Methodological and Application Problems Associated with Guidelines for Chiropractic Quality Assurance and Practice Parameters (Mercy Guidelines)

General Disclaimer -- Page iv

On the copyright page, under "general disclaimer," it is stated, regarding these guidelines, "Adherence to them is voluntary...The ultimate judgement regarding the propriety of any specific procedure must be made by the practitioner in light of the individual circumstances presented by each patient."

Proponents of the Mercy Center document have argued that their guidelines are "voluntary." The facts betray this claim. Consider the contents of a letter from the FCLB to the ICA MA Networker:

Standards have nothing to do with philosophy, and everything to do with competent practice and protection of the public from incompetent practitioners...We hope that the various licensing jurisdictions will use this document in disciplinary cases involving professional incompetency so that those individuals are not allowed to continue chiropractic practice.

It is clear that those persons who suggest that these guidelines are "voluntary" have not heard of FCLBs plan to encourage their members to de-license as "incompetent" those doctors whose practices are at variance with Mercy guidelines. This is extraordinary, particularly in light of the fact that the Mercy guidelines had not been distributed to the field for review or revision prior to release.

Effective Date -- Page iv

It is stated that the "effective date" of the guidelines is July 1, 1993. If the guidelines are "voluntary," why is an effective date necessary?

Chairman's Preface -- Page xxi

It is stated, "The captains had the responsibility of ensuring that all points of view were accurately included in the final document."

The highly biased and incomplete reviews of literature for subluxation-based instrumentation betray claims of objectivity. Furthermore, the guidelines are allopathic in design, and do not make acceptable provisions for wellness and spinal reconstructive care. The emphasis is on treating symptoms, not the correction of subluxations using objective biomechanical and physiological measurements.

Another questionable statement in the Chairman's preface: "The document represents the best effort possible by a representative cross-section of the profession."

The composition of the commission was skewed toward the allopathic/pain treatment paradigm. The ICA was seriously underrepresented. The FSCO/SCASA people had but one voting participant. A seriously underrepresented group was the subluxation-based field practitioner. Not one ICA radiologist was on the commission. Individuals conspicuously absent included the research director of the largest chiropractic college in the world, and the ICA chiropractic researcher of the year. Also of concern is that not a single member of the commission was affiliated with the world's largest chiropractic college.

The Agency for Health Care Policy and Research and the Development of Clinical Practice Guidelines -- Pages xxvi and xxvii

Under "establishing guidelines" the author states, "In the guideline development process, all available scientific evidence must be considered..." Mercy badly missed the mark. Selective reviews of literature abound in this document, particularly in areas relating to the vertebral subluxation complex.

It is also stated that an important aspect of guideline development by the Institute of Medicine of the National Academy of Science is an "open forum." In such a forum, "...every individual interested in providing oral or written testimony relevant to the guideline is invited to do so."

This is in sharp contrast to the "rules" of quasi-secrecy enforced at Mercy. Committee meetings were closed to observers. Only commissioners, observers, and support staff were permitted to attend plenary sessions, and only commissioners were permitted to speak.

The Evolution and Mechanics of a Consensus Process -- Page xxix

This section describes the author's concept of "benefit to patients." Specifically, "Benefit to Patients' means outcomes that matter to patients. For patients with back pain, this means outcomes such as relief of pain and ability to resume usual activities. It does not mean such outcomes as improvement in straight-leg raising, or the appearance of lumbosacral radiographs, or the findings on palpation examination of the spine."

This statement is in sharp contrast to the concepts expressed in the AHCPR publication "Healthy People 2000," which emphasizes preventive strategies, not merely the treatment of symptoms:

The nation has within its power the ability to save many lives lost prematurely and needlessly. Implementation of what is already known about promoting health and preventing disease is the central challenge of Healthy People 2000."

But Healthy People 2000 challenges the Nation to move beyond merely saving lives. The health of a people is measured by more than death rates. Good health comes from reducing unnecessary suffering, illness, and disability. It comes as well from an improved quality of life...Healthy People 2000 uses three approaches; of health promotion, health protection, and preventive services...it calls on medical and health professionals to prevent, not just to treat, the diseases and conditions that result in premature death and chronic disability."

The vision of AHCPR extends far beyond pain relief and improved activities of daily living. Preventive strategies have always been implicit in chiropractic health care. Mercy seems to have overlooked this.

Introduction and Guide to the Use of These Guidelines -- Pages xxxvii through xli.

The introduction expresses the observations of David Eddy stating,

The majority of standard treatments provided by all health providers for all disorders, whether these disorders be minor or life-threatening, have not been validated by formal scientific methodology. Only about 15 percent of medical interventions are supported by valid evidence and many have never been assessed at all.

