Evidence Based Medicine

flying cadeuciiHere’s a doctor’s health tip for patients that I’ll bet you haven’t heard before.

If you’re a patient who walks into a hospital for an elective procedure of any kind–surgery, or a diagnostic test–and you find out that Joint Commission reviewers are on site, reschedule your procedure and leave. Come back another day, after the reviewers have left.

Why? Because every single person who works there will be paying a lot of attention to Joint Commission reviewers with their clipboards, and scant attention to you.

The Joint Commission has the power to decide whether the hospital deserves reaccreditation. Administrators, doctors, nurses, technicians, clerks, and janitors will be obsessed with the fear that the reviewers will see them doing something that the Joint Commission doesn’t consider a “best practice”, and that they’ll catch hell from their superiors.

For you as a patient, any idea that your clinical care and your medical records are private becomes a delusion when the Joint Commission is on site. Their reviewers are given complete access to all your medical records, and they may even come into the operating room while you’re having surgery without informing you ahead of time or asking your permission.

Perhaps physicians and nurses have an ethical duty to inform patients when the Joint Commission is on site conducting a review. Right now, that doesn’t happen. Does the patient have a right to know?

Unintended consequences

How did any private, nonprofit organization gain this kind of power? Why do American healthcare facilities pay the Joint Commission millions each year for the privilege of a voluntary accreditation review? It’s a classic tale of good intentions, designed to improve healthcare quality, that turned into a quagmire of unintended consequences and heavy-handed regulation.

American surgeons in 1918 started a system of reviewing hospitals because they were rightly concerned about serious differences in quality of hospital care and standards of practice. They wanted to evaluate hospitals objectively and motivate substandard ones to improve. In 1951, the American College of Surgeons joined forces with the American Medical Association, the American Hospital Association, and other corporate members to form the Joint Commission for Accreditation of Hospitals (JCAH). Continue reading “What JCAHO Knows”

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David Katz MDOn Tuesday of this week (4/29/14), I was on the Katie Couric Show to discuss Integrative Medicine.

Somewhat ironically, I returned from Manhattan that same day to a waiting email from a colleague, forwarding me a rather excoriating critique of integrative medicine on The Health Care Blog, and asking me for my opinion.

The juxtaposition, it turns out, was something other than happenstance. The Cleveland Clinic has recently introduced the use of herbal medicines as an option for its patients, generating considerable media attention.

Some of it, as in the case of the Katie Couric Show, is of the kinder, gentler variety. Some, like The Health Care Blog — is rather less so. Which is the right response?

One might argue, from the perspective of evidence based medicine, that harsh treatment is warranted for everything operating under the banner of “alternative” medicine, or any of the nomenclature alternative to “alternative” – such as complementary, holistic, traditional, or integrative.

One might argue, conversely, for a warm embrace from the perspective of patient-centered care, in which patient preference is a primary driver.

I tend to argue both ways, and land in the middle. I’ll elaborate.

Continue reading “A Holistic View of Evidence-Based Medicine”

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flying cadeuciiI know it seems like the obvious choice, but I would not run a randomized clinical trial.

I have recently lamented the pernicious influence, within my domain of public health practice, of hyperbolic headlines proclaiming “this,” followed unfailingly by equally and oppositely hyperbolic headlines reactively proclaiming “that.”

But we are obligated to acknowledge that there are, generally, research studies underlying the headlines, however extreme the pop culture distortions of the actual findings. So to some extent, the problem originates before ever the headlines are a gleam in an editor’s eye, with our expectant anticipation of the next clinical trial, and the next, and the next.

By all means, bring on the clinical trials! They serve us well. They advance the human condition. I run a clinical research lab — my career is devoted to just such trials.

But still, I wouldn’t conduct one if my foot caught fire.

Of course, there is a very good case for running such a study, as many vitally important questions about the right response to a foot on fire are at present unanswered. What, for instance, would be the ideal volume of water? Should it be hard water, or soft? Fluoridated, or not? A controlled trial is very tempting to address each of these.

The vessel is even more vexing. What would be the best kind of bucket? What size should it be? What color should the bucket be, what composition, and what’s the ideal kind of handle? I think the variations here are the basis for an entire research career.

Perhaps the notion of running randomized, double-blind, controlled intervention trials to determine the right response to a foot on fire seems silly to you. But if so, you must be suggesting that science does not preclude sense.

That’s rather radical thinking in some quarters.

Continue reading “What I Would Do If My Foot Caught Fire”

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A recent case taught me a lot about how people perceive their medicines.

I was trying to help a 92-year-old man get off some of his medicine. I can’t go into the details, but suffice to say, there was much opportunity to trim a long list of drugs, many of which were threatening his existence and impairing his quality of life.

As I was discussing stopping many of the meds, the patient said (with a quite sincere tone):

“You doctors these days just want us old people to go off and die.”

