8-11-2012 draft for wikispace osteopathic strategic plan for research

Draft: August 11, 2012

2013 Osteopathic Strategic Plan for Research 1

Introduction 2 3 Research is not an option within a comprehensive medical profession, but rather is an ethical 4 and societal obligation. Osteopathic medicine has a legacy as a distinct model of medical 5 practice, whose methods have been disseminated and incorporated into many levels of the 6 healthcare system, but whose comprehensive application of the model remains a unique 7 characteristic of and challenge to the profession. The osteopathic philosophy not only 8 challenges its practitioners to provide the most up-to-date care based on population-based 9 research and subsequent practice standards, but also requires insightful and individualized 10 patient-specific care. Such care consists not only of active and relentless advocacy for the 11 evaluation and treatment of the multi-dimensional needs of patients, but also requires active and 12 insightful investigation that contributes to the rapidly expanding scientific knowledge base. 13 Success in fulfilling these roles requires astute planning, active engagement of the plan from all 14 sectors of the profession and routine assessment and refinement of the plan. 15

This strategic plan is the product of a nine month process, monitored by a large constituency 16 within the osteopathic profession and incorporating the views of diverse groups of invested 17 parties. The subheadings of the plan are consistent with those used in the 2003 Synergy White 18 Paper (see Appendix A) to promote continuity of thought and facilitate the monitoring of key 19 perspectives and goals over time. The plan consists of: 20

• SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis of 21 research in osteopathic manipulative medicine in light of the 2003 Synergy White 22 Paper goals 23

• Current research activities within the profession 24 • A concise proposal for a 2013-2023 Research Strategic Plan for the profession. 25

The 2003 Synergy White Paper specifically focused on OMM research. While OMM remains a 26 priority in this strategic plan, this plan is not limited to OMM research in recognition that the 27 profession has roles in supporting a broader range of clinically relevant research. 28

29


Part I: Summary of the 2012 SWOT Analysis Considering 30

Research Activities Occurring Over the Past Decade. 31

32 33 34 35 36 37

Funding and Resources 38

Reinstitution of AOA funding 39 Matching AOA funding from Osteopathic Heritage Foundations (OHF) 40 Establishment of Research Chairs by the OHF 41

Research Activities 42

Faculty based: 43

Improved quality and breadth of ongoing research at subset of COMs 44 Substantial increase in publications (evidence base) compared to previous decades 45 More osteopathic students involved in research 46 Ongoing research programs in neuromusculoskeletal research and OMT and other clinically 47

important areas. 48 Council of Research feedback that there exists improved rigor in AOA/OHF funded grants 49 Researcher feedback that there has been an increased number of osteopathic researchers 50

presenting work at major scientific conferences 51

Physician-in-training based: 52

Increased number of students participating in AOA annual research conference 53 Improved quality of student presentations at conference 54

Research Training 55

Increased number of students enrolled in and completing dual degree programs 56 More schools providing research based dual degrees. 57 Recent osteopathic graduates, trained in evidence-based medicine, have increased opportunity 58

and background to advance the profession in science. 59 60

Infrastructure 61

Expansion of schools/graduates increases potential for future research 62 More schools providing research-based dual degrees. 63 Greater recognition of the need to develop a strong evidence base for OMM and what is required 64

to achieve this goal 65 66 67

SUCCESSES/STRENGTHS


Health Policy - 68

Leadership – 69

Greater recognition of the need to develop a strong evidence base for OMM and what is required 70 to achieve this goal 71

Increased presence of DO representation at NIH 72

Other – 73 74 75 76 77 78 79 Funding and Resources 80

Lack of meaningful funding for establishing competitive lines of research for federal funding 81 Few clinicians are able to develop rigorous research methodologies 82 Limited priority in hiring and supporting clinician researchers into academic institutions 83


Few colleges are actively engaged in research and nearly none submit for NIH funding in the 85 OMT domain. 86

Limited number of research groups sustaining consistent directions of research 87 Lack of consensus regarding definition of evidence-based medicine 88


There is inconsistent attention paid to maintaining a rigorous evidence-base from which training 90 programs are developed 91

The most current research outcomes are inconsistently or not at all incorporated into osteopathic 92 manipulative medicine training programs 93

There is an inadequately trained / resourced research workforce that has the necessary skills to 94 succeed in preparing and implementing and OMM-centric research projects. 95

Training programs are not producing an adequate number of competent clinician researchers 96 Limited effectiveness of annual research conference - There are not enough quality venues and 97

at the same time too many venues (thus diluting impact) to bring together basic scientists and 98 OMM clinicians in a way that encourages dialogue and collaborative research efforts. 99

100

WEAKNESSES


Infrastructure 101

Limited number of faculty in OMT Departments 102 Inconsistent training of OMT Department faculty in the the domain of evidence-based medicine as 103

it specifically relates to training students in OMT. 104 Lack of substantial research across the Colleges of Osteopathic Medicine. It appears that the 105

Colleges of Osteopathic Medicine under priotize and undervalue research, and as a result, under-106 resource research programs aimed at advancing research, including that related to OMM. 107

Lack of infrastructure to assess the current clinical utilization and impact of OMM. 108 109

