Monday, June 30, 2008

Screening for hepatocellular carcinoma

According to this paper we’re not doing a very good job, despite the fact that it may provide the only opportunity for timely liver transplantation. Because many at risk patients are not established with gastroenterologists, the responsibility for screening may often rest with primary care physicians. Editorial comment here.

Acute coronary syndrome guideline review

The American Heart Association (AHA) and the American College of Cardiology (ACC) have improved their guideline development process by writing complete guideline revisions and focused updates at more frequent intervals. The acute coronary syndrome updates (STEMI, UA/NSTEMI and PCI) are featured in this Medscape CME offering.

Changes from earlier guidelines and points of interest:

For STEMI patients an electrocardiographic definition of failed thrombolysis (an indication for rescue PCI) has replaced the angiographic definition. (IIa).

Fibrinolytic therapy should be followed by systemic anticoagulation for at least 48 hours or the duration of hospitalization, up to 8 days. Due to the risk of HIT an anticoagulant other than UFH (i.e LMWH or fondaparinux) should be used if anticoagulation persists beyond 48 hours. (I).

Clopidogrel (Plavix) is added to ASA in virtually all patients. Minimum duration of treatment (14 days to 1 year) depends on type of ACS and other management strategies. For patients receiving drug eluting stents (DES) it’s 1 year or longer. For all other NSTEMI patients (bare metal stented and unstented) the duration is 1 month or longer. For unstented STEMI patients the minimum duration is 14 days. All clopidogrel recommendations are class I.

If warfarin is indicated (e.g., atrial fibrillation) in patients on dual antiplatelet therapy the appropriate INR target is 2-2.5. (IIa).

Before implanting a DES the cardiologist should discuss the duration of antiplatelet therapy with the patient and confirm ability to comply. (Can the patient afford Plavix for a year?). (I).

If surgery is anticipated in the next year consider avoiding a DES. (I).

Polypharmacy works. The more secondary prevention drugs the patient is on, the lower the one year mortality.

Was this activity commercially biased? Discussion of the sponsor’s products, Lovenox and Plavix, did not depart from best evidence and was not preferential to evidence based alternatives. The information presented was accurate and, over all, it was a useful exercise.

I do have a minor quibble regarding transparency. I wish the presenters had made it clearer that this was not to be considered a comprehensive overview of the guidelines. The coverage of drug therapy was slanted towards antithrombotic therapy. There was some mention of beta blockers and ACE inhibitors but no mention of statins. As with any other CME presentation, the remedy for this type of problem is additional study of primary sources. The original guidelines can be accessed here.

Saturday, June 28, 2008

Stacking the deck

Concerning my post about Rivaroxaban, Retired Doc said:

Good point about the dose of enoxaparin.I need to say more about that having made points about stacking the deck in randomized trials. Is that what we have here?

Both trials were sponsored by Bayer, which will participate and benefit from the marketing of the product. So, this may be a case of stacking the deck. It's a variant of the straw man fallacy in which the drug is tested against a "claim" that no one in the real world would make for the comparison drug. This has been seen in many other sponsored trials.

There's a larger point: I didn't look at the disclosures until I read the comment. I identified the flaw in these trials without knowledge of the funding source. I make it a practice to do this---to examine a paper critically before looking at disclosures. It’s a useful exercise in that it encourages critical examination of studies on their own scientific merits.

If authors are open in reporting their methods one can spot flaws without knowledge of financial conflicts. Disclosures create a type of bias on the part of readers. There was a time when scientific papers were evaluated primarily on their own merits. Some industry sponsored papers are scientifically rigorous, some are not. Some nonsponsored papers are rigorous and some are not. Is today's inquisition about conflicts of interest promoting intellectual laziness?

Friday, June 27, 2008

An oral anticoagulant in the pipeline


Rivaroxaban (Xarelto), an oral direct factor Xa inhibitor, was superior to enoxaparin (Lovenox) for VTE prophylaxis in patients undergoing hip and knee arthroplasty according to two NEJM reports this week.

These studies leave questions. First, the investigators may merely have defeated the following straw man: Lovenox is the best agent for VTE prevention when used at less than the recommended dose. That’s right, the lovenox dose for the comparison groups (40 mg daily) was below that which is recommended in the product labeling (30 mg Q 12 hours) for these indications.

