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2013 Osteopathic Strategic Plan for Research

Introduction
Research is not an option within a comprehensive medical profession, but rather is an ethical and societal obligation. Osteopathic medicine has a legacy as a distinct model of medical practice, whose methods have been disseminated and incorporated into many levels of the healthcare system, but whose comprehensive application of the model remains a unique characteristic of and challenge to the profession. The osteopathic philosophy not only challenges its practitioners to provide the most up-to-date care based on population-based research and subsequent practice standards, but also requires insightful and individualized patient-specific care. Such care consists not only of active and relentless advocacy for the evaluation and treatment of the multi-dimensional needs of patients, but also requires active and insightful investigation that contributes to the rapidly expanding scientific knowledge base. Success in fulfilling these roles requires astute planning, active engagement of the plan from all sectors of the profession and routine assessment and refinement of the plan. This strategic plan is the product of a nine month process, monitored by a large constituency within the osteopathic profession and incorporating the views of diverse groups of invested parties. The subheadings of the plan are consistent with those used in the 2003 Synergy White Paper (see Appendix A) to promote continuity of thought and facilitate the monitoring of key perspectives and goals over time. The plan consists of: SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis of research in osteopathic manipulative medicine in light of the 2003 Synergy White Paper goals Current research activities within the profession A concise proposal for a 2013-2023 Research Strategic Plan for the profession.

The 2003 Synergy White Paper specifically focused on OMM research. While OMM remains a priority in this strategic plan, this plan is not limited to OMM research in recognition that the profession has roles in supporting a broader range of clinically relevant research.

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Part I: Summary of the 2012 SWOT Analysis Considering Research Activities Occurring Over the Past Decade.

SUCCESSES/STRENGTHS
Funding and Resources Reinstitution of AOA funding Matching AOA funding from Osteopathic Heritage Foundations (OHF) Establishment of Research Chairs by the OHF Research Activities Faculty based: Improved quality and breadth of ongoing research at subset of COMs
Substantial increase in publications (evidence base) compared to previous decades

More osteopathic students involved in research Ongoing research programs in neuromusculoskeletal research and OMT and other clinically
important areas.

Council of Research feedback that there exists improved rigor in AOA/OHF funded grants Researcher feedback that there has been an increased number of osteopathic researchers
presenting work at major scientific conferences

Physician-in-training based: Increased number of students participating in AOA annual research conference Improved quality of student presentations at conference Research Training
Increased number of students enrolled in and completing dual degree programs More schools providing research based dual degrees. Recent osteopathic graduates, trained in evidence-based medicine, have increased opportunity and background to advance the profession in science.

Infrastructure Expansion of schools/graduates increases potential for future research More schools providing research-based dual degrees. Greater recognition of the need to develop a strong evidence base for OMM and what is required
to achieve this goal

Draft: August 11, 2012 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 Health Policy Leadership Greater recognition of the need to develop a strong evidence base for OMM and what is required
to achieve this goal

Increased presence of DO representation at NIH

Other

WEAKNESSES
Funding and Resources
Lack of meaningful funding for establishing competitive lines of research for federal funding Few clinicians are able to develop rigorous research methodologies Limited priority in hiring and supporting clinician researchers into academic institutions

Research Activities
Few colleges are actively engaged in research and nearly none submit for NIH funding in the OMT domain. Limited number of research groups sustaining consistent directions of research Lack of consensus regarding definition of evidence-based medicine

Research Training There is inconsistent attention paid to maintaining a rigorous evidence-base from which training
programs are developed The most current research outcomes are inconsistently or not at all incorporated into osteopathic manipulative medicine training programs There is an inadequately trained / resourced research workforce that has the necessary skills to succeed in preparing and implementing and OMM-centric research projects. Training programs are not producing an adequate number of competent clinician researchers Limited effectiveness of annual research conference - There are not enough quality venues and at the same time too many venues (thus diluting impact) to bring together basic scientists and OMM clinicians in a way that encourages dialogue and collaborative research efforts.

Draft: August 11, 2012 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 Infrastructure Limited number of faculty in OMT Departments Inconsistent training of OMT Department faculty in the the domain of evidence-based medicine as
it specifically relates to training students in OMT. Lack of substantial research across the Colleges of Osteopathic Medicine. It appears that the Colleges of Osteopathic Medicine under priotize and undervalue research, and as a result, underresource research programs aimed at advancing research, including that related to OMM. Lack of infrastructure to assess the current clinical utilization and impact of OMM.

