February 2007

Clinical meaningfulness of the chiropractic adjustment

by Robert H. Blanks, PhD, President, Research and Clinical Science

Part III: Impact on public, private and self‑payers

There are four major stakeholders in the health care equation, each with a distinct vantage point of sometimes overlapping, but often conflicting interests: 1) patients and health providers, 2) the research community, 3) public/private third‑party payers, and 4) public health policy officials.

In the first two installments of this article series, I covered the perspectives of the patients and providers, and the research community. This month, I'll evaluate the motivation of those paying for health services that fall loosely into public (Medicare, Medicaid, Veterans Administration) and private (health insurance companies) sectors, and the patients themselves (i.e., self‑payers).

These articles were inspired by a recent report by Joseph C. Keating, Jr., PhD, entitled "The Challenge" that issues the "challenge" to the profession "to determine the clinical meaningfulness (or lack thereof) of subluxation‑syndrome."

Dr. Keating states that "we've talked about it for more than a century... no one disputes the existence of subluxations ... but the question has always been whether or not subluxations (or other segmental lesions) have health consequences (i.e., subluxation‑‑syndrome)."

The focus of these articles is research and the whether new areas of discovery have clinical meaningfulness, that is, whether the observed change or difference means something, or does not and should be ignored.

The clinical meaningfulness of a patient's outcome is determined by the perspective of the audience. Patients and health providers normally focus on specific health concerns and/or preventative and wellness care, often independent of cost. Third‑party payers, on the other hand, commonly judge the "value of health care" by the extent to which changes in health care costs lead to added patient benefits. From the perspective of third‑party payers, the clinical meaningfulness of a new technique or procedure must we weighed against other factors, not the least of which is cost.

Cost and risk management

Health care costs are likely to continue to rise because of advancing technology, changes in diagnosis and treatment, an aging population and increases in the frequency of chronic diseases. The latter is particularly important in driving the overall cost of health care. Chronic diseases such as cardiovascular disease, cancer and diabetes are now among the most common, costly and preventable of all health problems. Chronic diseases account for about 70% of the deaths reported in the United States each year and 70% of all health care costs. [1]

Chronic diseases are also the most preventable. By adopting a healthy lifestyle behavior (tobacco avoidance, eating nutritious meals, regular exercise, etc.) individuals can prevent or control the effects of these diseases. [1,2]

It's already been shown that individuals undergoing subluxation‑centered care (specifically, in the case of the published research study, Network Spinal Analysis) undergo major beneficial changes in their health lifestyle behavior.

In this large retrospective study, subjects undergoing regular care (average duration 21 mo; 2‑3 times/wk) reported an 8% reduction in smoking and 26% reduction in caffeine consumption. Moreover, 39‑46% reported major improvement in dietary practices (vegetarian diet, vitamin and organic food consumption), and 40‑46% adopted a program of regular exercise, meditation and use of relaxation techniques. [3] Such are the documented benefits of the "chiropractic lifestyle."

Additional preventative strategies (regular screening for cancers, blood analyses, etc.) can help patients avoid the debilitating complications of chronic disease; early detection and treatment of chronic diseases improves reduces the overall cost of treatment and dramatically enhances patient quality of life.

In this respect, we need to keep our eyes on novel programs that blend the benefits of regular chiropractic adjustments with lifestyle monitoring and risk assessment. These programs have become very popular among employers to improve the health status of their employees, and control runaway cost of employee health benefits.

Funding new technology

Who makes the decisions to fund new health technology? Regulatory authorities are the gatekeepers who allow new treatments into the medical marketplace. Research supporting new treatments is scrutinized carefully to ensure safety, efficacy, and quality. For example, for the US Food and Drug Administration (FDA) to approve new pharmaceuticals or medical devices, promotional claims must appear on the label or be readily available upon request. The research evidence supporting the safety and efficacy of the new product must be of high quality, as evidenced by publication in peer‑reviewed journals. Generally a minimum of two well‑controlled, clinical trials must support the promotional claims and these must be presented with fair balance.

Next, public‑ and private‑sector policy‑making agencies must examine the new technology to determine whether the new product adds value to the patients care, and is consistent with pricing, reimbursement rates, and formulary placement (in the case of new pharmaceuticals).

