'Unanticipated" effects of the quality movement-JAMA commentary

Dr. Robert M. Wachter, of UCSF, is well known in medical circles for his writing and activities in the hospitalist phenomenon. In the June 21, 2006 issue of JAMA he writes about the quality and IT "revolutions".

His comments about the unforeseen effects of the quality movement resonant with me and likely many real life physicians who may have found the quality activities impeded their work as doctors.I quote:

" More typically, individuals and institutions begin to focus on improving their performance on the variable measure, in doing so turning away from others. This "playing for the test" is not only expected; in some cases it is the point of the whole exercise."

He comments on the most egregious examples of IT gone bad with the Cedars-Sinai debacle and the tragic increase in pediatric deaths occurring after the introduction of a commercial computer system.(Han,YY et al,Pediatrics,2005:116-1506-1512.)

With those facts on the table I find the following puzzling:

"Importantly,until the science of guidelines development and quality measurement improves, the systems must preserve physician's' ability to apply the art of medicine when patients do not fit the templates, such as in those patients with multisystem illness or rapidly changing disease course."

Of course, physicians must have the final say in clinical management,they cannot be replaced with computers and algorithms. The individual physician must be able to deal with the unique particulars of the case at hand. Wachter's use of the word "until" makes me flinch. He seems to believe that someday computers and IT system and EBM and algorithms will get to the point when physicians will not have to apply the art of medicine and will not be allowed to do so. We cannot escape the contingencies of life and medicine by all encompassing algorithms and computer prompts. I don't really think that Dr. Wachter thinks we can escape them but I worry about that "until".

Are Phase IV trials really "seed" trials-another way to manipulate physician behavior?

Dr. Bruce M. Psaty, a prominent clinical epidemiologist from Seattle, plunges into the topic of Phase IV drug trials in the June 21, 2006 issue of JAMA.

Phase IV trials are post marketing trials that,quotes Psaty, were discussed in a 1994 NEJM article by former FDA head David Kessler as a main technique to promote "me too" drugs.

Kessler said:
...because they are, in fact, thinly veiled attempts to entice doctors to prescribe a new drug being marketed by the company,they are often referred to as "seed trials"...[features include]the use of a design that does not support the stated research goals,the recruitment of investigators not because they are experts or leading researchers but because they are frequent prescribers of competing products [and] sponsorship of the studies by the company's sales and marketing division rather than its research department."

Clearly these seed trials are not high quality studies.Psaty talks about what distinguishes high quality studies. Randomization is not enough.

Psaty says that blood pressure drugs are commonly promoted in these trials.

"industry has supported thousands of small short-term randomized trials..."

Most of these seed trials proudly promote themselves as "randomized" and many are but randomization does not equate to a quality trial nor to one that asks a worthwhile scientific question or is otherwise well designed. As Psaty says other features need be present such as blinding,completeness of followup,ascertainment of outcomes to name a few.Randomization is not a sufficient condition for a trial to be worthwhile and/or meaningful and non-trivial.

At times,big pharma and the contract research organizations have taken some of the concepts and rhetoric of EMB and misused them to promote various products by funding and executing these largely bogus seed trials which may have influenced not only the physicians who participate in them but the other physicians who hear from the "thought leaders" how these randomized trials favor one brand over the other. A veneer of evidence based medicine is glued over what is no more than a promotional activity. If big pharma may have corrupted the EBM process, how should the physicians who take part in them be characterized?

Two nouns come to mind; dupes and co-conspirators and I wish I could think of some less pejorative words as alternatives. Some are simply naive and do not understand what is really going on. Some of the academics, however, probably cannot plead ignorance. They either know better or at least in recent years should know better.

Could the SMART trial have been better designed to bring about the results that GSK did not want?

More than one pulmonary disease specialist has referred to the SMART trial as the [not so] SMART trial. Its design is subject to criticism both in terms of what was offered to the patient volunteers and what was likely to happen in terms of results?

GSK was faced with the task of designing and executing a large clinical trial that had been brought about because of concern that salmeterol might be harmful to some patients with asthma. An earlier trial in Great Britain had shown a numerical increase in salmeterol treated patients that was not statistically significant. One lingering popular explanation for any possible increase in salmeterol treated patient death is that these patients were either under poor control at the beginning of the trial and/or perhaps used the medications improperly or inadequately.

So, what did they do?They recruited patients by advertisements, insuring a high proportion of patients who might not have been receiving good physician care, gave them either salmeterol or placebo and then provided only monthly telephone followup. At this point we have a group of patients, many of whom were not under good control or receiving regular physician hands-on follow up, who were given a medication that was purportedly possibly harmful and not monitored other than by telephone calls. They could not be accused of "cherry-picking" their study subjects in this trial.

This "phase one " recruitment ended when it appeared the trial would need over 60,000 participants (over twice what the original power computation indicated because of the relatively low mortality rate in both the control and treatment arms) and the recruitment process shifted to study investigators who recruited their own patients.This change brought about a situation at least resembling how the drug might be used in clinical practice.

There was a marked difference in the outcomes based on the method of recruitment. 13 of the 16 asthma related deaths occurred in patients recruited in phase one ( figure 2 in the SMART article in CHEST).There were about 15,00 patients in phase one versus about 11,000 in phase
2. The report's table 7 indicates that there were no statistically significant differences between salmeterol and placebo in any of the primary or secondary outcome measures in the phase 2 patients.

If there had been no phase 1 recruitment, there would likely be no black box warning on salmeterol containing products. It should be noted that this trial was terminated early by GSK. Only half of the subjects had been enrolled and the predefined criteria for terminations had not been met.The reasons given were the disproportionate number of events in African Americans and difficulty in enrollment.

What about the effect of prior or concomitant treatment with an inhaled corticosteroid (ICS) on salmeterol treatment outcomes? This is how salmeterol is currently used according to guidelines. As the study authors said " SMART was not adequate to determine whether or not ICS use affected the incidence of the key outcome events."

To me, the most robust finding of SMART is that asthma treatment is much better when a patient in under a physcian's care than when a prescription is given to a patient and he is told that they will be contacted by phone to see how they are doing.

Will a recent Meta-analysis be the tipping point to remove LABAs from the market?

Long acting bronchodilators (LABAs) have long been accused of increasing the number of asthma related deaths. My 12/23/2005 posting gave a brief summary of events up to that time.

Concern about LABAs was exacerbated by two studies that lead the FDA to issue a black box warning in November 2004.

A 16 week study from Great Britain, the Salmeterol National Surveillance Study (SNS) of 25,180 patients, found 12 deaths in the salmeterol group versus 2 in the placebo group a finding that was obviously numerically greater but not statistically significant.

Of greater concern was the SMART trial. This was a 28 week trial with 26,350 patients which demonstrated a 4.3 fold increase in asthma related deaths,( 13 versus 3) in the salmeterol treated group.

At least one important piece of information was not available from SMART. In the FDA statement we find this statement:

"The data from the SMART trial was not adequate to determine whether concurrent use of inhaled corticosteroids provides protection from this risk."

We really need to know if inhaled steroids mitigate or eliminate the putative increased risk from LABAs.Current recommendations essentially depend on that as the recommendation is to not start a LABA for asthma treatment until the patient is receiving at least moderate doses of steroids.

A recent meta-analysis published in the Annals of Internal Medicine seems to provide that missing information. Dr. Shelley R. Salpeter et al pooled results from 19 trials with 33,826 patients and found that LABAs ( not just salmeterol) increased exacerbations requiring hospitalizations (O.R. 2.6) and asthma related deaths (O.R.3.5). When the authors looked at the trials in which more than 75% of the participants were taking inhaled corticosteroids, the O.R. for hospitalizations was still increased at 2.1 ( 1.3 - 3.4).

While this may not be a slam dunk to answer all we need to know or to settle the issue, it is bound to raise the level of concern to a higher notch. Unfortunately, the authors do not give us more information about that part of their analysis nor do they include it in their article summary.However, in their concluding paragraph they say : " Concomitant inhaled corticosteroids do not adequately protect against adverse effects "

The LABA controversy will not be settled by this meta-analysis. A recent article from Australia quotes a Cochrane systematic review of LABA use in asthma and concludes they are safe and effective. As the editorial in the Annals noted, Evidence Based Medicine exhorts us to use the best evidence. Determining what is best sometimes is no easy matter. The medical literature dealing with the long acting beta agonists is extensive and replete with contradictory data. Since deaths from asthma are relatively uncommon, many physicians who use Advair and other LABA containing medications have not seen serious complications in their patients and typically observe better control in those patients requiring LABAs. It is not surprising that-as noted in the Salpeter article-the Black Box warning has not altered physicians's prescribing habits. Whether those habits should be changed or not seems to still be an open question.