Health Policy
Diminishing reimbursement for OMT

Leadership Lack of a coordinated, effective and substantial leadership within most administrations of the
colleges of osteopathic medicine and the American Osteopathic Association (AOA) promoting research, particularly in OMT Lack of clear action plans and timelines for engaging osteopathic research within colleges of osteopathic medicine Lack of a systematic monitoring of research activities, such as o number of those performing research o number and impact of peer reviewed publications o number of students performing research o number of students receiving dual degrees o the whereabouts of highly trained DO clinician researchers and whether they continue to carry out OMT research Lack of incorporating modern evidence (research outcomes) into osteopathic manipulative medicine training programs

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OPPORTUNITIES
Funding and Resources
New funding and research development opportunities with FORCE

Research Activities Field wide open for research in osteopathic manipulative medicine. Interest in manual therapies has become entrenched in several disciplines. Many disciplines are
interested in knowing what is effective in manual therapies. There are numerous opportunities for collaboration Increasing the quality of research will have a significant effect on the quality of education and future DOs. Increasing quality of evidence will increase credibility of the approach, changing what has been complementary into a standard of care methodology. There is a federal expectation that conferences within a field (ie. manual medicine) should become interdisciplinary to improve productivity and translation of findings across a broader research and clinical environment.

Research Training Pairing osteopathic clinicians/students with trained basic scientists from osteopathic and
allopathic institutions to create productive research teams

Infrastructure Expansion of schools/graduates increase potential for future research by faculty and for training
clinician researchers

Health PolicyLeadership Within manual therapy disciplines, the DO (full medical license) provides osteopathic physicians
the opportunity to broaden research questions and designs, thus putting DOs in a leadership role in directing and performing research within manual therapy. Hiring scientists with skills in priority areas of research for the profession and medicine in general (i.e., viscerosomatic reflexes, placebo effect, patient-physician relationship) Within manual therapy disciplines, the DO (full medical license) provides osteopathic physicians the opportunity to broaden research questions and designs, thus putting DOs in a leadership role in directing and performing research within manual therapy. Other: Compared to other manual medicine disciplines, DOs are able to research broader areas of manipulative medicine beyond only musculoskeletal and pain conditions Overall the osteopathic paradigm is unique compared to other disciplines using manual therapy, requiring broader perspectives in designing research

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Education and research are indelibly intertwined. Increasing the quality of research will have a significant effect on the quality of education and future DOs. Increasing quality of evidence will increase credibility of the approach. Help in reviewing evidence for dissemination through educational programs and marketing of identity

THREATS
Funding and Resources
Poor economic climate threatens even existing federal and foundational funding mechanisms

Research Activities
Loss of matching funds from OHF There is not a long term commitment for meaningful funding for research from the AOA/membership of AOA Unable to compete for federal funding Fear to investigate areas of dogma Fear to perform collaborative research with non-osteopathic scientists/clinicians in areas of dogma

Research Training Current evidence-based research is inconsistently incorporated into training programs By not actively incorporating premier evidence within our educational programs, students will not
respect and thus engage osteopathic principles and practices in their practice.

Over interpreting or misinterpreting current evidence in manipulative medicine since research in

this field has not been rigorously/adequately designed and performed

Failing to establish adequate training to maintain and improve osteopathic physician skills in
diagnostic and therapeutic palpation. This limits the ability to have clinicians whose skills will represent the potential of the osteopathic approach. Failure to demonstrate distinctiveness, first to those within the profession, particularly current students. Failure to investigate and educate osteopathic students aspects of patient care historically unique to osteopathic medicine beyond manipulative medicine

Infrastructure Not establishing an effective infrastructure to promote, facilitate, and monitor osteopathic
research, resulting in the inability to provide evidence what is occurring within osteopathic medicine/research to all levels of the healthcare system The expansion of schools without active commitment to extending the research base into those programs

Health Policy
Lack of payment for services

Draft: August 11, 2012 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 If the osteopathic profession fails to actively engage manipulative medicine research, deciding
outright to isolate itself from research opportunities or by lack of decision not to engage others performing research in this field, the profession will lose its distinctiveness and its heritage.

Leadership Lack of substantial, clear and coordinated leadership by most administrations of the colleges of
osteopathic medicine and the American Osteopathic Association (AOA) to promote research, particularly in OMT Lack of clear action plans and timelines for engaging osteopathic research within most of the colleges of osteopathic medicine Lack of a systematic monitoring of research activities, such as o number of those performing research o number of peer reviewed publications o number of students performing research o number of students receiving dual degrees Lack of incorporating modern evidence (research outcomes) into osteopathic manipulative medicine training program

Draft: August 11, 2012 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 In each section, the strategic goal followed by the rationale for the goal is given. Funding and Resources
All institutions and members within the osteopathic profession need to directly support fiscally the research efforts. o A matching $50.00/yr by clinicians and students for funding research. Those colleges who actively engage the research agendawill quickly recoup their investment. All contributors will receive the benefit of establishing an evidence base Broadening eligibility for funding so that the best research is being supported, no matter where it occurs o While funding should be prioritized at osteopathic institutions, funds should be directed to the researchers who have the greatest likelihood of advancing the practice of osteopathic medicine Mechanisms to promote collaboration with leading researchers. o Review process of grants should provide extra points to those projects that meet this standard Establish specific requests for proposals to help assure that a focus of research meets the threshold for impacting the scientific community and health policy.

