Two important analyses are discussed in the March 30, 2007 posting on Health Care Renewal. They deal with the fantastically, overhyped goal for hemoglobin A1c which is given a thoughtful and critical once-over as is the 4 hour rush-to-give antibiotics for patients diagnosed with community acquired pneumonia (CAP).
Dr. Roy Poses references and discusses two articles regarding these topics and raises serious questions regarding the dangerously simplistic foundational premises behind P4P.
Poses says
"... developing performances measures that will truly benefit patients will require...understanding of the clinical context,statistical analysis of the available research data and careful balancing of the benefits,harms and costs."
and calls for a detailed disclosure of all conflicts of interests of those involved in the guideline development processes.
A major problem that was discussed was the typical lack of risk adjustment in the guideline movement. For example, in regard to the glycoselated hemoglobin target, the one size fits all target is mandated for patients included even though they posses clinical characteristics which excluded them from the clinical trials which demonstrated the risk reduction benefit for lowering the A1c. In this group of patients, e.g. the elderly and very elderly and those with multiple other illnesses, the risk of hypoglycemic reactions may well negate any unproved theoretical benefit in long term cardiovascular and microvascular disease reduction. But that type of decision has to be made by a thoughtful physician in consultation with the patient taking into account the individual clinical context and the patient's values and preferences, none of which necessarily have anything to do with guidelines.
The further the decision making is removed from the rapidly- becoming- marginalized physician-patient decision making unit the more likely it is that harm will result and reasoned decisions will be pre-empted by treatment mandates that ignore the individual details that embody the patient.The overarching principles -even if they may not be driven by one special interest or another- of the guideline authors and advocates need not reflect the values and preferences of the patient.
More and more reasoned, thougtful critiques of P4P appear in the medical literature but the movement shows little signs of slowing down. I hope we are not seeing another instance of " the dogs barking and the caravan moving on" but I am afraid we are.
Friday, March 30, 2007
Does ACP's proposal for Medical Home ignore the reality of how patients run their lives?
I recently wrote about how P4P is very unlikely to work based on the way that patients run their lives and see various doctors. Exercising their freedom to choose whatever physician they want, patients may see numerous physicians within a year making it, in many instances, impossible to administratively "assign" a given doctor to a given patient.
The American College of Physicians (ACP) has proposed what they call The Medical Home and suggested that physicians be paid on the basis of a defined bundle of services and provide "patient centered care" through a "qualified medical home" in which a physician accepts overall responsibility for the care of the patient and leads a team that will provide integrated,comprehensive care.
If Mr Jones sees Dr. White, a primary care physician who recommends a treatment plan according to the very latest ADA guidelines, and then decides to see instead Dr.Black who recommends something else, who is "responsible" for his care ? What is Dr. White to do when Jones does not return for his 4 week followup,what does he do if Mr.Jones decided not to get his colonoscopy according to the latest American Cancer Society, or his eye exam according to ADA guidelines, or did not return for his flu shot which was recommended, etc etc. If later Mr. Jones injured his knee while bowling and went to see an orthopedist that his brother had recommended without letting Dr. White integrate his care and an "unnecessary" ( by some Ottawa decision rule or whatever) MRI and then arthroscopy were done, will Dr. White be responsible for misuse of "scarce medical resources"?
Here's the thing. As long as people are free to see whatever doctor or doctors they want and are free to conform with or ignore medical advice and take medicine or not the, ACP's suggested medical home ( and as mentioned before, P4P) will not work. If it could work without coercion, I would like to hear how. Does it make any sense outside of a single-payer-single tier system? Maybe that is what ACP wants.
Maybe Mr. Jones would have to sign a contract to adhere to the doc's plan or maybe there will come a time when a entity (government or a government sanctioned insurance agency) will assign Mr.Jones to a primary care doctor and permission wil have to be obtained to change doctors.
The American College of Physicians (ACP) has proposed what they call The Medical Home and suggested that physicians be paid on the basis of a defined bundle of services and provide "patient centered care" through a "qualified medical home" in which a physician accepts overall responsibility for the care of the patient and leads a team that will provide integrated,comprehensive care.
If Mr Jones sees Dr. White, a primary care physician who recommends a treatment plan according to the very latest ADA guidelines, and then decides to see instead Dr.Black who recommends something else, who is "responsible" for his care ? What is Dr. White to do when Jones does not return for his 4 week followup,what does he do if Mr.Jones decided not to get his colonoscopy according to the latest American Cancer Society, or his eye exam according to ADA guidelines, or did not return for his flu shot which was recommended, etc etc. If later Mr. Jones injured his knee while bowling and went to see an orthopedist that his brother had recommended without letting Dr. White integrate his care and an "unnecessary" ( by some Ottawa decision rule or whatever) MRI and then arthroscopy were done, will Dr. White be responsible for misuse of "scarce medical resources"?
