Clinical Guidelines for Chiropractic Practice in Canada
Introduction and Guide to Use of These Guidelines
B. Format C. Assessment Criteria
The majority of standard treatments given by all health providers for all disorders, whether these disorders be minor or life-threatening, have not been validated by scientific evidence. Only about 15% of medical interventions are supported by valid evidence and many have never been assessed at all.1,2 In the field of low-back pain, the most common presenting condition in chiropractic practice, a recent literature review commissioned by the government of Ontario confirms that scientific proof of the validity of chiropractic treatment is considerably stronger than the evidence for any medical treatment.3 However, virtually all aspects of chiropractic practice, like medical practice, require further research.
These facts, together with the unacceptable variations in practice and cost of health care, explain why the public and governments are now insisting that there be better guidelines for practice. In the United States in December 1989 the federal government established the Agency for Health Care Policy and Research to ensure that improved national guidelines for each health care profession and specialty were developed without delay. The message was clear - either the health professions developed their own guidelines or third parties would impose them. Soon afterwards, for similar reasons, federal and provincial governments in Canada established the Canadian Coordinating Office for Health Technology Assessment.
American guidelines for chiropractic practice were established following an extended consensus process at the Mercy Center Consensus Conference in California in January 1992.4 The guidelines in this publication, again developed according to established consensus methods, apply specifically to the practice of chiropractic in Canada.
Procedure Ratings (System 1)
Part V of each chapter, under the heading "Assessment Criteria", gives the ratings system used to develop and rank each recommendation. The key to comprehending these guidelines lies in understanding the ratings systems used.
Developing appropriate ratings is a major challenge because the technique of ratings is still evolving and these guidelines cover a broad territory, the whole practice of chiropractic. Ratings for one area of practice (e.g. when it is appropriate to use plain film xrays or a specific treatment approach - i.e. technical matters) are not suitable for other areas (e.g. what records should be kept, or when patient consents are required - i.e. procedural matters).
Two basic systems have been adopted and appear below. Some chapters use System 1, some System 2, and some both systems. To identify which system(s) is/are used in a given chapter look at Part V (Assessment Criteria) in that chapter. For details on the system(s), refer back to the explanations below.
Chapter 13 dealing with complications and contraindications, has its own rating system. This is described fully in Chapter 13 and summarized later in this introduction.
PROCEDURE RATINGS (SYSTEM II)
This system is suited to scientific/technical areas of practice. Features are:
The following example illustrates how a rating should be interpreted.
|Procedures are judged, in descending order of approval, established, promising, equivocal, investigational, doubtful and inappropriate. See Figure 1 for definitions. |
|The first three ratings (established, promising, and equivocal) are all positive. Procedures with any of these ratings are approved for use and reimbursement in clinical practice. |
The remaining three ratings (investigational, doubtful, and inappropriate) are negative. A procedure currently rated "investigational" has the potential to be raised to a positive rating for clinical practice on the basis of future clinical research evidence.
A specific procedure may have more than one current rating depending upon the circumstances in which it is used - see the examples in paragraph 3 below.
As noted in Figure 1, the rating chosen for a procedure is linked to the quality of evidence that supports use of that procedure.
In Chapter 4 on Diagnostic Imaging, Recommendation 4.9 deals with full spine radiography. The value of full spine radiographs is rated as established in the assessment of scoliosis, but promising for complex biomechanical disorders.
Both are positive recommendations. In the first case there is Class I evidence in support (i.e. controlled clinical trials - for full definition of Class I evidence see Figure 1). This quality of evidence justifies the rating established.
In the second case there can only be a rating of promising because, as is indicated in the recommendations, there is no Class I evidence. There is Class II and III evidence which justifies the rating promising. If there had only been Class III evidence the only positive rating possible would be equivocal.
Procedure Ratings (System 2)
|PROCEDURE RATINGS (SYSTEM 1)
ESTABLISHED: Accepted as appropriate by the practising chiropractic community for the given indication in the specified patient population.
PROMISING: Given current knowledge, this appears to be appropriate for the given indication in the specified patient population. As more experience and long-term follow-up are accumulated, this interim rating will change. This connotes provisional acceptance, but permits a greater role for the current level of clinical use.
EQUIVOCAL: Current knowledge exists to support a given indication in a specified patient population, though value can neither be confirmed nor denied. As more evidence and experience accumulates this rating will change. Expert opinion recognizes a need for caution in general application.
INVESTIGATIONAL: Evidence is insufficient to determine appropriateness. Further study is warranted. Use for a given indication in a specified patient population should be confined to research protocols. As more experience and evidence accumulates, this rating will change.