Growing consensus not to use beta-blockers as initial choice for blood pressure treatment

Fueled largely by the results of the blood pressure arm of ASCOT, various authoritative medical organizations are demoting beta-blockers (BBs) from their former role as first line treatment for elevated blood pressure. NICE (the British National institute for Health and Clinical Excellence) and the British Hypertension Society have recently published guidelines that recommend BBs not be used as first line BP treatment except in cases of angina and HBP or in patients with excessive sympathetic tone or if they cannot tolerate ACEs or ARBs. They also recommend that if a patient is already on beta-blockers and a second BP drug is needed that the additional drug not be a diuretic because of the increased risk of diabetes.(Apparently the argument that since an increased mortality was not seen in ALLHAT patients who developed diabetes it is somehow OK if some medications trigger diabetes did not have much credence with the panel)

For those of us enamored by pathophysiology I refer back to a earlier posting that briefly reviewed data suggesting that beta-blockers are not as good as we once thought because-at least in part- of their failure to lower the central blood pressure while the ACEs and ARBs do.

A nap and a cup of coffee-What a concept.

I have posted before on the excessive sleepiness awareness "educational" programs that are appearing on the free doctor dinner programs and in various publications, there was a interesting juxtaposition of reading material arriving in my mail box.

The Annals of Internal Medicine ( June 6, 2006 issue) featured two articles on the effect of naps and coffee on "real life" situations and an editorial (" Naps and Drugs to Combat Fatigue and Sleepiness") by a well known and prolific sleep researcher, Dr. Christian Guilleminault. ( Annals Internal Medicine-volume 144,number 11 p. 856)

The other was a special issue of Internal Medicine World Report on the topic of excessive Sleepiness (ES). (ES has joined the ranks of conditions designated by an abbreviation and may soon rival ED in the level of promotional material produced.) The Report offered free CME and the authors credited with its material were an academic family doctor teamed with PhD sleep researcher from University of Michigan. The readers are told that the supplement was provided by "CME Outfitters,LLC" and was supported by an educational grant from Cephalon, Inc.,the manufacturer of modafinil (trade name Provigil).

The readers of the supplement are told that in order to accurately diagnose ES a detailed sleep history is necessary. A 14 item list of questions is suggested and the readers are told that it is critical to ask patients about the quality and quantity of sleep. It seems that ES is not only wide spread but it is said to be under recognized so we should seek it out in our patients.The list of "alertness-promoting agents" is reviewed and not surprisingly modafinil seems to be the best choice.

One of the Annals' article dealt with nighttime driving and demonstrated that either a nap or a caffeine containing beverage reduced the number of impaired driving events.A study involving interns showed that naps lead to less sensation of fatigue. Both sets of results conform with common sense and everyday experience (and with references noted in the articles and the editorial) and neither seems particularly monumental and I cannot help but wonder if this was a slow news day at the Annals editorial offices.

I found one of Dr. Guilleminault's editorial comments thought provoking. Apparently some of the interns did not really nap during their nap time.Some worked on the charts and others continued to take call for their own patients. He says :

"Clearly a 'medical culture element' (responsibility for one's own patients) was conflicting with the napping concept." He continues, " Perhaps it is time for medical housestaff to give the same weight to their responsibility to be alert as they do to their responsibility to be available to their patients.".

I will need more time to mull that over. I thought being responsible for your patients was a good thing.

The editorial is supportive of the use of napping and coffee to battle fatigue and sleepiness and is less enthusiastic about modafinil "The shortcomings of modafinil raise questions about the use of pharmacologic agents..."

Those comments are not surprising as a NEJM article and editorial last year seemed to indicate that modafinil was about as good as a big dose of coffee.

To see what P4P is really all about, look at the Seattle Blue Shield experience

The May 26, 2006 posting on Health Care Renewal references a news report on the "quality" and P4P acitvities in Seattle.

As critical as I have been on the P4P issue, the reality seems even worse. In this case, according to the news report,the carrier dropped about 500 physicians from their plans by a secret quality assesment process (using biling records apparently), and sent letters to 8,000 patients telling them their docs were delisted because of quality and efficiency issues.

As an aside I would like to know why this is not libel per se or at least ordinary libel.

But that is not my main point. The following is:

If the physicians who advocate accepting P4P such, as the leadership at ACP, believe that P4P is or will be about thoughtful, well intentioned physicians agreeing on scientifically established quality indicators and compliant physicians being rewarded for showing they comply with them, I cannot help but believe they are either naive or disingenuous.It will be and-as in the Seattle case- already is about saving money and controlling physicians.

It was about a year ago that I blogged about the egregious "performance" program initiated by United Health Group in St. Louis. That program also had no resemblance to the features of a "good " P4P program that the AMA envisioned and was harmful to physicans and patients alike.

Physician groups who advocate P4P argue that if we do not work with the third parties to make the rules, all the rules will be made by them. The Seattle and St. Louis experience-as well as the entire managed care saga-tell us clearly the third party payers will make all the rules anyway.

Presumption seems to be Doctors will not do right by patients unless....

Dr. Philip R. Alper's "IM Insights" appearing in "Internal Medicine World Report" monthly continue to be packed with insights born of thoughtful consideration of years of experience. In the April 2006 issue, he discusses " Will the Real Patient Advocate Please Step Forward?"

He recalls from his days of Internal Medicine training in the 60's that the internist was the person who provided "effective and comprehensive patient advocacy that activity being a "cardinal characteristic that set internists apart". Now it seems that numerous voices are telling us that decisions about care that may have previously been a joint effort made the physician and the patient are too important and too likely to be handled badly by the physician to be left in their hands alone.

Now, that advocacy role is being eroded away by several forces, one of which is the multiplicity of entities that all proclaim the need for such advocacy and self proclaim that role for themselves. In the rhetoric of many such advocates the presumption has become "The doctor will not do right by the patient unless other agents intervene "

Who are these advocates and what energizes their activities?

Well, almost everyone, but the most visible and vocal are :the Institute of Medicine,AARP,and the HMOs and insurance carriers and even the American College of Physicians but motivations of various members of this diverse list are not all the same.

Alper asserts that a " kind of blame game " is being played by the carriers.When their,at times, blatant denials of care evoked the ire of the public they backed off a bit shifting to more patient cost-sharing and blaming the high cost of medical care on "poor quality". Patients were not getting good value for their money and of course it is the physician who largely provides that care.It would follow that someone must oversee and manage the physician's care because left to their own devices docs will crank out poor value care.Audits, guidelines,pay for performance (tipping the docs for doing a good job)are,in this view, necessary to protect the patients from the default position of poor quality which physicians typically deliver unless third parties intervene to protect the patient.

Managed Care is a major force in all of this on several levels.On a practical level the time crunch physicians face leaves little time to be an advocate in many situations.More broadly, Managed Care's "quality movement" may well function as a more sophisticated "denial of care"-saving money under the rubric of convincing everyone they are improving care.

The model of independent individual physicians providing care to individual patients is antithetical to those who are strong advocates of a single payer system.A quality gap is a concept they might embrace. A crisis is great opportunity to bring about change.

There are many thoughtful,dedicated physicians who sincerely want to improve care to patients and whose motivations are not those of the insurance carriers which is to save money. There are many aspects of medical care in this country ( and every country) that could and should be improved. Working to do that is not always motivated by the cost containment model but at least some of the rhetoric of "patient advocacy" and "quality" is motivated by exactly that desire. Also, some of that rhetoric is driven by a desire -for whatever reasons- to replace what remnants of fee-for- service medical care by independent physicians still exist with a system less sympathetic to the individual and more attuned to notions of social justice and public health.

How did a profession historically dedicated to the premise of doing the right thing for the patient find itself constantly apologizing for what it does and being blamed largely for being responsible for what is being characterized as crisis in care? Why are we accepting that blame? Why do we not hear of a crisis in legal representation, in the services rendered by architects,contractors, or even car salesman and roofing companies?

According to ACP, Quality initiatives takes time and money and (so far) no reimbursement

The ACP observer-an American College of Physician's monthly newspaper format publication- has a section called "Measuring Performance"

The May 2,2006 presents the reader with anecdotal material about several internists' efforts to "close [various] quality gaps".

One internist is said to have spent an estimated $15,000 to increase the number of her diabetic patients getting the recommended annual ophthalmologist eye exam. They finally "solved" the problem (at the beginning only 35% of her patients received the exam annually) by having her office call the eye doc's office and make appointments for all 2,000 of her diabetic patients. At 15 k per project you have to wonder how much quality this physician can afford while waiting for the P4W repayment for her efforts down the road.

