Stoll, Scott T. DO, PhD; McCormick, Justin PhD; Degenhardt, Brian F. DO; Hahn, Marc B. DO
In 2001, several osteopathic professional organizations agreed to jointly fund a national osteopathic research center (ORC) at one of the osteopathic medical colleges in a deliberate strategy to stimulate the research productivity within the profession. We discuss the long-term costs, benefits, and sustainability of the national ORC at the University of North Texas Health Science Center (UNTHSC) in the context of research accomplished, the training of new medical osteopathic researchers, and an effort to develop other successful regional ORCs.
Osteopathic Research: An Historical View
The osteopathic profession recognizes the critical importance of evidence-based medicine in all areas of clinical practice. However, the colleges of osteopathic medicine (COMs) in the United States have lagged significantly behind most allopathic medical colleges in terms of research capability, funding, and productivity. Leaders throughout the osteopathic profession recognize that despite rapid growth in the number of COMs, the increasing quantity and quality of osteopathic medical school applicants, and the improvements in postgraduate training opportunities in osteopathy, osteopathic medicine will ultimately fall short of its promise to provide a distinctive medical care system if it does not competently evaluate the efficacy of distinctly osteopathic principles and practices, such as osteopathic manipulative medicine (OMM), and the mechanisms that are responsible for this efficacy.
In an effort to enhance the research culture and capacity of its colleges, the American Osteopathic Association (AOA) has long provided competitive funding for pilot studies for research projects. Because of limited resources, the AOA prioritized grant awards to research that was uniquely osteopathic in nature. The AOA distributed these grants based on the merit of individual applications to a wide constellation of researchers and osteopathic institutions. Despite more than 20 years of funding for individual projects, very few investigators established a stable line of investigation that resulted in large, adequately powered clinical trials or even any National Institutes of Health (NIH) funding.
In 1999, a landmark success for the osteopathic profession occurred when The New England Journal of Medicine published an article by Andersson and colleagues1 indicating that OMM was as effective in treating low-back pain as conventional allopathic care and required lower utilization of physical therapy and fewer prescribed medications. This tremendously successful project resulted from a substantial investment by the AOA wherein it funded this multiyear, multicenter clinical trial. Despite the positive results, this research team sought no further research funds and never again conducted together any clinical research on this topic.
At about this same time in the late 1990s, three other important national events occurred that spurred the osteopathic profession to action. The first of these was the creation of the Office of Complementary and Alternative Medicine within the NIH by order of President William Clinton. This office soon transformed into the National Center for Complementary and Alternative Medicine (NCCAM), with an annual budget in 2008 of more than $100 million. The second event was the U.S. Congress mandate that NIH NCCAM fund a national research center within the chiropractic profession, which became the nidus for the Palmer Chiropractic Center for Research (PCCR). The third event was the rise of the specter of pay for performance wherein it seemed likely that most third-party payers (including the federal government) would reduce or eliminate reimbursement for clinical practices that lacked an objective evidence base.
Together, the Andersson and colleagues clinical trial, the development of NCCAM, the rise of the PCCR, and the advent of pay for performance helped the osteopathic profession’s leadership come to several realizations: (1) sustained, progressive osteopathic research success would require much greater and more long-standing financial support than had been invested to date, (2) the osteopathic profession did not have ready access to the funding necessary to sustain an enduring research enterprise, (3) necessary and substantial federal funding was finally available to seriously investigate the mechanisms of action and clinical efficacy of OMM, (4) the research effort of the osteopathic profession had fallen behind that of the chiropractic profession, which seemed poised to dominate and define the manual medicine research enterprise, (5) reimbursement for OMM, the modality that most clearly distinguishes doctors of osteopathic medicine (DOs) from doctors of allopathic medicine (MDs), may be in jeopardy because of a lack of research evidence of its efficacy, and (6) the osteopathic profession must focus its talent and financial resources at a single COM in order to become competitive for the NIH funding critical for sustained research success.
