Shaping the future of medical rehabilitation research: using the interdisciplinary research model1

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THE JOHN STANLEY COULTER MEMORIAL LECTURE

Shaping the Future of Medical Rehabilitation Research: Using the Interdisciplinary Research Model Joel A. DeLisa, MD, MS ABSTRACT. DeLisa JA. Shaping the future of medical rehabilitation research: using the interdisciplinary research model. Arch Phys Med Rehabil 2004;85:531-7. This memorial lecture addresses the fundamental requirements for developing a framework for interdisciplinary rehabilitation research. The needs for funding, clinical trials, staffing, education, and infrastructure are examined from the vantage points of my experiences as an educator, investigator, chief executive officer, department chair, and dean. Developing an academic base for the specialty of physical medicine and rehabilitation and demonstrating our expertise in rehabilitation research are fundamental to academic acceptance and will enhance our ability to compete for future funding for our investigations. Key Words: Evidence-based medicine; Interdisciplinary health team; National Institutes of Health (US); Randomized controlled trials; Rehabilitation; Research. © 2004 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation T IS AN HONOR and a privilege to present the 53rd Annual Coulter Lecture of the American Congress of Rehabilitation IMedicine (ACRM) on its 80th anniversary. As we mark this milestone for ACRM, it is appropriate to acknowledge the origins of this memorial lecture. John Stanley Coulter’s (1885– 1949) contributions to the Congress were substantial— he was president (1925–1926) and treasurer (1920 –1949), and he served as assistant editor of its official journal, the Archives of Physical Medicine. He was a charter member of the American Board of Physical Medicine and Rehabilitation and was the first president of the American Academy of Physical Medicine and Rehabilitation (AAPM&R) (1938 –1939). The first Coulter Lecture, given in 1951 by Kristian Hansson, was in the form of a eulogy to Dr. Coulter in which Hanson calls him the Father of Physical Medicine and Rehabilitation (PM&R).1 The overarching theme of the series has been the interdisciplinary approach, which is reflected in my title. My lecture relates to rehabilitation research and is meant to complement last year’s presentation by Bach-y-Rita.2 This is apropos because ACRM in 1997 shifted its mission to focus on rehabilitation research: “The ACRM serves people with disabling conditions by promoting rehabilitation research and facilitating information dissemination and the transfer of technology. Rehabilitation research that promotes health, indepen-

From the Department of Physical Medicine and Rehabilitation, UMDNJ–New Jersey Medical School, Newark, NJ; and Kessler Medical Rehabilitation Research and Education Corp, West Orange, NJ. No party having a direct interest in the results of the research supporting this article has or will confer a benefit on the author(s) or on any organization with which the author(s) is/are associated. Reprint requests to Joel A. DeLisa, MD, MS, Dept of Physical Medicine and Rehabilitation, 30 Bergen St, ADMC 101, Newark, NJ 07101-1709. 0003-9993/04/8504-8827$30.00/0 doi:10.1016/j.apmr.2003.12.003