Other physicians' efforts are described in the article including the experience of one physician whose practice not only had to foot the increased overhead bill(s) of quality project(s) but two physicians left the practice because they were unwilling to accept the higher costs of running the practice.

The quality issues described in this article and the ones often discussed seem to be those related to patient compliance,for example, patients taking their aspirin everyday, patients getting their colon cancer screening, etc. I have a problem accepting the concept that there is a quality problem with physician's care in the circumstance wherein the patient -for whatever reason-does not comply with the advice. How far does one have to go to maximize compliance? Is there at some point a tension with the concept of patient autonomy and respect for patient's decisions? Do patients have to be monitored like children to be sure they are taking their vitamins ? Are we moving towards a version of extreme "paternalism", with a new twist -the twist being -"not only do we know what is best for you we going to check up on you to make sure you do it?

The article says "Until reimbursement becomes a reality,quality improvement efforts can cost more that they can yield financially" As CMS and third party payers continue to decrease reimbursements,ACP's solution,in part, seems to be to encourage internists to spend money on quality projects that may be reimbursed someday and for which we still await evidence that it all will really improve patient care.

The "lets narrow the quality gaps" movements is part of the ACP's scheme to salvage internal medicine. Their own publication's article about the grass root efforts along those lines is more likely to discourage than energize private doctors to join the effort. Bottom line losses have to impact decisions. On a more fundamental level, I believe labeling these simplistic projects based on some organization's arbitrary "quality target" as improving quality is flawed. The author quotes a IM residency quality project involving encouraging diabetic patients to have an annual foot exam involving in part having "a colorful brochure in the waiting room with tips of what to ask the doctor".

I cannot help but remember when being an internist was more about having the skills and dedication to take care of patients with complex (and simple) medical problems than having colorful brochures in the office exhorting patients to do the preventive medicine measure of the day.

'Other people's money" and the moral costs of managed care

Dr. Patricia Illingworth is an associate professor of philosophy at Northeastern University and holds a PhD and JD degree. Her writings express well the observations that are commonly made by physicians about the world in which they live and work which is dominated by managed care.

Medical care came to be "managed " by the managed care sector because of the concept of "other people's money". To a large degree individuals pay for only a portion of their health care the remainder paid by either employers or the government. There was little issue made by these other people until the costs of health care rose to some threshold above which employers and other third party payers including CMS thought costs were getting out of hand. Then entered cost containment via the various cost savings actions of managed care.

Dr. Illingworth believes that the modification of the traditional fiduciary duties of physicians to patients by the duties of the for-profit corporation vis-a -vis shareholders is the root cause of many ethical problems generated by managed care. Basically the HMO strives to make money or save it and they introduce mechanisms to control physician behavior to that end even if that control involves abrogation of the fundamental duty of the doctor to place the patient first. The efforts of the HMO in that regard weaken the physician-patient relationship and damage the trust element in the relationship.

In her recent book, Trusting Medicine: The Moral Costs of Managed Care she outlines her argument and it is reviewed in the May 10,2006 issue of JAMA. It is gratifying to read an academician express many of the same views you would hear in the doctor's lounge at your local hospital- that is if there still was such a place.

In a review of an article she wrote for Northeasten University Magazine she is quoted:

"Part of the problem is that some commonly accepted principles of business ethics are fundamentally incompatible with traditional medical ethics...

Dr. Illingworth says bluffing (holding back certain information), puffing (exaggerating) and spinning (putting the best face forward on undesirable outcomes) are part of normal day to day business practices but have no place in the physician-patient relationship where honest relationships are essential to good practice. However, physicians dependent upon managed care companies may be influenced and controlled to the extent that their behavior favors the company's bottom line more than the patient's interests in spite of the doctor's effort to swim against the tide.

As the reviewer in JAMA noted, President Bush listed as one of the goals for health care was to "strengthen the doctor-patient relationship". Has the doctor patient relationship eroded so badly that it deserves to be a topic in a State of the Union address ? Maybe so.The erosion of patient trust and the deterioration of the physician-patient relationship are, in my opinion, directly related to managed care. I do not see how the trend can be reversed as long as managed care companies continue to exert hegemony over physicians.

As is so many matters,I have no solution but I do not believe that as long as managed care entities exert their domination over practicing physicians that such things as electronic medical records, having docs audit themselves to see to what degree they adhere to selected guidelines and calling it all a "medical home" will restore the deteriorating doctor-patient relationship.

Economy Class syndrome and which of Virchow's mechanism (s) may be to blame

A recent JAMA article (the full text is available on line) from Great Britain sheds some light on possible mechanism (s) involved in the development of venous thrombosis in long haul air travelers. ( Long haul is usually taken to mean 8 hours or more.)It does this by failing to demonstrate evidence for an increased tendency of the blood to clot after doing extensive testing for relevant blood coagulation system changes including tests for platelet activation,fibrinolysis,and coagulation factor activation.

The issue-in part- has been if the reported association between long haul flights and venous thromboembolism (VTE) is due to prolonged sitting -at times in cramped conditions- or does the air travel induce some increased tendency to clot perhaps related to hypoxia and or decreased atmospheric pressure ( hypobaria) and , of course, both could be operative.

This study simulated air travel using a hypobaric chamber to expose some 73 healthy volunteers to hypobaric hypoxia for 8 hours Persons with either the prothrombin gene mutation (G200210A) or Factor V Leiden were excluded. The study design compared sitting for 8 hours with and without the impositions of hypoxic hypobaric conditions. No significant differences in the various tests of the clotting system were found.

It seems that every talk on VTE has ( or at least used to have) an obligatory introductory section mentioning Virchow's triad of possible culprits predisposing to thrombosis; 1) damage to the vessel wall, 2) alterations in blood flow (stasis or turbulent flow) and 3) increased tendency of the blood to clot. This paper goes at least part of the way to shift the blame in economy class syndrome to the second category. This should encourage travelers to move around as much as possible on the long flights and might be a disincentive to take a sleeping pill and sleep for much of the flight. The rest of the current advice package-at least for persons at no known increased VTE risk is to keep well hydrated and avoid alcohol. Persons recognized to be at higher risk should use graduated pressure stockings and consider low molecular weight heparin pre flight depending on the level of perceived increased risk (such as those with a history of VTE).

It should be noted that persons with Factor V Leiden and or the prothrombin mutation represent a different situation.The editorial in the same issue of JAMA noted that some evidence of hypercoagulability has been noted in persons with those two inherited conditions with exposure to flight conditions. Whether they should be offered low molecular weight heparin is an issue about which experts differ.

How drug companies know what physicians prescribe

It seems to be common knowledge among practicing physicians that the drug reps know who prescribes what.That type information is thought to be important to big pharma marketing activities. However, I was ignorant about how all this works.

The Blog that Ate Mahattan (TBTAM) explains it and references an article in the NYT.

It seems that drug store chains sell that information to various data gathering companies that then merge the data with the AMA's physician masterfile. This the file that is generated by rank and file docs across the country filling out the AMA's form. The AMA sells this information to various entities including database companies that supply the info to drug companies so that the drug rep knows if you are really using whatever drug.

There are legitimate uses for the AMA data base base. For example, the black box "dear doctor" letters sent out by drug companies to warn of side effects or recalls uses this information. However, providing data about individual doctor prescribing habits to drug companies is not a legitimate use.

Go to TBTAM to learn how to achieve a limited opt- out of the drug reps prying into your business. The AMA is getting some deserved flak for this activity and they are trying to placate docs and still maintain their lucrative data selling business.

Devotion,curiosity, hard work and the Midnight Meal

JAMA has reviewed a book that would probably interest senior docs who trained in the 60' and 70's particularly at a big city hospital. According to the review there is plenty of interest for younger one as well. The book is The Midnight Meal and other Essays about Doctors, Patients and Medicine by Jerome Lowenstein,an internist who trained at Bellevue and stayed on to teach there.I like to think that thoughtful physicians who have been doing it for 30 years or more have something to offer. His comments do.

I took my pulmonary boards at Bellevue (back when it was an oral exam) and much he has to say resonates with my memories of another big city hospital, Charity in New Orleans.

In his section on
"Can you teach compassion? ", he writes

"...teachers in medicine can only hope to facilitate the development of students or young physicians,challenging and stimulating them and acting as role models."