The Establishment of the National ORC at UNTHSC
In view of these new insights, in 2002, three of the leading osteopathic professional organizations—the AOA, the American Osteopathic Foundation (AOF), and the American Association of Colleges of Osteopathic Medicine (AACOM)—agreed to fund a national ORC. Five osteopathic colleges prepared competitive applications for such funding. UNTHSC won the competition because of a combination of its research leadership, infrastructure, facilities, and relatively substantial history of federal funding. The national ORC was subsequently established at that college. Funding from the combined resources of these three osteopathic organizations consisted of an annual commitment of $275,000 for four years.
Figure 1 depicts the functional organization of the ORC. The funding organizations (AACOM, AOA, and AOF) created an External Advisory Committee to the ORC, composed of representatives from each organization. Its charge was to receive formal reports on the progress of the ORC and to report back on a regular schedule to the respective funding organizations. The ORC leadership organized an External Board of Scientific Counselors (EBSC), comprising the four individuals who, in the other four competing applications for the national ORC, had been proposed as executive directors. The EBSC was charged with being a leadership think tank and providing scientific guidance to help ensure that the ORC continued to optimally serve the profession and maintain appropriate prioritization of its research efforts.
The founders of this ORC created it with four specific aims: (1) to establish and maintain research infrastructure, (2) to provide research training, (3) to conduct local mechanistic clinical research, and (4) to conduct national collaborative clinical trials. As shown in Figure 1, the functional organization helped to accomplish these goals.
ORC Purpose and Priorities
From its inception, the focus of the ORC has been research and research training related to OMM. OMM was widely accepted as the appropriate focus because (1) the teaching and clinical practice of OMM is a key feature that materially distinguishes between the osteopathic and allopathic professions, (2) OMM is uniquely osteopathic, and so if the osteopathic profession does not study OMM, then no one else will, and (3) for the health and safety of society, the mechanisms and efficacy of OMM need to be investigated in order to optimize the medical education and clinical practices of the osteopathic profession. In fact, the origin of the ORC and its OMM focus emanate in part from the osteopathic profession’s response to Dr. Jordan Cohen’s comments at the conclusion of the 1996 conference on Current Challenges to MDs and DOs sponsored by the Josiah Macy Jr. Foundation, which included both the leaders of the osteopathic and allopathic medical professions. Dr. Cohen attended the Macy conference as the president of the Association of American Medical Colleges and noted the paucity of quality research in OMM as a critical factor undermining the credibility of the osteopathic profession. When asked what the allopathic profession would do if OMM were proven efficacious and cost-effective, Dr. Cohen indicated that OMM would then, of course, be incorporated into allopathic medical education and clinical practice.2
Determined to conduct rigorous research with enhanced yet still extremely limited resources, the ORC leadership, in association with its EBSC, agreed on the type of research that should be its top priority. The decision was to conduct a clinical trial on the efficacy of OMM in a systemic (visceral) disease process. The general line of thinking went as follows: although mechanistic studies are important and valuable, one should first demonstrate that OMM is effective (with a clinical trial) before determining how it is effective (with a mechanistic research project). Once ORC and external board leaders decided to prioritize clinical research over mechanistic, they decided to prioritize the study of the efficacy of OMM in infectious disease (like pneumonia or otitis media) over musculoskeletal problems (like low-back or neck pain). Although OMM is more commonly employed and more readily explained in the treatment of musculoskeletal problems, the application of OMM in infectious disease is more uniquely osteopathic. Other professionals such as athletic trainers, physical therapists, occupational therapists, massage therapists, and chiropractors also employ manual therapeutics in the treatment of musculoskeletal problems, but only osteopathic physicians incorporate OMM into the full spectrum of medical practice. Furthermore, the application of OMM in the treatment of infectious disease provides a vehicle through which osteopathic researchers and clinicians can educate the public and our colleagues about the mechanisms through which osteopathic doctors and researchers hypothesize OMM promotes health, effecting prevention of and providing treatment of infectious disease.