Health Policy – 110

Diminishing reimbursement for OMT 111 112

Leadership 113

Lack of a coordinated, effective and substantial leadership within most administrations of the 114 colleges of osteopathic medicine and the American Osteopathic Association (AOA) promoting 115 research, particularly in OMT 116

Lack of clear action plans and timelines for engaging osteopathic research within colleges of 117 osteopathic medicine 118

Lack of a systematic monitoring of research activities, such as 119 o number of those performing research 120 o number and impact of peer reviewed publications 121 o number of students performing research 122 o number of students receiving dual degrees 123 o the whereabouts of highly trained DO clinician researchers and whether they continue to 124

carry out OMT research 125 Lack of incorporating modern evidence (research outcomes) into osteopathic manipulative 126

medicine training programs 127

128


129 130 131


New funding and research development opportunities with FORCE 133


Field wide open for research in osteopathic manipulative medicine. 135 Interest in manual therapies has become entrenched in several disciplines. Many disciplines are 136

interested in knowing what is effective in manual therapies. There are numerous opportunities for 137 collaboration 138

Increasing the quality of research will have a significant effect on the quality of education and 139 future DOs. Increasing quality of evidence will increase credibility of the approach, changing what 140 has been complementary into a standard of care methodology. 141

There is a federal expectation that conferences within a field (ie. manual medicine) should 142 become interdisciplinary to improve productivity and translation of findings across a broader 143 research and clinical environment. 144


Pairing osteopathic clinicians/students with trained basic scientists from osteopathic and 146 allopathic institutions to create productive research teams 147

Infrastructure 148

Expansion of schools/graduates increase potential for future research by faculty and for training 149 clinician researchers 150

151

Health Policy- 152

Leadership 153

Within manual therapy disciplines, the DO (full medical license) provides osteopathic physicians 154 the opportunity to broaden research questions and designs, thus putting DOs in a leadership role 155 in directing and performing research within manual therapy. 156

Hiring scientists with skills in priority areas of research for the profession and medicine in general 157 (i.e., viscerosomatic reflexes, placebo effect, patient-physician relationship) 158

Within manual therapy disciplines, the DO (full medical license) provides osteopathic physicians 159 the opportunity to broaden research questions and designs, thus putting DOs in a leadership role 160 in directing and performing research within manual therapy. 161

Other: 162 163

Compared to other manual medicine disciplines, DOs are able to research broader areas of 164 manipulative medicine beyond only musculoskeletal and pain conditions 165

Overall the osteopathic paradigm is unique compared to other disciplines using manual therapy, 166 requiring broader perspectives in designing research 167

OPPORTUNITIES


Education and research are indelibly intertwined. Increasing the quality of research will have a 168 significant effect on the quality of education and future DOs. Increasing quality of evidence will 169 increase credibility of the approach. 170

Help in reviewing evidence for dissemination through educational programs and marketing of 171 identity 172

173 174 175 176 177


Poor economic climate threatens even existing federal and foundational funding mechanisms 179


Loss of matching funds from OHF 181 There is not a long term commitment for meaningful funding for research from the 182

AOA/membership of AOA 183 Unable to compete for federal funding 184 Fear to investigate areas of dogma 185 Fear to perform collaborative research with non-osteopathic scientists/clinicians in areas of 186

dogma 187


Current evidence-based research is inconsistently incorporated into training programs 189 By not actively incorporating premier evidence within our educational programs, students will not 190

respect and thus engage osteopathic principles and practices in their practice. 191 Over interpreting or misinterpreting current evidence in manipulative medicine since research in 192

this field has not been rigorously/adequately designed and performed 193 Failing to establish adequate training to maintain and improve osteopathic physician skills in 194

diagnostic and therapeutic palpation. This limits the ability to have clinicians whose skills will 195 represent the potential of the osteopathic approach. 196

Failure to demonstrate distinctiveness, first to those within the profession, particularly current 197 students. 198

Failure to investigate and educate osteopathic students aspects of patient care historically unique 199 to osteopathic medicine beyond manipulative medicine 200

Infrastructure 201

Not establishing an effective infrastructure to promote, facilitate, and monitor osteopathic 202 research, resulting in the inability to provide evidence what is occurring within osteopathic 203 medicine/research to all levels of the healthcare system 204

The expansion of schools without active commitment to extending the research base into those 205 programs 206

Health Policy – 207

Lack of payment for services 208

THREATS


If the osteopathic profession fails to actively engage manipulative medicine research, deciding 209 outright to isolate itself from research opportunities or by lack of decision not to engage others 210 performing research in this field, the profession will lose its distinctiveness and its heritage. 211

Leadership 212

Lack of substantial, clear and coordinated leadership by most administrations of the colleges of 213 osteopathic medicine and the American Osteopathic Association (AOA) to promote research, 214 particularly in OMT 215

Lack of clear action plans and timelines for engaging osteopathic research within most of the 216 colleges of osteopathic medicine 217

Lack of a systematic monitoring of research activities, such as 218 o number of those performing research 219 o number of peer reviewed publications 220 o number of students performing research 221 o number of students receiving dual degrees 222

Lack of incorporating modern evidence (research outcomes) into osteopathic manipulative 223 medicine training program 224 225

226

227

228

229

230

231

232

233

234

235

236

237


Part II: 2013 – 2023 Strategic Plan 238

239

In each section, the strategic goal followed by the rationale for the goal is given. 240


