Tuesday, January 31, 2006

Blood sugar control in the critically ill patient-the plot thickens

The Feb. 2, 2006 of the NEJM features a randomized trial regarding "tight" blood sugar control in intensive care patients.Physicians caring for the critically ill would have been happier with a more definitive answer but clinical reality continues to be messy and typically resists our efforts to understand it.

Belgian physicians randomized 1200 medical ICU patients into an intensive insulin control group (target blood sugar 80-110) and a conventional treatment group (give insulin if blood sugar greater than 215).

Overall, there was no difference in mortality. When data were analyzed based on length of stay in ICU various answers were forthcoming. Using a 3 day dividing line it seemed that those in ICU beyond 3 days enjoyed a mortality benefit ( 52.5 % vrs 43%). Those who stayed less than 3 days actually showed an increase in mortality. Using five days, the longer stay group enjoyed several benefits in terms of a variety of morbidity indicators but those less than 5 days showed no difference. The authors report less kidney damage in the treated group and earlier weaning from respirators.

The results here are complicated and we are inundated with data and with so much data and with medical ICU patients being so heterogeneous in presentation and in the other treatments received simple answers elude the researchers .Controlling one variable in an experiment with so many other variables influencing the outcomes may well lead to a bottom line more ambiguous than certain. Various sub-group analysis which may give hints as to what is going on may also give false positives due the multiple comparison phenomenon and false negative due to low power statistical power with the small numbers in each group. Which of the multiple outcomes analyzed should be determinative for the clinical physician caring for ICU patients? The trial that seemed to be the tipping point for more aggressive glucose control was done in a surgical ICU units with less seriously ill patients whose medical conditions were less multifaceted and complex.

Dr.Atul Malhotra, in his editorial tries to give the reader some suggestions. He looks at the bright side choosing to emphasize the reported improvement in some aspects of morbidity rather than ambiguity in mortality outcome. He suggests target blood sugar of less than 150 for the first 3 days and then use the 80-100 target used in this trial recognizing the possibility of harm being done to the patients in the short stay in ICC. Certaintly, hypoglycemia is not a good thing and there were more episodes in the treatment group. There is another trial in the wings (the NICE-SUGAR trial).Ignoring the overtly cute name of this trial, hopefully we can look forward to more clear cut answers when that is published.

Dr. Malhotra's suggestions seem reasonable based on the analysis of the Belgian data;it makes sense to be less vigorous in the first few days with insulin therapy and then tightening more on glucose control afterward. However the 3 day value may be more an artifact of the post-hoc analysis of the data than a magic number that may or may not hold up when further trials become available.

Sunday, January 29, 2006

More things I did not become an internist to do

The Jan-Feb issue of the ACP Observer in its "the Business of Medicine" section has a number of suggestions to improve the bottom line for internists who are being squeezed by decreasing reimbursements. Recently, I wrote about a piece by an internist who talked about things he did not become an internist to do. This article makes the list longer, at least for me.The author suggests group weight loss session and group smoking sessions clinics as well as group stress reduction clinics.Group therapy for whatever was somehow left out of my training program in internal medicine-we seemed to be hung up on mainly learning how to take care of sick patients with complicated medical problems- and even with the new program I somehow doubt internists are particularly trained so that they would consider the skills and knowledge base for those activities part of their "core competencies". In my opinion the list gets worse.They mention pulmonary function testing and "breathing treatments". Spirometry makes sense-it is a great tool.Breathing treatments for what? In my years of practicing with 4 other pulmonary docs, we seemed to have no indications for bring folks in for breathing treatments.Another was "dermatological procedures".Again, when did internists begin to think that have any business doing skin biopsies and skin tag removals.At a ACP meeting not too long ago, they offered a mini-course in how to do skin biopsies.The trick there is not so much the technical expertise but the clinical judgment of what lesions to biopsy.That is why we have dermatologists.Let me end with one more of their suggestions made that will certainly thrill the aunt Suzys and grandmother Marys as they wait in your office. Their suggestion of doing court order drug screening will certainly bring some interesting folks into your waiting Nothing like dealing with unhappy people who are ordered to be tested and who suddently develop shy bladder.The ACP at its meetings and in its publications seems to insist on trying to make internists more like family docs and in this article more like dermatologists,and psychologists and occupational docs. We will probably hear more of this until and unless major changes occur in how primary care doctors are reimbursed.

