Current issue of Mayo Clnic Proceedings critical of ED docs handling of vertigo and current diagnostic paradigm

Ever since I heard Dr. Martin Samuel's classic lecture on vertigo, I took his advice and tried to become fairly knowable about vertigo so I could really look forward to seeing my "next dizzy patient".

Part of his approach is incorporation of the widely used classification proposed in 1972 by Drachman and Hart in which four categories are outlined.

vertigo
presyncope
disquilibrium
non-specific, or lightheadedness ( what Samuels calls "true vertigo")

In the Nov. 2007 issue of the Mayo Clinic Proceedings, several authors are rather critical of the manner in which ED docs approach and manage vertigo patients. (Full text is available after registration on their site).

The editorialist comments that ED doc training seems lacking in neurological matters and in his analysis of a number of missed diagnosis of cerebellar infarction that histories were incomplete, neurological exams were inadequate and there was undue reliance on CT scans. I would like to hear what ED docs think of that ( if any read this).

One article suggested that the emphasize on "quality of symptoms" ( which is basically over emphasizing the above mentioned classification) may lead to missing diagnoses, the most important of which is cerebellar hemorrhage which in some instance is treatable by surgery. So not only are ED docs (just ED docs?) accused of screwing up, the paradigm taught for years and used by many is also under attack by this multi-institutional cadre of authors.

In a rather complicated article based on a survey of 505 ED attendings and residents the authors ( it seeemed to require 12 authors to interprete the results) concluded that "the dominant paradigm...is the quality of symptoms approach ....the standard approach ..suggests a potential link to misdiagnosis".

I think they are saying that over reliance on a simplified approach to vertigo/dizziness may lead to missed diagnosis of brain stem strokes and cerebellar infarcts or hemorrhages. The simplified approach they think is being used involves the following thought chain: vertigo--->vestibular--->otolaryngology type cause. The reasoning I thought was applicable was vertigo--->vestibular or central (brain stem or cerebellar cause.) In other words, one has to differentiate between peripheral and central causes of vertigo.

What always bothered me was "Don't miss cerebellar hemorrhage" and to that end I think the following points are valid and helpful,some of which the Proceeding's authors make.

Vertical nystagmus within a single bout of prolonged vertigo almost always means a central cause.

Head motion or positional trigger of vertigo usually means peripheral BUT cerebellar stroke related vertigo can also be made worse by head movement.

The typical head CT done in ED does not rule out a cerebellar hemorrhage and MR may be needed.

If the patient is so vertiginous or disqulibrated ( probably not really a word) that he cannot walk you had better really worry about a cerebellar stroke.

Absence of headache does not exclude a cerebellar hemorrhage.

You really need to do a history and a neurological exam. Brain stem strokes almost always have other neurological findings-diplopia,cranial nerve palsies ,dysarthria, etc-but midline cerebellar disease may only have vertigo, nausea and inability to walk so intense is the disequilibrium.So absence of cerebellar signs-upper extremity- dysmetria,past-pointing etc-does not exclude a cerebellar stroke.

I blogged about cerebellar hemorrhage before here.

In that posting I referenced an article written by an ED physician who missed a cerebellar hemorrhage and with more than a little courage discussed in detail how it happened.

The Proceeding authors' thesis is, in part, that more emphasis should be place on the timing or duration of the symptom(s) and on the triggers. Perhaps so but whether or not their survey indicates a major and widespread defect in diagnostic reasoning is unclear. David Drachman in a 2000 Annals of Internal Medicine editorial said that the physician needs to evaluate vision,vestibular function,motor function and search specifically for certain conditions. In other words, evaluate the patient,try and make sense of clinical findings and search particularly for potentially serious and treatable conditions. Rigid adherence to his categories was never intended.

Drachman's decades old outline is just that, an outline, a reasonable broad category checklist to consider in the evaluation of the dizzy patient not a rigid algorithm that would use a patient's description of symptoms as a mechanism for premature closure.

Consultant fees ,bribes or kick-backs to academic othro surgeons?

Medical ethics news seems to get worse and worse. Health Care Renewal refers to articles on orthopedic device manufacturers paying-in some instances-unbelievably large fees to orthopedic surgeons. The nature of what they did to earn such fees is let to the imagination but four orthopedic device manufacturers were charged with violating federal anti-kickback laws by paying orthopedic surgeons to use their products.

Sites that list in detail the physician recipients can be found on the Health Care Renewal blog. Perhaps the most striking payment was for over six million dollars to the head of orthopedics at Brighams and Women's Hospital. There were 21 instances of physicians receiving one million dollars or more from one manufacturer.

Certainly, physicians can perform various legitimate consultative activities for drug and device manufacturing companies and we do not know what the fees were for but the accusations of receiving kick-backs delivers still another blow to the prestige and reputation of physicians in general.

Earlier I wrote about the accusation of renal doctors receiving rebates for the use (and some would say the overuse) of erythropoesis stimulating agents in patients with renal failure. I have also commented on the accusation that oncologists were profiting from the in-office administration of chemo drugs and that such profit may have lead to the inappropriate use of such drugs. From my positive personal associations with renal docs and oncologists I had no reason to believe those accusations and did not want to believe them but some who commented to my blog believed otherwise. No doubt many in the lay community will apply the adage "where there's smoke, there's fire" to this most current revelation about money exchanging hands.

Several years ago my brother-in-law after paying $90 for his first month supply of Zocor commented that his physician was probably getting a kick-back from the drug company. I self-righteously told him that sort of thing doesn't happen. I am not sure what I would say now.

The old time "peripheral brain" of house officers is now the external universal mind

Returning home from a vacation in Europe I read a delightful and insightful piece by David Brooks in the International Herald tribune entitled "The External Brain". It can be found here.

I actually still have my little black book which was a lab coat pocket sized binder notebook in which house officers in the day wrote things that they thought they needed to know and no, I don't use it anymore. That and the Washington Therapeutic Manual were our "peripheral brains." I find an 40 year old entry under CHF which talks about how to slowly "digitalize" a patient with congestive heart failure and another on how to do the "Ivy bleeding time, both of which are medical museum pieces.

Brooks, in what I believe to be at least in part a tongue in cheek essay talks about how by becoming progressively reliant and dependent on his GPS system he was discovering the "Sacred order of the External Mind." He could now out-source mental tasks to a satellite brain, an external Mind. He says he may now no longer need a memory because with a few key-board strokes he can get what he needs on Google or Yahoo and the drudgery of having to remember so much stuff is eliminated or for more personal material open up his Blackberry.

He writes that he discovered that the magic of the information age was not we could now know more but that it "allowed us to know less."

The clunky,relative information-poor little black book of yesterday's intern has morphed into the powerful PDA through the mystery and magic of the silicon chip animated by the unforgiving logic of the algorithm.This can not only hold a PDR, one of the available antibiotic guides and five Minute Clinical Consultations,etc,etc but when Internet-enabled the entire universe of the external brain can be accessed.

Brooks continues " I have relinquished control of my decisions to the universal mind...Life is a math problem and I had a calculator"

One possibly disturbing counterpoint is noted in Brooks' reference to a piece by Clive Thompson in Wired which claims that one third of folks under age 30 can't remember their own telephone number.

Of course, physicians cannot really relinquish control to the universal medical mind. However, when you have the background and the context of experience, access to the "outboard brain" is unbelievably empowering and having tasted of it you never want to do without it. But as Clive Thompson said in his closing, I would like to still remember my own phone number.

There are no average patients

Dr. Robert Centor has an important entry in his blog, DB's Medical Rants, dealing with a issue dear to my heart. He refers to an article in American Scientist by Drs. Rodney Haywood and David Kent. These are the same docs who published a recent article in JAMA that I talked about here.

The basic notion here is that averages hide individual differences and Haywood and Kent emphasize the need for risk stratification to be included in randomized clinical trials.