Here's the thing. As long as people are free to see whatever doctor or doctors they want and are free to conform with or ignore medical advice and take medicine or not the, ACP's suggested medical home ( and as mentioned before, P4P) will not work. If it could work without coercion, I would like to hear how. Does it make any sense outside of a single-payer-single tier system? Maybe that is what ACP wants.
Maybe Mr. Jones would have to sign a contract to adhere to the doc's plan or maybe there will come a time when a entity (government or a government sanctioned insurance agency) will assign Mr.Jones to a primary care doctor and permission wil have to be obtained to change doctors.
Thursday, March 29, 2007
Guidelines-the mantra "treat to goal" re-shaping medical thought?
Two things stimulated the thoughts that follow.
The first was comments made by Dr. Jerome Groopman in the first chapter of his new book " How Doctors Think" when he opined that clinical algorithms (I tend to place algorithms and guidelines in the same conceptual box) fall apart when physicians need to think outside the box and (I would add) when the framing up of an ambiguous clinical situation needs to be done. His concern was that current house officers are so guideline and algorithm oriented that perhaps that the outside the box,creative, independent thinking region of their brains may be at risk for atrophy.
The second was observations from a "CME" dinner talk about diabetes (one that was not given by Joslin).It seemed that all of the questions hinged on how to get a patient to "goal". It did not seem to be at all about tailoring the treatment to the patient or really treating the patient at all but it was about the getting the numbers right. I wondered what even happened to old house office motto of " treat the patient not the numbers".
It seems to be all about number now. the numbers of the statistics of the clinical trial, the numbers that committees set for goals that should be achieved,the number of hours in which antibiotics must be given to reach a quality goal for treatment of community acquired pneumonia,the number of minutes a physician is allotted per patient, the likelihood ratio regarding a diagnostic test. Groopman said it well:
" Today's reliance on evidence-based medicine risk having the doctor choose passively,solely by the numbers. Statistics cannot substitute for the human being before you; statistics embody averages, not individuals."
Only a thinking physician in collaboration with the patient can determine if the "best therapy from a clinical trial fits a patient's particular needs and values"
Observing house officer on round lead Groopman to the following conclusion:
" ...the next generation of doctors was being conditioned to function like a well programmed computer that operates within a strict binary framework."
Is that valid?
The emphasis on guidelines and algorithms fits in nicely with those whose vision of medical care includes a major role for "mid-level" practitioners.(This is a interesting term.Note we do not say lower level practitioners.Who would want their medical problem assessed or treated by a lower level practitioner? If PAs and NPs are mid level, for what type of practitioner would we use the term "low level"practitioner?).
The guideline-algorithm mentality also may suggest the idea of a physician as an exchangeable commodity.Dr. Stuart Henochowicz , whose whose interesting blog is MEDVIEWS, defends the position that doctors are not commodities in a recent Medscape interview.
The first was comments made by Dr. Jerome Groopman in the first chapter of his new book " How Doctors Think" when he opined that clinical algorithms (I tend to place algorithms and guidelines in the same conceptual box) fall apart when physicians need to think outside the box and (I would add) when the framing up of an ambiguous clinical situation needs to be done. His concern was that current house officers are so guideline and algorithm oriented that perhaps that the outside the box,creative, independent thinking region of their brains may be at risk for atrophy.
The second was observations from a "CME" dinner talk about diabetes (one that was not given by Joslin).It seemed that all of the questions hinged on how to get a patient to "goal". It did not seem to be at all about tailoring the treatment to the patient or really treating the patient at all but it was about the getting the numbers right. I wondered what even happened to old house office motto of " treat the patient not the numbers".
It seems to be all about number now. the numbers of the statistics of the clinical trial, the numbers that committees set for goals that should be achieved,the number of hours in which antibiotics must be given to reach a quality goal for treatment of community acquired pneumonia,the number of minutes a physician is allotted per patient, the likelihood ratio regarding a diagnostic test. Groopman said it well:
" Today's reliance on evidence-based medicine risk having the doctor choose passively,solely by the numbers. Statistics cannot substitute for the human being before you; statistics embody averages, not individuals."
Only a thinking physician in collaboration with the patient can determine if the "best therapy from a clinical trial fits a patient's particular needs and values"
Observing house officer on round lead Groopman to the following conclusion:
" ...the next generation of doctors was being conditioned to function like a well programmed computer that operates within a strict binary framework."
Is that valid?
The emphasis on guidelines and algorithms fits in nicely with those whose vision of medical care includes a major role for "mid-level" practitioners.(This is a interesting term.Note we do not say lower level practitioners.Who would want their medical problem assessed or treated by a lower level practitioner? If PAs and NPs are mid level, for what type of practitioner would we use the term "low level"practitioner?).
The guideline-algorithm mentality also may suggest the idea of a physician as an exchangeable commodity.Dr. Stuart Henochowicz , whose whose interesting blog is MEDVIEWS, defends the position that doctors are not commodities in a recent Medscape interview.
