Big Pharma and the Society of Hospital Medicine meetings

The Society of Hospital Medicine regional and national meetings have grown rapidly in popularity due to the wide variety and high quality of their educational offerings. Although the success of these meetings is due in no small part to support from pharmaceutical companies, such support is controversial. Critics simplistically paint all industry support with the same broad brush, but there can be different degrees of involvement. At SHM 2008 several evening satellite symposia offered CME credit for a single topic presentation sponsored by a single company whose product related to the topic. Such activities are potentially problematic in contrast to the general sessions where industry support is broad based and insulated from meeting content.

Few would dispute that sales pitches and CME presentations whose topics directly relate to sponsors’ products influence doctors in favor of the products. It is also argued, but not supported by even a shred of evidence, that such promotions are harmful to patients. Although promotions may influence doctors away form best practice it is equally plausible that they influence doctors toward best practice. A case in point is that two of the seven satellite symposia were about DVT prophylaxis, a practice shown in study after study to be widely under utilized. The same was true for evidence based heart failure treatments such as beta blockers and ACE inhibitors back when those medicines were under utilized, on-patent and heavily promoted.

The critics, of course, claim to argue from evidence. Indeed, although there is no literature about patient outcomes much of the published material appears to show that the predominant influence on doctors is away form best practice. The problem with this large body of evidence, however, is that it’s biased. This bias manifests itself in the fact that the prescribing behaviors chosen for study are almost always ones known to be over utilized, e.g. antibiotic use and prescription of expensive antihypertensives. Nowhere in this vast repository of articles will you find surveys of doctors’ use of ACE inhibitors and beta blockers for heart failure, anticoagulation for atrial fibrillation or low molecular weight heparin for DVT prophylaxis.

But I digress. What about the general sessions? I believe adequate firewalls are in place to preserve the scientific rigor of the content. Next time you attend a national meeting of your specialty I challenge you to closely examine the general sessions and cite any content you think departs from best evidence to the potential harm of patients, and share your experience with me. And, if you don’t consider it beneath you, go to the exhibit hall and tell some of the reps you appreciate their support of the meeting.

Hypervirulent Clostridium difficile

A recent update appeared in Nature Clinical Practice Gastroenterology and Hepatology.

Drinking the Kool-Aid at SHM 2008

(This is the first in a series of observations on the SHM 2008 national meeting. I enjoy SHM meetings and attend as often as I can. Unfortunately I missed this one. Reading the many blog posts and talking with colleagues who have returned from San Diego may be the next best thing. This, my inaugural post, somewhat critical, does not reflect my overall positive impression of this and other SHM meetings as will be evident from future posts).

Being the fastest growing specialty in medicine must be heady stuff. Notwithstanding the excellent “hard core” clinical content at Society of Hospital Medicine (SHM) meetings the organizational portions of the content, from where I sit, are looking more and more like a Wal-Mart Shareholders Meeting. (If you lived in the back yard of Wal-Mart corporate headquarters as I do you’d know that that gala event is one massive pep rally).

But take a look at some of the self congratulatory and grandiose ideas bandied about in the official blog of the 2008 sessions! One of the speakers, referring to the lofty (and, in the view of some, unrealistic) opinions espoused by IHI leader Donald Berwick, urged attendees to “’drink the Berwick kool-aid’ and insert ourselves in the center of the healthcare system transformation.” Reading some of those posts you’d think the hospitalist movement was what was going to “fix” health care. Enough already. We need to drink a little less Kool-Aid and engage in some critical thinking about what’s being proposed.

There was a refreshing voice of moderation. Bob Wachter, wise and all knowing sage of the hospitalist movement, said in his podcast that hospitalists should be thoughtful about future growth. In the past the agenda of the movement was to make hospitalists indispensable. Now, noted Wachter, we need to be careful that we don’t become too indispensable. We can’t do everything. The hospitalist movement is not going to single handedly “fix” anything. If we as hospitalist colleagues can just help each other ascend the learning curve of cost effective, science based hospital medicine in the care of individual patients we will do well!

Prestige and money behind woo: The Institute of Medicine and The Bravewell Collaborative

Wallace Sampson’s recent Science-Based Medicine blog post about next year’s National Summit on Integrative Medicine and the Public Health, put on by the Institute of Medicine (IOM) and sponsored by the Bravewell Collaborative piqued my interest.

First a little background. In 2005 a committee of the revered IOM issued a report on complementary and alternative medicine in the U.S. I blogged about it at the time as being promotional of CAM’s irrational claims, citing Steve Barrett’s critical review of the report. Barrett noted:

Despite all the alleged experts involved in its preparation, the IOM report does not contain a single word of criticism against methods that are sufficiently irrational to be discarded now. Instead, it makes broad, sweeping generalizations and attempts to set an agenda for the widespread adoption of “CAM” research and teaching.

Barrett also discussed the report on his Quackwatch website in which he examined conflicts of interest inherent in the funding and heavy influence from the National Center for Complementary and Alternative Medicine (NCCAM).

The Bravewell Collaborative is a philanthropic organization which promotes questionable health claims in medical schools by funding the Consortium of Academic Health Centers for Integrative Medicine.

So what’s going on? Isn’t the IOM supposed give us a vision for quality health care? Whatever the vision is, it doesn’t appear to be a science based vision. Unfortunately the IOM’s promotions will lend an increasing appearance of credibility to unscientific health claims and encourage even more assimilation of woo into medical school curricula. As Sampson put it:

So “IOM,” in exchange for more $?millions as it did for the NCCAM committee, sells itself and its merit badge for “CAM”’s CV sash. Fair exchange in this capitalist system, yes?

How should we manage acute hypertension in stroke?

Current guidelines for ischemic stroke do not recommend emergency antihypertensive therapy until the systolic BP exceeds 220 or the diastolic exceeds 120 unless TPA is administered. The guidelines for hemorrhagic stroke allow a moderately more aggressive approach to blood pressure lowering depending on the clinician’s estimate or the actual measurement of intracranial pressure.

A new study suggests a change in this management strategy. Results from a small study (reported in Medscape) presented at the American Stroke Association's (ASA's) International Stroke Conference 2008 demonstrated that immediate antihypertensive treatment targeted to a systolic blood pressure of 145 to 155 mm Hg or a drop in systolic blood pressure of 15 mm resulted in improved stroke outcomes at 3 months.

The investigators acknowledged that the results of this small study should not change clinical practice and should be considered preliminary. Moreover, the study population was a mixture of patients with hemorrhagic stroke and ischemic stroke, limiting its applicability to either subgroup.

Cardiac memory phenomenon: a cause of non-ischemic T wave abnormality

Alteration in ventricular repolarization occurs during changes in ventricular activation as may occur with ventricular pacing, bundle branch block and various arrhythmias. This may result in T wave abnormalities which persist following cessation of pacing, resolution of bundle branch block or resolution of arrhythmia. Such changes may be confused with ischemia. The phenomenon, known as cardiac memory, is reviewed here in the American Journal of Emergency Medicine.

Don’t forget ECMO

Decades old studies suggested no improvement in outcomes for ARDS treated with extracorporeal membrane oxygenation (ECMO). Up until now the treatment has been viewed as a last resort. New evidence presented at the Society of Critical Care Medicine 37th Critical Care Congress (via Medscape) suggests it should be considered early in certain patients.

Most patients with ARDS die of causes other than hypoxemia, such as infection or the underlying disease that was a risk factor for ARDS. Those who appear at risk of dying of respiratory failure may be worthy of consideration for ECMO. The investigators used a Murray score of 3 or more as a criterion for patient selection.

The Murray score calculator is here. The study web site can be accessed here.

This evidence will undoubtedly cause a shift in thinking about ECMO. It remains to be seen how it should be incorporated into clinical practice, especially in hospitals lacking this capability. Should patients be shipped?

