. The federal government's interest in enhancing work opportunities for all Americans must be crafted into incentives that require people with disabling conditions to participate at all levels of society. Clinical Practice Guidelines Clinical practice guidelines, defined as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances," can be an integral part of technology transfer (Institute of Medicine, 1990, p. 38). Guidelines, usually constructed through informal consensus development, refine the clinical question and balance trade-offs, attempt to address issues relevant to the decision, emphasize clinical contexts, and usually make specific recommendations (Hayward et al., 1995). To be useful in the technology transfer process, clinical practice guidelines include rigorous science-based procedures as part of their development, focus on specific clinical circumstances, and must be practical and definite (Lohr, 1995). Clinical practice guidelines are therefore expected to achieve a number of goals, including improving the quality of health care, protecting professional autonomy, reducing litigation risk, minimizing practice variation, providing standards for auditing medical records, reducing health care costs (and therefore health care premiums), defining areas of practice, improving the efficiency of practice, and identifying inappropriate care (Woolf, 1990). Clinical practice guidelines can be instrumental in verifying the results of new or innovative research. Also, by exposing the results to scrutiny by different types of specialists, the intervention or procedure gains credibility and exposure to the professional community. As such, the guidelines can then serve their clear purpose: to guide the practice of
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--> rehabilitation. If practitioners can access and correctly implement the guidelines, then the process has effectively transferred newly researched ideas to the care of individuals with disabling conditions. Clinical practice guidelines can have positive and negative impacts on patient care. By using currently synthesized scientific information and expert opinion, properly developed guidelines can provide clear information regarding clinical decisions. However, if recommendations are impractical, poorly justified, biased, or otherwise flawed, rigid enforcement could interfere with appropriate health care decision making. A clinician must be able to review and evaluate the usefulness of clinical practice guidelines in daily practice situations (Hayward et al., 1995). The larger issue, however, is the impact of the guidelines. With regard to physician practices, expanding medical knowledge is the most likely outcome, as opposed to changing attitudes or behaviors, in part because of the varied quality of the present practice guidelines or the scientific evidence on which they are based (Woolf, 1993). Disclosure of the process and methodology used to develop guidelines is an initial step in allowing clinicians, policy makers, and others to make informed choices about the quality of the guidelines and how they should be used (Woolf, 1993). Physicians continue to express concern about "cookbook medicine" approaches to patient management and possible effects on autonomy of practice (Harding, 1994). Issues of implementation and enforcement have yet to be clarified. Guidelines, pathways, and audits have been used for quality assessment and physician performance measures in a variety of ways (Parker, 1995; AMA report, 1995). Implementation strategies have been directed at the local, regional, state, and national levels (Woolf, 1993; Gates, 1995; Kalunzy et al., 1995). Most success has been made locally or as a part of MCOs. What has become clear is that guidelines must be translated to the local environment to be accepted and effective. Support from the health care system is also important for making changes in behavior. Conducting symposia that facilitate the development of clinical practice guidelines should be a priority of the agencies sponsoring rehabilitation research. A program that does this is the Consensus Development Program of NIH's Office of Medical Applications of Research. Convening an expert panel to review recent research results can heighten the scientific community's awareness of the agency's activities and the professional community's awareness of the agency's results. By funding conferences or seminars to this end, the agency would disseminate the results of the research, and therefore increase the effectiveness of its research budget.
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--> Participatory Action Research People with disabling conditions can play a vital role in technology transfer as consumers. Unfortunately, they are often viewed as passive individuals whose only role is to reap the benefits from newly developed technologies. Contrasting this dated notion is the increasing attention that is given to a more active role for consumers. Increasing attention is being given to the philosophy and practice of participatory action research, which is described below. The spirit of collaboration that is the heart of participatory action research (Whyte, 1991) calls for the involvement of participants as active partners in the process of research and the dissemination of research findings. Thus, this relationship places the researcher in the role of learner as he or she better understands the participants' experiences with respect to their disabling conditions and other relevant issues. For some researchers, such collaborations are viewed as a waste of time and energy. For others it is invited, appreciated, and used to develop a research process leading to outcomes that are of higher quality and relevance. Fawcett (1991) provides three suggestions to actively involve constituents in the research process: First, constituents should assess the social significance of the research goals (e.g., Is the research likely to lead to outcomes that will be beneficial to the constituent populations to whom it is targeted?); Second, constituents should validate the social appropriateness