Another hazard of systematic reviews

---is that they go out of date, as this paper in the Annals of Internal Medicine reminds us.

So what, you’re thinking to yourself. All medical literature goes out of date!

OK, here’s what: Some EBM mavens worship the systematic review. Most EBM resources rate systematic reviews at the top of the evidence hierarchy, thus encouraging clinicians to preferentially seek systematic reviews to answer clinical questions. Many contain links that search only systematic reviews

Search strategies which focus on systematic reviews ignore randomized controlled trials published since the latest review and thus may not yield the best and most current evidence.

A quick Google image search reveals that the vast majority (although not all) evidence pyramids rank the systematic review at the top.

Why is tPA for stroke still so controversial 12 years after NINDS?

Because of all the screaming. Plenty of it on both sides.

On the affirmative side are false claims (“it saves lives”), egregious media spin and hyped up expert testimony.

On the negative side are knee jerk cries of “conflict of interest”.

What’s a doctor to do?

We need an objective analysis that cuts through all the noise and gives us a balanced perspective.

I think I’ve found such an analysis: Joseph Lex’s presentation at the FERNE 2007 Brain Illness and Injury Course.

Bottom line: Patient selection is difficult, therapeutic window is narrow and informed consent is crucial. Know how to inform patients and families. This presentation shows how.

Modest effects of pneumococcal vaccination in adults

Polysaccharide pneumococcal vaccination has been designated a core quality measure despite the fact that it does not prevent pneumonia and from the standpoint of absolute risk reduction its effects on the complications of pneumococcal infection are modest.

This study, reported in the Archives of Internal Medicine, compared vaccinated and unvaccinated patients hospitalized with community acquired pneumonia and found a reduction in a composite outcome of death or admission to the ICU in vaccinated patients. Buried in the body of the paper is the statement that the entire effect was due to the reduction in ICU admissions. There was no effect on mortality.

So, when you administer pneumococcal vaccine to your patients at discharge you won’t prevent pneumonia and probably won’t help them live longer, but you’ll decrease the likelihood of admission to ICU next episode.

The polysaccharide pneumococcal vaccine, which is the only kind approved for adults, is a weak sister compared to the conjugate vaccine approved for kids. We need a conjugate vaccine for adults. Is anybody out there working on it?

Massive pulmonary embolism leading to cardiac arrest

Emergency surgery may be an option. (Texas Heart Institute Journal).

Is your medical reading getting too dry?

Try Striped Giraffe Press. “…a publishing company dedicated to teaching medical knowledge in an offbeat fashion.”

The site appears to be under construction. Not much there yet, but could be interesting.

Core measures and P4P: rank-and-file doctors aren’t buying in

Bob Wachter used an electronic audience response system to poll over 500 attendees (mainly hospitalists) about this topic at his recent UCSF/SHM sponsored Hospital Medicine Course. Among physician groups, you’d think hospitalists would be the cheerleaders of the quality movement. But these doctors were overwhelmingly skeptical. Wachter presents the poll results here and euphemistically concludes: The bottom line: everybody’s got a lot of work to do if we’re going to get this thing right.

More discussion on intensive glycemic control in hospitalized patients

A review in Chest addressed the controversies on this topic and summarized results of clinical studies done up to the time of submission of the manuscript. Several tables display summaries of available data on the basis of duration of the intervention, types of outcomes and types of populations.

An accompanying editorial is linked here.

Early Goal Directed Therapy of sepsis

---from the perspective of an Emergency physician. Via Emergency Medicine News.

Remembering Proctor Harvey

W. Proctor Harvey, M.D., M.A.C.C., passed away on Sept. 26 at the age of 89. He was widely renowned as a master clinician and teacher of cardiac auscultation. His teaching sessions were legendary. I had the good fortune to attend a few of them at CME meetings through the years. Harvey taught, and demonstrated to his students repeatedly, that most cardiovascular disease could be diagnosed at the bedside.