Base pneumonia treatment decisions on risk factors

A retrospective cohort study in Chest compared patients with community acquired pneumonia (CAP) admitted to an ICU with those admitted to a medical ward:

Conclusions: ICU patients present with more severe disease and more comorbidities. ICU patients stay longer in the hospital and have a much higher mortality rate when compared to ward patients.

While this was not particularly surprising or instructive the body of the paper contained important findings about the microbiology of CAP. True to prior experience, the etiology could be determined in only a minority of patients and among those with a microbiologic diagnosis Streptococcus pneumoniae was the most common pathogen. Other findings of note: Legionella antigen was not found in those patients tested and a surprisingly high number of Pseudomonas infections was found in both groups.

An accompanying editorial stressed that within the category of CAP are distinct risk groups that require different strategies. Some patients need a broader spectrum of antibiotics to include coverage for MRSA and Pseudomonas.

Current guidelines for both CAP and healthcare associated pneumonia (HCAP) recognize the need for risk stratification. Taken together the two guideline documents are potentially confusing: Whereas CAP and HCAP supposedly refer to distinct high and low risk categories with respect to the likelihood of difficult to treat pathogens, within both guideline sets are two or more such categories. Specifically, CAP guidelines stratify patients into those with high or low risk for pathogens such as Pseudomonas and MRSA whereas the HCAP guidelines stratify patients as high or low risk for “multiple drug resistant” (MDR) organisms. Antibiotic recommendations for the low risk categories in the two guideline documents are similar though not identical, as is the case for the antibiotic recommendations for the high risk categories of the respective documents.

I was lost when I first tried to sort through this. After preparing for this post, however, particularly after reading the paper and editorial in Chest, I began to appreciate the reasons for the multiple subtle distinctions. There are lessons here. Read the guidelines carefully with particular attention to the risk categories. In every encounter with a pneumonia patient ask yourself what risk category or categories apply.

More bad news about intensive glycemic control in critical illness

A large cohort study published in the journal Critical Care found no benefit, and a statistically insignificant trend toward increased mortality, associated with intensive glycemic control in ICU patients with a variety of critical illnesses. The glucose target in the most aggressively treated group was 80-110 mg/dl.

Can we close the gaps in care transitions?

In his Christmas Day post Bob Wachter had this to say about fumbled handoffs:

“…If transitional glitches were measured, and if botching them carried consequences, every hospital in the country would identify an accountable person in a nanosecond.”

Get ready to clear out the corner office of the C-Suite for the Chief Transitions Officer.

Although we’re not very good at washing our hands, we are terrific at washing our hands of patients who leave our medical radar screens.

That post contained a link to a wonderful resource which I had glossed over until recently: The Care Transitions Program. There you’ll find interesting vignettes, all sorts of implementation tools and a strong business case for a transition team.

Show it to your administrators. I did!

Hard learned lessons in EMR/CPOE implementation

What happened after the dismantling of CPOE at Cedars-Sinai in 2002 just three months after go live? They went back to paper orders and, it seems, just recently began preparations for reimplementation.

I had heard of the fabled EMR debacle and was curious about the details. So, today I dredged up the story from the Washington Post.

By January 2003, at a heated showdown with management, several hundred doctors demanded an end to the hospital's short-lived experiment.

If you’re involved in planning for adoption of CPOE at your hospital, read the article.

Emergency care of patients with implanted pacemakers and defibrillators: tips for the non-electrophysiologist

Given the growing number of patients with implanted cardiac support devices it is increasingly likely that hospitalists, emergency physicians and primary care physicians will face clinical decisions with these devices. A review in the American Journal of Emergency Medicine offers tips for evaluating patients and troubleshooting problems.

Checkout time 11 AM!

Busy hospitals around the country have put in place bed control initiatives to improve efficiency, reduce patient diversion, reduce ER wait times and reduce ER crowding. One such measure involves setting an early morning discharge time, analogous to check out time at the Hilton as Bob Wachter recently put it.

Pressure to discharge by a certain time of day is driven largely by administrators. Busy doctors struggle with it. Though conceptually flawed, difficult and loaded with unintended consequences (read Wachter’s post and comment thread) the idea has surface appeal. Clearing out the hospital in the morning opens up beds to alleviate the mid day crunch. That, in turn, reduces ER crowding and ambulance diversion. In some cases there are discharge planning advantages. Nursing homes and other long term facilities may not accept patients late in the day, and trying to arrange follow up appointments and obtain medical equipment presents difficulties when it’s 4 PM.

Vanderbilt University Medical Center (VUMC), where I attended medical school back in the days of the House of God, has become a model institution for systems improvements and efficient resource utilization. I’ve followed developments there through the years and read with interest about their discharge timing initiative, launched a few years ago:

VUMC faculty and staff are launching a patient discharge initiative to reduce midday patient access problems at Vanderbilt University Hospital. As recommended by the project team, the Clinical Enterprise Group (academic department chairs and senior administrators) endorsed two new requirements.
• Doctors enter “anticipate discharge” orders at least 24 hours ahead of discharge.
• Doctors enter discharge orders before 9 a.m. on the day of discharge.

On a typical busy morning those requirements could turn a doctor’s work flow upside down. According to project leader and professor of medicine Allen Kaiser:

He said writing of discharge orders before 9 a.m. will be a major change for faculty and house staff. As morning rounds get underway, doctors have always tended to visit the sickest patients first, so that for the less sick patient who is ready to go home, writing of discharge orders is typically delayed until later in the day. “It’s natural and very understandable for doctors to start the day attending to the sickest patients,” Kaiser said. “Switching to round first on the least sick patients is a gigantic culture change.”

And easier said than done. The notion of “rounds” (starting in one area and working your way from unit to unit) may be obsolete in this era of high acuity and much sicker patients. Hospitalists on busy medical services, constantly pulled in different directions, don’t often have the luxury of orderly rounds. Deteriorating patients in the ICU, rapid response calls and families demanding to see the hospitalist now (and threatening to go to administration) demand immediate attention. The wheel that squeaks the loudest at any given time gets the grease and it’s not optional. It’s too bad such events can’t be scheduled for the afternoon after discharges are complete.

When I read about the Vanderbilt initiative I thought it was onerous. Wachter’s post suggests that initiatives of this sort are popping up everywhere. Doctors at his institution (UCSF) are feeling the pressure and a similar program is underway at Stanford, where an administrator said:

Given these benefits, the hospital is launching an initiative to set our discharge time at or before 11 a.m. What can we do to help bring about this change? First, we need to make discharge decisions earlier in the day. This may require some process changes, such as conducting our attending rounds earlier.

Next, physicians need to plan ahead the night or the day before discharge

.

If it’s 3 PM and you realize your patient is stable for discharge why not discharge then rather than wait until the next morning? It may blow your time of discharge stats but it would help the hospital’s bottom line if the patient’s insurance plan (e.g. Medicare) doesn’t reimburse on a per diem basis.

Because setting an early discharge time may require keeping the patient an extra night hospitalists, also under pressure to cut the length of stay, find themselves under competing demands. Again, from Wachter’s post:

So when I am pressured to “improve” my time of discharge, I usually respond, “If you’d like, I can move the average discharge time up to 8 am. It’ll just be one day later than I had planned.” CFOs don’t like to hear that.Which brings me to my final plea: I believe it should be illegal to report Time of Discharge without also – in the same document – reporting adjusted average length of stay (or LOS against appropriate benchmarks). Time of discharge and ALOS are inextricably linked. The service that has a long length of stay AND a late discharge time might really have a problem. But the service with a short length of stay and a late discharge time is probably doing very good work, and harassing it over its TOD is annoying and counterproductive.