Multi-Center Osteopathic Pneumonia Study in the Elderly
This clinical research focus on infectious disease was coincident with a rising interest within the leading private osteopathic supportive foundations to facilitate a large, scientifically sound clinical trial investigating the efficacy of OMM. The Osteopathic Heritage Foundation (OHF) joined forces with the Foundation for Osteopathic Health Services and approached the ORC at UNTHSC with an offer to fund ($1.5M) an appropriate proposal for a multisite clinical trial of the efficacy of OMM in an infectious disease state. A DO from AT Still University who had completed two prior pilot studies in this area—both of which were well conducted and had produced positive results—accepted an invitation to direct this project. Over four years (2004–2007), the Multi-Center Osteopathic Pneumonia Study in the Elderly enrolled 406 participants at seven hospitals utilizing 84 treatment providers (including residents). The project concluded in 2007, and investigators who were involved are preparing manuscripts that describe the research methods and results. The goal of the ORC is to keep this research team together and to help seek federal funding for future research studies in this area as appropriate.
Mechanistic OMM Research
As described above, the ORC set, as its first priority, the investigation of the clinical efficacy of OMM in infectious disease. However, in 2003, because of the high cost and negative results of early NIH NCCAM–funded clinical trials, the NCCAM decided its priority was to fund mechanistic studies on manual medicine rather than efficacy studies. In response to NCCAM’s policy, the ORC expanded its priorities and submitted to NCCAM a series of R-21 grant applications that proposed to investigate the mechanistic basis of OMM. One researcher associated with the ORC bundled these R-21 applications together to form a U-19 proposal, that is, a proposal to support a Developmental Center for Research on OMM. The proposal was awarded $1.87M for a three-year study (2004–2007). The foci of these projects were the effects of (1) biomechanical strain on human fibroblasts in culture, (2) OMM (lymphatic pump) on lymphatic duct lymph flow in chronically instrumented dogs, and (3) OMM on pain and autonomic function in human participants. From this work, a number of discoveries (see below) and multiple publications have resulted. The NIH is currently reviewing an application for continuation of funding for these types of studies.
In addition to the private-foundation-funded pneumonia study and the NIH NCCAM–funded mechanistic studies, the ORC at UNTHSC has participated in a wide variety of research projects. Table 1 provides information on the research activities of the ORC, subdivided by grant title (topic), principal investigator, funding source, level of funding, and funding timeline.
We have summarized five key research findings by the researchers associated with the national ORC below. These represent the work of different teams of researchers and lines of research to which the ORC is committed.
* One minute of simulated indirect manipulation can reverse the proliferation of proinflammatory cytokines caused by eight hours of repetitive strain in an in vitro fibroblast model that mimics fascia and connective tissue.3,4
* Lymphatic pump technique significantly increases canine lymph flow through the thoracic duct5–7 and significantly increases immune cell flux approximately eightfold in the thoracic duct.6
* Trained osteopathic physicians can reliably identify the presence of induced canine coronary ischemia solely via palpation of upper thoracic paraspinal tissues. This viscerosomatic interaction is abolished by coronary sympathectomy.8
* Systematic review and meta-analysis show that osteopathic manipulative treatment reduces pain levels in patients with acute, subacute, and chronic low-back pain.9
* A randomized controlled trial shows that osteopathic manipulative treatment slows the progression of pain and impairment of back-specific functioning during the third trimester of pregnancy.10
These scientific discoveries have led to more research questions, which the team of researchers at the ORC and at other affiliated sites are currently pursuing.
One of the primary aims of the national ORC is to enhance research training within the osteopathic profession. The ORC has successfully secured funding from NIH and from some private sources to accomplish this task. To become competent consumers of current research, osteopathic medical students and physicians-in-training require training in research. Those osteopathic physicians who desire to become researchers themselves require special training and years of one-on-one mentorship if they are to meet their goal of conducting independent clinical research. As part of its training effort, the ORC oversees an annual conference on OMM research training and also participates in numerous other national and international OMM research conferences. These research conferences include meetings such as the International Manual Medicine Federation, NIH NCCAM–sponsored manual medicine conferences, the annual Research Conference of the AOA, and the Osteopathic Collaborative Clinical Trial Initiative Conference (held in coordination with the annual American Academy of Osteopathy Convocation). In addition, the ORC has developed and actively manages a variety of mentored research training programs, including both master’s and doctoral degree programs in physical medicine and in OMM clinical education and research. Finally, the ORC administers NIH-funded K-30, R-25, T-35, K-23, and K-24 research training awards.