dence, productivity, and quality of life conditions is highly valued. We are committed to research that is relevant to consumers, educates providers to deliver best practices, and supports advocacy efforts that ensure public funding for our research endeavors.”3 Conducting true interdisciplinary rehabilitation research, however, requires a strong infrastructure and ongoing financial support. For most organizations, these essential components can only be cost-justified when the scope of the research program has attained the required scale. These global issues were addressed in a recent article4 I coauthored with Dick Verville, which has facilitated discussion about whether there should be an institute or an independent center for medical rehabilitation research within the National Institutes of Health (NIH). The companion commentary by Laurence,5 the former deputy director of the National Institute of Diabetes and Digestive and Kidney Diseases, underscores the issues to consider in establishing a new Institute for Medical Rehabilitation Research. Rehabilitation medicine is well known for its use of interdisciplinary teams in the clinical setting, but it has not done a very good job with respect to interdisciplinary research. NEED FOR RESEARCH IN PM&R For rehabilitation medicine to flourish as an academic discipline, it must develop a stronger research base.6-9 Most of our research is clinical and tends to be observational rather than hypothesis driven. Clinical research is more expensive than bench research because the researcher must control not only the intervention but also the environmental influences that occur outside the parameters under investigation. These influences present even greater challenges when conducting clinical research in rehabilitation. Research is essential to determine whether any therapeutic regimen provides more than a placebo effect. As in other disciplines, medical rehabilitation therapy must be clinically effective and cost effective to be acceptable to the health insurers. Similarly, cost-effectiveness studies are aimed at determining the ratio of costs to outcomes of a particular intervention or treatment and at comparing costs of standard interventions to alternatives.10 However, the black box of rehabilitation does not lend itself readily to cost-effective analysis because of the complex set of treatments provided. Analyses must focus on more limited aspects, such as specific interventions and specific aspects of outcome. Also, determining whether a cost is justified by a given outcome requires consideration of socioeconomic factors that often are influenced by cultural traditions and belief systems. Therefore, translating the research methodology into the clinical setting remains a significant challenge. Opportunities for Medical Rehabilitation Research The opportunities are almost unlimited because we deal with severe, debilitating diseases that by and large have no definite cure but are amenable to rehabilitative efforts. At one end of the research spectrum, our opportunities consist of studying the impact of diseases of the musculoskeletal and neuromuscular systems, as well as those involving the cardiovascular and Arch Phys Med Rehabil Vol 85, April 2004

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SHAPING THE FUTURE OF MEDICAL REHABILITATION RESEARCH, DeLisa Table 1: Rehabilitation Model: Framework of the Revised International Classification of Impairments, Disabilities and Handicaps Term for Level of Illness

Alternative Term

Pathology

Disease, diagnosis

Impairment

Symptom; signs

Activity (previously “disability”)

Function, observed behavior

Participation (previously “handicap”)

Social positions and roles

Domain for Contextual Factors

Examples

Personal

Previous illness

Physical

House, local shops

Social

Laws, friends

Comment

Abnormalities or changes in the structure or function of an organ or organ system Abnormalities or changes in the structure or function of the whole body Abnormalities, changes, or restrictions in the interaction between a person and his/her environment or physical context (ie, changes in the quality or quantity of behavior) Changes, limitations, or abnormalities in the position of the person in his/her social context Comment

Primarily attitudes, beliefs, and expectations, often arising from previous experience of illness in self or others Primarily local physical structures but also includes people as careers (not as social partners) Primarily legal and local cultural setting, including patients’ expectations of important people in their lives

Data from WHO.18

cardiopulmonary systems. At the other end of the spectrum is function-oriented research, which focuses on patients’ adjustment to their disability, integration into their community, and efforts to resume a productive lifestyle and satisfactory quality of life (QOL). Improving physical capabilities is furthered by research into prosthetics, orthotics, and other forms of assistive technology and their effects on the level of function. The same is true of the physical modalities: heat, cold, and electricity. The psychologic responses of patients to dysfunction and techniques of optimal behavioral or psychosocial management for both the patient and family are also important research issues. Vocational interventions and environmental modifications offer many opportunities for interdisciplinary research. Advances in basic science research and clinical research need to be integrated into the academic base of rehabilitation medicine.11 Nerve regeneration research and pharmaceutical interventions, such as how to improve memory or modify spasticity, are exciting areas that should be central themes for our research. Neuroplasticity, a concept pioneered by Bach-y-Rita,2,12,13 has important implications for rehabilitation research. Although rehabilitation medicine was slow to pick up on the idea, it has been accepted by neuroscience and has proliferated with the advent of functional magnetic resonance imaging and transcranial magnetic stimulation.2,14,15 In the past, much of rehabilitation research has concentrated on the motor system, as well as cognitive research. I predict major advances in augmenting sensory capacities in the coming decade. Functional neuromuscular stimulation uses electric stimulation of the nervous system to restore function in people with neurologic impairment.16 This is a positive example of the application of rehabilitation engineering to situations where there once was little hope for functional improvement. Applications involve both sensory and motor systems (eg, auditory prosthesis) and range from feasibility studies to clinical use. These advances must be integrated into our training programs. The leadership of the ACRM, AAPM&R, and the Association of Academic Physiatrists have discussed convening a research summit with an agenda aimed at stimulating increased research capacity and productivity in rehabilitation medicine. In July 2003, the National Center for Medical Rehabilitation Arch Phys Med Rehabil Vol 85, April 2004