of the procedures (e.g., How effective or practical is this procedure or intervention for me?); Third, constituents should have opportunity to validate the social importance of the proximal, intermediate, and distal effects of the intervention (e.g., Is there an increased amount of function? Will it allow me to become more independent? Could I live alone?). Many factors present potential challenges to developing the consumer's role in the project team. Plausible obstacles include the availability or willingness of constituents to participate in the research process, the lack of transportation to attend scheduled meetings, the education level of potential constituents, and the lack of funding to include constituents (and their personal assistants if needed) in the research process. Although these and other formidable obstacles may act as potential deterrents to research programs, rehabilitation and engineering researchers must be steadfast and proactive in involving their consumers in the research process. Current Governmental Mechanisms Many government agencies are designed to facilitate technology transfer. Some of the best opportunities for technology transfer occur either at entry and planning stages of a research project or at its conclusion. The
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--> former involves bringing participants from other research, academic, and industrial communities into the research and development program as partners who then have a stake in the research and who are free to commercialize or market the findings. The latter depends on disseminating the findings of research to the greater corporate, industrial, or health related communities. Implementation usually consists of conferences, publications, or other means of promulgating the results of the research. National Institutes of Health and the Veterans Administration provide two examples of how government research handles technology transfer. NIH Mechanisms As mentioned above, NIH has several means of transferring research results. The Office of Technology Transfer and the Community Clinical Oncology Programs are two mechanisms for this. Other offices that NIH has at its disposal are described below. Office of Medical Applications of Research The Office of Medical Applications of Research (OMAR) is another means of technology transfer for NIH as a whole, focusing on disseminating the results of research rather than developing partnerships for research. By linking the individual technology transfer sections of each institute, OMAR provides a coordinated effort in disseminating medical technologies and the applications of medical research, principally through the Consensus Development Program. Through this program NIH holds conferences on the most recent developments in medical research. The conferences bring together the scientific, governmental, industrial, and consumer communities and result in a NIH consensus statement, prepared by a nonadvocate, nonfederal panel of experts. The statement is based on (1) presentations during a 2-day public session by investigators working in areas relevant to the consensus questions, (2) questions and statements during open discussion periods from conference attendees that are part of the public session, and (3) closed deliberations by the panel. This statement is an independent report of the panel and is not a policy statement of NIH or the federal government. The conferences and consensus statements attract attention to new technologies and methods and corroborate the evidence with an independent, expert appraisal. Other Technology Transfer Efforts Most institutes maintain their own offices and programs for technology transfer. Some of these have goals and methods similar to
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--> those of NIH's Office of Technology Transfer, whereas others have different methods for encouraging dissemination. For example, some institutes, such as NCI, also offer a Technology Transfer Fellowship Program. This type of program provides an opportunity for professionals to receive specialized training in methods of technology transfer and become familiar with the issues and activities of technology transfer through 1- or 2-year fellowships. The program addresses strategies for dissemination, intellectual property development and management, mass communication, and market research, but it also personalizes each fellowship to meet the background and interests of the participants. VA Mechanisms Technology Transfer Section The Rehabilitation Research and Development Service of VA includes a Technology Transfer (TT) Section that serves as its primary means of cooperation with and dissemination to industry. The TT Section initially brings in industry and other research partnerships at the beginning and planning stages of a project. Its goals are identifying potential products for development (the Product Recruitment Program, see Box 8-2), establishing criteria and processes for evaluating products, and commercializing government-developed products in the marketplace. The Rehabilitation Research and Development Service also works at the other end of the research process, distributing the findings through publications, holding conferences, and managing the interdisciplinary professional relations of the TT Section. By making developed products available to the market and making research findings accessible to clinicians and physicians, the Veterans Health Administration transfers and disseminates rehabilitation products to the private sector, where they can reach the most veterans with disabling conditions. NIDRR Mechanisms Although most governmental sponsored technology transfer activities focus on a specific product or piece of research, some programs exist exclusively for the purpose of disseminating extant technology. NIDRR has two such programs that focus on linking individuals with disabilities with organizations involved in research in assistive rehabilitation technology. These are the consumer assistive technology transfer network and ABLEDATA. A description of these two programs follow.