Finally, I chuckled at this from the Vanderbilt initiative:

Leutgens said plaques will be mounted on every hospital room door frame to inform patients of the VUH 10 a.m. discharge time.

Just like the Hilton.

Fasicular tachycardia

This is the rare exception to the rule that you never treat a wide complex tachycardia with verapamil. These patients are often hemodynamically stable. If you’re going to use verapamil, really know what you’re doing and don’t hesitate to get some help from a cardiologist or the EP folks.

Vanderbilt Medical Center critical care podcasts

These are from Vanderbilt’s burn ICU rounds but cover issues of general interest to critical care and hospital medicine. A new topic is posted every week or so. This resource is free of charge.

When your patient can’t afford low molecular weight heparin

Here’s a regimen for out patient (post hospital) treatment of VTE using subcutaneous unfractionated heparin without PTT monitoring.

Why did this patient suffer a cardiac arrest in the hospital?

Common medications conspired with “borderline” electrolyte levels to produce this outcome.


Via Medscape.

Brand new medical school wants its inaugural class to be competitive

How does the University Of Central Florida College Of Medicine, scheduled to open next year, plan to do it? By making it free of charge!

Each of the first 40 students will receive a full tuition scholarship with living expenses for all four years. This is an unprecedented opportunity in the history of medical education.

Read the rest here.

The adoption of electronic medical records

In an ars technica piece from yesterday Jonathan Gitlin discussed the ins and outs of electronic medical records. He opened with:

Doctors' poor handwriting might be a cliché, but being able to accurately read medical records can often be a matter of life and death. The ubiquity of the personal computer has allowed the clinic to enter the digital age, and given that computers excel at managing information, the development of electronic health records (EHR) has been a no-brainer.

That’s part of the problem. Maybe we’d all be better off if more thought was put into development and implementation. Read the rest here.

Via Kevin M.D.

How good is PubMed?

Around this time last year I wrote that while no search engine had a singular advantage in all situations PubMed was the most reliable. I still believe that’s true, at least for clinical medicine.

Last Saturday virologist PhD student and blogger Anna Kushnir expressed a different view:

For a site that is as vital to scientific progress as PubMed is, their search engine is shamefully bad. It’s embarrassingly, frustratingly, painfully bad.

She gave these examples:

I can hold a paper in my hands, search for two authors’ last names and have PubMed come up with nothing. My friend searched for microRNAs and her virus of interest. The search engine (can I even call it an engine? It’s more like a tricycle) came up with papers dating back to 1997. I am pretty sure no one knew about microRNAs in 1997. Yet another friend was only able to find publications about his compound of choice after empirically defining one of its functions in the cell… which is when he found out this information had been available all along. He couldn’t pull up the relevant papers without searching specifically for the compound and that one effect on the cell.

While the issues here may stem from limitations of PubMed they may also reflect a misunderstanding of search strategies.

She asks, for example:

How does it even work? Does it search only the abstract? Does it also search the body of the papers that are available online?

Those answers are readily available and there are two ways to know. You can tell PubMed exactly how to do the search through the use of Boolean operators and PubMed field tags or you can type in a simple free text search word or phrase and let PubMed decide the strategy. In the former case you know what PubMed did because you told it what to do. In the latter case you can find out by clicking the details tab on the results page to see the strategy. The information displayed there is extremely useful because it suggests ways to refine your search for better results.

The details display also reveals some of the hazards of simple free text searching. Here’s what PubMed did, for example, when I simply typed “diabetes” (click image to zoom):

It retrieved results for both diabetes mellitus and diabetes insipidus. Chances are I’d be looking for one or the other, not both. It also tells me it searched text words through the title and abstract in addition to applicable subject headings (MESH terms).

Sound complicated? You can always get help from your medical librarian but you don’t have to. You can learn to do it yourself. After some initial effort (take the tutorial) and a little practice it’s not that hard. If you can blog you can do PubMed. If you can navigate an electronic medical record you can do PubMed.

That said, I have little experience using PubMed for basic topics in molecular biology and the like, where its performance may not be as suitable as in clinical medicine.

Via White Coat Notes and Kevin M.D.

Antibiotics no good for sinusitis?

That’s what recent evidence suggests and it’s in keeping with all the latest buzz. Well, a jury didn’t buy it and it cost the docs $3 million bucks. (The fact that they didn’t follow their own procedures for supervising midlevels didn’t help).

Via Kevin.

ECG manifestations of pulmonary embolism

Lacking sensitivity and specificity, the ECG can not be the sole modality to diagnose or exclude pulmonary embolism. It can provide clues, however, which point to the diagnosis, as well as information on the physiologic state of the right ventricle. The topic is reviewed here in the American Journal of Emergency Medicine.

More on the triple rule out CT scan for evaluation of chest pain

New technology is promising but technical obstacles are substantial.

American Medical Student Association teams up with naturopathic medicine

Thanks to a link from one of Panda Bear’s commenters I found the naturopathic medicine page of AMSA’s web site, where we learn that the president of the American Association of Naturopathic Physicians recently spoke at AMSA’s national meeting. And take a look at the reading list and some of the links. Unbelievable.

Dr. Anonymous returns

As many of you know, Dr. Anonymous recently put his blog on hiatus. Well, he’s back blogging now, expansive and upbeat as ever. Concerning his radio show, due to return March 27, he gives us this tease:

Boy, will I have lots to talk about. So much so, that I'm not even scheduling a guest. It will be me talking about stuff and you calling in and telling me what's been happening with you. First of all, I'll kind of talk about what happened for me to take the blog break in the first place.

That should be interesting. Anyway, glad you’re back, Dr. A.

AMSA exposed

Panda Bear on AMSA’s promotion of complementary and alternative medicine.

Via Kevin M.D.

Don’t neglect lead aVR

Often relegated to the status of placeholder in the electrocardiogram, aVR may contain the critical data for the diagnosis of a number of conditions. A review in the American Journal of Emergency Medicine highlights pericarditis, left main coronary obstruction, orthodromic tachycardia and acute tricyclic antidepressant poisoning.

Additional references:

ST elevation in aVR as a sign of left main coronary artery obstruction.

Review of electrocardiographic clues obtainable from aVR (JACC).


Classic paper on the electrocardiographic changes of pericarditis.

The electrocardiogram in non cardiac conditions.

EBM in the ER

Can EBM be practiced in the real world? Investigators put this question to the test in the most difficult environment imaginable---the ER. Time pressed and constantly interrupted, ER physicians searched for the answer to 81% of clinical questions they encountered and were successful 87% of the time. Impressive indeed!

The 64 slice CT and the triple rule out for chest pain: ready for prime time?

Find out here in a review published in the American Journal of Emergency Medicine.

Orac on AMSA’s CAM leadership training program

As Orac pointed out so well, it’s about advocacy and promotion, not critical analysis. The American Medical Student Association (AMSA) is grooming the next generation of academic leaders to take medical school woo to a whole new level.

Orac also noticed AMSA’s double standard for scientific claims, something I’ve hammered at many times in reference to their PharmFree campaign:

This is, of course, ironic given the way that AMSA makes such a big deal of mentioning evidence-based approaches when it comes to dealing with the claims of big pharma while strongly promoting non-evidence-based approaches.

To say the least it leaves a credibility gap.

Should quality and safety measures be held to evidence based standards?

From time to time I and a few other bloggers have criticized the quality and safety enthusiasts for pushing measures that are not supported by evidence. Some instances involve truly evidence based therapies not shown to be effective when promulgated as ill conceived “core measures.” Most of the debates swirling around the field have appealed to evidence. At least until now.