Friday, January 27, 2006

Is CMS administrator threatening doctors to report on quality measures?

American Medical News (subscription required) quotes Dr. Mark McCleland as saying " there is a strong congressional interest in not doing more than one year payments adjustment without seeing more visible progress in quality reporting and quality improvement programs". According to American Medical News, Dr. McCleland declined to say exactly which legislators were saying that.He might not just be threatening physicians as you could argue the real losers in further cuts in medicare payments are the elderly who are bumping up against more internists and FPs opting out of Medicare and by cutting fees, often practices respond by cutting time spent with patients.Some physicians and some Medicare recipients might wonder how CMS can talk about docs improving quality on the heels of a somewhat less than stellar kickoff of Medicare Part D following promotion of the program which including a major underestimate of the cost when the program was spun to Congress. This week in Houston hundreds of volunteers are gathering to try and help explain the program to those eligible.25 states are having to pay for meds for folks who otherwise might go without meds due to glitches in the program. Similar programs are sprouting up over the country as citizens voluntarily do what they can do to fix a typical government snafu.Physicians,whose practices are admonished to improve their quality, are taking time in their busy office practices to try and explain the program to their patients.

Tuesday, January 24, 2006

reports of serious liver toxicity with Ketek

FDA's Medwatch reported 3 serious cases of liver toxicity with Ketek (telithromycin).The patients were not on other medication and said to be in good health.Some alcohol use may have involved in some case(s). This drug has been heavily promoted not only by usual advertising but also I have been to several "CME" events which seemed to emphasize the theoretical advantage of less resistance developing with this drug as have discussions in journal supplements gently leading the reader to the conclusion that the problem of increasing drug resistance might be mitigated by using telithromycin. It makes sense to not be among the first physicians who prescibe a new drug particularly in situations where there are multiple alternatives whose track records are long and the side effects are better known.

Saturday, January 21, 2006

Does Legionella not cause pneumonia any longer?

A recent article in the Archives of Internal Medicine by Dr. D. Shefet et al who performed a systematic review and an editorial review of that article with comments in Courtlandt Forum might make you think there is no Legionairre's disease and therefore no need to empirically include antibiotic coverage for that possibility in patients hospitalized with community acquired pneumonia (CAP).The Archives article and the comments in Courtlandt are similar to a meta-analysis published in the BMJ in 2005 by Mills et. al. from New Zealand and comments in the Cleveland Clinic Journal that I wrote about last year.That MA focused on less than severely ill patients and found beta-lactams did as well as antibiotics that are effective against the atypicals except in the subgroup with Legionella infection.The authors concluded that beta-lactam should remain (that is or was the standard recommendation in UK) the antibiotics of choice in mild or moderately severe cases of CAP which is contrary to the guidelines of both the Infectious Disease Society of America (IDSA) and the American Thoracic Society.My reading of the Shefet article is that they did show an advantage to appropriate coverage in cases of Legionella although the conclusion does not give that impression nor does the review in Courtlandt. Further, the regimens which were compared were a beta-lactam and either a fluroquinolone or a macrolide given as single drugs.While the IDSA guidelines include the option of a fluroquinolone alone the alternative recommendation and one that is commonly used is the combination of a macrolide plus either of two specific cephalosporins ( ceftriaxone or cefotaxime).The Archives systematic review had no data on that issue. The results section said "these regimens[those with coverage for atypical pathogens] showed a significant advantage in clinical success for Legionella pneumophilia." The summary said " "no benefit of survival or clinical efficacy".
The section in the Courtlandt Review is called "evidence-based medicine"and purports to highlight "important new studies applicable to primary care".The section editor,Dr. Daniel Tobin, concluded that even though the systematic review may be underpowered to show a difference that "there does not appear to be a benefit to survival or clinical efficacy" to atypical coverage not quoting the results section comments regarding the clinical success advantage. He stops short of recommending not to give atypical coverage but this seems to be implied by his approach or at least could easily be interpreted in that way unless the original article is studied and the issue considered in light of "all of the evidence".
I consider this analysis typical of what I believe is an increasingly common "application" of what passes for EBM, namely emphasizing a meta-analysis as if it should be determinative and ignoring the context of the totality of evidence and other concerns regarding a particular issue.In this regard here is some of the other evidence that is necessary to consider in antibiotic management of CAP: 1)L.pneuomophilia is a recognized cause of serious and at times fatal cases of CAP 2)fluroquinolones and macrolides are effective treatment for L.pneumophilia infection.3)there is no test nor set of clinical findings that can exclude with reasonable certainty that L.pneumophilia is present at the time of clinical presentation of CAP.4)In seriously ill CAP patients antibiotics need to be given promptly and be correct (ie cover the usual suspects). From this set of evidentiary material the conclusion to cover atypicals (basically to cover L.pneumophilia as mycoplasma and chamydia are generally less potentially serious) follows. That- in part- is the evidence likely considered by the panels responsible for the current U.S. guidelines. In addition, macrolides and fluroquinolones are not particularly toxic or difficult to use medications and the practice of giving broader coverage initially and then focused therapy if and when a specific organism is identified continues to be sound practice.A systematic review for which the statistical power is suspect is not the type of trump card evidence that should overturn current practice.
Evidence based medicine should be based on the totality of the evidence and then blended with clinical judgment and in those regards there is more to factor in than simply randomized trials and systematic reviews of coarse grained outcome data.Systematic reviews should not be dismissed out of hand but neither should their results be determinative. They should be considered and given appropriate weight in the analytic process,