Nowadays the abuse (wasteful, ineffective use, sometimes to the harm of patients) of sophisticated technology, especially in cardiovascular medicine, is common. That’s because medicine has lost the legacy of Proctor Harvey: the importance of basic clinical skills. Another master teacher, J. Willis Hurst, has said that unless one masters low technology (basic clinical skills) one is bound to abuse high technology. He said it here in this way:

When low technology, consisting of the history, physical examination, electrocardiogram, and chest x-ray film, is used poorly it is very likely that high technology will be used poorly. It is not possible to take a second step (high technology) without taking a well placed first step (low technology).

During my training it seemed there was never quite enough time to teach basic skills properly. Today there is even less time, given the many new and competing demands of medical education, not to mention all the fluff and woo. Now as in years past practicing physicians must teach and reteach themselves these skills.

Dr. Harvey realized that fact and at one of his CME presentations announced a collaboration with engineer David C. Canfield and Roche pharmaceuticals to capture live recordings of heart sounds from hundreds of patients, put them on cassette tapes along with a set of booklets to be distributed as freebies by drug reps to interested physicians. (Dr. Harvey, true to his reputation for humility, didn’t think it beneath himself to collaborate with a drug company to make this wonderful educational resource available!).

A tribute to Dr. Harvey in the Texas Heart Institute Journal described the project:

In recognition of the importance of his message, numerous educational grants have enabled the distribution of his writings to American medical students and physicians. Roche Pharmaceutical company alone is responsible for distributing 75,000 copies of Clinical Auscultation of the Cardiovascular System, a work that includes 10 high-fidelity audio cassettes of various heart sounds and murmurs, recorded from more than 450 patients, together with a text that describes the compendium of acoustic findings and their significance. Harvey's voice is heard throughout the cassettes as he sprinkles in his “cardiac pearls.”

I still have my set, pictured here.

Shamelessly and with no sense of “reciprocal obligation” I would like to express my thanks to Roche Laboratories for making this wonderful resource available.

For those who would like to feel morally superior by paying for this resource, last time I looked one was being sold on ebay.

Meet the newest member of the trauma team: the reiki master!

I considered not writing about this because I’m a little late for the party. Orac has already covered it extensively and Kevin has posted a link. But the incredible story on the introduction of reiki to the University of Maryland’s Shock Trauma program deserves exposure, and the more we can give it the better. It represents infusion of pseudoscience into mainstream academic medicine (a trend I’ve followed on this blog for some time) taken to a new level. Not only is reiki among the wooiest of woo, it’s being introduced into the (up to now) pristine specialty area of emergency and trauma medicine!

Another reason for me to weigh in is that Orac, it seems, is beginning to feel a little lonely and frustrated in his battle to restore scientific integrity to academic medicine:

I'm beginning to wonder if I should just give up this quixotic battle to try to insist on evidence-based medicine in academic medical centers. I'm clearly losing the battle, and sooner or later I'll be relegated to the sidelines along with the other dinosaurs who advocate scientific medicine over unproven, non-evidence-based therapies. If I were to join the Dark Side, I could probably attract a bunch of grants to fund clinical trials to look at whatever the woo du jour is. I'd never do that, of course, if only because as a former skeptic I'd represent a truly valuable scalp for the world of non-evidence-based medicine, but I feel as though I'm increasingly alone in holding out.

Yes, it must get a little lonesome. Out here in the hinterlands I can only wonder what’s going on in academic medicine these days. Is there anyone there for whom the standards of science mean anything at all? Well, there must be. There are plenty of people who teach and write about evidence based medicine. And how about the rising chorus of voices calling for the purging from academic medicine of the biased influence of drug companies? They claim to stand for scientific purity, so why do they (with the notable exception of Arnold Relman) remain silent about woo?

