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Evidence-Based Medicine


By Steven D. Feinberg, M.D.
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Steven D. Feinberg, M.D., is a board certified specialist in Physical Medicine & Rehabilitation, Pain Medicine, and Electrodiagnostic Medicine, and has authored many articles on pain treatment. In this article he discusses current issues with using opioids in treating pain in workers’ compensation cases.
 

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What is Evidence-Based Medicine (EBM)?

Dr. David Sackett defined evidence-based medicine 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 clinical evidence from systematic research.”1 He noted that "good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough."

Evidence-based medicine (EBM) equates to the best available scientific medical evidence which is then applied to clinical decision making.2 It seeks to assess the strength of medical evidence of the risks and benefits of treatments (including lack of treatment) and diagnostic tests.3

Wouldn’t it be nice if it were that simple and the use of EBM translated directly into quality utilization review which helped doctors practice better medicine and where injured workers benefitted from such care? Why are employers/payers and injured workers/providers so frustrated with the current workers’ compensation medical care system?

Hierarchy of Evidence

The quality of evidence is based on the study design (from meta-analyses and systematic reviews of double-blind, placebo-controlled clinical trials at the top end [i.e., high quality evidence], down to consensus to conventional wisdom at the bottom [low quality evidence]).4

Evidence Levels


High: Randomized, controlled trials (RCTs); meta-analyses; well-designed, systematic reviews

Intermediate: Case-control or cohort studies, retrospective studies, certain uncontrolled studies

Low: Consensus statements, expert guidelines, usual practice, opinion


Treatment Guidelines

Treatment Guidelines may or may not be based on high-quality EBM. Often Treatment Guidelines are a mixture of consensus and high-level evidence. Many common interventions have a consensus evidence base only.

Insurance companies, not-for-profit medical specialty organizations and for-profit businesses interpret EBM data to develop treatment guidelines which are used during the utilization review/certification process to authorize or deny requested treatment.

The ideal is to provide the best and most cost-effective care possible but the reality from the treating physician and patient is sometimes different than from the perspective of the employer/payer.

Payer and Provider Dichotomy

EBM seeks to clarify those parts of medical practice that are in principle subject to scientific methods and to apply these methods to ensure the best prediction of outcomes in medical treatment. Clinicians are charged with using and applying EBM consistently in clinical practice in combination with their individual expertise along with the patient’s own preferences and expectations, to achieve the best possible outcomes.

From the employer/payer perspective, there is concern (and appropriately so) that medical care rendered be cost-effective. The implication is that the injured worker receives care that is beneficial. There is concern (as there should be) about medical care that is ineffective at best and damaging at worst. Certain medical care recommendations may not in the injured worker’s long-term best interest including unnecessary medications, failed invasive interventions, excessive opioid prescribing, and damaging spine surgeries. EBM guidelines seek to check excesses while directing physicians toward quality medical practice in the future.

On the other hand, there is a strong belief among many providers and patients that EBM and utilization review is being used to deny and deter quality medical care at the expense of injured workers.

Problems with EBM Guidelines

In many areas of medicine, there are no treatment guidelines; and where they exist, they are often conflicting and unreliable.

The whole idea behind guidelines and protocols is that it is appropriate to treat patients with similar conditions the same way. But individuals are individual. They don’t always respond to same treatment interventions the same way. Remember, all guidelines, are inevitably written for the average patient. But suppose the individual’s medical problem is not average. EBM tells us that the guideline is only a “guideline” and NOT a mandate. The physician is to use good medical judgment at all times. Another twist to the issue of EBM is its application by UR doctors. As doctors you would think they too could be permitted to use their best medical judgment and certify outside Guidelines. Experience with UR suggests that with some exceptions, even the most medically reasonable explanation to step outside the protocols and give care based on the physician’s training, knowledge and experience will not pass utilization review if it is not in the guideline.

Practice should, as much as possible, be based on good science. Randomized clinical trials can provide the best evidence, but they have serious limitations. First, many clinical situations, such as cardiac arrest and pain relief, do not lend themselves to randomization. Second, trials seldom study well the effects seen in different subgroups, nor are results always be extrapolative from those few patients recruited into trials. Finally, there are multiple potential biases: the failure to report "negative" trials, biased presentation of results by investigators and sponsors, undisclosed relationships, etc.

