Saturday, February 27, 2010

The Healthcare Summit

Here's the skinny from Medscape.

Anyone expecting some glorious "eureka!" moment at the White House healthcare summit today that would forge a compromise on contentious reform proposals between Democrats and Republicans has to be disappointed...

Was anything substantive decided at the summit? Obama and Democratic leaders strongly indicated that they may resort to the parliamentary procedure known as reconciliation if that is what it takes to get a bill passed. This would mean that the legislation could pass with a simple majority in the Senate, rather than the usual 60 votes needed to end a filibuster. Republicans characterize the tactic as pushing through the bill on a strictly party-line basis.

The public opposes using reconciliation by 52% to 39%, according to a USA Today/Gallup poll...

What's next? Democrats could try to push through their bills through the reconciliation method by a party-line vote, although they acknowledge that is a high-risk strategy, if even possible.

When hospitalist programs run on fumes

---it's diminishing returns for hospitals.

I ran across this post at Better Health by Dr. Wes via a tweet at Med Rants to a post at Kevin MD.

Dr. Wes raised a point which is under discussed and difficult to quantify but well known by those in the trenches of hospital care: every hospitalist program has an optimal patient load above which its economic value to the hospital wanes.

It appears hospitalist services are increasingly finding themselves overwhelmed with admissions and the promise of a reasonable lifestyle can be assured by either limiting the number of patients admitted to each hospitalist or hiring more of them. But new hires are becoming tougher to justify in this “do more with less” economic time in medicine. As a result, it appears existing hospitalists are quickly finding they’ve hit the peak speed of their clinical-care gerbil wheels.

Hospitals may think they're saving money by under staffing programs. But good resource utilization takes time, and under staffing may result in decreased efficiency.

Avandia and disclosure

In reference to yesterday's post there's an interesting thread on disclosure, both as it relates to Dr. Mintz's handling of his postings on Avandia and to disclosure in general, over at Retired Doc's Thoughts. Most of the public discussion on disclosure consists of posturing, platitudes and name calling. What's needed is frank, respectful and open treatment of the issue. The thread over at Retired Doc's is a good start. Dr. Poses, Dr. Mintz and I have already weighed in and I hope more readers will.

Friday, February 26, 2010

Revisiting Avandia and personal attacks against Dr. Mintz

Almost 3 years after the safety hoopla raised by Nissen's NEJM meta-analysis the issue has resurfaced. It seems a report on the Avandia controversy by Senators Grassley and Baucus was recently made public and covered by the New York Times. The Times piece was distorted and inaccurate (maybe I'll write a separate post about that later) and uncovered nothing new.

That prompted Dr. Mintz, who has written a great deal about it before, to reassess the controversy in his blog and as a guest blogger over at the Forbes health blog, The Science Business. He reviewed the evidence and pointed out that there's nothing new in the discussion concerning the risks and benefits of Avandia. Then Retired Doc, citing Mintz's analysis, asked readers why we're stirring the pot again. He got one response to his question and that was from Dr. Roy Poses at Health Care Renewal:

Perhaps Dr Mintz may have been influenced by his financial ties to GSK (not disclosed in his blog post that you linked to, but now mentioned in the Forbes Science Business blog version of it, see here:

The undisclosed conflicts were first noted in the PharmaLot blog, see here:

Dr. Poses's response is troubling in a way that is typical when issues of science are thrown into the arena of popular debate. At best it confuses things by conflating questions about Avandia's safety with those concerning the ethics of Dr. Mintz. Or, worse, it may represent the intellectually lazy approach of applying a simple litmus test (Pharma ties) to summarily reject Dr. Mintz's analysis. That sort of ad hominem attack may rarely be justified if ones opponent makes baseless claims without pointing to primary sources of evidence. While Dr. Mintz's analysis is not a systematic review it did appeal to primary sources. There is more than sufficient warrant to accept or reject Dr. Mintz's argument on its own merits. Personal attacks in this case are inappropriate and unnecessary.

Meanwhile over at Pharmalot (linked above by Dr. Poses) the whole thing morphed into a full-scale attack on Dr. Mintz---not so much in the body of Ed Silverman's post, but in the comments. And, to be fair to Silverman, he wrote with a singular focus and made no pretense of evaluating Avandia.

For those readers who take me at my word that I have no Pharma ties (not all readers do!) here's my skinny on type 2 diabetes treatments starting with the categories associated with greatest harm down to the ones with greatest benefit:

Known macrovascular harm

Probable macrovascular harm (Dose and usage pattern related)

Question raised about macrovascular harm without convincing evidence
Rosiglitazone (Avandia)

Preliminary evidence of macrovascular benefit, in need of confirmatory data

Probable macrovascular benefit
Pioglitazone (Actose)

Definite macrovascular benefit
Diet, exercise

No evidence to guide clinicians as to macrovascular benefit, harm or neutral effect
All other agents!

Note that this listing is not a treatment algorithm (you can find that here). It is only concerned with macrovascular effects of diabetes treatments, because that's the focus of the current controversy. It ignores other benefits of glycemic control such as microvascular benefit.

On a related note, another area of obfuscation by the popular media and even some physician writers (who should know better) is the confusion of macrovascular harm with the heart failure issue. Although TZDs cause fluid retention and there are heart failure concerns the evidence is now clear that it is a peripheral effect with no direct adverse effect on the heart. This was well illustrated in a study which showed that although Avandia was associated with increased need for treatment of edema there was no finding of adverse cardiac effect as evidenced by lack of change in cardiac ejection fraction.