I know much of my development was influenced by role models.I can still remember much about those physicians in surprising detail many years later. The passage of time has made it very clear to me how important those role models were

The reviewer says " Devotion, curiosity and hard work were the messages of these teachers"

The messages I got from my role models also included respect for the patient,duty to do what was right for the patient,the obligation to know as much as you could because that may actually save a life or mitigate an illness's effect.There was no message sent about going home at five o'clock and leaving the problems to some one else.

The "midnight meal" part of the book's title refers to a meal, leftovers mainly, served late at night to the docs on call.Charity Hosptial did that as well-we called it "Late Doctors" It was a good time to catch consultants (our paging system left a little to be desired). The late meal was often the highlight of a night on call. It seemed that way at the time but the real highlight was the incredible and intense opportunity to learn how to be a physician by taking care of real patients often late into the night under the tutorage of more senior (sometimes only by a year or so) physicians.

JAMA reviews book on clinical judgment-"phronesis"

There is a favorable book review in the May 3,2006 issue of JAMA regarding what seems to be a very interesting book titled How Doctors Think: Clinical Judgment and the Practice of Medicine by Kathryn Montgomery. Dr. Montgomery is a professor of bioethics and medical humanities at Northwestern University.

One of her main themes is that clinical medicine is not a science.Even though I wonder if that statement is a straw man (I have always considered science as only part of medical practice as is implied when we talk about about the art and the science of medicine),there are a number of insights quoted in the review-enough to motivate me to order the book.

I quote from the review:

"Rather than considering medicine a science,she proposes that it be conceptualized as a rational,science-using practice.She draws on phronesis-the flexible interpretive capacity that enables moral reasoners to determine the best action to take when knowledge depends on circumstances-to characterize physician thinking in the clinical encounter as interpretive practice. In clinical medicine, this interpretive practice is displayed as clinical judgment which enables physicians to combine scientific information,clinical skill, and collective experience with similar patients to make sense of the particulars of one patient's illness and to determine the best action to take to cure of alleviate it."

"Clinical judgment done well is the intuitive and iterative negotiation of the patient's narrative of illness...This focus come with experience"

Aristotle spoke of the virtues of the ordered mind as including sophia (wisdom of first principles),episteme (emperical knowledge, techne (technical knowledge) nous (intuition) and phronesis (practical wisdom or prudence).

The evidence based medicine era with its emphatic focus on episteme and techne may foster the illusion that good clinical practice can be encapsulated in guidelines and pathways and that quality lies in obedience to them but it is the blending of those elements of science and technique with practical wisdom that makes good practice.

While Aristotle may have been bit harsh on the young the following quote captures the thought well that the particulars must sharpen the broad outline and abstractions of the "universals" that might correspond to the general clinical rules or guidelines and give them operational meaning tailored to the facts at hand:

"Whereas young people become accomplished in geometry and mathematics, and wise within these limits, prudent young people do not seem to be found. The reason is that prudence is concerned with particulars as well as universals, and particulars become known from experience but young person lacks experience, since some length of time is needed to produce it."
(Nichomachean Ethics)

Another reason to distrust company sponsored drug trials-fraud

Health Care Renewal in its May 3,2006 posting quotes a Wall Street Journal article that reveals alarming information about one drug trial involving telithromycin(Ketex),a macrolide antibiotic recently incriminated in causing serious liver toxicity and one that has been heavily promoted in various free "educational" publications and talks by infectious disease "thought leaders".

Physicians have probably to some degree become accustomed to looking more carefully at drug trials-when they have time to do it-to watch out for the usual bag of tricks, such as comparing the highlighted drug with an inadequate dose of a comparator drug. However, presenting outright bogus data-such as fabricated "patients" is a different level of egregious behavior.

HCR calls attention to the role of a contractor company,Pharmaceutical Product Development,INC (PPD) that facilitates and organizes -among other things-drug treatment trials as the most blatant culprits in this saga were private practice docs.

The story in a nutshell is that at least two of the private physicians taking part in the trial apparently fabricated data. Questions arise regarding the adequacy of oversight by both PPD and the contracting Big Pharma company, Sanofi-Aventis and the FDA conduct in the approval process will likely generate criticism as well. One of the doctors who ran a weight control practice somehow managed to enroll 30 new patients a day (the patients were supposed to have a respiratory tract infection requiring antibiotic therapy).The physician was subsequently convicted of mail fraud in regard to her activities in this trial.

As the investigation unfolds we will likely hear from both PPD and Sanofi-Aventis that they did everything according to the usual rules of research conduct but the bottom line seems to be that a drug was approved by the FDA and data from a very flawed trial may have been used to attest to its safety.

Randomized clinical trials (RCT) may be able to serve us well in the setting of determining the efficacy of a drug but the label of RCT on a publication does not tell us anything about the integrity of the data which in this case seems corrupted by fabrication. Fraud, lying and cheating may be harder to detect than statistical slanting of the data.


To me,the worse part of this sad story is that the most flagrant behavior was exhibited by private practice doctors.

Annals Internal Medicine letter" Seasoned internist blames Academic Medicine for much of internist's crisis

In the May 2, 2006 issue of the Annals of Internal Medicine, Dr. Ashok V. Daftary in a letter to the editor blames academic medicine for much in the unfolding saga for the demise of internal medicine.

He writes:

"Academic medicine is the carpenter that fashioned the coffin of internal medicine.Instead of reengineering internal medicine to accommodate changes, it cannibalized the discipline by reducing its worth, creating the hospitalist and ambulatory care internist. These were both nails that helped seal the coffin; the former reduced the influence of the internist in the acute care environment and the latter blurred distinctions between internists and those without medical degrees who practice in the ambulatory settings."

"...absent an identity, the internist's only remaining role is thought to be that of provider of ambulatory care to chronically ill whose medical problems are beyond procedural intervention and lucrative compensation."

I do not know the relative contributions of academia and managed care to the birth and growth of the hospitalist phenomenon but my default position is to always blame managed care. The "follow-the money" rule does not always lead to the right answer but that it where the smart money bets. I think at most some academic and "thought leader" internists were complicit.

I believe, though, that the recommendations to change the IM residency program to allow (or encourage?) the third year residents to opt to do more in patient or more out patient training-based on their future plans will only make worse the schism betweeen the hospital internist and the "officist" and do little to lessen the increasing fragmentation of medical care. And the idea that an IM resident could do the training, opt to be a office doctor and never -after the residency-take care of patients with complicated serious ilnesses in the hospital is so contrary to what a internist is (used to be ?) all about.

Australian study demonstrates calcium only works if you take the pills.

The April 24, 2006 issue of the Archives of Internal Medicine published a study from Australia that examined the effects of a twice daily supplement of 600 mg. of calcium carbonate on fracture rates and bone density.

This was a 5 year, double blind, placebo-controlled trial of 1660 women older than 70 years of age.

They found:

1.Using an intention-to-treat analysis, supplementation did not significantly reduce fracture rate.

2.But, of the 56.8% of the study participants who actually took the calcium, there was a reduced fracture rate ( hazard ratio 0.66) and improved bone density measurements.

So when viewed from a "public health perspective" it was not effective. However, calcium seems to work if you take the pills.

These results are similar to those of the recently published Woman's Health Study which also demonstrated that pills only work when you take them. Unlike the U.S. study this one did not find an increase in kidney stones. The misread and sometimes mis-reported results of the WHS may have lead some to stop their calcium in the belief that calcium supplemention does not help.
It does seem to decrease risk of fracture and it may even reduce the risk of colon polyps.

More on bribing doctors to do their job

I recently posted on Dr. Faith Fitzgerald's principaled stand against pay for performance(P4P).
Ironically in the same issue of Internalmedicinenew.com, as Dr. Fitzgerald's article Dr. Christine K Cassel is featured promoting the ABIM scheme to tie "voluntary" reporting of quality data to obtain points to be used to obtain internist recertification and alleged future remuneration from Medicare.

The measurement of quality indicators is part of the ABIM's Practice Improvement Models (PIMs).

Dr. Cassel is trying to sell all of this because the collected quality data can be used"for multiple purposes."

Dr. Fitzgerald talked about "tipping doctors"for doing their duty.So far as regards CMS,there is just a promise of possible tipping in the future. ABIM seems to be making "an offer you can't refuse" by the threat of non-re certification for docs who don't play their quality game.

Some of us remember Dr. Cassel's commentary in the Annals of Internal Medicine in which she supported a flawed Annals article which bashed older docs in which she took the opportunity to promote the ABIM recertification dicta. See here for Dr. Roy Poses's comments regarding that issue. Promoting physician autonomy and the individual doctor patient relationship clearly is not part of the ABIM mission.

Another argument against pay for performance (P4P) Should doctors be tipped?