In the latest issue of JAMA Donald M. Berwick, a leader at the Institute for Healthcare Improvement, writes that the prevailing standards of clinical evidence are too rigid for the evaluation of safety and quality practices. He cites what he believes to be the inadequacy of the randomized controlled trial and “injudicious assaults on bias.”

Although Berwick’s language is oblique to me he seems to be calling for less scientifically rigorous ways of evaluating quality and safety measures. Bob Wachter blogged about this last Saturday and described Berwick’s position more plainly:

He argues that traditional rules of evidence-based medicine should be suspended or relaxed when it comes to safety and quality practices, since the risks and costs of the practices are generally low (at least compared with drugs or devices), rigorous studies are difficult to do (since they deal with such complex settings), and the “evidence” from experience and theory is often sufficiently compelling to merit adoption.

Wow. It kind of reminds me of Andrew Weil arguing for a relaxed evidentiary standard for complementary and alternative medicine. Now don’t get me wrong. I’m not a stickler for evidence when it comes to simple common sense safety practices. I don’t need a systematic review to tell me I should wash my hands between patient encounters. But I do demand evidence when the measure in question is expensive (such as the IHI promoted universal screening measure for MRSA, debunked in the same JAMA issue) or mandated as a core quality measure without due regard for potential adverse consequences (four hour antibiotic rule, intensive glycemic control, the fifth vital sign---I could go on). I’m also concerned that our non-evidence based zeal for a zero defect health care environment unrealistically inflates public perceptions which could drive intrusive legislation and law suits. Wachter said it well:

On the other hand, in our zeal to “do something,” vigorously promoting or mandating practices with weak evidence risks squandering scarce resources, diverts us from better strategies, and subjects the safety field to the whims of opinions and biases. Berwick worries that our EBM pushback gives intellectual ammo to the dark forces of status quo. This is a reasonable concern. But given the public interest in quality and patient safety, I worry more that the distance between “this seems like a good idea” to “let’s include it as part of a campaign” to “let’s make it a new Joint Commission standard” to “let’s make it a state law” is perilously short. Accordingly, we should require awfully strong evidence that we’re doing the correct thing as we traverse that path, particularly when practices are complex and expensive.

Psychoanalyzing medical bloggers on NPR’s Morning Edition

The program featured Kevin MD, and Robert Wachter along with psychiatrist and psychoanalyst Deborah Peel. Dr. Peel thinks it’s inappropriate for medical bloggers to vent their frustrations on line. Here’s what Wachter had to say about her comments:

…personally I thought the psychiatrist went a bit overboard when she said,

"If you are unhappy with the people that you're supposed to be serving and taking care of, you probably need therapy," she says. "You don't need to be venting your frustrations in a public manner like that. That's very inappropriate and unprofessional."

Re-read my last post on resuscitating 90-year-olds with metastatic cancer and dementia. Do I need a head shrinker?

No Bob, you don’t, but maybe Dr. Peel needs to work a few shifts in an ER or spend a few sleep deprived call nights on a busy medicine service.

High profile HIPAA violations at UCLA

It seems some unauthorized users were poking around in Britney Spears’ records.

More evidence in favor of “the new CPR”

Arizona investigators have been telling us for years that the CPR guidelines fall short. The latest evidence is found in this week's issue of JAMA. You read it first here.

John Ritter malpractice case decided in favor of defendant doctors

Read the Associated Press report here.

One of the defense attorneys, speaking on behalf of the two doctors, said "They were the only doctors with the courage to stand up and come to court in a celebrity case."

From what I have been able to glean from all the reports, no malpractice was committed at any level. Nevertheless other parties previously settled for $14 million.

Video from KNBC is here. “They were asking for an amount of money that no doctor anywhere in the United States unless his last name was Trump could afford to pay.”

The hospitalist movement and what it means to PCPs

Medical Economics discusses the state of the movement from the viewpoint of the primary physician.

Cochrane collection podcasts

---are now on line.

Via Clinical Cases and Images blog.

Don’t miss Wellens syndrome

Wellens syndrome is a distinct electrocardiographic entity. It is highly predictive of proximal LAD stenosis and progression to myocardial infarction despite apparent response to medical management. The initial electrocardiographic manifestations may be subtle, presenting as biphasic T waves or a small “dimple” in the terminal portion of the T wave.

Abdominal involvement in giant cell arteritis

Reviewed in Medicine.

Fluid balance in ARDS/ALI

Findings presented at the Society of Critical Care Medicine 37th Critical Care Congress reinforced what we have already learned from the Fluid and Catheter Treatment Trial. Negative fluid balance was associated with better outcomes.

Via Medscape.

Thrombocytopenia in hospitalized patients receiving heparin

---be it low molecular weight or unfractionated heparin, in systemic anticoagulant doses, is common (36.4% of patients in the CATCH registry) and associated with increased mortality despite the fact that heparin induced thrombocytopenia (HIT) was not suspected or proven in the vast majority of patients.

The National Practitioner Data Bank: How does it work?

This is chilling. Via Medical Economics.

Hyperglycemia in acute coronary syndrome: the AHA statement

A just released American Heart Association scientific statement on the management of hyperglycemia in patients with ACS is refreshingly circumspect and free of dogma.

Strong pathophysiologic rationale supports aggressive glycemic control in patients with ACS but questions remain about the proper targets and the hazards of hypoglycemia.

The AHA report contains a nice evidence summary and concludes that while hyperglycemia should not be ignored the jury is still out concerning the appropriate glucose target. The report provides some “soft” recommendations with the disclaimer that they are for general reference only and points out that evidence does not support glycemic control as a quality measure during ACS hospitalization.

This is a must read, must bookmark document for physicians practicing hospital medicine.

New Framingham tool for estimating cardiovascular risk

Published in Circulation and discussed in Medscape.

Maybe this will motivate people to exercise

A large VA study found a robust inverse relationship between fitness level and all cause mortality.

More on hospital deaths at night and on weekends

Two studies were recently presented showing increased mortality in stroke when admission takes place at night or on the weekend. One of the investigators commented:

"I think it's a public health issue about why we find this acceptable, that hospitals can provide basically a different business model on the weekends," Dr. Reeves said.

Via Medscape’s coverage of the International Stroke Conference 2008.

Survival of cardiac arrest in relation to time of occurrence was discussed here.

The latest woo from BMJ: acupuncture as an adjuvant for in vitro fertilization

Wallace Sampson, in a recent Science Based Medicine blog post, discusses “how to establish ineffectiveness in presence of conflicting information without submitting every nutty idea to infinite numbers of trials.” That, of course, is the problem with the National Center for Complementary and Alternative Medicine (NCCAM) which so far has spent about a billion dollars on such ideas. Its promotion of nutty ideas is often aided and abetted by the British Medical Journal (BMJ), earning it a place on Quackwatch’s list of nonrecommended periodicals under the category of “Journals, Excellent Except for Too Many Poorly Reasoned Articles on ‘Complementary’ and/or ‘Alternative" Medicine.’”

A systematic review and meta-analysis on acupuncture for in vitro fertilization (IVF) in this week’s BMJ suggests that the journal won’t be delisted any time soon. The review, which purported to demonstrate a favorable effect, included studies comparing acupuncture with sham acupuncture or no adjuvant treatment.

A commentary in the same issue concluded with:

So is this review by Manheimer and colleagues a well conducted review, worthy of consideration when making decisions about IVF? Yes. Is it perfect? No. However, several thousand systematic reviews are published each year in health care, and none of them is likely to be perfect. This one seems as good as many. Unless, of course, you know differently?

Well, yes, we know, or should know, differently. Questions abound. How, for example, can sham acupuncture points be defined when there’s no historic agreement or anatomic basis for the “real” ones? What conclusions would Bayesian analysis reach?

