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THE DEVELOPMENT AND FUNDING [CARE AND FEEDING] OF A RESEARCH PROPOSAL:
A REVIEW OF THE PROCESS OF GRANT APPLICATIONS TO FCER

In its 64 years of existence, FCER — with the assistance of the National Chiropractic Mutual Insurance Company and the ACA — can take pride in its provision of nearly $10M for research and postgraduate study. This communication will address the issue of the funding of research, for which FCER has provided at least 160 grants to individuals mostly at chiropractic and non-chiropractic institutions but occasionally in private practice as well.

Among the chiropractic colleges that have benefited from recent research grant support are National, Northwestern, Palmer, Los Angeles, and Logan Colleges of Chiropractic, as well as New York, Canadian Memorial, Western States, and Life West Chiropractic Colleges. Non-chiropractic colleges and universities which have received grant funding either individually or in collaboration with researchers at the aforementioned chiropractic institutions include Harvard, Yale, Kansas State, and Arizona State Universities--as well as the Universities of Calgary, California [Los Angeles], Illinois [Chicago], Iowa, Saskatchewan, and Toronto. Finally, clinics and institutes which have been FCER grant recipients are represented by the RAND Corporation; Abt Associates, Inc.; the Duke Center for Clinical Health Policy Research; Colorado Prevention Center; Institute for Alternative Futures; the Pacific Health Institute; the Tokyo Metropolitan Institute of Gerontology; and the Trends Research Institute.

Compared to federal grants, research grants awarded by FCER are comparatively modest, ranging from our lowest recent award of $1,965 to $746,522 awarded to the RAND Corporation nearly 10 years ago to conduct a nationally representative study of the use of chiropractic services. Typically, awards for clinical trial pilot projects may run from $40,000-$180,000, whereas full-scale clinical trials may range from about $100,000 to $350,000. The design of our program is to not only conduct investigations in areas of high priority [to be addressed below], but to enable researchers to obtain more robust and presumably longer-term funding from federal and other outside sources. It is important to recall that, up until less than 10 years ago, virtually no federal funds had ever been awarded for chiropractic research.1 As of 1998, however, nearly $7.5M of federal grants pertaining to chiropractic research could be identified, virtually all having been supported with pilot and preliminary projects that were originally funded by FCER! In this manner, FCER can serve as a bridge to the dedicated and productive researcher in obtaining more substantial and long-term funding.

 

I.  Funding Priorities: 

A.  The Disease model:

Often labeled as specialists, chiropractors have commonly faced the responsibility of treating patients with specific conditions. Numerous anecdotal and case reports, in addition to handful of clinical trials, have recently emerged to support the effectiveness of chiropractic care in the management of conditions beyond low-back pain. These include:

  1. Upper cervical conditions;

  2. Headache;

  3. Carpal tunnel syndrome:

  4. Fibromyalgia, arthritis and other muscular conditions;

  5. Pulmonary and cardiac disorders [asthma, hypertension, and angina];

  6. Neurological problems [Bell’s palsy, cerebral palsy, epilepsy];

  7. Gastrointestinal syndromes [irritable bowel syndrome, ulcers];

  8. Chronic fatigue and chronic fatigue syndrome.

To gain credibility, chiropractic interventions regarding any of the above conditions [or others in addition to back problems] depend upon appropriate research, the design of which is to be discussed below.

At the same time, the identification of new groups of patients is a high priority for future chiropractic research. This would involve women [obstetric and gynecological disorders, such as premenstrual syndrome, chronic pelvic pain and dysmenorrhea], children and infants [otitis media, colic, enuresis, scoliosis, hyperactivity, and attention deficit disorders], and elderly populations.

B.       The Wellness Model:

A basic tenet of chiropractic theory envisions chiropractors being able to forestall or prevent specific conditions from emerging through the treatment of subluxations through the application of chiropractic adjustments. A broader school of clinicians has engaged in nutrition/diet and lifestyle/ergonomic counseling in the effort to treat or prevent diseases. With the problems of effective health care reform, cost control, and effective primary care becoming national priorities within the past year, FCER seeks research efforts involving chiropractic care that are addressed to diet and nutrition as well as ergonomic issues, maintenance and prevention.

A major outcome of documenting both an expanded list of conditions treated by chiropractic intervention and establishing chiropractic as means for preventative health care is the establishment of the chiropractor as a primary health care physician. Given the recent growth of managed health care systems, having the chiropractor function as the first point of contact as well as a referral service is a matter of great priority. It should thus be readily apparent why publishing the research to document both parts (A) and (B) of this discussion is of major importance.