The bigger question on every one’s mind is whether it will replace warfarin, with the promise of reduced laboratory monitoring. That answer awaits studies on patients with atrial fibrillation and established VTE, early in the game at present. Don’t expect warfarin to disappear from the planet anytime soon.

Other blog reactions:

Clinical Cases and Images

Retired Doc
Image source: Wikipedia

Joint Commission’s 2009 patient safety goals

---have just been rolled out (H/T to Wachter’s World). Here’s my take on a few of the hospital goals. (I’m not sure which ones are changed from 2008 but these are some I found interesting).

Redundancy: For identifying the correct patient and the correct surgical site. Bar coding is part of this redundancy. It doesn’t replace people.

Infection control: Lots of organizational structure and documentation requirements found here. Expect more paper shuffling and longer committee reports. Buried somewhere in all this verbiage are the actual best practice recommendations for prevention of central line and surgical infections. Facility associated infections that result in unexpected death or permanent loss of function are to be handled as sentinel events.

Medication reconciliation: At discharge the medication instructions must be both written and verbal (you can’t just hand the patient a piece of paper!). What about in the ER? Say the patient comes in with a laceration. Do you have to do complete med rec? No. It’s not required provided the patient is cognitively intact, not admitted and no changes are made in long term medications. If the patient has changes made in long term medication, is admitted, or is confused a complete medication reconciliation process, to include documentation of name, dose and route, is required.

Fall prevention: I was underwhelmed by this section. More paper work, committee reports and raised awareness won’t do it. They’ve taken away restraints and Vail beds. If you want to make patient falls a never event, hire a sitter for every elderly patient. (What hospital can afford that?). Otherwise they’re gonna fall.

Thursday, June 26, 2008

Infection control, patient safety and a culture of blame

Health care facility related infections have a history of being measured. Recently, certain ones have been shown to be largely preventable. Ergo, when an event occurs it’s an “error” and somebody’s to blame. Therein lie unintended consequences. Those consequences will be magnified come October when Medicare’s no pay policy kicks in.

Bob Wachter recently blogged about infection control’s increasing importance in patient safety. He noted:

Branding a healthcare-associated infection a “preventable adverse event” meant that failure to adhere to the practices that could decrease the rates of these events could be deemed “medical errors.” Ergo, the failure by a healthcare provider to clean his or her hands wasn’t simply an annoyance to infection control professionals… it was A MEDICAL ERROR!

There is a distinction between defining a process breach (failure of hand washing) and a bad outcome as an error. While it could be reasonably argued that failure to wash one’s hands before patient contact is an error it’s quite another thing to label every catheter related infection or episode of ventilator associated pneumonia as error. Wachter seems to make the distinction but a commenter said this:

Hospital derived infections are often physician errors and to align incentives and protect patients it may be worth considering that the physicians be responsible also financially for their patients' infections this may be draconian but necessary.

With a possible move in the offing to bundle physician fees with hospital DRG payments, it could happen. Why not?

The patient safety movement was supposed to move us away from a punitive culture of blame. That, we were told, would promote the transparency and openness necessary for us to confront the system issues important for patient safety. Ironically, our efforts seem to have had the opposite effect.

We’re under treating MRSA in hospitals

This study from Clinical Infectious Diseases demonstrated failure to prescribe an anti-MRSA agent not only empirically on day one but also after confirmatory cultures came back in a concerning number of patients with MRSA infections. Maybe we’ve been over-indoctrinated by “say no to vanco.”

Via Medscape.

Wednesday, June 25, 2008

Debate continues on the value of the hospitalist model

Two academic leaders in hospital medicine, Dr. Mark Williams and Dr. Robert Centor (our own DB) debated the model in the current issue of Archives of Internal Medicine. Links to the point-counter point exchange can be found in DB’s post on the topic.

In short, Dr. Williams maintains that the model improves outcomes and efficiency, that the evidence is in and the debate is over. DB says “not so fast”, citing mixed evidence and marked variation in the model. As much as I’m excited about the potential for the hospitalist model and as much as I love my hospitalist career (that’s my conflict of interest disclosure) I have to go with DB on this one.

For those who can access the articles in the original, many aspects of hospital medicine were covered. I’ll restrict my comments to Dr. Williams’s claim that the model has been proven to improve efficiency and outcomes. From where I sit the evidence is all over the map. It’s mixed at best. I’ve blogged about it many times, most recently here. The most talked about study last year was this one published in NEJM. The conclusion of that largest ever study on hospitalist outcomes and efficiency was underwhelming. There was no improvement in patient outcomes. Hospitalist care was associated with decreased charges per case in comparison with internists but not family practitioners.

Although a number of smaller studies showed superior efficiency with the hospitalist model the next largest study, and one with superior design, showed no efficiency or outcome benefits. It was a prospective multicenter study presented at SHM 2005 which you can access in this issue of The Hospitalist. The results:

Twelve thousand and onepatients were cared for by hospitalists and 19,890 by non-hospitalists. There were no statistically significant differences in age, race, gender, Charlson Index, or distribution of primary diagnosis be­tween the 2 groups. There were no statistically significant differences in in-hospital mortality, 30-day readmission and emergency room use, 30-day self-reported health status, or patient satisfaction. Mortality data up to 1 year after admission are pending. Average length of stay was 0.05 days shorter for hospitalist patients but this difference was not statistically significant. Costs were also similar between the groups.

We’re still waiting, by the way, for the one year mortality data. What’s important about that study? It’s the fact that, following some early hype in the blogosphere (here, here, here and here) it got buried. It wasn’t mentioned in Dr. Williams’s article. And because it was never published in a Medline indexed journal it was not included in the systematic review cited by Williams and others who promote the model.

This debate will never be settled. There will be few, if any, new studies. With traditional practitioners fleeing hospitals in droves, soon there will be no comparison groups against which to study the model. It’s a moot point. The model is here to stay. We don’t need these metrics to establish our value.

Can we measure the value (or harm) of CME?

In response to one of my posts on the Medscape CME controversy a commenter, Supremacy Claus, said this:

This point is missing from the discussion. CME itself is garbage. It does no harm. It has no demonstrable benefit. Demanding an example of a benefit is as valid as demanding an example of harm. I could not name a specific fact of benefit, just as Carroll cannot name an instance of specific harm. CME is an unfunded mandate imposed by the clinician hater lawyer oppressor running the medical licensing boards. There is no evidence of any benefit to any patient from this massive waste of time and paper shuffling. There is no evidence the academic windbags presenting these programs know anything of value to patients. There is no evidence anyone remembers their trite, narrow, useless technical points 5 minutes after walking out. There is certainly no evidence anyone changes any practice after these programs.

I do believe a physician’s life long learning produces benefits for patients. These benefits, however, are intangible and cannot be measured in any meaningful way. Moreover, it makes little or no difference whether this learning is “logged in” as accredited CME hours. Learning needs and styles vary from one physician to another. That’s why the responsibility for life long learning should lie with the individual physician, not with government bureaucracy, and that’s what the academic windbags, who think one learning formula fits all, don’t get.

I’ve used Up to Date as a point of care look up reference for several years. When Up to Date became a CME provider I was able to log in accredited hours with no extra effort. Was the learning experience suddenly enhanced? No. Did my use of Up to Date change? No. Although I more than satisfy my state’s CME requirement by using Up to Date, for me the most meaningful accredited learning experiences come from meetings such as Bob Wachter’s and Mayo Clinic’s hospital medicine courses, activities which would not exist without industry sponsorship.

The academics are clamoring for metrics to gauge CME’s effects on doctors’ “behavior.” There being no meaningful way to measure such an intangible, the best they’re likely to come up with are perfunctory “core quality measures” used today for pay for performance and public reporting, Unfortunately these measures are crude, sometimes non-evidence based and often have produced unintended consequences that far outweigh their benefits. If applied as measuring sticks for CME they are sure to have a dumbing down effect.

Tuesday, June 24, 2008

Want to ban industry supported CME? Evidence please!

Draconian policy measures have unintended consequences. Proponents of measures against industry supported CME should sustain a burden of proof that such measures would help patients. What is the evidence?

This month the Accreditation Council on Continuing Medical Education (ACCME) released a report of a literature review on this subject. Their conclusion:

We found no studies that directly addressed the question of whether commercial support produces bias in accredited CME activities.

Whether or not the content is biased, do supported activities result in increased prescribing of sponsors’ products? The only two studies that found such an association were based on decades old data reflecting CME activities which predated today’s policies and standards and are not on the table for discussion in today’s debate. And, although there has been limited study regarding the influence on prescribing there are no data concerning the impact on patient outcomes.

Via Policy and Medicine.

Monday, June 23, 2008

CME safe---for now

I’m a little late with this, but the AMA proposal to eliminate industry supported CME went down in flames. Pathobilia cited the arguments leveled against the proposal:

[T]he report ignores the dramatic difference between certified CME and other non-certified 'education' and thus overlooks the significant advances in the management and resolution of conflicts of interest mandated in the last several years by government, industry and the [ACCME].

[T]he report's conclusions are not based on current and scientifically relevant and rigorous evidence in the context of certified CME and do not respect dramatic progress in the past decade.

[T]he report lacks a plausible, detailed plan to ensure that the proposed elimination of $1 billion in certified CME funding would improve the quality of certified CME and patient care.

The long and the short of it? Proponents could not offer a shred of evidence that this draconian measure would benefit doctors or patients. I guess I won’t cancel my AMA membership just yet.

More push for open access

Articles based on NIH funded research will now be required to be available as open access in Pub Med Central.

Via VUMC Reporter.

Diabetic gastroparesis

This condition, reviewed in Hospital Physician, is one of the more frustrating disorders to treat. It can sabotage the best laid plans for diabetes control and treatment response is often unrewarding.

Hospital medicine: A mile wide and an inch deep?

My last post on the hospitalist as a Swiss Army knife drew this comment:

I agree that being a hospitalist is being a Swiss Army knife, but I happen to think these knives are great. I think what you are confusing is being a hospitalist versus being an internist. If we are to argue that hospitalists are a new specialty, which I think they are, then we have to differentiate ourselves from being a hospital-based internist. An internist sees internal medicine problems. A hospitalist manages hospitalized patients, and is a specialist in providing the highest quality care regardless of the diagnosis. An ER doctor specializes in taking care of patients in an emergency setting regardless of
whether it is medical (MI) or surgical (trauma). Likewise, a hospitalist specializes in caring for hospitalized patients. We should not confuse the concept of the hospitalist, which involves improving the care of all hospitalized patients, from the present reality, which is that we are not adequately staffed to do this. These are 2 separate issues.

This comment gets to the heart of some important questions about the hospitalist movement but it makes assumptions about issues that are far from settled. Is hospital medicine a subspecialty of a parent field (such as internal medicine) or, as the commenter suggests, a new specialty altogether? Other new fields in medicine have resolved this question in different ways. Emergency medicine became its own specialty while critical care medicine became a subspecialty of internal medicine. So far the hospitalist work force has been populated mainly by internists, whose training has traditionally focused on hospital medicine. It’s a good fit for them because it provides the best opportunity to practice in the original concept of internal medicine. Internal medicine’s emphasis on in depth care of severely ill patients with complex medical problems also serves hospitals well.

Hospitalists who care for patients outside the domain of internal medicine are aligning themselves with other appropriate specialties. Pediatric hospitalists, for example, according to the American Academy of Pediatrics are simply hospital based pediatricians. For surgical patients there are surgical hospitalists.

The complexity of the hospital today demands a focused and nuanced approach. I hope hospital medicine doesn’t morph into a single specialty to provide care for all inpatients. If it does it will be a mile wide and only an inch deep. That’s not very promising for career satisfaction and, in my opinion, may not be best for patients.

Friday, June 20, 2008

The medical Thought Police target Medscape

In my post Tuesday about the growing assault on industry supported CME I briefly mentioned Daniel Carlat’s attack against Medscape. Characterizing Medscape in general as “nothing more than a CME industry voicebox” he cited a drug company supported activity titled Managing Schizophrenia in a Patient with Alcohol Abuse and Hepatic Impairment. Noting that the CME article was sponsored by the makers of one of the drugs in question (Janssen’s Invega) he pointed out that the information presented was (gasp!) favorable to Invega. After quoting at some length from the article and ranting about Medscape’s corruption Carlat made this interesting observation: “Has Janssen--I mean, Medscape--said anything inaccurate in this puff piece? No.”

What, then, is Dr. Carlat’s issue? It’s promotional (read: positive towards the drug in question) we’re told. Somehow that makes it irrelevant that the information happens to be true. I left me struggling to find a way to see his argument as anything other than an ad hominem attack.

If Carlat’s post was interesting this post at Health Care Renewal by former Duke psychiatry chairman Bernard Carroll was jaw dropping. Full of invective (Medscape’s content is “tacky” and “pedestrian”) and unsubstantiated allegations (“Some items are academic wallpaper, non-promotional pieces designed to create an appearance of commitment to education”), the post offered no examples of inaccurate CME content in Medscape. At the end, though, we got this tease:

We will examine that trope in my next posting, which features the poster boy for compromised KOLs in psychiatry, Charles Nemeroff, MD from Emory University’s
department of psychiatry. In that example, Medscape joins forces with Nemeroff to promote an entirely new level of sleaze. Stay tuned.

The sleaze, we learned in Carroll’s next post, was a Medscape expert interview with Nemeroff. In what reads like an attack piece against Nemeroff Dr. Carroll did cite some objectionable content from the interview. But this whole discussion is about CME. The problem with the example cited is that it’s not a CME offering. It is what it is---an expert interview in which the expert delivers his opinions. It makes no pretense at being anything else.

In the comment thread of his follow up post on Medscape CME Dr. Carlat said:

But regarding your opinion that most of Medscape's content is "editorially uninfluenced by sponsorship," this is an empirical question. I can't accurately scrutinize their CME offerings in say, cardiology or endocrinology, but on casual inpection they are as saturated with industry sponsorship as the psychiatry section. Hopefully, there's a cardiologist and an endocrinologist out there who has the time to put the "biascope" up to those activities as I have done in psychiatry.

If Dr. Carlat will indulge the observations of a non-academic hospitalist I’ll offer my take. First some disclosures. I have no financial ties to the pharmaceutical industry. I have written a few (non industry supported) Roundtable Discussion pieces for Medscape. I have no financial interest (as Dr. Carlat does) in providing industry free CME.

Medscape’s content spans multiple levels of scientific objectivity ranging from video rants and blog type entries to peer reviewed journal articles. Most are not offered as CME. The demarcations between these content areas are clear. I have written many blog posts with links to Medscape CME activities in the areas of cardiology, critical care and hospital medicine. These articles, by and large, are accurate and scientifically rigorous. What qualifies me to make that claim? As my readers know I regularly check the content against primary sources and, in most cases, link to those sources.

Of course I am judging Medscape’s content on its own merits. Where did we get the mindset that educational content must be judged primarily on the basis of who paid for it? If you can’t understand what’s wrong with that thinking I highly recommend Thomas Stossel’s recent commentary or, better yet, KJ Rothman’s important but long forgotten article on The new McCarthyism in science.

Wednesday, June 18, 2008

More on SHM and hospitalist career satisfaction

A senior executive with the Society of Hospital Medicine (SHM) left a comment on one of my posts in which I said SHM needed to make career satisfaction a higher priority. He pointed out that the SHM career satisfaction Task Force has issued a white paper on the subject which can be accessed here. I’m not sure he understood my concerns.

Although the white paper contains helpful suggestions for individual programs it ignores an important megatrend which may now be the major threat to hospitalist career satisfaction. It’s what Bob Wachter cleverly terms life as a Swiss Army knife. It refers to an ever expanding and more nebulous job description which asks hospitalists to perform duties outside the scope of their training and comfort levels. It’s a recipe for burnout.

It may attract short timers, but who wants to sign up for life as a Swiss Army knife as a career? Hospital medicine, in whatever organizational form it takes in the coming years, must address this problem.

Tuesday, June 17, 2008

CME under attack

For a long time I’ve been warning readers (as in this post) about the movement afoot to limit doctors’ CME options. Recently this McCarthyesque purge has developed into a full frontal attack on some of the more popular forms of CME, namely Medscape and professional society meetings that receive industry support.

In recent conversations with several leaders of professional society affiliated CME events I have been told that these meetings barely break even in spite of pharmaceutical industry support. If the present inquisition succeeds many such meetings will cease to exist. (If you think I’m kidding check out the latest discussion thread over at Wachter’s world regarding his popular hospital medicine course. The 2008 meeting may be the last!).