What do hospitalists need to know about stroke care? is important now that the practicing hospitalist is facile in the treatment of patients with cerebrovascular disease-and it is likely to become progressively more important over time.

That's from the opening of a two part review on stroke in the Journal of Hospital Medicine.

Part 1. Part 2.

This two part series addresses issues in stroke care that bedevil hospitalists. I would suspect that, nation wide, as it is in many areas of medicine, best practice adherence in stroke care is low. This review should help.

First, the astute clinician is wary of stroke mimics. But when stroke is the working diagnosis an NIH stroke score should be done in the early moments in the ER (resource here).

In cases of intracerebral hemorrhage, although surgical indications are shrinking, patients may benefit from aggressive medical care and the review authors warn against an inappropriate rush to a DNR decision, citing literature that such a decision may be an independent risk factor for poor outcome (self-fulfilling prophecy).

In their discussion of tPA the authors mention the SITS-MOST study, a large phase IV study confirming that tPA performs as well as it did in the NINDS trial. The importance of informed consent for this risky therapy is emphasized (although written consent is not a firm requirement) and a discussion on administration of tPA when such consent is unobtainable is provided. Data in support of the new 4.5 hour time window are discussed although the authors come short of making a recommendation.

For patients who present too late for tPA but inside of 8 hours catheter based treatments (extraction or intra-arterial thrombolysis) are possible. Actually the most recent AHA/ASA guidelines only provide for a 6 hour window and read thusly:

Intra-arterial thrombolysis is an option for treatment of selected patients who have major stroke of <6>

If this type of treatment is “on the table” then CT angiography would be part of the stat imaging in the ER to identify or rule out a large vessel occlusion amenable to catheter based therapy. For this to go smoothly the interventional radiologist (either at your facility or the referral center) would need to be involved early in the ER planning to discuss timing, anticipated total dye loads, etc.

For patients presenting past 8 hours anti-platelet therapy is the only anti-thrombotic option early on. Aspirin should be given early. It is the only anti-platelet agent that has been studied for acute stroke. For patients already taking aspirin there is little to guide clinicians. That issue is discussed in detail in the text of the review.

Systemic anticoagulation is not recommended for any situation except cerebral venous sinus thrombosis, although in a few other situations systemic heparinization is considered. From part 1 of the review:

...a number of exceptions exist, based more on tradition and theory than on evidence. These exceptions, for which an IV heparin drip will at times still be considered, include acute ischemic stroke due to dissection of the carotid or vertebral arteries, cardioembolic stroke with fresh clot seen on echocardiogram (ECHO), and a clinically progressive syndrome suggestive of basilar artery occlusion...

Long term systemic anticoagulation with warfarin is indicated for patients with atrial fibrillation, but not with systemic heparinization in the acute phase. Nuances are discussed in the text of the review and in the guidelines.

Basilar artery occlusion syndrome and malignant middle cerebral artery occlusion syndrome are special situations which may warrant intra-arterial intervention and decompression craniotomy, respectively.

Discussions on general supportive care are included. A couple of points from the guidelines bear mention. The conservative threshold for acute hypertension treatment is well known, but absent such extreme blood pressure elevations what should be done with the patient's home blood pressure medication? The guidelines suggest starting them approximately 24 hours post stroke onset.

Glycemic control in hospitalized patients is controversial right now. In stroke, hyperglycemia is known to be associated with worse outcomes, but neither the target nor the threshold for intervention is precisely known. Accordingly, the guideline statement is vague:

The minimum threshold described in previous statements likely was too high, and lower serum glucose concentrations (possibly greater than 140 to 185 mg/dL) probably should trigger administration of insulin, similar to the procedure in other acute situations accompanied by hyperglycemia (Class IIa, Level of Evidence C).

Indications for carotid endarterectomy, arterial dissection and PFOV are discussed but a discussion of other indications for warfarin and for TEE (based on the TOAST classification) were conspicuously absent.

Thursday, February 25, 2010

Interpreting HIT antibody results

When evaluating patients for heparin induced thrombocytopenia (HIT) we commonly order two tests: antibodies to heparin-platelet factor 4 complex and a serotonin release assay (SRA). Both tests are sensitive but the antibodies are nonspecific. Invariably the antibodies come back first. If they come back positive you're faced with a dilemma: should you go ahead and treat or wait for the more specific SRA result? According to a study in the Journal of Thrombosis and Haemostasis the magnitude of positivity of the antibody result, expressed as optical density, correlates well with strong SRA positivity, thus predicting true HIT:

Results: For patient sera investigated for HIT antibodies, a weak-positive result (0.40–less than 1.00 OD units) in either EIA indicated a low probability (less than or epual to 5%) of a strong-positive SRA; the risk increased to approximately 90% with an OD greater than or equal to 2.00 units. Quantifying the EIA–SRA relationship for 1553 referred patient sera, we found that for every increase of 0.50 OD units in the EIA–IgG, the risk of a strong-positive SRA result increased by OR = 6.39 [95% confidence interval (CI), 5.13, 7.95; P less than 0.0001]. For every increase of 1.00 OD units in the EIA–IgG, the risk increased by OR = 40.81 (95% CI, 26.35, 63.20; P less than 0.0001). Conclusions: The probability of HIT antibodies (strong-positive SRA result) inferred by a positive PF4-dependent EIA varies considerably in relation to the magnitude of the EIA result, expressed as OD values. In our laboratory, the probability of HIT antibodies being present reached greater than or equal to 50% only when the OD level was greater than or equal to 1.40units.