Earlier on I had been able to access a full text version of a classic article on this same general topic but now my attempts to link to that have been met with the realization that now a subscription is required. This is a real shame as it is an article every med student and physician should read and digest.
The Journal is

Milbank Quarterly ( 82(4),661-687, Dec. 2004 and the article is " Evidence-based Medicine;Heterogeneity of treatment effects and the trouble with averages" by Kravitz,RL,Duan N, and Braslow J.

Here is the abstract ( apparently all you can get without a paid subscription now) with my addition of the highlighting of certain phrases.

"Evidence-based medicine is the application of scientific evidence to clinical practice. This article discusses the difficulties of applying global evidence ("average effects" measured as population means) to local problems (individual patients or groups who might depart from the population average). It argues that the benefit or harm of most treatments in clinical trials can be misleading and fail to reveal the potentially complex mixture of substantial benefits for some, little benefit for many, and harm for a few. Heterogeneity of treatment effects reflects patient diversity in risk of disease, responsiveness to treatment, vulnerability to adverse effects, and utility for different outcomes. Recognizing these factors, researchers can design studies that better characterize who will benefit from medical treatments, and clinicians and policymakers can make better use of the results."

Guidelines are based-ideally-on evidence.The highest rung on the evidence ladder is generally said to be the randomized clinical trial(RCT).The conclusions of RCTs are expressed in terms of averages and the problem is averages are abstractions of data and there are no average patients.

I am glad that DB is pushing on with this topic. He is widely read and a prominent educator and at least his students will benefit from discussion of averages and the madness of guidelines. Also be sure and read the insightful comments to DB's entry by Dr. Richard Fogoros

More on "Is there no end to the wonders that statins will bring about?"

Here is a link to one more in the ever growing list of the wonderful things that statins can do for us all. We now learn that the rate of loss of lung function is lessened in statin users with COPD.

Earlier I had listed some of the other benefits attributed to statins . These included

decreased risk of death from COPD and heart failure
decreased risk of advanced cancer of the prostate
decreased risk of pneumonia in diabetic patients

I also previously commented a study that seemed to show a decreased risk of sepsis in dialysis patients who took a statin. I cynically wondered aloud if some or all of these observational studies on the benefits of statins were not a big push by the statin manufacturers to generate more evidence that the value of the statins extend far beyond the LDL lowering effects and include the nebulous effects "pleotrophic" effects. Such a effort could well be triggered by the market success of Zetia.

There was also the issue of the dueling case-control studies that dealt with the question "do statins decrease the risk of colon cancer" with various studies reaching opposite conclusions. That saga seemed to prove once again you should not bet the farm based on the results of a case-control study.

I certainly do not rule out that some or all of the statins may bring about some type of benefit apart from the cholesterol lowering but the fact is the studies mentioned above are observational studies and are a hotbed of all the potential biases that we learned about in doctor school and basically cannot prove causation. and we need to particularly be wary of the healthy user effect.

changing mind set in medicine

Kevin MD references a posting on what life is like for a hospitalist at Kaiser that tells the readers more than what life is like for a hospitalist at that particular HMO.The blog that Kevin refers to is EM Physician-Back Stage Pass and here is the essay.

I believe it tells a great deal about what may be a major paradigm shift in the self image or mind set of physicians in this new culture of managed care.

Here is a quote:

Medical students and residents are seeking a better lifestyle for themselves. I guess we're finally coming to realization as a group that medicine isn't worth your happiness and sanity. That it's hardly admirable to subject yourself to abuse (by CMS, by DHA, by joint commissions,by society by medicine) and be absent in the lives of your loved one. Maybe when doctors were respected,autonomous and paid well...but now,not as much. when this happens, when docs start seeing themselves as employees with jobs,continuity of care sounds like crazy talk. Think how crazy it would sound if we suggested that nurse (or anyone else on the 'healthcare team' were made to "feel guilty" about going home at night....Everyone has a job these days..which is what government created and physicians (at least the professional societies) have allowed to happen.

The loss of pride that DrRich and I have blogged about seems evident in this doctor's view. It seems the doctor author sees himself as 'only" an employee. I re-read his piece and I go back and re-read the an early entry I submitted for this blog which dealt with the transformation of a lay person to a physician and at first conclude that our views are miles and ages apart.Or maybe my views are what I was taught a physician should be and his/hers are what the reality of the current economic medical landscape are turning physicians into.

Different meta-analytic technique fails to confirm increased risk from rosiglitazone

It was only a matter of time before someone published an article using a different meta-analytic technique from that used in the now famous rosiglitazone study by Nissen that failed to confirm Nissen's findings. George Diamond is the senior author of such an article in the Oct. 16, 2007 issue the Annals of Internal Medicine in which by using different techniques from Nissen neither an increased nor a decreased risk from the use of rosiglitazone in diabetic patients was demonstrated.( a subscription is required for full text )

No one should be surprised. The tools of the meta-analysis trade are arcane and the average or even way above average physician reading a meta-analysis either has to accept the findings at face value or ignore the thing entirely because he basically does not understand what was done and is in no position to meaningfully critique the techniques.If the issue is important and/or major economic forces have an interest there will soon be what we have here namely dueling statisticians.(I am not implying that the authors of the Annals article were motivated by those forces and would be surprised if they were)

Is the technique used by Nissen correct or is the method used by Diamond or is that even a meaningful question? It may be the case that combining disparate, incomplete sets of data, often without patient level data cannot ever answer certain questions such as the one posed by the rosiglitazone data analyses. It may well be a randomized clinical trial is the only way to possibly generate a meaningful answer which is what , at least in regard to the "rosi" question, is what Diamond et al suggested.

I have ranted on and on about meta-analyses (MAs) before and have borrowed heavily from the powerfully instructive writings of Dr. Steve Goodman. Medical students should have the following sentence grafted into their frontal lobes. The outcome of a meta-analysis is a function of the studies that one decides to include and the summary statistic used and various experts differ in regard to what statistic to use and the method of inclusion of studies.

They are basically observational studies in which the "subjects" are studies or trials and the "truth obtaining" value of observational studies is well recognized to be several notches lower that the randomized trial. Statistically combining two or three randomized trials does not always magically generate a higher degree of truth ( ie. correspondence to reality) than does the individual trials although sometimes it might. The trick is how to figure how when it does and it is a trick I have not learned.When are we dealing with apples and oranges and when are we merely seeing apples with minor and insignificant variations in color and consistency?

There is an editorial in the same issue of the Annals by Mulrow et al that says in part:

The analyses by GlaxoSmithKline,Nissen and Wolski and Diamond and colleagues and the FDA teach us that summarizing data about scarce adverse events is difficult. Summary estimates, confidence bounds and statistical significance can vary depending on analysis techniques.

This means that well meaning, honest investigators can reach completely opposite conclusions based on how they decide to analyze the data and there can be honest disagreements about how to decide on which technique to use.

But in regard to rosi I believe we cannot get the cats back in the bag. With what has been published and magnified in the news and on the web to prescribe rosi to a new type 2 diabetic would be to pin a large target on your back with a sign that says sue me please even if we really are not sure if rosi increases risk of cardiovascular events or not and we may never "really know". Sometimes issues are just dropped and we move on to something else.

Even PAs are moving away from primary care?

An article that can be found here suggests that my prediction that not too far down the road primary care will be delivered mainly by "mid level" practitioners may not be on target. It seems that fewer PAs are opting for primary care mirroring a trend in med students to shun primary care. Low pay, shrinking prestige ,cost of education and low level of job satisfaction are factors said to push docs away from primary care and the same factors may have a similar effect on PAs .

Thanks to KevinMD for calling attention to the article referenced above.

Maybe "mid levels" will be replaced by something like PA assistants (PAAs) or NPAs ( nurse practitioner assistants). The third party payer spin doctors will need a better name than "lower levels" to refer to them, however.

The 2007 Chicago marathon-a hot weather wipeout

The weather is not supposed to be hot for the Chicago marathon which is held in October. This year it was hot and so hot that things seemed to get out of hand. One news report described what took place as "havoc".