Research (NCMRR) within NIH and other organizations sponsored the conference “Physical Disabilities Through the Lifespan,” which focused on the practical aspects of establishing an agenda to advance science and to inform public policy. MODELS OF ILLNESS Models of illness, disablement, and rehabilitation are helpful in the analysis and understanding of clinical problems, and they can form a framework for the planning of interventions, as well as the allocation of resources.17 Models are useful in identifying high-priority areas and framing the future of rehabilitation research. The International Classification of Impairments, Disabilities and Handicaps (ICIDH) was developed under the auspices of the World Health Organization18 (WHO) and subsequently revised in the International Classification of Functioning, Disability and Health19 (ICF) (table 1). The aim of the revised classification is to provide a common language for describing functional states associated with health in order to improve communication among health care providers, others in the public sectors, and people with disabilities. The model is designed to facilitate the accurate comparison of data across countries, disciplines, and services. It can be used as a tool for structuring research, collecting data, developing social policy, or for clinical assessment and education. The ICF has revised essential terms. “Disability” has become “activity,” and “handicap” has become “participation.”20 Activity is “the execution of a task or action by an individual,” and participation is “an involvement in a life situation”—that is, an engagement in society or perhaps a social role. The 2 are listed together in the same set of chapters in the ICF because of difficulties in clearly distinguishing the 2. The ICF has also redefined “impairment” into 2 dimensions: (1) “body functions” (“b” items), defined as “physiological functions of body systems,” and (2) “body structures” (“s” items), defined as “anatomical parts of the body.”19 Compared with the original ICIDH, the new terms used in the ICF do not focus on negative or limiting characteristics. Although one end of the scale for each category indicates problems, impairment, or activity or participation restriction, the other end indicates nonproblematic aspects or positive

SHAPING THE FUTURE OF MEDICAL REHABILITATION RESEARCH, DeLisa Table 2: Codes and Severity of the Problem ICF Code

xxx.0 No problem (none, absent, negligible. . .) xxx.1 Mild problem (slight, low. . .) xxx.2 Moderate problem (medium, fair. . .) xxx.3 Severe problem (high, extreme. . .) xxx.4 Complete problem (total. . .)

Percentage of Involvement

0–4 5–24 25–49 50–95 96–100

functioning. The ICF is perhaps most lauded for adding 1 new dimension critical to understanding the disablement, namely, descriptions of the environment (“e” items). Functions—that is, what a person can do and how much they can participate in society—are categorized and coded in detail. In fact, the ICF attempts to identify everything that a body does, both autonomic and deliberate, and everything people ordinarily do. Each function is defined and given a 2- to 4-digit numeric code. For example, “Specific mental functions of recognizing and using signs and symbols and other components of language” is coded as b175.19 Walking d450 is defined as “moving along a surface on foot, step by step, so that one foot is always on the ground. . ..”19 “Acquiring a place to live” is d610. Environmental factors are similarly coded: for example, “Products and technology for personal use in daily living” are e115, and the “Immediate family” is coded under e310. The codes can be further quantified by an additional digit, providing a rating of severity of the problem (table 2). The classification system provides a valuable, if complex, new way of looking at and discussing traditional notions of impairment, disability, and handicap and provides a means of making comparisons across diverse situations and over time. International efforts are underway to define “ICF Core Sets”— that is, to identify smaller subsets of ICF codes that are routinely relevant to major health conditions such as stroke or musculoskeletal conditions. Although this model has its weaknesses (eg, it does not fully encompass well-being, QOL, social roles, or personal factors), it provides a promising framework for a more widespread and systematic analysis of rehabilitation outcomes. I believe that this model will eventually be linked to the consumption of health care resources, thereby allowing comparison of the cost effectiveness of various rehabilitation interventions. To ensure that we can provide optimal care in the future, we must continue to improve our outcome measures. There is an ongoing need to develop useful models of disablement and rehabilitation. Decades ago, Nagi21 did much of the early conceptual work on this topic, elucidating how disablement is not produced solely by disease but involves an interaction with the social and physical environment. A given “impairment,” in his terms, may or may not develop over time into a disability in the sense of a generally handicapped person, limited in his/her independence, productivity, and self-esteem. Although much work has subsequently been done on “models of disability,” much of it has been limited to terminology and taxonomy. Today we are plagued by multiple terms for the same thing: Nagi’s “disability” is much the same as the ICIDH1’s “handicap,” which in turn is much the same as “participation,” which overlaps semantically and empirically with “activity.” The field needs more agreement on terms and also a willingness to listen when others use different terms for important domains. This will strengthen our understanding of