In the concluding paragraph the term “HIT antibodies” means truly functional antibodies, thus predictive of HIT.

Glycemic control in cardiac surgery patients

Recent evidence has been disappointing concerning tight glycemic control in the general critically ill population, and the suggested threshold for intervention is now 180mg/dl. Different considerations may apply in special populations, and for cardiac surgery patients the target is unclear. A new literature review of glycemic control post cardiac surgery, published in the Baylor University Medical Center Proceedings, concluded thusly:

Based on recent information, the new Society of Thoracic Surgeons guidelines and the AACE/ADA consensus statement seem appropriate and allay the concern for hypoglycemia with the new recommended range of less than180 and 140 to 180 mg/dL. More studies analyzing blood glucose target ranges seem necessary to further recommend an intensive blood glucose goal range of 80 to 110 mg/dL, especially in the cardiac surgery population. Even throughout the Van Den Berghe trials, the average blood sugar of patients in the intensive control arm was approximately 140 mg/dL. Thus, aiming for blood glucose levels around 140 mg/dL appears reasonable. Mortality and morbidity benefits are seen with overall control of hyperglycemia; however, the exact range is still not clearly defined, as previously thought.

More free educational and entertainment resources

H/T to Clinical Cases and Images for pointing me to this repository. Open course-ware, free movies, free books, you name it.

Wednesday, February 24, 2010

How many consumers are willing to pay for Internet content?

Most, by far, are going for the free stuff.

H/T to STLMedia.

Some hospitalists are reducing readmissions

---by not being hospitalists anymore. Disturbing.

There's an interesting discussion on the use of check lists

---over at DB's Medical Rants.

On a hectic and busy medical service the checklist can be an important housekeeping tool for the tired, distracted and constantly interrupted hospitalist. I'm trying to develop my own, and these are the items I'm considering for inclusion:

Have today's labs been addressed and appropriate action taken?
Is chemical VTE prophylaxis being given where indicated?
Is discharge planning underway (including order entry for case management consultation and entry of the anticipated discharge date)?
In patients on steroids for asthma or AECOPD is tapering proceeding apace?
Is it time to modify antibiotic orders based on culture results, clinical status or duration of therapy?
Are medications properly reconciled, i.e. are home medications being held that should be and are those being continued (statins, beta blockers) that should be?
Is the patient's activity order appropriate and has PT been ordered if needed?

This list may not be appropriate for everyone, but reflects things that don't have reminders built in at my institution.

Related post at Wachters' World.

Tuesday, February 23, 2010

Here's one to add

---to Joint Commission's list of unapproved abbreviations.

More on Emily Rosa and Therapeutic Touch

Out of the mouth of a babe.

Background on Emily Rosa here.

Remember the girl who debunked therapeutic touch in JAMA?


Conclusions.—Twenty-one experienced TT practitioners were unable to detect the investigator's "energy field." Their failure to substantiate TT's most fundamental claim is unrefuted evidence that the claims of TT are groundless and that further professional use is unjustified.

Monday, February 22, 2010

Torsade de Pointes in hospitalized patients: prevention is key

AHA/ACCF has issued a new scientific statement on this topic.

Here are a few background comments and points I found interesting:

Prolongation and distortion of repolarization is the defining characteristic of TdP, more so than the twisting of the QRS complex about the isoelectric point. The latter feature may not be apparent in a given lead.

Although the traditional assessment for prolongation of repolarization is the measurement of the QT interval, that assessment is simplistic and fraught with error due to controversy about normal limits and rate corrections, poor T wave demarcation, poor distinction between the T wave and the U wave and cycle length dependency. More subjective features including pause dependency, particularly in short-long cycle sequences, splayed T waves (or TU fusion) and macroscopic T wave alternans may be more important.

Among drugs that prolong the QT interval amiodarone has a uniquely low risk of producing TdP because the prolongation of repolarization it induces is homogeneous. Heterogeneous repolarization abnormality is the more likely substrate for TdP.

The list of QT prolonging drugs is evolving. As new ones are added older ones (quinidine, erythromycin, droperidol (inapsine) are disappearing from hospital wards. Aside from anti-arrhythmic drugs methadone and haloperidol have the highest profile right now in hospitalized patients.

The risk of drug induced TdP, even though idiosyncratic, is generally dose related. A notable exception to the usual dose relationship is quinidine, because at higher doses its sodium channel blocking effect has a counterbalancing effect on action potential duration.

The idiosyncratic susceptibility to drug induced TdP appears to be based on a forme fruste of LQTS.

A repository of QT prolonging drugs every hospitalist should have bookmarked is the Arizona CERT.

A multi-hit model for incident TdP is emerging where two or more risk factors conspire (e.g. genetic susceptibility + drug#1 + drug#2 + hypokalemia=TdP).

Among the recommendations in the scientific statement:

Continuous QTc monitoring is appropriate for drugs deemed most at risk to cause not only QT prolongation but also TdP. After administration of an at-risk drug, if the Qtc exceeds 500 ms or there has been an increase of at least 60 ms compared with the predrug baseline value, especially when accompanied by other ECG signs of impending TdP, prompt action is indicated. Appropriate actions include alternative pharmacotherapy; assessment of potentially aggravating drug-drug interactions, bradyarrhythmias, or electrolyte abnormalities; and the ready availability of an external defibrillator. Patients should not be transported from the unit for diagnostic or therapeutic procedures, and they should be in a unit with the highest possible ECG monitoring surveillance. ..