Often, the economic ramifications must be compared across competing therapeutic areas. Health policy groups, pricing and third‑party payers require other standards to assess differences between competing technologies.

Fortunately, new outcome measures have emerged that have allowed policy makers and third‑party payers to evaluate the cost‑benefit ratio from the perspective of the patient, i.e. patient‑centered outcomes.

The use of quality of life (QOL) assessment and quality adjusted life years (QALYs) are methods to assess the patients' own perception of their health, so data can be compared to the type and cost of care being received. [5]

Over the years, QALYs have become a standard reference for health economics [6], permitting the computation of cost‑effectiveness analysis. In short, the patient preference‑weighted QOL addresses the trade‑offs between "how long" vs. "how well" the person lives their life and have been used successfully in clinical studies across numerous studies such as rheumatoid arthritis, [7] immunodeficiency syndrome, arthritis and cystic fibrosis. [8]

The only way to bring forth the "value" of new technology for inclusion and third party payment is through research ... and clinical meaningfulness is a big part of this computation. However, regulatory and third party payers are demanding much more. The value of new treatments and measures demands evaluation of pricing, reimbursement, and formulary placement (for new drugs) discussions before public‑sector agencies can render decisions about the "value" of the new technology.

Paying their own way

There are serious economic reasons why many people must pay out of pocket for medical and health coverage. The number of Americans without insurance has increased since 1994 by an average of one million per year, and 2.4 million in 2002.

By 2002, 43 million Americans were uninsured, comprising 17.3% of the non‑elderly population. [9] Many Americans have lost coverage throughout the past decade because of the increasing cost of health insurance and decreased availability of employer‑based health insurance. [10]

However, for those with viable economic means, the decision to pay their own health services is complex. A number of health behavior change models and theories have been developed to explain why certain individuals maintain healthy lifestyle choices with often significant out‑of‑pocket costs. These include Transtheoretical Model/Stages of Change, Theory of Reasoned Action/Theory of Planned Behavior, and the Health Locus of Control model (see http://tinyurl.com/y86v7v for a full discussion of these theories.)

Although different, each of these models attempts to correlate the attitudes that predict behavior across a wide range of choice selection from buying cars, voting for political candidates, or performing certain health related activities (exercise, diet, etc.). Interestingly, the cost of the health lifestyle behavior can be a factor but it is less of a barrier when the subject has a strong belief or attitude towards the behavior.

As a number of studies have shown, chiropractic patients have a high level of satisfaction with the care they receive, which is consistent with the cognitive behavioral models and translates into a strong belief in the benefits of service.

In an earlier study of Network Spinal Analysis, the out‑of‑pocket cost for longitudinal care (which averaged 21 months at 2.1 times per week) was not a significant factor in the overall structural equation model linking subject belief and their utilization of chiropractic services. [3,4]

RCS research strategy

The research plan developed by RCS (Research & Clinical Science) is unique because it focuses on the health benefits of correcting vertebral subluxations.

Those involved in RCS believe strongly that what makes chiropractic distinct from other health care approaches are the specific chiropractic adjustments directed at reducing or correcting subluxations.

A clear definition of vertebral subluxation exists as articulated by the Association for Chiropractic Colleges: "A subluxation is a complex of functional and/or structural and/or pathological articular changes that compromise neural integrity and may influence organ system function and general health" (www.chirocolleges.org/paradigm_scopet.html).

The RCS research plan addresses this definition using a variety of research formats in a large practice‑based population. We believe this is the best way to establish chiropractic as health disciplines distinct from others (e.g., osteopathy and even physical therapy and medicine) that practice the common domain procedure of Spinal Manipulative Therapy (SMT).

Trying to establish a unique identity for chiropractic by competing in the medical symptom arena presents a number of problems. The areas where the greatest literature exists in support of SMT ‑‑ low back pain and headaches ‑‑ are symptoms that are poor indicators of underlying pathophysiology as indicated by the problems (and cost of treating) "medically unexplained symptoms."

This poorly understood class of symptoms is associated with high rates of disability. [12‑14]. Van Hemert et al. [15] estimate that over half of all appointments in one medical referral practice received a doubtful or no medical diagnosis.

In another study, a large survey of the number of unexplained symptoms in another multispecialty secondary medical care system in England averaged 21%. [16] In this group, gastroenterology and neurology had the largest number (50%) of referrals that were medically unexplained.