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various strategies for improving the health, functioning, and QOL of persons with disability. EVIDENCE-BASED MEDICINE In my Zeiter Lecture in 1998,22 I described evidence-based medicine (EBM) with respect to rehabilitation medicine. It is defined as the conscientious, explicit, and judicious use of the current best evidence in making decisions about the care of individual patients.23 The application of EBM requires integrating individual clinical expertise with the best available external clinical evidence drawn from systematic research. Proponents claim that EBM offers support for practice decisions, improves quality of care, serves as an educational tool, reduces costs, reduces inappropriate care, and creates a research platform.23 Critics of EBM claim that it was introduced by insurance companies and managed care organizations rather than by physicians, that it promotes cookbook medicine, that it is slanted to the average patient, and that it has serious ethical implications, including rationing of care.24 The data for EBM are derived primarily through randomized controlled trials (RCTs) and meta-analyses, although occasionally observational studies are used. The results show comparative efficacy of treatment for an “average” randomized patient and may not be relevant for pertinent subgroups formed by cogent clinical features such as severity of symptoms, illness, comorbidity, and other clinical nuances.22 Most RCTs are also based on selected subgroups of patients with “pure” or single conditions. In practice, rehabilitation must address patients with multiple health conditions. Our field needs to increase the time devoted to teaching research evaluation skills and applying them to EBM.25 I would like to compliment Clinical Orthopaedics for its recent series addressing EBM.26-29 ACRM should also be commended for designating evidence-based rehabilitation as the overall theme of its 1998 meeting. Also, the Brain Injury Interdisciplinary Special Interest Group of ACRM, under the direction of Keith Cicerone,30 published an evidence-based review of cognitive rehabilitation that provided preliminary support for the effectiveness of several forms of cognitive rehabilitation for persons with stroke and traumatic brain injury (TBI). However, ACRM needs to continue to emphasize this important concept in each of its annual meetings. Long-term collaborative work with other professional groups will be needed to develop, evaluate, and disseminate evidence-based clinical practice guidelines, standards, and recommendations for interdisciplinary medical rehabilitation. Some online resources for EBM are listed in table 3. RANDOMIZED CONTROLLED TRIALS Tate et al31 published an excellent article, the goal of which was to provide researchers and clinicians with a basic understanding of RCTs and their potential applications to PM&R. Parallel-designed, double-blind RCTs form the theoretical foundation for EBM. To address the need for clinical research, Kessler Medical Rehabilitation Research and Education Corporation (KMRREC) cosponsored a national conference on RCTs, the proceedings of which were published in the American Journal of Physical Medicine and Rehabilitation.32 This supplement expresses a definite view: that rehabilitation professionals can and should conduct more RCTs to test the efficacy of interventions and that these studies need to be rigorously designed using the best methodologies. Clinical trials for which the hypothesis and study design are developed specifically to answer the questions faced by decision makers are called practical clinical trials (PCTs).33,34 The major features of PCTs are noted in table 4. PCTs are designed Arch Phys Med Rehabil Vol 85, April 2004

