February 2006

Understanding health outcomes research

What is it and why chiropractic needs it now

by Robert H. Blanks, PhD, President of RCS

In spite of a great deal of enthusiasm from most sectors in chiropractic and outside the profession, there is some confusion about the "health outcomes" approach taken by RCS (Research & Clinical Science).

One of our most outspoken critics (who also happens to have a very large e‑mail list) has suggested that the health outcomes research design used by RCS is biased, and would only be of interest if other researchers in chiropractic were conducting the work. Others worry that the approach could raise concerns about issue of patient or practitioner confidentiality.

Concerns were voiced about similar issues beginning almost a quarter century ago years when the medical community first began to conduct outcomes research of its own. Fortunately, procedures and policies have been developed by the public health profession to insure the quality, integrity and privacy of patient and practitioner information.

RCS is proud to be associated with an outstanding team of health researchers and basic scientists, and the company has implemented the well‑proven public health model for the purpose of conducting a valid assessment of chiropractic.

One of the most gifted scientists of the late 1800s, Lord William Thomson Kelvin, is credited with publishing 661 papers and was awarded 70 patents in thermodynamics, electromagnetic theory and communication. He wrote:

"When you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot express it in numbers, your knowledge is of a meager and unsatisfactory kind. It may be the beginning of knowledge but you have scarcely, in your thoughts, advanced the state of science."

Lord Kelvin could have been talking about the challenges facing health care delivery in the United States today. The nation has been insisting that health services be empirically‑ and evidenced‑based, and administered with the precision of a science. Payers, policy makers and patient‑advocacy groups are demanding accountability of quality, utility and cost‑effectiveness.

The public outrage over the quality and cost of medicine may have been popularized by such books as "Lethal Medicine: The epidemic of Medical Malpractice in America" (Author H. Wachsman, S. Alschuler; 1993) and media pieces of the time (e.g., "What's causing the deficit disease? Health care" (Business Week, Nov 21, 1994.

In response to this growing concern over health care quality, costs and the measurement of these factors, the federal government, American Medical Association (AMA), national medical specialty societies, and others began working cooperatively to continue to improve health care quality and performance measures, including outcomes research.

Simply stated, outcomes research is the study of the results of health care interventions.

Outcomes data are important measures of the quality of health care because they are direct measures of whether health interventions have been successful. Beginning in 1989, the AMA established two working groups, the Practice Parameters Partnership and the Practice Parameters Forum whose work over the next seven years involved input from major stakeholders (80 physician organizations, 14 of the largest medical specialty societies, the Agency for Health Care Policy and Research, the Joint Commission of Accreditation of Healthcare Organizations, and the American Hospital Association).

Opinions were also solicited from individuals with scientific and clinical expertise to insure the development of scientifically sound, clinically relevant practice parameters and health care quality performance measures that was useful to physicians in the day‑today practice of medicine. Finally, their outcomes research protocols were vetted across thousands of physician providers to insure general acceptance of the procedures. The final document "Principles of Outcomes Research" was published in the AMA Policy Compendium.

These principles of research design and execution have become the standard for virtually all public health outcomes research. Literally thousands of large‑scale patient data repositories have been developed over the past 15 years to conduct outcomes research. Millions of patient encounters have been recorded electronically at places like the Veterans Administration, Mayo clinic and Henry Ford Health Systems to improve patient care. There are also numerous specialty data bases for cancer (National Cancer Institute), arthritis (ARAMIS), strokes (BUSTOP), renal dialysis, hypertension and other diseases that are actively used for health outcomes research to improve health care delivery, examine cost effectiveness, etc..

Chiropractic has become active in conducting health outcomes research largely utilizing practice‑based measures and also some use of central data repositories. Unfortunately, these studies have been limited to analyses of data from existing (medical claims) databases (Stano and Smith, 1996; Stano et al., 2002).

The biggest concern with this approach is that it only traps information from patients with a specific diagnosis (i.e., conditioned‑based) and would thereby favor largely the musculoskeletal conditions and exclude other positive changes in patients' health not documented in the file. The latter is often obtained in medical studies by patient self‑reported symptom inventories and satisfaction scales.

Fortunately, data of this type is now being obtained in smaller chiropractic studies to evaluate cost effectiveness of treating musculoskeletal conditions (Haas et al., 2005). Of particular concern is the absence of large chiropractic databases with which to evaluate the full range of health outcomes currently being assessed by the RCS software and many of the medical databases, e.g., clinical measures, patient self‑reported symptom inventory, quality of life, patient satisfaction, patient social networks and health lifestyle practices, etc.

RCS has followed the general public health guidelines in establishing the procedures and policies for health outcomes data collection in the chiropractor's office, for storage and analysis of these data in a secure electronic repository, and all issues relative to federal guidelines governing the privacy of protected health information. Our sophisticated, comprehensive outcomes measurement system will not only allow the chiropractic profession to effectively respond to these external forces governing the profession, but such information will also provide the necessary tools to eventually establish internal quality assurance programs.

More importantly, in following the guidelines established for public health outcomes research, we hope to create a representative database to help define optimal practice parameters, strategies for patient management, developments to assist provider decision‑making, and thereby improving the quality and appropriateness of health care services.

Members of the RCS International Scientific Advisory Panel will assist in the analysis and publishing of these data in a wide spectrum of peer‑reviewed scientific journals; access to the database will also be given to other researchers upon request.

The RCS data repository will also provide importance information linking quality of care issues with patient‑centered outcomes such as patient satisfaction and quality of life indicators.

In fairness to those of our critics with legitimate concerns, there are challenges with the initiation of any new approach. But, by following the well‑proven public health outcomes methodologies governing research design, statistical significance, sample size, use of outcomes data and confidentiality, it will be possible to develop an electronic process to evaluate the heath outcomes of all patients in the participating offices. Moreover, with a large representative sampling of offices from all parts of the profession, it will be possible to generalize the findings across the entire profession.

Finally, guidelines for conducting health outcomes research emphasize that outcomes data should 1) be used in an educational, not punitive, manner, 2) be available to all providers for their review and response, as education tools allowing practitioners to improve their practices, and 3) remain confidential with respect to individuals patient and the chiropractor. These requirements are paramount for successful operation of the RCS data collection network, and are a critical part of our contract with each participating office.

We look forward with great excitement to conducting the first (three‑year) phase of health outcomes research.

Sources

Stano M, Smith M, "Chiropractic and medical costs of low back care." Med Care, 34(3):191‑204, 1996.

Stano M, Haas M, Goldberg B, Traub PM, Nyiendo J. "Chiropractic and medical care costs of low back care: results from a practice‑based observational study." Am J Manag Care, 8(9): 802‑9, 2002.

Haas M, Sharma R, Stano M. "Cost‑effectiveness of medical and chiropractic care for acute and chronic low back pain." J Manipulative Physiol Ther 28(8):555‑63, 2005.

(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.)