I have neither time nor knowledge of the original literature you cite, so I can't comment on the specifics you describe below. A few more general comments: "Evidence-based medicine" is not cost-effectiveness or cost reduction. It is not a cabal, or cult. It is a set of principles applied to teaching and practice that guide the selection of interventions for our patients. The guiding principles is that physicians should know the level of evidence that supports a particular decision. That doesn't mean you never do anything unless it is supported by grade A/Level 1 evidence; far from it. That would be unrealistic, given the state of the literature and body of studies to support our practice. What it means is that when given a choice between two or more therapies, you should have a preference for those that are proven to be effective in well-designed studies. Evidence-based medicine is not a research movement, except to the extent that education about appropriate study design and common biases will hopefully lead to more, better designed studies in the future (I think this is clearly happening already). At a policy level, the application of evidence-based principles is a refreshing step forward. Of course, just as in clinical practice, we shouldn't apply these principles thoughtlessly or carelessly. Also, EBM is NOT cost-effectiveness, although it is often mistaken as such by policy-makers and payors. The statement that "the level of evidence in policy decisions is 0.50" betrays a poor understanding of statistics, if nothing else. This suggests that we should pay for therapies when there is a 50% probability that the "benefit" was due to chance. I think it is reasonable that the government or insurers shouldn't be asked to pay for treatments or tests that have not been shown to be beneficial in well-designed studies. When there are no studies, we must rely on consensus and expert opinion until studies are done. The technological imperative in this country ("don't just stand there, do something") means that we have a hard time waiting for evidence, though. Perhaps "don't just do something, stand there" should be an acceptable alternative! The 50,000 Americans dead because we prematurely adopted the anti-arrhythmics encanide and flecanide would agree. Mark Ebell, MD, MS -----Original Message----- From: [log in to unmask] [mailto:[log in to unmask]] Sent: Tuesday, May 02, 2000 10:59 PM To: EBHC Subject: Some very naive questions Dear List: Please forgive the intrusion of a retired psychologist from the 'States, but I urgently need suggestions from members of this list. I have learned everything I know about "evidence-based-medicine" in the past six months, and now barely know enough to ask, hopefully, the right questions. THE BACKGROUND As you may know, in the USA a federal agency called the "Health Care Financing Administration" (HCFA) administers the national health insurance program, "Medicare". Although this program pertains only to the elderly, the majority of private health insurance programs look to Medicare for leadership in evaluating technology and coverage issues, so their influence extends far beyond their mandate. Recently a new generation of staff members at HCFA decided to use an "evidence-based-medicine" approach to reach coverage decisions. The new approach was applied first to the use of "biofeedback" and "electrical stimulation" to the treatment of urinary incontinence. (Biofeedback is much more highly developed in the United States than it is in Europe, where Electrical Stimulation has been widely used for many years. But, as a reasonable estimate, 90% of the commercial support for biofeedback comes from very small businesses (less than 20 employees), who are not in a position to mount a serious challenge to government policy.) Last fall HCFA invited professional organizations to submit written testimony by early December in preparation for public hearings in January, 2000. At the last minute HCFA postponed the hearings and announced that they would be held on April 12-13. Still, all professional organizations were under the assumption that their prepared testimony had been submitted to the "Medical - Surgical Panel" of the "Medicare Coverage Advisory Committee" for consideration. Less than a month before the hearings professional organizations were informed that none of their prepared testimony had been distributed, but instead, an "Evidence-based" evaluation of these technologies, prepared by the "Technology Evaluation Center" of the "Blue Cross Blue Shield Association", would be the sole evidence debated at the Panel meeting. The professional organizations, which included the American Urological Association, American College of Gynecologists, the American UroGynecological Society, as well as the Association for Applied Psychophysiology and Biofeedback, the Agency for Health Care Policy and Research, as well as the national physical therapists' and nurses' organizations -- all scrambled to revise their testimony in two short weeks to accomodate the new rules for debate. [BTW, NO professional organization desented on the value of biofeedback, and only one on electrical stimulation.] Two days before the public hearings, HCFA posted to its website a list of "official" questions which would be addressed to the panel. And it was only at the hearing itself that these questions were formulated into a formal "flow chart", such that if the panel could not conclude that there was sufficient "evidence-based" research PROVING the effectiveness