How would such an analysis be done? Sampson in his post suggests quantitative methods, but they are mostly applicable to individual trials. Bayes’ theorem evaluates data in light of prior knowledge and probability. BMJ makes only a nominal gesture at such an analysis:

What is already known on this topic:

In vitro fertilisation is lengthy, expensive, and stressful.

Safe, low cost, adjuvant treatments to improve success rates would benefit patients and reduce costs.


What this study adds:

Current evidence from methodologically sound trials showed an odds ratio of more than 1.6 for clinical pregnancy after in vitro fertilisation with adjuvant acupuncture.

On average, 10 women would need to be treated with acupuncture to bring about one additional clinical pregnancy. The magnitude of this effect depended on the baseline pregnancy rate.

The “analysis” is totally uncritical but is telling in that it implies no prior knowledge on the subject. There’s certainly no rationale on the basis of scientific principles.

I won’t attempt to do all the math, but here’s my semi-quantitative analysis.

P(AIB) = [P(BA) x P(A)] / P(B). P(AIB) (the probability of A given B) is the “bottom line” assessment after taking into account prior knowledge and the new evidence. P(A) is the “prior probability”, or the probability that the effect of acupuncture is true given prior knowledge and scientific plausibility. Since P(A) has to be infinitesimally small and occupies the numerator of the equation, the probability that acupuncture has a real effect on the success of IVF would have to be very small.

Quackery’s Newspeak dictionary

In Orwellian fashion the alties have manipulated the language, creating their own Newspeak of euphemisms for quackery. Kimball Atwood explains.

Online ECG resources

Clinical Cases and Images has updated its collection.

H/T to Kevin MD

Sorting out the causes of severe hypokalemia

Via the American Journal of Emergency Medicine.

The Brugada pattern can be dynamic and its significance is not always clear

Here’s a case report and literature discussion of Brugada pattern during febrile illness. Temperature sensitive genes are postulated.

I’m not ashamed of my CME

The hue and cry against pharmaceutical industry support for CME is growing louder. The latest salvo comes from Merrill Goozner in a post entitled The Shame of CME. (H/T to Kevin MD). Goozner cites a recent JAMA commentary critical of industry funding.

The JAMA piece notes increased commercial support for CME, jumping from $302 million to $1.2 billion between 1998 and 2006. But that’s not the whole story. According to a recent report in Medical Marketing and Media a downward trend began in 2003 along with a similar decline in the portion of educational monies spent on accredited activities, from 75% to 50%. It reflects increasingly onerous compliance standards that must be met for accredited CME funding. As detailed in the report, drug companies now have firewalls in place to help separate educational and marketing activities.

Nevertheless the JAMA opinion writer finds the current state of CME funding “at best very troubling” and Goozner believes states should ban accreditation of industry supported CME if the situation continues.

Why all the fuss? The argument goes something like this: Drug company support for CME is an extension of marketing and promotion. It has to be because the companies wouldn’t do it if it didn’t work. The drug companies influence the content of the CME, rendering it biased and unreliable. The only solution is for industry support to go away.

This popular and well worn argument seems appealing but on close examination is specious. Can drug companies spend large amounts of money on educational material and not influence content? Yes, they can and do. One of the best examples is MerckMedicus, a web site sponsored by Merck & Co., offering doctors free and unlimited access to the full text of dozens of journals and textbooks including Harrison’s, Cecil’s and Ferri’s Clinical Advisor. The site is pristine, with no advertising and no content other than that of the journals and textbooks in their original form. What’s in it for Merck if they don’t advertise on the site or influence its content? Good will, perhaps. Whatever the case, they’ve been offering it for years.

Critics of industry supported CME love to point to the free drug company lunches and evening speakers over dinner at expensive restaurants. I agree that type of activity is of little educational value, but it’s not at issue here because such events are seldom accredited. Those and other questionable sponsored activities may increase, though, if industry is banned from supporting accredited programs. According to the Medical Marketing and Media report cited above the trend may already be in that direction, with non-accredited funding jumping from 25% to 50%.

What about industry support of educational meetings sponsored by reputable professional societies such as the American College of Physicians, the American College of Cardiology and the Society of Hospital Medicine? While most of us believe those courses to be scientifically rigorous, a vocal minority seeks to ban their accreditation as long as they receive industry support. Their innuendo about such activities being only an extension of marketing appeals to public fear but not to evidence, because there isn’t any. Not a shred.

I had to chuckle at Robert Steinbrook’s conclusion in the JAMA piece: “Although eliminating support from pharmaceutical and medical device companies would involve more change than the alternatives, this approach will likely allow the medical profession to control its own continuing education.” Now how does he figure that? Cutting off industry funding would force many CME offerings out of existence and make others much more expensive, thus reducing doctors’ options. How is that supposed to give doctors more control? I don’t think this is what the rank and file of the medical profession want. They remain silent, perhaps because they don’t know what’s at stake. As the Medical Marketing and Media report pointed out, “For continuing education to continue, commercial funding must remain healthy. The future of CME depends on it.”

Do bureaucratic delays in Canada’s prescription drug plan increase mortality after coronary stenting?

Possibly, according to a study recently published in the Canadian Medical Association Journal. The authors attributed it to the red tape patients had to go through to get their Plavix filled following coronary stenting. It’s been known for quite a while that even a minor delay in getting the Plavix filled is associated with worse outcomes.

I’m thankful that here in the U.S. I don’t have to send paperwork to Washington (or Little Rock) when I prescribe Plavix for patients.

When to suspect autoimmune insulin resistance

Autoimmune insulin resistance, also known as type B insulin resistance, is rare compared to the more common forms of insulin resistance related to obesity and acute illness in type 2 diabetes. Patients with type B insulin resistance tend to have other autoimmune diseases and may have insulin requirements of thousands of units daily. A case presentation and review was recently published in Nature Clinical Practice Endocrinology and Metabolism.

Dr. Rob’s handout on antibiotic myths

In general, says Dr. Rob, it is inappropriate to “call in” antibiotics for patients. I agree, although there are a few exceptions. Let’s look at some common patient misperceptions cited by Dr. Rob.

If mucous is green, it is time for antibiotics. Agree. That’s a myth.

When a fever starts, it is time for antibiotics. That’s not necessarily a myth. The best answer is “it depends.” What if the patient has a history of splenectomy or is neutropenic? Should you tell the patient to take two aspirin and call you in the morning? You may not get that call! Of course, calling in antibiotics would not be appropriate. That patient needs to go to the ER, pronto.

Sinus pain means you need antibiotics. Yeah, that’s a myth. The patient doesn’t necessarily need antibiotics, at least initially. He/she may ultimately need them, though.

“The last time I had this I needed antibiotics, so I wanted to catch it early this time.” That appeals to patients’ intuition but isn’t necessarily true.

Bronchitis requires antibiotics. NOT a myth, at least according to recent evidence. Popular dogma has taught that it’s inappropriate to treat bronchitis with antibiotics, then along came this study. It provided robust evidence that, at least in the elderly patient with bronchitis, a “preemptive strike” with antibiotics prevents pneumonia with a NNT of only 39. That’s way, way better than adult pneumococcal vaccine!

“I am immune to amoxicillin.” Whatever that means.

“Can I have antibiotics to be on the safe side?” Again, it depends.

“Can you call in an antibiotic?” Doctors in the middle of a busy day are often maneuvered into doing this. Stop and think first.

“When I got an antibiotic last time, I got better. That means the antibiotic made me better.” The post hoc ergo propter hoc fallacy.

Via Kevin M.D.

Dismissed from a frivolous shotgun malpractice suit

---this doctors troubles weren’t over. Via Medical Economics.

Carisoprodol abuse and withdrawal---a newly emerging problem

Case descriptions and topic review from Pharmacotherapy.

The fifth vital sign is meaningless

Vital signs are supposed to be objective measurements. Read this White Coat Rant.