When discharged, the patient should be educated about avoiding the culprit drug, other related drugs, and potential drug-drug interactions. A list of possible QT-prolonging drugs (available at should be provided to the patient and appro-priate documentation made in the medical record. If drug- induced TdP has occurred, a careful review of the patient’s personal and family history should be obtained, because it may be the sentinel event heralding the presence of congenital LQTS. If a personal/family history of unexplained syncope or premature sudden death emerges, a 12-lead ECG should be recommended for all first-degree relatives, and consideration should be given to clinically available genetic testing for congenital LQTS.

Guidelines and principles for interaction with hospitalists

Although this was released by AAFP for its members it has the imprimatur of AAFP as a guideline document and so would apply to all specialties who participate in the hospitalist model.

I thought this was of interest:

If patients present to the emergency department (ED) and the ED physician assesses them, the ED physician should then contact the patient's family physician to determine if admission is necessary or if close follow up or outpatient work up is more appropriate.

If admission is necessary, the family physician should communicate information on pre-hospital treatment, work up, co-morbidities and ongoing specialty consultations, along with family and social concerns, advanced directives, etc., to the inpatient care physician who is assuming management of the patient's care.

In other words not just the hospitalist but also other providers bear some responsibility in the transfer of information.

And this says a lot:

The inpatient care physician should be readily available to discuss the patient's medical problems and hospital course with the family and should provide timely updates to the family physician designated by the patient. Communication with the family physician is extremely important at the time of any changes in the patient's status, complications or new diagnoses (e.g. cancer).

The inpatient care physician should communicate the treatment plan and follow up recommendations to the patient's family physician or the covering physician on the day of discharge. This may be best accomplished by having the discharge summary dictated and faxed to the family physician.

When family physicians refer their hospitalized patients to the care of an inpatient physician, the AAFP strongly encourages them to maintain ongoing communication with the patients, their families, and the inpatient care physician throughout the hospitalization.

So communication between hospitalist and PCP is a two way street, a push-pull mechanism. And, according to this guideline, the responsibility for patient satisfaction rests in part with the PCP. When PCPs maintain communication with hospitalized patients and their families it builds confidence and defuses a lot of issues.

Free fluid, electrolyte and acid-base e-book

Along with other e-books. Via Clinical Cases and Images.

Wednesday, February 17, 2010

Get moving and preserve your kidneys

From the Archives of Internal Medicine:

Rapid decline in kidney function decline (RDKF) was defined by loss of more than 3.0 mL/min/1.73 m2 per year in glomerular filtration rate, which we estimated by using longitudinal measurements of cystatin C levels...

After multivariate adjustment, we found that the 2 highest PA groups (scores of 7-8) were associated with a 28% lower risk of RDKF (95% confidence interval, 21%-41% ower risk) than the 2 lowest PA groups (score of 2-3). Greater kilocalories of leisure-time PA and walking pace were also each associated with a lower incidence of RDKF.

Statins decrease VTE in cancer patients

Report in Green Journal.

Early repolarization on the electrocardiogram: no longer so benign!

Reports have surfaced over the past couple of years on the early repolarization pattern, traditionally considered benign, in patients with idiopathic ventricular fibrillation, and the pattern is now considered a marker of risk for sudden cardiac death. [1] [2] [3]

NEJM now has this new report:

Results The early-repolarization pattern of 0.1 mV or more was present in 630 subjects (5.8%): 384 (3.5%) in inferior leads and 262 (2.4%) in lateral leads, with elevations in both leads in 16 subjects (0.1%). J-point elevation of at least 0.1 mV in inferior leads was associated with an increased risk of death from cardiac causes (adjusted relative risk, 1.28; 95% confidence interval [CI], 1.04 to 1.59; P=0.03); 36 subjects (0.3%) with J-point elevation of more than 0.2 mV in inferior leads had a markedly elevated risk of death from cardiac causes (adjusted relative risk, 2.98; 95% CI, 1.85 to 4.92; P less than 0.001) and from arrhythmia (adjusted relative risk, 2.92; 95% CI, 1.45 to 5.89; P=0.01). Other electrocardiographic risk markers, such as a prolonged QT interval corrected for heart rate (P=0.03) and left ventricular hypertrophy (P=0.004), were weaker predictors of the primary end point.

Conclusions An early-repolarization pattern in the inferior leads of a standard electrocardiogram is associated with an increased risk of death from cardiac causes in middle-aged subjects.

Early repolarization associated with SCD is usually present in the inferior leads but not exclusively so. Two patients in the JACC series later turned out to have Brugada syndrome. The full text of these references is worth reading, as they contain illustrations of the pattern.

Tuesday, February 16, 2010

Discussing and documenting resuscitation status

DNR discussions are challenging. Through the years I've noticed several common mistakes which form barriers to meaningful decision making:

Use of medical jargon. Patients and their families watch TV and read newspapers, and think they understand this terminology, but they often don't.

Misunderstanding of clinical issues. A lack of understanding of the patient's disease processes on the part of the person leading the discussion may lead to over or under estimation of the prognosis.

Cursory or hurried discussions. Pressure to adhere to a regulatory or institutional policy may drive such discussions, which are not informative to patients and families.

Discussions postponed until the moment of crisis.