Recently, the NIH NCCAM awarded a five-year, $1.5M K-30 research curriculum development award to an investigator (S.S.) affiliated with the ORC. Also, the NIH awarded a researcher at the ORC a five-year ($760,000) R-25 research education grant to develop research training in OMM and complementary and alternative medicine (CAM). A recent matching grant from a private osteopathic foundation (a public/private partnership) will facilitate implementation of this OMM/CAM research training program at other COMs. Clearly, research training must remain a priority in order to maintain the momentum of uniquely osteopathic research efforts, to leverage the talents of current active researchers, and to mentor the next generation of such researchers.
Stability and the Risk of Diversity
Considering the scope of the mission and aims of the national ORC, the seed funding from the osteopathic profession’s leading professional organizations, $275,000 per year for four years, was insufficient for long-term sustainability. When the funding became available, the UNTHSC matched the profession’s investment. With the designation as the national ORC, private osteopathic-supportive foundations also provided funding to help this new research center accomplish its goals. As a result, the ORC was able to obtain significant federal funding. But in order to survive and retain the funding and designation as the national ORC, the ORC had to grow fast enough to show progress to its sponsors.
By 2005, the fourth year of its operation, the ORC had leveraged internal and external funding equal to six times the amount originally invested by the three osteopathic professional organizations. Figure 2 illustrates the growth in financial support of the ORC from 2002 through 2007, subdivided by funding source. The ORC receives only 8% to 12% of the indirect funding received from federal sources. The balance supports the UNTHSC Research Office.
After its third annual report to and site visit by the External Advisory Committee (the official liaison between the ORC and its sponsoring professional organizations), the ORC was granted another four years of funding, at a somewhat reduced level ($225,000 annually). The following year, the new president of the UNTHSC immediately listed the ORC as one of the top four research foci on campus and committed an additional $1M across four years (2006–2010) to hire successful biomechanics researchers in order to enhance the ORC’s research capabilities. In response to the renewed funding by the profession and the increased investment by UNTHSC, the OHF provided $1.5M to match an additional $1.5M in funding from the UNTHSC to create the Osteopathic Heritage Foundation Physical Medicine Core Research Facility. This facility provides research support to the ORC and the university as a whole.
These investments in the ORC support a diverse portfolio of research activities (Table 1) ranging from basic science to clinical research, from studies of in vitro fibroblasts to in vivo studies on the function of canine and rat immune systems, and from pediatric otitis media to geriatric pneumonia. The reach of the activities ranges from national research presentations and training conferences to graduate student education and medical student basic research competency. All of these activities are related through their specific focus on OMM. With such a diverse portfolio, running into a dead end in one area of research, or the loss of one researcher, does not bring an end to the mission. Nevertheless, if the talent and resources of the ORC are spread too thin, one risks faculty and staff burnout. The effort required to submit a series of competitive research grants (at a 10%–20% NIH funding rate), conduct the research, and publish the results should not be underestimated. Failure is not an option, and success begets even more work.
When the national ORC was first designated and funded late in 2001, it was expected that within four years federal funding through NCCAM would be secured to provide the infrastructural funding for the ORC and for specific research projects. This hope was not fulfilled. It soon became clear that the federal grant awards were dedicated to supporting the project described in the grant proposal and were sometimes inadequate to accomplish these goals. The core infrastructure funding needed to develop and expand future research initiatives, which was currently supplied by the osteopathic professional organizations, would remain a key support element. The External Advisory Committee communicated the message that continued funding by the osteopathic professional organizations was necessary if the ORC was to continue to make progress.