C.       Basic Research:

Within the past decade, chiropractic research has attracted the interests of basic scientists as well as clinicians. Thus, one finds biochemists, clinical chemists, biostatisticians, epidemiologists, and more and more M.D.’s taking an active interest and role in chiropractic research. This is not unlike the advent of molecular biology in the early 1950’s, when the interests of chemists, mathematicians, and physicists converged with those of the biologists to propose a working model of DNA that in turn led to an explosion of discoveries in cellular biology and medicine.

If chiropractic researchers are to be truly conversant with research interests that stand to add as much to chiropractic theory as the Watson-Crick model of nucleic acids added to our understanding of cell biology, we must look to relevant basic research interests as well as the applied. This would include more thorough understanding of such areas as:

  1. The biomechanics of the spine, loading, adjustments, and repetitive stress;

  2. Electromyographic or biochemical characteristics of muscle, ligaments, or soft tissue presumed to be involved in pain;

  3. The physiological and molecular basis of receptors, nerve transmission [including signal transduction], and neuroplasticity;

  4. The chemical and molecular basis of immunological functions in relation to chiropractic intervention;

  5. The chemical and molecular basis of nutrition;

  6. Healthy and unhealthy states and alterations of analytes in the blood, urine, and lymph systems.

D.      Verification of Instruments, Design, and Data Processing Techniques:

To support outcomes and basic research, the validity of any measurement and evaluation techniques employed must be clearly established. This includes the verification of various types of apparatus, questionnaires, and statistical procedures. At the same time, recent structural flaws have called into question the validity of experimental designs long considered to be “gold standards,” such as randomized clinical trials.

So called “sham” procedures, thought to represent placebo controls in randomized clinical trial, have been observed to produce reflex effects of their own; as contact procedures with the patient, they could not possibly represent all that does not occur when a patient undergoes chiropractic care. 

While chiropractic intervention undoubtedly has gained virtually mainstream status in the management of low-back pain by dint of well-crafted clinical trials which have been published in the indexed journals within the past two decades, it has also had to endure studies of questionable execution and/or interpretation which have appeared within the past year in The New England Journal of Medicine and Pain. This raises the need to add new and better-crafted clinical trials to the chiropractic research literature, in addition to new case and cohort studies which, after all, represent the observational efforts from which all clinical trials are ultimately designed. 

E.       Economic and Practice Patterns of Chiropractic Care:

As managed health care comes to the forefront of the health care reform debate, cost-benefit data concerning alternative health therapies will undoubtedly become increasingly important to third-party providers as they consider and approve covered services. Thus it is to the benefit of the profession to provide data addressed to the comparative costs of traditionally covered [allopathic] and chiropractic modalities. FCER’s research interests extend to topics involving both the economic and practice patterns of chiropractic care. This concern includes cost-effectiveness and patient satisfaction as additional indices with which to assess chiropractic care in relation to other health care modalities.

F.       Educational Research:

Given the increasing importance of proper accreditation and the inevitable comparisons that are made between the chiropractic education process and that of other healthcare professions, a major priority has been to focus many of our research capabilities upon the actual chiropractic program of instruction itself. In particular, we need to ask:

  1. What models of clinical training are appropriate for achieving either a successful specialist or generalist role?

  2. What models of research training may be incorporated into the educational program?

  3. How can we integrate the named techniques into the formal educational program based on evidence?

  4. What are the best means available for training and enhancing the effectiveness of preceptors?

  5. How may competencies in delivering patient-centered care be developed and monitored?

G.       Psychosocial Aspects:

Especially within the past two decades, all healthcare professions have become increasingly aware of the importance of the psychological status of the patient in both resisting and overcoming disease. Extremely high patient satisfaction has always been a hallmark of chiropractic health care, and this has now been recognized to the point at which the better-designed clinical trials must now assess patient attitudes and expectations in addition to what are usually considered to be the more “objective” outcomes. Chronic pain, on the other hand, is now understood to have a major psychosocial component which takes into account the patient’s own perception of well-being or its opposite. In terms of the necessary research which must document these phenomena, we need to know, for example:

  1. In what ways does the satisfaction and expectation of the patient affect the quantity and quality of visits to the practitioner?

  2. In what ways is the patient affected by non-therapeutic [placebo] effects?

  3. What is the role in choosing a provider in producing therapeutic effects?

  4. What are the elements of therapist-patient interaction leading to more effective patient responses?

  5. How are patient beliefs formed with regard to therapists, treatments, and health in general?

To summarize, seven lines of investigation are woven together in the chiropractic research efforts to be supported by FCER: somatovisceral and musculoskeletal outcomes research; basic research [including biomechanics]; wellness and prevention; the verification of instruments, design and data processing techniques; economic and practice patterns of chiropractic care; educational research; and psychosocial issues. These areas, therefore, form the nucleus of the research objectives and scope of interest at FCER.