It is obvious that a consensus panel cannot fabricate non-existent data by taking a vote. It should also be evident that it is foolish to impose more burdensome criteria on chiropractic methods than those generally encountered in other healing arts.

Mercy, however, did not choose to play by its own rules. Under "Procedure Ratings" it is stated, "There must be one or more controlled trials (Class I evidence) for a Type A rating of established." This rule applied to Rating System 1.

This was not followed in Chapters 2, 3, 4, 7, 8, and 13, all of which purported to use Rating System 1. Specifically, in Chapter 2, recommendations 2.1.1, 2.3.1, and 2.4.1 received "established" ratings in the absence of Class I evidence. In Chapter 3, recommendations 3.2.1, 3.3.3, 3.4.3, 3.9.1, and 3.9.2 received "established" ratings despite the absence of Class I evidence. No Class I evidence is cited to support recommendations 4.1.1, 4.1.2, 4.1.3, 4.1.4, 4.1.5, 4.1.9, 4.1.12, 4.1.13, 4.1.14, 4.2.7, 4.2.8, 4.2.9, and 4.2.25. In Chapter 7, recommendations 7.1.2, 7.3.3, 7.5.4, and 7.5.5 received "established" ratings in the absence of Class I evidence. Recommendation 8.2.1 confers an "established" rating without Class I evidence. Finally, Chapter 13 provides an "established" rating for recommendation for 13.1.1 with only Class III evidence.

Chapter 1, History and Physical Examination

Page 7

The only examination procedures specified "regardless of chief complaint" are evaluation of pulse rate, blood pressure, and recording of height and weight." No provision is apparent for subluxation evaluation in the asymptomatic patient.

In a somewhat contradictory paragraph, it is stated,

Practitioners may use any on all diagnostic procedures pertinent to the physical examination, however sophisticated, dependent on individual training and the legal statutory framework within which they work.

Could this result in a claim of negligence against a chiropractor who failed to use "...any or all diagnostic procedures pertinent to the physical examination, however sophisticated?" Will such a practitioner be branded "incompetent" and disciplined by the state board per the FCLB recommendation?

Chapter 2, Diagnostic Imaging

Page 14 -- Spinography

It is stated that "It is not appropriate to image patients simply because of clinical uncertainty or prior negative results." We believe these are excellent reasons to consider imaging studies.

It is also stated, "There is little documented need to image patients prior to release from care." This could be interpreted to limit the appropriateness of "post" x-rays for those techniques requiring them.

Page 18 -- Spinography

There are devastating remarks concerning spinographic analysis. Many appear to be based upon the false assumption that x-rays should somehow reveal patient complaints. The fact that chiropractors use spinographs for subluxation analysis is not discussed. Selective reviews of literature cast biomechanical analysis in a very unfavorable light.

Damaging comments include,

Mensuration and other geometric assessments have been criticized for their lack of intra-and inter-examiner reliability, and lack of association to patient complaints...Correlation of patient complaints of mechanical pain and objective findings on the plain film radiograph remains unreliable.

It should be obvious that x-rays are taken for biomechanical and pathological analysis, not to determine the presence or absence of pain.

Page 19 -- Full-Spine Radiography

It is stated that full spine radiographs are not appropriate substitutes for sectional radiographs. This could result in the need to x-ray the same anatomical region twice in each plane. This is an obvious abuse of ionizing radiation. This recommendation is particularly disturbing since it seemingly contradicts the statement on page 18 that "With proper patient selection and technical detail, full-spine radiography is safe and effective."

Page 19 -- Stress Studies

Several comments could be very damaging to doctors using ASBE, Chiropractic Biophysics, or other techniques which involve stress studies for biomechanical analysis. It is claimed such studies are "of limited diagnostic value and no therapeutic significance."

Pages 19-20 -- Videofluoroscopy

This section contains devastating remarks concerning VF which could cause serious problems in deposition or trial testimony. Many are simply untrue, or represent questionable opinions.

It is stated, "Digitization is not considered possible outside the laboratory at this time." This is untrue, as commercial digitizing hardware and software are readily available.

Another dubious claim is that "Quantification of normal has not been adequately defined." This is another example of a selective literature review, where the works of Fielding, White, Jackson, Keats, and others are conveniently ignored.

The concluding statement is, "The literature does not speak strongly for spinal Videofluoroscopy as a technique for clinical use at this time." This does not seem consistent with an unbiased review of the literature or consideration of the lower radiation levels possible when Videofluoroscopy is used in lieu of plain stress radiographs.