The race directors at some point canceled the race in mid course due to the excessive heat which should not have been a surprise as the preceding week had been unusually hot. Many runners continued ,however, ignoring barriers and the shut down of the watering stations. One runner died but the official report is that he did not die from heat related cause but from a pre-existing cardiac condition. Some runners blamed the race directors for poor planning and at least one person connected with the race blamed the runners for pouring water over their head instead of drinking the water. He was quoted as saying he had never seen runners pour water over their heads. He should watch runners in the summer and fall in Houston.Apparently some runners left the course to get drinks at local stores. Things did not go smoothly.

Many runners were treated by the medical teams set up for the race. This brings to mind the issue of medical management of the collapsed runner, an issue of personal and professional interest to me. Professional because internists are supposed to know all about electrolytes and the like and personal because I continue to participate in marathons and if I ever collapse I hope someone knows what to do.

I have posted before on this subject quoting the work of Dr. Noakes from South Africa who is a well known authority in this area who has emphasized the importance of hyponatremia and the critical necessity to know the serum sodium level in a collapsed runner and has urged race directors to arrange for access to point-of-care serum sodium determinations. The point has been made that determining the sodium level should precede the reflex starting of normal saline as that is not the appropriate treatment for severe hyponatremia.

This sodium issue has to be raised in regard to the death of the young runner concerning whom news reports indicate he died from mitral value prolapse (MVP).

I was puzzled as to how MVP would be the mechanism of death and my doubt was reinforced by a very recent posting by a cardiologist, Dr. Wes. He knows much more cardiology than I and he expressed his doubt about the putative cause of death.You have to wonder about electrolyte problems and arrhythmias.There are well documented deaths in marathoners due to severe hyponatremia . After the 2000 Houston marathon ,during which temperature was as high as 86 degrees, which was only slightly cooler than Chicago, there was a report of four young female runners were hospitalized with severe, life threatening hyponatremia , all of whom were successfully treated.

I bet there will be many calls from patients with the diagnosis of MVP- many of whom have in fact very little wrong with their hearts- to their primary care doctors or to cardiologists.

Yet another reason why students do not choose primary care-from DrRich

Primary care providers-at least those with a M.D. degree- are seemingly moving along a path leading to extinction. In The Covert Rationing Blog, DrRich gives us an important essay describing another reason why docs will not be going into primary care and those who in doing it now will be more likely to opt out.

The latest reason is the rise ( I am not sure how widespread the practice really is) of something called care management consultants.

Go to his blog and read his comments and the reference to a Wall street Journal article on that topic.

This is still another chapter in the book entitled "Medicine is too important (read costly)to be left in the hands of the physicians and their patients".

Cynics would say that these management consultants are just another mechanism to decrease the expenditures of insurance companies while the "vision " statements of the companies proudly state they are trying to improving the quality of health care. To read details about how the big three insurers are improving quality for folks who signed up for the Medicare funded health plans go to this essay by Dr. Roy Poses.

Are physicians no longer "proud" and "Ethical"

The Covert Rationing Blog's author DrRick uses the phrase "Once-proud,once ethical" to refer to the medical profession. I certainly do not want to believe that the modifier "once" is correct.
However, there seems to be much awash in the land to push the vectors in the direction of less pride and less ethical behavior.

When a doc has to depend on a clerk in some distant place to tell her if she can order a certain test or prescribe a certain drug or perform a certain operation, obviously pride will suffer. What does it do to the ethical framework when a doc in tempted to game the system to make it possible that that test or that drug can be ordered or that operation be perform? How much pride can you feel when you rush through a 7 1/2 minute patient encounter when you realize there are issues that the patients brought up that you can only brush off and move on to the next overly-hurried,doomed to be incomplete patient encounter?

What happens to pride when your medical group agrees to mandate 32 patient encounters per day rather than the leisurely 30 you now plow through? Does your spider-sense ethics tingle
annoyingly when you realize you are setting the stage for even more inadequate medical practice solely because of the perceived need to increase volume? Does your pride titer decrease when you agree to no longer attend patients in the hospital, even though a major part of your internal medical training and to date professional experience has been caring for seriously ill,complicated patients in the hospital and you know that you can do a better job than the recently hired internist-self proclaimed hospitalist who is one year out of training solely because it appears to be economically advantageous to do so?

Does your pride suffer when you see the latest survey of professional compensation that illustrate that your years of training as a internist or psychiatrist or pediatrician or family physician earns you about the same as a CRNA?

What is the effect on your pride when you are labeled a "disruptive" physician because you repeatedly pointed out that the four-hour rule for treatment of pneumonia is wrong headed and likely to cause more harm than good?

I personally am not proud of the-what I consider to be a sea change-in the stated principles of medical training for internists? I refer to the deletion of what was the touchstone of an internist's training- "... in no case should the resident go off duty until the proper care and welfare of the patient is ensured."

I personally am not the proud of the concepts slithered into the new medical professionalism.I have written about this before .I refer to an attempt to substitute for the time honored and pride generating fiduciary duty to the patient a collectivist view of conserving society's resources.

Having said all of that, the really big elephant in the room derives from the fact that much of medical care is paid for with other people's money and as expected those other people want to spend less money and much of their concern seems manifest -as DrRich has eloquently explicated-by covert rationing. With those economic forces at work pride and traditional medical ethics are not likely to enjoy any resurgence any time soon.

Who is at risk for venous thrombosis on long haul flights?

A large international study from Leiden attempts to answer some of the questions regarding venous thrombosis in air travelers and is available here in PLOS.This was a large (n=8755) follow-up study (over a five year period) involving employees from a number of companies.

First on all, short flights-less than 4 hours-seem to not be an issue while longer ones may be.

Some interesting observations were made.

Shorter travelers ( less than five five) and taller ones(over six one) seemed at greater risk and- perhaps surprisingly- so did younger folks (less than 30 years of age). So, it seemed best to not be too young, short or tall. Some speculations regarding vein compressions in the short and not enough room for the legs in the tall seemed plausible but why younger travelers. The investigators suggested that one of the many epidemiological traps for the unwary might be in play.This may be an example of the "attrition of the susceptibles". Individuals who are susceptible to a given event are likely to experience it soon after the start of exposure.The younger travelers likely had not been doing long haul flights for very long while the older employees had and those with clotting tendencies may have been deselected-i.e. no longer traveling or perhaps even taking prophylactic measures.

The relationship between risk and "extremes" of height had been made previously as had their other major observation that women on oral contraceptives had an increased thrombosis risk (Incidence rate ratio of 3.6). I had blogged previously about a 2006 JAMA article which presented some evidence that a major factor in the pathogenesis was blood flow alterations as opposed to coagulation system changes brought about by the flight.

The best advice still seems to be to get up and walk around as much as you can on long plane trips. What about the patient who has previously experienced a thrombotic event in temporal proximity to a long air flight and who is ready to travel again? Should they take low molecular weight heparin pre- flight? I think I would.

Policy side effects:thinking beyond Stage One

DB 's MEDICAL RANTS recent comments about the need to consider the potential "side effects" of health policy decisions stimulated me to revisit Thomas Sowell's Applied Economics-Thinking beyond Stage One. Economics seems to be much about effects and side effects.

In this book Dr.Sowell examines economic policies in terms of their "later repercussions" not just their immediate effects of their apparent aim or their "hoped-for" result.For Sowell, a program's "unintended consequences" are often foreseeable if the processes involved were considered in terms of the incentives and constraints and not in terms of the desirability of the goals. Rent control brings abut housing shortages,black markets and poor quality housing not the
readily available, affordable housing promised for the poor.The caps on earning found in some Canadian provinces predictably brings about shortages and long waiting lines as described by the former Canadian, The Physician Executive. Tendency to cherry pick patients and treat the chart and emphasize quality measures while ignoring other important features of patient care were clearly foreseeable consequences to P4P.

The seasoned physician knows he may have to wait a while to learn about the problems that may occur with use of a new drug (i.e. those side effects not evident in the randomized trials that are done for drug approval). However,the shortages and other problems that are well recognized with socialized systems such as Canada and Great Britain are things that should not surprise us when they appear if similar systems were put into place in this country.