Friday, January 20, 2006

More on alternative medicine and falsifiability,Karl Popper and Andrew Weil

Two medical bloggers have recently disagreed a bit regarding integrative medicine or alternative medicine. We speak of the art and the science of medicine. The philosopher of science, Karl Popper, was very interested in the question of what separated science from pseudo-science . His well read essay on this issue can be found here.
It should be part of any handouts given in a medical school course in evidence based medicine.This is particularly important now given the prevalence of pseudo-scientific alternative medical disciplines given inappropriate implicit validation by various medical schools. Popper's formulation is that science as opposed to pseudoscience is stated in such a way that the proposals can be tested and thereby falsified.This is way Popper put it:
"Every good scientific theory is a prohibition:it forbids certain things to hapen.The more a theory forbids,the better it is....A theory which is not refutable by any conceivable event is non-scientific.Irrefutability is not a virtue of a theory but a vice....Every genuine test of a theory is an attempt to falsify it, or to refute it.testability is falsifiability...One can sum up all this by saying the criterion of the scientific status of a theory is it falsifiability, or refutability,or testability."There are elements of what passes for alternative medicine that can be tested. We can even do a randomized trial for some as we could to see if this or that proposed ancient medication did what its advocates claim it does.
Now, lets see if we can think of a way to test, for example, the Qijong proposition of sound and posture being able to cleanse and recharge the internal organs of stagnant energy.Perhaps we could devise experiments of delivering sounds to patients and then measuring the stagnant energy of organs.Wait, how can we measure stagnant energy when no one know what that even means ?Well, you get the point.
So why did the title mention Dr. Andrew Weil? (let me give a plug to Arnold Relman's essay about Weil.) He is being featured at a meeting sponsored by AMA on medical communication.The AMA can invite whomever they want to a conference but I question the appropriateness of inviting folks who advocate non-scientific alternative medicine.Does that not give Weil an implicit endorsement? I will , of course, have to admit Weil has been very successful at communicating whatever it is he is selling and it is a conference on communication but could they have not found someone who is skilled at selling science and scientific thinking?

Thursday, January 19, 2006

The big three cure for all that ails medicine.

Singly or in combination it seems that whatever problem is identified,worried about or exaggerated, the proposed cure will be 1)IT-that is, some form of information technology, 2) a single payer system and/or 3) evidence based medicine. Those who have irrational exuberance for these panaceas might look carefully at how well the Medicare Part D has worked so far as it relates to items one and two mentioned above. At least we can't blame EBM for this fiasco. So far, it looks like the states have had to jump in to help seniors who otherwise would leave the pharmacy without their meds and the federal government is proposing legislation to repay them. All of this on the heels of numerous reports of the profound difficulty many seniors had in trying to figure out what the program was and how to sign up.Naturally a congressional investigation will be formed to try and determine why a government program did not work as advertised. Can you imagine such a thing?