What conflicts of interest might be involved? It’s partly about money. Consumers demand woo and to an astonishing degree pay for it out of pocket. There’s also the ever more lucrative pipeline of government grants to promote and “research” woo. And, as Orac pointed out, there is the dinosaur phenomenon. Increasing pseudoscientific indoctrination of medical students over the last few years means changing priorities and values for the academic medical center as these students become faculty members. As the culture of the academic medical center becomes more and more steeped in woo it must be getting difficult to stand up for science. It takes courage to risk the dinosaur label.

So, for what it’s worth, I’m weighing in. As Orac points out, not only is reiki unsupported by evidence but, even worse, it’s utterly implausible. Its purported mechanisms involve a mysterious, undocumented energy which can traverse time and space provided the proper symbols are used. (That would be mighty handy if it worked. The reiki master wouldn’t even have to show up). Such credulity in academic medicine is astonishing. What’s going on?

At the University of Maryland, as well as, I suspect, other academic medical centers, there appears to be a new standard. Alternative medicine modalities, unlike pharmaceutical agents, no longer have to be evaluated with the measuring stick of science. A different standard has been adopted, one which was articulated by the University of Maryland’s own director of integrative medicine, Dr. Brian Berman, in his BMJ editorial from a few years ago. His statement is telling (emphasis mine):

When in 1992 we developed a complementary and alternative therapy curriculum at the University of Maryland we thought it was important to present the therapies in the context of their own philosophies and models of health and illness.

The Baltimore Sun piece quotes Berman as saying patients’ reactions to reiki therapy make it “ripe for study”. And I had to laugh at this:

At Shock Trauma, a clinical research study is under way to look at the effectiveness of acupuncture on trauma patients, to see whether it lessens a patient's reliance on drugs. A reiki study could follow, which might quiet skeptics who still wonder whether its power is little more than one of suggestion.

Well, I’ve got news for reporter Stephanie Desmon. It’ll take more than “a study” to quiet the skeptics and move reiki out of the category of extreme woo, especially considering the type of study that’s most likely to be conducted. In order to evaluate reiki’s energy based claims, and test whether it’s anything more than a relaxation technique it would have to be compared with those same techniques. It would require a control group of patients undergoing an equivalent form of relaxation, stripped of the name “reiki” and all its associated energy and religious woo. It might also be necessary to blind patients to the fact that there is a comparison group. (Suppose you told the control patients they were only receiving “reiki light” and being compared with patients getting the real thing. What would that do to the placebo effect?). Suppose reiki demonstrated a positive effect. What then? Well, reiki is an extraordinary claim. The results would need to be duplicated at other study centers, preferably those (if they exist) which have no interest in promoting woo. If a robust effect were observed repeatedly then the basic scientists would need to get to work in search of a mechanism.

Like Orac, I lament the fact that woo seems to be running rampant in academic medicine. I know there are leaders there who share my concerns. I hope they’ll comment here. I’d like to know why they remain largely silent and what, if anything, they are doing to stand against this trend in their own institutions.

Does mainstream medicine treat the whole patient?

I have a certain hesitation in talking about the “whole patient”. As important as the notion is, in recent years it seems to have lost some of its meaning, at least in popular usage. That’s because it’s been hijacked by the boosters of alternative medicine who relentlessly accuse the mainstream of focusing on the disease and organ system at the expense of the person who has the disease. The American Medical Student Association, for example, in its promotional web page on Integrative, Complementary and Alternative Medicine, says this:

The above examples suggest that CAM fills a hole in conventional medicine. Michael Cohen describes the biomedical vs. holistic paradigms. Conventional medicine has almost perfected the biomedical approach. This system views the body as a machine and reduces the body to its components. The biomedical paradigm works well for emergency problems or diseases with one specific cause. The holistic paradigm, embraced by many CAM practitioners, sees the body as more than the sum of all of its parts. It emphasizes lifestyle changes, stress reduction and nutrition to enhance the patient's healing process. Biomedicine often falls short in treating chronic problems, while many patients with chronic problems find some relief with the holistic approach of CAM therapies.