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SHAPING THE FUTURE OF MEDICAL REHABILITATION RESEARCH, DeLisa Table 3: EBM Online Resources Resources

Website

Agency for Healthcare Research and Policy Centre for Evidence-Based Medicine Centre for Health Evidence, Users’ Guides to Evidence-Based Practice Cochrane Collaboration BMJ Publishing Group

http://www.ahrq.gov http://www.cebm.net http://www.cche.net/usersguides/main.asp http://www.cochrane.org http://www.clinicalevidence.org

for comparisons of viable alternative clinical strategies. They may be extremely costly to conduct because they can require large sample sizes and may have long-term follow-up. PCTs are not a major focus for the NIH. About 70% of NIH grants are devoted to basic biomedical research with the remainder being clinical research of all types.35 Although NIH has been successful at biomedical discovery, it has been less consistent in supporting clinical research that translates discovery into improved patient care and public health.36 In 2001, NIH spent $20.3 billion on all research projects. Of this, $5.3 billion (26%) was spent on clinical research, which has a very encompassing definition; $1.1 billion (5%) of this was for clinical trials.37 Industry funding of clinical trials is several times greater than NIH spending: in 2000, it was $3.8 billion to $850 million. However, although most PCTs are phase 4 trials, only about 15% of individual funding for research is spent on phase 4 clinical trials.37 In my opinion, it would be advantageous for the rehabilitation field to assemble a formal network of RCT sites offering the appropriate administrative and statistical expertise and infrastructure including information systems technology. Such a network would be well positioned to attract federal and private funding, including pharmacologic funding to evaluate treatment modalities with respect to the rehabilitation process and medical devices. The development and funding of RCTs should be guided by the likelihood of improving both the function and the QOL of persons with disabilities. Research Stakeholders The stakeholders in rehabilitation research are people with disabilities, clinicians, researchers, rehabilitation providers, payers, purchasers, significant others, professional societies, pharmaceutical and medical devices enterprises, academic health centers, and health policy makers.38 Research can be either basic (fundamental) or applied. With respect to designing research, we should concentrate on the following criteria: (1) Is it new? (2) Is it true? and (3) So what?39 FUNDING SOURCES FOR REHABILITATION RESEARCH Davidoff et al40 have indicated that the lack of research funding from other sources may reflect the lack of initiative and enthusiasm in many PM&R departments to develop methods for funding their research programs outside their own financial bases. During times of health care reform, this source of

Table 4: Features of PCTs Select clinically relevant, alternative interventions to compare Include a diverse population of study participants Recruit participants from heterogeneous practice settings Collect data in a broad range of health outcomes

research funding may become severely restricted. Recently released NIH data on extramural funding for medical schools by department for FY 2002 are revealing. As noted in table 5, PM&R’s $15.4 million is far below that of internal medicine ($2.5 billion), psychiatry ($751 million), neurology ($321.3 million), family practice ($37.1 million), or orthopedics ($32.1 million). For PM&R, this $15.4 million represents 49 grants, which is up from the $8.3 million in 1997.22 I suspect neurology’s research funding base was markedly aided by “The Decade of the Brain.” Rehabilitation medicine did not capitalize on that opportunity, although we may have been poorly prepared to do so. We must not make the same mistake with

Table 5: NIH Extramural Funding for Medical Schools by Department, FY 2002 Total Funding

Internal medicine Psychiatry Biochemistry Pediatrics Microbiology/immunology/virology Physiology-biophysics Pathology Pharmacology Genetics Anatomy/cell biology Neurology Public health & preventive medicine Surgery Radiation: diagnostic/oncology Ophthalmology Obstetrics & gynecology Biology Neurosciences Anesthesiology Otolaryngology Neurosurgery Dermatology Urology Family medicine Other basic sciences Orthopedics Biostatistics & other mathematical sciences Other health professions Veterinary sciences Physical medicine & rehabilitation Psychology Total