All institutions and members within the osteopathic profession need to directly support fiscally the 242 research efforts. 243

o A matching $50.00/yr by clinicians and students for funding research. Those colleges 244 who actively engage the research agendawill quickly recoup their investment. All 245 contributors will receive the benefit of establishing an evidence base 246

Broadening eligibility for funding so that the best research is being supported, no matter where it 247 occurs 248

o While funding should be prioritized at osteopathic institutions, funds should be directed to 249 the researchers who have the greatest likelihood of advancing the practice of osteopathic 250 medicine 251

Mechanisms to promote collaboration with leading researchers. 252 o Review process of grants should provide extra points to those projects that meet this 253

standard 254 Establish specific requests for proposals to help assure that a focus of research meets the 255

threshold for impacting the scientific community and health policy. 256


Faculty based: 258

Establish and empower a structure to monitor, assess, and promote research within the 259 profession. Such a structure must have strong leadership from the colleges and post graduate 260 training programs as well as the AOA. Bench marks and timelines are to be managed by this 261 group. 262 Points for monitoring: 263 Funded research 264 Researchers performing OMM research 265 Publications – national and international 266 Dual track DO students and the jobs they obtain after graduation 267 Evidence-based training activities 268 269

To broaden the research infrastructure for the profession, a system from mentorship between 270 established, successful researchers and young clinician and basic science researchers needs to 271 be established. 272

o Through the training programs and grant applications, talented and passionate clinicians 273 or basic scientists should receive special mentorship and support. This could be done in 274 conjunction with conferences and technology mediated interactions. 275

Improve grant review process by having all funded investigators participate in grant and abstract 276 reviews and require all funded individuals to present their progress at yearly venues. 277 278


Physician-in-training based: TBD 279


Promote a system to rigorously assess the literature and disseminate conclusions to the training 281 programs 282

o This should be done by a combination of representatives from the Educational Council on 283 Osteopathic Principles and accomplished researchers. 284

o Evidence-based teaching modules need to be developed and disseminated for 285 incorporation into pre- and post-graduate training programs. 286

Infrastructure 287

Health Policy 288

Leadership 289

AOA needs to establish visionary research directives connected to the accreditation standards for 290 colleges and hospitals. 291

Establishing priority areas of research to help focus and assure success of the research 292 directions for the profession 293

Development of a system to annually assess research activities at the college campuses. 294 295

296 Other – 297 298

Scientific conferences need to be modernized to meet the goals of increasing education and 299 collaboration of the profession’s researchers, to increase the quality and impact of the research 300 being performed, and to collaborate with other manual medicine disciplines. 301

o One model for change would be to host/participate every three years in an 302 interdisciplinary research conference/congress, and on the alternative years, have a 303 conference specifically for researchers and clinician researchers in training and one 304 where the program is truly integrated into OMED wherein selected keynote speakers are 305 the profession’s premier researchers so most if not all specialty college members are 306 updated on the latest evidence on osteopathic principles and practices and the 307 osteopathic profession’s contribution to the general medical system. Additionally, a 308 prominent osteopathic researcher should be invited to sit annually on the OMED 309 organizing / planning committee in order to ensure that the OMT research priority and 310 agenda are center stage during critical times of the annual meeting 311

o Since the poster session seems to run well at OMED, perhaps the morning could be set 312 up for student research presentations and training sessions and the afternoon be 313 maintained for the poster session. 314

315


Table 1: Reasons for limited accomplishments from the 2003 Synergy White Paper 316

(reprinted in Appendix A) 317

2003 Strategic Plan Goals Accomplishments Reason for limited progress/impact

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.

Received support by AAO, Council of Research, and AOA? Currently being used as a template for strategic planning

There was no group with assigned leadership and responsibilities to use document for allocating resources and research promotion

2. Support actions to maintain and increase financial and human resources for OMM research.

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

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

3. Adopt mechanisms for implementing and testing research-related undergraduate and postgraduate Clinical Research Competencies throughout the profession’s educational system.

Awaiting update, ORC Awaiting update, ORC

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.

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

5. Investigate and implement synergistic strategies for increasing the number of quality OMM researchers and rewarding career researchers and mentors.

Not performed No group of leaders designated to perform this duty. Strategies with a system for meaningful accountability is needed.

6. Seek profession-wide collaboration to maintain and support a long-range

Not performed – ORT dissolved in 2004.

No organizational structure with authority has been assigned this


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.

task.

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).

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.

8. Support the Osteopathic Research Task Force and the National OMM Research Synergy Conclave in their leadership roles.

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).