Part II: 2013 2023 Strategic Plan

Research Activities Faculty based:

Establish and empower a structure to monitor, assess, and promote research within the profession. Such a structure must have strong leadership from the colleges and post graduate training programs as well as the AOA. Bench marks and timelines are to be managed by this group. Points for monitoring: Funded research Researchers performing OMM research Publications national and international Dual track DO students and the jobs they obtain after graduation Evidence-based training activities

To broaden the research infrastructure for the profession, a system from mentorship between established, successful researchers and young clinician and basic science researchers needs to be established. o Through the training programs and grant applications, talented and passionate clinicians or basic scientists should receive special mentorship and support. This could be done in conjunction with conferences and technology mediated interactions. Improve grant review process by having all funded investigators participate in grant and abstract reviews and require all funded individuals to present their progress at yearly venues.

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Physician-in-training based: TBD

Research Training
Promote a system to rigorously assess the literature and disseminate conclusions to the training programs o This should be done by a combination of representatives from the Educational Council on Osteopathic Principles and accomplished researchers. o Evidence-based teaching modules need to be developed and disseminated for incorporation into pre- and post-graduate training programs.

Infrastructure Health Policy Leadership

AOA needs to establish visionary research directives connected to the accreditation standards for colleges and hospitals. Establishing priority areas of research to help focus and assure success of the research directions for the profession Development of a system to annually assess research activities at the college campuses.

Other Scientific conferences need to be modernized to meet the goals of increasing education and collaboration of the professions researchers, to increase the quality and impact of the research being performed, and to collaborate with other manual medicine disciplines. o One model for change would be to host/participate every three years in an interdisciplinary research conference/congress, and on the alternative years, have a conference specifically for researchers and clinician researchers in training and one where the program is truly integrated into OMED wherein selected keynote speakers are the professions premier researchers so most if not all specialty college members are updated on the latest evidence on osteopathic principles and practices and the osteopathic professions contribution to the general medical system. Additionally, a prominent osteopathic researcher should be invited to sit annually on the OMED organizing / planning committee in order to ensure that the OMT research priority and agenda are center stage during critical times of the annual meeting o Since the poster session seems to run well at OMED, perhaps the morning could be set up for student research presentations and training sessions and the afternoon be maintained for the poster session.

Draft: August 11, 2012 316 317 2003 Strategic Plan Goals 1. Approve the White Paper on National OMM Research Synergy and the attached OMM Research Synergy Conclave Strategic Plan for discussion and use it as a template for identifying and allocating resources to promote OMM research and research synergy. 2. Support actions to maintain and increase financial and human resources for OMM research. Table 1: Reasons for limited accomplishments from the 2003 Synergy White Paper (reprinted in Appendix A) Accomplishments Received support by AAO, Council of Research, and AOA? Reason for limited progress/impact There was no group with assigned leadership and responsibilities to use document for allocating resources and research promotion

Currently being used as a template for strategic planning

3. Adopt mechanisms for implementing and testing research-related undergraduate and postgraduate Clinical Research Competencies throughout the professions educational system. 4. Analyze existing policies and implement new strategies to optimize timely publication/dissemination of OPP/OMM research and integration to maximize impact within the profession and in healthcare. 5. Investigate and implement synergistic strategies for increasing the number of quality OMM researchers and rewarding career researchers and mentors. 6. Seek profession-wide collaboration to maintain and support a long-range

Lost AOA funding for 3 years during the past decade. Re-initiation of funds was increased by matching funds by the Osteopathic Heritage Foundations. Awaiting update, ORC

Current funding is consistent with the funding of two pilot projects at the NIH level.

Awaiting update, ORC

New policies have been developed and established by Council of Research.

There has been a significant increase (3 fold) in the number of OMM articles published in peer reviewed journals

Not performed

No group of leaders designated to perform this duty. Strategies with a system for meaningful accountability is needed. No organizational structure with authority has been assigned this

Not performed ORT dissolved in 2004.

Draft: August 11, 2012 strategic plan designed to expand and disseminate the OMM evidence base. This plan should be reviewed and updated annually by the Osteopathic Research Task Force. 7. Maintain and expand ongoing support for the profession-wide resources developed to support the specifics of OMM research citations, discussion, conduct, activity, etc (ORC, OSTMED , Glossary of Osteopathic Terminology, National Thesaurus, Foundations for Osteopathic Medicine text, National Clinical Research Database, electronic SOAP note, etc). 8. Support the Osteopathic Research Task Force and the National OMM Research Synergy Conclave in their leadership roles. task.

Partial accomplishments were made. 3rd ed FOM completed. COM has not been successful in meeting this goal even though funding was available. Check with VCOM and UNTHS

No organizational structure with authority has been assigned this task.

Dissolved in 2004. Some of the taskforce roles were assumed by the OCR but were not continued in 2008.