Vague and overly subjective discussions. Early in the conference the patient may say something like “Do whatever you have to if you think it will help” and there ends the discussion. Individual modalities of resuscitation and their anticipated benefits are often not addressed specifically.

Shared assumptions that DNR status means giving up. DNR patients may still warrant aggressive care, including ICU care. At Mayo Clinic, for example, (see below link) DNR status does not preclude the option of intubation and mechanical ventilation for patients who develop respiratory failure.

Issues concerning DNR discussions are reviewed in a recent issue of the Green Journal.

Thanks CMS and IOM

---for giving us our next malpractice crisis:

While this issue is so new that not many cases have yet hinged on the term "never event," the term has a foreboding and ominous ring to it that plaintiffs' lawyers love. It is likely to become a more important factor in future cases. Imagine that your deposition is being taken for Mr. Smith's case. The plaintiff's lawyer asks these questions:

"Now Doctor, you are familiar with the term ‘never event,’ aren't you?"

"The federal government has a list of injuries a patient should never suffer in a hospital, doesn't it?"

"Our government considers these ‘Never Events’ to be such serious errors in medical care, and so easily prevented, that Medicare won't even pay the doctor or hospital for treatment needed when these ‘never events’ occur, true?"

"And inpatient fall is on that list, isn't it? It's an event the federal government considers a serious preventable medical error that should never happen, true?"

Background here, here, here and here.

Comprehensive Hospital Medicine

Portions of the book are available for browsing at Google Books, embedded at Clinical Cases and Images.

Monday, February 15, 2010

Churg-Strauss syndrome review

In Kidney International via Medscape.

Tylenol to protect the kidneys in rhabdomyolysis??

Don't try it just yet, but the scientific rationale is sound and the results in an animal model are promising.

Background here.

New guidelines for RBC transfusion

---have been released by a joint task force of EAST (Eastern Association for Surgery of Trauma) and the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM). The guidelines target critical illness in a variety of settings.

Guideline article in Critical Care Medicine.

PDF of the full document.

Medscape commentary.

A few points of interest:

This is a more conservative strategy than we've been used to. A threshold of a Hgb of 7 is recommended for almost all hemodynamically stable situations except for acute coronary syndromes in which a threshold of 8 is suggested.

Although the recommendation summary says “RBC transfusion should not be considered as an absolute method to improve tissue oxygen consumption in critically ill patients” it is acknowledged in the body of the document that a Hct target of 10 in patients with septic shock may be applicable according to the EGDT protocol during the first 6 hours of treatment.

The document notes the risks of acute infection, SIRS, MOFS and TRALI associated with transfusion and comments on the underappreciated nature of TRALI as well as the need for diagnostic efforts and reporting when the condition is suspected.

How useful is bone marrow examination in patients with FUO?

In this study it was pretty helpful, especially if the patient had anemia or thrombocytopenia:

Results Overall, a specific diagnosis was achieved by BMB and histological examination in 31 cases (diagnostic yield, 23.7%). Three types of diseases were found: hematological malignant diseases in 25 cases, including 19 patients with malignant lymphoma, 4 with acute leukemia, 1 with hairy cell leukemia, and 1 with multiple myeloma; infectious diseases in 3 cases; systemic mastocytosis in 2 cases; and disseminated granulomatosis in 1 case. Thrombocytopenia (odds ratio, 4.9; 95% confidence interval, 1.04-9.30) and anemia (odds ratio, 3.24; 95% CI, 1.13-9.34) were the most reliable predictive factors regarding the usefulness of BMB. Bone marrow cultures had very limited value in our cohort. Finally, corticosteroid use did not seem to affect the yield of BMB.

Sunday, February 14, 2010

Remember when---

A laptop would run you $6000? 5.25 inch floppies were out and 3.5 inch floppies were in?

From a 1988 edition of Computer Chronicles via the Internet Archive.

Clinton's stents, Obamacare and comparative effectiveness research

You know where this is going. First, a look at a disappointing piece of coverage from Fox News:

Here as in many news reports we see a conflation of issues concerning stent therapy. The reporters seem confused about the applicability of the results of COURAGE, which studied only patients with low risk stable angina. That would not apply to Clinton who, from what we can gather from news reports, had acute coronary syndrome. He was complaining of chest pains.

Under some all-powerful government CER panel would Clinton have received the stents? What does CER tell us about the best treatment for ACS? We have comparative effectiveness studies out the wazoo on this issue alone and they would be too numerous to mention here. For the most part these studies are compiled and evaluated in the latest ACC/AHA guidelines for unstable angina/NSTEMI, which is what Clinton most likely had. Under these guidelines either an initial conservative or invasive strategy is allowed, and if the patient stabilizes clinically a stress test is recommended before cardiac catheterization. Positive cardiac markers and ST segment or T wave changes suggest, but do not mandate, an initial invasive strategy under the guidelines. My summary is a gross oversimplification. Be assured the government will oversimplify even more. The Fox piece is distorted and non-informative but suffice it to say that in an era where government panels wrest EBM from the hands of physicians Clinton (or some ordinary person with a presentation like Clinton's) might have been denied his stents.

Saturday, February 13, 2010

Almost three years after COURAGE and still too many stents?

DB cites a Wall Street Journal article which tries to make that point and notes:

The cardiologists truly mean well, and care deeply about their patients. But, I believe they do too much stenting...