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

318

319


Appendix: 2003 Strategic Plan 320

Osteopathic Manipulative Medicine Research: A 21st 321

Century Vision 322

323 National OMM Research Synergy White Paper 324

325

Prepared by the Research Synergy Conclave, a subcommittee of the Osteopathic Research 326 Task Force 327 328

Introduction 329

330

This is a paper discussing the imperatives associated with current and future research efforts 331 into the efficacy of osteopathic manipulative medicine (OMM). It provides a brief overview of the 332 background and significance of OMM research to the osteopathic profession and to the public, a 333 summary of accomplishments to date, a description of the National OMM Research Synergy 334 Conclave and recommendations for action. This paper is intended to educate, inform and 335 inspire members of the osteopathic medical profession, policy makers, funding organizations 336 and others interested in validating the efficacy of OMM, as well as those interested in 337 understanding the underlying mechanisms of OMM. Members of the National OMM Research 338 Synergy Conclave believe that the greatest challenge facing the osteopathic profession today is 339 that of “building its research base to support and expand its claims of efficacious and unique 340 practices. Without demonstrable substantiation of its claims to a unique role in health care, the 341 osteopathic profession risks its existence.”1 342

343

In this era of modern health care, insurers, policy makers and consumers are interested in 344 evidence-based medicine. Therefore, it is of paramount importance for physicians to document, 345 through well-designed and well-executed research studies, which specific aspects of the clinical 346 care they provide to patients are proven to be beneficial. This is particularly true in osteopathic 347 medicine. Instead of saying, “we know it works because patients get better,” the profession must 348 channel its resources to determine through scientific research studies whether osteopathic 349 manipulative medicine (OMM) does indeed improve patient outcomes in a broad range of 350 specific situations. The profession must also elucidate the mechanisms by which this unique, 351 hands-on approach to patient care works. 352

353

For more than 40 years, leaders of the osteopathic profession have declared the need for solid 354 clinical research studies to evaluate the efficacy of osteopathic manipulative medicine. 355 Advocates of osteopathic medicine such as George Northrup2, Norman Gevitz3 and Michael 356


Patterson4 have said numerous times that the future of osteopathic medicine and its unique 357 approach to patient care is in the hands of the profession itself. This future must include a focus 358 on evidence-based medicine that evaluates the efficacy of the osteopathic approach to healing 359 and wellness. 360

361

In 1996, the Macy Foundation issued a report on the status of osteopathic and allopathic 362 medicine in which it concluded, the United States of America benefits from two parallel but 363 distinct medical systems,5 which is predicated on the potential of each to contribute uniquely and 364 synergistically to healthcare in this country. The Macy Report notes the specific need for 365 expanding the evidence-base and demonstrating the mechanisms of action and clinical 366 outcomes associated with osteopathic manipulative treatment (OMT). 367

368

The Present and Future of Osteopathic Manipulative Medicine Research 369 370

Osteopathic Manipulative Medicine (OMM) is the “application of osteopathic philosophy, 371 structural diagnosis, and the use of OMT in the diagnosis and management of the patient.”6 372 Research in this arena explores and documents what is unique about the osteopathic 373 physician’s approach to patient care. Therefore, it makes logical sense that the osteopathic 374 profession would concentrate the majority of its research efforts and resources in this arena. If 375 the osteopathic profession does not commit to documenting the benefits of its unique approach 376 to patient care, the profession’s very existence may be compromised, and certainly, future 377 growth opportunities will be seriously limited. Many osteopathic organizations have a research 378 arm, but there has been a lack of a unified strategic plan to develop the agenda of OMM clinical 379 research across the profession. To this end, the Osteopathic Research Task Force (ORT) was 380 created and supported by key osteopathic educational, research and professional organizations 381 to help foster cooperation and collaboration across the profession in order to enhance the 382 quality and quantity of uniquely osteopathic research. 383

384

Organizations represented through the Osteopathic Research Task Force and others within the 385 osteopathic profession understand the vital importance of expanding the evidence base that 386 supports osteopathic diagnosis, treatment and integrated OMM healthcare practices, but none 387 is capable of carrying the entire research agenda alone. Many significant and positive changes 388 have occurred in the clinical OMM research activities of the profession in the past five years 389 including the development of the national Osteopathic Research Center. Several of these 390 initiatives have been outgrowths of a series of Osteopathic Clinical Collaborative Trials Initiative 391 Conferences (OCCTIC). The ORT, who is responsible for planning these annual conferences, 392 determined that research synergy and a cohesive, directed plan was essential to focusing 393 limited resources into a timely research agenda. In June 2003, a sub-committee of the 394 Osteopathic Research Taskforce7, representing 12 national osteopathic medicine research-395 related organizations, convened a National Research Synergy Conclave to study the current 396 state of OMM research and research training. Their findings are reported in this white paper. 397


398

Using a specific strategic planning process, the members of the Conclave identified six main 399 components of a strategic plan that would propel the profession forward in its pursuit of the 400 vision to position osteopathic medicine as an evidence-based form of health care by the year 401 2013, and to have key health care policy making bodies recognize and value the contributions 402 that osteopathic physicians make to health. These six areas are: funding and resources, 403 research activities, research training, infrastructure, health policy issues and leadership. 404 Accomplishments and recommendations for further growth in each of these six areas are 405 discussed throughout this white paper. 406

407

The most critical area of need identified by the group was the tenuous nature of funding 408 available within the profession for pilot studies. Pilot studies are the first step in the 409 approximately decade-long process it takes to produce a NIH-level researcher.8 Through these 410 early grants, researchers learn how to develop a research hypothesis, write a well-designed 411 study, and be accountable for disseminating the results of the study to the scientific community. 412 Pilot grants set the stage for projects that may ultimately be funded by NIH or other federal 413 granting agencies if the data shows that the concept being considered could improve health. 414 Members of the Research Synergy Conclave would like to see a minimum of $500,000 set 415 aside by the profession each year to help fund pilot studies. If targeted appropriately and with 416 appropriate investigator accountability, this investment could support several carefully crafted 417 pilot studies and well conceived multi-center collaborative trials that would generate findings 418 worthy of applying for larger studies through the National Institutes of Health and other federal 419 funding sources such as the Department of Defense by the end of a five-year period. 420