With relatively uncommon,non-acute side effects we often just have to wait and see if in the long term a new drug will cause harm while with certain policy moves using knowledge of human nature, history of how things have worked in the past and analyzing the relevant incentives and constraints we may well know what to expect.

Applying group data to individual patients-the problem revisited and perhaps a solution sugested

How does one apply the results of even the very best designed and executed randomized clinical trials (RCT) to the individual patient? I guess the answer is very carefully and not too literally.

I have written about this issue here in discussing the classic,everyone-must-read, article from the 2004 Milbank Quarterly by Kravitz, Duan and Braslow entitled "Evidence-based Medicine;Heterogeneity of treatment effect and the trouble with averages". It can be found here.

The basic fact is that everyone does not react the same to a given medication.The summary statistic of a clinical trial does not reveal that there is a mixture of

"substantial benefit for some, little benefit for many and harm for a few"

In other words you cannot expect the average effect to occur in your patient.

In the Sept 12, 2007 issue of JAMA, David Kent and Rodney Hayward revisit this issue and offer what they believe to be a solution to the problem. ( "Limitations of Applying summary results of clinical trials to individual patients-The need for risk
stratification",JAMA vol 298, no 10, pg 1209.

They propose that the answer is risk-stratified analysis which will greatly increase the power of the detecting the critical differences in treatment effect but ,the authors suggest is rarely used. I am not sure I have ever seen it used in a major clinical trial publication.This risk stratification is supposed to be a definite improvement over the simple sub-group analysis which typically takes one characteristics( e.g. gender or some co-mobidity) at a time,the problems of which are well known including lack of power and increased likelihood of false positive associations.

Had the authors treated us to a few good examples it would have been more convincing;the one graphical illustration of how this method improves things probably will not turn the heads of many readers.But it is good that folks who know more about statistics and analysis than I do are thinking seriously about improving the way we use group data to manage the patients who have a pernicious tendency to be individuals.

New COPD guidelines-the guideline epidemic continues unbated

Here is a link to comments about the new GOLD COPD guidelines and here are the guidelines. Even with references it is only a merciful 26 pages.

The category of Stage 0 was eliminated which makes sense to those among us who wondered abut the logic of defining the first stage of a disease as a condition that poses the increased risk of that disease.

I was glad to see that mention was made of the problem of overestimating the degree of impairment using spirometry in elderly patients, particularly if one uses the percent predicted methods. This method designates a given FEV1 , for example, as 76 or some other number percent of predicted. This method works fairly well, although it never had sound statistical basis, it just happens to work reasonably well but older folks and shorter people tend to get short shrift and appear to be more imparted that they should be. Further there is a normal decrement in lung function which is incompletely "Corrected for" when one use the percent predicted formula.I don't have a solution for that other than be aware that the old folks' pulmonary function impairment may not be a severe as the percent predicted value would indicate.

Some of the old time lung doctor treatments are not recommended including mucolytic agents and continuous antibiotic prophylaxis.

P4P and Covert rationing

DrRICH's posting on P4P is a masterpiece and it is only Part One. I have ranted on and on about P4P here wherein I seconded the notion that it was unethical and as such physicians should not be negotiating about the details of the process and here wherein I discussed the disastrous results of an insurance carriers P4P program in Seattle. His posts delve into more sweeping and fundamental aspects.

He tackles the Axiom of Industry that states:

Standardization of any process improves quality and reduces cost.

The axiom may make some sense in processes involving making widgets and it that setting may be able to actually increase quality and decrease cost but for the most part medicine involves processes involving living human beings and their diseases both of which vary widely along multiple dimensions making , for example, treating someone with heart failure as different as it could be from making widgets.

P4P is only part of the current landscape of medical practice which is dominated by managed care. DrRich offers a description of and an insight into this world in which words may not mean what they seem or are usually taken to mean and one in which the goals of the physicians and the managed care companies could not be more in opposition. Simply put, if physicians do their job they may well spend the insurance company's money, while if the insurance company is doing its job it will not spend money.

Practicing physicians who take the time to read his "Manged Care in an age of covert rationing" will never look at what they do in the same way again and if medical educators do not make its reading mandatory they have little defense against the accusation of dereliction of duty.

MEDICARE taketh away and giveth back -sorta

Recently, various Government agencies have been very active in regulating the use of erythropoiesis stimulating agents (ESAs) . The major ESA players are recombinant human erthropoietin (Epogen,Procrit) darbepoetin (Aranesp). In several groups of patients (mainly renal patients and patients with head and neck cancers receiving radiation therapy) clinical studies indicated increased mortality and thrombotic events in patients in whom the targeted hemoglobin was greater than 12. This lead the FDA to issue safety warnings and guidelines regarding the target level of hemoglobin and then CMS to propose limitations on Medicare and Medicaid coverage for the use of ESAs. This is a follow up to an earlier posting regarding this issue bearing some limited "good news".

Unfortunately, not only were renal patients the focus of proposed Medicare coverage restrictions but also were other clinical groups who have received ESAs with clinical benefit. Of particular concern to hematologists were patients with myelodysplastic syndromes (MDS). There is a ten year history of safe use of ESAs in MDS and evidence that there is improved survival and decreased progression of MDS to leukemia as well as decreased transfusion requirements .

Several professional groups ( including the American Society of Hematology, SWOG and ASCO) protested to CMS regarding possible restrictions regarding use of ESAs in MDS patients and apparently CMS listened and made no national coverage determination (NCD in CMS jargon) limiting its use in MDS patients.This gives the green light to its use if there are no limitations imposed by regional Medicare carriers.

So, it is at least a partial victory for the physicians and their patients but battles may still have to be fought with the local Medicare contractors.

Some of us can still remember from the early days of Medicare when the powers that be needed the cooperation of both physicians and hospitals to make the thing work and they promised to not interfere with patient treatment and the physician and hospital fees were not directly determined by the government. The days of " reasonable and customary" charges are long gone and doctors now have to refer to the latest CMS decision memo to see what medications they can use.

New Asthma guidelines-some more some less

Here is the latest version of asthma guidelines. The full report is 487 pages and is entitled " Guidelines for the diagnosis and management of asthma." Asthma specialists can be appropriately proud because this report is longer than the 304 page tome penned by a joint group (ACC/AHA) dealing with the 2007 guidelines for the management of patients with unstable angina/non-ST segment elevation myocardial infarction. Both overshadow in bulk the rather brief (88 page) guideline publication from GOLD (Global Initiative for Chronic Obstructive Lung Disease) and the 2004 86 page treatise (JNC 7) which still incites seemingly irreconcilable differences between blood pressure experts regarding how to treat blood pressure and can be found here.

Not only are there more guidelines published all the time they seem to get bigger and bigger.The dominate paradigm seems to be "more is better". Recent discussions regarding asthma are suggesting that in regard to mild persistent asthma less may be about as good as more in terms of intensity of therapy even while the guideline verbiage grows and grows.

It will take sometime to contrast the details with earlier versions of the asthma guidelines but one difference I noticed was that there it is permissible ( or mandatory) to not only increase treatment when control is not adequate but it is also allowable to actually decrease treatment intensity when asthma is well controlled.

I will need a little more time to try and wrap my understanding around what I might really need to know after the fluff is filtered out (you can't have a paper that long without some fluff) but here is what the reviewer for Med Page Today had to say about it and here is an overview with some details from Medscape. Long acting beta agonist (LABAs) are not recommended as mono therapy for persistent asthma nor for treatment of acute exacerbations. Lip service is given to long acting theophylline oral medications as an alternative but I suspect the docs using them are hard to find. Fortunately, the panel was not frightened off by the meta-analysis published by the Salpeters,which I ranted about over and over, and continue to recommend the use of the combo treatment of LABA plus inhaled steroids.

