The Future of Evidence-Based Medicine in Pain Management: Q&A With Dr. Laxmaiah Manchikanti of the American Society of Interventional Pain PhysiciansWritten by Abby Callard | February 13, 2012
Laxmaiah Manchikanti, MD, is the chairman of the board and CEO of the American Society of Interventional Pain Physicians and the Society of Interventional Pain Management Surgery Centers; medical director of the Pain Management Center of Paducah (Ky.); and associate clinical professor of anesthesiology and perioperative medicine at the University of Louisville, Kentucky.
Q: What will 2012 bring for evidence-based medicine in pain management?
Dr. Laxmaiah Manchikanti: [ASIPP] is worried that evidence-based medicine will be converted into a witch hunt through overly empowered insurers. This is manifested by comparative effectiveness research and Patient Centered Outcomes Research Institute. PCORI and comparative effectiveness research may appear patient friendly and innocuous; however, once they make a draft determination, insurance companies will pick it up and start using and essentially denying the care.
There are protections against PCORI and comparative effectiveness research abuses with Medicare and Medicaid; however, these protections do not apply or extend to third-party payors. In fact, recent CMS evaluations have shown that essentially none of the treatments work — that is why it is extremely important that evidence be assessed appropriately.
Consequently, with the support of ASIPP and its members, Kentucky Rep. Brett Guthrie (R-2nd) introduced a long awaited bill to repeal PCORI and comparative effectiveness research funding. HR 3827 was introduced in the House Jan. 25, 2012 and if passed, would repeal PCORI and maintain patients' access to the appropriate care and treatments that they and their doctor chose. The bill has been referred to the House Energy and Commerce committee and is expected to gain strong bipartisan support.
Evidence-based medicine, comparative effectiveness research and clinical guidelines are experiencing exponential growth, not only in terms of publications, but also in terms of funding with disagreements in the evidentiary basis of certain treatment as well as competing interests of payors, practitioners, health policy makers and third parties benefiting from development of the guidelines as cost saving measures. Guideline preparation has been described as based on prepossession, vagary, rationalization or congeniality of conclusion.
Q: Why is it important for treatment to be based on high level studies?
LM: For any aspect of human life you would want to have something which works the best, and, consequently, in the medical profession we want the best quality evidence before applying those techniques on human beings. Essentially, a high level of evidence means it works safely.
Evidence-based medicine conveys the idea that up-to-date evidence can be applied consistently in clinical practice, in combination with the clinicians' individual expertise and the patients' own preferences and expectations to achieve the best possible outcome. Even though 20 years have elapsed since the concept of evidence-based medicine originated, the benefits of evidence-based medicine have not materialized for numerous conditions including spinal pain. We expect to see strong evidence for almost everything. Amazingly, for two-thirds of Americans with diabetes and half of those with hypertension — conditions with strong evidence-based guidelines — these conditions are inadequately controlled. There are also differences of opinion; some focus only on the randomized trials and the highest level of evidence, but there are multiple biases in these evaluations. These are considered hazards of evidence-based medicine which may actually reduce access, based on proclamation rather than evidence.
Q: What pain management treatments are currently supported by high level evidence studies?
LM: Theoretically, none of the pain management studies are supported by a high level of evidence. On the same token, neither the surgical interventions, physical therapy nor other medical interventions are supported by high level of evidence.
There is good evidence for the following procedures:
• Epidural injections in the cervical and lumbar spine, which incorporate caudal, lumbar interlaminar, cervical interlaminar, thoracic interlaminar and lumbar transforaminal epidural injections
• Facet joint interventions involving medial branch blocks and radiofrequency neurotomy with medial branch blocks in the cervical, thoracic, and the lumbar spine; with radiofrequency neurotomy, there is good evidence for cervical and lumbar spines only
• Percutaneous adhesiolysis in post-surgery syndrome and spinal stenosis
• Spinal cord stimulation for post-surgery syndrome and neuropathic pain
Q: Who sponsors these high level studies?
LM: Historically medical device companies and the pharmaceutical industry sponsored the studies. However, because most of the studies sponsored by them provided positive results, they are now considered biased and tainted. A new era is emerging, and now insurers are sponsoring the studies. There is also inherent bias in these studies sponsored by insurers. Further, unending bias and networking among these experts sponsored by one or another agency and even penetrating the government agencies is becoming more common. The problem with government agencies or any other agency is that these experts lack technical ability and continue to change the criteria based on their need.
Q: How can the healthcare industry support high level studies?
LM: Industry should give unrestricted grants to organizations which sponsor research and do not control it. If [industry sponsors] do control it, they have to stay out of it without controlling the data. These should be performed independently. Their involvement should be only for the protocol preparation and support.
Q: How do insurance companies use these studies and how does that affect care?
LM: Insurance companies attempt to use them in their favor, take only the negative rather than the positives and convert all the studies into negative evidence — most of the time. Insurance companies are unable to decide the difference between a simple, randomized trial or placebo-controlled, double-blind trial. They also request that these trials should be performed in highly specified academic settings as such.
If these trials are performed, [insurance companies] criticize that they are performed in specialized setting. In an active control group — essentially meaning that two treatments are tested against each other — insurance companies as well as methodologists tend to classify one group even though it is an active as a placebo and determine that there is no difference between the two groups. Instead they should be looking at baseline status and improvement or lack thereof with one or both the treatments rather than only the differences between the treatments.
Q: Is evidence-based medicine more challenging when dealing with a subjective finding such as pain?
LM: Pain is a subjective finding, but there are also objective features such as improvement in function, returning to work, reduction in medication and general well-being with improvement in the quality of life. Assessment of these aspects plays a significant role. If one says that only pain is improved, but function deteriorated or quality of life has not improved, then it becomes questionable. The treatment is not effective. It should be always functional status improvement rather than just pain.
Q: What is the role of pain management physicians in the push toward evidence-based medicine?
LM: Pain management physicians have substantial evidence. The issue is how they can collect the data and report it. More pain management physicians should come forward and conduct randomized, double-blind, controlled trials. It is not that difficult to conduct the studies when utilizing an active controlled design nor is it expensive since both groups are getting a treatment — but a different treatment. Further, it is imperative on all pain physicians to emphasize the importance of active control trials and also expose the deficiencies in methodological quality in determining the evidence and if necessary educate all parties.
Q: How can pain management physicians get involved with high level evidence studies?
LM: Physicians can get involved with high level evidence studies by designing their own studies or associating with others who do these. They can also associate with industries and obtain funding for the organizations which can sponsor these studies without becoming involved in critical aspects of the study. Pain physicians must maintain independence and avoid bias.
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