421

One key source of funding for pilot studies in the profession is provided by the American 422 Osteopathic Association through the Bureau of Osteopathic Clinical Education and Research. 423 Members of the Conclave are asking that the AOA continue to preserve monies in the 424 Osteopathic Research Development Fund exclusively for research, that the AOA commit a 425 specific amount of money to fund well-designed pilot studies each year, and that the dollar 426 amount committed be honored regardless of investment returns. 427

428

Three other key areas that the group marked for major improvements were the areas of 429 research activities, research training and infrastructure. In order to develop a culture of research 430 within the profession, several changes need to be made across the educational system. For 431 example, a few colleges of osteopathic medicine have listed OMM research as an institutional 432 priority and have begun to fund these initiatives. They also have created a structure that 433 protects faculty time for research and provides incentives for faculty who conduct research. Until 434 a vast majority of the 20 osteopathic medical schools make the same type of commitment to 435 funding, protected faculty time and incentive programs, the profession will have a difficult time 436 reaching its goals in the OMM research arena. In addition to providing a system that fosters the 437 development of faculty researchers, it is critical that all 20 colleges of osteopathic medicine 438


develop and implement curriculum changes that train osteopathic medical students in minimum 439 research competencies. A list of minimum research competencies has been developed by staff 440 of the national Osteopathic Research Center, and has been broadly endorsed by many key 441 osteopathic organization involved in OMM research. Not only do minimum research 442 competencies need to an integral part of the undergraduate curriculum, research competencies 443 need to be integrated at the graduate medical education level as well. Finally, a mechanism to 444 evaluate students’ knowledge of core research competencies needs to be developed and 445 implemented. Including questions about research competencies on all three levels of the 446 Comprehensive Osteopathic Medical Licensure Examination (COMLEX) would be a logical way 447 to test students’ knowledge of research concepts. 448 449

Another major problem area identified by members of the Research Synergy Conclave that is 450 affected by insufficient research to document the efficacy of osteopathic manipulative medicine 451 pertains to reimbursement to osteopathic physicians for providing osteopathic manipulative 452 treatment to patients. Without an adequate evidence base, third-party payers will continue to be 453 reluctant reimburse osteopathic physicians for using OMT in their clinical practices. If 454 osteopathic physicians do not receive adequate reimbursement for OMT, they will be reluctant 455 to use these techniques to care for patients. 456 457 The last area identified by the Conclave as essential to promoting the OMM research agenda 458 across the profession is leadership. While many osteopathic institutions and organizations have 459 a research arm in place, the lack of a cohesive strategic plan and the inability of any single 460 group to function in a leadership capacity have been two key factors limiting the success of 461 OMM clinical research. In recent months, the Osteopathic Research Task Force has worked to 462 fill this void, which is logical because the majority of osteopathic organizations and institutions 463 involved in clinical OMM research activities are represented on the task force. 464 465

Current Strengths of OMM Clinical Research 466 467

Members of the Conclave felt that in the past five years, the osteopathic profession had made a 468 great deal of progress in the area of OMM research. Contributions to this progress include: 469 470

Research Activities 471 472 More osteopathic medical schools are conducting OMM clinical research; 473 A few colleges of osteopathic medicine have created and supported OMM research centers 474

within their institutions; 475 Seventy five percent of principal investigators and co-investigators of AOA-funded clinical 476

research studies are OMM specialists; 477 There has been a modest increase in the number of D.O./Ph.D. researchers participating in 478

clinical research efforts; 479 Several multi-center, single-site and federally-funded clinical trials are underway that set the 480

stage for future studies. This represents a significant move forward for the profession. 481 482

Research Training 483 484


Student demand for research training opportunities has increased, and student involvement 485 in the research activities of professional osteopathic organizations has increased; 486

Several colleges of osteopathic medicine have created combined degree opportunities for 487 osteopathic physicians-in-training to obtain master of science, master of public health, 488 and/or Ph.D. degrees; 489

A few osteopathic postdoctoral training institutions have created support structures and 490 policies to advance osteopathic research during residency training; 491

The profession has secured and established a K-30 grant for training osteopathic medical 492 students in clinical research through the national Osteopathic Research Center. 493

494

Infrastructure 495 496

Creation of the Osteopathic Research Task Force to provide synergistic leadership for the 497 profession in this area. The Task Force consists of members from several majors 498 osteopathic organizations;9 499

Development of an annual collaborative clinical research conference focused on OMM 500 research (OCCTIC); 501

Creation of a national Osteopathic Research Center; 502 Osteopathic physicians from the United States are significantly represented on the scientific 503

committees of international osteopathic and manual medicine organizations involved in 504 research design; 505

Several tools have been developed or are currently being developed that will be critical 506 pieces of the profession’s OMM research infrastructure. These tools include the Ostmed® 507 literature database, the osteopathic thesaurus, the AACOM Clinical Research Database, the 508 electronic SOAP Note and the national clinical database. 509

510

Leadership 511 512 The core group of people who represent the organizations involved in osteopathic research 513

in this country have passion, communicate often and have common nomenclature. This core 514 group has come to consensus on what needs to be done. 515