That may be true but the WSJ piece does not prove the case. Unfortunately the article, all too typical of medical news reporting in popular media, is simplistic and deceptive. It cites data for the total number of stents. Stenting for stable angina, which is what COURAGE addressed, accounts for less than a third of those stents. By far most stents are implanted for acute coronary syndromes. Moreover COURAGE looked at a select group of people with very stable and clinically mild CAD. So the number of stents addressed by COURAGE is probably far less than a third of the total.

Also consider that more than 30% of the patients in the medical treatment arm of COURAGE, which used an intention to treat analysis, crossed over to revascularization. Similar finding in BARI 2D. That means that for 30% or more of stable angina patients you treat conservatively all you can hope to do is postpone their revascularization, according to the best evidence from two prospective randomized controlled trials.

So, the actual number of stent implants that were influenced by COURAGE cannot be determined from the data cited by WSJ, as those implants are diluted by the much larger number of patients stented for ACS.

Also, the WSJ article provides only a graph (no numeric data and no indication of statistical significance) and no link to the primary source. I went to the Millennium web site and could not find the raw data. Graphs can give a distorted impression but it looks as though the number of stent implantations is still down from the pre-COURAGE peak.

Why did the number of stents drift upward again after the initial drop following the COURAGE announcement? Certainly old habits tend to recur over time but the crossover I alluded to above may also be a factor.

The poor uptake of best evidence has been known a long time and practice patterns following COURAGE are no exception, but this Wall Street Journal article gives a very distorted picture of what's going on.

Friday, February 12, 2010

ACLS recertification

--- the other day came at somewhat of a bad time, as the 2005 guidelines are about to be updated. Publication is expected this fall. It got me thinking---what will the new guidelines look like? Our instructors had no inside information on the changes. As one who's tried to keep up with the field I thought now would be a fun time to offer some predictions. Now, I can only offer what changes I think the AHA should make. What they'll actually do is anybody's guess. In the past the guidelines have tended to be a few years behind where they need to be. So here goes (disclaimer---adult cardiac arrest only):

EMT providers who arrive at the scene of a cardiac arrest should start pumping immediately while one rescuer inserts an oral airway and provides oxygen via a nonrebreather mask. The victim should receive 200-300 compressions before rhythm analysis and defibrillation with the AED. Initial rescue breaths will be eliminated and intubation delayed. There will need to be some wiggle room for clinical judgment if collapse to arrival time is known to be less than 5 minutes, if good quality CPR is already in progress or if circumstances strongly indicate a respiratory arrest progressing to cardiac arrest. The recently announced ROC PRIMED trial caused public confusion on this issue and added little to our knowledge of appropriate timing of initial defibrillation.

Rescue breaths should be eliminated in witnessed arrest unless circumstances strongly indicate a primary respiratory etiology.

Resuscitation medications should remain in the algorithms but, in view of mounting studies which question the impact of drugs for cardiac arrest, the wording and class of recommendations may need to change.

The guidelines should incorporate the three phases of resuscitation---electrical, hemodynamic and metabolic---as a conceptual framework for discussion of assessment and intervention.

The guidelines will need to incorporate new evidence concerning post resuscitation care, particularly therapeutic hypothermia. Code teams will need to anticipate and prepare for post resuscitation care. In the new era of applied hypothermia neurologic assessment immediately following return of spontaneous circulation should be considered unreliable in planning subsequent care of comatose patients.

Background: the Resuscitation Outcomes Consortium, an updated repository of research in out of hospital cardiac arrest.

Liberation from mechanical ventilation in heart failure

Heart failure poses special challenges in liberation from mechanical ventilation, whether the heart failure is the principal reason for mechanical ventilation or is a complication of other disease states leading to mechanical ventilation. Mechanical ventilation decreases preload and afterload, effects which are beneficial to cardiac function. When the ventilator is removed these effects are lost and otherwise stable patients may decompensate quickly. This review covers pathophysiology and strategies for successful removal of invasive ventilation.

Failure to adhere to the Surviving Sepsis Campaign guidelines was associated with high mortality

---in this study.

Thursday, February 11, 2010

Perioperative evaluation and management of patients with obstructive sleep apnea

From the Perioperative Medicine Summit.

Undiagnosed OSA is common and time may not permit formal testing before surgery. If simple screening questions raise suspicion one proceeds as if the patient has OSA and follows the relevant guidelines.

Lung pathology in 2009 pandemic H1N1 influenza

From the American Journal of Respiratory and Critical Care Medicine:

Scientific Knowledge on the Subject
Most patients with H1N1 infection present flulike symptoms with a benign course. Patients with comorbidities may have a serious clinical presentation with respiratory failure. The main cause of death is acute respiratory distress syndrome. The pulmonary pathology of patients who died with the H1N1 infection is incompletely described.

What This Study Adds to the Field
This study shows that the main pathological changes associated with H1N1 infection are localized to the lungs, where three distinct histological patterns can be identified: diffuse alveolar damage (DAD), necrotizing bronchiolitis, and DAD with intense alveolar hemorrhage. There is also evidence of ongoing pulmonary aberrant immune response.

A patient safety curriculum for house staff

---at the University of Miami.

Non-atheroprotective benefits of statins

I've mentioned this several times and summarized the points in a recent post here.