Dr. Faith Fitzgerald,professor of Medicine at UC Davis,speaks out against P4P in the April 13,2006 issue of Internal Medicine News.(www.internalmedicinenews.com)

She makes two major points.

1)recommendations by "expert"panels are subject to reversal due to the fragile and provisional nature of medical conventional wisdom. Physicians feel bad when they make certain recommendations ( e.g. HRT for postmenopausal women) and later learn they may have harmed their patients, but at least they thought they were doing the right thing based on the information available at the time. However, with P4P, " Shall we have the same solace if we make these decisions,not because we think they are right but for money?

2"...the very concept of pay for performance for doctors,especially we when collaborate in the creating of the concept:Pay for performance embodies the tacit assumption that if we are not delivering it, it is because we are not being paid enough."...it[P4P] corrodes the conception of self-governance and correction that is part of the definition of professional. ...We must not servilely accept gratuities for doing our duty."

I believe P4P is wrong on so many levels. Thanks to Dr. Fitzgerald for emphasizing the aspect of how P4P is antithetical to physicians' professional identity.

JAMA article:more on why single disease guidelines don't work for multi disease and frail patients

Thankfully,more and more authors of medical journal articles are pointing out the obvious-single disease guidelines applied by role to complicated patients is not a good thing. Clinical judgment is actually required.

In the April 26.2006 issue of JAMA, Dr. Samuel C. Durso writes about the issues involved in using clinical guidelines for older patients with diabetes and complex health status.He referenced an article called "Guidelines for Improving the Care of the Older Person with Diabetes Mellitus." The JAMA article and by reference the "guidelines" he discusses seem to really be a permission to deviate from various single disease guidelines as the physician and patient attempt to do what seems best for the patient taking into consideration prioritizing goals and the patient values and wishes reminding me of Dr. Norton Hadler's "clinical truth".

There have been earlier articles critical of the rote use of single disease guidelines in patients with multiple diseases and this article's focus in on older diabetic patients and highlights problems in frail patients with short life expectancies.

Here are some quotes from Durso's article:

"Most clinical guidelines for common conditions are disease-focused and do not provide guidance for prioritizing multiple medical conditions including geriatric syndromes that are common in older adults."

"Nor do most guidelines make explicit provisions for addressing a patient's health care preferences when they differ from guideline recommendations."

The closing sentence is interesting:

"Clinicians also must be trained in complex decision making"

It that not what internists had been trained to do over the years?

I am a bit taken back that he seems to be talking about " guidelines for guidelines"(I do not believe there can be an algorithm for everything) but there is clear value in recognizing the importance of placing guidelines in the overall clinical picture and knowing when to hold them and when to fold them.

Medscape offers pro and con discussion re" P4P

I have to give credit to Medscape for publishing arguments against pay for performance (P4P) in the form of a point-counterpoint piece.

Dr. Robert M Centor, professor at University of Alabama and president elect of the Society of General Internal Medicine (and well known blogger) presented a well reasoned discussion pointing out concerns and problems regarding P4P.I believe internists and family physicians who populate the real world of patient care will be heartened by the position he presented.

Dr. Michael S.Barr,one of the vice presidents of the American College of Physicians, was assigned the job of delivering the ACP party line and what appeared to me to be a rather luke warm defense of P4P-"Many physicians have indicated significant concerns about P4P, and rightly so."

Barr does not address the points made by Centor(in fairness this was not a debate with time for rebuttals) but relies on giving a version of recent history of the issue which as usual begins with a mandatory reference to the seemingly-above-challenge "Crossing the Quality Chasm " authored by the IOM and advice to physicians to "reframe their thinking."

No doubt, there are thoughtful physicians and others who believe the P4P will improve quality but I cannot but think that the major driver for this movement is to reduce costs. The major players in that regard are the government, insurance and HMOs and with their resources seem to dominate the debate and have largely defined the universe of discourse regarding the issue.(Note-even I have given up bothering to put quotes around the word quality.)

Dr.Centor, in his role at the Society of General Internal Medicine,does have a forum to express his views and I applaud his efforts and hope others can join the fray.

What could be better than a Randomized Clinical Trial?

What would be better than a RCT? Answer- a RCT that makes a comparison between realistic alternatives. This issue was the subject of a insightful editorial in the April 12, 2006 issue of JAMA.(Recent Trials in Hypertension-compelling science or commercial speech;JAMA, vol 295, no. 14, p1704-1706)

Three researchers well known for their expertise in this area authored the piece,B.M. Psaty,N.S. Weiss and C. D Furberg.

Full text requires subscription. Here are some highlights.

We are all becoming increasingly aware that a RCT comparing two drugs does not mean squat if the comparator drug is given in too low a dose or is one that no one (or hardly anyone) would choose anyway.

Is one treatment superior to another? Lets do a RCT. O.K. but " a fundamental principle of active treatment-controlled trials is the scientific obligation to use the best available treatment in the control group."

The editorialists were addressing the issue of blood pressure active treatment trials (an active treatment trial compares one drug with another- not with a placebo) and point out that in the ASCOT trial, low dose diuretics were not used in 45% of the atenolol group.Further,the ASCOT investigators acknowledged that possibly atenolol was not the appropriate comparator drug
for contemporary BP treatment. (Atenolol has fallen into some disrepute in that regard)

One point is that one could argue that low dose diuretics would have been a more appropriate comparator drug and atenolol is not the best beta-blocker to use as well.

Comparing drugs or sequences of drugs in hypertension trials is not simple.Many- if not most- patients require two or more medications to achieve control and the protocols in active comparisons trials may not reflect the way BP is really treated in the non-RCT world in which real physicians live. The highly hyped and highly criticized ALLHAT trial has also been accused of that fault.

The authors point out that although atenolol does not have a great track record in decreasing cardiovascular disease mortality in treated hypertensive patients, 3 large recent industry-sponsored trials used atenolol as the comparator drug.

The editorial quotes a recommendation of the National Heart,Lung and Blood Institute Working Group proposing a comparison of several drugs in patients who were receiving low dose diuretics, i.e. adding on an ARB, or an ACEi, or a CCB or a beta-blocker (but not atenolol) and doing a head-to-head comparison.

Senator raises questions about the quality of Quality Improvement Organizations ( QIOs)

Probably most people and likely many physicians have never even heard of QICs. Here is their website where we learn that the QIC program is directed by CMS and consists of 53 QICs who are tasked "to make sure patients get the right care at the right time."

Senator Chuck Grassley is asking for changes in this program because- according to a recent news blurb in the Capital Health Call section in JAMA of "questionable expeditures,potential conflicts of interests and lack of effectiveness." He raises questions about the quality of the program purported to ensure quality of medical care.

The American Health Quality Association, which is described as a QIC trade organization seems to admit that the program need changes-probably they would favor more funding- but blames the problems on poorly written laws.

Purportedly, there was a need for these QICs because physicians left to their own devices would not deliver "quality care", so it would seem reasonable that what we need now is another layer of quardians who can watch over and insure the quality of the organizations that were to insure the quality of care., but ,of course, they will have to be audited.

More on Disease Mongering

Health Care Renewal recently referenced a symposium on Disease Mongering (DM) and the full text essays are now available on the PLOS website.

In recent months,I have written about certain aspects of the promotion of the diagnosis and treatment of two conditions,bipolar disorder and restless legs syndrome (RSL) as having features of the DM phenomenon.

Let me attempt to preempt one line of possible criticism by stipulating that Bipolar Disease is a very serious psychiatric disorder and warrants treatment by qualified physicians and that RLS can be in some patients a very disturbing disorder with definite morbidity relief from which could be very worthwhile.

However, I had questioned the drug company initiative to round up primary care doctors to seek out and take on the often daunting task of managing a bipolar patient,an enterprise in which psychiatrists really earn their fee.(I will admit that in No-trees Texas type locations the PCP may have to take on the job as the region may be bereft of psychiatrists).I also questioned the wisdom of screening for RLS with a drug company sponsored questionnaire with the objective of offering treatment with a dompamine agonist for positive screenees.

The PLOS symposium essay on RLS is worth reading as it takes up several aspects of this matter with much greater development of the issues than my gut feeling sense of it that I posted. Hats off to Doctors Steven Woloshin and Lisa M. Schwartz of Dartmouth Medical School .

Another article questions the evidence or lack of it underpinning the whole issue of diagnosis and treatment of bipolar disorder.

It can be argued that the marketers manipulate the motivations of physicians and various support groups . The physicians are obviously an essential element in the equation. It is their desire to foster the welfare of their patient and do the right thing that is necessary for the DM process to flourish. I believe the "shame of being ignorant" is branded into the limbic cortex of medical students .Hats off to the ever insightful author of the blog PURRY GUD (tomwaitsatemyaby.blogspot.com) who used that phrase recently.