Lack of consistent leadership driving the research agenda. Primary function of the Council of Research has been managing grants and the annual scientific meeting

9. Continue to provide financial support and staff resources to support the annual Osteopathic Collaborative Clinical Trials Initiative Conference (OCCTIC). 318 319

Financial support and staff resources were assumed by the ORC when ORT dissolved. No designated funding was given to the ORC for this purpose.

Draft: August 11, 2012 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 For more than 40 years, leaders of the osteopathic profession have declared the need for solid clinical research studies to evaluate the efficacy of osteopathic manipulative medicine. Advocates of osteopathic medicine such as George Northrup2, Norman Gevitz3 and Michael In this era of modern health care, insurers, policy makers and consumers are interested in evidence-based medicine. Therefore, it is of paramount importance for physicians to document, through well-designed and well-executed research studies, which specific aspects of the clinical care they provide to patients are proven to be beneficial. This is particularly true in osteopathic medicine. Instead of saying, we know it works because patients get better, the profession must channel its resources to determine through scientific research studies whether osteopathic manipulative medicine (OMM) does indeed improve patient outcomes in a broad range of specific situations. The profession must also elucidate the mechanisms by which this unique, hands-on approach to patient care works. This is a paper discussing the imperatives associated with current and future research efforts into the efficacy of osteopathic manipulative medicine (OMM). It provides a brief overview of the background and significance of OMM research to the osteopathic profession and to the public, a summary of accomplishments to date, a description of the National OMM Research Synergy Conclave and recommendations for action. This paper is intended to educate, inform and inspire members of the osteopathic medical profession, policy makers, funding organizations and others interested in validating the efficacy of OMM, as well as those interested in understanding the underlying mechanisms of OMM. Members of the National OMM Research Synergy Conclave believe that the greatest challenge facing the osteopathic profession today is that of building its research base to support and expand its claims of efficacious and unique practices. Without demonstrable substantiation of its claims to a unique role in health care, the osteopathic profession risks its existence.1 Appendix: 2003 Strategic Plan

Osteopathic Manipulative Medicine Research: A 21st Century Vision

National OMM Research Synergy White Paper
Prepared by the Research Synergy Conclave, a subcommittee of the Osteopathic Research Task Force Introduction

Draft: August 11, 2012 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 Organizations represented through the Osteopathic Research Task Force and others within the osteopathic profession understand the vital importance of expanding the evidence base that supports osteopathic diagnosis, treatment and integrated OMM healthcare practices, but none is capable of carrying the entire research agenda alone. Many significant and positive changes have occurred in the clinical OMM research activities of the profession in the past five years including the development of the national Osteopathic Research Center. Several of these initiatives have been outgrowths of a series of Osteopathic Clinical Collaborative Trials Initiative Conferences (OCCTIC). The ORT, who is responsible for planning these annual conferences, determined that research synergy and a cohesive, directed plan was essential to focusing limited resources into a timely research agenda. In June 2003, a sub-committee of the Osteopathic Research Taskforce7, representing 12 national osteopathic medicine researchrelated organizations, convened a National Research Synergy Conclave to study the current state of OMM research and research training. Their findings are reported in this white paper. In 1996, the Macy Foundation issued a report on the status of osteopathic and allopathic medicine in which it concluded, the United States of America benefits from two parallel but distinct medical systems,5 which is predicated on the potential of each to contribute uniquely and synergistically to healthcare in this country. The Macy Report notes the specific need for expanding the evidence-base and demonstrating the mechanisms of action and clinical outcomes associated with osteopathic manipulative treatment (OMT). Patterson4 have said numerous times that the future of osteopathic medicine and its unique approach to patient care is in the hands of the profession itself. This future must include a focus on evidence-based medicine that evaluates the efficacy of the osteopathic approach to healing and wellness.

The Present and Future of Osteopathic Manipulative Medicine Research

Osteopathic Manipulative Medicine (OMM) is the application of osteopathic philosophy, structural diagnosis, and the use of OMT in the diagnosis and management of the patient.6 Research in this arena explores and documents what is unique about the osteopathic physicians approach to patient care. Therefore, it makes logical sense that the osteopathic profession would concentrate the majority of its research efforts and resources in this arena. If the osteopathic profession does not commit to documenting the benefits of its unique approach to patient care, the professions very existence may be compromised, and certainly, future growth opportunities will be seriously limited. Many osteopathic organizations have a research arm, but there has been a lack of a unified strategic plan to develop the agenda of OMM clinical research across the profession. To this end, the Osteopathic Research Task Force (ORT) was created and supported by key osteopathic educational, research and professional organizations to help foster cooperation and collaboration across the profession in order to enhance the quality and quantity of uniquely osteopathic research.