DOUBTFUL: Given current knowledge, this appears to be inappropriate for the given indication in the specified patient population. As more experience and long-term follow-up are accumulated, this interim rating will change.
INAPPROPRIATE: Regarded by the practising chiropractic community as unacceptable for the given indication in the specified patient population.
QUALITY OF EVIDENCE
CLASS I: Evidence provided by one or more well-designed controlled clinical trials; or well-designed experimental studies that address reliability, validity, positive predictive value, discriminability, sensitivity, and specificity.
CLASS II: Evidence provided by one or more well-designed uncontrolled, observational clinical studies, such as case-control, cohort studies, etc; or clinically relevant basic science studies that address reliability, validity, positive predictive value, discriminability, sensitivity, and specificity; and published in refereed journals.
CLASS III: Evidence provided by expert opinion, descriptive studies or case reports.
This system is suited to procedural/administrative aspects of practice. Accordingly it is used in chapters such as Informed Consent (Chapter 1), Record keeping (Chapter 2) and Professional Relations (Chapter 12). Again, one can discover which rating system is being used by looking at Part V (Assessment Criteria) of each chapter.
|Rating levels are necessary, recommended, discretionary and unnecessary. |
|Once again rating is linked to quality of evidence - see Figure 2 for details. |
QUALITY OF EVIDENCE
NECESSARY: Strong positive recommendation based on Class I evidence, or overwhelming Class II evidence when circumstances reflect compromise of patient safety.
RECOMMENDED: Positive recommendation based on consensus of Class II and/or strong Class III evidence.
DISCRETIONARY: Positive recommendation based on strong consensus of Class III evidence.
UNNECESSARY: Negative recommendation based on inconclusive or conflicting Class II, III evidence.
The following categories of evidence are used to support the ratings.
|E.||Evidence of clinical utility from controlled studies published in refereed journals|
|F.||Binding or strongly persuasive legal authority such as legislation or case law. |
|G.||Evidence of clinical utility from the significant results of uncontrolled studies in refereed journals. |
|H.||Evidence provided by recommendations from published expert legal opinion or persuasive case law. |
| I.||Evidence of clinical utility provided by opinions of experts, anecdote and/or by convention.|
|J.||Expert legal opinion |
Special Rating System for Complications
A special third rating system has been developed for the unique area of potential complications of high-velocity thrust procedures. See Part V (Assessment Criteria), Chapter 13. The basic rating is a level of contraindication, which may be:
- No contraindication
- Relative contraindication: "high-velocity thrust procedures may be used with appropriate care and/or modification".
- Relative to absolute contraindication: "careful clinical judgement dictates whether contraindication is relative or absolute with each specific patient".
- Absolute contraindication
The recommended level of contraindication appears as a short paragraph in each recommendation and is supported by specific evidence. For example Recommendation 13.2, which relates to high-velocity thrusts in the presence of sub-acute or chronic ankylosing spondylitis, reads:
13.2 Sub-acute and chronic ankylosing spondylitis and other chronic arthropathies in which there are no signs of ligamentous laxity, anatomic subluxation or ankylosis are not contraindications to high-velocity thrust procedures applied to the area of pathology.
What this means is:
Condition Rating: Type I, II
Quality of Evidence: Class III
1. The conditions mentioned are not contraindications to high-velocity thrust procedures.
2. Potential complications are not severe - for definitions of minimal, moderate, and high-level severity of complication see Part V, Assessment Criteria, paragraph A (p. 142).
3. On the basis of the severity rating just given and probability or likelihood of harm, there is a `condition rating' of Type I - for definitions of Type I, Type II and Type III conditions ratings see Part V, Assessment Criteria, paragraph B (p. 142).
4. Finally, there is a rating for quality of evidence - for definitions of Class I, Class II and Class III evidence see Part V, Assessment Criteria, para C (p. 142).
Chapter 12 lists the various potential complications of high-velocity thrust procedures under categories of:
D. THE GUIDELINES IN CONTEXT
Bone Weakening and Destructive Disorders
Circulatory and Cardiovascular Disorders
Individual recommendations or guidelines must be read in context. Thus:
|1.||Each chapter has a section entitled `Definitions' (Part II). It is often important to consult this section and the Glossary to understand the meaning of technical words used in the guidelines.|
For example under Modes of Care and Management (Chapter 10) high-velocity thrust procedures are rated established for many neuromusculoskeletal disorders (Recommendation 10.1a). The question might be raised whether this includes respiratory or digestive dysfunctions assessed as having a somatovisceral or spine-related component. In chiropractic practice the basis for management is the presence of subluxation or spinal dysfunction, and such disorders can be seen as neuromusculoskeletal.