Physicians-many at least-are haunted by the fear that we will harm someone or fail to help someone because of something we do not know (there are certainly other ways we can harm also). This motivation to know what we need to know allows marketers to direct our energies to detection of new illness and to accept wider definitions of disease . Medications are not prescribed because we like the free food or notepads or pens even if we like the free food. Free lunches are not really the problem. The marketers not only manipulate the physcians' hypertrophied sense of duty but the prestige of evidence based medicine as well with all the tricks and traps one can squeeze into a randomized trial to give the veneer of solid science to something that may be no more than a comparison of their drug with one no one would use anyway.

The good news here, if there is any, is that we are catching on. The DM symposium is evidence of that.

We are getting more skeptical about what we read.We are realizing there is more to a RCT than the fact is randomized and blinded. With Google and other search engines it is easier to more quickly confirm or deny material from various promotional efforts. (The bad news is who has time to check and analyze everything that appears in print)

But even as our duty pushes us to strive even harder to figure out what it is we should do to do the right thing we learn of still another tactic to thwart and divert our efforts.

Medical news you really can't use

Medical Journals sometimes publish POEMs-which in this context stands for "Patient Oriented Evidence that Matters". The criteria for a study to be elevated to high level on the epistemological food chain are:

1.addresses a question physician face.
2.has measure(s) of outcome and
3.has the potential to change the way doctors practice.

There are several "medical news newspapers" typically distributed without charge to physicians, one example of which is the " Internal Medicine Report",which I usually read if for no other reason than for the excellent essays by Dr.Philip R. Alper . This type of publication has no shortage of information that you really can't use,as well as some you can , the trick being to know the difference.

Here are some of the "unPOEMs" from that publication.

They reference an case control study from Urology (2005,67:73-79,which noted that risk for BPH was increased by eating more cereal,bread, eggs and poultry while risk was decreased by eating more soup,legumes, cooked veggies and citrus fruit. Try putting this factoid into your practice. Mr. Jones, with your BPH- I would recommend you eat less bread and more soup.

Another reference was to a paper presented at meeting of the American Stroke Association in which patients who had endovascular closure of patent foramen ovale (PFO) has less migraine headache than a comparison group that was treated medically.This was a retrospective,nonrandomized study and recall bias was an obvious issue. Again try and put this "observation" into practice.

In the same issue we also "learn" that Sulfonyluea therapy for type 2 diabetes linked to cancer" and "moderate coffee consumption may keep Type 2 diabetes "at bay".

Many of these factoid unPOEMs derive from case control studies that are correctly described as hypothesis generating studies that sometimes alert researchers to apparent associations that lead them to push on with more definitive techniques and sometimes are just statistical noise dead ends.

Carotid endarterectomy-AAN guidelines

The updated and long awaited guidelines from the American Academy of Neurology are available on line in full text. Their previous guidelines were published in 1990.

Two large Class I studies provide good data for their recommendations regarding symptomatic carotid stenosis (CS), the NASCET trial and the ECST. Entry into the studies required a TIA or non-disabling stroke within the previous 6 months.

For symptomatic patients with stenosis greater than 70% ( but less than "near total" occlusion) carotid endarterectomy (CE) is recommended if the surgical stroke or death frequency is believed to be less than 6% and the patient has an expected survival of five years or more. The absolute risk reduction is 16% with a NNT of 6.3.

If the stenosis is less than 50%, surgery is not recommended and medical treatment is preferred.

In regard to asymptomatic patients CE should be considered if the stenosis is 60-99 % and the surgical stroke or death risk is less than 3% and the patient has an expected 5 year or greater survival.

Due to the slow accumulation of big time Class I studies we may have gone about as far as we are likely to go any time soon with learning about CE versus medical treatment, but what about carotid stents? The jury is just beginning to hear the evidence and there are advocates with convincing arguments on each side.

Coronary stents have certainly become worthy rivals of CABGs and catheter treatment of cerebral aneurysms -at least in some clinical situations-may be better than surgical clipping. I believe that increasingly we will see more and more endovascular catheters at work and less classical surgery. I wonder how long it will take for enough data with head to head ( or neck to neck) comparisons between CE and stenting to accumulate to determine the role of catheters versus surgery in this setting.

You need more than FEV1 to judge bronchodilator response

Bronchodilator drug trials and often clinical followup have focused on the changes in the forced expiratory volume in one sec (FEV1) to judge therapeutic response. However, it is recognized that exercise intolerance and dyspnea may improve with no significant change in expiratory flow rates.
Improvement in exercise tolerance actually seems to correlate better with indicators of improvement in overinflation,a simple measure of which is the inspiratory capacity (IC).

The IC is the sum of the tidal volume and the inspiratory reserve capacity which is the volume of air inhaled on top of a tidal volume. In COPD the IC is reduced as a result of the hyperinflation ( increased residual volume and functional residual capacity) so that the tidal volume is performed at the upper part of the lung's pressure volume curve which is a region of low compliance and an increased load on the inspiratory muscles.The overinflation present at rest is worsened with increasing airtrapping during exercise with increased respiratory rate and decreased time to exhale and is currently thought to be a major variable that relates to exercise intolerance and the sensation of dyspnea.

In the March 2006 issue of Chest ( subscription required for full text), authors from Holland demonstrated that a long acting bronchodilator (LABA),formoterol plus once a day tioptropium ( a long acting anticholinergic) brought about significant improvement in expiratory flow rates and -probably more importantly from a symptom improvement point of view-a significant increase in the inspiratory capacity.

Scores of bronchodilator trials focused only ( or at least mainly) on FEV1 measurement. ( I was involved in several as a pulmonary fellow) and as we learn more about the pathophysiology and the clinical correlates of lung function measurements we are better able to develop therapeutic measures to improve the disabling exercise intolerance of COPD patients.

It may have taken the surgical lung volume reduction experience to remind lung doctors that we have been doing pharmcologic lung volume reduction therapy all along when we have been using bronchodilators.

Comments about Deficiency of clinical skills

Dr. RW's post referencing Dr. Herb Fred's editorial in the Texas Heart Journal generated several negative responses in KEVINMD's march 30.2006 blog following his reference to that piece.

Several ad hominem comments accused Dr. Fred of being basically a disgruntled, out of date, grumpy old doc who-in the words of one such writer-never practiced in the real world. Ad hominem arguments are -well -just that and usually do not warrant detailed refutation.

Unlike some of the commenters' suggestions, Dr. Fred seems quite aware of the calling-the-shots nature of managed care and the time restriction brought about by the third party payers' domination. He says that the HMOs force physicians to care for a maximum number of patients, in a minimum number of minutes for the lowest number of dollars.

His rant is about the decline of clinical skills and the factors responsible.He believes that values and priorities are not what they used to be.
When he trained in the mid-1950s ( and also when I trained in the 1960s) :

"... hard work,self pride,devotion to duty, strict accountability and pursuit of excellence were the norms" .

To expand on that-Things were framed in the relationship between the individual doctor and the individual patient.We did not speak about or -except in extreme circumstances-consider the " greater good" or conservation of some abstract and apparently collectively owned "resources".It seems that the core competencies of the ACGME do espouse-at least in part-values other than the one-on-one doctor patient relationship.

The ACGME core competences speak of :

..Responsiveness to the needs of patients and society

...practice cost effective health care and resource allocation

...understand how their patient care and other prorfessional practices affect...the health care organization, and...the larger society.

If I were managing an HMO, those "values" are certainly those that I would have inculcated into the doctors who are allocating my resources.

Not enough time for medical training-A problem in Europe as well?

The restriction of work hours for residents has lead to complaints from several fronts and concerns from both sides of the Atlantic.

Aggravated Docsurg has recently discussed the issue and quotes an interesting article in the American Journal of Surgery. The article reveals that 89% of surgery residents who completed an anonymous survey reported they "cheated" on the 80 hour work restriction rule. That is- they worked longer but did not report the hours correctly. This also occurred in 74% of non-surgery residents.

The authors of the article seemed to be alarmed that surgery residents were placing their allegiance to the concept of individual responsibility for patient care above a team approach and to adhere to the rules. When did individual responsibility stop being a core value of being a physician or -in current jargon- a major element of professionalism ? Recent apparent revisions in the expressed views of ACME seem to point in that direction. I have written about that before. In 2003 the ACME eliminated the statement that is a touchstone of interning training:

"Physicians...Must recognize their obligation to patients is not discharged at any given time or any given day".