The idea that we may not need to treat mild persistent asthma as aggressively (intensely) as we now recommend has been written about recently in two clinical trials in the NEJM and in the form of an editorial in the Annals of Internal Medicine. The NEJM articles can be found here and here.

One of the reason for use of so-controller ( as opposed to rescue therapy) in persistent asthma is the expectation (hope? theory?) that chronic mediation will control or minimize the inflammatory processes so that long term lung function loss will not occur. Short term trials of such therapeutic ploys such as use of rescue combo inhaler of an ICS plus a LABA ( as was done in one such trial ) cannot address the long term concerns and I suspect that ICS will continue to be the mainstay of the treatment of persistent asthma for some time to come.

Efficient claims payments is the last thing Medical insurers want

Everyone who has ever been stooged by Insurance carriers regarding medical claims, patients and physicians alike, has to read this entry in the Covert Rationing Blog and , of course, everyone has been stooged. DrRich has this great comment describing how insurance companies screw docs out of their fees.

They accomplish this by employing byzantine rules, by strictly enforcing unintelligible requirements that shift like the sands, by establishing arcane appeals processes, and, when all else fails, by generating a series of black holes into which claims mysteriously disappear, so that (if the doctor still insists on being paid) the claims process must be initiated all over again. Call it the “Shoots and Ladders” model of claims processing.

If we need to squeeze just one more sentence into the medical school curriculum, it should be that one.

DrRick refers the readers to details written by Dr. Stanley Feld in the blog Repairing the HealthCare System.
Go there to learn more alarming and infuriating details.

Consequences of Medicare's new don't pay for certain problems policy

Dr. RW discusses some of the problems associated with Medicare's latest ploy to decrease costs. You can bet there will be predictable consequences and some others we might not be smart enough to predict.

In my consultative foray into certain limited aspects of occupational medicine, I had the opportunity to see some consequences of a OSHA program which on the face on it was designed to improve workplace safety. Employer are supposed to record on a form (at the time the OSHA 200 form) certain injuries at work. Plant managers looked at the statistics and the safety officers were either given high marks or trouble depending on the numbers. If the safety officer were imaginative enough he could turn a real injury into one that did not require recording but the event still occurred. If an employee twisted his ankle on a slick walkway it would not be recorded if he could accompany the employee to the ER and convince, cajole the ER doc to treat the worker without using a prescription medication as that would trigger a recording. Basically the record was treated and more time was spent playing the game than working to improve workplace safety ( at least in some instances).

You can be certain that hospitals will be as least as devious and clever as some workplace safety officers and will devise ways to treat the record or spin the facts or something to minimize the "occurrence" of those complications the treatment of which will be no longer paid for by CMS. Hospitals will find ways to cheat and it is very unlikely that those ways will improve patient care.

If we required evidence before initiating quality projects, there would be many fewer such projects

This thoughtful and -I think-spot-on commentary in the NEJM is worth reading.I always like to read things that make me say, "I wish I had said that", things that fit my current set of biases and beliefs.

The authors' main message is that in the rush to do the "right things" regarding improving medical quality and improving safety in health care, sometimes ( probably many times) the rules of evidence have been suspended. We are not demanding the same evidence we would to use adopt a new therapy. Quality measures are put into place without proof of efficacy and safety and often after they are in place no systematic evaluation of their value is done and to suggest that they should be is likely to evoke accusations of not being a team player or even worse being disruptive. It seems as if the skeptical analysis of the scientific approach has been pushed aside by blind belief in and allegiance to the paradigm of continuous improvement and other management buzz words of the month.

The authors list and refute a number of pseudo reasons used to justify programs that lack evidence of their effectiveness . Here are some of them.

Argument 1: We cannot wait.

Argument 2: Anything we do to improve something must be better than what we have now (my paraphrase)

Argument 3: Company X did it and it was great.

I can particularly relate to number 3. I had the occasion to do consultative work for 2 large corporations over the years and had the opportunity to be a bemused fly on the wall on some of the quality projects . Since it widely believed you have to quantify something to show how much you have improved, a early session with the highly paid outside consultant quality experts involved a mini course in how to draw a x-y graph. The pupils in the class I sat in on were from the company research center and were in fact senior scientists there most of whom had a PhD
in some hard science area. They were all made to do a "quality" project and then everyone had to agree how helpful it was. Later the company claimed how valuable their quality project was.

Some of the baseless medical quality efforts may not be as blatantly hypocritical as this one but the nurses and doctors who often get caught up in these programs feel the same type pressure to be a team player and not "disrupt" the effort with thoughtful criticism or healthy skepticism.

Twenty years ago when I began to do some consultative work with the corporate world,I felt rather smug that my field (medicine) was immune to the Dilbert like silliness that seemed to pervade the corporate culture. However,medicine has become more and more corporate and the business school belief that one does not need know a business to run it is increasingly applied to medical practice . The business-speak jargon now echoes through the hospitals and clinics and we talk about vision statements and leveraging this and that and the suits with MBAs are no longer minor distractions but are in control. What the Dilbert cartoons depict are as applicable to much of medicine as they are to the bureaucratic world of big business.

UnitedHealth Group's "Medical Home" -Old wine new bottle?

DrRich in his latest commentary in The Covert Rationing Blog delves into the Medical Home as it is being put into motion by Unitedhealth Group. I am glad to see someone else expressing concern about this latest effort to control costs using a different rhetorical smokescreen. I had had my say about that here.

Dr. Rich says it well:

Whether you call it medical home, pay for performance, or just plain managed care, as long as the big insurers (and the feds) are the ones who determine the doctor’s viability as a practitioner, and as long as patients are the individuals who cause doctors to risk their viability as practitioners, the genuine practice of medicine - and the fabled doctor-patient relationship - must remain fond dreams.

I continue to be puzzled about the role of ACP in all of this.Is the leadership naive or is this nudge,nudge wink, wink or do they want to be the power position of making the rules that the rank and file physicians will play by? The family docs might be asking similar questions about their self appointed leaders. Is refusing to participate in all plans and Medicare the only way to maintain the doctor-patient relationship that some of us remember ?

United Health Care Teams with internist,peds, and FP groups for medical home-for whose benefit

Health Care Renewal raises important concerns and asks pertinent questions regarding the recently announced alliance of Unitedhealth Group and ACP( and AFP,AAP and AOA) here and I will not repeat all of Dr. Poses's points but wish to add a few concerns of my own.

The press release talks about how the physician in the medical home will be responsible for the patient's total health picture. How does that work if/when the patient goes to see another physician for a medical condition outside of the internist's area of competence? This pesky problem of freedom has always vexed planners of medical care systems.Will the patients have to sign some sort of exclusivity care arrangement.?

When I first read about the concept of medical home, I thought it was just another lame attempt by ACP to try and do something to salvage the dwindling away of internists ( I remembered their slogan of internists as "doctors for adults) but although available details (while quality platitudes are plentiful) are still sketchy we can get some sense of what operationally this medical home concept might be-at least in the version involving a major health insurance company. My early assessment is that we will see more of a third party's attempt to save money on health care and exert more control over physicians using a new rhetorical cover .

Let's look at what the press release says about the role that United Health Care will play.

UHC will support it by integrating its extensive quality improvement and care management programs into the practices's infrastructure. I imagine this will include practice guidelines and algorithms and flow charts designed by UHC by some process that mere private practitioners could never generate the mental juice to conceive which will be more efficient (translate save more money) and of course, improve quality.

In regard to the payoff we learn the following:

Unitedhealth Group will pay participating practices a monthly management fee based on projected savings for all patients that select a medical home...the company will share any excess saving (excess saving is an interesting concept) that accrue from the pilot program and by way of premium reductions with employers.

This looks like a combination of capitation and reward for being a compliant doc. Does this sound like an HMO? Is this an early effort to set up the "integrated delivery systems" that I have ranted about before and have been hyped by leaders of ACP and the medical insurance industry.