Draft: August 11, 2012 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 Three other key areas that the group marked for major improvements were the areas of research activities, research training and infrastructure. In order to develop a culture of research within the profession, several changes need to be made across the educational system. For example, a few colleges of osteopathic medicine have listed OMM research as an institutional priority and have begun to fund these initiatives. They also have created a structure that protects faculty time for research and provides incentives for faculty who conduct research. Until a vast majority of the 20 osteopathic medical schools make the same type of commitment to funding, protected faculty time and incentive programs, the profession will have a difficult time reaching its goals in the OMM research arena. In addition to providing a system that fosters the development of faculty researchers, it is critical that all 20 colleges of osteopathic medicine One key source of funding for pilot studies in the profession is provided by the American Osteopathic Association through the Bureau of Osteopathic Clinical Education and Research. Members of the Conclave are asking that the AOA continue to preserve monies in the Osteopathic Research Development Fund exclusively for research, that the AOA commit a specific amount of money to fund well-designed pilot studies each year, and that the dollar amount committed be honored regardless of investment returns. The most critical area of need identified by the group was the tenuous nature of funding available within the profession for pilot studies. Pilot studies are the first step in the approximately decade-long process it takes to produce a NIH-level researcher.8 Through these early grants, researchers learn how to develop a research hypothesis, write a well-designed study, and be accountable for disseminating the results of the study to the scientific community. Pilot grants set the stage for projects that may ultimately be funded by NIH or other federal granting agencies if the data shows that the concept being considered could improve health. Members of the Research Synergy Conclave would like to see a minimum of $500,000 set aside by the profession each year to help fund pilot studies. If targeted appropriately and with appropriate investigator accountability, this investment could support several carefully crafted pilot studies and well conceived multi-center collaborative trials that would generate findings worthy of applying for larger studies through the National Institutes of Health and other federal funding sources such as the Department of Defense by the end of a five-year period. Using a specific strategic planning process, the members of the Conclave identified six main components of a strategic plan that would propel the profession forward in its pursuit of the vision to position osteopathic medicine as an evidence-based form of health care by the year 2013, and to have key health care policy making bodies recognize and value the contributions that osteopathic physicians make to health. These six areas are: funding and resources, research activities, research training, infrastructure, health policy issues and leadership. Accomplishments and recommendations for further growth in each of these six areas are discussed throughout this white paper.

Draft: August 11, 2012 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 develop and implement curriculum changes that train osteopathic medical students in minimum research competencies. A list of minimum research competencies has been developed by staff of the national Osteopathic Research Center, and has been broadly endorsed by many key osteopathic organization involved in OMM research. Not only do minimum research competencies need to an integral part of the undergraduate curriculum, research competencies need to be integrated at the graduate medical education level as well. Finally, a mechanism to evaluate students knowledge of core research competencies needs to be developed and implemented. Including questions about research competencies on all three levels of the Comprehensive Osteopathic Medical Licensure Examination (COMLEX) would be a logical way to test students knowledge of research concepts. Another major problem area identified by members of the Research Synergy Conclave that is affected by insufficient research to document the efficacy of osteopathic manipulative medicine pertains to reimbursement to osteopathic physicians for providing osteopathic manipulative treatment to patients. Without an adequate evidence base, third-party payers will continue to be reluctant reimburse osteopathic physicians for using OMT in their clinical practices. If osteopathic physicians do not receive adequate reimbursement for OMT, they will be reluctant to use these techniques to care for patients. The last area identified by the Conclave as essential to promoting the OMM research agenda across the profession is leadership. While many osteopathic institutions and organizations have a research arm in place, the lack of a cohesive strategic plan and the inability of any single group to function in a leadership capacity have been two key factors limiting the success of OMM clinical research. In recent months, the Osteopathic Research Task Force has worked to fill this void, which is logical because the majority of osteopathic organizations and institutions involved in clinical OMM research activities are represented on the task force.

Current Strengths of OMM Clinical Research

Members of the Conclave felt that in the past five years, the osteopathic profession had made a great deal of progress in the area of OMM research. Contributions to this progress include: Research Activities More osteopathic medical schools are conducting OMM clinical research; A few colleges of osteopathic medicine have created and supported OMM research centers within their institutions; Seventy five percent of principal investigators and co-investigators of AOA-funded clinical research studies are OMM specialists; There has been a modest increase in the number of D.O./Ph.D. researchers participating in clinical research efforts; Several multi-center, single-site and federally-funded clinical trials are underway that set the stage for future studies. This represents a significant move forward for the profession. Research Training

Draft: August 11, 2012 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 The National OMM Research Synergy Conclave looked at challenges facing the profession relative to OMM research in six major areas. Student demand for research training opportunities has increased, and student involvement in the research activities of professional osteopathic organizations has increased; Several colleges of osteopathic medicine have created combined degree opportunities for osteopathic physicians-in-training to obtain master of science, master of public health, and/or Ph.D. degrees; A few osteopathic postdoctoral training institutions have created support structures and policies to advance osteopathic research during residency training; The profession has secured and established a K-30 grant for training osteopathic medical students in clinical research through the national Osteopathic Research Center. Infrastructure Creation of the Osteopathic Research Task Force to provide synergistic leadership for the profession in this area. The Task Force consists of members from several majors osteopathic organizations;9 Development of an annual collaborative clinical research conference focused on OMM research (OCCTIC); Creation of a national Osteopathic Research Center; Osteopathic physicians from the United States are significantly represented on the scientific committees of international osteopathic and manual medicine organizations involved in research design; Several tools have been developed or are currently being developed that will be critical pieces of the professions OMM research infrastructure. These tools include the Ostmed literature database, the osteopathic thesaurus, the AACOM Clinical Research Database, the electronic SOAP Note and the national clinical database. Leadership The core group of people who represent the organizations involved in osteopathic research in this country have passion, communicate often and have common nomenclature. This core group has come to consensus on what needs to be done.