Via Kevin M.D.

Accredited woo for fourth year med students

In the springtime a medical student’s fancy turns to thoughts of woo. It’s almost time again for the AMSA sponsored University of Florida accredited Humanistic Elective in alternative medicine, Activism and Reflective Transformation (HEART).

If last year’s program is any indication students can look forward to sessions on shamanism, Tai-chi, dosha testing, Ayurveda and more.

Anticonvulsant hypersensitivity syndrome

Anticonvulsant hypersensitivity syndrome (AHS) was recently reviewed in Pharmacotherapy (free full text via Medscape).

Key points:

AHS belongs on the clinician’s list of dermatologic emergencies.

Phenytoin, carbamazepine, and Phenobarbital lead the list of causative agents

Not only many clinicians, but also computerized pharmacy databases, are unaware of potential cross sensitivity among several anticonvulsants.

Valproic acid, benzodiazepines and other nonaromatic anticonvulsants should be safe. (Rare reports of valproic acid related AHS do exist).

Look for a triad of fever, rash and internal organ involvement (usually in the form of liver function abnormalities). Fever and rash are universal.

AHS may overlap with Stevens-Johnson syndrome of toxic epidermal necrolysis although the rash of AHS can take other forms.

The pathogenesis is complex and, among other mechanisms, involves reactivation of latent viruses (HHV 5,6,7) in the more severe cases.

Treatment consists of removal of the offending drug, general supportive care and, in many cases, corticosteroids.

Painless aortic dissection: an uncommon manifestation of an uncommon disease

Internist Lisa Sanders, M.D., writing for the New York Times Magazine, recently presented an uncommon presentation of an uncommon disease: painless aortic dissection. Actually the patient, later in his brief ER course, did develop ischemic leg pain but for practical purposes the dissection can be considered painless given the absence of typical chest and back pain. In the International Registry of Acute Aortic Dissection such atypical presentations were uncommon (6.4%) and were associated with increased mortality.

DB’s Med Rants linked to the article and attributed the successful outcome to the doctor’s avoidance of premature closure, a frequent cognitive error in diagnosis. (The doctors, apparently, were tempted to start immediate heparin to treat the patient’s ischemic limb). I’m not sure how often that particular error would be made in the real world. Before starting anticoagulation (which could delay the safe performance of limb saving invasive procedures) most clinicians, it would seem to me, would first want some type of vascular imaging study such as CTA or MRA to define anatomy and explore options for urgent limb salvage. Such a study would have likely diagnosed the dissection even if aortic dissection hadn’t been initially suspected.

A situation more likely to lead to premature closure is aortic dissection presenting with chest pain. It’s especially true with today’s convenient substitutes for thought, those handy templates and order sets in which anticoagulants are embedded in the chest pain protocols.

I have a couple of quibbles with the article. Immediately following the onset of symptoms the patient was taken to the ER via ambulance where a CT was performed within moments of arrival:

A few minutes later the patient-doctor was whisked out of the E.R. to get a CT scan of his head. If this was a stroke, there was a good chance it would show up.

That’s likely to drive already inflated public expectations of CT scans and other fancy imaging techniques. Given that the CT was performed very early following symptom onset it’s unlikely the scan would have shown a stroke unless it happened to be a hemorrhagic stroke.

The article, unfortunately, concludes with this:

An aortic dissection is one of the classic difficult diagnoses in medicine. Far too often it’s not even considered. Or as in the case of John Ritter, who died of a dissection in 2003, it is considered but too late. (That case is now being litigated in a Glendale, Calif., courtroom, with Ritter’s family charging wrongful death.)

Ritter’s doctors won’t be happy with that statement, I’d wager. While this story may contain lessons about premature closure we have no reason to believe his doctors made that error. How do we know Ritter’s doctors considered dissection “too late?” Equally likely, that possibility went through their minds immediately upon Ritter’s presentation, was considered in the brief time available, and rejected when symptoms, risk factors and initial diagnostic tests pointed to acute coronary syndrome as more likely than aortic dissection. Occasional wrong diagnosis is inevitable even with pristine care and does not equal error.

Dismantling evidence based medicine

I’m finding it harder and harder to defend evidence based medicine (EBM) these days. My usual defense is to explain away all the things that are wrong as distortions of EBM rather than EBM itself. And while this defense seems valid, the term EBM has become so synonymous with those distortions that maybe we need a new name. How about Science Based Medicine in recognition of the new blog of the same name? In this post I will present a roundup of blog entries and articles which express important concerns about EBM as it is promoted today.

EBM as originally conceived was a sound notion. What the EBM movement has become is problematic. Sackett and colleagues defined EBM in a classic editorial years ago:

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.

There’s nothing wrong with that basic idea. The key word is judicious. But somewhere in the history of the movement the boosters issued some injudicious rules about how doctors should use evidence. The result was a devaluation of basic science, prior knowledge and pathophysiologic rationale. Plausibility was out the window. Preposterous claims were legitimized as questions for “research.” When chance variation conspired with publication bias, biased Medline indexing and conflicts of interest numerous forms of quackery (often euphemistically termed “complementary and alternative medicine” or CAM) appeared validated. While the evidence was weak it was enough to stimulate the infusion of millions of tax dollars into dubious research. Although unanticipated by EBM’s founders the movement helped fuel a “CAMbrian explosion.”

I began to realize this early in my blogging career when I wondered why we should even bother with research on homeopathy. I later elaborated on the importance of plausibility in a post citing Steve Barrett’s blistering attack on the Institute of Medicine’s pro-CAM report and Wallace Sampson’s classic paper documenting the promotion and advocacy of quackery in American medical schools. Sampson recognized early on the inability of EBM (or what EBM had become) to critically assess the claims of quackery and said in his paper:

With inadequate approaches that fail to uphold criteria for validity and plausibility, so called ‘evidence-based’ medicine remains fluid and loses its value to help physicians discern what is truly useful.

Several years later, in a paper published in The Medical Journal of Australia, Sampson and coauthor Kimball Atwood IV said this about EBM’s inability to evaluate quacky health claims (emphasis mine):

Evidence-based medicine (EBM), relying on results of randomised trials, should be a bulwark against the Absurd. However, the heterogeneity of clinical trial methods and designs, differing population bases, and varying endpoints often result in heterogeneity of outcomes. This has precluded systematic reviews of CAM methods from defining a line of inefficacy. EBM also does not include plausibility or consistency with basic science in its methods and reviews, leaving each to physician and patient interpretation. Moreover, there are no solid criteria for evaluating the quality of trials and reviews, especially for detecting erroneous, manipulated, and faked data. Thus, most CAM systems remain in an indeterminate limbo state, awaiting enough negative clinical trials to return consensus opinion to the state of decades prior.

In a recent Medscape Roundtable Discussion, while defending the core notions of EBM I criticized its de-emphasis on basic science and noted some of its other failings.

More recently, in a series of three posts, (the first two of which I discussed here) Atwood provided a more formal and quantitative discussion of the failings of EBM by using Bayesian analysis (warning---not light reading).

On Friday Retired Doc posted an insightful discussion on the consequences of EBM’s dogmatic evidence hierarchy. He quoted this paper by M.R. Tonelli which made the point that EBM has wrongly defined pathophysiologic rationale as “evidence”, then relegated it to the bottom of the hierarchy. That makes it possible for implausible CAM claims to be “validated” when, with the help of chance variation and publication bias, they happen to squeak by and pass the evidentiary test. The evidence, no matter how weak, always trumps basic science rationale even when the claim is clearly (or should be) refuted by the latter.