Medically unexplained symptoms account for 27‑33% in cardiology, rheumatology, orthopedics and ENT, a lower percent (11‑17%) in fields such as internal medicine, ophthalmology, pulmonology and general surgery and almost zero (3%) in dermatology.

Evidence indicates that iatrogenic factors such as inappropriate information, over‑investigation, and over‑treatment are common in the management of patients with medically unexplained symptoms. [17,18]

Of particular importance to chiropractors was the observation that abdominal pain, chest pain, headache and low back pain were commonly found to be medically unexplained.

Unfortunately, all patients with medically unexplained symptoms, including the poorly defined headache and low back pain patients, require extensive investigation and referral and thus account for a high proportion of health care costs. [13,14,20]

Thus, it seems unwise to focus the identify chiropractic on symptom relief, particularly in areas such as low back pain and headaches where there is poor diagnostic value and high cost.

However, a great deal of useful information can be gleaned from a study of medically unexplained symptom behavior.

The lack of correlation between symptoms and the degree of pathophysiologic findings has been examined along a behavioral continuum ranging from symptom amplification at one end to symptom dampening at the other. [21,22]

Unfortunately, most studies have found that since health‑care‑seeking behavior is complex, researchers can only predict about 10‑15 percent of the variance in medical utilization. [23]

Although medical symptoms often increase a patient's perception of personal vulnerability, they may choose to schedule health visits immediately but frequently delay health care seeking. [24] Patient age, sex and income are strong determinants of access and utilization of health systems and out‑of‑pocket expenses.

The importance of these data for chiropractors is clear.

Chiropractic has to define itself scientifically by publishing a minimum of two major clinical trials in areas defining the field. A number of trials have been conducted on SMT and low back pain, but low back pain is a weak foothold in the health marketplace because, although low back pain accounts for a high incidence of disability, the symptom is of relatively low diagnostic value and accounts for a high incidence of medically unexplained symptoms.

Chiropractic has to define itself scientifically, beginning with a careful delineation of the health consequences of subluxation syndrome.

If the field wishes to better position itself for third‑party reimbursement, then clinical meaningfulness must be established in the new topic areas (e.g., immune system, general wellness, etc.), and there needs to be careful evaluation of pricing, reimbursement, and other health economic factors before public‑sector agencies can render decisions about the "value" of the new technology.

The RCS research strategy of practice‑based surveys of large populations will allow investigators to determine whether or not vertebral subluxations have health consequences (that is, provide proof of clinical meaningfulness).

This approach continues with the current research being conducted by RCS in its first study of large populations in the United States and Canada. This will then be followed by specifically designed clinical trials of secondary outcome measures, e.g., immune enhancement, allergic asthma, woman's health, of particular interest to public health officials and third‑party payers.

References

1. US Department of Health and Human Services. Centers for Disease Control and Prevention. "Indicators for Chronic Disease Surveillance" Morbidity and Mortality Weekly Report, Sept 2004, Vol 53, No. RR‑11.

2. Pelletier AR, Siegel PZ, Baptiste MS, Maylahn C. Revisions to Chronic Disease Surveillance Indicators, United States, 2004. Prev Chronic Dis [serial online] 2005 Jul. Available from http://cdc.gov/pcd/issues/2005/jul/05_00003.htm.

3, Blanks RHI, Schuster TL, Dobson M. "A retrospective assessment of Network Care using a survey of self rated health, wellness and quality of life." J Vert Sub Res. 1997,Vol 1 (4):15 31.

4. Schuster, TL, Dobson, M, Jaregui, M, Blanks, RHI. "Wellness lifestyles II: Modeling Relationships Between Wellness, Health Lifestyle Practices, and Network Spinal Analysis." J. Alternative and Complementary Med. 10(2):357 368, 2004b.

5. Grimm RH Jr, Grandits GA, Cutler JA, et al. "Relationships of quality‑of‑life measures to long‑term lifestyle and drug treatment" in the "Treatment of Mild Hypertension Study." Arch Intern Med. 1997; 157:638‑648.

6. Gold MR, Patrick DL, Torrance GW, et al. "Identifying and valuing outcomes." In:Gold MR, Siegel JE, Russell LB, Weinstein MC, eds. "Cost‑effectiveness in Health and Medicine." New York, NY: Oxford University Press; 1996:82‑134.

