Can Clinical Guidelines be Trusted?

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Can Clinical Guidelines be Trusted?

In a recent BMJ article, “Why we can’t trust clinical guidelines,” Jeanne Lenzer raises a number of concerns regarding clinical guidelines[1]. She begins by summarizing the conflict between 1990 guidelines recommending steroids for acute spinal injury versus 2013 cllinical recommendations against using steroids in acute spinal injury. She then asks, “Why do processes intended to prevent or reduce bias fail?

Her proposed answers to this question include the following—

  • Many doctors follow guidelines, even if not convinced about the recommendations, because they fear professional censure and possible harm to their careers.
    • Supporting this, she cites a poll of over 1000 neurosurgeons which showed that—
      • Only 11% believed the treatment was safe and effective.
      • Only 6% thought it should be a standard of care.
      • Yet when asked if they would continue prescribing the treatment, 60% said that they would. Many cited a fear of malpractice if they failed to follow “a standard of care.” (Note: the standard of care changed in March 2013 when the Congress of Neurological Surgeons stated there was no high quality evidence to support the recommendation.)
  • Clinical guideline chairs and participants frequently have financial conflicts.
    • The Cochrane reviewer for the 1990 guideline she references had strong ties to industry.

Delfini Comment

  • Fear-based Decision-making by Physicians

We believe this is a reality. In our work with administrative law judges, we have been told that if you “run with the pack,” you better be right, and if you “run outside the pack,” you really better be right. And what happens in court is not necessarily true or just. The solution is better recommendations constructed from individualized, thoughtful decisions based on valid critically appraised evidence found to be clinically useful, patient preferences and other factors. The important starting place is effective critical appraisal of the evidence.

  • Financial Conflicts of Interest & Industry Influence

It is certainly true that money can sway decisions, be it coming from industry support or potential for income. However, we think that most doctors want to do their best for patients and try to make decisions or provide recommendations with the patient’s best interest in mind. Therefore, we think this latter issue may be more complex and strongly affected in both instances by the large number of physicians and others involved in health care decision-making who 1) do not understand that many research studies are not valid or reported sufficiently to tell; and, 2) lack the skills to be able to differentiate reliable studies from those which may not be reliable.

When it comes to industry support, one of the variables traveling with money includes greater exposure to information through data or contacts with experts supporting that manufacturer’s products. We suspect that industry influence may be less due to financial incentives than this exposure coupled with lack of critical appraisal understanding. As such, we wrote a Letter to the Editor describing our theory that the major problem of low quality guidelines might stem from physicians’ and others’ lack of competency in evaluating the quality of the evidence. Our response is reproduced here.

Delfini BMJ Rapid Response [2]:

We (Delfini) believe that we have some unique insight into how ties to industry may result in advocacy for a particular intervention due to our extensive experience training health care professionals and students in critical appraisal of the medical literature. We think it is very possible that the outcomes Lenzer describes are less due to financial influence than are due to lack of knowledge. The vast majority of physicians and other health care professionals do not have even rudimentary skills in identifying science that is at high to medium risk of bias or understand when results may have a high likelihood of being due to chance. Having ties to industry would likely result in greater exposure to science supporting a particular intervention.

Without the ability to evaluate the quality of the science, we think it is likely that individuals would be swayed and/or convinced by that science. The remedy for this and for other problems with the quality of clinical guidelines is ensuring that all guideline development members have basic critical appraisal skills and there is enough transparency in guidelines so that appraisal of a guideline and the studies utilized can easily be accomplished.

References

1. Lenzer J. Why we can’t trust clinical guidelines. BMJ 2013; 346:f3830

2. Strite SA, Stuart M. BMJ Rapid Response: Why we can’t trust clinical guidelines. BMJ 2013;346:f3830; http://www.bmj.com/content/346/bmj.f3830/rr/651876

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Proton Beam Therapy For Prostate Cancer

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Proton Beam Therapy For Prostate Cancer

As of this writing, there is insufficient evidence to conclude that proton beam is more effective in treating prostate cancer than conventional radiation therapy; and there is no evidence of significant differences between proton therapy and radiation therapy in total serious adverse events.  Readers may be interested in a recent article where the investigators point out that patients diagnosed with prostate cancer and  living in areas where proton beam therapy is readily available are more likely to be treated with this new technology than with conventional radiation therapy. The cost of treating prostate cancer with proton beam therapy can exceed $50,000 per patient which is twice the cost of radiation therapy. Increasingly, we are seeing new technologies with staggering costs. In prostate cancer, for example, as we write this, proton centers are being built all over the country at a cost of up to $200 million.

Reference

Aaronson DS, Odisho AY, Hills N, Cress R, Carroll PR, Dudley RA, Cooperberg MR. Proton beam therapy and treatment for localized prostate cancer: if you build it, they will come. Arch Intern Med. 2012 Feb 13;172(3):280-3. PubMed PMID:22332166.