516

Challenges Facing the Osteopathic Profession in the OMM Research Arena 517 518

Despite the significant progress that has been made relative to expanding OMM clinical 519 research in the past five years, significant challenges remain that are hindering the profession 520 from making the progress in this area that will allow the profession to document the unique 521 contributions it makes to healthcare in the United States and around the world. 522

523

The National OMM Research Synergy Conclave looked at challenges facing the profession 524 relative to OMM research in six major areas. 525


526 Funding and Resources 527 528

A lack of adequate money to fund pilot projects and to develop the infrastructure required at 529 colleges of osteopathic medicine that will foster an environment conducive to enhancing 530 research activities is the biggest obstacle the profession faces in moving the clinical 531 research agenda forward in the area of OMM research. Funding for pilot studies is minimal, 532 and sources within the profession are tenuous at best. A consistent stream of funding for 533 pilot projects would help place the clinical OMM research agenda on a fast track to success 534 if managed correctly. 535

536

Research Activities 537 538

There is an insufficient number of OMM research studies underway, and an insufficient 539 number of OMM studies measure relevant clinical outcomes or mechanisms of action; 540

Inadequate interactions between basic and clinical scientists hinder optimal resource use 541 within the profession to advance research of underlying mechanisms; 542

Inadequate vehicles for disseminating research results inhibit the profession’s ability to 543 garner recognition and credibility from research data as it becomes available; 544

An inadequate supply of trained researchers significantly inhibits the profession’s ability to 545 carry out OMM research activities at the level required to demonstrate the efficacy of the 546 osteopathic approach to patient care; 547

A lack of accountability for researchers impacts funding sources, and very often, pilot 548 projects are funded when the researcher has not presented a plan for expanding that 549 research question beyond the pilot study; 550

Osteopathic physicians who are non-OMM specialists question OMM research relevance to 551 their own clinical practices; 552

No central data pool is universally accessible to those seeking information about previous 553 OMM research studies. 554

555

Research Training 556 557

There are insufficient opportunities for research training in OMM, and an insufficient number 558 of influential, high-quality research mentors in OMM; 559

There are no broadly adopted minimum research competencies in osteopathic medical 560 education, and there is no standardized assessment of research competencies; 561

There is a lack of defined coordination of research learning objectives, and a lack of 562 research opportunities for training for undergraduate medical education; 563

There is no NIH-supported osteopathic medical scientist training program (MSTP); 564 There is no identified mechanism to train and support mid-career physician scientists; 565 There is a no dedicated pool of money for timely resident and student research. 566 567

Infrastructure 568 569


Many colleges of osteopathic medicine have not made the commitment required to develop 570 the infrastructure and environment that fosters a culture of research. This results in small 571 pockets of research activity in the profession, and makes developing a profession-wide 572 culture of research very difficult. 573

574

Health Policy 575 576

There is a general paucity of evidence-based medicine to justify reimbursement. Because of 577 this lack of evidence-based research, insurance companies do not understand OMM. 578 Further complicating the reimbursement situation, OMM specific parameters are not 579 recorded in a consistent manner; 580

The evidence-base that does exist is not recorded or disseminated in a manner sufficient to 581 impact stakeholders and health policy decision-makers; 582

Few people in the profession have been trained to know how to integrate the knowledge 583 gained through OMM research studies and apply it to clinical practice and to the educational 584 curriculum; 585

There has been poor communication of these critical OMM research issues between OMM 586 researchers, OMM research oriented committees and organizations, and the AOA 587 leadership. 588

589

Leadership 590 591

Unclear OMM research priorities and little coordination between organizational strategies 592 leads to a lack of cohesiveness in OMM research that will be required to move the 593 profession forward in this area; 594

The small cadre of people pushing the OMM clinical research agenda forward for the 595 profession is at serious risk of burnout because these individuals are carrying a heavy load 596 for the profession without adequate human and financial resources; 597

The Osteopathic Research Task Force, and it subcommittee the National OMM Research 598 Synergy Conclave, have not been given formal, broadly recognized authority to serve as the 599 strategic leader of OMM research efforts, yet this is precisely where leadership in OMM 600 research is occurring. 601

602

Recommendations for Enhancing OMM Research 603 604

There are many opportunities to enhance the quality and quantity of OMM research currently 605 being conducted in the United States. A small group of researchers and other professionals in 606 the osteopathic profession have demonstrated that they can make significant progress with few 607 human and financial resources. These individuals are passionate about and committed to 608 developing the evidence base necessary to demonstrate how the uniqueness of the osteopathic 609 approach to patient care impact the health of the nation in a positive manner. They also are 610 extremely dedicated and work well together. With an increase in human and financial resources, 611 progress would increase exponentially. 612 613


Members of the National OMM Research Synergy Conclave make the following 614 recommendations for serious consideration and implementation by osteopathic institutions and 615 organizations. 616 617

618


In order to move the OMM Research Agenda forward and foster a culture of research 619 across the osteopathic profession, the Conclave asks that the Colleges of Osteopathic 620 Medicine consider implementing the following: 621 622

Funding and Resources 623 Allocate financial resources to fund well-designed pilot studies. 624 625 Research Activities 626 Make OMM research a priority on each institution’s research agenda; 627 Increase the number of non-institutional and career researchers in OMM; 628 Increase the quality of OMM research being conducted; 629 Increase the amount of D.O./Ph.D. collaboration; 630 Collaborate within the profession on OMM research; 631 Cultivate strategic research collaboration outside the profession designed to gain expertise, 632

credibility, or funding to benefit OMM research in the long run; 633 Create opportunities for novice researchers; 634 Develop, validate and distribute pertinent research instruments and tools; 635 Recognize and reward research excellence; 636 Have more physicians use a patient satisfaction tool in their prospective outcome studies. 637 638 Research Training 639 Integrate minimum research competencies endorsed by osteopathic organizations into each 640

college’s curriculum in order to insure that the next generation of osteopathic physicians is 641 better able to understand the fundamentals of research and its importance to clinical 642 practice, which will enhance the quality of OMM research being conducted; 643

Develop, adopt and review on accreditation visits a vertically-integrated curriculum of 644 general research fundamentals for pre- and post-doctoral training; 645

Encourage more students to pursue dual degrees that provide research training so that 646 more individuals in the next generation of osteopathic physicians will have the proper 647 training to choose OMM research as a career track; 648

Develop training programs for current faculty that teach the fundamentals of research so 649 faculty can better mentor students in this area, and so they themselves can become leaders 650 in the OMM clinical research arena; 651

Develop a long-range plan for continuing expanding research studies beyond the pilot data 652 phase; 653

Encourage dual-degree candidates, residents and graduate physicians to emphasize OMM 654 research; 655

Develop and design a delivery system for an OMM research-specific curriculum and written 656 materials; 657

Recognize that early introduction to research training will be most cost-effective; 658 Educate and engage basic scientists and osteopathic physician researchers who are non-659

OMM specialists to include OMM in their research; 660 Partner with non-osteopathic research organizations to develop research training programs. 661

662 Infrastructure 663 Protect time for faculty to participate in and spearhead clinical studies in OMM; 664 Develop and implement a system of incentives that encourage rather than inhibit faculty 665

involvement in clinical research studies to increase the number of career researchers in 666 OMM; 667

Have COM senior administration lead OMM research support. 668


669

In order to move the OMM Research Agenda forward and foster a culture of research 670 across the osteopathic profession, the Conclave asks that the osteopathic professional 671 organizations including the AOA, AACOM, ORT and osteopathic foundations consider 672 implementing the following: 673 674

Funding and Resources 675 Allocate financial resources to fund pilot projects; 676 Develop a system of accountability for researchers who receive funds that requires them to 677

publish the results of their findings in a timely manner, and that requires researchers to 678 present a plan with their request for funding that articulates how they will take pilot studies to 679 the next level. No request for funding should be approved without these elements; 680

Increase OMM research funding as a priority within osteopathic organizations; 681 Increase osteopathic representation in funding organizations outside the osteopathic 682

profession; 683 684

Research Activities 685 Recognize that improved quality and increased publication of OMM research will attract 686

funding; 687 Conduct collaborative research with established researchers in other institutions and/or 688

fields; 689 Conduct collaborative research with 3rd party payers. 690

691 Health Policy Issues 692 Translate results of studies into practice; 693 Recognize that the Health Policy Fellowship can focus research toward application; 694 Make results of relevant osteopathic research understandable and available to health policy 695

stakeholders; 696 Encourage use of standardized documentation tools in clinical practice; 697 Educate insurance companies about the OMM evidence base; 698 Educate people on positive impact of OMM on the process of care. 699

700 Leadership 701 Coordinate profession-wide OMM research strategies; 702 Establish a system of recognition for OMM research; 703 Develop a clearinghouse for OMM research data, topics, and outcomes; 704 Improve the quality and quantity of OMM research journals, particularly JAOA; 705 Establish a premier research conference and enhance research conferences as a vehicle 706

for training; 707 Collaborate with outside international and national groups with the potential to value and 708

support the OMM evidence base; 709 Continue to communicate outcomes of osteopathic clinical research studies to a broad 710

range of audiences; 711 Facilitate the development of regional or topical OMM think tanks; 712 Coordinate the various think tanks toward synergistic goals; 713 Enlist new individuals from OMM and non-OMM organizations into leadership roles; 714 Disseminate think tank conclusions to appropriate organizations and constituents; 715 Develop white papers and strategic plans on issues of OMM research. 716


717 Conclusion 718

719 The osteopathic manipulative medicine evidence base needs to be expanded 720 exponentially in a short period of time. Given today’s emphasis on evidence-721 based medicine, it is critical that the osteopathic profession study and evaluate 722 the efficacy of the osteopathic approach to patient care in a timely and 723 scientifically rigorous manner, and that it investigate mechanisms of action 724 where possible. The results of evidence-based research on osteopathic 725 manipulative medicine will be a key component of many areas of the profession 726 including in education, clinical care, health policy and reimbursement. This issue 727 must be of the highest priority for the osteopathic profession. The elements 728 identified by the Task Force that would create the greatest opportunity for the 729 profession to succeed should be adopted by osteopathic organizations and 730 colleges of osteopathic medicine. 731 732 Key action steps include: 733 734

10. Approve the White Paper on National OMM Research Synergy and the attached OMM 735 Research Synergy Conclave Strategic Plan for discussion and use it as a template for 736 identifying and allocating resources to promote OMM research and research synergy. 737