7. Hurst NP, Kind P, Ruta D, Hunter M, Stubbings A. "Measuring health‑related quality of life in rheumatoid arthritis: validity, responsiveness and reliability of EuroQol (EQ‑5D)." Br. J Rheumatol. 1997;36:551‑559.

8. Kaplan RM, Anderson JP, Wu AW, Mathews WC, Kozin F, Orenstein D. "The Quality of Well‑being Scale: applications in AIDS, cystic fibrosis, and arthritis." Med Care. 1989;27(3,suppl):S27‑S43.

9. Kaiser Family Foundation/Lehrer Survey About the Uninsured, February 2000.

10. Cooper PF, Schone BS. "More offers, fewer takers for employment based health insurance: 1987 and 1996." Health Aff (Milwood) 1997; 16(6):142‑149.

11. McDonald W, Durkin K, Iseman S, Pfefer M, Randall B, Smoke L, Wilson K. "How Chiropractors Think and Practice: The Survey of North American Chiropractors," Institute for Social Res, Ohio Northern Univ, Ada, Ohio, 2003.

12. Smith Jr GR, Monson RA, Ray DC. "Patients with multiple unexplained symptoms: their characteristics, functional health and health care utilization." Arch Intern Med 1986; 146: 69‑72

13. Kroenke K, Mangelsdorff AD. "Common symptoms in ambulatory care: incidence, evaluation, therapy, and outcome." Am J Med 1989; 86: 262‑266

14. Katon W, Lin E, von Korff M, Russo J, Lipscomb P, Bush T. "Somatization: a spectrum of severity." Am J Psychiatry 1991; 148: 34‑40

15. Van Hemert AM, Hengeveld MW, Bolk JH, Rooijmans HGM, Vandenbroucke JP. "Psychiatric disorders in relation to medical illness among patients of a general medical out‑patient clinic." Psychol Med 1993; 23: 167‑173.

16. Reid S, Wessely S, Crayford T, Hotopf M. "Medically unexplained symptoms in frequent attenders of secondary health care: A retrospective cohort study." Brit Med J. 2001. 31:322(7289): 767.

17. Kouyanou K, Pither C, Wessely S. "Iatrogenic factors and chronic pain." Psychosom Med 1997; 59: 597‑604

18. Kouyanou K, Pither CE, Rabe‑Hesketh S, Wessely S. "A comparative study of iatrogenesis, medication abuse, and psychiatric morbidity in chronic pain patients with and without medically unexplained symptoms." Pain 1998; 76: 417‑426

19. Zook CJ, Moore FD. "High‑cost users of medical care." N Engl J Med.1980;302:996‑1002.

20. Garfinkel SA, Riley GF, Iannacchinoe VG. "High‑cost users of medical care." Health Care Financing Review 1988;9:41‑52.

21. Barsky AJ, Hochstrasser B, Coles NA, Zifsein J, O'Donnell C, Eagle KA. "Silent myocardial ischemia: is the person or the event silent?" JAMA 1990; 264: 1132‑5.

22. Lumley M, Rowland L, Torosian T, Bank A, Ketterer M, Pickard S. "Decreased health care use among patients with silent myocardial ischemia: support for a generalized rather than a cardiac‑specific silence." J Psychosom Res 2000; 48: 479‑84.

23. Russo J, Katon W, Lin E, Von Korff M, Bush T, Simon G, Walker E. "Neuroticism and extraversion as predictors of health outcomes in depressed primary care patients." Psychosomatics 1997; 38: 339‑48.

24. Barsky AJ. "Patients who amplify bodily sensations." Ann Intern Med 1979; 91: 63‑70.

(RCS co‑founder and President Dr. Robert Blanks is Professor in the Department of Biomedical Sciences at Florida Atlantic University and a past Professor of Anatomy and Neurobiology at the University of California, Irvine. Prior to this he spent two years at the Max Planck Institute for Brain Research in Frankfurt, Germany and two years in the Department of Anatomy at Harvard Medical School. Dr. Blanks is on the Advisory Board of the International Spinal Health Institute, is a Board Member of the Council on Chiropractic Practice and is actively involved in chiropractic research. To learn more about health outcomes research and RCS, call 800‑909‑1354 or 480‑303‑1694.)