$2,542,552,648 $751,021,698 $515,771,376 $513,274,471 $512,038,379 $506,113,318 $498,249,224 $430,763,663 $402,328,346 $380,708,115 $321,373,145

5917 1914 1638 1394 1603 1537 1464 1438 757 1158 808

$252,416,135 $248,228,981 $237,999,673 $166,855,395 $165,251,988 $125,117,178 $107,011,329 $91,555,417 $70,405,608 $57,232,512 $52,619,851 $45,386,729 $37,129,625 $33,796,301 $32,126,445

438 770 626 480 430 420 288 285 203 161 183 111 99 147 137

$29,283,269 $29,257,754 $27,480,900 $15,431,590 $13,238,843 $9,212,019,906

58 76 56 49 40 24,685

Data from National Institutes of Health.48

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No. of Grants

Department

SHAPING THE FUTURE OF MEDICAL REHABILITATION RESEARCH, DeLisa Table 6: NCMRR Budget Growth by Year Year

Budget (million)

2001 2000 1999 1998 1997 1996 1995 1994 1993

$46 $38 $27 $21.4 $22.2 $18.7 $15 $14 $10

Data from Verville and DeLisa.4

respect to “The Decade of the Bone and Joint” (2000 –2010).41,42 This international effort was established through a consensus meeting in Sweden in April 1998 and is cosponsored by WHO. It seeks to increase awareness of the scale and impact of musculoskeletal disorders such as rheumatoid arthritis, osteoarthritis, osteoporosis, spinal disorders, and severe limb trauma on individuals, caregivers, health care systems, and society. The goal of the bone and joint decade is to improve the health-related QOL of people with musculoskeletal disorders throughout the world. The decade’s objectives are to (1) raise awareness of the suffering and cost for society associated with musculoskeletal disorders, (2) empower patients to actively participate in decisions concerning their care, (3) promote cost-effective prevention and treatment of musculoskeletal disorders, and (4) advance understanding of musculoskeletal disorders and improve prevention, diagnosis, treatment, and rehabilitation through research. An important component of the Decade of the Bone and Joint initiative is the Bone and Joint Monitor Project. This project’s objective is to provide evidence to enable development of policies and strategies to improve the prevention and treatment of musculoskeletal conditions, relevant to the geographic and socioeconomic setting.43 Further information on this important endeavor, is available at http://www. boneandjointdecade.org and http://www.usbjd.org. It is unclear to me how many departments of rehabilitation medicine, if any, have built the infrastructure necessary to be competitive to take advantage of this opportunity. The major funding agencies for rehabilitation-related research are the National Institute on Disability and Rehabilitation Research (NIDRR); NCMRR; other NIH agencies; the Department of Veterans Affairs and other federal agencies such as the Department of Defense, Agency for Health Care Research and Quality, and Centers for Disease Control and Prevention; and foundations, both public and private. NIH is mainly investigator-initiated, nondirected research, whereas NIDRR is mainly program focused (ie, model systems, research and training centers, rehabilitation engineering research centers).38 The field of rehabilitation medicine made a concerted effort in the late 1980s and early 1990s to convince NIH and the US Congress to establish NCMRR. Since then, NCMRR’s budget has grown and developed (table 6). Unfortunately, the field of rehabilitation medicine research is still fragile, and the classic NIH research model is only partially compatible with our overall views. Recently, NCMRR leadership has been challenging the field to become more productive in the quality and quantity of research proposals. I challenge NCMRR to reevaluate how creative and innovative it has been to provide the