American Medical News article on "relationships" leaves retired doc confused

The Jan 16, 2005 issue of American Medical News (subscription required) features a frontpage article on what they describe as the new buzzword in medical care "relationship". A special supplemental issue of the Journal of General Internal Medicine is devoted to that topic.The references to what this movement is about in the AMNews article left me uneasy. I could not get my mind around what was being said.One quote:" At its core, relationship-centered care calls on physicians and patients to have longstanding compassion relationships with each other." So, we or someone is to call on patients to have compassion for the doctor? Our job is to take of the patient, to place the patient first, to have a fiduciary relationship with the patient. Physicians may well have compassion for their patient, we typically do empathize with patients. What would generate compassion for the physician? Typically we are well paid,enjoy a generally prestigious status in the human food chain, are in a position of knowledge superiority in the patient's medical condition .The fact we work hard and often really seem to care-and often do care-make well cause the patient to feel a variety of emotions toward the doctor: gratitude, resentment (the doctor is is not sick),faith in her ability, relief of being told nothing serious is wrong, hope that the physician's reassurance is correct, and many others but compassion does not seem one of them. Quite frankly , I have trouble deciphering what is meant or hoped to be accomplished by comments like "moving away from the customer comes first and into something more focused on producing a fruitful, robust relationship." I would like to know what that "something" is and what will be the focus and I always though the "customer" formerly known as patient did come first. The editor of the special issue of the general medicine journal is quoted as saying " this is not just sitting around and holding hands and singing 'Kumbaya"...
But,knowing only what is in the AMNEWS report and observing doctors and patients for 40 years and while realizing that a good relationship is important, until I can learn more specifics about what it is they are advocating it does seem like hand holding and singing.Hopefully one of the handful of readers of this blog who have a better handle on this movement can help me understand it and it may well be that the news article did not do justice to what these folks are advocating.

Wednesday, January 18, 2006

inguinal hernia-JAMA article:some you can just watch

An article in the Jan 18,2005 issue of JAMA reports on a randomized trial of watchful waiting versus surgical repair of "minimally symptomatic" inguinal hernias and conclude for some watchful waiting is appropriate.The accompanying editorial by Dr. David R. Flynn is interesting as it discusses in some detail some basic issues in the analysis of trials. Should one look at intention-to-treat (ITT) or make the comparison on the basis of the treatment actually received? This becomes an issue as it did in this instance when there is considerable cross over in a trial. Nearly 25% of those assigned to the watch and see group opted to have surgical repair by two years and about 1/3 had done so by the end of the trial (4 years).Further 17% of those assigned to surgery decided not have the procedure. At first thought one wonders what sense it makes to look at results in which nearly 4/10 patients did not actually receive the treatments assigned to them.The argument is that the alternative is worse because here selection bias may enter into the picture since randomization no longer controls who receives which management option.The important point made by the editorial is that what was compared here was not so much treatments per se but management advice, i.e. what you tell the patient and in this regard the two approaches were about the same.As always in RCTs before they are construed too broadly, one has to look at the exclusion criteria for the patients in the trials.Only men were in the trial and only those who were at most minimally symptomatic.

Friday, January 13, 2006

Central versus brachial blood pressure, it that a key to differences in efficacy of medications

The ASCOT trial which demonstrated that amlodipine plus perindopril was superior to a combination of atenolol and a thiazide in terms of reduction in cardiovascular and renal outcomes and overall mortality had an interesting substudy known as CAFE. The Conduit Artery Function Evaluation study investigated the role of central versus peripheral blood pressure in cardiovascular outcomes.The amlodipine-perindopril group had lower central pressures while brachial pressures differed little. Could the greater reduction in central pressure be the reason for the apparent better outcomes of the amlodipine-perindopril regimen? There are data that indicate that calcium channel blockers and ACE inhibitors lower central pressure while atenolol does not.These two data sets were not obtained with catheters in the aorta but rather estimated central aortic pressure with something called "radial applanation tonometry". There are data indicating that this is a reproducibbe technique and provides a good estimate of central aortic pressure.Arterial stiffness as quantitated by several parameters derived from this pulse wave study seem to correlate with coronary artery disease and may be considered a type of end organ damage to which various outcome data correlate. Internists have a tradition of being enamored with pathophysiology and having grown up medically with the imperative of striving to "reason in terms of pathophysiology", I continue to find it intellectually gratifying to find instances where the data seem to be "explained" by underlying pathophysiological observations and theories.Having said that, I realize the theories are provisional and subject to refutation as we continue to try and discern how things work. Still, the mantra of the ALLHAT devotees of "diuretics and beta-blockers are best" is becoming less and less convincing.See also DB"s Medical Rants for an important perspective on diuretics.