Half truths and innuendo of this sort are pervasive in alternative medicine literature. Such “whole patient” promotions generally mislead and have the potential for great harm because they drive widespread uncritical acceptance of non-evidence based health claims.

But do they have a point? Has the mainstream become too reductionistic? The answer, in part, is that external barriers have caused a disconnect between real world practice and the teachings and ideals of mainstream medicine.

Mainstream medicine has always taught that doctors must treat the whole person. My favorite medical school mentor, the late Thomas E. Brittingham, pounded the notion into students’ heads. In his annual introductory letter to incoming third year students about to begin their medicine clerkship he wrote:

I expect you to spend time with each one of your patients after the initial workup in establishing rapport with him, obtaining an extensive personal history by indirect and easy means, and in showing the patient that you have a keen interest in him as a person and friend as well as a disease.

Dr. Brittingham wasn’t pushing some altie agenda. (There was no room for that in medical school in those days!). He was teaching the fundamentals of mainstream medicine. And despite the unfortunate fact that quackery is making its way into the curricula of MD granting schools today, the “mainstream” teachers in these schools still emphasize a comprehensive approach that treats the patient and not just the disease. One of our favorite “mainstream” bloggers, DB of DB’s Medical Rants, teaches this philosophy to students and house staff at the University of Alabama School of Medicine. For a sample of his writing on this subject check out his last two blog entries.

But, as I alluded to above, physicians encounter difficulty translating this principle into real world practice. Economic incentives force doctors to see too many patients in too little time. Perfunctory “quality” measures distract from things that really matter in patient care. The ever present threat of litigation makes the patient a potential adversary. These dehumanizing forces are significant obstacles to treating patients as whole persons.

There are no easy fixes, but at both the individual and the system level we in medicine must continually oppose these barriers to our professionalism. Without knowledge and skill in the humanistic dimensions of medicine we cannot be effective clinicians, but “integrative” medicine is not the answer. We can spend all the time in the world learning about the patient’s psychological make up, temperament and social interactions, but when we’re not grounded in the biomedical model we become incompetent.

We as doctors need to appreciate patients as people, but guess what? We also need to know about organs. And diseases. Our thought leaders do well to teach about the healing of whole persons. But they must also insist that the principles of Western science be rigorously applied to the healing of those persons.

Screening for coronary artery disease with CT calcium scoring and carotid intima media thickness: ready for prime time?

Prevention guidelines for cardiovascular disease have advocated treatment guided by the assessment of traditional risk factors. The Framingham risk score is often used for this purpose. Recently, interest has grown in the use of noninvasive imaging to assess risk in asymptomatic patients, particularly CT calcium scoring and ultrasound measurement of carotid intima media thickness (IMT), due to accumulating evidence of superior predictive power of these modalities. Risk assessment strategies have not been studied head to head for clinical outcomes. And, unfortunately, they’re not likely to be anytime soon:

That appears unlikely, at least for now, said Dr. Diane Bild, a medical officer at the National Heart, Lung, and Blood Institute, the logical agency to conduct such research. She said specialists there have already rejected the idea of a head-to-head study looking at how patients who received the high-tech screening fared long term, compared with those screened using more traditional methods.

The institute, Bild said, ``has a lot of competing priorities, and this type of study would be very expensive to conduct, and it just hasn't reached that level where we've gone forward with it."

(Competing priorities indeed. Like the multimillion dollar promotion of quackery by the NCCAM which, like NHLBI, is also a subsidiary of the NIH. But I digress). Needless to say we won’t have the benefit of outcome based trials to guide in the assessment of patients. For the foreseeable future we must settle for lower level evidence. Does that mean we can’t make evidence based decisions? No. Evidence based medicine would have us apply clinical judgment and expertise to come up with the best synthesis of evidence we can, even when this evidence is “low level”. But when a group of experts with special interest in cardiac imaging attempted to do just that and promulgated their own guidelines a firestorm of controversy erupted.