EBM Bias

The acronym EBM in reality often means “experience-based medicine.” Much of the evidence in any clinical guideline is likely to come from expert opinion. Most guideline committees use expert consensus to reach decisions, drawing on a mixture of available scientific research and clinical practice and observation, with clinical judgment still playing a key role. The risk of bias may be considerable, and the term “evidence based clinical guidelines” can be misleading.5

So who are the research “sponsors” of scientific studies? Who pays for the studies? Well it can be the U.S. Government through a grant but nowadays often research studies are paid for by the companies that are promoting the product.

There is also a “business” side to guidelines. Guidelines from both for-profit and not-for-profit companies and organizations receive revenue by sale of those guidelines and the purchaser is often the employer/payer.

Guidelines are often written by people who are not disinterested. Medical specialty organizations may interpret EBM in light of their own biases and self-interest.

For-profit, not-for-profit, and medical organizations do rely on honorable “experts” to study the scientific literature and to provide guidelines and those individuals may not perceive a bias but when those individuals have a personal belief in or receive income from those products or procedures, receive honorariums from manufacturers, there is an inherent bias whether perceived or not.

How to Respond to UR Denials based on EBM

While many view UR as draconian, the great majority of UR physicians try to apply the available EBM Guidelines fairly and equitably. The physician prescribing a treatment needs to provide clear and concise justification with "medical necessity" for the request. It behooves the physician to be familiar with and to have requests clearly supported by relevant guidelines. If for any reason there is an outlier or co-morbidity it must be clearly documented.

When working outside of established EBM guidelines, the requesting physician should dialogue with the UR physician and discuss their point of view without anger but with logic and attempt to secure a reasonable answer.

Conclusion

Ideally, the use of EBM takes the best medical scientific evidence and integrates it with the physician’s best clinical judgment to provide the patient the most efficacious and cost-effective medical care possible. This is a goal, not a promise.

There is lots of criticism to go around from all sides about EBM Guidelines and their use, but in fact employers/payers and physician providers should continue to dialogue while focusing on providing the most cost-effective care possible for injured workers that minimizes the effects of injury while maximizing good health and return to a normalized life including return to work.

References

1 Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-Based Medicine: How to Practice and Teach EBM. London: Churchill Livingstone; 2000.

2 Timmermans S, Mauck A (2005). "The promises and pitfalls of evidence-based medicine". Health Aff (Millwood) 24 (1): 18–28.

3 Elstein AS (2004). "On the origins and development of evidence-based medicine and medical decision making". Inflamm. Res. 53 (Suppl 2): S184–9.

4 Wikipedia, Evidence-based medicine (accessed 02/13/12)

5 Croft P, Malmivaara A, van Tulder M (2011) “The Pros and Cons of Evidence-Based Medicine”. SPINE Volume 36, Number 17, pp E1121–E1125.


   
 
Steven D. Feinberg, M.D

Dr. Feinberg is a physiatrist and pain medicine specialist practicing in Palo Alto. He is an Adjunct Clinical Professor and teaches at the Stanford University Pain Service. Dr. Feinberg is the Chief Medical Officer of American Pain Solutions, Inc. He is a past president (1996) of the American Academy of Pain Medicine (AAPM). He served as a California Society of Medicine & Surgery (CSIMS) Year 2001 President. He serves on the Board of Directors of the American Chronic Pain Association and is lead author of the 2012 ACPA Resource Guide to Pain Medication & Treatment. He is the Medical Director of Cedaron AMA Guides Software.

Dr. Feinberg served on the ACOEM Chronic Pain Guidelines Panel Chapter Update and also as an Associate Editor and he also serves as a consultant to the Official Disability Guidelines (ODG). He readily admits to a bias towards a functional restoration treatment approach.

American Board of Pain Medicine
American Board of Electrodiagnostic Medicine
American Board of Physical Medicine & Rehabilitation
Qualified Medical Evaluator

Chief Medical Officer
American Pain Solutions, Inc.
825 El Camino Real Palo Alto, CA 94301
Tel 650-223-6400
Fax 650-223-6408
stevenfeinberg@hotmail.com
www.FeinbergMedicalGroup.com


  Steven Feinberg