Challenges Facing the Osteopathic Profession in the OMM Research Arena

Despite the significant progress that has been made relative to expanding OMM clinical research in the past five years, significant challenges remain that are hindering the profession from making the progress in this area that will allow the profession to document the unique contributions it makes to healthcare in the United States and around the world.

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Funding and Resources A lack of adequate money to fund pilot projects and to develop the infrastructure required at colleges of osteopathic medicine that will foster an environment conducive to enhancing research activities is the biggest obstacle the profession faces in moving the clinical research agenda forward in the area of OMM research. Funding for pilot studies is minimal, and sources within the profession are tenuous at best. A consistent stream of funding for pilot projects would help place the clinical OMM research agenda on a fast track to success if managed correctly. Research Activities There is an insufficient number of OMM research studies underway, and an insufficient number of OMM studies measure relevant clinical outcomes or mechanisms of action; Inadequate interactions between basic and clinical scientists hinder optimal resource use within the profession to advance research of underlying mechanisms; Inadequate vehicles for disseminating research results inhibit the professions ability to garner recognition and credibility from research data as it becomes available; An inadequate supply of trained researchers significantly inhibits the professions ability to carry out OMM research activities at the level required to demonstrate the efficacy of the osteopathic approach to patient care; A lack of accountability for researchers impacts funding sources, and very often, pilot projects are funded when the researcher has not presented a plan for expanding that research question beyond the pilot study; Osteopathic physicians who are non-OMM specialists question OMM research relevance to their own clinical practices; No central data pool is universally accessible to those seeking information about previous OMM research studies. Research Training There are insufficient opportunities for research training in OMM, and an insufficient number of influential, high-quality research mentors in OMM; There are no broadly adopted minimum research competencies in osteopathic medical education, and there is no standardized assessment of research competencies; There is a lack of defined coordination of research learning objectives, and a lack of research opportunities for training for undergraduate medical education; There is no NIH-supported osteopathic medical scientist training program (MSTP); There is no identified mechanism to train and support mid-career physician scientists; There is a no dedicated pool of money for timely resident and student research. Infrastructure

Draft: August 11, 2012 570 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586 587 588 589 590 591 592 593 594 595 596 597 598 599 600 601 602 603 604 605 606 607 608 609 610 611 612 613 Many colleges of osteopathic medicine have not made the commitment required to develop the infrastructure and environment that fosters a culture of research. This results in small pockets of research activity in the profession, and makes developing a profession-wide culture of research very difficult. Health Policy There is a general paucity of evidence-based medicine to justify reimbursement. Because of this lack of evidence-based research, insurance companies do not understand OMM. Further complicating the reimbursement situation, OMM specific parameters are not recorded in a consistent manner; The evidence-base that does exist is not recorded or disseminated in a manner sufficient to impact stakeholders and health policy decision-makers; Few people in the profession have been trained to know how to integrate the knowledge gained through OMM research studies and apply it to clinical practice and to the educational curriculum; There has been poor communication of these critical OMM research issues between OMM researchers, OMM research oriented committees and organizations, and the AOA leadership. Leadership Unclear OMM research priorities and little coordination between organizational strategies leads to a lack of cohesiveness in OMM research that will be required to move the profession forward in this area; The small cadre of people pushing the OMM clinical research agenda forward for the profession is at serious risk of burnout because these individuals are carrying a heavy load for the profession without adequate human and financial resources; The Osteopathic Research Task Force, and it subcommittee the National OMM Research Synergy Conclave, have not been given formal, broadly recognized authority to serve as the strategic leader of OMM research efforts, yet this is precisely where leadership in OMM research is occurring.

Recommendations for Enhancing OMM Research

There are many opportunities to enhance the quality and quantity of OMM research currently being conducted in the United States. A small group of researchers and other professionals in the osteopathic profession have demonstrated that they can make significant progress with few human and financial resources. These individuals are passionate about and committed to developing the evidence base necessary to demonstrate how the uniqueness of the osteopathic approach to patient care impact the health of the nation in a positive manner. They also are extremely dedicated and work well together. With an increase in human and financial resources, progress would increase exponentially.

Draft: August 11, 2012 614 615 616 617 618 Members of the National OMM Research Synergy Conclave make the following recommendations for serious consideration and implementation by osteopathic institutions and organizations.