Apparently some medical groups have agree to go with this. I cannot conceive of agreeing to a set of practice guidelines approved of by a major third party payer and to compensated in part by how well I complied with these guidelines, most if not all of which are not likely to be made known before the agreement and the basis and origin of which are probably proprietary . Talk about selling your soul to the devil and probably for not much of a good price. All this with the blessing and cooperation and encouragement of the ACP and the other professional groups.With friends like the ACP, practicing internists......

I suppose the same could be said for pediatricians and family docs because
the leadership of pediatric and family practices organizations seem to be fellow travelers in this journey to what sounds something that makes regular managed care a pretty good deal.

Dr. David Dale, President of the American College of Physicians offers reassuring words:

Primary care practices should exemplify ...dedication
to team care,...clinical information systems, ...coordination of care ,and (we should never forget) continuous performance assessment and improvement.

Multi "generational" agreement -it is all about time (and money)

Health Care Renewal called my attention to a Over My Med Body posting suggesting another force pushing in the direction of fewer docs going into primary care, time spent with the patient during the clinical rotations in medical school. He points out that in the teaching clinics the primary care patient are zipped through in 15 minutes-never mind they might have 5 different illnesses and 10 different meds and three new complaints-while at the specialty clinics 30 minutes is allowed.The student has more time to understand what is going on and naturally feels better about the encounter there than in the primary care clinics which may well influence his choice of career path.

Dr. Robert Centor in his blog, DB'S Medical Rants, has repeatedly emphasized the importance of having adequate time as have I. So, we have medical students, physicians in practice and even retired physicians all agreeing about the importance of time.Yet third party payers and managed care have pushed to allow less time(more throughput) per patient encounter and it is the practicing and retired physicians who have allowed this to happen.

Of course, the even bigger driver in the demise of primary care physician and the underlying reason for the time crunch is the paying-with-someone else's-money- reimbursement issue which is discussed brilliantly by Dr. Roy Poses here.

The FDA's deliberations on Avandia-worthwhile insights

Dr. Clifford Rosen speaks candidly in the NEJM about the multi-faceted situation regarding the issue of cardiovascular risk of Avandia and how hard it is to pluck out the "truth" from often conflicting and incomplete data.

His full text comments are available here from the NEJM.

One of the important points he makes is that is more than just very hard to discern small increases in risk between groups when the disease or event of interest is fairly common such as myocardial infarction. I have written before about how statistics works well to find big difference but struggles to differentiate between small things and nothing at all.

Dr.Rosen provides a good overview of the various data sets that were analyzed in the FDA panel's effort to reach a decision about what to do with Avandia. I believe at the end of the day public sentiment and physician assessments of the risk has for the most part lead to the end of the road for Avandia.

He also speaks of several guiding principles to apply in regard to drug approval.
Two of which are :
the pathogenesis must be "fully understood"
treatment options should be clarified through an evidence based system.

Worthy aspirations to be sure, but I doubt we can wait for the pathogenesis to be "fully understood" to make judgments. What diseases can you think of in which we fully understand their pathogenesis, certainly not hypertension, heart failure,diabetes, depression for which many drugs have received FDA approval.

The Avandia saga and the panel's deliberations illustrate how difficult it can be and usually is to discern the truth from conflicting and incomplete data. At the end of the day someone has to decide something. It is commonly said of trials and court decisions that they do not produce justice so much as they settle the issue and the participants can move on. FDA's decisions are sort of like that.

Quality can be hazardous to your health

"No man's life,liberty or property are safe when the legislature is in session".

This thought has been attributed to various sources but according to this website, it originated in a court decision in the 19 th century. Having read about the harmful and probably unintended consequences of some quality rules ( the word guideline has become a euphemism) I believe you could as well say : " When the quality rule makers are at work, no patient's well being is safe".

The four hour pneumonia antibiotic treatment rule has lead to patients without pneumonia getting antibiotics within four hours of arrival in the E.R. A recent posting by Dr. RW pointed out the weak evidence supporting rigid blood sugar control in sick hospitalized patients is poorly suited to mandate such an approach to all sick hospitalized patients yet guidelines mandating just that seem to be being prepared if not already proposed.Peri-operative use of beta blockers became a guideline but now there is more than a little doubt about the utility universal application.

The evidentiary best of the quality rules are supported to varying degrees by randomized clinical trials but even here one should proceed slowly as the reality of the well known efficacy-effectiveness gap tolerates simplistic approaches poorly. RCTs are often small and fail to capture the rich and perplexing diversity of relevant pathophysiological variables (known and unknown) that coexist in complex, hospitalized patients. It is in the sickest patients that rules formulated by committees based on what-ever that the most harm can be done and in whom the pathophysiological diversity is likely to overwhelm premature generalizations and an overly eager rush to mandate treatment rules.

The hubris,arrogance and naivete that I believe characterize those who make rules for how to treat individuals based solely on group data ignoring the input of the physicians on the scene is even worse that the folks who simplistically sprout out coarse grain outcome data quality indicators such as percentages of patients with HbA1c less than 7 %. In the later they are just counting beans in the former they are making rules about treatment decisions that might be determinative of the outcome. It all seems to be part of the notion that medicine is too important to be left to the individual physicians and patients.

The mandatory and quasi mandatory nature of guidelines or quality indicators as wielded by the CMS mandarins become even more dangerous with the spreading use of the "disruptive physician" doctrine. Not only must you go by the rules you can't complain about them without incurring the wrath of the hospital's disruptive physician committee.

In a recent post Dr. Robert Centor , of DM's Medical Rants quotes from a thoughtful article that correctly states that black and white answers are rare in clinical research and those that may seem clear cut today may not be as more data are accumulated. Committee derived quality indicators mandate that the grey be magically transformed into black and white and CMS and other third party payers give powerful financial valence to the process .

Crisis in medical professionalism or 'professionalism" highjacked for social policy agenda

A commentary in the August 8,2007 issue of JAMA by an international group of authors (U.S.,England,Canada) presents the notion that the professional responsibilities that physicians are "honor bound" to fulfill are beyond the control of individual physicians and will require a "medical societal alliance". Only an extract can be found on line here. ("Alliance Between Society and Medicine",The Public's stake in medical professionalism", Cohen,J, Cruess, S and Davidson,C. JAMA vol. 208, no.6,p 670)

On first reading you have to wonder what the authors are taking about because when the basic ethical precepts of a physician come to mind no alliance of anyone to anyone else seems to be required or even makes sense. The physician is the one solely responsible for not harming the patient, placing the patient welfare first, honoring the patients autonomy and the confidentiality of the patient information.etc. So what are they talking about?

However, it is not the old but the new tenets of professionalism that the authors believe to be unworkable by physicians solely by their own efforts. You may ask when did we get new ethics and what was wrong with the old ones

The new ethical precepts were written in a joint effort several groups of internists (ACP,ABIM, and the European Federation of Internal Medicine) and was revealed to the world in 2002 in the Annals of Internal Medicine and spoke of three ethical principles:

Primacy of patient welfare.
Principle of patient autonomy
Principle of social justice, "to promote justice in health care including the fair distribution of health care resources"

The professional responsibilities that physicians cannot achieve by themselves in living up to the third principle are enumerated in the JAMA article and include the following all of which the authors say cannot be done without this alliance. (some have been paraphrased for brevity)

ensure that all have access to basic health care
provide an infrastructure to improve quality and safety
construct a medical liability system that encourages dissemination of lessons learned from medical error.
align payments with professional values and performance
provide medical education and research funding

The authors leave undefined the nature of this alliance but we are told it must "interrelate .. with the country's policy and decision making apparatus" ( I think this means government) and the primacy of public welfare,public accountability and social justice must prevail.

I have written before about the serious conceptual and ethical problems of inclusion of the concept of social justice into medical ethics before.