Chapter 3, Instrumentation

This chapter contains many selective reviews of literature. Favorable subluxation related research is ignored or discounted. Furthermore, like Chapter 2, the chapter deviates from the rating system described earlier in the document. Many criticisms made in this chapter claim poor "discriminability" but fail to define the groups to be discriminated. The definition offered gives the example of "healthy" vs "unhealthy" patients, but these very nebulous terms remain undefined throughout the chapter.

Page 40 -- Moiré Topography

It is claimed that "no good correlation to physical findings exist. Adequate interpretation is therefore lacking." This conclusion is based upon a selective literature review, with many key studies ignored.

Page 40 -- Automated Measurements of Posture

It is claimed that these devices are not useful in general practice. Again, selective literature review seems the basis for this conclusion, which could be devastating to Metrecom users.

Page 41 -- Thermocouple Devices

These devices are dismissed as "highly doubtful" with only two references cited. Neither is a chiropractic reference. Positive works are not cited, including Palmer, Duff, Kale, and others. The relationship between altered skin temperature patterns and vertebral subluxation is not explored.

Page 43 -- Surface Electromyography

SEMG is rated "investigational" on the basis of a highly biased literature review. Again, the straw man of "discriminability" is paraded before us, and subluxation related applications are not addressed. Lack of "effectiveness" is claimed, although the question, "effective for what?" is not addressed. Favorable Class I evidence (Shambaugh, Ellestad) is ignored. There are over 290 references on Medline relative to SEMG.

Needle EMG procedures, despite inferior reliability, are rated "established."

Chapter 4 -- Clinical Laboratory

The role of clinical laboratory procedures in assessing the effects of the vertebral subluxation complex is not discussed. The chapter presents an allopathic perspective. Chapter 4 also deviates from the requirements of Rating System 1, which it purports to use.

Chapter 5 -- Record Keeping and Patient Consents

No comments.

Chapter 6 -- Clinical Impression

Page 95 -- Definitions

"Analysis" is re-defined without any mention of subluxation. The definition reads:

The act of separating into component parts the clinical evaluation of a condition or disease in order to identify the clinical impression or determine the diagnosis.

Page 96 -- Diagnosis

Although subluxation is mentioned in some of those reports as a portion of the diagnosis, additional diagnoses are used to describe the patients or conditions.

This may be interpreted by some to mean that subluxation alone is not an adequate diagnosis.

Page 97 -- Content

It is stated,

The primary clinical impression, diagnosis, diagnostic conclusion, or analysis should address the chief complaint expressed by the patient.

What if there is no chief complaint? What if the patient is asymptomatic? What about the subluxation?

Chapter 7 -- Modes of Care

Page 104 -- Neuromusculoskeletal Conditions

Differentiates between "type M" and "type O" disorders. This differentiation may be used to limit or eliminate our ability to provide chiropractic services to patients with "type O" disorders; medical referral may also be required if such conditions exist. This section contains no mention of the subluxation, or its relationship to either "Type M" or "Type O" conditions.

Pages 105 and 106 -- Literature Review

Much of the literature presented to support "manipulation and mobilization" in the treatment of low back pain involved techniques other than chiropractic adjustment. Furthermore, many of these studies suffer from serious design flaws. Specifically, reliable and valid criteria for determining the nature and appropriateness of the intervention applied are absent (segment, listing, technique used, etc.) as are criteria to determine successful application of the manipulative procedure.

An incomplete literature review is provided which presents a very biased perspective on visceral involvement. Conspicuously absent is the work of osteopathic researchers, the work of Pottinger, and findings from the B.J. Palmer Clinic. It is one thing to criticize the shortcomings of some of these works; it is quite another to ignore them entirely.

Pages 107 through 112 -- Recommendations

Although the literature review admits, "There is a paucity of information in the literature comparing one manual approach to another" (P. 106) ratings differ substantially for different adjusting procedures and their applications.

It should be noted that this section rates the different procedures in terms of their applicability to groups of conditions, not their efficacy in correcting subluxations. This section is allopathic in perspective and inappropriate to the practice of subluxation-based chiropractic.

It should be noted that adjustments for other than neuromusculoskeletal conditions are rated "investigational" to "equivocal." It should also be noted that acupuncture received a "promising" rating. This is a higher rating than that received by many adjusting procedures. No differentiation of applicability for neuromusculoskeletal vs. organic disorders is made relative to acupuncture.

Homeopathic remedies received an "equivocal" rating, equal to or higher than the ratings received for many adjusting techniques. No differentiation of applicability for neuromusculoskeletal vs. organic disorders is made.

It is clear that this section exhibits many shortcomings:

1. The reviews of literature are incomplete and biased.

2. Medical manipulation studies are inappropriately used to establish a rationale for chiropractic as a treatment for back pain.

3. Research relating spinal lesions to visceral involvement is omitted.

4. A more burdensome standard is placed on chiropractic procedures than homeopathy and acupuncture.

5. Adjusting to correct manifestations of the vertebral subluxation complex is not addressed.

6. Includes the use of materia medica (drugs) both homeopathic and allopathic (phonophoresis).

Chapter 8 -- Frequency and Duration of Care

Page 118 -- Adequate Trial of Treatment/Care

This is defined as follows:

A course of two weeks each of two different types of manual procedures (four weeks total), after which, in the absence of documented improvement, manual procedures are no longer indicated.

This is one of the most dangerous statements in the document. It may have the effect of establishing two to four week "caps" on chiropractic services. "Documented improvement" is not defined. However, taken in the general context of the document, this could mean symptomatic change. The statement that "manual procedures are no longer indicated" after such a trial could be used to deny lifetime benefits after one "unsuccessful" episode.

It is particularly disturbing that this, and other definitions, were not debated at the Mercy Center Conference.

Page 120 -- Predictions From The Case History and Page 121 -- Passive Care

These sections suggest that most cases responded "well" within six weeks of intervention, and that those for whom care beyond six weeks was required, the mean number of additional sessions required is 3.8. The studies cited are based upon symptomatic treatment of specific complaints. Reduction of the manifestations of the vertebral subluxation complex is not addressed.

Pages 124 and 125 -- Recommendations

Very narrow recommendations are offered which are inconsistent with what is known about soft tissue injury, prespondylosis, and hypersensitivity. Reconstructive care is not addressed. Recommendations are based upon symptomatic relief rather than spinal correction.

CHAPTER 9 -- Reassessment

Page 133 -- Subluxation Syndrome

The definition offered is:

The clinical signs and symptoms thought to relate to pathophysiology or dysfunction of spinal motion segments or to peripheral joints that may be amenable to manipulative/adjustive procedures.

What are the symptoms of subluxation? This is not defined. The asymptomatic "subluxation syndrome" is not addressed.

Page 143 -- Literature Review

The document states,

Spinal radiography is used widely as a reassessment tool but definitive studies on level of appropriateness are lacking. There is also little scientific evidence to validate many of the commonly used procedures and tests in neuromuscular diagnosis. There is even less documentation of validity and reliability with respect to procedures specific to the manual arts.

Such a statement could be devastating in a deposition or trial. Conspicuously absent are references to support these very damaging remarks.

CHAPTER 10 -- Outcome Assessment

Page 142 -- Definitions

The definition of "subluxation syndrome" differs from that offered in Chapter 9. The definition on page 142 is as follows:

This term is defined here to mean the clinical signs and symptoms that relate to pathophysiology or dysfunction of spinal and pelvic motion segments or to peripheral joints that may be amenable to manipulative/adjustive procedures.

This definition includes "pelvic motion segments," while the definition in Chapter 9 does not.

A very disturbing definition is "Spinal Manipulative Therapy (SMT):

This term refers to the range of manual care delivered in chiropractic practice. It includes adjustive, manipulative, and mobilization procedures.

This downgrades the adjustment to just another "therapy" used to "treat" the "signs and symptoms" of a "subluxation syndrome." By lumping the adjustment together with manipulation and mobilization, the unique character of this service is lost.

Page 143 -- Functional Outcome Assessments

Broad scope therapeutics is promoted by the following statement:

This is not to suggest, however, that chiropractic care is synonymous with spinal manipulative therapy. Chiropractic care encompasses a wide range of conservative therapeutics.

Page 144 -- Patient Perceptions Outcome Assessments

It is stated:

It makes sense for practitioners to attempt to measure pain as a way of evaluating the success of their care.

To the chiropractor, however, there are several significant shortcomings to pain-based models for outcome assessment:

1. Such schemes assume that the objective of chiropractic care is symptomatic treatment of pain.

2. Pain is a highly subjective, private sensation which cannot be directly measured or observed.

3. In some instances, unless the pain is robust enough to restrict activities of daily living, a "false negative" could result.

4. Pain criteria cannot be applied if the patient has symptoms other than pain, or no symptoms at all.

5. Pain criteria are useless in the evaluation of asymptomatic patients undergoing maintenance or reconstructive care.

Pain is not a reliable and valid indicator of vertebral subluxation. Despite this, Chapter 10 disparages objective outcome assessments which measure manifestations of the vertebral subluxation complex.

Page 146 -- Thermography

Devastating remarks are made concerning thermography. Absent is the work of many distinguished investigators. This is another example of an incomplete, biased review of literature.