Arrangements were made to extend the funding for the ORC at UNTHSC through 2009. However, a critical challenge remained. The original vision of the ORC financial sponsors was that the osteopathic profession’s financial resources would fund the first ORC until it could sustain itself and that these resources then would be reinvested to create a second and eventually a third regional ORC. The goal was to have strong regional research centers at the most research-oriented COMs to advance research within the profession. The ultimate goal was to develop many such research centers.
The success obtained by the profession’s investment in the ORC at UNTHSC is evident. But because its resources are finite, the profession must decide whether to continue to provide funds to the ORC at UNTHSC, which has a proven track record of success, or to use the available funds to support the development of another ORC. This would likely slow the progress of the ORC at UNTHSC, which might be harmful for the profession as a whole.
Funding an additional ORC or maintaining the one at UNTHSC is a real and difficult decision that the osteopathic profession faces. The leaders of the ORC at UNTHSC are among those most knowledgeable concerning the need for its own continued infrastructure support and the impact this funding can have on the profession’s research goals. However, when the ORC leaders attempt to advise the profession regarding the need for continued ORC funding, no matter how true and critical their message, their advocacy inevitably appears self-serving.
Critical Nature of Research Teams and Career Paths
The early success of the national ORC at UNTHSC is the result of an investment in the creation of critical research teams and career paths.
A research team is a collection of researchers who work together in close proximity and have a common research focus. Such a concentration of talent fosters and enables intellectual cross-fertilization and research collaborations that otherwise might not occur. A research team like the one found at the ORC at UNTHSC, which includes both basic scientists and clinician researchers, fosters bench-to-bedside research progress. In this era of high competition for research funding, proposals that do not include evidence of collaborations across disciplines and translational research have little chance of gaining funding. Creation of research teams at the ORC has been indispensable for its success.
A research career path is a recognizable, financially reliable, and predictable career path for a research scientist or physician. For most established lines of research (e.g., cancer, cardiovascular studies), new research talent comes from students, postdoctoral fellows, and residents who are mentored by well-established investigators. In these areas, a well-established career path that leads junior investigators to progressively more responsible positions exists. In academic institutions, the path typically begins with becoming an instructor, an assistant, then associate, and finally a full professor. Well-trained physicians, basic scientists, and social scientists receive promotions as they obtain progressively larger research funding from the NIH or elsewhere and as their prestige as researchers grows.
However, investigators interested in manual medicine research have had a problem. In the 1990s, the AOA was the only reliable source of funding for research topics of unique interest to osteopathic physicians. However, it funded fewer than 10 projects per year, each for less than $50,000 per year. Furthermore, it did not allow any of the funds to support faculty salary. In short, until recently, no recognizable reliable career path in the area of manual medicine research has existed.
The creation and development of the NIH NCCAM in the late 1990s provided the first real opportunity for university faculty members to develop a career path focused on research in OMM. The temporal convergence in this first decade of the 21st century of the creation of the ORC at UNTHSC by the collaborative efforts of the osteopathic profession’s leading organizations, the existence of NIH NCCAM, and the availability of significant funding from private osteopathic foundations has, for the first time, created a research career path for faculty interested in areas unique to osteopathic medicine. The availability of funding and the publication of studies by the ORC at UNTHSC and other COMs indicating that OMM can play a strong role in health care are likely to entice osteopathic medical and graduate students, resident physicians, and young clinicians to this area of research. If they perceive a stable commitment of funding for such research during the next 10 to 20 years, they will become the next generation of manual medicine researchers.
Few appreciate the high cost involved in the development and maintenance of a research center or the fragility of such an organization. As funding decreases, researchers seek new and more reliable career paths. As individuals choose new career paths, the research team disperses. The leaders who created the ORC used research teams and career paths to create state-of-the-art research and research training programs on OMM. Creating and sustaining a national ORC and/or regional ORCs is critical to the development of OMM research career paths. Sustained infrastructure support for the ORC at UNTHSC and the stepwise development of additional ORCs is necessary if the true potential of OMM is to be objectively evaluated and understood.