The JAMA article is basically the work of the same folks who gave us the new professionalism rules as it arose out of a meeting with the European internists and ABIM and ACP. Some of the same players (Dr. Casell of ABIM and Dr. Brennan of Aetna) wrote an earlier article in JAMA that may give us some hint about one road this alliance could take to make real many of its goals. That article,that I have written about before, speaks of large vertically integrated health systems that would be responsible for the health of groups-the so-called "accountable care organizations" or "integrated delivery systems". What better than a giant HMOoid organization could provide quality,cost effective, just, efficient,professionalism-promoting, conflict of interest free, patient centered, evidence based compassionate care and thus prevent the "public health crisis" that is brewing if we do not stop the erosion of medical ethics?

I cannot help but notice that is took five years for the folks who brought us the new ethics to realize ("on close reading'") that the precepts that this international consortium devised were in fact something that was beyond the control of physicians in the first place. Could the positioning of the concept of social justice into medical ethics serve to highjack medical ethics into promoting a social agenda and will the insurance companies quietly gloating not be in the wings ?

Physician fiduciary duty-a thing of the past?

Has the increasing hegemony of third party payers over physicians lead to a change in medical ethics, one that is compatible with and may even serve to justify a collective approach to medicine.

Until it was deleted in 2003 by the ACGME, Resident Review Committee (RRC) for Internal Medicine, the following statement was a touchstone of IM training and future practice ;

"Physicians...must recognize their obligation to patients are not discharged at any given hour or any particular day of the week.In no case should the resident go off-duty until the proper care and welfare of the patient is ensured".

It has been suggested that the most significant change in post graduate medical education occurred in 2003 when the ACGME instituted rules limiting house office duty hours. I suggest at least in regard to internal medicine the above omission signaled a more significant change.

However, I believe a broader change occurred with the publication of the "New Professionalism" In this, physicians are charged with more than care of their patients they are somehow to serve as stewards for the collective medical resources.

The New Professionalism speaks of three fundamental principles

Primacy of patient welfare. Here they got off to a very good start and one that apears to be without conflict with the (unstated) "old Professionalism".

Principle of Patient Autonomy

Principle of Social Justice. Here physicians are urged to promote " justice in health care including the fair distribution of health care resources".

In the first two principles the issue is simply ( simple in theory not in practice) to do the best thing for the patient. The locus of concern is the patient. Fidelity to his/her welfare , to act in the interest of the patient are the goals of the physician. In the third- problems arise, however.

"Justice" is a term with multiple meanings and interpretations but the authors of the new professionalism seem to specify a certain type of justice, namely "social justice". However, even the term social justice is not without different meanings and interpretations. Libertarians would argue that social justice in one of its more common interpretations violates the principle of "non-aggression". Social justice advocates commonly argue for equality of results versus the libertarian view of equality of opportunity and equality under the law and for legislative actions to bring about those allegedly fair outcomes.

Similarly what one considers as fair is determined in part by what concept of justice one has.

The arguments and related philosophical considerations could take up volumes but my point here is simply that the terms social justice and fairness do not mean the same to everyone and there is no reason that a small of physicians ( the authors of the "New Professionalism") should preemptly settle those arguments and disagreements by declaring what philosophical stance is appropriate for the physician as she practices medicine.

Critics of the new professionalism argue that the first and third principles stand in contradiction to each other. Proponents counter simply that there is no contradiction. This is much like the arguments that goes "health care is a right" "- No it is not." Debate will not settle polar opposite views .

I believe that principle number three justifies a collectivist approach to medicine and if one follows the "follow the money rule of thumb" the new professionalism could serve well as a philosophical cover for the "movement" that claims that the solution to all of American medicine's problems are medical collectives in which the greater health good can be achieved. Physicians who are locked into the fiduciary model would not be eager participants in this new world and the philosophical trial balloons for a utilitarian alternative have been floating for some time.

Fewer internists passing re-certification exam

According to an ABIM website in 2001 the first year of the current re-certification test for internists 92% passed, in 2004, 86 %passed the re-certification exam ( now called maintenance of certification or MOC) while in 2005 84% passed, now we are told the pass rate is down to 75%.

Is the test harder or less relevant to what internists do and need to know or is the knowledge base of the internists falling in proportion to the test scores? Are younger internists not as sharp as the older docs, a position 180 degrees from the views expressed a while back in an Annals of Internal Medicine editorial by Dr. Christine Cassel in which she defended and accepted an unusually poorly done article- see here for some comments regarding that issue- that claimed as physicians aged so did the quality of their care.

Dr. Cassel, President and CEO of the American Board of Internal Medicine (ABIM) defends the test and opines that perhaps the current cohort of internists are less competitive,whatever that means.She also wonders if those who take the test early (certification has a ten year cycle and some docs may take the test early and she thinks those may be less prepared because they will have another chance before they are defrocked.)

I have a theory that could actually be tested by surveys of the test takers. Could the decrement be due to more general internists limiting their practice to office patient encounters? If you never treat seriously ill patients in an in-patient setting how current do you feel you should be in regard to a wide variety of medical conditions? Your practice is more involved in seeing if your patient is at goal for this or that and have they had their bone density and flu shot than the choice of antibiotics for a seriously ill patient with pneumonia or sepsis or how to manage emergent upper GI bleeding. It would be interesting to know if internists who practice as hospitalists do better than those whose office day is closer to that of the typical family practice physician.

Hospitalist-A deal with the Devil or why bother to learn all that ICU stuff?

D. Rob has a thoughtful piece concerning his group's (IM-PED) experience with the new world of the hospitalist. Dr. Rob is a meds ped physician and in the era pre hospitalist he spent considerable time caring for sick IM patients in the hospital and taking call which on weekend was often a time of no stop work.

Enter the hospitalist. Now his office is more available to patients ( longer hours), his pay per time spent is better, and there is more sleep and family time. This , in a many ways, could be portrayed as a win-win situation for the office based physician who does not do hospital work.

But ,as he explains, everything did not get better. His patients ( the folks he sees now only as outpatients) have their care fragmented and all are not pleased by having a stranger as their doctor at a time when they are sickest and most vulnerable to stress and fear. He laments that typically there is a major informational disconnect between the in and the out patient care.

So it is a trade off. If you follow the money you have to conclude that there is little chance that the hospitalist movement will be reversed. Both the hospitals and the office based physician seem to benefit financially.

If a residency trained internist becomes a "officist" you have to wonder what was the point of the ICU, CCU sick-patient training in the hospital that he endured and that in fact took up the bulk of his training. I suppose you could say he will be more able to recognize who needs to go be temporarily managed by the hospitalist and arguably better at zebra spotting which could be offered as one feature distinguishing the office internist from the FP physician which may well be a distinction without a difference in the eyes of the patient . As best I can tell and as much as I hate to say it in regard the average 10 minute encounter with a blur of a white coat there is little or no difference if the coat is worn by a FP or IM doctor except the former probably does a better job with derm and office type ortho problems.

Air quality in airplane cabins and TB

I have held for a long time an erroneous idea of the risk of disease transmission aboard airplanes.I envisioned the passenger cabin as some sort of 3-d Petri disk crammed full of various viruses and other pathogens just waiting for a new host.

An excellent article in the July 2007 issue of Mayo Clinic Proceedings corrected my misconceptions. The editorial " Dealing with threat of Drug-resistant Tuberculosis" written by Dr. Priya Sampathkumar is an excellent review of the basics of drug resistant TB and the quality of air in a plane from a medical point of view and can be found free, full text here.


He tells us that the recommended rate of air exchanges in a hospital isolation room used for TB patients is 6-12 exchanges per hour while modern passenger aircraft have 20-30 exchanges per hour. Further,there are high efficiency particulate air filters that remove 99.9% of particles that are between 0.1 and 0.3 micra. The TB bacteria is about 0.5 to 1.0 micra. More reassurance comes from the fact that air enters and leaves the cabin at the same seat row there being little flow from the front to the back of the plane. Of course, all of this assumes everything is working as it should and as always anything that can work can break down. The cases of TB that have been linked to in-flight exposure apparently all occurred in persons who were seated within 2 or 3 rows of the patient.

White Matter Lesion (WMLs) link hypertension to frontal lobe dementia

A good deal of evidence links leukoaraiosis (white matter lesions or WML) to decline in executive function and there is much evidence linking WML to hypertension.