Thursday, January 12, 2006

New dyspepsia guidelines from American College of Gastroenterology

Upated guidelines for management of patients with dyspepsia have been published by the American College of Gastroenterology (AGA). The AGA publishes its guidelines on line free for everybody. The panel defines dyspepsia as "chronic or recurrent pain or discomfort centered in the upper abdomen" and discomfort as a" subjective negative feeling that is nonpainful". Dyspepsia is distinguished from GERD by the symptoms of heartburn and acid regurgitation.For patients with dyspepsia greater than age 55 or those with alarm symptoms
(GI bleeding,jaundice,odynophagia,palpable mass or enlarged lymph nodes,progressive dysphagia,unexplained iron deficiency anemia or unintended weight loss) early endoscopy is recommended. For those younger patients several approaches are acceptable. These include a trial of proton pump inhibitors (PPIs), testing for H. pylori (with the stool antigen or urea breath test) and then treating if positive with triple therapy and several variations of those themes.They do not recommend h, pylori treatment without a positive test.The entire paper is worth reading as it offers the latest party line thinking and specific treatment details for a very common complaint.The issue of non-gerd dyspepsia continues to be vexing for patients and physicians and in this regard they talk about "fundic dysaccomodation" and visceral hypersensitivity for neither of which is there clear cut advice.
The panel presents data that indicate that only a minority of patients with dyspepsia are shown to have reflux esophagitis (though they may have reflux symptoms),peptic ulcer or gastric cancer. Further although h. pylori may be diagnosed and treated the presenting symptoms may remain. Even so the treatment algorithm for dyspepsia relies on PPI trials and treatment for h.pylori. Those tools work well for those two specific conditions but many patients' symptoms are not due to those conditions. We are left with many patients labeled as functional dyspepsia and for them we have nothing as effective as PPIs are for acid reflux symptoms.

Wednesday, January 11, 2006

Where is HIPAA when you really need it?

Civil libertarians-and even folks who are not that libertarian-are alarmed at the actions of public health officials in New York. According to news report,hemoglobin A1c levels are being reported from the labs who perform the test without the consent of the patients or the physician involved.Carrying nanny- state activities to new levels may be an understatement. Cynics might say that HIPAA never was really about protecting patient confidentiality but rather making sure that everyone use the same set of insurance billing codes with the result being very large savings for the insurance industry and the confidentiality trappings were appended by the Clinton policy wonks later.It was never designed to protect patient privacy from the government.In a way, it is not surprising for a public health department to dive into diabetes or other chronic illnesses as the introductory statements of many medical articles begin with an almost obligatory comment characterizing the condition being discussed as a "public health problem" by which the authors probably really mean it is common and important and not that the public health agencies should get involved..To put some real teeth into a program like this might require reporting from grocery stores to the public health folks to see who is buying pecan pie and twinkies.

Still another algorithm for diagnosis of pulmonary embolism

The Jan. 11, 2006 issue of JAMA has an article (The Chistopher Study,vol..295,no.2,172-179) with a proposed system or algorithm for diagnosing pulmonary emboli (PE) using the Wells decision rule, the d-dimer blood test and the CT scan. It works like this: if the Well's score is less than 4 then a negative dimer sufficiently excludes PE so that no further tests are done. If the Wells number is 4 or more then a CT is needed even if the dimer is negative.Less than 4 is said to make PE Unlikely and 4 or more is Likely.
This was a large (3306 consecutive patients) study from 12 centers in Holland. The absence of PE was not determined by pulmonary angiography but the study relied on a nearly complete 3 month followup. An important issue is which d-dimer test was used. This study used a very sensitive immunosorbent assay (Vidas d-dimer).The immunosorbent and immunoturbidimetric tests are very sensitive-said to be greater than 95%- while the latex agglutination assays are less so. Excluding PE on the basis of a "unlikely"Wells score plus a negative d-dimer will only work well if a very sensitive assay is used.
I wonder if the "dichotomized"version of the Wells decision rule is too simple.All patients in the "unlikely" category are not equally unlikely to have PE. I have a problem with reducing a physician's assessment of how likely the diagnosis may be to a mechanistic rule and apparently excluding any and all other elements that a physician may call upon to decide the likelihood of a diagnosis. for example a decreased o2 saturation. A clinician's "global assessment"( i.e. considering the overall clinical picture not just the check list from Wells) should trump the decision rule.If you believe PE or DVT is a reasonable diagnosis to pursue,testing should be done even if the Wells rule suggests low risk or unlikely and the d-dimer is negative.(show me a blood test that can't be wrong)
An editorial in the same issue is written by a well respected DVT/PE expert ,Dr. R.D.Hull from Calgary who is enthusiastic about the Christopher study authors' proposed algorithm. He says in part " ... firm recommendations can now be made concerning practical and fairly simple diagnostic algorithms for evaluating patients with suspected PE or deep vein thrombosis". D-dimer testing and the increasingly technically impressive CT imaging techniques are giving us better tools for the often elusive and vexing problems associated with venous thromboembolism but I have concerns that reliance on decision rules make things seem more simple than they really are and there is much more to clinical judgment than is captured in a simple checklist decision rule.