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resources and support for helping the field to create more research capacity. NCMRR needs to collaborate with other research-oriented organizations to look outside the box to create new and more successful mechanisms for promoting the research productivity of the field. Do we need a new model? NIH has recently acknowledged the need for improvements in the clinical research enterprise.44 The field’s new initiative to hold a research summit to seek innovative means of expanding quality research productivity should be fully embraced by NCMRR and by other funding organizations. As indicated in the recent articles with respect to the proposed National Institute of Medical Rehabilitation Research, a review of the budget growth of other new institutes that have been formed at NIH suggests that, in almost every case, the budget of the new entity has grown faster than it did before the new entity was formed or has at least kept pace with the growth of the NIH budget overall.4,5 INTERDISCIPLINARY MEDICAL REHABILITATION RESEARCH It is also true that most physiatry departments have few MD PhDs or PhDs, especially PhDs devoted mainly to research.22,45 These latter individuals are critical catalysts for most successful research programs, and their salaries are lower than those of physiatrists. I urged all academic physiatry departments to find funds to hire at least 1 full-time research PhD and to expect that person to become primarily grant funded within 5 years.22 Over the long term, it would be difficult to sustain a successful research infrastructure core around 1 individual, and so the typical department will find that as many as 3 to 5 investigators will be needed for a successful research program. Physician clinical researchers are becoming difficult to recruit and retain and have been called by some the “endangered species.”46 Yet physicians are an essential part of clinical research. This is in part due to escalating medical school debts (the average debt for medical school graduates in 2002 was $103,85547), increased demands for clinical productivity, lack of successful mentors, and the difficulty in competing effectively for grants. Also, most physicians are unwilling to give up the practice of medicine and devote their careers to full-time research. To be a successful externally funded researcher, one needs to devote considerable time to grant writing. The number of applications by physicians for available NIH funds that support biomedical research lags far behind the number of applications from PhDs by almost 3 to 1. The funding success rate of clinical research proposals is roughly half that of basic science proposals. Also, the number of graduating medical students interested in research careers is steadily falling.35 Thus, I believe that it is critical to develop an interdisciplinary PhD research model in rehabilitation medicine research that includes physicians. A Proposed Model We have developed an interdisciplinary approach to rehabilitation research at KMRREC. The directors of all of the laboratories (outcomes, neuropsychology and neuroscience, movement and motion analysis, rehabilitation engineering) are all PhDs and represent multiple disciplines including neuropsychology, biostatistics, physical therapy, and biomedical engineering. With respect to disease areas, such as spinal cord injury, TBI, and stroke, I have attempted to pair a physiatrist and a PhD leader to develop the research programs. All of the PhD researchers are full time, and the research physiatrists must spend a minimum of 80% of their time in research. The vice president for research is a PhD with a degree in clinical Arch Phys Med Rehabil Vol 85, April 2004

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psychology. All of these people are expected to obtain significant external grant funding, and the growth of their individual laboratories reflects their grant-funding success. Each laboratory is expected to submit an NIH R-O1 grant, and they are strongly encouraged to develop research-training grants supported by external funding, which support the advanced training of postdoctoral fellows and physician scientists. We have received training grants from both NIDRR and NIH. All of these scientists hold their academic appointments through the department of physical medicine and rehabilitation at UMDNJ–New Jersey Medical School (NJMS). They are encouraged to work with researchers in other departments and with other academic institutions both in and out of state. KMRREC currently has an annual budget of up to $5.7 million provided by the Henry H. Kessler Foundation and approximately $2.6 million from external grants. In addition to research, this funding must also cover space rental, support our academic library, and maintain our small education department. It also supports our accounting department, grant administrator, and institutional review board, as well as human resources. As for the future, I would like to see us develop a musculoskeletal core that could easily complement our rehabilitation engineering and human performance laboratories. This would allow us to take advantage of funding opportunities for the Decade of the Bone and Joint. We are also formalizing our ability to perform clinical trials and have set up an office of clinical trials with a PhD leader who has expertise in statistics, experimental design, and neuropsychology. We hope to attract federal funding to our site, as well as funding from pharmaceutical and medical device technology companies. I would also like to expand our rehabilitation engineering program beyond biomechanics and bioinstrumentation, possibly to include biomaterials. I have decided to broaden our research agenda as opposed to increasing the depth of researchers in smaller areas. An external interdisciplinary scientific advisory board has been established that has helped provide the KMRREC board, management, and myself with an objective critical analysis of our research portfolio and programs. RESEARCH PRODUCTIVITY I would like to address the key concept of research productivity from 4 perspectives: dean, department chair, chief executive officer, and researcher. Dean Based on my experience as interim dean at the NJMS, it is clear to me that medical schools are widely judged by their NIH research dollar rankings. They must be supportive (space, equipment, personnel) of those departments that bring in NIH dollars, along with its high indirect rates. This situation works against PM&R departments, because our largest federal benefactor is NIDRR, which is not part of NIH. Also, some research organizations that are located off campus (like KMRREC) often submit their federal grants directly to sponsoring agencies rather than through the medical schools in which their investigators hold faculty appointments. Thus, NIH grants are often not attributed to their affiliated medical schools or to their PM&R departments. At NJMS, the dean’s office makes space allocations to various departments by specific mission, such as clinical space, education space, administrative space, and research space. It was easy to calculate grant dollars by research square foot by department and to reward those departments that obtained grants with extra space, at the expense of those who were not as productive. Thus, status and place with respect to resources in a medical school are very dependent on external Arch Phys Med Rehabil Vol 85, April 2004

