Thursday, August 15, 2013

Why Are Back Pain Treatment Guidelines Ignored?

Back PainAccording to a new investigation published online ahead of print in JAMA Internal Medicine, the care of patients with back pain could be enhanced and the U.S. healthcare system could see significant cost savings if practitioners would adhere more rigidly to published clinical guidelines for the management of back pain. Among other transgressions, healthcare providers allegedly overprescribe powerful opioid analgesics for back pain; however, evidence is lacking to substantiate this contention one way or the other.

In a news release, lead author of the study John N. Mafi, MD — of the Division of General Medicine and Primary Care at Beth Israel Deaconess Medical Center in Boston — stated, “Back pain treatment is costly and frequently includes overuse of treatments that are not supported by clinical guidelines, and that don’t impact outcomes. Improvements in the management of spine-related disease represent an area of potential for improving the quality of care and for potential cost savings for the health care system.”

The objective of the study by Mafi and colleagues [2013] was to characterize the treatment of back pain in the United States during a 12-year period, from January 1, 1999 through December 26, 2010. They studied changes in the use of diagnostic imaging, physical therapy or referral to other physicians, and prescription of medications for back pain.

The researchers observed that current published guidelines for routine back pain recommend nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen, plus physical therapy of some sort. Prior research shows that within 3 months of these first-line treatments back pain usually resolves.

Furthermore, back pain guidelines, which have remained consistent since the 1990s, suggest that the need for diagnostic imaging or advanced treatments are typically unnecessary, as most cases of routine back pain improve with conservative measures. Other recommendations considered to be discordant with guidelines would include prescription of opioid analgesics or referral to a medical specialist, presumably for consideration of an invasive procedure or surgery to treat back pain.

Using representative data from the U.S. National Ambulatory Medicare Care and National Hospital Ambulatory Care surveys between 1999-2010, the researchers identified nearly 24,000 visits for spine problems, which were considered as representative of an estimated 440 million visits in total. The patient sampling included outpatients with a chief symptom and/or primary diagnosis of back or neck pain, as well as those with secondary symptoms and diagnoses of back or neck pain. However, the researchers excluded visits with concomitant “red flags” of serious complications, including fever, neurologic symptoms, or cancer.

Approximately 58% of patients overall were female, and mean age increased from 49 to 53 years during the study period. In absolute terms, NSAID or acetaminophen use per visit decreased by 12%, from roughly 37% in 1999-2000 to 25% in 2009-2010. At the same time, opioid use for back pain increased by 10%, from about 19% to 29%. All changes were statistically significant (p< 0.001).

Although referrals for physical therapy remained unchanged during the study period, at approximately 20%, referrals to other physicians (eg, specialists) increased significantly from 6.8% to 14.0% (p<0.001). Additionally, the number of radiographs (x-rays) remained stable at approximately 17%, whereas the number of computed tomograms (CT-scans) or magnetic resonance images (MRI) increased from roughly 7% to 11% during the study period (p< 0.001).

In sum, there were significant increases in the frequency of advanced imaging, such as CT or MRI, referrals to other physicians (presumably for procedures or surgery), and the use of opioid analgesics. Along with that, there was a decline in the use of first-line medications such as NSAIDs or acetaminophen, but no change in referrals to physical therapy. Of some interest, while opioid prescribing increased overall, there were lower odds of receiving these agents among female, Black, Hispanic, and other race/ethnicity patients, which may signify potential disparities in pain management that have been noted elsewhere.

The researchers found that back-pain treatment trends remained similar after adjusting for a number of possibly confounding variables, such as age, sex, race/ethnicity, symptom duration, visits to primary care providers (PCPs) vs non-PCPs, geographic region, and metropolitan location. They conclude that, despite numerous published clinical guidelines, management of back pain has relied increasingly on guideline-discordant care. Therefore, improvements in the management of spine-related disease represent an important area for bolstering the quality of patient care and potential cost savings for the healthcare system in the U.S.

As might be expected, news media widely reported on this study, but without acknowledging its many limitations and controversial aspects. In many cases, news reports gave the impression that healthcare providers in the U.S. are increasingly becoming renegades who ignore well-founded guidelines for treating back pain and, instead, over-prescribe expensive tests and risky drugs.

From a more balanced perspective, a commentary article by Donald E. Casey, MD — of New York University School of Medicine, New York — in the same journal edition as the Mafi et al. study raises questions about the complexities of treating back pain and the validity of existing guidelines [Casey 2013]. For one thing, Casey notes that a query of the U.S. Agency for Healthcare Research and Quality [AHRQ] National Guideline Clearinghouse found 183 guidelines documents addressing just “low back pain.” So, which of these — if any — is most correct and worthy of adherence?