That was a zinger, a real punch in the gut. I was trying to do the opposite–allow him to live a longer and better life–but the patient perceived me as a mini-death panel.

I’ve been thinking a lot about this case. Why was this man “attached” to his meds? Why had he associated his longevity with chemicals that now threatened his existence?

The answer, I believe, is a knowledge gap. He, like many people, doctors included, fell into the trap of association and causation. He associated his health with his medicines; he overestimated their benefits. He thought the pills were keeping him alive. They were not. He lived despite his medicines.

What I tried to explain to this patient was that benefits from medicines do not continue indefinitely. Things change in the elderly, and, what is for younger patients may not be in the aged.

Take the case of preventing stroke in the elderly. Simple drugs, such as high blood pressure medicines and statins, may no longer offer a net benefit to the patient over the age of 80. Really. It is true.

Let me tell you about a recent commentary in the journal Evidence Based Medicine (from BMJ).

Dr Kit Byatt is a doctor in the UK who specializes in Geriatric Medicine. He wrote this refreshingly concise summaryoutlining four reasons why the medical community should reconsider its overenthusiastic views of stroke reduction in patients over the age of 80. In the title, Dr. Byatt asks whether we are being disingenuous to ourselves and to our elderly patients.

The answer is yes.

Continue reading ““You Doctors These Days Just Want Us To Go off and Die …””

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[This post is the third and final part of a commentary on “Medicine in Denial,”(2011) by Dr. Lawrence Weed and Lincoln Weed. You can read Part 1 here and Part 2 here.]

It seems that Dr. Larry Weed is commonly referred to as the father of the SOAP note and of the problem list.

Having read his book, I’d say he should also be known as the father of orderly patient-centered care, and I’d encourage all those interested in patient empowerment and personalized care to learn more about his ideas. (Digital health enthusiasts, this means you too.)

Skeptical of this paternity claim? Consider this:

“The patient must have a copy of his own record. He must be involved with organizing and recording the variables so that the course of his own data on disease and treatment will slowly reveal to him what the best care for him should be.”

“Our job is to give the patient the tools and responsibility to organize the knowledge and slowly learn to integrate it. This can be done with modern guidance tools.”

These quotes of Dr. Weed’s were published in 1975, in a book titled “Your Health Care and How to Manage It.” The introduction to this older book is conveniently included as an appendix within “Medicine in Denial.” I highlighted it this section intensely, astounded at how forward-thinking and pragmatically patient-centered Dr. Weed’s ideas were back in 1975.

Thirty-eight years ago, Dr. Weed was encouraging patients to self-track and to participate in identifying the best course of medical management for themselves. Plus he thought they should have access to their records.

Continue reading “Medicine in Denial: What Larry Weed Can Teach Us About Patient Empowerment”

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A useful and well-written summary of open access to publications in the medical field triggered some thoughts I’d like to share. The thrust of the article was that doctors need more access to a wide range of journal publications in order to make better decisions. The article also praises NIH’s open access policy, which has inspired the NSF and many journals.

My additional points are:

  • Open publication adds to the flood of information already available to most doctors, placing a burden on them to search and filter it. IBM’s Watson is one famous attempt to approach the ideal where the doctor would be presented right at the point of care with exactly the information he or she needs to make a better decision. Elsewhere, I have reported on a proposal to help experts doctors filter and select the important information and provide it to their peers upon demand–a social networking approach to evidence-based medicine.
  • Not only published papers, but the data that led to those research results should be published online, to help researchers reproduce the results and build on them to make new discoveries. I report in an earlier article on this site about the work of Sage Bionetworks to get researchers to open their data. Of course, putting up raw data leaves many challenges: one has to be careful to deidentify it according to accepted standards. One has to explain the provenance of the data carefully: how it was collected and massaged (because data sets always require some culling and error-correction) so it can be understood and properly reused. Finally, combining different data sets is always difficult because they are collected under different conditions and with different assumptions.
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We are asking doctors to help us study what access to all medical research would mean for their practice. To study the value of such access, we are providing physicians who participate in this Stanford University Public Access Study with eleven (11) months of complete access to virtually all medical journals, as well as to an evidence-based clinical decision-support service.

Participating physicians will have free, one-click access to this vast body of research on their computer or tablet, whenever and wherever they are online. The study is intended to inform current discussions and legislation on the state of public and professional access to federally funded medical research.

Demands on Participant:  Participants must be a physician licensed to practice in the United States. Data will be collected on participants’ use of research, with selected participants asked to participate in a 30-minute confidential interview. As a control measure, participants are given an extra month of the evidence-based clinical decision-support service, either prior or following the eleven months of access to the research literature.

To learn more and/or to begin immediate participation (after providing informed consent) in the Public Access Study, follow this link: http://nihpublic.stanford.edu/.