Draft: August 11, 2012 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 644 645 646 647 648 649 650 651 652 653 654 655 656 657 658 659 660 661 662 663 664 665 666 667 668 In order to move the OMM Research Agenda forward and foster a culture of research across the osteopathic profession, the Conclave asks that the Colleges of Osteopathic Medicine consider implementing the following: Funding and Resources Allocate financial resources to fund well-designed pilot studies. Research Activities Make OMM research a priority on each institutions research agenda; Increase the number of non-institutional and career researchers in OMM; Increase the quality of OMM research being conducted; Increase the amount of D.O./Ph.D. collaboration; Collaborate within the profession on OMM research; Cultivate strategic research collaboration outside the profession designed to gain expertise, credibility, or funding to benefit OMM research in the long run; Create opportunities for novice researchers; Develop, validate and distribute pertinent research instruments and tools; Recognize and reward research excellence; Have more physicians use a patient satisfaction tool in their prospective outcome studies. Research Training Integrate minimum research competencies endorsed by osteopathic organizations into each colleges curriculum in order to insure that the next generation of osteopathic physicians is better able to understand the fundamentals of research and its importance to clinical practice, which will enhance the quality of OMM research being conducted; Develop, adopt and review on accreditation visits a vertically-integrated curriculum of general research fundamentals for pre- and post-doctoral training; Encourage more students to pursue dual degrees that provide research training so that more individuals in the next generation of osteopathic physicians will have the proper training to choose OMM research as a career track; Develop training programs for current faculty that teach the fundamentals of research so faculty can better mentor students in this area, and so they themselves can become leaders in the OMM clinical research arena; Develop a long-range plan for continuing expanding research studies beyond the pilot data phase; Encourage dual-degree candidates, residents and graduate physicians to emphasize OMM research; Develop and design a delivery system for an OMM research-specific curriculum and written materials; Recognize that early introduction to research training will be most cost-effective; Educate and engage basic scientists and osteopathic physician researchers who are nonOMM specialists to include OMM in their research; Partner with non-osteopathic research organizations to develop research training programs. Infrastructure Protect time for faculty to participate in and spearhead clinical studies in OMM; Develop and implement a system of incentives that encourage rather than inhibit faculty involvement in clinical research studies to increase the number of career researchers in OMM; Have COM senior administration lead OMM research support.

Draft: August 11, 2012 669 670 671 672 673 674 675 676 677 678 679 680 681 682 683 684 685 686 687 688 689 690 691 692 693 694 695 696 697 698 699 700 701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 716 In order to move the OMM Research Agenda forward and foster a culture of research across the osteopathic profession, the Conclave asks that the osteopathic professional organizations including the AOA, AACOM, ORT and osteopathic foundations consider implementing the following: Funding and Resources Allocate financial resources to fund pilot projects; Develop a system of accountability for researchers who receive funds that requires them to publish the results of their findings in a timely manner, and that requires researchers to present a plan with their request for funding that articulates how they will take pilot studies to the next level. No request for funding should be approved without these elements; Increase OMM research funding as a priority within osteopathic organizations; Increase osteopathic representation in funding organizations outside the osteopathic profession; Research Activities Recognize that improved quality and increased publication of OMM research will attract funding; Conduct collaborative research with established researchers in other institutions and/or fields; Conduct collaborative research with 3rd party payers. Health Policy Issues Translate results of studies into practice; Recognize that the Health Policy Fellowship can focus research toward application; Make results of relevant osteopathic research understandable and available to health policy stakeholders; Encourage use of standardized documentation tools in clinical practice; Educate insurance companies about the OMM evidence base; Educate people on positive impact of OMM on the process of care. Leadership Coordinate profession-wide OMM research strategies; Establish a system of recognition for OMM research; Develop a clearinghouse for OMM research data, topics, and outcomes; Improve the quality and quantity of OMM research journals, particularly JAOA; Establish a premier research conference and enhance research conferences as a vehicle for training; Collaborate with outside international and national groups with the potential to value and support the OMM evidence base; Continue to communicate outcomes of osteopathic clinical research studies to a broad range of audiences; Facilitate the development of regional or topical OMM think tanks; Coordinate the various think tanks toward synergistic goals; Enlist new individuals from OMM and non-OMM organizations into leadership roles; Disseminate think tank conclusions to appropriate organizations and constituents; Develop white papers and strategic plans on issues of OMM research.

