Search This Blog

26 February 2011

Evidence-Based Medicine: The Current System of Scoliosis Management in the United States is Not Supported by EBM

Evidence-based medicine (EBM) or evidence-based practices (EBP) are poorly understand by the general public and also by many members of the healthcare profession. They are often misinterpreted to mean that only interventions with published research can be considered part of EBM; this is untrue. EBM began in Ontario, Canada, at McMaster's University, as a way of closing the gap between clinical practice and clinical research. David Sackett, one of the originators, describes EBM as: "the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research. [emphasis added]"

It is also important to note that it is the patient who has the final say in accepting, rejecting, or modifying care. For example, if surgery is found to be the best intervention through research and the clinical expertise of the doctor, but the patient either does not want surgery or there are reasons why that individual patient might be at a greater risk in having the surgery performed, the published research & doctor's expertise play only a secondary role to the free will of the patient.

The triad of EBM is thus; the patient's preferences, combined with the doctor's clinical expertise, and the best available research evidence.

The difficulties arise when no high-quality evidence is available on a specific intervention. In these cases, it is appropriate to apply lower levels of evidence, such as observational studies and case reports. According to a study published in the British Medical Journal in 2007, 15% of the interventions evaluated so far have been proven to be beneficial; 22% are likely to be beneficial; 2% appear to be a "trade-off" between potential risks & benefits; 5% are unlikely to be beneficial; and, 4% have been shown to be likely to harm. The remainder of interventions, 47%, do not have sufficient evidence to make a decision either way.

One of the most interesting facts about EBM is that it itself fails its own test! The process of EBP has not been rigorously tested according to its own standards, so we do not know for certain if it actually results in improved health. (Straus & McAlister 2000) This does not mean that EBP has been proven to be ineffective; it means, quite simply, we do not know enough to decide either way. "No evidence of effect is not the same asevidence of no effect." (Tarnow-Mordi & Healy 1999)

When the standards of EBM are applied to bracing (Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review, Dolan & Weinstein, Spine 2007), the conclusion is, "Comparing the pooled rates for these two interventions shows no clearadvantage of either approach. Based on the evidence presented here, one cannot recommend one approach over the other to prevent the need for surgery in AIS. This recommendation carries a grade of D, indicating that the use of bracing relative to observation is supported by 'troublingly inconsistent or inconclusive studies of any level.'"

When EBM is applied to surgery, "a medical indication for this treatment cannot be established in view of the lack of evidence." (Weiss & Goodall, Rate of complications in scoliosis surgery - a systematic review of the literature, Scoliosis 2008)

Interestingly enough, exercises have been shown to have the most evidence to support their use in the treatment of scoliosis, yet there are no medical scoliosis centers in the United States that currently utilize these methods.

"A growing body of evidence from independent sources is consistent with the hypothesis that exercise-based approaches can be used effectively to reverse the signs and symptoms of spinal deformity and to prevent progression in children and adults." (The use of exercises in the treatment of scoliosis: an evidence-based critical review of the literature, Hawes 2003)

"Contrary to current dogma, the condition may be corrected with this therapy." (Mooney et al, Exercise for managing adolescent idiopathic scoliosis, Journal of Musculoskeletal Medicine, 2007, 6th Interdisciplinary World Congress on Low Back & Pelvic Pain)

"Results show that in literature there is proof of level 1b on exercises." (Negrini et al, Rehabilitation of adolescent idiopathic scoliosis: results of exercises and bracing from a series of clinical studies, Europa Medicophysica-SIMFER 2007 Award Winner, Eur J Phys Rehabil Med 2008)

On the topic of chiropractic and scoliosis, preliminary evidence appears to indicate that manual therapy alone (e.g., chiropractic adjustments performed in the absence of any other modalities) does not alter the natural history of scoliosis (Negrini et al, Manual therapy as a conservative treatment for adolescent idiopathic scoliosis: a systematic review, Scoliosis 2008). However, a growing body of case reports have reported positive results when manual therapy is combined with other rehabilitation approaches (Brooks 2009, Chen 2008, Brooks 2007, Morningstar 2004 & 2006). According to the standards of EBM, case reports and case series are considered level 3 evidence - above expert opinion, but below case-control studies, RCT's & systematic reviews. This places the level of evidence in support of CLEAR's treatment approach as equal to the level of evidence in favor of bracing. All it will take is one well-conducted case-control study to place the level of evidence in favor of CLEAR above the level of evidence in favor of bracing(and believe me, I'm working overtime and donating all of my time to make that happen!).

Warm Regards,
Josh Woggon DC
Director of Research, CLEAR Institute

No comments: