Friday, December 28, 2007

Top ten issues in hospital medicine for 2007, issue 1: quality, transparency and core measures---the skeptics are still winning

This issue (in my mind at least) retains the number one spot it held in last year’s top ten list. And, like last year, the skeptics are still winning. As Bob Wachter has said in so many words on more than one occasion, we have a long way to go before we get this thing right. Here’s a roundup of some of this year’s buzz.

The Optimize study found no benefit associated with most heart failure core measures.

The four hour antibiotic rule was found to be associated with over diagnosis of pneumonia (and consequently overuse of antibiotics).

"Ditto" said another study in Chest.

Pain management “quality” initiatives were found to have unintended consequences.

Bob Wachter made a convincing argument that core quality measures may be distracting from more important matters.

A systematic review failed to validate rapid response teams.

Pneumococcal vaccination in adults was again shown to have modest effects at best.

A poll of an audience at a popular hospital medicine course revealed skepticism.

Top ten issues in hospital medicine for 2007, issue 2: hospitalists and the interface with primary care

Two facets of this issue were on the radar screen this year. One concerns what may be the biggest downside to the hospitalist model: the information gap between the hospitalist and the primary physician. An important paper in JAMA this year which I linked and discussed a few months ago demonstrated poor communication between hospitalists and primary care physicians following hospital discharge. As I was finishing this post I found an excellent commentary by Bob Wachter. He believes every health care system need a transitions officer; I couldn’t agree more.

The other facet is the controversy over what effect the hospitalist movement is having on the primary care shortage. The primary care shortage is creating a larger and larger niche for hospitalists. On the other hand the hospitalist movement has created an attractive career choice for internists, thus perpetuating the shortage of primary care physicians. It’s a self reinforcing cycle. Internists who flock to the hospitalist career are looking for professional satisfaction. It’s not just about money. As I blogged before, General Internal Medicine has lost its identity thanks to economic forces and the American College of Physicians which merely defines internists as “doctors for adults.” About a year ago Retired Doc spoke volumes with the title to one of his posts: Is being a hospitalist the only way to still be an old time internist?

Bob Wachter summarized the issue nicely with posts here and here.

Top ten issues in hospital medicine for 2007, issue 3: does the hospitalist model of care improve efficiency and outcomes?

Two papers in 2007 weighed in on this debate. First was this study from the Archives of Internal Medicine showing a statistically significant reduction in length of stay (5.01 vs 5.87 days) associated with an academic hospitalist model in comparison with non-hospitalist care at Albert Einstein College of Medicine.

Just out is this paper from NEJM comparing hospitalitalist care with that of non-hospitalist internists and family practitioners. Hospitalist care was associated with a shorter length of stay than traditional care by internists and FPs (0.4 days for both comparisons), a reduction in cost per case of $268 compared with traditional internal medicine care and no significant difference with family practice care. (Maybe that means family practitioners order fewer or less expensive tests than internists).

How can we interpret these results in light of what was already known? There have been too many papers for me to link here, so I’ll offer an oversimplified timeline. Early in the movement, small studies suggested that the hospitalist care model was associated with reduced charges and length of stay. A study presented at the 2005 meeting of the Society of Hospital Medicine, however, burst the bubble. That largest to date study showed no superiority of hospitalist care in terms of outcomes or efficiency. To my knowledge that was the largest study conducted until the NEJM study linked above. Bob Wachter, commenting on the Archives paper, said there were more than 20 studies with results favoring the hospitalist model. (I didn’t know there were that many!).

From the varied blog reactions to the NEJM paper it seems there are a gazillion ways to interpret the evidence. Dr. Wes is skeptical of the results, seems to question the meaning of $268 per case and laments the discontinuity of care that is built into the hospitalist model. The Happy Hospitalist has a happier spin, doing a little math to suggest how $268 per case translates into real money over multiple admissions and comments on some intangible benefits of hospitalist care. Retired Doc offers a nice summary of the blog reactions here and concludes with perhaps the only statement we can all agree on: the hospitalist movement is here to stay. Bob Wachter weighed in here (did I miss anybody?).

Wachter has some interesting observations on how the fallout from this study may affect the hospitalist looking for a job or jockeying for better compensation. As I see it, it could play out in any number of ways. Wachter suggests that this study, which shows a smaller resource saving than some older studies, could prompt hospital administrators to tighten their budgets for hospitalist compensation:

Since most hospitalist groups get (and require) hospital support, and much of that support has been predicated on a Return-on-Investment drawn from earlier findings of 15 percent LOS and cost reductions, expect some skirmishes at budget time, with hospitals trying to tighten the screws on their hospitalist groups (“why should we raise your support – you only save us $200 per patient!”).

But I could see it play out another way. Given that the economic value of the hospitalist model was in dispute at least in the minds of some, administrators who look at this paper as having settled the issue once and for all may now say “Hospitalist care is supposed to save money. Why aren’t you doing better than your non-hospitalist peers?”

No matter how you slice it, you’re better off if you can convince folks that there are non-economic and intangible benefits of hospitalist care. As Wachter said,

The hospitalist group that has not convinced its CFO that the true ROI doesn’t hinge on pure cost reduction – but rather on systems improvement, QI, patient safety, and more – may be in for a bumpy ride.

Thursday, December 27, 2007

Top ten issues in hospital medicine for 2007, issue 4: evidence based management of sepsis---is it time to unbundle?

The Surviving Sepsis Guidelines (SSG) are now over 3 years old. I’m going to look into the crystal ball of recent evidence and make some predictions about what the next version will look like, realizing, with apologies to Yogi Berra, that “predictions are risky, especially when they’re about the future.”

The SSG recommendations were put forth as a “bundle” by the Institute for Healthcare Quality (IHI) and other organizations. Recently some key components of the bundle are being challenged by new evidence.

Perhaps the most contentious measure in the guidelines is the recommendation for Drotrecogin Alfa (activated protein C). Drotrecogin Alfa was controversial from the time of its original FDA approval because that approval was based on a subset of patients in a single RCT. Nevertheless, at the time of publication of the SSG this was the best and most current evidence available. Although recent evidence calls the use of Drotrecogin Alfa into question the loudest criticism, a perspective piece in NEJM (really more of a rant containing little in the way of perspective) which preceded this evidence, was not based on evidence at all. As I pointed out in posts here and here it seemed more like an ad hominem attack on the guideline authors for their association with Eli Lilly.

But recent disturbing evidence on Drotrecogin Alfa has surfaced including this paper which raised concerns about real world use of the drug and called for additional clinical trials to assess the risks in relation to the benefits. There was also a meta-analysis I linked to and discussed here which suggested a lack of mortality benefit.

The NEJM perspective authors launched another salvo in a recent letter to the editor of Critical Care Medicine, reported by Hooked: Ethics, Medicine and Pharma and Health Care Renewal. I can’t access the letter, so I don’t know whether it’s another exercise in Pharma bashing, a “see I told you so” or a sober assessment of the new evidence. Nevertheless the new evidence calls into question the efficacy, safety and cost effectiveness of Drotrecogin Alfa. If the letter writers made an appeal to this evidence they’ve gained my respect. If the writers of the next version of the SSG moderate their recommendation for Drotrecogin (and I expect they will) it should help put to rest concerns about marketing being disguised as evidence based medicine.

The use of corticosteroids in stress doses, another component of the bundle, took a hit with the release of CORTICUS (discussed here) which showed no mortality benefit. The study was underpowered, having been halted early due to enrollment difficulties, but showed no signal of benefit. It contained less ill patients than those in earlier smaller studies which showed benefit. Although critical illness related corticosteroid insufficiency (CIRCI) is real, the results of CORTICUS tell us that, while some patients need to be treated, a blanket recommendation is not warranted. Patient selection is now unclear. The best candidates for steroid treatment may be those among the more severely ill (matching the populations evaluated in older studies) who fail to respond to cortrosyn. Expect a more restrictive corticosteroid recommendation in the next version of the SSG.

Glycemic control has been challenged by evidence published since the release of the guidelines. There is little question that glycemic control is important in critical illness but the targets are unclear. Glycemic control recommendations will remain in the guidelines but I expect some refinement in the next update.

Early goal directed therapy, timely initiation of appropriate antibiotics, source control and other components of the bundle remain intact, having withstood the test of time.

Top ten issues in hospital medicine for 2007, issue 5: therapeutic hypothermia and early goal directed therapy

Hospitals, scrambling for good public report cards, have implemented various core “quality measures” promulgated by Joint Commission, CMS and others. Unfortunately these measures have suffered from lack of evidence, ill conceived implementation and unintended consequences. Among the unintended consequences is distraction from other measures which may be better supported by evidence and which really matter.

Early goal directed therapy for sepsis and the application of hypothermia to promote neurologic recovery after cardiac arrest are examples of evidence based therapies that matter, but which are currently being ignored by the core measure police. In addition the detailed planning, organizational requirements and expense involved in the implementation of these therapies constitute institutional barriers.

This year I found and posted links to several papers which addressed practical aspects of implementation. Articles on therapeutic hypothermia are linked here and here. Implementation issues for early goal directed therapy are discussed here and here.

Top ten issues in hospital medicine for 2007, issue 6: Medicare, CMS and hospital “mistakes”

This year the Centers for Medicare and Medicaid Services (CMS) revamped the prospective payment system and diagnosis related groups (DRGs). Among other provisions starting in October of 2008 (and this is the part that sparked the most controversy) when certain adverse events and conditions occur in the hospital (or aren’t documented to be present on admission) they can no longer be coded to enhance the DRG payment.

The language of the CMS regs implied that events such as hospital falls and hospital acquired decubitus ulcers were avoidable mistakes. Worse, the popular media simplistically spun the new regulations as “Medicare no longer paying for mistakes.” I wrote a series of posts (here, here and here) about unintended consequences and why the newspaper spin was wrong. The short version of my remarks is that a) Medicare hasn’t really paid for the care patients actually received, irrespective of “mistakes”, since 1984 and b) most falls, decubitus ulcers and many infections acquired in the hospital are not the result of mistakes.

Wednesday, December 26, 2007

New concerns about cefepime

Cefepime (Maxipime) is one of the big gun beta-lactams we reach for in serious infections such as health care associated pneumonia and fever with neutropenia. Two recent papers suggest we need to rethink our choice of big guns.

A meta-analysis of trials comparing anti-pseudomonal beta-lactam antibiotics for treatment of febrile neutropenia concluded that cefapime was associated with increased mortality compared with other beta-lactams.

More recently a meta-analysis was done comparing cefipime with other beta-lactams for a variety of indications, again finding an increased mortality with cefipime. The increase in mortality could not be attributed to treatment failure, superinfection or specific adverse events. The authors speculated that discrepancies between in vitro and in vivo results or unidentified adverse effects may have explained the increase in mortality. Possible adverse effects include encephalopathy and non-convulsive status epilepticus, which have been noted in post marketing reports.

Top ten issues in hospital medicine for 2007, issue 7: new developments in perioperative medicine

The buzz this year was about perioperative beta blockers, statins and stents. Perioperative beta blockers were already being questioned in 2006. In response the American College of Cardiology (ACC) issued a focused update which recommended a much more restrictive strategy for perioperative beta blockers. In July of this year I discussed the new concerns, linked to the ACC focused update and cited the MaVS and DIPOM trials, both of which demonstrated no benefit from perioperative beta blockers.

In September the ACC released its 2007 updated guidelines for perioperative evaluation and care which incorporated the interim focused update on beta blockers. The class I recommendations were to continue beta blockers in patients already receiving the drugs for a cardiovascular indication and to administer them in patients undergoing major vascular surgery who had ischemia demonstrated on preoperative testing. Class IIa recommendations were to administer beta blockers to patients undergoing vascular surgery who had known CAD or risk factors (with certain caveats about the level of vascular surgical risk in relation to the number of risk factors).

Barely a month after the release of the ACC guideline update came the announcement of the disturbing results of the POISE trial at an American Heart Association meeting. As reported in Med Page Today (H/T to Wachter’s World):

Perioperative metoprolol (Lopressor, Toprol-XL) started two to four hours before surgery prevented 15 MIs, three revascularizations, and seven atrial fibrillation events per 1,000 treated patients compared with placebo, according to a large prospective trial presented here at the American Heart Association meeting.

But this came at the expense of eight deaths, five severe strokes, 42 cases of significant bradycardia, and 53 significant hypotension events per 1,000 patients, reported P.J. Devereaux, M.D., of McMaster University in Hamilton, Ontario, and colleagues.

Does this make the ACC guidelines obsolete concerning beta blockers one month after publication? The class I recommendation for continuation in patients already taking beta blockers still seems sound. The class IIa recommendations are now problematic. For an analysis of what it all means for real world practice Wachter’s follow up post on this issue is worth reading in its entirety.

Clinical Cases and Images blog weighed in about beta blockers here.

Statins are increasingly making news in the arena of perioperative medicine. I have blogged several times about possible beneficial effects of statins in the perioperative period, including this post from last September. Will statins replace beta blockers as a beneficial perioperative medication? The new ACC guidelines linked above contain recommendations for statins which, for the first time, give them virtually equal status with beta blockers, including a class I recommendation to continue statin drugs in patients already receiving them.

Patients with cardiac stents who require non-cardiac surgery provided fodder for intense discussion this year. How should we manage patients who require urgent or emergency surgery soon after implantation of stents? How long should we wait to do elective surgery after stent implantation? The guidelines address these questions. (According to the guidelines if the patient has a drug eluting stent, wait a year! You can read the rest in the guidelines linked above, which are available free in full text).

Top ten issues in hospital medicine for 2007, issue 8: new guidelines and evidence for diagnosis and treatment of venous thromboembolism

This year saw the publication of new guidelines for the diagnosis and treatment of venous thromboembolism which can be accessed as free full text, which I linked in a post here.

Just out a week or two ago was this randomized trial comparing CT with V/Q scanning for the diagnosis of pulmonary embolism. The results were equivalent. Neither method emerged as the clear diagnostic modality of choice. This was consistent with previous evidence.

Top ten issues in hospital medicine for 2007, issue 9: more questions than answers concerning inpatient glycemic control

Just about the only thing everyone agreed on this year was that hyperglycemia should not be ignored in hospitalized patients. The unresolved questions relate to what target for what indication. For many of us those targets seem to be moving.

Most of the discussion has centered around glycemic control of critically ill patients in the ICU, particularly septic patients. A landmark 2001 study from Leuven, Belgium demonstrated a decreased mortality with intensive glycemic control in a population of surgical patients. Despite questions about how these results might be extrapolated to critically ill medical patients this study was met with general enthusiasm as insulin drip protocols sprung forth in many hospitals.

Evidence suggested that the greatest benefits of intensive glycemic control occurred with near normal glucose levels at the price of an increased incidence of hypoglycemia. Due to concerns about hypoglycemia the Surviving Sepsis Guidelines compromised and recommended less than 150mg/dl as the target.

In 2004 a “before and after” study (related editorial here) looked at the effects of institution of a glycemic control protocol in a “real world” ICU and found a reduced mortality following the intervention.

Enthusiasm was dampened by publication in 2006 of another study by the Leuven group (sometimes referred to as Leuven-2) in patients with medical illness. There was mortality benefit in patients who remained in the ICU for 3 or more days, harm in patients with less than 3 day stays and no significant mortality benefit overall. Inability to predict patients’ lengths of ICU stay made it difficult to apply conclusions from this study.

Two other recent studies which failed to show a mortality benefit were troubled by inadequate statistical power and a troubling incidence of severe hypoglycemia. Some critics regard these studies as failed trials rather than negative trials.

Questions also remain concerning non-critical patients on the ward and patients with specific diagnoses such as myocardial infarction (the DIGAMI studies yielded differing results and confusion as to whether intensive glycemic control or GIK treatment confers benefit) and stroke.

Thus the clinician faces a daunting task when confronted with a hospitalized patient with hyperglycemia: a glycemic control target must be planned. Selection of the target may depend on the patient’s diagnosis and, if in the ICU, the anticipated length of ICU stay. Moreover, the decision must be made with less than clear evidence from clinical studies. For patients in the medical ICU a possible strategy would be to start with the compromise target of 150mg/dl as recommended by the Surviving Sepsis Campaign, then, if/when it becomes clear that the patient’s ICU stay will be prolonged, shift to the more aggressive targets used in the Leuven studies.

The best synthesis of all the evidence came out this year in the July issue of Chest in the form of a review article and accompanying editorial. The authors seem to favor intensive glycemic control in critical illness provided the ICU is sufficiently organized and equipped to achieve recommended glycemic targets while minimizing hypoglycemia. They point out the ongoing NICE SUGAR trial which may give more definitive answers.

Top 10 issues in hospital medicine for 2007, issue 10: unintended consequences of the 5th vital sign

About a decade ago people began to wake up to the fact that the medical profession was doing a poor job of treating pain. Treatment was all too often irrational and ineffective. Education and quality improvement initiatives were needed. Unfortunately, well-intentioned initiatives were hijacked by activism and pain management became politicized. The scientific rationale of pain management became difficult to distinguish from dogma. As Joint Commission pain management initiatives got into high gear concerns about narcotic addiction, respiratory depression and other adverse effects fell on deaf ears. These were medical myths perpetuated by a culture of undertreatment and underconcern, we were told. Activism really got into high gear and struck fear in the hearts of physicians with the astounding news in 2001 of a $1.5 million verdict against a California internist for undertreating pain. The award was made possible by a novel legal strategy which bypassed California’s malpractice laws and withstood a substantial burden of proof that the doctor had acted with criminal recklessness. This was despite the lack of diagnosis of a terminal condition (only later confirmed to be untreatable lung cancer) and reliance on a nebulous pain scale which had become enshrined as the "5th vital sign." Lacking a firm diagnosis of terminal illness the physician was understandably concerned about the "double effect" of hastening death in the process of providing comfort and was hampered by California’s onerous prescription documentation requirements for strong narcotics.

The case sent shock waves through the media and medical journals. A Western Journal of Medicine editorial about the case was typical:

Another message to physicians implicit in these verdicts is that there is a standard of care for pain management, a significant departure from which constitutes not merely malpractice but gross negligence. Even if professional boards might not hold their licensees to that standard, juries will. With the implementation of the new pain standards by the Joint Commission for the Accreditation of Healthcare Organizations, which recognize the right of patients to the appropriate assessment and management of their pain, public expectations will likely increase exponentially.

Indeed they did. Scientific discourse about pain management was now hopelessly tainted by popular debate. An otherwise well appearing patient walking into the emergency department announcing pain at "10 out of 10" was an urgent indication for narcotics. Adverse effects of narcotics administered on the wards were minimized in importance.

Many of us who realized that the teaching about pain management was based more on dogma than science were worried about unintended consequences. This past year the adverse consequences have been brought to light. A JAMA news report earlier this year documents an alarming rising trend in narcotic related deaths which began in 1999, about the time the new pain management initiatives began to be promulgated. Our pain management dogma that "addiction is rare" was challenged by this systematic review of outcomes for opioid treatment of chronic back pain, which showed addictive behavior to be quite common. Thought leaders this year began to question the science behind the rise in opioid use, calling for the same standards of scientific rigor we apply to other treatments. Finally, a paper from the Journal of the American College of Surgeons earlier this year (H/T Aggravated Doc Surg) demonstrated that since the promulgation of recent pain management initiatives we have changed from a culture of undertreating pain to one of overmedication and underconcern for adverse effects of narcotics, resulting in patient deaths.

Perhaps 2007 will be remembered as the year of appreciation of the adverse consequences of pain treatment dogma.

Top 10 issues in hospital medicine for 2007

It’s time again for a year-end wrap up of developments in the field of hospital medicine. What were the defining issues in 2007? Although there are more answers to that question than there are people reading this blog I have a top 10 list, one that reflects my own biases. As I prepare to present it here as a series of posts over the next few days I’m struck by how the list is evolving. Some of the issues (e.g. Natrecor) have gone into dormancy, perhaps to resurface in future top 10 lists. Others, such as quality and safety remain on the front burner with the skeptics still winning the day. Occasional issues (such as sepsis bundles) seem to have come full circle while still others (glycemic control) remain ever-moving targets.

Here are my top 10 lists for 2006 and 2005---

2006:
State of the hospitalist movement.
Surviving sepsis guidelines under fire.
Debates about ALI and ARDS put to rest.
Medication reconciliation.
Outsourcing of hospital services.
Perioperative medicine.
The new C diff.
ER crowding.
EMR and CPOE.
Enthusiasm versus skepticism on the quality movement and core measures.

2005:
Diagnosis of pulmonary embolism.
Inpatient glycemic control.
Quality and accountability.
Combining modalities in treatment of sepsis.
EMR and CPOE.
ACLS, ECC.
Controversies in hypercoagulability.
Emerging infections.
The Natrecor controversy.
State of the hospitalist movement.

Tuesday, December 25, 2007

Grand Rounds at MedGadget

With a Christmas theme, of course.

Merry Christmas

Christmas at RW's place was special not only for the kids and grandkids---


but also for the dogs.


It was a day of eating too much, no-brain TV and, of course, a little blogging.

Monday, December 24, 2007

Stem cells: the basics

Think you can understand the stem cell debate? Not if you don’t know the biology. Some resources are here. Compiled by Life Sciences Education.

Dr. RW's online museum of antique drug company freebies

I was cleaning out closets and ran across some very old drug company trinkets. Now, I'm not as old as these images would indicate. Some of them are hand-me-downs!














































Sunday, December 23, 2007

CPR and EBM

I was about to cite a couple of new articles and an editorial from Circulation to seize a SITYS (see I told you so) moment when I found that California Medicine Man beat me to it. It concerned predictions I made in a series of posts starting in October of 2005 about changes I thought were overdue in the guidelines for CPR and emergency cardiac care. California Medicine man beat me not only to the SITYS (not that that was his intent) but also to a post back in 2005 which predated mine by several months (back before I started blogging).

The posts concerned data on CPR from a group of Arizona investigators spearheaded by Dr. Gordon Ewy, Chief of Cardiology at the University of Arizona College of Medicine and author of the cited editorial. In it Ewy notes poor survival rates following CPR and asks:

Why have survival rates not improved? One possibility is that the guidelines are not optimal. The guidelines advocate the same approach for 2 entirely different pathophysiological conditions: respiratory arrest in which severe arterial hypoxia and hypotension eventually lead to secondary cardiac arrest, and primary cardiac arrest in which the arterial blood is fully saturated with oxygen at the time of the arrest.

Despite that rationale (and it’s pretty strong pathophysiologic rationale) to adopt compression only resuscitation for certain types of cardiac arrest, traditional CPR with compressions and rescue breathing has persisted through multiple iterations of the guidelines. Ewy, himself an early leader in this field, has been telling us for years that we’ve been doing it all wrong. Why have the guideline writers ignored his pleas? I believe it’s an unintended consequence of evidence based medicine (EBM).

Don’t get me wrong. I’m an advocate of EBM. There’s nothing in EBMs basic principles, which tell us to seek the best and most current evidence available to guide treatment, to stop guideline writers from adopting Ewy’s recommendations. Rather, the problem seems to be a popular distortion of EBM which summarily rejects pathophysiologic rationale, animal studies and "low level" human data, anything, in fact, other than a randomized controlled trial (RCT). I’m a fan of the RCT but I recognize that there are some questions which are extremely difficult to subject to that method of investigation. In such cases we must go with the best available information.

So I have a somewhat different take on CPR and EBM from that of California Medicine Man. He seems to think EBM will come to the rescue and bring about needed guideline changes. That may be true. But I feel EBM (well, not really EBM but the popular distortion of EBM I referenced above) has stalled important updates to CPR protocols. I made that point earlier this year in a Medscape Roundtable piece about EBM controversies:

Sometimes, EBM proponents' insistence on patient outcome-based studies slows the wheels of medical progress. The American Heart Association 2005 guidelines for emergency cardiac care provide a recent example. Investigators at the University of Arizona, Tucson, have been publishing evidence for years in support of changes in emergency cardiac care for adult victims of out-of-hospital cardiac arrest.[8,9] Despite this evidence, the guideline authors, dutifully trying to be evidence-based, failed to adopt the new methods because of a reluctance to base changes on anything other than randomized trials. However, the evidence, although based on "low-level" physiologic rationale, was compelling. More recently, the Arizona investigators were vindicated by direct evidence that the new procedures save lives. This situation represents a failure of EBM, not due to any shortcomings of EBM itself, but due to the misappropriation of its principles.

Ewy expresses a similar view in the editorial even though prospective randomized trials comparing the two methods are finally underway:

Will these reports finally be enough to result in guideline changes in the near future, or as suggested by the authors of the Swedish study, should this decision await the published outcome of randomized trials of CCC and CPR now underway? My conclusion is that guideline changes should be made as soon as possible because they are long overdue.

So that’s the question. If the RCTs now underway prove that traditional CPR with rescue breathing is superior to compression only CPR for bystander-witnessed primary cardiac arrest the EBM extremists will be vindicated.

What does the evidence show so far? California Medicine Man’s posts summarize it pretty well. Not mentioned is this study of implementation of the changes in a region in Wisconsin, showing that the new protocol is associated with improved survival as well as data presented by Ewy’s group at the American Heart Association meetings in 2006 showing markedly improved survival in Phoenix resulting from compression only CPR. In summary, we have pathophysiologic rationale, strong data from animal studies as well as comparison studies in humans using historical controls which show either equivalency or superiority of compression only CPR for survival and neurologic outcomes.

The zealots of EBM like to trot out the CAST study and trials on estrogen replacement therapy as examples of the hazards of over reliance on low level data. Those are important lessons, to be sure, but one has to wonder whether the insistence on RTCs is always appropriate or, as I asked in my Roundtable, whether we’ve gone too far with EBM.

Thursday, December 20, 2007

Transfusion and mortality in acute lung injury

It’s been well known for a while that transfusion can cause acute lung injury (ALI). Now, a cohort study in Chest suggests that red cell transfusion increases mortality in patients with established ALI. The results were adjusted for confounding variables. An accompanying editorial reviews other literature in favor of conservative transfusion strategies and emphasizes the need for controlled trials.

Adverse outcomes associated with RBC transfusion in critically ill patients have driven interest in the use of erythropoietin in such patients. Unfortunately, that strategy has not been shown to be beneficial.

Exceptions to a conservative transfusion strategy in critically ill patients include bleeding, early goal directed therapy for sepsis and coronary artery disease.

Wednesday, December 19, 2007

Use of vasoactive drugs in septic shock

The old adage was “levophed, leave ‘em dead.” Now it’s “who’s the dope that started dopamine?” Although current evidence suggests superiority of levophed (norepinephrine) in septic shock the choice is not always simple and must be tailored to specific hemodynamic goals. A head to head trial comparing norepinephrine and dopamine is ongoing.

A review in Chest discusses these issues as well as other pressors, including an update on the adjunctive use of vasopressin infusions.

Tuesday, December 18, 2007

Resolved: “mainstream” medical education is slouching towards quackery

In our recent Medscape Roundtable Discussion Roy Poses and I took the affirmative side of this debate while our colleague Nick Genes argued for the negative. If Nick feels all alone he can take solace in the discussion thread which, so far, seems to be lining up in his favor. It was my hope that this edition of the Roundtable would spark debate and give the controversy exposure beyond the blogosphere.

In a spirit of friendly debate let me answer some of Nick’s objections. He takes a more optimistic view the last decade of medical education, arguing that for some time after the Flexner report medical education remained dogmatic, only in more recent years embracing the rigorous scientific principles of evidence based medicine (EBM). While this popular view of medical education would seem to be in diametric opposition to what I said, it’s not so simple.

He writes:

So, if you subscribe to Dr. Donnell's narrative, you'd be inclined to believe that for nearly a century, physicians were consistently trained to critically evaluate scientific literature. You would think the tests that they employed, and the therapies that they prescribed, were based on a strong foundation of supporting evidence.

In fact, this was not the case. Medical education was dogmatic after Flexner. However, instead of calling upon the wisdom of the ancients, or their chakras, doctors relied on animal physiology experiments and the observations of a few brilliant, dead clinicians.
The treatments that medicine espoused throughout the 20th century had a basis in science, to be sure, but whether these therapies were really helping patients was unknown -- and often not even properly studied.

Unknown? What about antimicrobial agents, vaccines and CPR? Granted, clinical investigation early in the 20th century didn’t meet the standards of EBM as we know it today, but this was not the result of mainstream medicine’s adherence to dogma. According to M.L. Meldrum’s fascinating paper on the history of the randomized controlled trial, efforts were made in the early 20th century to garner evidence on the clinical effectiveness of therapies but they were beset with lack of funding and organization. The American Medical Association, at about the same time it helped commission the Flexner Report, began initiatives aimed at the evaluation of drug effectiveness, including publications such as Useful Drugs. Controlled studies became increasingly common in the 1930s. The publication in 1935 of Fisher’s The Design of Experiments was a landmark development in the progress towards clinical trials. In the late 1940s shortages of streptomycin allayed ethical concerns about randomized trials of this agent in the treatment of tuberculosis. These examples from Meldrum’s paper comprise just a portion of the time line of advances in clinical investigation in the first half of the 20th century.

When I was a medical student in the early 70s many randomized clinical trials including the University Group Diabetes Program study, the Coronary Drug Project, the Lipid Research Council trial, several early hypertension trials and the early coronary artery bypass trials, early trials on anticoagulation for myocardial infarction and thromboembolism were completed or underway in planning or implementation. Although the term “evidence based medicine” was not popularized until 1992 history shows that throughout the 20th century medicine was indeed gradually becoming more and more evidence based.

Nick goes on to criticize what he apparently believes to be an over emphasis in 20th century medical education on the basic sciences:

Of course, medical school also emphasizes scientifically determined biochemical pathways, with their opportunities for intelligent drug interventions. However, upon entering the wards, a significant student function is to push fluids and dole out cold remedies. Which ones? How much? Until recently, there was little scientific guidance for these decisions; students learned to simply do what their mentors and colleagues were doing.

No wonder CAM gained a foothold. If students were being made to learn arcane trivia and give time-honored but untested therapies, why not invoke energy fields and pressure points?

Well, the reason why not should be obvious.

The principal point of his argument is that medical education in the last decade has advanced critical thinking and evidence based medicine, not pseudoscience:

Students are now trained to critically appraise the literature. They can determine likelihood ratios for a diagnosis on the basis of a test result, and calculate how to properly judge a new therapy. They can point out the inherent biases and methodologic shortcomings in a study. Equipping future doctors with the tools of EBM has encouraged critical thinking about the way medicine is practiced, and has helped expose the inadequate underpinnings of 20th-century medicine's diagnostic and therapeutic modalities.

But recent surveys suggest that’s not true. A recent study published in JAMA demonstrated that medical house staff had a very poor working knowledge of the quantitative aspects of EBM. Here’s a link to a study showing a lack of proficiency among medical house staff in EBM searching.

So, there’s reason for concern that while medical schools talk a good game about EBM they’re not very effective in teaching it. But more striking to me is the irony of teaching EBM alongside the uncritical promotion of pseudoscience.

Orac weighs in here about the Roundtable.

Saturday, December 15, 2007

Another review on noninvasive ventilation

See previous post here.

One of the tricks of noninvasive ventilation is to monitor the patient for signs of failure so that if the patient is destined for invasive mechanical ventilation timely intubation can be carried out before a crisis point is reached.

This is another helpful review of the topic, published in Critical Care Medicine, as free full text via Medscape. Noninvasive ventilation is expanding its niche as new promising indications are explored.

Friday, December 14, 2007

Where are the nice guys?

Non-medical, I know. A fascinating post over at Dr. Helen explores the question. Short version: women send confusing messages by choosing jerks while lamenting the shortage of “nice guys.” A gem from the comment thread:

Ah, the fruits of the sexual revolution are sweet, aren't they?Today, nobody spends the time to really get to know a person get to find out if they are someone to whom they can and should commit themselves. No, following the siren call of the 60's and 70's, you just jump into bed with what ever slithers up to you. Then, too late, you find out they are human debris and you are left diseased, broken hearted, bitter, lonely, or sadder, but no wiser. Bon Appetit.Enjoy the poison my generation left for you. You are to [sic] stupid to see that it is poison.

Thursday, December 13, 2007

Differing views juxtaposed

Kevin says ----

Doctors aren't paid enough. There, I said it.

But medical student and AMSA fellow Paige thinks we’re greedy:

The annual starting salary for the lowest paid group, pediatricians is 140,000. On what planet is that not enough money? Even with debt and a family, it's possible to get by pretty comfortably. As a profession we have gotten greedy, and this greed percolates through our entire profession.

Whadaya think?

Blogiversary greetings to Orac

Orac belatedly observed his third blogiversary yesterday, recounting the development of his very successful blog from humble beginnings. Orac has linked to many of my posts about the pseudoscientific invasion of mainstream medicine, helping to give the issue the exposure it deserves, a level of exposure far greater than would have been possible by my efforts alone. Of course those Oraclanches are nice too.

Non invasive positive pressure ventilation

A topic update outlining practical implementation tips, contraindications and current evidence appears in CMAJ.

Key points of the evidence summary by indication:

COPD exacerbation with respiratory failure---established.

Status asthmaticus---controversial. Some promising early results. Large studies needed.

Acute cardiogenic pulmonary edema (CPAP or NPPV)---established (especially CPAP) in patients without acute myocardial infarction. (Contraindicated if myocardial infarction present).

Miscellaneous forms of respiratory failure including non-cardiogenic hypoxemic respiratory failure and post operative respiratory failure---results appear to vary with setting and etiology of respiratory failure. Promising for some indications.

Selected patients who fail spontaneous breathing trials while intubated (in which extubation followed by NPPV is used as an alternative to continued intubation)---shows great promise and may emerge as a popular strategy given present day concerns about ventilator associated pneumonia and length of ICU stay.

Use in extubated patients, to prevent recurrent respiratory failure and need for reintubation---effective in selected high risk patients.

Use in respiratory failure occurring after extubation---not effective.

Many caveats and precautions apply, which should be read in their entirety in the referenced article.

Wednesday, December 12, 2007

Confessions of an integrative medicine failure

A favorable blog reaction to our Medscape Roundtable on integrative medicine taught in medical school was posted by California Medicine Man. Concerning the Flexner Report, the focus of our article, he notes:

The original report published in 1910 covered a lot of ground but a central point was that medical education needed to be based on data-driven scientific knowledge. Flexner eschewed hokey, unproven, unquestioned dogma and established that modern medical education needed to do better than that.While I have not studied the extent to which medical schools of today are getting away from that paradigm, it seems that we are to some degree. Integrative medicine is the new big thing.

California Medicine Man works in academic medicine. He sees the woo invasion first hand. He asks:

So why give these treatments the prestige that explicit support by allopathic medical schools engenders? It would be one thing if the principles of integrative medicine were being presented simply as information med students need to be aware of. It can be argued that such knowledge will facilitate communication with their patients (many of whom are using or considering such therapies). But that's only part of it. As the article discusses, fewer and fewer judgments are being made as to their validity and they're being presented as legitimate alternatives to standard treatments.

In other words, medical schools are putting their good names and scientific reputations behind pseudoscience. As was pointed out in the Roundtable article, non-evidence based and implausible health claims are being promoted rather than critically examined.

Naturally I like California Medicine Man’s post because he agrees with me, but what’s most interesting is his personal anecdote about an intense, sophisticated acupuncture course (there are a number of CAM courses offered by mainstream academic institutions). He writes:

I read the textbooks, memorized the meridians and the accupuncture points (it was harder than gross anatomy).

Sure it was, especially given the lack of any consistent definition of the points let alone any rational basis for their locations.

He goes on:

I learned the different diagnostic protocols, the personality types, etc. I practiced "feeling the Qi" when placing the needles in my classmates. I failed miserably. I simply couldn't do it. I've asked myself many times why this discipline so thoroughly eluded me. The bottom line was that I just couldn't "let go".


Evidently in this, one of the more sophisticated and rigorous courses available, the learning was experiential and subjective, requiring the student to suspend critical thinking. But the California Medicine Man just couldn’t do it. That’s why he describes himself as an “integrative medicine failure.”

I have read the CAM web pages of numerous medical schools and the extensive promotions by the American Medical Student Association. In most cases the subjective, experiential and promotional approaches to CAM seem to dominate their educational efforts. Not a healthy trend in my view.

Tuesday, December 11, 2007

Chantix suicide warnings vary

Pharmalot has a summary of actions and warnings in different countries. I offered some speculation as to the cause of the association here.

Via Kevin M.D.

Stent thrombosis is a bad disease

Investigators at the annual congress of the European Society of Cardiology reported on the outcomes in patients who present with stent thrombosis. From Internal Medicine News:

Dr. Freek W.A. Verheugt noted in an interview that one-quarter of patients who experience stent thrombosis never make it to the catheterization laboratory because they die immediately.

“The Italian study shows that stent thrombosis—whether with a bare-metal or drug-eluting stent—is a malignant disease. One out of four patients die immediately, and the other three-quarters face an in-hospital mortality of 12%. That's terrible. We haven't seen anything like that in many years,” he said.

Putting evidence into practice: therapeutic hypothermia after cardiac arrest

Although therapeutic hypothermia is in the current ACLS guidelines there are numerous practical barriers to implementation. The journal Critical Care Nurse has an article on the organizational and practical aspects of using therapeutic hypothermia, including a protocol developed at the author’s hospital.

For a related post on real world application of therapeutic hypothermia see this.

Subclinical hypercortisolism in patients with osteoporosis

More common than you might think. Via Annals of Internal Medicine.

Sweet’s syndrome

A comprehensive and detailed review with over 400 citations.

Via Orphanet Journal of Rare Diseases.

Monday, December 10, 2007

Familial dilated cardiomyopathy

Here’s a recent review of the topic. The fact that the review appeared in the Orphanet Journal of Rare Diseases is a little misleading, as familial dilated cardiomyopathy may be the most common cause of DCM and is an underappreciated condition. Screening of family members of patients who have “idiopathic” DCM is controversial. While this review recommends ECG and echocardiographic screening of first degree relatives of patients with DCM the 2005 ACC practice guidelines for chronic heart failure come short of such a recommendation, merely stating that such screening should be considered.

Genetic counseling and screening is complex and is discussed in references I linked to here.

Evaluation of abdominal pain in the ER: can it be evidence based?

Investigators in The Netherlands are working on it.

Sunday, December 09, 2007

Thrombolysis for DVT---new concerns raised

---in a recent presentation at the Vascular Annual Meeting as reported in Internal Medicine News. An analysis of patients treated between 1998 and 2003 showed an increase in CNS bleeding and in hospital mortality. One of the investigators, in an interview with Internal Medicine News, speculated that most of the patients received catheter delivered local thrombolysis rather than systemic thrombolysis although those numbers were not available for analysis.

Thrombolytic therapy for DVT, particularly catheter guided local thrombolysis, has become increasingly appealing as an option for prevention of post thrombotic syndrome though never considered standard of care. Local thrombolytic therapy, along with various catheter extraction techniques, has also garnered interest as a possible remedy for the desperate situation of venous gangrene (phlegmasia cerula dolens).

I previously reviewed the controversy here.

Valproate induced hyperammonemic encephalopathy

CMAJ presents a case report and brief review of this under appreciated condition.

Saturday, December 08, 2007

Purple urine bag syndrome

Have you seen this? The topic was recently reviewed in SMJ. (Free full text via Medscape). It’s due to a combination of intestinal overgrowth (often due to chronic constipation), urinary tract infection with urine alkalinity and a reaction with plastic components of the urinary drainage system. It may be alarming to patients, family and nursing staff, but its only clinical significance is that the patient has a UTI.

Friday, December 07, 2007

The latest Medscape Roundtable covers medical school promotion of pseudoscience

In my mind and perhaps in the minds of a few other bloggers med students may have to start checking their brains at the door to the lecture hall if present curriculum trends continue. I’m referring, or course, to the uncritical promotion and teaching of pseudoscience in medical schools under the rubric of “complementary and alternative medicine.” Not everyone agrees, and starting today this spirited debate will play out in the pages of Medscape!

It’s the topic of our latest Medscape Roundtable Discussion, a lively point-counterpoint among Nick Genes, Roy Poses and myself. Although the Roundtable Discussion is featured in the med student portal (what better place to hold this debate!) it will receive some general exposure across Medscape. I wish to thank Medscape for helping take this issue beyond the blogosphere.

Internal Medicine department blogs

Internal Medicine department blogs afford residents, faculty and students an opportunity to share cases and ideas. Clinical Correlations, the NYU IM blog celebrates its first anniversary. It features CPC presentations, grand rounds summaries and journal roundups. Although I scour the web regularly for resources such as these I was not aware of this site. Clinical Cases and Images, which pointed me to this blog, has an earlier post which lists other similar blogs. Many of those blogs, unfortunately, are either dead or in hibernation.

To that list I’ll add another one from my old training ground, SLU Medicine Resident which, though not dead, seems to be suffering from a dearth of posts.

Another TIA update

This one from Today’s Hospitalist.

The impact of alcohol and drug abuse on sedation and mechanical ventilation

This study confirms what we’ve long suspected: alcohol and drug abusers are frequent customers in our ICUs and require lots more sedation.

The Disease Database

Generate a differential diagnosis, get a list of manifestations, generate a search and more, here.

Pituitary problems after head injury and subarachnoid hemorrhage

They’re more common than you might expect. Here’s a literature review from JAMA.

Wednesday, December 05, 2007

Perioperative consultation and co-management of surgical patients

This has been trumpeted as an important role for hospitalists. Recent data from UCSF, though, are a bit disappointing. Consultation with generalists (read: hospitalists) in this study had no impact on cost, length of stay or outcome. The rate of VTE prophylaxis was increased (on PO day 1 only) but that was about it.

Intravenous magnesium in acute onset atrial fibrillation

It may be a useful adjunct for rate control.

Exercise associated hyponatremia

Case report and review. Via Baylor Medical Center Proceedings.

Essentials of TIA management

A recent topic review in Cleveland Clinic journal of Medicine presents the nuts and bolts of patient evaluation and management including an update on recently promulgated risk score systems.

Tuesday, December 04, 2007

Dennis Quaid sues Baxter Health Care

…over the heparin overdose given to his newborn twins last month. What piece of this am I missing? From Reuters:

Their lawyer Susan Loggans said the babies were now back home and "doing fantastic."

"The last thing the Quaids want to do is to file a lawsuit but the objective is to prevent this happening to someone else," Loggans said.

It’s great that the Quaids and their lawyer want to champion the cause of patient safety but isn’t there a more constructive way? In order to bring suit don’t there have to be damages?

There’s more:

Loggans said Quaid had not yet decided whether to sue Cedars-Sinai, one of the leading hospitals in the United States, over the mix-up.

"Cedars-Sinai has already apologized and we are waiting to see what they do to respond," Loggans said.

Whadaya bet?

A new treatment for peripartum cardiomyopathy?

When I posted earlier today about reversible cardiomyopathy I mentioned peripartum cardiomyopathy but overlooked this post by Dr. Wes from yesterday. It seems that a cleaved (16 kDa) form of prolactin is instrumental in the pathogenesis of peripartum cardiomyopathy (there’s pathophysiologic rationale and a mouse model) and a JACC article reports treatment of two patients with bromocriptine. Preliminary but interesting.

The ethical problems of template charting

It’s clear to many of us in clinical practice that the medical record has been hijacked by the coders and bean counters. What’s equally clear, at least to those of us who have been in practice for a long time, is that the coders and bean counters were aided and abetted in this effort by the rising popularity of template based medical records. Templates became popular in the paper era and are rising to a whole new level with electronic medical records.

Potential benefits of templates are more efficient coding and documentation. Paragraphs of clinical information can be generated by a few clicks of the mouse. What’s more, the template prompts the user to document more components of the history and physical exam to enhance coding.

I’ve often wondered whether these templates push the envelope of fraud. Through the years I’ve seen template generated notes with what I thought was gratuitous documentation. (It may not be fraud, but do you really need a 12 system review and a comprehensive physical exam for a single problem encounter?).

I’ve never directly observed or verified a case of template generated fraud. But this blogger has, and it’s rampant in his emergency department:

Our ED Physician came in and did his exam from the door way holding his Tablet PC marking off items into the Electronic T-sheet while he asked a few basic questions. He was in and out in less than a minute. Out of curiosity, I reviewed his documentation and not surprisingly there was a comprehensive assessment documented. Abdominal findings, lungs sounds, heart sounds, pupils and ocular movements, neuro exam, all beautifully documented in a long paragraph and all normal. Not bad for an exam conducted from the doorway. I watched without comment throughout the day and noticed the same general exam pattern on most of his patients and the same comprehensive documentation of his exams. About one half of the Docs in this ED practice operate in a similar way…

For years a logical fallacy has been shoved down the throats of doctors, and it goes like this: “if you didn’t document it you didn’t do it.” Is it any surprise, then, that some doctors might embrace the inverse of that statement, the equally false premise that “if you did document it you did do it?" Those electronic templates make it all too tempting and all too easy.

I agree with blogger ER Murse that the electronic template is merely the enabler. Part of the recipe for fraud is a susceptible provider---one who is under financial or administrative pressure to “improve coding and documentation” or, perhaps, one who buys into the logical fallacy cited above.

The ER Murse post has links to some good documentation and compliance resources for EMRs, but for the most part template facilitated fraud has been missing from the discussion of unintended consequences. Maybe it’s an elephant in the room that people would rather not talk about. It needs to be on our radar screen.

Reversible cardiomyopathy

When patients present with non ischemic dilated cardiomyopathy (DCM) they are often labeled as idiopathic. In some cases “viral myocarditis”, all too often a waste basket, becomes the default diagnosis. Underappreciated causes of cardiomyopathy was the subject of a recent article in Cardiology in Review.

When confronted with a patient with “idiopathic” DCM how often do you consider the following diagnoses?

Iron overload cardiomyopathy. This can present as either a restrictive or a dilated cardiomyopathy, and may result from hereditary hemochromatosis or various secondary iron overload syndromes

Acromegalic cardiomyopathy presents with left ventricular hypertrophy and/or systolic dysfunction and responds to octreotide.

Thyrotoxic cardiomyopathy may be mediated by a combination of chronic tachycardia, autoimmune damage and the direct effects of thyroid hormone excess.

Chronic tachycardia induced cardiomyopathy may be the most reversible of those listed and has been discussed previously here.

Amyloid cardiomyopathy carries a poor prognosis, but survival is improved with treatment of the underlying serum protein disorder.

The cardiomyopathy of Fabry’s disease may respond to enzyme replacement.

Peripartum cardiomyopathy and takotsubo cardiomyopathy were also mentioned. These are underappreciated disorders although clinical circumstances usually suggest their presence.

ICU protocol bundles and mortality

After four evidence-based protocols were introduced in their ICU (lung protective strategy for acute lung injury, activated protein C for severe sepsis/septic shock, intravenous insulin for hyperglycemia control and a protocol for sedation/analgesia) Mayo Clinic investigators reported a reduction in mortality. “Using the pre-protocol period as a reference, the severity-adjusted risk (95% confidence interval) of dying was 0.777 (0.655 – 0.922) during the protocol period (P = 0.0038).”

The impact of introducing multiple protocols in critically ill patients had not previously been well studied. Via BMC Emergency Medicine.

Monday, December 03, 2007

The trial lawyers are scanning the medical journals

Internet solicitation of lawsuits spikes after journal publication of adverse drug outcomes. Via CMAJ.

IV colchicine related deaths

Were they med errors, non-evidence based use or woo? Maybe all three. My original post from last May is here. The CDC’s analysis along with case descriptions was just published in JAMA. Patients tended to present with acute illness resembling sepsis which spiraled into refractory multi-organ failure.

Diabulemia

…refers to insulin omission in type 1 diabetes to control weight. Many teens with DM-1 do this at one time or another according to a report from Internal Medicine News.

Topic review of electronic medical records

An article in the Cleveland Clinic Journal of Medicine offers practical tips for implementation and a review of current evidence. And what does the evidence show? Lots of appealing features, “process improvement” tools, a few unintended consequences and no consistent evidence of improvement in “outcomes that matter.” (Try getting a new drug approved with that level of evidence!).

How is the EMR as a communication tool? It depends on the system. The one at Cleveland Clinic works quite well according to the editorial. On the other hand I frequently encounter computer generated notes so cluttered with verbiage to satisfy the coders and core measure police that I can’t tell what’s really going on with the patient, let alone what the doctors are thinking.

Sunday, December 02, 2007

Pete has second thoughts about Stark

A post from the Science Business Blog recounts Congressman Fortney “Pete” Stark’s regrets for writing the self-referral laws that bear his name. Kevin M.D. points to the Stark laws as an example of what happens when government officials who know nothing about medicine try to regulate physicians. Physicians eventually learn how to survive while complying with the regulations. Once that happens the regulations change, and on the game goes.

Mainstream promotion of woo is unethical

New York Times Magazine ethicist Randy Cohen gets it right in response to a question from “name withheld”, a St. Louis hospital worker who’s witnessed promotion of therapeutic touch and related energy healing methods:

Something needs to be adjusted here, but it is the nurses’ behavior, not the patients’ energy fields. These nurses, however well intentioned, should not perform unproven therapies — if these are unproven; opinions differ passionately — on unwitting patients. To do so is to tell a kind of lie to patients, who reasonably assume that their care meets hospital standards.

I would go a step further and say that patients reasonably assume that hospital standards line up with the standards of science. When woo is offered by a hospital, Cohen maintains, it “carries a sense of official approval”. That adds a whole new level of ethical problems over and above the non-mainstream offerings of woo.

H/T to the Health Fraud List.