March 2007

Clinical meaningfulness of the chiropractic adjustment

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

Part IV: Affecting public health policy

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

This series of articles was inspired by a report by Joseph C. Keating Jr. PhD entitled "The Challenge." In his words, the "challenge" to the profession is "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.

Previous articles examined how well‑designed and clinically meaningful research improves the public's confidence in clinical services rendered and the communication between the patient and provider. I also explored how the merits of new research findings are evaluated by the scientific and health community, and how these results are eventually considered along with cost, competing issues, etc., to possibly be incorporated into services that are reimbursed by third‑party payers.

This is a long process, but at each step the validity of the research is weighed ‑‑ which is why clinical meaningfulness is so important to establish from the beginning.

New technology must be compared with all other innovation to be incorporated into health policy in the supercharged sociopolitical arena of state and federal politics. Not surprisingly, few biomedical breakthroughs are readily embraced by policy makers, but there are roadmaps that drive those that will be eventually incorporated into national health policy.

Healthy People 2010. One of the roadmaps for biomedical innovation is a comprehensive set of health promotion and disease prevention objectives for the nation to achieve over the first decade of the new century.

The overarching goals of initiative are to increase quality and years of healthy life, and eliminate health disparities. Healthy People 2010 builds on other federal initiatives beginning in 1979 with the Surgeon General's Report (1979), Promoting Health/Preventing Disease: Objectives for the Nation (1980), and Healthy People 2000.

The plans were also meant to serve as the basis for the development of state and community health plans. As a discipline, chiropractic is certainly in a position to have an impact on many targeted objectives of Healthy People 2010, but much more research and a systematic research agenda will be required before the profession is able to affect health policy in these areas.

National Institutes of Health (NIH) Roadmap. A sweeping reform in health research policy was recently instituted by the NIH. The so‑called "NIH Roadmap" was initiated in 2002 by then incoming Director of the NIH, Elias Zerhouni MD. The purpose was to identify major opportunities and gaps in biomedical research that the agency must accomplish, but that no single institute at NIH was currently tackling.

The NIH Roadmap agenda was developed over a two‑year period by more than 300 nationally recognized leaders in academia, industry, government, and the public, and focuses on three main areas: new pathways to discovery, research teams of the future, and re‑engineering the clinical research enterprise.

The first of these themes ‑‑ new pathways to discovery ‑‑ applies primarily to the basic scientists and addresses the need for better understanding of the complexities of biological networks pathways, molecular (gene) libraries, bioinformatics and computational biology and new fields such as nanomedicine.

However, the remaining two themes of the NIH Roadmap should be of considerable interest for the chiropractic profession.

The research teams of the future must be crafted to deal with the complexity of today's biomedical research problems. As part of this initiative, the NIH Roadmap will try to encourage the development of alternative models for conducting research, e.g., interdisciplinary research and public‑private partnerships of the type that would allow chiropractic researchers to make a substantial contribution to the scientific direction of the research team.

Re‑engineering the clinical research enterprise addresses the many difficulties of conducting research on disease mechanisms, prevention, diagnosis and treatment.

One targeted model is the creation of new partnerships of research with organized patient communities, community‑based health care providers, and academic researchers. This also includes the need to build better research interactions between academic centers with qualified community‑based health care providers and their patient populations.

The objective of the latter is to set up networks of practice‑based populations who can participate in large research cohorts and thereby more quickly develop, test, and deliver new interventions. Clearly, this is an area where well‑trained and organized networks of chiropractors and their patients could have an impact on the biomedical research culture and health policy in general.

One objective of RCS (Research & Clinical Science) is to structure such interactions with community chiropractors, allowing their patient data to contribute to the evidence‑based culture supporting the field. Considerably more effort along these lines will be required to advance a national research agenda for chiropractic that will eventually impact health policy.

Who sets health policy?

Health care and health care policy are highly distributed events that involve multiple agencies and departments at the state and federal government and literally thousands of private, university‑based and public health policy groups and health care lobby organizations.

Federal Health Policy: Once Congress or the Executive branch has initiated health policy, other branches of the government get involved. The Health Resources and Services Administration (HRSA), created in 1982, is an agency of the U.S. Department of Health and Human Services (HHS).

HHS and, in particular, HRSA are the primary federal agencies for enforcing policy governing access to health care services for people who are uninsured, isolated or medically vulnerable. With an annual budget of $6.6 billion (for FY2006) and 1,600 employees, HRSA provides leadership and financial support in grants (90% of their total budget) to health care providers in every state and U.S. territory.