Here's a systematic review:

...noted consistent benefits of statin use in improving outcomes of ventricular arrhythmias, sudden cardiac death, cardiac transplant rejection, chronic obstructive pulmonary disease, and sepsis. However, for these conditions, the level of evidence was inadequate to recommend statin use. The evidence for improving outcomes in atrial fibrillation, mortality in heart failure, contrast-induced nephropathy, cataract, age-related macular degeneration, sub-arachnoid hemorrhage, osteoporosis, dementia, and cancer incidence was conflicting and inconclusive.

Wednesday, February 10, 2010

Heliox during noninvasive ventilation in COPD exacerbation

A non-statistically significant small trend towards fewer intubations, but otherwise no effect in this study.

What does the research literature say about hand washing compliance rates in hospitals?

From a systematic review of all studies up to 2009:

We found an overall median compliance rate of 40%. Unadjusted compliance rates were lower in intensive care units (30%–40%) than in other settings (50%–60%), lower among physicians (32%) than among nurses (48%), and before (21%) rather than after (47%) patient contact.

Benefits of exercise

An entire issue of the Archives of Internal Medicine is devoted to the topic.

The many hidden benefits of exercise

Imagine if they marketed a pill that did all this.

Via Clinical Cases and Images.

Tuesday, February 09, 2010

Cardiac resynchronization therapy for heart failure: underutilized

From the IMPROVE HF registry:

A total of 1,373 patients were eligible for CRT based on current guideline criteria, and 533 (38.8%) received a CRT device...

Despite being evidence based and guideline recommended, CRT is underutilized in eligible patients with significant variations associated with age, insurance, QRS duration, and geographic location of practices.

The critically ill burn patient

These patients, even in community hospitals awaiting transfer to a burn center, should be cared for primarily by the surgeons. So why should hospitalists be concerned? Well, with comanagement the way it is these days you never know. Here's a review that might come in handy.

Monday, February 08, 2010

Steroids and insulin in septic shock

Despite the recent diminution in the indications for corticosteroids in septic shock, they are still used in limited situations, particularly when hypotension is refractory to pressor agents. When glycemic control deteriorates during the use of steroids should it be approached differently? A new JAMA study looked at this question and investigated the effect of fludrocortisone as a secondary objective:

Patients were randomly assigned to 1 of 4 groups: continuous intravenous insulin infusion with hydrocortisone alone, continuous intravenous insulin infusion with hydrocortisone plus fludrocortisone, conventional insulin therapy with hydrocortisone alone, or conventional insulin therapy with intravenous hydrocortisone plus fludrocortisone. Hydrocortisone was administered in a 50-mg bolus every 6 hours, and fludrocortisone was administered orally in 50-µg tablets once a day, each for 7 days...

Conclusions Compared with conventional insulin therapy, intensive insulin therapy did not improve in-hospital mortality among patients who were treated with hydrocortisone for septic shock. The addition of oral fludrocortisone did not result in a statistically significant improvement in in-hospital mortality.

VTE prophylaxis in surgical patients

This is a very useful update from the Perioperative Medicine Summit.

If there's one thing we can learn from the woosters

---it's that we need to spend more time with patients:

The demand for complementary medicine (CM) is growing worldwide and so is the supply. So far, there is not much insight in the activities in Dutch CM practices nor in how these activities differ from mainstream general practice. Comparisons on diagnoses and visit length can offer an impression of how Dutch CM practices operate...

The CM physicians registered activities in a total of 5919 visits in 1839 patients. In all types of CM practices general problems (as coded in the ICPC) were diagnosed more often than in mainstream general practice, especially fatigue, allergic reactions and infections. Psychological problems and problems with the nervous system were also diagnosed more frequently. In addition, each type of CM physician encountered specific health problems: in acupuncture problems with the musculoskeletal system prevailed, in homeopathy skin problems and in naturopathy gastrointestinal problems. Comparisons in visit length revealed that CM physicians spent at least twice as much time with patients compared to mainstream GPs.

Thursday, February 04, 2010

Adverse events after hospital discharge of geriatric patients

This study was from Norway.

118 patients (65 % female), with mean age 83.2 +/- 6.4 years participated. Median Barthel Index at discharge was 18 (interquartile range 16-19) and median Mini Mental Status Examination 24 (interquartile range 21-26). A total of 146 unwanted incidents were registered in 70 (59 %) of the patients. Most frequent were unwanted incidents related to drug prescription regime (32%), exchange of information in and between the GEMU and the primary health care (PHC) (25%) and service or help provided from the PHC (17%).

Despite a seemingly well-organised system for transition of patients from the GEMU to their homes, one or more unwanted incidents occurred in most patients during discharge or four weeks post discharge. The study has revealed areas of importance for improving transitional care of geriatric patients.

Management of severe asthma in the ICU

This is one of the best reviews I've encountered.

Tuesday, February 02, 2010

Obama's comparative effectiveness agenda: tools versus rules

Jerome Groopman's recent piece in the New York Review of Books is a must read for anyone who's serious about health policy. His opening paragraph reveals the President's naiveté about scientific medicine:

The administration's stimulus package already devoted more than a billion dollars to "comparative effectiveness research," meaning, in the President's words, evaluating "what works and what doesn't" in the diagnosis and treatment of patients.

Reducing the evaluation of medical treatment down to “what works and what doesn't” ignores important questions about individual patient attributes and scientific plausibility. Accordingly, for example, the Obama administration has opened the door to implausible CAM treatments, some of which appear to “work.” Deciding that a treatment “works or doesn't work” is simplistic on many levels, has a subjective dimension and is open to value judgments.