Are there competing visions- the individual responsibility physician versus the shift work doctor.?

The new work hour restrictions in Europe have generated concern that there is not enough time to properly train specialists.Summer's Radiology Site references an article in which British gastroenterologists report trainees no longer have time to perform the necessary number of endoscopies to become proficient due to the duty time restrictions. This lead to the following comments by one of the GI docs involved in a training program:

"You can't shoehorn more training and other work into less and less time and expect the same quality of training."


This statement echos the opinion of the training program directors quoted above who said:

"There is simply insufficient time to educate the internal medicine residents in the present regulatory environment."

This transatlantic meeting of the minds is sobering. The folks who make the rules (ACGME in the U.S.) and whoever in Europe ought to listen to the real life experiences of those program directors and the trainees who have to live by their rules before we have a generation of less well trained specialists who will go home at 5 p.m.

Archives Internal Medicine article-some good news about the third heart sound and practice

The March 27,2006 issue of the Archives of Internal Medicine published an article that happily tended to confirm some of my biases. ( "Relationship between Accurate Auscultation of a Clinically Useful third heart sound and Level of experience." Marcus,G et al. Arch Int Med. vol 166,March 27, 2006 p.617-622)

The authors studied the auscultatory prowess in regard to detection of a third heart sound (S3))of docs at various levels of experience-from intern to cardiac fellow to attending cardiologist) by having them examine 100 patients shortly after cardiac cath and constructed correlations with LV ejection fraction, BNP and echocardiography.

Findings include:

The finding of a S3 by auscultation is very specific for heart failure (HF).In other words a S3 goes a long way to ruling in heart failure but it is not very sensitive- so not great at ruling out HF.

A cardiologist's perception of an S3 is as good as a phonocardiogram.

And here is the one I really like -Cardiologists and cardiology fellows do better than interns and residents in internal medicine. Who would have thought?

Yes Virginia, practice and experience matter and sometimes the physical exam may be of value.

We speak now of third sounds-in an earlier era we talked more about " gallops " and "gallop rhythms". Dr. George Burch in his 1953 text " A Primer of Cardiology" says a " protodiastolic gallop rhythm is present when the gallop sound occurs early in diastole"..It is due to an exaggerated third heart sound and is common in congestive heart failure."

The medical language of the 1950s did not include the words sensitivity and specificity but the cardiologists and internists of the day knew that a gallop usually ruled in heart failure.

Practice and experience do matter and Dr. David L Simel who wrote the editorial discussing the article wondered if the current trend in reduced house staff training time will be counterproductive in creating an environment wherein that practice and repetition can take place. I think the answer is obvious, of course it will- absent some major effort on the part of the training program to remedy that,given the recent history of ACGME to pile more and more new requirements to be carried out in less and less time.

Physicians' " Guild" breakup and the alleged move to free markets

I believe everyone should read HEALTH CARE RENEWAL everyday but a recent post exceeds that blog's high standards. The article is entitled " The consequences of Breaking the Physicians' "Guild" ".

According to Dictionary.com a guild is "An association of persons of the same trade or pursuits, formed to protect mutual interests and maintain standards "

In it, Dr. Poses ( about whom we have to wonder when he sleeps) talks about Alain Enthoven's managed competition and his strategy to break up the physicians guild which- in Enthoven's view- is the main reason why medicine costs so much and is of such poor quality in this country. We also hear about the consequences of this strategy.

You would be wrong if you thought Enthoven's views on prepaid group practice, universal coverage and managed competition went away with the demise of Senator Clinton's health care task force.

In the same piece, Dr. Poses give a chilling rendition of the transformation of the pharmaceutical marketing landscape including comments about the new drug reps aka Drug Ken and Drug Barbie.

I'll admit I must have slept though most of the 1980s and 1990s ignorant of the Jackson Hole group and the "intellectual" verbiage that feed the HMO movement, my hat is off to Poses and the other contributors to HCR. They are doing us all a great service.

NEJM article on who is at greatest risk of poor quality health care

The March 16, 2006 issue of NEJM published an article reporting the results of applying RAND's Quality Indicators ( some 439 of them) for 30 medical conditions based on telephone interviews followed by review of medical records for those participants who gave permission.

The quality indicators were chosen by a nine member multispeciality "expert panel" using the RAND-UCLA modified Delphi method. The degree to which physicians "comply" with these opinions of what is good care is the measure of quality.

One could haggle with how to measure quality in this type study but nevetheless some of results will give ammunition for health policy wonks of almost any persuasion.

Those who believe a single payer (government) system is best will have to gloss over the authors' sentence that says:

" In the United Kingdom,with universal coverage, a study using our methods found that the overall proportion of recommended health care that was received was similar to what we have reported"

and what they report in this article is that the " problems with quality of care are indeed widespread and systemic and require a system wide approach."

You have to wonder what approach they would recommended as they seem to say both the single payer and the current U.S. set up give equally unacceptable results.

Surprisingly they found that :
"..Blacks had higher scores than whites for the quality of heath care".

This differs markedly from what many other studies have shown.

They also found that
"...health insurance status was largely unrelated to the quality of care".

So is all this concern about the large number of uninsured people misdirected?

This is not outcome data. We have no idea from this study what effect these alleged non-compliances have on the health outcomes. This is process data collected by a method prone to bias ( telephone interviews),using a huge list of quality indicators some of which are evidence based and some expert based. If the medical record did not document a given medical act it is counted as it it did not occur. Further, we are not told in the article what sort of infractions occured and how serious they may be. It is like being told there were 17,242 crimes in a given state over a given time period and we are left in the dark as what types of crimes were documented and how many in each category.

I'll bet we will see a flurry of letters to the editor attacking various aspects of this article.

New Orleans Charity hospital- Dead? But not forgotten

Having grown up medically in halls and wards of Big Charity, news items and blocs about it attract me immediately.

The March 15,2006 issue of JAMA has a poem by a physician, Dr. Wayne F. Larrabee, Jr. who trained there. The poem states in part:

"Charity Hospital, New Orleans 1735-2005 ...Generations climbed her stone steps, disappeared for years inside gray walls, learned to live thirty-six hour days and then to sleep without dreams...

Our hands remember though how to wield a knife, separate good tissue from bad, preserve vessel and nerve and something more- how to touch a dying patient whisper a wordlessly benediction and receive a blessing in return. "

The Haversion Canal blog, authored by a Tulane med student is keeping us current on a planned rally at Charity to save the hospital which has sat unoccupied since Katrina and it seems the state of Louisiana has determined it cannot be repaired and must close permanently.

The featured speakers include LSU and Tulane faculty. I wish I could be there and I wish there were some hope to salvage the institution. It is impossible to think of LSU Medical School and Tulane Medical School without thinking of Charity. I think the med students and house officers who trained there all received a " blessing in return ".

Caveats regarding carotid sinus massage

The March 12, 2006 issue of the Archives of Internal Medicine has an interesting article on the issue of syncope and carotid sinus hypersensitivity and a useful related editorial.

The editorialist make a good point about the contraindications for carotid sinus massage (CSM) as a diagnostic maneuver. The presence of a bruit has traditionally been considered a contraindication but because of the limited diagnostic value of listening over the neck arteries Dr. Neil Coplan suggests it would make more sense to do a carotid ultrasound first if there is concern about the presence of carotid artery disease. And in an elderly patient with a history of syncope you would almost always have that concern and the suggestion is that the absence of a bruit may not be sufficient reassurance.

The article, itself,showed that among community dwelling older folks in England, carotid sinus hypersensitivity was seen in 35 % of the sample ( n=1,000) who did not have a history of falls, syncope or even dizziness. So the point is that a positive result on CSM does not necessarily mean that the patient with syncope has carotid sinus hypersenstivity as the cause and other causes still need to be ruled out. How do you determine if the hypersensitivity is the causative? Basically you check out the other likely suspects and make a clinical judgment.

Since carotid sinus hypersensitivity may be fairly common in the older population, a comment regarding safe use of stethoscope seems in order. At some point in time, which so far has not been accurately pinpointed by medical historians, a sea change occurred in the way stethoscopes are worn. Older docs may still place the ear pieces around the back of the neck while younger ones drape the instrument around the neck with the ear pieces dangling on one side of the chest and the heads of the instruments on the other. Why or when this important cultural change occurred is unclear and the ergonomic issues need to be discussed but older docs need to shift to the modern method if for no other reason than to avoid syncope. This link shows the safe way to carry your stethoscope when not in use and on this link we see Dr. Kildare with the style of another stethoscope era.. Another reason that it is good to keep current.