Here is a recent paper linking non-amnestic mild cognitive impairment(MCI) to hypertension.
A number of cross-sectional studies linked hypertension with WML, here is one prospective study showing the same findings increasing the weight of the evidence of the association.

The periventircular WMLs seem to correlative with frontal lobe dysfunction ( such as diminution in executive function) and also with abnormalities of gait. In fact, a paper from the Bronx Aging study published in NEJM showed a clear relationship between the development of a "frontal lobe" type gait and the subsequent appearance of a vascular type dementia with relatively good retention of verbal memory skills but much difficulty in executive function. The widely used Mini-Mental status is not a great tool for detection of the "hypo-frontal" patient. Watching the patient walk can give valuable information about the elderly patient whose mental status has become an issue.

Oscar the cat,confirmation bias and NEJM editorial judgement

All of the above topics were touched upon in an excellent posting by Dr. Steven Novella. You would expect the President of the New England Skeptical Society to be skeptical and he is as he discusses the matter of a nursing home cat whose visits to residents of a certain nursing home are claimed to portend imminent death. An article in the NEJM called national attention to this claim.

One thing to consider in regard to this and similar claims, this would include the famous seizure dogs and weird things happening when the moon is full, is the phenomenon of confirmation bias. A related thought is expressed in the concept of "numerator based"statistics. In Oscar's case the article in the NEJM failed to give us the denominator of interests , i.e. the number of visits made by Oscar to patients' rooms and beds.

Should the NEJM publish stuff like this? It may well have been intended to be a cute (although nursing homes deaths might not be considered the stuff of cuteness) rather whimsical piece of writing and nothing more, but the editors might want to consider how much impact their publication has and that rightly or wrongly folks tend to believe what the NEJM writes.

You can tell a big thing from a little thing but a litle thing from nothing at all is really hard

I have obsessed about the issue of small relative risks before and quoted some folks who know a lot more about it that I do. One of those folks' quote is paraphrased in the title to this piece. Michale Thun,VP of epidemiology and Surveillance at the American Cancer Society said:

With epidemiology you can tell a little thing from a big thing.What's very hard to do it to tell a little thing from nothing at all.

If you don't think it is hard, plow through the material presented to the FDA panel and their considerations in regard to the issue of Avandia cardiovascular safety.

Robert Temple ( of the FDA-at least at the time he was quoted) said in regard to the topic of "small" relative risks,

My basic rule is if the relative risk isn't at least 3 or 4 , forget it.

The relative risk in the Avandia, NEJM Nissen article was 1.43. That was not ignored and not forgotten. So is this purported increase risk in cardiovascular events that is attributed to Avandia something or nothing at all ? The experts at the recent FDA hearing couldn't really agree on that. Some thought the evidence indicated an increased risk really exists while others believed that the data was not sufficient to reach that conclusion.

The fact that something is a close call does not mean we can suspend action. Even if something is close sometimes someone has to make the call. In the course of human events this happens all the time. Human brains seemed to have evolved to make decisions with inadequate data. Issues cannot be debated ad infinitum, at some point a call is made and we move on. The panel made a call: add a warning label about c-v risk and do not remove it from the market. The action of many individual docs and many individual patients will likely to a large degree remove it anyway. I can think of no reason for a physician to add Avandia to a diabetic patient's treatment program in light of recent events even though we may never know with apodictic certainty if there is an increased risk of heart attack or not. I wouldn't prescribe it because people are worried about it and there is a drug in the same family that could be used not because I know that the Peto method-used by Nissen-was the statistically correct thing to do and his analysis lead to the "correct" answer. ( Heck, I have no clue as to what the Peto method really is.)

The Nissen relative risk may not have been "big" in the sense of a big RR such as 7 or 8 designating the risk of cigarette smoking and lung cancer and we may never be able to determine what the risk situation really is but it was big enough to kick off a argumentative storm that likely will lead to the demise of Avandia with the statistical arguments put forth by the statistical team at Glaxo falling on the deaf ears of many doctors and patients.

Breakthrough govt.study-patients don't always take their meds

A report is out regarding a government study that demonstrated patients do not always take their medications as they should.Earlier work has suggested they do not always eat their vegetables. Not only do patients fail to take their medications regularly , they often take them incorrectly and stop medications that are supposed to be long term treatment, take them with food when they shouldn't and take them on a empty stomach when they should take them with food. There are even reports of patients not filling their prescriptions at all.

Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality , in announcing the results of the trial proposes an "in your face" campaign . Help seems to be on the way.

The success of previous government educational programs is the stuff of legends. Drunk driving,teenage sex, teenage use of drugs, to name just a few, have all been virtually eliminated.
Public Services Announcements have resulted in highways free of litter and it has become nearly impossible to find someone who does not floss or use sunscreen or a pregnant woman who smokes or drinks alcohol.A campaign to urge or cajole everyone to take their medications correctly will likely have similar impact.

Shorter, more focused CPR course sounds better

Kudos to these folks who tried out a shorter version of the CPR course and found it worked better in terms of retention of concepts ( and less wasted time). Waste of time was always the main thing in my mind as I went through these courses on multiple occasions.The Red Cross and American Heart Association have padded their courses with so much fluff that it gets in the way of learning what folks need to learn from these courses. The key to learning things is practice, practice, practice and these courses typically let the filler material take time away from potential practice time. The use of the AEDs involves very simple techniques and I believe the traditional courses are less successful because they try to say too much.

American Heart Association gets on band wagon for pumping weights

Even since I heard the term "sarcopenia" I began to worry about this muscle loss that accelerates as we get older. I began to counsel patients about the changes described when the sex hormones begin to fall and that their weight could stay the same but the muscles mass decreases and the subtle increase in body fat replaces the muscle weight and little net weight gain occurs .

I became convinced that we all-regardless of gender-should add some resistance exercise to the aerobic programs that we all advocate for general health and sometimes do. Now the American Heart Association has seen the wisdom of this approach.

The story of what goes on mechanistically as our muscles wither away is of course still being worked out but some interesting aspects have been investigated.

There is disconcerting evidence that at least one factor in the diminution of muscle mass as we age is loss of motor neurons in the spinal cord. Until I read this review I had not considered that the muscle atrophy of old age could be neurotrophic but there is considerable evidence suggesting just that. Details can be found in Dr. Lexell's review linked above.

At least two lines of evidence is presented. First, there have been a fairly limited number of morphological studies involving the human lumbosacral cord showing loss of motor neurons after age sixty. One such study demonstrated an alarming 50% decrement in motor neurons in some subjects while the average was only 25% and another study reported a more reassuring loss of only 5%. The small numbers of subjects in these studies limits the accuracy of percentages that are quoted and we have to wonder how much individual variation in this process occurs. Secondly, the histological pattern of muscle loss is of the type seen when nerve fibers or nerve cells fail. As motor units drop out a process of compensatory reinnvervation kicks in and interestingly there is a tendency to replace some of the fast twitch fibers units with slow twitch units, a process referred to a motor unit remodeling. The muscle loss with aging is both in number and size of muscle cell and the fast twitch fibers are disproportionately involved. The remodeled motor units are less efficient, slower and generate less force.

Data also point to decreased numbers of fast twitch muscle fibers even in regular joggers and swimmers at least in the thigh muscles which are those usually tested and biopsied. This is not surprising as the the quadriceps do little more than contract on foot strike to stabilize the patella when we run on level ground and swimming is more a shoulder activity that a quad workout. So jogging or swimming will not immunize against sarcopenia.

Decreased muscle protein synthesis and various hormonal decrements also characterize aspects of the aging sarcopenic process. Replacement of growth hormone-which declines with aging-has not improved muscle strength and function. Muscle protein synthesis does increase with regular resistance training even in the very elderly and muscle function improves along with muscle strength and fiber size.

In short, the only thing to date that can mitigate sarcopenia is resistance training (RT). There are no data to indicate that we can stop motor neuron death but RT is all we've got.