11. Support actions to maintain and increase financial and human resources for OMM research. 738 12. Adopt mechanisms for implementing and testing research-related undergraduate and 739

postgraduate Clinical Research Competencies throughout the profession’s educational 740 system. 741

13. Analyze existing policies and implement new strategies to optimize timely 742 publication/dissemination of OPP/OMM research and integration to maximize impact within 743 the profession and in healthcare. 744

14. Investigate and implement synergistic strategies for increasing the number of quality OMM 745 researchers and rewarding career researchers and mentors. 746

15. Seek profession-wide collaboration to maintain and support a long-range strategic plan 747 designed to expand and disseminate the OMM evidence base. This plan should be 748 reviewed and updated annually by the Osteopathic Research Task Force. 749

16. Maintain and expand ongoing support for the profession-wide resources developed to 750 support the specifics of OMM research citations, discussion, conduct, activity, etc (ORC, 751 OSTMED , Glossary of Osteopathic Terminology, National Thesaurus, Foundations for 752 Osteopathic Medicine text, National Clinical Research Database, electronic SOAP note, 753 etc). 754

17. Support the Osteopathic Research Task Force and the National OMM Research Synergy 755 Conclave in their leadership roles. 756

18. Continue to provide financial support and staff resources to support the annual Osteopathic 757 Collaborative Clinical Trials Initiative Conference (OCCTIC). 758

759

References and Notes 760 761

Draft: August 11, 2012 1 Patterson MM. Osteopathic research: challenges of the future. In: Ward RC (ed). Foundations 762

for Osteopathic Medicine (2nd Edition). Baltimore, MD: Lippincott Williams & Wilkins; 763 2003:1219-1228. 764

2 Northup GW. An adventure in excellence. J Am Osteopathic Assoc 2001;101(12)726-730. 765 3 Gevitz N. Parallel and distinctive: The philosophic pathway for reform in osteopathic medical 766

education. J Am Osteopathic Assoc 1994: 94 (4) 328-332. 767 4 Patterson MM. Osteopathic research: challenges of the future. In: Ward RC (ed). Foundations 768

for Osteopathic Medicine (2nd Edition). Baltimore, MD: Lippincott Williams & Wilkins; 769 2003:1219-1228. 770

5 Current Challenges to M.D.s and D.O.s, A conference sponsored by the Josiah Macy, Jr. 771 Foundation. Report published by the Josiah Macy, Jr. Foundation, New York, New York; 772 1996. 773

6 Patterson MM. Osteopathic research: challenges of the future. In: Ward RC (ed). Foundations 774 for Osteopathic Medicine (2nd Edition). Baltimore, MD: Lippincott Williams & Wilkins; 775 2003:1219-1228. 776

7 Educational Council on Osteopathic Principles. Glossary of Osteopathic Terminology. In: Ward 777 RC (ed). Foundations for Osteopathic Medicine (2nd Edition). Baltimore, MD: Lippincott 778 Williams & Wilkins; 2003:1229-1253. 779

8 Members of the National OMM Research Synergy Conclave are: Michael Clearfield, D.O., 780 representing the American Osteopathic Association Bureau of Research, Patrick Coughlin, 781 Ph.D., representing the American Association of Colleges of Osteopathic Medicine and basic 782 scientists, des Anges Cruser, Ph.D., representing the national Osteopathic Research Center, 783 Brian Degenhardt, D.O., representing the A.T. Still Research Institute of the A.T. Still 784 University-Kirksville College of Osteopathic Medicine, Kari Hortos, D.O., representing the 785 Association of Directors and Medical Educators, Cathleen Kearns, representing the American 786 Association of Colleges of Osteopathic Medicine, Michael Kuchera, D.O., representing the 787 OMM Research Center at the Philadelphia College of Osteopathic Medicine and the 788 International Federation of Manual Musculoskeletal Medicine, David Russo, D.O., 789 representing the Postgraduate American Academy of Osteopathy, Sandra Sleszynski, D.O., 790 representing the American Academy of Osteopathy’s Louisa Burns Osteopathic Research 791 Committee, Michael Smith, Ph.D., representing basic scientists, Scott Stoll, D.O., Ph.D. 792 (chair), representing the national Osteopathic Research Center, and Student Doctor Heath 793 White representing the Student Osteopathic Medical Association. 794

9 Wolf, M. Clinical Research Career Development: The Individual Perspective Academic 795 Medicine (77)11, p.1084-1088, (2002). 796

10Member organizations of the Osteopathic Research Task Force are the American Academy of 797 Osteopathy, the American Association of Colleges of Osteopathic Medicine, the American 798 Osteopathic Association, the American College of Osteopathic Family Physicians, the 799 Association of Directors and Medical Educators, the American Osteopathic Hospital 800 Association, the Council of Osteopathic Student Government Presidents, the International 801 Federation of Manual/Musculoskeletal Medicine, the National Osteopathic Research Center, 802 the National Undergraduate Fellows Academy, the Postgraduate American Academy of 803 Osteopathy and the Student Osteopathic Medical Association. Representatives from the 804 osteopathic research centers at the Kirksville College of Osteopathic Medicine of A.T. Still 805


University and from the Philadelphia College of Osteopathic Medicine round out the task 806 force membership. 807

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