In this context the answer is no - see the definition (Part II - p. 105). For the purposes of this chapter the term `neuromusculoskeletal' excludes internal organ dysfunctions.
|2.||The rest of the chapter may modify a particular recommendation. The overview (Part I in each chapter) often does. In addition, other recommendations often qualify a given recommendation. |
Under Chapter 8 on Frequency and Duration of Care, for example:
|a.||Recommendation 8.4 suggests a guideline for management of patients with acute, uncomplicated disorders - four weeks of manual procedures, two weeks of two different approaches, with continuing care only if there is "demonstrable improvement." |
|b.||That this recommendation applies to patients with neck pain and headache as well as low-back pain may only become apparent on reading comments in the overview and literature review. |
|c.||The number of treatments recommended per week appears in another recommendation (8.3). |
|d.||The answer to whether or not four weeks of treatment is an absolute time within which there must be demonstrable improvement is qualified by Recommendation 8.2 which provides for some of the factors that modify the guideline and treatment plan - e.g. severe pain, four or more previous episodes, or pre-existing conditions. |
|e.||In summary, Recommendation 8.4 can only be understood when read in context, and together with other recommendations. |
Properly understood, these recommendations do not give a `cookbook' approach to duration of care or number of treatments. The guidelines recognize that many factors may influence treatment regimes, including pre-existing conditions, re-injury or failure to comply with patient-centred aspects of management. Such factors may explain why a guideline is exceeded yet the care still considered appropriate in an individual case.
In summary, chiropractic practice should conform with the guidelines in general, and there should be documented reasons for continuing with manual procedures in the absence of anticipated improvement in specific cases. A problem arises only when the management of a specific case is outside the guidelines with no apparent reason.
E. CONSENSUS LEVELS
Next to each recommendation or guideline there appears a level of consensus on a scale of 1-5. This defines the level of agreement for that recommendation as voted by the 36 members of the consensus panel at the Glenerin meeting. Consensus levels adopted were:
Level 1 (Full agreement) - over 85% (more than 30 votes out of 36)
Level 2 (Consensus) - 70-85% (25-29 votes)
Level 3 (Majority/Minority Opinions) - 51-69% (i.e. a majority)
Level 4 (Multiple Minority Opinions) - 26-50%
Level 5 (No Consensus) - no agreement by more than 25%
The meeting produced an extremely high level of consensus. The great majority of recommendations received Level 1 consensus or full agreement, and none received lower than Level 3 consensus.
F. PROFESSIONAL TITLE
The use of professional title is governed by law and individual preference, and varies according to jurisdiction. The most common titles used for the general practice of chiropractic in Canada are `chiropractor', and 'doctor of chiropractic'. Both of these titles are used in this document.
Specialties exist in chiropractic, in areas such as clinical sciences, radiology, and sports chiropractic. Specialist practitioners are given their common and usual titles (e.g. chiropractic radiologist).
G. CONCLUSION - HOW TO FIND A GUIDELINE
It is suggested that the following process be followed:
1. Consider which chapter will cover the guideline topic in question. If necessary, use the Index at the back for assistance.
2. Consult Part III (List of Subtopics of guidelines) of the relevant chapter.
3. Turn to Part VI of the chapter, which lists the recommendations or guidelines, and consult the relevant guideline.
4. Read the guideline carefully, and check for other guidelines in the chapter that may modify or qualify it.
5. Refer to other parts of the chapter, especially the overview (Part I) and the Definitions (Part II and Glossary).
1. Smith R (1991) `Where is the Wisdom: The Poverty of Medical Evidence', BMJ (1991) 303:798-799. Quoting David Eddy MD, Professor of Health Policy and Management, Duke University, NC.
2. Rachlis N and Kuschner C (1989) `Second Opinion: What's Wrong with Canada's Health Care System and How to Fix It', Toronto: Collins, 1989.
3. Manga P, Angus D et al (1993) 'The Effectiveness and Cost-Effectiveness of Chiropractic Management of Low-Back Pain', Pran Manga and Associates, University of Ottawa, Canada. 1993: Martham, Toronto.
4. Haldeman S, Chapman-Smith D and Petersen DM, eds. 'Guidelines for Chiropractic Quality Assurance and Practice Parameters', Gaithersburg, Maryland: Aspen Publishers.