Medicare payment and hospital “mistakes”

Ever since my initial rant about the new Medicare policy I’ve waited for Bob Wachter’s take. Wachter is an expert on safety and quality and does his share of preaching about it. Yet, he approaches the subject with a degree of skepticism and humor I find refreshing. You can tell he’s not far from the trenches of day to day patient care.

He finally weighed in with a post on February 11 along with a link to this article he coauthored in The Joint Commission Journal on Quality and Patient Safety. His conclusion was more optimistic than mine despite the fact that he cited virtually all the negatives I did.

Wachter noted four conditions to be met for the policy to be reasonable:

Evidence demonstrates that the adverse events in question can largely be prevented by widespread adoption of achievable practices.

The events can be measured accurately, in a way that is auditable.

The events resulted in clinically significant patient harm.

It is possible, through chart review, to differentiate adverse events that began in the hospital from those that were “present on admission” (POA).

Clearly the policy as written fails to meet condition number one, particularly for decubitus ulcers and patient falls (which Wachter believes should be off the list). Condition number four is problematic. The POA provision will result in system gaming. (Take it for granted that creative hospital charting will rise to a new level).

In his article, Wachter suggests that the policy creates a business case for patient safety. But that implies hospitals didn’t have a business incentive already. A recent paper in JAMA went so far as to say hospitals are currently incentivized to allow adverse events by means of coding modifiers that provide increased DRG payments for complications. I posted a strong disagreement with that thinking and gave the example of hospital acquired sepsis:

So they’re saying, in effect, that hospitals have been incentivized to allow patients to experience complications! But that’s based on the dubious assumption that the increase in DRG reimbursement exceeds the added cost of caring for patients who have experienced complications in the hospital. The example given assumes that an extra $3468.77 would more than pay for an episode of sepsis. But what if the patient’s sepsis requires 10 days of big gun antibiotics, the use of activated protein C, consumes the resources of an early goal directed therapy team and requires 5 days in the ICU? Hospital resource managers know better and, ever since the advent of DRGs in 1984, have considered such events to be costly.

And how strong is the business case, really, for prevention efforts? How, for example, and at what expense, can hospitals make patient fall injury a “never event”? Given today’s anti-restraint culture and the recent banning of Vail beds hospitals’ only recourse (unless they want to adopt Happy Hospitalist’s mandatory helmet policy) is to hire a full time sitters for all hospitalized elderly patients. From a purely business point of view (not the point of view I would advocate) hospitals might be better off doing nothing.

Wachter concludes his article with this statement:

In light of all of this uncertainty and risk, “not paying for errors” should be viewed as a bold experiment and its initial implementation a pilot study, whose consequences should be carefully monitored.

That implies that when the unintended consequences surface Medicare will take steps to mitigate them and if the experiment is a failure Medicare will dismantle it. Somehow I’m not comforted. In the 63 year history of this grand experiment’s unintended consequences and abuses, what’s been the track record?

DB weighs in here.

Kevin’s take on Pete Stark

This needs no elaboration:

Mr. Stark's profound ignorance of medical issues is stunning and dangerous. It is frightening that a politician of his stature is so openly biased and antagonistic against physicians.

Wish I’d said it.

Quackademic medicine

---is proliferating faster than Orac can update his on line hall of shame, the Academic Woo Aggregator. His February 18 post notes some observations by David Colquhoun, author of DC’s Improbable Science, on just how rampant quackery promotion is in U.S. academic medical institutions. Both posts make for compelling reading.

Medicare and “never events”

My rantings against Medicare’s impending no pay for adverse events policy have been largely theoretical. Happy Hospitalist gives us an example of just how unfair the policy really is. Via Kevin.

Performance enhancing drugs for docs?

When I glanced at the title and abstract of this JAMA study the other day I decided to skip the rest of the article. It looked pretty ho-hum. Investigators found that survival from in hospital cardiac arrest was lower at night and on week ends. Well, duh. But after reading this post from Dr. Wes about the article I thought I’d give it a closer look. At the end of the discussion section the authors suggest the use of performance enhancing drugs for night shift workers: Chronobiologic scheduling, naps, or use of medications such as modafinil may also improve nighttime staff performance. Modafinil, in case you don’t know, is Provigil, a wakefulness promoting drug used in patients with narcolepsy and sleepiness associated with sleep apnea. Before you decide this suggestion is completely off the wall, note that Provigil is approved for shift work sleep disorder (ICD-9 307.45).

Another interesting tidbit, from the paper’s introduction, is the authors’ suggestion that the night and weekend deaths are a result of “medical error.” I can see the next Medicare initiative coming: DRG payment penalties for unexpected night and weekend deaths.

ARDS and ALI: Is recruitment PEEP better than conventional PEEP?

A few years ago an ARDS network study said no for mortality and ventilator free days. Two recent studies published in JAMA revisited the question. In neither study was there a difference in mortality. One study attributed a reduction in refractory hypoxemia to the high peep strategy and the other one demonstrated that the high peep strategy was associated with more ventilator free days and organ failure free days.

Two related editorials were published in the same issue. The one by Gattinoni and Caironi was favorable to the high PEEP strategy for patients with more severe hypoxemia. The other one by Chiche and Angus was more reserved, citing the difficulties in interpreting studies of complex interventions, and suggesting that high PEEP strategies may ultimately emerge in clinical practice.

Taken together, what do these studies mean for real world practice? In neither study did there appear to be harm, and effects on secondary endpoints were encouraging, so why not implement the strategy? For the LOV study, at least, the devil may be in the details. Their protocol involved recruitment maneuvers and allowed plateau pressures to rise as high as 40(!), pretty dicey stuff if you’re not an expert. This is the type of thing that will likely perform better in the hands of expert clinical trialists than in the community.

On the other hand, the protocol used by the Express investigators looks much more doable. I look forward to more discussion and expert opinion on this topic to help us synthesize these findings with what we knew before and to help us decide how to incorporate them into real world practice.

Retired Doc offers some perspective here.

Evidence based medicine does not equal science based medicine

That’s right, I said it. I’ve tried really hard over the last several years to learn about, read about and practice EBM. Along the way I’ve noticed something peculiar: evidence based medicine (EBM) has become a powerful enabler of complementary and alternative medicine (CAM). I touched on this briefly in a post in which I pondered the reasons why woo has so successfully corrupted academic medicine:

Finally, and somewhat paradoxically, the rise in unfounded CAM modalities may be an unintended consequence of the EBM movement. EBM advocates devalue scientific rationale and physiologic plausibility.

The problem may be a form of extreme empiricism applied to clinical questions. Empiricism, according to the dictionary, regards direct experience and observation as the only source of knowledge. In medicine, according to the definition, empiricism “disregards scientific theory and relies solely on practical experience.” That is not a core principle of EBM as I understand it, but it is a popular and pervasive distortion.

How many times, for example, have you heard the old saw “there is no alternative medicine; there is only medicine which has been shown to work and medicine which has not been shown to work?” That may be appealing at first glance, but EBM’s obsession with finding out what treatments “work”, with total disregard for biologic plausibility and prior knowledge, has spawned an explosion of dubious “clinical studies” on all sorts of woo, from acupuncture to those wooiest forms of woo such as homeopathy and Reiki. Seldom is anything solved by such studies. No claims are ever proven, nor are they totally dismissed. The lingering doubt perpetually fuels more inconclusive “research.” The track record of the National Center for Complementary and Alternative Medicine speaks for itself in this regard.

I examined some of the failings of EBM in a post last year. Methodologic flaws in CAM research, chance variation combined with positive publication bias and biased Medline indexing are just a few of the reasons. But I’m afraid I didn’t make these points nearly as well as Kimball Atwood recently did in two wonderful posts in the Science Based Medicine blog.