This controversy bears careful examination for several reasons, not the least of which is the nagging question of how best to stem the epidemic of cardiovascular disease. It also impacts broader areas of guideline development relating to potential conflicts of interest and disagreement with other guidelines.

The new guidelines, known as the SHAPE guidelines, expand the recommendations for imaging modalities to screen patients, calling for the use of CT calcium scoring or ultrasound IMT measurement for all asymptomatic men ages 45-75 and women ages 55-75 except for those defined as very low risk. This represents a radical departure from the American College of Cardiology Foundation/American Heart Association expert consensus document, just updated this year to recommend screening only for those patients deemed to be at intermediate risk.

Publication of the guidelines in a supplement to the American Journal of Cardiology was supported by Pfizer pharmaceuticals, eliciting the usual knee-jerk cries of “conflict of interest”. (Joining the chorus were medical thought leaders Arnold Relman and Jerome Kassirer. Do those guys ever miss a chance to pounce on the drug companies?).

Dr. Steven Nissen, no stranger to controversy and hyperbole, also chimed in with:

This issue is not about the conservatism of the ACC and AHA, it’s about the practice of evidence-based medicine. The AEHA is a group of shameless self-promoters who have no scientific basis for their assertions.

The controversy was nicely covered in a point counterpoint in the Cleveland Clinic Journal of Medicine. While I believe Nissen was wrong to say the guideline authors had no scientific basis for their assertions I have chosen not to take sides in this controversy. A reasonable clinician could take either view. All physicians involved in preventive medicine should familiarize themselves with both sides of this debate. These tests are being promoted to patients, who will come to their appointments with questions.

In defense of traditional lecture based CME

Right now I’m feeling a little morose as Bob Wachter over at Wachter’s World posts bittersweet reminders of the fact that I missed this year’s just completed UCSF Hospital Medicine Conference in San Francisco. It’s one of several high quality CME courses I repeat on a rotating basis, chock-full of updates and thoughtful presentations on this ever more complex field.

As I console myself thinking “maybe next year” I‘m a little concerned about an emerging threat to the existence of this type of meeting. There are people out there, people in high places, who would like nothing more than the end of traditional didactic CME conferences as we now know them. A rising chorus of voices calls for the end of pharmaceutical company support for CME activities, without which many conferences of the high caliber exemplified by the UCSF meeting would simply cease to exist. Others call for a virtual end of all traditional didactic CME, including Dr. Jordan Cohen, former president of the AAMC.

Wachter addresses these criticisms in the concluding paragraph of his post:

People wonder about whether CME does any good, either because content taught in big lectures tends not to stick or because many CME courses are golf-laden boondoggles. It is now Saturday morning, and 90% of our registrants are still here (and they’ve already received their CME certificates and it is gorgeous day in San Francisco – lots of excuses to play hookie). I admire their commitment, and, though I can’t prove it, I think we’re saving a few lives here in the Fairmont Hotel.

No, he can’t prove it, but having attended a couple of Bob’s past conferences I suspect he’s right. I come home from courses like this, read and re-read the syllabus, look up related material and primary sources on the Internet, then return to work with batteries charged, newly inspired to try and make a difference.

As far as "proof" of efficacy of CME goes, some critics of traditional programs insist that accreditation somehow be based on verification that each content element be correlated directly with a change in physician “behavior”. For a more lengthy rant of mine on what’s wrong with that thinking click here.

New and noteworthy medical blog

One of the latest additions to the growing medical blogosphere is Wachter’s World, Robert Wachter’s new blog devoted to hospital medicine. The subtitle reads Lively and iconoclastic ruminations on hospitals, hospitalists, quality, safety and more… Having heard Wachter speak many times I have no doubt that he’ll deliver on that promise. Stop by for a dose of healthy skepticism on the hospitalist movement along with the latest buzz on hospital medicine. I’ll be linking from there often. It’ll be on my blog roll once I get around to the next update.