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--> BOX 8-2 VA Product Recruitment Program The goal of the VA Product Recruitment Program is to seek projects that have the potential to satisfy worthwhile ongoing clinical projects in the Neuromuscular Systems, Orthopedic Biomechanics, and Human Machine Integration sections of the Palo Alto Rehabilitation Research and Development Center and to seek projects with potential from clinical services in VA Medical Centers. The program conducts clinical needs assessments, solicits wish lists, holds focus groups, and contacts physicians and therapists to allow them to provide their input into this process. Falls due to impaired balance present a serious health hazard to people who are elderly as well as to people who have just had surgery and people who are partially disabled but ambulatory. Balance, as well as hearing and vision, declines with age or injury. Each year one third of elderly people living at home will fall. Approximately 1 in 40 of these people will be hospitalized as a consequence of the fall. Impaired mobility due to balance deficits or a fear of falling can diminish a person's ability to perform activities of daily living, and often makes the difference between living independently at home or being supervised in a nursing home facility. SOURCE: Sacks et al. (1994). Consumer Assistive Technology Transfer Network The Consumer Assistive Technology Transfer Network (CATN) is a 2-year project funded by NIDRR The grant was awarded to the New Mexico Technology Assistance Program and is administered by Career Services for Persons with Disabilities, a consumer-driven organization in Albuquerque, New Mexico Initiated in late spring 1996, CATN has established a network to link the primary stakeholders in the technology transfer process It is anticipated that the network will eventually maintain itself CATN links consumers, family members, and service providers through the Rehabilitation Engineering Research Center for Technology Evaluation and Transfer that links federally funded research and development projects, manufacturers, and suppliers of assistive technology with the state technology projects and their companies A National Board of Directors provides technical assistance. The Rehabilitation Engineering and Assistive Technology Society of North America's also provide support to link relevant activities within Tech Act programs CATN will provide the network through which advanced technology can be located to address disability-related issues and a means by which consumers may express unmet technology needs, researchers can obtain
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--> consumer and industry direction for the application of emerging technologies, and product developers can find commercialization assistance. The use of the Internet is central to CATN, particularly because of the Internet's multimedia accessibility capabilities for people with disabilities. The CATN Internet's communication coordination facilitates and demonstrates the distribution and translation of assistive technology transfer requests or ''cases" between consumers-providers and the engineers, researchers, and product developers. ABLEDATA The National Rehabilitation Information Center (NARIC) is an information service established by NIDRR in 1979. NARIC attempts to collect and disseminate publications and material pertinent to disability issues, as well as the results of federally funded research projects; NARIC acts as a library in that regard. Another information resource is ABLEDATA, is a national database that contains descriptions of some 22,000 commercially available assistive devices and new designs for accessibility. This provides the opportunity to link companies, universities, or individuals who have new rehabilitation equipment with others who need those products. Both ABLEDATA and NARIC provided information on disk and cassette, in large print, in braille, and over the Internet. Staff members of both projects can assist with a search if necessary. However, the utility of NARIC and similar approaches is largely unknown, and should be subjected to scientifically acceptable cost-benefit analyses. Conclusions and Recommendations One of the major objectives of rehabilitation science and engineering research is to develop interventions that effectively limit disabling conditions and the environmental factors that contribute to the disabling process. Accomplishing this will require an effective dissemination of knowledge, both to consumers and to others who can develop products and services. Barriers to such dissemination include: (1) limited research, and (2) even more limited mechanisms for technology transfer. In contrast to other medically oriented technology transfer methods, rehabilitation science and engineering requires transfer mechanisms that go beyond physicians to include the spectrum of rehabilitation professionals, as well as people with disabling conditions and their families, architects, engineers, and policy makers (including elected officials, insurers, and administrators). The following recommendations are presented to facilitate the development of technology transfer mechanisms that will improve the commu-
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--> nication among relevant disciplines, bring consumers appropriately into the research process, and facilitate the translation of research from the bench to the consumer. Recommendation 8.1 Mechanisms for the transfer of rehabilitation technology should be enhanced to ensure that consumers have access to the knowledge and technology generated with federally funded rehabilitation research. This includes developing models of technology transfer that involve local medical agents (including therapists, nurses, and physicians), particularly in underserved areas of the country. Recommendation 8.2 Mechanisms should be developed to foster an evidence-based paradigm of rehabilitation practice, driven by scientifically based models that are tested or testable through clinical research. To assist in the development of this paradigm, a standardized database should be developed that allows for the characterization of the national variability in the provision of rehabilitation services. Characteristics of this paradigm would include: effective intervention strategies that have been validated in outcomes and/or process-oriented research; reliable and responsive measures of impairments, functional limitations, disability, and quality of life that have predictive value for outcomes and which will promote standardization of rehabilitation services; patients and clients who are empowered with a greater ability to manage the long-term consequences of disabling conditions; and technology transfer mechanisms that provide incentives for practitioners to conform to best practice standards. At minimum, those health care programs that the federal government is currently in charge, including Medicare, Medicaid, VA, and CHAMPUS (Civilian Health and Medical Program of the Uniformed Services) should provide clear stipulations for practitioners to conform to best practice standards as they design and implement programs to meet the patients' or clients' needs. Recommendation 8.3 Consumers with potentially disabling conditions should be involved, whenever possible, throughout the process of research design, technology development, and dissemination to ensure that researchers understand the issues faced by consumers as they live their lives with disabilities.
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--> Recommendation 8.4 More clinical research is needed to foster the development of rehabilitation science that can guide practice. This research must be equivalent in rigor, prestige, and funding to basic and other medical sciences. This includes but is not limited to more clinical outcomes studies. In particular, clinical research on functional limitations, disability, and the environment are needed to help guide clinical decisions. Recommendation 8.5 The federal government should not allow payers to limit rehabilitation research conducted in the context of care. Such restrictions will impede the progress of medical research that is necessary to improve the health of the public and reduce the cost of care. Recommendation 8.6 Clinical practice guidelines should be developed by the federal government that include not just diagnosis-related guidelines but also guidelines for rehabilitation of impairments, functional limitations, and disabilities. Recommendation 8.7 University and federal researchers should seek partners in private industry to cooperate on the research and development of technologies that can ultimately benefit people with disabling conditions. Recommendation 8.8 More rehabilitation-related research should be published in the peer-reviewed literature. Making material available on the Internet or directly to the public does not relieve rehabilitation scientists and engineers of their obligation to submit their work to peer-review.
Representative terms from entire chapter: