"Are Your Treatment Protocols Evidenced-Based?"
The challenge to the clinician implicit in the title of Dr. Haldeman's talk at the 2004 ABS meeting is clear enough. Chiropractors are so used to being asked, "Where's the proof that chiropractic care is effective?" that it is worth pointing out that Haldeman was addressing an interdisciplinary audience, including more MDs than DCs. No profession can escape the following contemporary paradox: While the cost of treating back pain has gone up exponentially, the impact of this care on back pain appears to have been minimal.
Increasingly sophisticated ways of conducting research, and of evaluating the quality of such research, make it incumbent upon clinicians to familiarize themselves with this growing body of information. To put it bluntly, those who are unable to demonstrate the clinical and cost effectiveness of the care they provide are less likely to be reimbursed for providing it.
As an example of this tendency, recent legislation in California and elsewhere, requiring evidence supporting the value of care, is having a large impact on chiropractors' ability to deliver care. A similar process in Canada has led to the "delisting" of chiropractic care in the province of Ontario. Although in a research setting, it is commonly stated that the "lack of evidence is not evidence of lack," this does not carry over very well into a third-party-payment setting, where lack of evidence often translates into lack of reimbursement. Patients saying that their pain is reduced, that they are satisfied with their care, or that they would be willing to once again undergo the same surgical procedure, no longer counts as evidence.
Personal Injury Claims and the Doctor
At this ABS meeting, two presentations focused on medicolegal issues; specifically, on personal injury. One presentation came from an attorney's perspective (Steven Mendelson, Esq., from Oakland, Calif.), and the other from an independent medical examiner's perspective (Dr. Daniel Wolens). The attorney took a rather dim view of the motives of most "independent" examinations ("Defense doctors always lie."), whereas the doctor described how such exams could in principle be independent, and thus credible.
Having heard Mr. Mendelson present at previous ABS meetings, I should state at the outset that he strongly believes that the stereotype of the dishonest patient and crooked attorney in cahoots is very much exaggerated. At the same time, Mr. Mendelson presents a rather stark view of the motivation of the insurance company; by definition, it is not interested in the welfare of the patient, but only in seeking the best rate of return on its capital, while paying as little as possible for the risk it buys. This workshop had the objective of alerting doctors as to the skills they need to persevere under the most trying of circumstances.
There are many things working against doctors, and ultimately, their patients, in the medicolegal setting. As Mendelson put it, "Jurors come to the courtroom full of skepticism for the injured party and their attorney." They, at least initially, usually afford the doctor some degree of respect, but that will not last long if the doctor is not able to teach the jurors enough chiropractic medicine to withstand the defense barrage.
Although Dr. Wolens, in discussing how to avoid the pitfalls of conducting an independent medical examination (IME), cracked a joke about being the one asked to give administrative rather than scientific type of talks; medicolegal presentations such as his are clearly of great interest, given today's increasingly complicated medicolegal climate. After all, great clinicians are not in a very good position to help patients if the practice environment gets in the way.
The IME covers necessity of care, causation, maximal medical improvement, permanent partial impairment, disability, delayed recovery, and claim adjudication. The primary challenges in rendering the IME result from the intrinsically adversarial relationship with the patient, from the patient's anger, litigation status, lack of cooperation, and (frequently) psychological disease. It is important that the patient understand that by definition, there is no doctor-patient relationship during the IME, and that there should be no typical "report of findings" during any such examination. On the other hand, the doctor need be aware that the patient must be informed of obvious serious or emergent health issues.
The patient must be informed that he or she is in control of the IME, and thus can refuse to answer questions, or can even leave the examination. To avoid even the pretense of injury, the IME should involve active rather than passive range of motion, and must never require the patient to exceed his or her perceived capacity during any physical examination procedure. Each of the following precautions can help avoid an injury claim: Obtain informed consent, have the examination observed, utilize audio or videotaping, and use a satisfaction survey. It should go without saying that the examination should not include defamation, libel/slander, false allegations, derogatory statements, or malicious actions. Such precautions are especially important in that liability and malpractice insurance may not cover claims related to the IME. In closing, Dr. Wolens offered the following advice: Document, document, and document - the best defense against any type of liability.
From the Artificial Disc Department
Each ABS meeting involves an update on clinical trials utilizing the artificial disc and the X-STOP (extension stopper) device for treating spinal stenosis; I have covered these updates in previous columns. At this meeting, Dr. Zucherman, of Saint Mary's Spine Center, addressed the artificial disc, and Dr. Hsu of Stanford covered the X-STOP. The mainstream advent of the artificial disc became apparent to me recently while watching an episode of CSI, in which the key to solving the crime turned on the fact that the murdered person had an artificial disc, which enabled easy identification of the victim. On that show, Dr. Albert Robbins [played by actor Robert David Hall] was reasonably accurate in stating that the artificial disc "matches range of motion, flexibility, and axial rotation of a normal spine."
Unlike the current standard of surgical care for degenerative disc disease, which involves fusing the motion segment, inserting a titanium/polyethylene prosthetic device preserves function and thus a better postsurgical quality of life. Unlike fusion, the artificial disc does not transfer mechanical stress to other vertebral levels, thus reducing the risk of future surgeries. It is also relatively inexpensive, with a recovery period measured in weeks, rather than months. The PRODISC device was so successful in European trials that the FDA accepted the data as a pilot study and thus allowed multisite trials in America to begin, now in progress. More recently, Dr. Zucherman has begun testing the all-metallic FLEXICORE device, which he claims to be more stable than its predecessors. Cervical disc replacements are now on the horizon.
Dr. Hsu described the X-STOP device, an easily installed spacer that prevents lumbar spinal extension just at the affected level(s) in spinal stenosis causing neurogenic claudication. The initial data in an FDA-approved multisite study are showing clinical outcomes about twice as good as the nonoperative control group that was treated with existing conservative measures. The X-STOP device also seems preferable to laminectomy, the standard surgical treatment, because it has less adverse consequences and complications.
Discography: Increasing the Accuracy
Discography is controversial, with naysayers claiming it generates an unacceptable rate of false positives, or diagnoses of symptomatic discs in normal patients. Caragee has shown that individuals with abnormal psychometrics are especially likely to increase the false positive rate. Dr. Richard Derby and his colleagues set out to carefully identify criteria that would increase the accuracy of lumbar discography. As he sees it, the painful, internally disrupted disc lacks a gold standard for identification, but discography, with all of its pitfalls, remains the best we have.
According to Derby, pressure-controlled discography, although an imaging procedure, functions very much like palpation for tenderness, in which the contrast dye evokes pain by two mechanisms: by stimulating nociceptive free-nerve endings (at low pressures); and by increasing intradiscal pressure and distending tissues (at higher pressures). He finds that the accuracy of lumbar discography in distinguishing symptomatic from nonsymptomatic discs approaches 100 percent, provided the following criteria are met: careful measurement of intradiscal pressures; careful measurement of opening pressure (when the dye is first seen in the nucleus); VAS pain over 6/10 at <50 psi; less than 3.5 ml of dye injected; evoked pain concordant with incoming pain; adjacent discs not pain-provocative; and abnormal patient psychometrics taken into account.
Derby has created a four-level grading system for lumbar discography: "Chemical" discs have pain at minimal pressure (<15 psi); mechanical discs at higher pressures (15-50 psi); indeterminate discs show pain above 50 psi; and normal discs evoke no pain. Pain provocation above 50 psi cannot be considered clinically significant, since normal discs may exhibit pain at pressures that great. The Dallas discogram scale grades annular disruption on a four-point scale: grade 0 shows the contrast dye wholly contained in the nucleus, whereas grades 1-3 show extension of the contrast dye into the inner third, middle third, and outer third of the annulus. It turns out that grades 0 and 1 are rarely painful, while 75 percent of grade 3 disruptions are painful, with grade 2 disruptions being irregular in their relation to pain.
Utilization of Patterns of Pain Response in Back Pain Management
In my ABS coverage column of August 2004 (www.chiroweb.com/archives/22/17/05.html), I covered Dr. Donelson's 2003 ABS presentation on research then in progress, on the importance of subtyping patients into groups likely to respond, or not to respond, to different interventions in a randomized clinical trial (RCT). The unflattering outcome of some RCTs may result from the unwarranted assumption that all patients with
"nonspecific" low back pain are essentially the same. Subgroup identification is the Holy Grail of randomized clinical trials; that is, it is foundational for clinical decision-making, predicting outcomes, and understanding the disease process.
By the time of the 2004 ABS meeting, the results of that study had been published in Spine.1 Donelson presented the study and its implications not only at this ABS meeting, but also as an invited speaker at the 2004 Research Agenda Conference in Las Vegas. Briefly, 230 of 312 subjects enrolled in the study were identified as exhibiting "directional preference": a direction that reduced the intensity of symptoms and/or centralized symptoms (made them more proximal). Of the 230 directional preference subjects, three directions were identified during the baseline assessment; 191 (83%) preferred extension, 16 (7%) preferred flexion, and 23 (10%) were lateral responders. Following subtyping,
patients were randomly assigned to three treatment groups; the first received McKenzie exercises matched to their examination findings, the second received mismatched exercises, and the third group received nondirectional conventional exercises. Using a variety of outcome measures, the matched group did much better than either the mismatched or nondirectional exercise group. None of the matched subjects got worse, whereas 15% and 17%, respectively, of the mismatched and nondirectional subjects worsened. Although there were no dropouts in the matched group, about one-third of the subjects dropped out of the other two groups, presumably because of poor treatment outcomes.
Why is this important to chiropractors, who, after all, don't seem to use the McKenzie method very much? We have precious little evidence in chiropractic that knowing the correct diagnosis (i.e., subluxation listing) results in an enhanced clinical outcome. In Donelson's very relevant study, it certainly did. While subjects in the mismatched group showed lower mean pain ratings and improved Roland Morris Disability Questionnaire scores posttreatment, 34.8% of this group withdrew early, 60.3% reported no improvement, and 15.3% reported worsening. As a general rule, we must be careful not to overinterpret group means that show improvement, because there may be subtypes of the patients who exhibit worsening. These, in fact, may be the most interesting of subjects. I have previously gone on the record as saying that when it comes to getting the listing right, "the right thing is better than the wrong thing, and the wrong thing is preferred to nothing." With Donelson's work now published, I now think that statement is only somewhat true.
Reference
- Long A, Donelson R, Fung T. Does it matter which exercise? A randomized control trial of exercise for low back pain. Spine 2004;29(23):2593-602.
Dr. Robert Cooperstein, a professor at Palmer College of Chiropractic West, can be reached at www.chiroaccess.com, or by e-mail at cooperstein_r@palmer.edu.