Sunday, January 08, 2006

Should we do PSA screening,Case control studies will not settle this issue

Randomized clinical trials enjoy the view from the top of the hierarchy of "truth seeking epidemiologic mechanisms". Medical students are taught that the randomization process serves to immunize the study against the dreaded selection biases. Clinicians generally feel more intellectually confident in reading about a RCT.
Case control studies are another matter.The vagaries of analyzing potential confounders in case control studies elude many physicians and our distrust of case control studies is intensified by the number of dueling or contradictory non -randomized studies over which we have puzzeled.I never get tired of mentioning the juxtaposed, non-randomized, 1985 NEJM articles in which we were told by one group of prestigious researchers that post-menopausal hormone replacement therapy decreased the risk of coronary heart disease (by about one half) and another group of researchers, from an equally prestigious department, told us that the risk increased by a factor of two.These were not rookie epidemiologists or young aspirating medical authors with freshly minted MPH degrees data dredging to bolster their CVs. We are talking about Harvard and the Framingham study.A well respected epidemiologist, Dr. John C. Bailar, has commented that either study taken alone would have been convincing. An editorial by him in that issue seemed to conclude that both articles seemed to be sound in their methodology and that a reason(s) for the discrepancy was not apparent.Bailar suggests that observational studies are subject to a great deal more variation than is usually captured by the statistical tests that are used and that differences such as these may well be due to confounders that are either unrecognized or have larger effects that anyone recognized.
So it is with no surprise that an editorial in the Jan.9,2005 issue of the archives of Internal Medicine ( The PSA Conundrum, Arch. Intern Med/vol 166,Jan 9,2006 pg 7-8)struggles to explain why one case control study concluded PSA screening is efficacious and another concludes it is not. I certainly do not feel competent to assess the relative merits of varying methodological approaches in conflicting case-control studies and I doubt if most physicians do either let alone have the time or energy to attempt to do so. Dr. Michael J. Barry , the editorialist tells us 78% of male primary care physicians and 95% of male urologists reported having a PSA on themselves suggesting physicians seem to believe that on balance PSA screening is a good thing. I am not sure if it is or not but I am sure that another case control study purporting to show either positive or negative results is not going to convince many physicians to change their minds.Two large randomized trials are underway.There is the PLCO screening trial in the U.S. and the ERSPC trial in Europe addressing the issue of PSA screening.Results from both are due in 2009.Let us hope that the two trials point in the same direction.

Friday, January 06, 2006

Quality in Medicine-is it a low defect rate?

