GUIDELINES FOR CLINICAL GUIDELINES?

There seems to be a progressively increasing number of practice guidelines appearing on the horizon for Chiropractors. If enough of these are generated could it get to the point that depending on whom a Chiropractor is dealing with, they will need to behave and practice in a chameleon-like fashion – what’s good for one patient, may be very different to what is good for another – depending on which guideline oversees that person’s situation?

Some of these guidelines appear to be less like best practice guidelines and more like agenda-based guidelines.

Most recently the Chiropractors Registration Board of Victoria has crossed over a boundary not previously entered into, and that is into the arena of clinical practice guidelines (http://www.chiroreg.vic.gov.au/comment.php). This is being justified on the basis that they act to protect the public against unethical chiropractice – but once reviewed against the standard of everyday chiropractic one might ask who will protect the chiropractor from the public and other third parties?

And if many established and widespread chiropractic practices such as X-raying for biomechanical assessment, use of physiological assessments such as surface EMG, adjusting children and newborns, caring for people with non-musculoskeletal conditions, maintenance and even wellness adjustments are guidelined as fringe, questionable and even unacceptable behaviours, then will future chiropractic practice resemble the service that so many chiropractors have offered to their communities for over 100 years?

Most of these guidelines are presented under the umbrella of “evidence-based practice”: Evidence-based clinical practice is defined as “The conscientious, explicit, and judicious use of the current best evidence in making decisions about the care of individual patients... (it) is not restricted to randomized trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions.” (Sackett DL. Editorial. Evidence Based Medicine. Spine 1998.)

However it appears that some guideline developers twist the definition of “best” – disqualifying research and publication, or evidence, which isn’t the “best” – that is, if it isn’t a randomised, placebo-controlled, longitudinal, multi-centred, independently peer reviewed, published in a journal which the expert panel subscribes to, then it ain’t “best” and therefore it doesn’t exist…

In fact “best evidence” means the best level of evidence that we can find and what it tells us… If we don’t have the gold standard evidence, then do we have silver, bronze and even minor placing evidence to review and interpret? It is no secret that not only is chiropractic not very amenable to controlled study for a plethora of reasons, but the bulk of our evidence exists in the realm of longitudinal outcome studies, case series, and case studies. If this is the “best evidence” what does it tell us – there can be no denying that they tell us that a massive diversity of health complaints present in chiropractors’ offices, and that positive changes seem to happen?

We can’t say that if 100 “Syndrome A” sufferers present to chiropractic offices tomorrow, what percentage of these people will receive some degree of improvement let alone a complete resolution. But based on the evidence wouldn’t it be fair to say that if a “Syndrome A” sufferer presents to your office tomorrow, that it would be rational to initiate a course of treatment with clear goals and terms for review? How does that seem inferior or unacceptable to any other health care profession’s plan of action? Even after the gold standard research measures that 45% of patients receive an average of 35% improvement, what can we guarantee Mrs Jones on Monday morning? A course of care with clear goals and terms for review…

“Well it might mean that they aren’t receiving necessary medical intervention and maybe they have some terminal condition and detection will be delayed by this unproven approach!” Welcome to the life of a health care consumer trying to deal with a “primary care practitioner” – maybe the medications that the MD would prescribe as an “alternative” to our care would be ineffective or even damaging; may mask or delay the identification of other pathology; and maybe it could take months and even years to get a correct diagnosis in the medical system anyway? Sound familiar?

The chiropractic profession is not alone in the struggle to produce relevant and applicable guidelines which guide best practice, as opposed to restricting practice. “The National Health and Medical Research Council (NHMRC – an Australian Government body) has statutory responsibilities to raise the standard of individual and public health throughout Australia and to foster the development of consistent health standards. As part of this role, the NHMRC encourages the development of evidence-based guidelines by expert bodies.” (NHMRC standards and procedures for externally developed guidelines, updated September 2007)

Is a health care profession’s registration board an example of such an “expert body”? A quick read of the profiles of members of the board suggests that there is not much representation of the chiropractic profession’s academic and scientific community. So has the board received significant funding to employ the services of such experts? Who would know – no names or qualifications of any contributors or peer review panel members are listed in any of the guidelines. The guideline which covers the issue of paediatric care is an exception: It gives thanks to a Medical Paediatrician and an American Chiropractor who also holds Medical Degree, who is a self proclaimed “Quackbuster” who deals with healthcare consumer protection, and is therefore about quackery, health fraud, chiropractic, and other forms of so-Called "Alternative" Medicine (“sCAM”): Is this our desired expert body?

“It is now widely recognised that guidelines should be based, where possible, on the systematic identification and synthesis of the best available scientific evidence. The NHMRC requirements for developing clinical practice guidelines are rigorous so as to ensure that this standard is upheld. As such, guidelines with NHMRC approval are recognised in Australia and internationally as representing best practice in health and medical knowledge and practice.”