The concern in all this for practicing physicians and their patients, according to Groopman's article, lies in the administration's plan to take over many areas of clinical decision making. At its mildest it would take the form of “libertarian paternalism” where government guideline sanctioned treatments would be “default options” which physicians could opt out of if they could defend their choices as “reasonable.” At its worst it would involve coercion. If it sounds incredible note this from Groopman's article:

Such freedom of choice, however, is not supported by a second key Obama adviser, Peter Orszag, director of the Office of Management and Budget. In June 2008, testifying before Max Baucus's Senate Finance Committee, Orszag—at the time director of the Congressional Budget Office—expressed his belief that behavioral economics should seriously guide the delivery of health care. In subsequent testimony, he made it clear that he does not trust doctors and health administrators to do what is "best" if they do no more than consider treatment guidelines as the "default setting," the procedure that would generally be followed, but with freedom to opt out. Rather, he said,

To alter providers' behavior, it is probably necessary to combine comparative effectiveness research with aggressive promulgation of standards and changes in financial and other incentives. [Emphasis added.]

The word "probably" is gone in the Senate health care bill. Doctors and hospitals that follow "best practices," as defined by government-approved standards, are to receive more money and favorable public assessments. Those who deviate from federal standards would suffer financial loss and would be designated as providers of poor care.

Practicing doctors, Orszag apparently realizes, are not always so intellectually lazy as to accept the default option.

Now this piece was written before the election of Scott P. Brown and that Senate bill is all but dead today. The point remains, though, that Obama and his czars would like more control over our clinical decision making and who knows what they might be able to leverage in the health care provisions of the stimulus package.

Some support for the coercive approach comes from within our own ranks. Hospitalist leader Bob Wachter recently said this (my emphasis):

We simply must find ways to drive the system to produce the highest quality, safest care at the lowest cost, and we need to drag the self-interested laggards along, kicking and screaming if need be. Comparative effectiveness research is the scientific scaffolding for this revolution, so bring it on.

Those self interested laggards, by the way, are us, the rank-and-file of practicing physicians.

Groopman goes to considerable length in his article to expose the fallacy of the simplistic approach of mandating treatments because they “work” as opposed to those that “don't work”, citing recommendations for tight blood sugar control, perioperative beta blockers and all those useless and sometimes harmful CMS core performance measures.

Finally, he discusses the newly promulgated USPSTF mammography guidelines, the latest example of a government sponsored “default option.” Whether that will morph from an option to something more coercive is anyone's guess right now. A recent post by Orac is as nuanced and thorough an analysis of the new guidelines as you're likely to find, illustrating how the complexity of the issue goes far beyond whether screening mammography before age 50 “works” or not. In fact, the guidelines are based more on value judgments than new science, as he points out:

In the meantime, I'm not entirely buying these new recommendations, at least not the argument that they are more "science-based" than the older recommendations when, in actuality, they also arbitrarily decide that screening 1,300 women to save one life is an acceptable cost but screening 1,900 to save a life is not.

Retired Doc in his recent post on the Groopman article characterized the differences between libertarian paternalism and the Orwellian Orszagian coercion model this way (my emphasis):

Basically the LP camp seems to say we ( the experts ) know what is best for you and we will in various not- really- coercive ways gently push you in the right direction. The more traditional progressive view, as exemplified by Orszag, is we know what is right and we,if necessary, will summon the force of law to make you do it.

Who knows where things are headed? Right now the National Guideline Clearing House, an initiative of the AHRQ, is merely a repository of guidelines created by various professional societies. Some government policy leaders, though, would apparently like to replace them with their own guidelines and turn them into mandates. Adopting Dr. Paul Keckley's maxim when he was Vanderbilt's EBM maven---give doctors tools, not rules---I plan to stick with Up to Date, Harrison's, Pub Med and whatever other sources my independent judgment leads me to.

Now, just so no one misunderstands: I am in favor of comparative effectiveness research. I am skeptical and concerned, though, about the agenda behind it.

Image source: screen shot from BBC's 1954 television production of George Orwell's “1984.” Public Domain.

Monday, February 01, 2010

Yet another study on the impact of EMRs

Early hype about the benefits of the electronic medical record was bolstered by low quality data, unwarranted comparisons with industry and reliance on opinion. Now, despite an increasing body of evidence that such claims are unwarranted, naïve enthusiasm continues. Another large study has been published in the Green Journal. The paper opens with a description of the initial enthusiasm for the EMR:

Enthusiasm for health information technology spans the political spectrum, from Barack Obama to Newt Gingrich. Congress is pouring $19 billion into it. Health reformers of many stripes see computerization as a painless solution to the most vexing health policy problems, allowing simultaneous quality improvement and cost reduction.

But the study findings, like those of previous research, were that the impact of the EMR is somewhere between slim and nothing:

Hospital computerization has not, thus far, achieved savings on clinical or administrative costs.

More computerized hospitals might have a slight quality advantage for some conditions.

No reliable data support claims of cost-savings or dramatic quality improvement from electronic medical records.

Concerning that second point, the slight quality advantage cited refers merely to the adherence to performance measures which, as has been repeatedly shown, is not a surrogate for real quality. It says even less, of course, about patient outcomes. The authors concede that any improvement in performance scores attributable to the EMR may merely reflect facilitation of documentation to make scores look better.

Homeopathy for fibromyalgia: CV + PB = EBW

That stands for chance variation plus publication bias equals evidence based woo. Well illustrated by this paper.

Acute kidney injury in the ICU

A review for the non-nephrologist.