He points out that treatments must pass not only the evidentiary test but also the test of scientific plausibility. Because EBM devalues the latter it is inadequate for the evaluation of implausible claims even though it may perform well in evaluating plausible ones. This fundamental error is built into EBM’s system of analysis as illustrated by its evidence hierarchy, which places physiologic rationale and scientific principles at the bottom of the heap. Atwood illustrates the consequences of such faulty analysis in the first of his two posts:

Thus a “positive” clinical trial is given more weight than “physiology, bench research or ‘first principles’,” even when the latter definitively refute the claim.

Using the example of homeopathy, the focus of the first of his two posts, Atwood goes through a long list of fundamental scientific principles in opposition to the claims of homeopathy and then asks:

Is it realistic to assume that this “level” of evidence, when brought to bear on a claim that has no explanatory power in nature, can be overthrown by ambiguous clinical trials of dubious design? EBM tacitly makes that assumption.

In the second post Atwood gives the issue a more quantitative treatment by contrasting EBM’s use of popular frequentist statistics with Bayesian statistical analysis which seeks to determine how new evidence modifies prior knowledge (such as basic science principles, physiologic rationale, etc.). Most of us are familiar with the use of Bayesian analysis in evaluating laboratory test results in individual patients because it is widely advocated and taught as a tool for diagnosis. Although equally valid (and superior in many ways to the popular frequentist approach) for analysis of clinical trial data for evaluation of treatments, it is not a tool of EBM.

Atwood issues a plea for incorporation of Bayesian thinking in the evaluation of clinical claims because it takes into account scientific plausibility. According to Bayes’ theorem, whether you’re evaluating the probability of disease in a patient or the probability that a health claim is true the prior probability, P(A), based on what was known before, occupies the numerator of the equation. Thus if P(A) is zero no amount of observational data could establish the hypothesis as true. If P(A) is infinitesimally small nothing short of overwhelming experimental evidence could establish the hypothesis as true.

Homeopathy, Reiki and Therapeutic Touch immediately come to mind. Bayesian analysis of claims such as these is a formal and quantitative method of establishing what common sense has always told us concerning those occasional weakly positive, methodologically questionable studies of implausible claims. They’re what I call evidence based woo. Consider the miniscule value of P(A) in Bayes’ theorem for such claims as the woo factor, a factor which evidence based medicine leaves out of its analysis.

We need a balanced view. EBM proponents are correct in saying that pathophysiologic rationale alone is not sufficient. (They’re fond of trotting out the CAST study to make that point). But they are wrong to ignore and devalue such knowledge. In order to evaluate the claims of CAM we need clinical evidence taken in the light of fundamental biologic principles.

More on the Surviving Sepsis Guidelines 2004-2008

Last Tuesday I began a review of the changes in the Surviving Sepsis Guidelines (SSG) as reflected in the 2008 revisions, recently made available in full text via Medscape. In that post I focused on the controversial recommendations concerning activated protein C, noting that the guideline authors had taken into account the best and most current evidence. Their decision to downgrade the recommendation for activated protein C should put to rest concerns about commercial influence corrupting the guidelines.

What else is new and of interest? I’ll present a summary here of other significant changes from 2004, along with points of special interest.

Early goal directed therapy (EGDT)

The recommendation for EGDT remains strong and has not significantly changed from the 2004 guidelines. The authors again emphasize that the protocol should begin immediately upon recognition of hypoperfusion and not be delayed until ICU admission. The assessment of a patient’s candidacy for EGDT, which can be rapidly and simply done in the ER, includes establishing that SIRS is present, infection is clinically suspected, hypotension or lactate elevation is present and that the patient does not have an advanced decision documented which would preclude hemodynamic resuscitation.

Antibiotic selection

The guidelines contain stronger language than in 2004 concerning the importance of a broad spectrum of initial antibiotic therapy and add a discussion of the importance of anti-MRSA coverage. Noteworthy is this new statement:

Patients with severe sepsis or septic shock warrant broad-spectrum therapy until the causative organism and its antibiotic susceptibilities are defined. Restriction of antibiotics as a strategy to reduce the development of antimicrobial resistance or to reduce cost is not an appropriate initial strategy in this patient population.

They go on to stress that antibiotics can be narrowed later after microbiologic date are available.

Choice of vasopressor

Data in recent years from observational studies, including the SOAP study which came out since the 2004 guidelines, have suggested inferior outcomes with dopamine. Nevertheless, the guideline authors recommend norepinephrine and dopamine as equal alternatives for initial pressor therapy, noting that high level direct comparison studies have not been done.

Corticosteroids

The corticosteroid recommendation, as I predicted late last year, was made more restrictive in keeping with evidence from the CORTICUS study. The 2004 recommendations called for “stress doses” of hydrocortisone in patients requiring pressors after fluid resuscitation. The 2008 guidelines restrict the use of steroids to patients who demonstrate refractoriness to pressor therapy. The guidelines do not recommend cortrosyn stimulation testing to diagnose critical illness related corticosteroid insufficiency (CIRCI). CIRCI, however, is to be distinguished from classical adrenal insufficiency, which may warrant testing in critically ill patients.

Glycemic control

The 2008 SSGs provide a strong recommendation for glycemic control utilizing an insulin drip protocol. However, the recommendation for a specific target (150 mg/dl) is a weak one, reflecting controversy and uncertainty that has prevailed about the appropriate target since publication of the 2004 guidelines.

This summary of the 2008 SSG recommendations is not comprehensive. The document should be read in the original and maintained for reference.

The John Ritter malpractice trial

---is underway and a spate of news reports offers some glimpses. I may comment and link from some of them later. For now I’ll just present excerpts from one of my commenters on an earlier post. It speaks well to the issue and requires little elaboration:

What we do know from the AP, is that the Defense attorneys will provide evidence that Ritter had failed an insurance exam 3 years prior to the incident for "incredibly abnormal" blood levels. Triglycerides were 7 times normal. He had evidence of plaque build-up. He was advised to see a cardiologist. He never did.For three years, Ritter repeatedly missed follow-up visits, did not get a cardiologist, worked long hours on the set and was decidedly overweight. When he became ill, he went to the ER.

Av overweight appearance would be deceptive in that it is not the body habitus one would typically see in patients at risk for dissection.

The commenter goes on:

In court yesterday, according to ABC news, the plaintiff's Cardiac Surgeon
(supposed unbiased expert)………

Upon cross examination, things became heated when it was revealed that the Expert had a conflict of interest. In fact, Ritter's wife, Amy Yasbeck, had spent time speaking at the Expert's symposium recently.The Cardiologist's Defense Attorney also quoted from this Expert's OWN book that stated, finding an aortic dissection was like looking for a "needle in a haystack" and that (essentially) in malpractice situations, physicians should be given the benefit of the doubt because they are so difficult to find and so easily mistaken for a heart attack.

Read the rest.

To the attorneys who commented with “measured responses” urging us to temper judgment, I would ask at what point you say “enough’s enough.” Is there any amount of damages that should trigger outrage?

Maharishi Mahesh Yogi passed away Tuesday

Maharishi Mahesh Yogi, developer and promoter of Transcendental Meditation (TM), died February 5, 2008. TM is a topic of interest to me for two reasons. Caught up in the Beatles generation when it was all the rage, I was fascinated by its claims. I have since come to believe that it is the best example (one of many) of Eastern religion cloaked in pseudoscientific and self-help jargon and repackaged for Western consumption (Yoga, anyone?).

To further sanitize it in order to introduce it into the public schools it was, for a time, renamed “The Science of Creative Intelligence.” However, its claims that it required no religious accommodation did not stand up to close scrutiny. It failed an establishment clause challenge in 1977 and the New Jersey public schools were enjoined from teaching it.

Interesting acid-base case posted at Medrants

DB posted a case from morning report and put me on the spot with a challenge! I posted my best guess in his comments.