As for Medscape, the leading provider of free online CME, Daniel Carlat thinks it’s corrupt and he’s complaining to the AMA and the ACCME. Meanwhile Medscape Editor-In-Chief Dr. George Lundberg sees this as a siege against CME and intends to continue Medscape’s offerings.

If you believe the CME provided by Medscape and professional society meetings is worthwhile now is the time to let your voice be heard.

(H/T Kevin MD).

More on redefining medical error

With missed diagnosis getting more respect these days a whole new category of adverse events is subject to being redefined as “medical error.” After blogging about this issue last week I ran across an interview with Dr. Robert McNutt, a patient safety expert who believes that missed diagnoses are often wrongly adjudicated as errors:

Dr. McNutt, who focuses much of his work on “diagnostic mistakes,” contends that in many cases where patients have been said to have been harmed by “missed or delayed diagnoses,” physicians have in fact done nothing wrong. Far from being preventable errors, he says, many wrong diagnoses are often nothing more than adverse events. Doctors, he says, should not be held to standards—in this case, regarding diagnostic processes—that either do not exist or are not based on evidence.

McNutt and his colleagues presented a more detailed analysis of the problem of misattribution in an article in Emergency Medicine which was reproduced here on the AHRQ WebM&M site. They believe research efforts toward better diagnosis may be hampered by overcalling diagnostic error.

Monday, June 16, 2008

Hilarious comments found on Rate MDs: June 16, 2008

If you can’t shut ‘em down you may as well laugh. Here’s a sample patient comment buried in the archives:

He claimed that a tooth was the cause of the ear pain. Knowing there was a very bad ear infection (because other doctors said so)I told him, "sure I know the tooth is bad, but that won't cause this infection to not go away". His answer... "I really doubt that you have an ear infection, but if you say so". Then he looked into the ear and said "wow, you really do have an ear infection. I'm really surprised". DUH ya freakin' idiot!

SHM must focus on hospitalist career satisfaction

When Bob Wachter gave Grand Rounds at UT-Houston (you can find his presentation in the archives here) he noted that hospitalists have become “this pluripotential group of physicians who can basically help fix a wide variety of problems and issues as they arise.” In his talk (and elsewhere) Dr. Wachter described the hospitslist’s career as “life as a Swiss Army knife.” He told the audience “This is a terrible job for somebody that wants to know exactly what their job will look like ten years from now.”

Comments such as these, also heard at SMH 2008, raise red flags concerning the future of the movement. As the specialty of hospital medicine matures it should be defining its boundaries. While we can’t know exactly what the field will look like in ten years we do need a job description. These days the description is a little fuzzy. Some vague notion of the hospitalist’s job morphing into a little bit of everything may be fine for doctors seeking temporary employment, but doctors looking for a career need a road map which offers some promise of long term professional satisfaction.

The specialty will be stronger if it can attract career hospitalists, but, as I wrote last week, it will be manned increasingly by transient labor unless leaders provide a stronger vision for career satisfaction. According to an article in the latest issue of Today’s Hospitalist the trend is already underway:

Like a growing number of program directors around the country, Dr. Tsuboi often has little choice but to hire short-timers. But like many colleagues, he wonders if by hiring short-timers, he’s setting himself—and the specialty—up for problems down the road.

The article goes on to describe some of the problems:

But Dr. DeLue’s biggest concern is that a revolving door creates an image issue for the specialty. “It makes more prevalent the idea that ‘good hospitalists’ don’t stick around,” he says. “The other thing is that it is hard to maintain the chemistry you build among the team if you have people leaving every year.”

Hospitalists are taking on too much too fast. If leadership doesn’t take definitive steps to moderate the trend it will be costly for the specialty. A quote from another article in Today’s Hospitalist sums it up well:

“When we started out, we were going to be the key to hospital cost control, then we took on quality and safety,” said presenter Tosha Wetterneck, MD. “Now we’re taking over care of medical subspecialists’ patients and, with the resident work hour restrictions, some of that duty as well. The question is: Are we going to be able to be all things to all people?” Not without incurring the risk of broad-scale burnout in the specialty, replied Dr. Wetterneck, assistant professor of medicine and a practicing hospitalist at the University of Wisconsin- Madison.