Media credulity towards alternative medicine

If woomeisters put the good name of academic medicine behind their claims those claims must be true. If they admit that quackery really does exist they must be appropriately skeptical. Right? Wrong, but don’t tell that to CNN which recently published this credulous piece: 5 Alternative Medicine Treatments That Work.

The article well illustrates two things I’ve been harping on for a while, these being the harm done when academic medicine promotes quackery and the distortion of health issues by popular media. Needless to say it would have been fun to write a debunking piece about this article. I thought about it the other night but was just too tired. Fortunately Mark Hoofnagle and Orac came through. Although both posts are worth reading in their entirety Orac’s conclusion best summarizes what’s really wrong with the recent infusion of pseudoscience into academic medicine:

The bottom line is that the infiltration of woo into academic medicine is a threat to evidence-based medicine because it lends the prestige of scientific medicine to modalities that are not evidence-based, thereby promoting the belief that they are on an equal footing, even though the vast majority of them are not. In so doing, it blurs the line between science and non-science, between scientifically supported treatments and quackery. Moreover, the faculty of the institutes, divisions, and departments dedicated to CAM in medical schools are, by and large, not made up of skeptics, but of true believers, be they M.D.s or not, who apply a veneer of skepticism and science to their studies and curriculae and then give interviews to credulous reporters like Elizabeth Cohen to publish on CNN.com.

Controversies in antiphospholipid syndrome

Terminology can be confusing. Diagnostic and treatment strategies are evolving. This update in Current Opinion in Hematology is timely.

Noteworthy points:

Among antiphospholipid antibodies, those which prolong the aPTT (so called Lupus anticoagulants) may carry a higher risk of thrombosis than anticardiolipin antibodies (OR 11.0 and 1.6 respectively). This marked difference may be biased by inclusion in the meta-analyses on which these data are based of patients with low titer anticardiolipin antibodies which are of doubtful clinical significance and do not meet current diagnostic criteria for antiphospholipid syndrome.

A common scenario is the need to evaluate a patient for thrombophilia after anticoagulants have been started. Lupus anticoagulant assays can be done on such patients but require special handling and advance notification to the laboratory.

Patients with antiphospholipid antibodies and venous thrombosis, following acute treatment with some form of heparin overlapped with warfarin, should be treated with warfarin adjusted to an INR of 2.0-3.0 long term for a duration of one year to indefinitely.

Data are less clear for patients with stroke and antiphospholipid antibodies. Absent another indication for anticoagulation warfarin adjusted to an INR of 1.4-2.8 or aspirin is suggested. For non-cerebral arterial thrombosis warfarin adjusted to an INR of 2.0-3.0 is recommended.

Two emerging outdoorsy infections

Naegleria fowleri---it’s the brain eating Amoeba we’ve been hearing about, with 6 infections reported this year in contrast with 23 reported in a 9 year period. Think of it if your patient has been swimming, has an illness resembling meningitis and has a negative CSF gram stain.

Rabies---early recognition is now more important because it may not be hopeless. Think of it in any patient with undiagnosed neurologic disease. An article beginning on page 17 of this issue of The Hospitalist tells you what a hospitalist needs to know about it.

The electrocardiogram in heart failure

The Resting Electrocardiogram in the Management of Patients with Congestive Heart Failure: Established Applications and New Insights, originally published in PACE, has many useful and fascinating pearls about information that can be teased out of the electrocardiograms of patients with heart failure. Via Medscape.

Vitamin K for warfarin reversal

Following early confusing but dramatic case reports of severe systemic reactions to parenteral vitamin K there has been a persistent and widely promulgated notion that it causes anaphylaxis.

In a recent article in Emergency Medicine News Dr. James Roberts critically examines this claim and attempts to make sense of the evidence. He concludes that there is reason for caution although the mechanism of the reaction, the degree of risk and any relation to prior vitamin K exposure is unclear. Although the problem may be overblown there is likely some risk. Oral vitamin K appears to be safer and should be used when possible.

Clostridium difficile

Another review published in Pharmacotherapy, via Medscape.