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Critical Appraisal Matters

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Critical Appraisal Matters

Mike and I make it a practice to study the evidence on the evidence.  Doing effective critical appraisal to evaluate the validity and clinical usefulness of studies makes a difference.  This page on our website may be our most important one and we have now added a 1-page fact sheet for downloading: http://www.delfini.org/delfiniFactsCriticalAppraisal.htm

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The Elephant is The Evidence—Epidural Steroids

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The Elephant is The Evidence—Epidural Steroids: Edited & Updated 1/7/2013

Epidural steroids are commonly used to treat sciatica (pinched spinal nerve) or low back pain.  As of January 7, 2013 at least 40 deaths have been linked to fungal meningitis thought to be caused by contaminated epidural steroids, and 664 cases in 19 states have been identified with a clinical picture consistent with fungal infection [CDC]. Interim data show that all infected patients received injection with preservative-free methylprednisolone acetate (80mg/ml) prepared by New England Compounding Center, located in Framingham, MA. On October 3, 2012, the compounding center ceased all production and initiated recall of all methylprednisolone acetate and other drug products prepared for intrathecal administration.

Thousands of patients receive epidural steroids without significant side effects or problems every week. In this case, patients received steroids that were mixed by a “compounding pharmacy” and contamination of the medication appears to have occurred during manufacture. But let’s consider other patients who received epidural steroids from uncontaminated vials. How much risk and benefit are there with epidural steroids? The real issue is the effectiveness of epidural steroids. Yes, there are risks with epidural steroids beyond contamination—e.g., a type of headache that occurs when the dura (the sac around the spinal cord) is punctured and fluid leaks out. This causes a pressure change in the central nervous system and a headache. Bleeding is also a risk. But people with severe pain from sciatica are frequently willing to take those risks if there are likely to be benefits. But, in fact, for many patients who receive epidural steroids the likelihood of benefit is very low. For example, patients with bone problems (spinal stenosis) rather than lumbar disc disease are less likely to benefit. Patients who have had a long history of sciatica are less likely to benefit.

We don’t know how many of these patients were not likely to benefit from the epidural steroids, but if the infected patients had been advised about the unproven benefits of epidural steroids in certain cases and the known risks, some patients may have chosen to avoid the injections and possibly be alive today.  This is an example of the importance of good information as the basis for decision-making. Basing decisions on poor quality or incomplete information and intervening with unproven—yet potentially risky treatments puts millions of people at risk every week.

Let’s look at the evidence. Recently, a fairly large, well-conducted RCT published in the British Medical Journal (BMJ) reported that there is no meaningful benefit from epidural steroid injections in patients who have had long term (26 to 57 weeks) of sciatica [Iverson].  As pointed out in an editorial, epidural steroids have been used for more than 50 years to treat low back pain and sciatica and are the most common intervention in pain clinics throughout the world [Cohen]. And yet, despite their widespread use, their efficacy for the treatment of chronic sciatica remains unproven. (We should add here that many times lacking good evidence of benefit does not mean a treatment does not work.) Iverson et al conclude that, “Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy [Iverson].”

Of more than 30 controlled studies evaluating epidural steroid injections, approximately half report some benefit. Systematic reviews also report conflicting results. Reasons for these discrepancies include differences in study quality, treatments, comparisons, co-interventions, study duration and patient selection. Results appear to be better for people with short term sciatica, but improvement should not be considered to be curative with epidural steroids. In this situation, it is very important that patients understand this fuzzy benefit-to-risk ratio. For many who are completely informed, the decision will be to avoid the risk.

With this recent problem of fungal meningitis from epidural steroids, it is important for patients to be informed about the world of uncertainty that surrounds risk, especially when science tells us that the evidence for benefit is not strong.  Since health care professionals frequently act as the eyes of the patient, we must seriously consider for every intervention we offer whether benefits clearly outweigh potential harms—and we must help patients understand details regarding the risks and benefits and be supportive when patients are “on the fence” about having a procedure. Remember Vioxx, arthroscopic lavage, vertebroplasy, encainide and flecainide, Darvon and countless other promising new drugs and other interventions? They seemed promising, but harms outweighed benefits for many patients.

References

1. http://www.cdc.gov/HAI/outbreaks/meningitis.html accessed 12/10/12

2.  Cohen SP. Epidural steroid injections for low back pain. BMJ. 2011 Sep 13;343:d5310. doi: 10.1136/bmj.d5310. PubMed PMID: 21914757.

3.  Iversen T, Solberg TK, Romner B, et al.   Effect of caudal epidural steroid or saline injection  in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial. BMJ. 2011 Sep 13;343:d5278. doi: 10.1136/bmj.d5278. PubMed PMID: 21914755.

 

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