A dictionary definition of quality is "a measure of excellence".I believe that when most people use the term outside of a technical sense this is about what they mean. A quality product or service is who that is really good and about which the user or consumer has little to complain. The Total Quality Movement (TQM) or " six sigma" body of thought, which was popularized by Motorola, frames quality in terms of "defect rate" and the reduction of process output variability. The six sigma quality goal is to reduce process output variability to no more than 3.4 defects per million opportunities. If you producing computer chips or pencil erasers that type of imperative makes sense.In dealing with inanimate materials, mechanical parts and a process of human design performance measured in terms of defects per makes sense and apparently the TQM movement has been successful in operations of that type. In a manufacturing process variation is undesirable and efforts to eliminate outliers and execeptions makes sense.
In medicine variation is the rule.All patients do not react the same way to a given medication and we do not know ahead of time who will benefit and who will suffer a side effect or fail to enjoy improvement.Some patient get well without treatment.Manufacturing process that turn out bad parts do not spontaneously fix themselves.A well organized and TQM manufacturing process may well achieve a 6 sigma goal of no more than 3.4 defects per million opportunities. Consider the best we may do in a highly selected group of patients with for example coronary artery disease, we may reduce the risk of a coronary event by say 22% (so far it has not been 100%). So that many patients that we treat with all of the currently recommended medications will still have a heart attack. The prestigous-and apparently rarely challenged-Institute of Medicine (IOM) had defined quality in medicine as " the degree to which health services for individuals and groups increase the likelihood of desired outcomes and are consistent with current medical knowledge". So treating the coronary artery patient with all of the currently recommended meds would be quality care as the likelihood of the desired outcome would be increased and the program is compliant with current professional knowledge. This begs the questions of what evidence is required to justify a claim of increased likelihood and who is to determine what is accepted medical knowledge.A low defect rate has nothing to do with it and the manufacturing paradigm is just not applicable.Accordingly if we wanted to measure quality in a clinic or doc's practice we could look at the treatment offered to a patient with coronary artery disease.That would be the quick and dirty way.That would be the way to do it if clinical judgment and patient values did not matter.The question arises, who will do this measurement and for what reason(s). Insurance companies and HMOs do this and their claim is they do it to improve quality and concerning that we discern another apparent definition of quality,doing things as cheaply as we can get away with it.

Wednesday, January 04, 2006

HCAP as a new pneumonia category

A basic fact about pneumonia is that physicians recommend treatment without knowing the specific pathogen.This is because we have no reliable tests that will identify the culprit bug quickly and accurately.We have to decide on treatment based on what are believed to be the likely etiological agents in a given clinical situation. A scheme that has worked out fairly well is to consider where the infection began,namely in or out of the hospital because different sets of infectious agents are likely to be involved based on that simple dichotomy. So that we talk about community acquired pneumonia (CAP) and nosocomial or hospital acquired pneumonia(NP) and base empirical treatment accordingly.It is also useful to split out those patients who acquire pneumonia while receiving mechanical ventilation (VAP) or ventilator acquired pneumonia because certain bacteria are likely to be involved.
A large data base review by Kollef et al in the December 2005 issue of Chest argues for also splitting off from CAP those patients designated as having "health care associated pneumonia" (HCAP).This designation applies to patients who have been in contact with the health care environment or have been recently hospitalized. It includes therapy in a dialysis center,a nursing home or extended care facility, patients receiving home infusion therapy or home wound care. Kollef's data indicate that patients in these categories are likely to be infected with bacteria that would not be typically covered by the usual antibiotic regimens chosen for empirical treatment of CAP. The data indicate that HCAP is more like NP that it is CAP.
The recent guidelines from the American Thoracic Society and the Infectious disease Society of America for the treatment of NP include patients with HCAP in their nosocomial pneumonia recommendations. Basically this mean that HCAP patients be treated for potential multidrug resistant pathogens including MRSA (methicillin resistant staph. aureus) and resistant gram negative bacteria. It has been my experience that generally physicians are treating nursing home patients with pneumonia with coverage for those two possibilities already but the HCAP category will likely be useful to alert doctors to other non-hospitalized patients who need an antibiotic combo different from the usual garden variety CAP.

Tuesday, January 03, 2006

Wernicke's syndrome not just for malnourished alcoholics any more

Ataxia, confusion and opthalmoplegia, the classic triad of Wernicke's, that all the IM residents at Charity Hospital were aware of and had the IV thiamin at the ready is said to only occur in about 20% of the cases. Our index of suspicion was aimed at the malnourished alcoholic but now it sometimes can be a disease of medical progress-to the extent that gastric bypass for obesity is considered progress. Medscape presents a CME case of a young woman some few months post op from gastric by-pass whose astute physicians were able to diagnose and treat it. Apparently the MRI has some fairly typical findings.Recovery is variable and the ocular palsy resolves first but ataxia may persist as may the memory problems.How commonly it is associated with by pass association is unclear.A recent report from Brazil documents 4 cases.Vomiting may be the trigger as it seemed to be in two cases reported from Spain.Another case reported from South America described a man with no vomiting but with rather marked voluntary reduction in food intake which lead to this thiamin deficiency syndrome. It is clearly something to be aware in a gastric-bypass patient with vomiting as early treatment can reverse much of the abnormal neurological picture but not always all of it.What about prevention?