Page 147 -- Posture

A grossly incomplete review which downplays the importance of posture in health. The reader is referred to the review by M.E. Jenness in NINCDS Monograph No. 15 to gain a perspective on how inadequate and potentially misleading the review on page 147 of Mercy is.

Page 148 -- Vertebral Position

A study by a psychologist is cited which states,

One study (Keating, 1990) found no reliability of palpation for misalignment of vertebrae. There are no clinical trial outcomes studies using palpation of bony landmarks as indicators of misalignment.

Such a comment could be very damaging to doctors who employ palpation.

Page 148 -- Abnormal Spinal Segmental Motion/Lack of Joint Endplay

It is stated,

Haas and Nyiendo (1990, 1991) have questioned the validity and reliability of lateral lumbar bending radiographs for patients with low-back pain. There does not seem to be a greater prevalence of "abnormal" findings in persons with a history of back pain compared to those without back pain.

How can one expect to evaluate pain on a radiograph? It is not possible to discriminate between a living patient and a fresh corpse on spinal radiographs, either! X-rays are taken to evaluate biomechanics and pathology, not to measure pain.

Page 149 -- Asymmetric or Hypertonic Muscle Contraction

A selective, highly biased review of literature is presented. SEMG is attacked on the basis of claims that are not made by subluxation based chiropractors. Specifically, as a test of motor activity, it can hardly be expected to discriminate between pain and non-pain populations. It is also claimed that "There is very little standardization of examination procedures at this time." However, literature describing standardized protocol is not cited.

Pages 151 and 152 -- Thermography

It is stated,

There is very little scientific data to support the responsiveness of thermographic measurements to changes in health status.

Thermography is rated "Investigational to equivocal as an outcome assessment for patients with neuromusculoskeletal conditions."

In Chapter 3, thermography is rated "equivocal/promising."

Page 152 -- Vertebral Position Assessed Radiographically

The rating in this chapter is "equivocal," although Chapter 2 rates plain radiography for biomechanical assessment "promising." (Page 27)

Page 152 -- Asymmetric Segmental Motion Assessed Radiographically

The rating in this chapter is "investigational," while Chapter 2 rates videofluoroscopy for kinematic and other biomechanical purposes "promising." (Page 27)

Page 152 --Asymmetric or Hypertonic Muscle Contraction

Fixed electrode SEMG is rated "equivocal" as an outcome assessment for patients with neuromusculoskeletal conditions.

Scanning EMG is rated "investigational to equivocal" as an outcome assessment for patients with neuromusculoskeletal conditions.

These are inconsistent with the ratings in Chapter 3.

Chapter 11 -- Collaborative Care

No comments.

Chapter 12 -- Contraindications and Complications

GENERAL

This Chapter was substantially changed in editing. All references to probability have been wisely deleted. However, one must question whether ratings and recommendations can be deleted by editors without convening a conference of the original commissioners.

Page 169 -- Joint Dysfunction

The definition offered lumps subluxation in this category without regard for the neurological component or adjustment:

Joint Dysfunction (manipulable lesion, subluxation, functional spinal lesion): Decreased or aberrant joint mobility for which manipulation is indicated. In this context the term excludes states of hypermobility of instability.

Pages 173 through 175 -- Recommendations

The paucity of case reports makes it difficult to assess the relative risk of chiropractic adjustments under various circumstances. Many of the complications reported following "manipulations" did not involve adjustments administered by chiropractors.

Although less harmful than the original manuscript, this chapter fails to differentiate complications arising from adjustments administered by chiropractors and complications following other manipulative procedures administered by non-chiropractors.

Chapter 13 -- Preventive/Maintenance Care and Public Health

Page 183 -- Use of Chiropractic Adjustments

The rating given is "equivocal." Acupuncture and physical therapy modalities fared far better in Chapter 7.

Page 183 -- Wellness Care

This is also rated "equivocal."

CHAPTER 14 -- Professional development

No comments.

EPILOGUE

Page 194 -- Future Consensus Conferences

The document states,

It is unlikely that any substantial revision of these guidelines will occur and be sponsored by a credible portion of the profession within the next two or three years.

Thus, the damaging precedents set by these guidelines will be with us for a long time.

It is admitted,

It was not possible to address each area of practice in the degree of detail which may be desirable.

Indeed, we have disclosed areas where incomplete, biased, unchallenged reviews of literature were used to disparage the subluxation concept and the technologies for evaluating manifestations of the vertebral subluxation complex.

In the closing paragraph, the following statement is made:

At no time, however, must political considerations be allowed to supersede basic scientific principles and health care ethics.