I’ll leave it to the educated reader to review the current proposed guidelines based on the following information:

Key principles for developing guidelines:

The nine key principles are:

1. The guideline development and evaluation process should focus on outcomes: This statement shouldn’t be glossed over as it seems that some of the worst examples of guidelines are more interested in practice than outcomes.

2. The guidelines should be based on the best available evidence and include a statement concerning the strength of recommendations. Evidence can be graded according to its level, quality, relevance and strength; (Ideally, recommendations would be based on the highest level of evidence. However, it has been acknowledged that the levels of evidence used by the NHMRC for intervention studies are restrictive for guideline developers, especially where the areas of study do not lend themselves to randomised controlled trials. It is proposed that this issue will be addressed when the toolkit publications are reviewed.)

It is tradition when presenting scientific evidence, to cite the source of your evidence. The proposed guidelines of the Registration Board list no references, and request for such evidence is refused on the grounds of “intellectual property”. Does this mean that there is no evidence? Is it only some “expert’s” opinion? Or are there too many pages of citations to fit in the publication? Who would know?

3. The method used to synthesise the available evidence should be the strongest applicable;

4. The process of guideline development should be multidisciplinary and include consumers early in the development process. Involving a range of generalist and specialist clinicians, allied health professionals and experts in methodology and consumers has the potential to improve quality and continuity of care and assists in ensuring that the guidelines will be adopted;

The board’s approach is to implement this step as late as possible, input only being sort after the guidelines have been drafted; and if past guidelines are representative, additional input will only lead to minor amendments at best.

That’s also why it is best to employ a medical paediatrician and an overseas chiropractor to produce a guideline on chiropractic care for children in Victoria. Perhaps the Australian chiropractic paediatric specialists that abound and the university academia that are responsible for the undergraduate paediatric curriculum were out to lunch when the document was written?

5. Guidelines should be flexible and adaptable to varying local conditions;

6. Guidelines should consider resources and should incorporate an economic appraisal, which may assist in choosing between alternative treatments;

7. Guidelines are developed for dissemination and implementation with regard to their target audiences. Their dissemination should ensure that practitioners and consumers become aware of them and use them;

In the case of the guidelines being discussed here you can download them from the web-site – otherwise you can get someone else to download them from the web-site for you.

8. The implementation and impact of the guidelines should be evaluated; and

9. Guidelines should be updated regularly.

I look forward to the dissemination of the steps and process for implementation of steps 3 and 5 to 9 with our newest guidelines – don’t hold your breath.

So, if the Registration Board’s attempt to offer guidelines is severely flawed where can we turn?

Guidelines have been produced which would more likely live up to the standards of the NHRMC. The Council on Chiropractic Practice Clinical Practice Guideline (“CCP”) is currently undergoing its’ second revision. Following publication of the CCP Guidelines the document was submitted to the National Guideline Clearinghouse for consideration for inclusion. The NGC is sponsored by the U.S. Agency for Health Care Research and Quality and is in partnership with the American Medical Association and the American Association of Health Plans.

Its mission is as follows: “The NGC mission is to provide physicians, nurses, and other health professionals, health care providers, health plans, integrated delivery systems, purchasers and others an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their dissemination, implementation and use.” In other words the US equivalency of the NHRMC.

The AHRQ contracts with ECRI, a nonprofit health services research agency, to perform the technical work for the NGC. ECRI is an international nonprofit health services research agency and a Collaborating Center of the World Health Organization.

In November of 1998, following review by ECRI, the CCP Guidelines were accepted for inclusion within the National Guideline Clearinghouse.

The CCP has developed practice guidelines for vertebral subluxation with the active participation of field doctors, consultants, seminar leaders, and technique experts. In addition, the Council has utilized the services of interdisciplinary experts in the Agency for Health Care Policy and Research (AHCPR), guidelines development, research design, literature review, law, clinical assessment, chiropractic education, and clinical chiropractic.

The Council additionally included consumer representatives at every stage of the process and had individuals participating from several major chiropractic political and research organizations, chiropractic colleges and several other major peer groups. The participants in the guidelines development process undertaken by the CCP and their areas of expertise are clearly disclosed.

The Guidelines offer ratings of practices based on the following system:

Established: Accepted as appropriate for use in chiropractic practice for the indications and applications stated.

Investigational: Further study is warranted. Evidence is equivocal, or insufficient to justify a rating of “established.”

Inappropriate: Insufficient favorable evidence exists to support the use of this procedure in chiropractic practice.

Categories of Evidence underpinning each rating are presented as:

E: Expert opinion based on clinical experience, basic science rationale, and/or individual case studies. Where appropriate, this category includes legal opinions.

L: Literature support in the form of reliability and validity studies, observational studies, “pre-post” studies, and/or multiple case studies. Where appropriate, this category includes case law.

C: Controlled studies including randomized and non-randomized clinical trials of acceptable quality.

To download the full version and updates of the CCP guidelines go to http://www.worldchiropracticalliance.org/