research funding. Some institutions give special credit for Nobel prize winners and members of the National Academy of Science and the Institute of Medicine. Deans are seeing centers develop in their schools that cross departmental lines. These do provide opportunities for rehabilitation research and certainly are interdisciplinary. However, academic institutions must learn how to measure the contribution of the center and to examine the role of each member within the team.34 Chair Evaluation of faculty productivity is a key expectation for all chairs. Each department and institution must decide on the criteria they will use to measure research as well as educational, clinical, and administrative productivity. A fundamental question is the amount of time devoted to research by each faculty member. This is recorded through medical school time studies, hospital time studies, Centers for Medicare and Medical Services time studies, NIH, and other sponsoring organization studies. A chair would like to gain salary dollars from grants to offset some of the salary time and offer greater department budget flexibility. Another possible metric could be the quality and quantity of research publications. These are also key indicators for promotions and tenure. The least controversial metric is the dollar value of the extramural grants, including the indirect monies. A more subtle issue is how to assign credit to coinvestigators and participants in multidepartment and/or multi-institutional grants. Chief Executive Officer My job is to build the research infrastructure and to develop the strategic plan. The recruiting and retention of successful researchers is a must. Compliance with federal research laws is very important, especially as it applies to human protection and privacy issues. Some potential metrics to monitor are (1) externally funded research expenditures, (2) indirect costs recovered by external grants, (3) number of peer-reviewed publications, (4) number of new grant submissions, (5) success rate of grant submissions, (6) number of new grants funded (excluding noncompetitive renewals), and (7) number of people who have received research training and number who continue to be actively involved in research. Individual Researcher Each investigator must consider the source of their research funding and the perceived instability of federal funding.46 Most investigators are trying to become successful grant-funded researchers and develop an area of expertise, and they are looking for needed infrastructure as well as for job security. They are interested in intellectual property and patent protection as well as a merit incentive plan and need the support system and tools to accomplish these goals. They also need to see growth potential for themselves and their research program. CONCLUSIONS I believe that the interdisciplinary approach is a key to developing the academic base of this specialty. Although I have focused primarily on academic PM&R departments in a medical school environment, interdisciplinary rehabilitation research occurs in the context of, or in conjunction with, schools of rehabilitation science or health-related disciplines at major universities. Establishing clear priorities will generate enthusiasm for rehabilitation research and attract dedicated researchers. A strong research presence will not only improve patient care but will also ensure academic acceptance for our specialty.8 Demonstrating solid advances in rehabilitation research will encourage funding agencies to increase our share of resources.

SHAPING THE FUTURE OF MEDICAL REHABILITATION RESEARCH, DeLisa

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