Homocysteine- three randomized trials suggest maybe everyone will not benefit from supplementation with b12 and folate

A pre-publication release from the NEJM on line gives us the results of 2 randomized trials (RCTs) which investigated the effects of treating patients with known cardio-vascular disease with folic acid and B12. These trials known as the HOPE 2 trial and the NOVIT trial join the previously published VISP trial.

Overall, there was no benefit in terms of the composite end point of recurrent myocardial infarction,stroke or sudden cardiac death. In HOPE 2, there was a statistically significant reduction in stroke among treated patients versus placebo. In all 3 trials the treatment did reduce the homocysteine levels. The concept of using composite end points is interesting and leaves me a bit puzzled. What is the rational of adding up cases of MI and strokes? Is not each outcome an important concern per se? How do authors decide to lump or split outcomes?

These trials do not provide evidence against the practice of attempting to lower elevated homocysteine levels in patients with CV disease as the trial treated all comers , not just those with elevated levels. What about patients with elevated levels and no history of CV disease?

I cannot leave this topic without noting a meta-analysis quoted by the editorialist in the same NEJM issue as the two articles quoted above. That article "determined" that a 25% reduction in the serum homocysteine levels was associated with an 11 % lower risk of ischemic heart disease. The fact that we now have 3 RCTs that contradict a Meta-analysis should no longer be noteworthy as we see that more than occasionally. My point is that to imply such precision exists in how much benefit will accrue from a given therapeutic manipulation based on a meta-analysis is not warranted and approaches the threshold for silliness. When authors do that it applies a coat of "apparent validity" paint to a structure held together by a complex collection of assumptions.

After I use up my current supply of b12 I guess there is no reason to buy any more.

Physicians deal with individuals not with averages

I blogged previously that a key maxim that medical students should have branded into their brains is "Every one does not react in the same way to treatment".

There is more to it than that. Everyone with the same illnesses does not present in the same way,everyone with same illness does not always have the same results on lab tests or imaging and everyone does not accept a physician's recommendation in the same way.

I came across a memorable quote that captures all of that in an eloquent way and needs to be appended to the hypothetical handout for med students of the very important Milbank Quarterly article by RL Kravitz which is entitled "Evidence-based medicine;heterogeneity of treatment effects and the trouble with averages"

The author is Dr. Leon Eisenberg,the reference "Medicine-Molecular,Monetary, or More than Both", JAMA july 26,1995-vol 272, no. 4 p 331" While I do not agree with all he said the following is dynamite"

"...Medicine deals with phenotypes,not genotypes. Between genotype and phenotype, a lifetime of individual experience has fashioned what began as an envelope of stochastic probabilities into a singular personal embodiment: the patient who faces us.

In clinical practice, it is the particularities and idiosyncrasies of the individual patient that challenge the physician. The same disease never presents in quite the same way in successive patients.

Complaints vary: severity varies, response to treatment varies. Nondisease, that is, nonorganic disease, mimics "real disease" with remarkable fidelity"

In short, there is heterogeniety of almost everything and possibly why Hippocrates noted that experience was treacherous along with judgment being difficult.

Required reading" Aggravated Docsurg's post onThe AMA,Pay for peformance (P4P)

I have written about P4P before and am more concerned than ever about it in light of AMA recent apparent support of it.

Aggravated Docsurg has an excellent post of this topic replete with great links to well written and thoughtful essays pointing out what a bad idea P4P is. I can add nothing to his comments and those he references. The P4P may well work out to be even worse than managed care if that is even possible.

The latest Holly Grail Test for bacterial infection? -Procalcitonin

"Use less antibiotics" has become a common theme. Antibiotics are expensive, pneumonia is a very big ticket item for CMS and hospitals and then there is the often invoked specter of antibiotic resistant in regard to which the conventional wisdom is that overuse of antibiotics is one of the causal elements. Recently, I referenced an article that suggested that effective "education" about overuse of antibiotics might have negative health effects because of underuse.

Procalcitonin, (PCT) as the name implies, is a precursor to the thyroid hormone calcitonin. Normally this substance is found in the thyroid glands but in some conditions,notably bacterial infections-but maybe not viral-blood levels rise.

A recent paper ( reported in the Feb. issue of "Pulmonary Medicine, pg 3, " Procalcitonin can guide antibiotic use in CAP cases) explored its use in community acquired pneumonia, in which the authors claimed that one could use the test to determine duration of antibiotic therapy. For the most part, how long we treat pneumonia is a function of physician preference and reliance on expert opinion.

As a recent journal club discussion of procalcitonin's role in detecting bacterial infections pointed out, already there are a number of "yes,buts" and "howevers". PCT may not always be elevated in bacterial sepsis, and may be elevated in heart failure and cardiogenic shock and I'll bet as time goes by more conditions and medications will be found to effect blood levels.

Appropriate restraint in the enthusiasm for thinking that PCT will always paint a bright line between bacterial and viral infections is expressed in this review by two investigators who have done some of the often quoted research in this area. PCT testing may well evolve into common use as one of the diagnostic elements to consider in evaluating a patient with possible infection.

Annals Internal Medicine article-you can't rely on RCTs alone to determine drug safety

In the Feb.21,2006 issue of the Annals of Internal Medicine, Ioannidis et al have an excellent article on adverse efffects (AEs).(Ioannidis,et al "Adverse effects;The more you search, the more you find", Ann Int Med 144 (4) Feb 21, 2006)

"It is almost always inappropriate to make statments about no difference in adverse rates between groups of non-significant p values....rates of adverse events that are derived from single, modest-sized trials that are not statistically significant typically do not exclude with certainty the possibility of major,clinical important differences in harm between groups"

Randomized trials are often small and designed to test efficacy in patients in which the dosing is well controlled and often patients with co-morbidities are excluded. Only after many more patients are treated do side effects become apparent.

The latest two in what could be a very long list of medications for which serious safety issued arose after RCTs were done and FDA approval issued are Tegrin (gatifloxacin) and Ketex.

The issue with gatifloxacin drug is diabetes and now it seems to be contraindicated in patients with diabetes. Serious liver problems have been noted with Ketex.

Interestingly, gatifloxacin has been associated both with hypoglycemic reactions in diabetics on treatment and hyperglycemia in patients previously not known to be diabetic.One cannot but wonder what the mechanism(s)is/are.

A recent review of gatifloxacin-hyperglycemia cases found most were associated with decreased renal function. That the blood sugar effects are not limited to just gatifloxacin is suggested by another recent review that showed approximately equal numbers of "dysglycemias" with gatifloxacin and levofloxacin.Still another review study demonstrated a greater risk of blood sugar alterations with gatifloxacin.

Even though the RCT rests on the top perch in the party-line version of the heirarchy of the evidence used in evidence based medicine, we have to fall back on the lowly case report and observational studies to alert us to serious drug side effects. We have to realize RCTs may be best to determine efficacy not the risk of adverse effects.

ACP'S " Advanced Medical Home" will that dog hunt?

If you live in Texas, sooner or later you have to say something about "dogs and hunting" and I apologize in advance for seeming to treat a very serious,and I presume thoughtful, set of suggestions from the American College of Physicians in what seems to be a flip manner.

The ACP rightfully claims that primary care medicine is in a crisis mode. I agree. Their proposal called "Advanced Medical Home" (AMH) call for widespread changes in reimbursement, practice mechanics and systems and even medical education.

The proposal recommends:

"Voluntary certification and recognition of primary care and specialty medical practices that provide patient-centered care based on the principles of the chronic care model; use evidence based guidelines, apply appropriate health information technology, and demonstrate the use of best practices to consistently and reliably meet the needs of patients while being accountable for the quality and value of the care provided".



The ACP calls for:

public policy and third party financing changes and changes in medical education and national pilot testing of their proposal.

Reading though the 20 plus pages (plus appendices) I am somewhat discouraged by finding every current buzz word and platitude that are usually used in policy wonk type discussions of health care ( patient centered, value, best practices,etc,etc) but it is clear that primary care is in trouble and the ACP is at least aware of some of the issues. They seem to rely on the hope that evidence based medicine and information technology and the team approach will save the day for primary care and that somehow or other the folks with the check books (CMS,insurance companies) will cooperate with their suggestions.

The model that they proposed is supposed to improve quality and reduce cost and physicians can share in this "system wide" savings. We all know how physicians shared in the cost savings that Managed Care was to bring about. In this era of evidence based medicine where is the evidence of efficacy or safety for what they propose? Where is the evidence that this approach will save money.

Will what they propose matter? Will anyone ( CMS and third party payers)
listen? Does it all make any sense? I would be very interested in what the real doctors out there think about this.