Casey observes that it has been only since 2007 that guidelines for back pain have been based on analyses of existing published evidence. Unfortunately, the quality of such evidence has been poor to moderate at best; hence, there may be good reasons why practitioners do not rigidly adhere to back-pain treatment guidelines. In fact, Casey suggests at least 8 possible explanations for the discordances noted by Mafi et al. in their study:

  1. There has been an admonition that practitioners fail to adequately treat patients’ pain, so this may motivate them to pursue more aggressive diagnostic and therapeutic approaches when it comes to back pain;

  2. a greater availability of diagnostic imaging centers facilitates convenient access to such testing;

  3. primary care physicians have less time these days for more conservative approaches to back pain relying on frequent followup, ongoing assessments, multimodal therapies, and patient counseling;

  4. there is a lack of effective tools for shared decision-making and helping to facilitate patient understandings of key recommendations within the guidelines;

  5. patients most typically demand actions that provide more immediate answers and resolution of symptoms;

  6. there is a perception that specialists are experts and, hence, more qualified to treat patients with enduring back pain and to provide the best care;

  7. there is a general and growing fear by many physicians of malpractice liability for “missing something” by not adequately considering all possibilities and/or ordering relevant diagnostic studies;

  8. neither practitioners nor patients are adequately aware of or sensitive to price or cost-effectiveness factors and concerns when it comes to prudently accessing healthcare services, such as advanced imaging.

Casey emphasizes that the treatment of back pain is complex, usually requiring individualized approaches that may or may not be concordant with published guideline recommendations. And, considering the current lack of high-quality evidence behind the guidelines to begin with, the Mafi et al. study may reflect certain entrenched biases that need further scrutiny.

For example, expressing disfavor of opioids for back pain by referring to a study from Martell and colleagues [2007], Mafi et al. write: “A recent meta-analysis revealed that narcotics provide little to no benefit in acute back pain, they have no proved efficacy in chronic back pain, and 43% of patients have concurrent substance abuse disorders, with aberrant medication-taking disorders as high as 24% of cases of chronic back pain.”

The Martell et al. review and meta-analysis is often used as evidence against recommending opioids — or more pejoratively, “narcotics” — for back pain; however, the investigation was based on only 11 studies, which were small in scale, highly heterogenous, weak in quality, and short term (only 1 study extended as long as 16 weeks). Rates of opioid prescribing ranged from merely 3% to a high of 66% (in 1 study). Aberrant medication-use behaviors — which were vaguely defined — ranged from a low of 3% to 24%. Substance-use disorders were mostly unevaluated, and poorly defined in merely a handful of studies — with only a single questionable instance of a rate as high as 43% (which was lifetime prevalence, not concurrent incidence of the disorder).

In brief, the study by Martell et al. is a poor choice of evidence to validly support anti-opioid contentions. Yet, Mafi et al. further state, “Although we lack adequate data to make firm recommendations on narcotic medications, which may be indicated in certain circumstances, such increases in narcotic prescriptions may be contributing to a current crisis in public health….” Indeed, the lack of adequate high quality data is problematic, and this deficit invalidates assertions about the appropriateness or public harms of opioid therapy for back pain one way or the other.

There is an implication that NSAIDs and/or acetaminophen are strongly preferred first-line therapy for the treatment of back pain. And, during the 12-year study period, there was a relative 51% decrease in NSAID or acetaminphen use compared with a relative 51% increase in opioid prescriptions, including a near doubling in patients with chronic back pain. Is this necessarily an unfavorable trend?

When considering the treatment of chronic noncancer pain (CNCP) overall, some research has found that NSAIDs and acetaminophen have been overprescribed. As discussed in a recent UPDATE [here], a large-scale study by Rafia S. Rasu and colleagues spanning 2000 to 2007 found that healthcare providers overwhelmingly preferred to prescribe NSAIDs for CNCP, which the researchers said was in accordance with several clinical practice guidelines.

However, an over-reliance on NSAID agents may have incurred significant harm due to adverse effects, particularly since cardiovascular disease was a comorbidity in 13% of patients, but this was not examined in the study by Rasu et al. Adjunctive medications and non-medication approaches for CNCP management appeared to be greatly underused, which merits further research and explanation. Similarly, the back pain study by Mafi et al. did not explore the use of adjunctive pharmacotherapies (eg, SSRIs, antispasmodics, anticonvulsants), physical modalities (eg, massage), or psychological approaches (eg, cognitive behavioral therapy) that are often mentioned in guidelines or discussion documents as being helpful for some patients.

At best, the study by Mafi et al. could be incomplete by not considering the total range of approaches to back pain that are mentioned in guidelines and may be appropriate for certain patients. At worst, an evident bias promoting NSAID use in treating back pain while disparaging opioids, without high-quality evidence to substantiate this, may not be in the best interests of practitioners, patients, or the healthcare system.

> Casey DE. Why Don’t Physicians (and Patients) Consistently Follow Clinical Practice Guidelines? JAMA Intern Med. 2013(July); online ahead of print [
access by subscription here].
> Mafi JN, McCarthy EP, Davis RB, Landon BE. Worsening Trends in the Management and Treatment of Back Pain. JAMA Intern Med. 2013(July); online ahead of print [
abstract here].
> Martell BA, O’Connor PG, Kerns RD, et al. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med. 2007;146(2):116-127 [
abstract here].

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