March 2006

When you've finished changing, you're finished

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

Research is the mechanism by which health professions operate, grow and change in the face of internal and external pressures. In his own draconian style, Benjamin Franklin might have been writing about the change cycle in health professions when he said: "When you've finished changing, you're finished."

If research is the "change agent," then the value of the change depends upon the integrity of research study design and methodologies. As we discussed in last month's article ('Understanding health outcomes research'), there are well‑established rules of scientific study design and these are being followed by RCS in our research studies of chiropractic. Many individuals have contacted us and praised the efforts of RCS to help build the evidence‑based literature supporting chiropractic. Even my medical colleagues' salute us for attempting to apply a rigorous research approaches to the study of chiropractic.

However, some good questions about research have been raised ‑‑ as have some not so good ones. Ironically, the only critic is someone within the profession. This individual has set aside scientific reasoning and logic and has openly stated:

"The most basic violation of research design is to think that you know the answer to your research question a priori, and then set out to 'prove' you are right. This is how the RCS project is set up...i.e. they have a foregone conclusion in advance, and now set out to make sure they gather data that supports their views. This is backwards...scientific research is exploratory by definition. If we knew the answer to our question, why ask the question and test it through scientific research?"

Not only is this statement blatantly wrong, it also has a sinister undertone that attempts to bias and misdirect the serious efforts of researchers inside and outside the profession to advance evidence‑based chiropractic. To be sure, evidence‑based chiropractic is not a wish, or a good idea, or an ancillary activity to do in your spare time. An aggressive research agenda must be a fully‑integrated and mainstream component of every health profession. This is the mechanism by which professional organizations change and respond to new demands.

Critics of research need to understand and accept the process or step aside and allow trained individuals to perform the necessary evaluation. The colleges understand the need for research, the accrediting body Council of Chiropractic Education (CCE) has mandated that research be an integral part of the chiropractic curriculum, the chiropractic clinical practice guideline groups are leading the efforts by collecting and analyzing the literature supporting the profession, and there is a growing number of well‑trained experts in the public and private sector (like RCS) who have set up the necessary infrastructure to collect and analyze the required data from large groups of chiropractic patients under care.

To be absolutely clear, it is wrong for our outspoken critic to state that:

"The most basic violation of research design is to think that you know the answer to your research question, a priori, and then set out to 'prove' that you are right."

The Scientific Method

On the contrary, scientific knowledge results from experience and is based on structured observations (empiricism). Fundamental to the scientific method is the use of hypotheses to be tested empirically. In most instances, a null hypothesis is advanced by the investigators to be tested statistically. This process determines whether the experimental intervention has "no effect," meaning that the treatment and control groups will not differ as a result of the intervention. Investigators usually hope that the data will demonstrate some effect from the intervention, thereby allowing the investigator to reject the null hypothesis. It is important to understand that scientific theories and hypotheses can never be "proven true" but can only be supported (confirmed) or not supported (disconfirmed) by currently available data. Well‑supported hypotheses are then used to develop and advance theories to organize their empirical observations.

Scientific understanding must be based on objective and systematic observation. Objective observations can be experienced directly and are repeatable, making it possible for scientists working independently to verify each others' work. Systematic observations are obtained under clearly specified, and, where possible, controlled conditions that can be measured and evaluated. Valid research methodology, such as practiced by RCS, provides the tools needed to produce objective and systematic observations (empirical data) and to ensure that inferences based on these observations are grounded in logic.

What Research is RCS Doing?

We have stated on numerous occasions that RCS will be conducting several different types of research in chiropractic. The initial efforts are descriptive and will evaluate the current state‑of‑the‑art in a large group (cohort) of patients. This is health outcomes research. From this large data repository we will also subsample to publish case reports on interesting new areas and/or benefits of chiropractic. In parallel, we will be collecting data on research volunteers, naive to chiropractic, thereby permitting the use of case‑controlled design. This particular research design compares persons with a given condition or disease (the cases) and persons without the condition or disease (the controls) with respect to antecedent factors. The condition we will be evaluating is vertebral subluxation.

Furthermore, chiropractic patients from the participating offices will be followed longitudinally (forward through time) thereby permitting a very powerful research design called a time series where, in essences, each patient is their own control. Eventually we will be able to conduct the larger longitudinal design in which one or more subject cohorts can be evaluated over extended periods of time.

The well‑known Framingham Study, begun in the 1950s, was designed this way to monitor the incidence of coronary artery disease in over 5,000 residents who were examined every two years for a period of twenty years. The intention of RCS is to conduct a longitudinal design to evaluate the long term effects of vertebral subluxation and the "chiropractic lifestyle" on health.

The challenge over the next three years will be to put in place a structure to track the necessary experimental and control cohorts for such a longitudinal study. This means tracking large population of individuals who are under chiropractic care and another group not under care but who return on a regular basis to undergo the same assessment as those patients being tracked. Eventually, we will have sufficient data to design and conduct clinical trials into new and exciting areas for chiropractic (e.g., woman's health, immune status, etc.).

Each of the experimental designs to be used by RCS is hypothesis driven. The choice of study design depends largely upon the nature and goals of the research. Clinical trials establish causality, i.e., the cause‑effect relationship between a given intervention and the specific outcome(s) measured. Clinical trials are expensive and place participants at risk because there is the potential that they would be randomized into the control group not receiving care.

Clinical trails are only attempted when there is sufficient evidence from other research -- beginning with case reports, case‑controlled or time series, and limited randomized designed, etc. -- to design a full‑blown trial with sufficient power (number of patients) to support or reject the hypothesis under study. The so‑called "culture of evidence" that builds on a systematic use of all research designs is what allows a health profession to change and respond to internal and external pressures.

Few would argue that chiropractic has not already established itself in the musculoskeletal marketplace. However, there is also growing evidence for benefits in many other areas that could be benefitted by further investigation. Moreover, chiropractic has only been evaluated in limited sociodemographic populations. Research is, therefore, needed to evaluate more fully the effects of age, sex, and race/ethnicity on the chiropractic intervention. This is the role of a well‑balanced and open research agenda for the chiropractic profession.

However, our outspoken critic's assertion that: "... they [RCS] have a foregone conclusion in advance, and now set out to make sure they gather data that supports their views..." is wrong and grossly misleading. The scientists and statisticians working with RCS have developed hypotheses (not foregone conclusions) in advance, and the intent is to test these hypothesis using standard methodologies. Finally, whereas researchers would agree that "...scientific research is EXPLORATORY BY DEFINITION...," our research team is in absolute disbelief about the statement of our critic that: "...if we knew the answer to our question, why ask the question and test it through scientific research?"

Scientific questions must be posed in the form of hypotheses, which are then supported or rejected by the data collected. If they are supported by the experimental design then one can begin to advance new experiments and eventually theories. If the hypothesis is rejected, one must start again and reconsider a new hypothesis. This is the scientific method.

Valid criticisms in research are to be encouraged. However, when there is what appears to be a deliberate effort to bias and mislead honest research efforts it is time to take a hard look at the motives of the critics. All groups within the profession need to get on with research and the challenges of developing evidence‑based chiropractic. It is time to change ... time to lead, to follow or get out of the way.

(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.)