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Conclusion The osteopathic manipulative medicine evidence base needs to be expanded exponentially in a short period of time. Given todays emphasis on evidencebased medicine, it is critical that the osteopathic profession study and evaluate the efficacy of the osteopathic approach to patient care in a timely and scientifically rigorous manner, and that it investigate mechanisms of action where possible. The results of evidence-based research on osteopathic manipulative medicine will be a key component of many areas of the profession including in education, clinical care, health policy and reimbursement. This issue must be of the highest priority for the osteopathic profession. The elements identified by the Task Force that would create the greatest opportunity for the profession to succeed should be adopted by osteopathic organizations and colleges of osteopathic medicine.
Key action steps include: 10. Approve the White Paper on National OMM Research Synergy and the attached OMM Research Synergy Conclave Strategic Plan for discussion and use it as a template for identifying and allocating resources to promote OMM research and research synergy. 11. Support actions to maintain and increase financial and human resources for OMM research. 12. Adopt mechanisms for implementing and testing research-related undergraduate and postgraduate Clinical Research Competencies throughout the professions educational system. 13. Analyze existing policies and implement new strategies to optimize timely publication/dissemination of OPP/OMM research and integration to maximize impact within the profession and in healthcare. 14. Investigate and implement synergistic strategies for increasing the number of quality OMM researchers and rewarding career researchers and mentors. 15. Seek profession-wide collaboration to maintain and support a long-range strategic plan designed to expand and disseminate the OMM evidence base. This plan should be reviewed and updated annually by the Osteopathic Research Task Force. 16. Maintain and expand ongoing support for the profession-wide resources developed to support the specifics of OMM research citations, discussion, conduct, activity, etc (ORC, OSTMED , Glossary of Osteopathic Terminology, National Thesaurus, Foundations for Osteopathic Medicine text, National Clinical Research Database, electronic SOAP note, etc). 17. Support the Osteopathic Research Task Force and the National OMM Research Synergy Conclave in their leadership roles. 18. Continue to provide financial support and staff resources to support the annual Osteopathic Collaborative Clinical Trials Initiative Conference (OCCTIC).

References and Notes

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Patterson MM. Osteopathic research: challenges of the future. In: Ward RC (ed). Foundations for Osteopathic Medicine (2nd Edition). Baltimore, MD: Lippincott Williams & Wilkins; 2003:1219-1228. 2 Northup GW. An adventure in excellence. J Am Osteopathic Assoc 2001;101(12)726-730. 3 Gevitz N. Parallel and distinctive: The philosophic pathway for reform in osteopathic medical education. J Am Osteopathic Assoc 1994: 94 (4) 328-332. 4 Patterson MM. Osteopathic research: challenges of the future. In: Ward RC (ed). Foundations for Osteopathic Medicine (2nd Edition). Baltimore, MD: Lippincott Williams & Wilkins; 2003:1219-1228. 5 Current Challenges to M.D.s and D.O.s, A conference sponsored by the Josiah Macy, Jr. Foundation. Report published by the Josiah Macy, Jr. Foundation, New York, New York; 1996. 6 Patterson MM. Osteopathic research: challenges of the future. In: Ward RC (ed). Foundations for Osteopathic Medicine (2nd Edition). Baltimore, MD: Lippincott Williams & Wilkins; 2003:1219-1228. 7 Educational Council on Osteopathic Principles. Glossary of Osteopathic Terminology. In: Ward RC (ed). Foundations for Osteopathic Medicine (2nd Edition). Baltimore, MD: Lippincott Williams & Wilkins; 2003:1229-1253. 8 Members of the National OMM Research Synergy Conclave are: Michael Clearfield, D.O., representing the American Osteopathic Association Bureau of Research, Patrick Coughlin, Ph.D., representing the American Association of Colleges of Osteopathic Medicine and basic scientists, des Anges Cruser, Ph.D., representing the national Osteopathic Research Center, Brian Degenhardt, D.O., representing the A.T. Still Research Institute of the A.T. Still University-Kirksville College of Osteopathic Medicine, Kari Hortos, D.O., representing the Association of Directors and Medical Educators, Cathleen Kearns, representing the American Association of Colleges of Osteopathic Medicine, Michael Kuchera, D.O., representing the OMM Research Center at the Philadelphia College of Osteopathic Medicine and the International Federation of Manual Musculoskeletal Medicine, David Russo, D.O., representing the Postgraduate American Academy of Osteopathy, Sandra Sleszynski, D.O., representing the American Academy of Osteopathys Louisa Burns Osteopathic Research Committee, Michael Smith, Ph.D., representing basic scientists, Scott Stoll, D.O., Ph.D. (chair), representing the national Osteopathic Research Center, and Student Doctor Heath White representing the Student Osteopathic Medical Association.
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Wolf, M. Clinical Research Career Development: The Individual Perspective Academic Medicine (77)11, p.1084-1088, (2002). Member organizations of the Osteopathic Research Task Force are the American Academy of Osteopathy, the American Association of Colleges of Osteopathic Medicine, the American Osteopathic Association, the American College of Osteopathic Family Physicians, the Association of Directors and Medical Educators, the American Osteopathic Hospital Association, the Council of Osteopathic Student Government Presidents, the International Federation of Manual/Musculoskeletal Medicine, the National Osteopathic Research Center, the National Undergraduate Fellows Academy, the Postgraduate American Academy of Osteopathy and the Student Osteopathic Medical Association. Representatives from the osteopathic research centers at the Kirksville College of Osteopathic Medicine of A.T. Still

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Draft: August 11, 2012 806 807 808 809 University and from the Philadelphia College of Osteopathic Medicine round out the task force membership.