The principal investigator of the Public Access Study is John Willinsky, Khosla Family Professor, Stanford University, Stanford CA; john.willinsky@stanford.edu.

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Sir Muir Gray, of evidence-based medicine fame, is a man who speaks his mind – often in 140 characters or fewer. “Show me a paper by a management academic,” he Tweeted, “that has changed the way we deliver health services” [and, implicitly, improved patient outcomes].

Part of me agreed with him, but I’m married to a management academic (“Oops sorry, better man than me,” Muir backpedalled), who helped me rise to Muir’s challenge.

We kicked off with a paper almost every clinician has heard of:

Kaplan and Norton’s ‘balanced scorecard’, published in Harvard Business Review in 1992 and cited over 8000 times since [1]. The scorecard was aimed at company directors who wanted some quick (and, one is tempted to suggest, dirty) metrics to monitor what their customers thought of them and where they should direct their efforts for the future. It has certainly changed practice (many healthcare organisations use it), but we were not overly sold on its transferability to the healthcare setting.

Continue reading “Have Management Papers Ever Changed Practice in Healthcare?”

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This week, The New York Times gave heart-wrenching accounts of newborn babies enduring opiate drug withdrawal because of their mothers’ addictions. The story provided only one cause for optimism: Both babies and their painkiller-dependent mothers can benefit dramatically from being maintained on medications such as methadone or buprenorphine.

Unless, of course, these mothers were members of a military family, in which case such essential, life-saving care would be denied to them.

The most effective treatment for opiate addiction — long-term buprenorphine or methadone maintenance — is not covered by the Department of Defense’s TRICARE insurance program. The program limits methadone and buprenorphine prescriptions to short-term detoxification, and its regulations state, “Drug maintenance programs when one addictive drug is substituted for another on a maintenance basis (such as methadone substituting for heroin) are not covered.” The premise that prescribing opiate substitutes is no different from uncontrolled opiate abuse goes back to the anti-methadone hysteria of the 1970s. Since then, opiate-substitution treatment has become a staple of modern addiction medicine, particularly with the addition of buprenorphine in 2002. Unlike methadone, burenorphine can be prescribed for maintenance by patients’ regular primary physicians, outside traditional venues of addiction treatment, which had long posed forbidding barriers for many patients.

In fact, many of the best clinical trials of methadone and buprenorphine were conducted in Veterans Health Administration studies with former military personnel as patients. The treatment is so established that in 1997, the National Institutes of Health called for an end to the unnecessary regulation of these medications and for these medications to be included in public and private insurance coverage. These treatments are now standard within the addiction field, are FDA-approved and have been used to treat opiate dependence disorders for several decades. Long-term methadone and buprenorphine maintenance are now available to patients through Medicaid, through many state-funded programs, and, increasingly, through private insurance. Continue reading “Bad Medicine: TriCare’s Noncoverage of Evidence-based Opiate Maintenance Therapy”

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One of the founders of the evidence-based medicine movement, Muir Gray

Fascinating, how in the same week two giants of evidence-based medicine have given such divergent views on the future of quality improvement. Here (free subscription required), Donald Berwick, the CMS administrator and founder and former head of the Institute for Healthcare Improvement, emphasizes the need for quality as the strategy for success in our healthcare system. But here, one of the fathers of EBM, Muir Gray, states that quality is so 20th century, and we need instead to shine the light on value. So, who is right?

Well, let’s define the terms. The Merriam-Webster dictionary defines quality as “the degree of excellence.” The same source tells us that value is “a fair return or equivalent in goods, services or money for something exchanged.” To me “value” is a holistic measure of cost for quality, painting a fuller picture of the investment vis-a-vis the returns on this investment. What do I mean by that?

Simply put, the idea behind value is to establish what is a reasonable amount to pay for a unit of quality. Let’s take my used 1999 VW Passat as an example. If my mechanic tells me that it needs to have some hoses replaced, and it will cost me under $100, and the car will run perfectly, I will consider that to be a good value. However, if my transmission has fallen out in the middle of Brookline Ave. in Boston (really happened to me once, many years ago and with a different car), and it will cost me $5,000 to fix, I may say that the value proposition is just not there, particularly given that the car itself is worth much less than $5,000. Given that my budget is not unlimited, I have to make trade-off decisions about where to put my money, so I may instead spend the money on another used Passat that has good prospects.

But in medicine, we routinely avoid thinking about value. There seems to be an overall impression that if it out there on the market, and especially if it is new, it is good and I am worth all of it. This impression is further enabled by the fact that CMS has no statutory power to make decisions based on value of interventions — they are legislatively mandated to turn a blind eye to the costs. Does this make sense? How toothless is our comparative effectiveness effort likely to be if it has to ignore half of the story? Continue reading “Quality or value? A Measure for the 21st Century”

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