of these technologies, they were not allowed to even address the issue of whether or not there was sufficient evidence, none the less, to justify coverage of them in the absence of conclusive evidence. THE VOTE ON SCIENCE After reviewing the TEC report, the physician-members of the Panel voted 9 to 2 that the evidence was not conclusive for biofeedback. All of the males voted against biofeedback, while the two females voted in favor of biofeedback. Several male panel members remarked later that they agreed with the principle voiced by one of them, that "the level of evidence in science is 0.05, but the level in policy decisions is 0.50". But the panel was NOT allowed to discuss policy. As one might imagine, the process used by HCFA is now the subject of a popular uprising that may or may not generate sufficient political pressure to reverse the results of the HCFA hearings. That is another topic in its own right. I have joined this list to pursue a different tact. MY NAIVE QUESTIONS 1. Who decides which questions are addressed in "evidence-based-medicine?" The TEC report investigated only those RCTs which compared "Biofeedback" with "Pelvic Muscle Exercises Alone". In contrast, in the companion report, they investigated RCTs that (1) compared Stim to placebo (sham), as well as (2) Stim compared with alternative treatments. In the first instance, the Burgio et al 1999 JAMA study (which was given the highest methodological rating in Berghmans' recent review) was NOT considered at all because Burgio compared biofeedback to drugs and placebo, but NOT to PMEs alone. [If the same criteria that was used for stim was used for biofeedback, Burgio would have been included, with very different results.] Is this kind of manipulation common in "evidence-based-medicine"? 2. By what standards are RCTs dismissed from consideration because they do not present sufficient evidence of not guarding against selection bias, etc.? The TEC report(s) never established that several studies WERE defective in these areas, but merely intimated that they MIGHT be. 3. To what extent has "evidence-based-medicine" investigated behavioral therapies such as biofeedback and pelvic muscle exercise? Clearly there are many areas of medicine that lend themselves to clear and simple analysis. In pharmacological studies, for example, it is fairly simple to ask how many milligrams of the active ingredient were used? There is some controversy in the incontinence field, however. In some of the studies that were classified as "Pelvic Muscle Exercises alone", subjects actually received repeated vaginal evaluations by a trained physiotherapist who coached subjects on how to contract their pelvic muscles. These studies were then compared with studies where the "feedback" was through a machine only. In the two largest studies (Burns, 1993; Berghmans 1996) verbal feedback was not statistically different, in outcome, from machine-feedback. (In the largest study of all, Burgio 1999, machine feedback was dramatically superior to drugs or placebo, ! bu! t that comparision wasn't included.) 4. How do you experts account for the problems that may be created by uneven or incompetant treatments being tested? In drug studies, for instance, its seems warranted to assume that the subjects who were given "50 mg of drug X" really GOT "50 mg of drug X", and those who got placebos got placebos. Drug manufacturers are required to employ chemists who certify the integrity of their products. But in behavioral therapies, who is to decide if the subjects who got six sessions of biofeedback training REALLY GOT six session of competent biofeedback training? The therapist in Burns' study was never formally trained in biofeedback techniques. At the time, her biofeedback subjects set a new record LOW for treatment success (61% Sx reduction). The subjects in Berghmans' study used an electrical stimulation electrode (circular electrodes) instead of an EMG sensor (longitudinal electrodes); they then set a new record for poor results from biofeedback (55% Sx reduction). Would it be considered appropriate to compare surgeries performed by first year medical students with surgeons who are board certified? So my question is, who decides if the "treatment" meets minimal professional standards? Or isn't that a consideration in "evidence-based-medicine"? If so, isn't that a serious limitation of evidence-based-medicine? Or are these factors normally considered? Well, I have more quesitons, but that's enough for now. You can find the relevant documents at the HCFA website, http://www.hcfa.gov/quality/8b.htm and follow the links to biofeedback and Incontinence. The documents from our professional societies are available on my website, http://www.incontinet.com; there are detailed descriptions of available testimony in the first three paragraphs in the text of the home page. On behalf of tens of thousands of urologists, nurses, physicians, physical therapists, and their many patients, I hope that some of the members of this list will look into this subject and provide guidance as to the adaquacy of the "evidence-based-medicine" being promoted by our government. It is even a possibility that this recent activity will reflect badly upon the "evidence-based" movement, at least in the United States. Thank you in advance. John D. Perry, PhD, MDiv, BCIA, FAACS Committee on HCFA of the Association for Applied Psychophysiology and Biofeedback 1192 Lakeville Circle Petaluma, CA 94954 USA %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%