Concise summaries of the actual research which has brought chiropractic to its current level of recognition are available in previous publications.2-4

II.  Designs of the Research

It has to be understood that the entire spectrum of clinical research methodology must be embraced to build the future knowledge base of chiropractic or any health profession. In order to assure a balanced program of clinical investigations, FCER encourages not only randomized clinical trials, but prospective, retrospective, and single case studies to be included in the mix of research efforts.

 

The most elaborate and publicized multisite, blinded, crossover and placebo-controlled randomized clinical trials all had their beginnings with “lowly” case studies—and so the research objectives of the profession within the next few years are necessarily predicated upon the observations gleaned from every clinician’s office. It is part of FCER’s mission to reach out to these locales and encourage the research development of practitioners whose work is deemed promising and within scientific guidelines. We would only expect that sound rationales and complete literature reviews be included in the research proposals submitted to us.

 

The rules for designing effective basic and instrumentation research do not follow all the guidelines for clinical investigations that were just discussed; rather, they require concise statements of the hypotheses, a consideration of possible complications that may be anticipated in the research, and, above all, a clear discussion as to how the problem to be considered relates to chiropractic health care.

III.  Housekeeping Issues: The Research Proposal

The grant application itself is submitted on a multipage form available from FCER [380 Wright Road, P.O. Box 400, Norwalk, IA 50211; Tel. 515-981-9888; Fax 515-981-9427; Email FCER@fcer.org]. Nine copies of the application may be submitted for consideration for deadlines of either March 1 or October 1 of any year. In addition to containing demographic and biographical information [including publications] of the principal investigators, it includes a detailed budget form which requires justification for each item entered and a form which certifies that the application has been adequately reviewed by an impartial ethics committee which does not have a vested interest in the research proposal.

The heart of the proposal, however, is the research plan, a narrative which must not exceed 25 pages of text [excluding appendices, figures, and references]. Its purpose is not only to convey the purpose of the research plan [by addressing the gaps of knowledge which exist in this area with a substantial review of the background literature], but to [i] convey the specific hypotheses to be tested and the methodology for doing so and to [ii] convince the reviewers of the application that the investigative team is both sufficiently prepared and capable of accomplishing the outlined research with the time period proposed. This entails presenting as much background material published and preliminary experiments performed by the research team as possible.

To this end, the applicant must reflect a thorough knowledge of the problem area. This means competence and most likely a track record as well. Overall, the proposal needs to answer three basic questions: [i] What do we already know or do; [ii] How does the particular question under study relate to what we already know or do; and [iii] Why select the particular method(s) proposed? The best proposals make the reviewers’ tasks easy, informative, and enjoyable. This means that the following attributes are essential: [i] Superior organization, clarity, and accessibility; [ii] clear, unpretentious and nonpolemical writing style; and [iii] an uninterrupted chain of thinking providing ample refutation to the time-honored retort of the delightfully caustic writer Dorothy Parker: “Your train of thought has left the station!”

Completed applications which fit within our areas of funding priorities are referred to a committee of external reviewers in chiropractic research and related fields for scientific review. Approximately 10 weeks after the deadline dates, blinded reviewers’ comments are returned to the applicants in order to give the applicant some idea of how they are faring in the competition. Applicants have the right to respond and/or refute the criticisms contained in the critiques in writing, although this by no means guarantees a positive funding decision. Typically, grant submissions require an average of 2 submissions in different application cycles to satisfy most or all of the reviewers’ criticisms—although there have been instances in which more minor points of critique have been answered in letter form within a single grant review cycle. Funding decisions are made after an internal review of each grant application has been made by the Research Committee of FCER. On the average funding of about 15-20% of the 10-15 grant applications received during any funding cycle can be expected. This figure is actually quite similar to the percentage of grant applications funded by the NIH during any submission cycle.

REFERENCES:

1Corporate Health Policies Group. An evaluation of federal funding policies and programs and their relationship to the chiropractic profession. Arlington, VA: Foundation for Chiropractic Education, 1991.

2Rosner AL. Musculoskeletal disorders research. In Redwood D [ed]. Contemporary Chiropractic. New York, NY: Churchill Livingstone, 1997, pp. 163-187.

3Rosner A. The Role of Subluxation in Chiropractic. Foundation for Chiropractic Education and Research, Arlington, VA, 1997.

4Rosner A. The Chronicity of Pain in Patients. Foundation for Chiropractic Education and Research, Des Moines, IA, 1999.

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