December 2005

Answering the top two questions about RCS

by Robert H. Blanks, PhD, Professor of Biomedical Science, Florida Atlantic University

All too often, chiropractic is criticized as an "unscientific" discipline, lacking empirical research to validate the assertion that vertebral subluxation has an adverse effect on the human nervous system , on general health and by extension, on society as a whole.

My colleagues, Dr. Matthew McCoy and Dr. David Jackson, and I have started a private research and development company called Research & Clinical Science (RCS) to specifically evaluate these assertions. We are assisted in the process by a distinguished panel of 12 members of our International Scientific Advisory Panel and will soon appoint a clinical chiropractic advisory panel.

Indeed, private research and development companies are common place in biomedicine (e.g., RAND Corp.), but they are almost unheard of in chiropractic which triggers two of our most commonly asked questions:

1) What type of research will RCS be conducting?

2) Who regulates the research conducted by RCS and is it ethical?

These are important questions so let me address these one at a time.

What type of research will RCS be conducting? The first, three‑year research plan calls for the establishment of an electronic data capture network to automate clinical record keeping in community‑based chiropractic offices, and the creation of a centralized data repository to support a variety of research formats (retrospective, case reports, time series, controlled clinical trials).

Patient data will be "de‑identified" as per HIPAA requirements and coded such that the privacy of patient information is protected throughout all aspects of electronic data capture over the Internet and storage in the central data repository. The research design is practice‑based, time series, open enrollment, health outcomes study of clinical information and patient self‑reported quality of life and health lifestyle behaviors.

There are two groups of research subjects: Patients in the office of participating chiropractors who will be sampled according to the following inclusion criteria: (1) any age providing proper IRB human subjects informed consent has been obtained, and (2) no limit as to duration of care prior to going on study, and research volunteers (18 years and older) who will be recruited to assess the incidence and severity of vertebral subluxation in a population that has never received, or has recently been under regular chiropractic care.

The research volunteers will receive a general chiropractic assessment and will be asked to complete an on‑line quality of life and health lifestyles questionnaire. As research volunteers, however, they will not receive any chiropractic intervention or other services offered in the office (e.g., therapeutic massage, yoga, etc.).

Variables under study are: 1) clinical findings from physical examination, instrumentation such as surface EMG, thermography, automated range‑of‑motion, etc., x‑ray with other imaging findings, and other assessment tools, 2) patient sociodemographic, 3) quality of life and health lifestyle behavioral questionnaire, 4) patient billing information and other practitioner characteristics including, in particular, the type of chiropractic technique being employed in the office.

Chiropractors in the participating data collection sites will receive extensive training on human subject's compliance, data collection, entry and interpretation, and will lease a turn‑key data collection (tablet PC) and computer server for office record keeping and automated data transfer.

Data will be subjected to multivariate statistics to identify interactions between patient and practice parameters and signs of vertebral subluxation (the dependant variable). Statistical (structural equation) modeling will be conducted to identify the dynamic relationships between chiropractic intervention, patient self‑reported wellness, and health life style practices (Blanks et al., 1997; Schuster et al., 2004a, b).

The clinical practice and attitudes of the participating chiropractors will be surveyed and compared to a national representative sampling of chiropractors, allowing the patient data in the central data repository to be from chiropractors representing the range of professional attitudes and beliefs across the country. Sampling techniques across a representative sample of chiropractic offices in the United States, and worldwide, will control for the assessment, adjusting techniques and co‑therapies offered in the office. This allows patient data in the central repository to be generalized and, thus, representative of the broader chiropractic community.

Who regulates the research conducted by RCS and is it ethical?The research being conducted by RCS is fully approved and monitored by an Institutional Review Board (IRB), is HIPAA compatible to assure compliance with privacy of all patient records, and meets the federal standards for ethical conduct of research employing human subjects.

A short historical perspective is important here. Research has produced major scientific breakthroughs and benefits to society. It has also posed a number of challenging ethical questions that have had to be systematically addressed over the past 60 years. Following World War II, attention was focused on the abuses of human subjects in biomedical experiments during the Nuremberg War Crime Trials. Also during the 1940s in this country, the Tuskegee study used disadvantaged black men to study the untreated course of syphilis that was by no means confined to that population.

However, since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have been adopted. The best known are the Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified July 12, 1974) of the National Research Act (Pub. L. 93‑348) which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

The results of the latter commission, known as the Belmont Report, are statements of basic ethical principles and guidelines that assist in resolving the ethical problems that surround the conduct of research with human subjects.

The code consists of rules that bind the investigator and the reviewers of their research. All research employing human subjects in the United States must adhere to these US Department of Health and Human Services regulations that are administered through the National Institutes of Health Office for Human Research Protections (OHRP). Under authority of OHRP, local and regional Institutional Review Boards (IRBs) throughout the country have delegated authority to review and approve research involving human subjects and to monitor all activities to insure that the research is conducted in full compliance with federal regulations governing ethical principles and guidelines for research involving Human Subjects.

In reviewing our proposed research project (or any research project) the IRB must assure that it meets the basic ethical principles of respect of persons, beneficence and justice among other issues. Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents (an individual capable of deliberation about personal goals and of acting under the direction of such deliberation) and to provide written informed consent for such participation in research.

Further, the law provides that persons with diminished autonomy (such as children, prisoners, or the mentally incapacitated) are entitled to protection. Autonomous agents and those with diminished autonomy not only have the right to choose to participate, but they can also choose to withdraw from a study without prejudice. Beneficence is understood as an obligation to 1) do no harm, and 2) to maximize possible benefits and minimize possible harms.

The beneficence clause requires that IRBs must carefully weigh the risks and benefits of participation in research before granting approval. Finally, the question of justice applies that the research formulates just ways to distribute the burdens and benefits.

Questions of justice have long been associated with social practices such as taxation and political representation. Whereas during the 19th and 20th centuries the burdens of serving as research subjects fell largely upon the poor ward patients, the benefits of improved medical care was bestowed primarily upon the private patients.

Under the guidelines enacted since 1947, the selection of research subjects need to be scrutinized in order to determine whether some classes (e.g., welfare patients, persons confined to institutions) are not being systematically selected because of their ease of availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.

Accordingly, all applications to conduct research on humans require ethical consideration of the following requirements: informed consent, risk/benefit assessment, and the selection of subjects of research. IRB approval assures that the research will be conducted in an ethical manner and in compliance with all federal guidelines governing research with human subjects.

In conclusion, the management of patient clinical data and other outcomes information is specialized and requires comparing patient progress to their baseline data, as well as to standardized populations undergoing the same care regimen. The data repository to be created by RCS and the participating chiropractors in the community will provide the required baseline data. It is hoped that these experimental strategies and analyses of a large representative population undergoing chiropractic care will help to promote the quality of care for the patient, grow the evidence‑based documentation supporting chiropractic, identify the critical health and wellness benefits of chiropractic, and analyze the cost effectiveness of chiropractic across primary and secondary outcome measures, thereby promoting the establishment of rationale health policies.

References

Blanks, RHI; Schuster, TL; Dobson, MA: "Retrospective assessment of network care using a survey of self‑rated health, wellness and quality of life." J. Vertebral Subluxation Res. 1:15‑31, 1997.

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, 2004.

Schuster, TL; Dobson, M; Jaregui, M; Blanks, RHI. "Wellness Lifestyles 1: A Theoretical Framework Linking Wellness, Health Lifestyles, and Complementary and Alternative Medicine." J. Alternative and Complementary Med. 10(2):349‑356, 2004.

(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.)