The mission of HRSA is far reaching and "provides national leadership, program resources and services needed to improve access to culturally competent, quality health care" and cuts across these seven major goals:

1) improve access to health care,

2) improve health outcomes,

3) improve the quality of health care,

4) eliminate health disparities,

5) Improve the public health and health care system,

6) enhance the ability of the health care system to respond to public health emergencies, and

7) achieve excellence in management practices.

Each of these objectives is essential for promoting a fully‑integrated and smoothly functioning health‑care system. With sufficient and well‑documented (i.e., clinically meaningful) research, chiropractic could directly impact half of these topic areas, i.e., improvement of health outcomes, improvement of quality of health care, and improvement of the public health and health care system.

A good place for chiropractic to start would be the successful design, implementation and outcome of several well‑chosen pilot programs funded by HRSA in order to gain recognition as being part of the national health policy pipelines.

State and local health policy agencies: There are also a number of agencies that work at the state or local levels. For example, the National Academy for State Health Policy (NASHP) is an independent academy of state health policymakers working together to identify emerging issues, develop policy solutions, and improve state health policy and practice.

NASHP conducts its work by convening state leaders to solve problems and share solutions, conducting policy analyses and research, disseminating information on state policies and programs, and providing technical assistance to states.

As chiropractic gets closer to asserting a national agenda, based upon well‑documented research, it needs to consider working through NASHP because this organization has a forum that cuts across all lines of authority and states, and has close collaborative relationships with influential state organizations such as the National Governors' Association, the National Conference of State Legislatures, the Association of State and Territorial Health Officials, the American Public Welfare Association, and others.

Clinical Practice Guidelines: Health guidelines and policies are developed by health professional organizations through a systematic process employed by the Federal Agency for Healthcare Research and Quality (AHRQ).

The best definition of the process comes from the Institute of Medicine: "Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." [1]

Once developed, clinical practice guidelines are published by the National Guideline Clearing house. Chiropractic has established Evidence‑Based Clinical Practice Guidelines developed by a peer‑review process through the Council of Chiropractic Practice (CCP); the first edition of the CCP Clinical Practice Guidelines #1 Vertebral Subluxation in Chiropractic Practice was published in 1998. The revised edition was published in 2003 and is the only clinical practice guidelines for vertebral subluxation recognized by the National Guideline Clearing House (www.guideline.gov).

Optimal Health Policy Compliance ‑‑ Electronic health records: The real challenge is for health professionals to follow health‑care standards and public health policy once established. In this respect, electronic health records (EHRs) are promising tools to improve quality and efficiency in health care. Unfortunately, a recent survey on EHR compliance in the United States through 2005, finds that only 23.9% of physicians used EHRs in the ambulatory setting, and even fewer (i.e., 5%) hospitals used computerized physician patient data entry. [2]

The nation is, therefore, a long way from complying with a presidential mandate for full‑implementation of IHR by the year 2010. Chiropractic could and should take the lead in this area. The task would be easier because there are many‑time fewer outcome measures in chiropractic than in medicine.

Optimal Health Policy Compliance ‑‑ Public reporting and financial incentives by health insurers: Do we have to pay hospitals and providers extra to follow the correct clinical protocol? The answer appears to be "yes."

By enacting the recent Deficit Reduction Act (2005), [3] Congress showed support for financial incentives by instructing Medicare and Medicaid to develop plans for hospital "value‑based purchasing."

Pay‑for‑performance programs are intended to improve compliance with established clinical protocols and policy, and move away from more onerous and somewhat unpopular hospital‑based "quality assurance" programs. [4,5]

Other health policy compliance measures have emerged such as public reporting of quality measures, and these work to some degree by appealing to the professional ethics of hospitals and health providers; however, compliance with health policy and clinical standards is generally low. [6]

An important example of financial incentives is a three‑year Medicare study in which 266 major US hospitals were closely monitored in a pilot program to improve health outcomes across five areas: joint replacement, coronary artery bypass graft, heart attack, heart failure and pneumonia.

Under the experiment, hospitals could earn a bonus only if they rank among the top 20% in at least one of five areas of evaluation. This year Medicare is awarding a total of $8.7 million to 115 hospitals that were the top performers in this pilot study. A recent summary of the Medicare program, published in the New England Journal of Medicine finds the program to be effective but only modestly so. [7]

Pay‑for‑performance was associated with improvements ranging from 2.6% to 4.1% compared to control hospitals who only complied with public reporting of health outcomes over a two‑year period.

The public needs to remember that health care performance incentive programs are flawed because only the top performers (in this case top 20%) are awarded for implementing required clinical protocols, whereas others could be seriously out‑of‑compliance and go unnoticed.

Hospitals and health professionals also criticize the incentive program because they are not responsive, i.e., there is need for some of the measures to change more quickly when new research treatments are better. More importantly for chiropractic, how will new innovation be implemented, regardless of whether the findings are meritorious and "clinically meaningfulness," when the system is so slow to embrace change.

A future vision for chiropractic: Clearly, practice‑based research and well‑designed clinical trials are required to link the chiropractic adjustment with health benefits, and these changes must be "meaningful" at all levels (practitioner, patient, researcher, third‑party payer) to achieve the level of truly impacting the public health policy.

RCS is a research company performing research on health outcomes data from chiropractic offices and will initiate carefully selected practice‑ and institution‑based clinical trials to enhance the evidence‑based documentation supporting subluxation‑centered chiropractic.

These efforts will require the support and participation of community practitioners to recruit patients and control subjects. However, a common research front is required if chiropractic is to achieve its deserved position in the health and wellness marketplace.

The only way to establish balanced national health agenda is to invite well‑trained and established chiropractic investigators to join the interdisciplinary teams conducting the nation's biomedical research. National health policy formats such as Healthy People 2010 and NIH Roadmap already exist to support this major goal. The problem of course is to identify and train sufficient chiropractors to realize these objectives.

Research Plan: A three‑part strategy is proposed to advance the research and training agenda over the next five years. First, encourage a practice‑based multifaceted research agenda; second, engender a research culture among all stakeholders in the chiropractic equation (practitioners, students, teachers and college administrators) so that research and evidence‑based chiropractic is a core component of professionalism in chiropractic, and third, establish a health policy forum to promote chiropractic nationally and globally.

It is easy to see how steps one and two could be achieved by putting pressure on the research and teaching efforts in the profession. Research groups such as RCS can be a big help in solving these problems. The third step, however ‑‑ health policy reform ‑‑ will require an entirely new entity in the profession and one with the broadest possible representation to advance the profession.

The Chiropractic Health Policy Agenda: "Health Communication" is a hot field and one of the most exciting new programs at Harvard School of Public Health and other Public Health schools across the country. The curriculum could be taught concurrently with the DC degree as easily as teaching physical therapy.

Health Communication is the study of how health information is generated and disseminated and how that information affects individuals, community groups, institutions and public policy. The field includes the study of secular communication, as well as the strategic communication of evidence‑based health information to professional and non‑professional audiences.

Every health professional needs to be trained to recognize real value in health information and learn how to communicate this to friends, family, patients, co‑workers, fellow health professionals and health agencies. Structured knowledge in managing health information will allow health professionals, as aptly stated by Harvard School of Public Health officials "to be able to identify the contexts, channels, messages and reasons that will motivate individuals to heed and use health information ‑‑ whether designing health communication programs for vulnerable populations, framing a health policy issue for legislators, or educating patients on medications." (www.hsph.harvard.edu).

Now is the time to consider a national and international research agenda to train chiropractic researchers and conduct research at all levels. Of even greater concern is to modernize the chiropractic curriculum by teaching health communication, enabling every college graduate with research credentials and the passion to use evidence‑based chiropractic to achieve a more balanced vision for chiropractic in the overall health equation.

References

1. Institute of Medicine. (1990). "Clinical Practice Guidelines: Directions for a New Program," M.J. Field and K.N. Lohr (eds.) Washington, DC: National Academy Press. page 38

2. Jha AK, Ferris TG, Donelan K, DesRoches C, Shields A, Rosenbaum S and Blumenthal D. "How Common Are Electronic Health Records In The United States? A Summary Of The Evidence Health Affairs," 25, no. 6 (2006): w496‑w507 doi: 10.1377/hlthaff.25.w496.

3. Deficit Reduction Act of 2005. S. 1932 Section 5001 Public Law No. 109‑1/1.

4. Millenson MI. Pay for performance: The best, worst choice. Qual Health Care. 2004;13:323‑4.

5. Epstein AM, Lee TH, Hamel MB. Paying physicians for high‑quality care.  N Engl J Med 2004; 350:406‑10.

6. Marshall MN, Shekelle PG, Leatherman S, Brook RH. The public release of performance data: what do we expect to gain? A review of the evidence. JAMA 2000, 283;1866‑74.

7. Lindenauer PK, Remus D, Roman S, Rothberg MB, Benjamin EM, Ma A, Bratzler DW. Public reporting and Pay for performance in hospital quality improvement. N Engl J Med 2007;356:486‑96.

(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.)