Tuesday, March 27, 2007
The COURAGE trial-fewer PCIs down the road for stable angina
The biggest news from the American College of Cardiology meeting in New Orleans(March 2007) has to be the results of the COURAGE trial. This trial compared optimal medical therapy with the combination of medical therapy plus PCI for stable angina patients and medical therapy did just as good. This lead to headlines across the news channels proclaiming that many angioplasties are unnecessary.Full text of the report and a commentary is available from the New England Journal web site for free.
It is important to look at who was not included in this trial:
Patients with very severe angina (CCS stage iv-meaning rest angina or angina brought on by any physical activity)
Patients with very positive stress tests (meaning st changes in stage 1 and/or hypotension brought on by the exercise)
ejection fraction less than 30%
history of revascularization in the previous six months.
Patients had to have at least one epicardial coronary artery with 70% stenosis plus objective evidence of myocardial ischemia to be eligible for the trial.
The study showed no difference in mortality or myocardial infarction in the 4.6 years of observation and was consistent with earlier,smaller trials that suggested no mortality benefit to PCI but perhaps greater relief of anginal symptoms.
I found the following sentence helpful in trying to understand what may be the relevant pathophysiology:
"Unstable plaques that lead to myocardial infarction are not necessarily severely stenotic and severely stenotic plaques are not necessarily unstable ."
While the severely stenotic plaques may be a marker for the unstable variety being present elsewhere in the coronary circulation it is the latter that typically causes the myocardial infarction or acute coronary syndrome so that dilating the former may relieve angina symptoms but is not likely to prevent infarcts.On the other hand, medical therapy is thought to treat all of the coronary arterial tree and may make unstable plaques less likely to cause trouble.
PCIs will be continued to be recommended for many acute coronary syndromes and for anginal patients whose symptoms resist medical therapy but there are bound to be fewer PCIs done for stable anginal patients because of this trial.
It is important to look at who was not included in this trial:
Patients with very severe angina (CCS stage iv-meaning rest angina or angina brought on by any physical activity)
Patients with very positive stress tests (meaning st changes in stage 1 and/or hypotension brought on by the exercise)
ejection fraction less than 30%
history of revascularization in the previous six months.
Patients had to have at least one epicardial coronary artery with 70% stenosis plus objective evidence of myocardial ischemia to be eligible for the trial.
The study showed no difference in mortality or myocardial infarction in the 4.6 years of observation and was consistent with earlier,smaller trials that suggested no mortality benefit to PCI but perhaps greater relief of anginal symptoms.
I found the following sentence helpful in trying to understand what may be the relevant pathophysiology:
"Unstable plaques that lead to myocardial infarction are not necessarily severely stenotic and severely stenotic plaques are not necessarily unstable ."
While the severely stenotic plaques may be a marker for the unstable variety being present elsewhere in the coronary circulation it is the latter that typically causes the myocardial infarction or acute coronary syndrome so that dilating the former may relieve angina symptoms but is not likely to prevent infarcts.On the other hand, medical therapy is thought to treat all of the coronary arterial tree and may make unstable plaques less likely to cause trouble.
PCIs will be continued to be recommended for many acute coronary syndromes and for anginal patients whose symptoms resist medical therapy but there are bound to be fewer PCIs done for stable anginal patients because of this trial.
Sunday, March 25, 2007
How doctors think and the importance of "check your premises"
Jerome Groopman's new book, "How Doctors Think" has attracted a bit of media attention replete with a favorable write-up in Time magazine.
Groopman discusses a topic of considerable personal interest and one that I have blogged about now and again. The topic of how cognitive mechanisms such as heuristics serve us well most of the time but can also lead us down a very wrong end is well is illustrated by Groopman with clinical histories, sometimes of his own medical adventures and misadventures. Placing the abstract concepts with real life clinical vignettes give them limbic valence.
Pattern recognition seems to be very important in the diagnostic acumen of experts and a well functioning pattern recognition system which develops over time and with experience seems to be a major distinguishing feature of the expert from the novice. It is useful but not perfect based as it is based on generalizations and abstractions. Generalizations are generally right but not always- so that even with optimal functioning of pattern recognition mistakes can occur.
This pattern recognition system ( a.k.a heuristics, or mental shortcuts) while serving the expert well comes with a dark side, one aspect of which is the phenomenon of "premature closure". This refers to making a diagnosis or an initial impression and then shutting out consideration that the diagnosis may be wrong even as contradictory evidence accumulates.
To mitigate this premature closure,using Groopman's words, the physician needs to:
" repeatedly factor into the analysis the possibility that he is wrong" ... "cogent medical judgments meld first impressions-gestalt-with deliberate analysis." and the physician:
"should be schooled in heuristics-in the power and necessity of shortcuts and in their pitfalls and dangers."
Good diagnosticians need to frequently remind themselves to reconsider the diagnosis as events unfold and test data comes in play asking What else could it be? What have we missed? What is the worst thing it could be?
Basically what we are talking about was nailed by Any Rand when she had her super-heroes say:
"Whenever you think you are facing a contradiction, check your premises, you will find that one of them is wrong." Atlas Shrugged.
For physicians who might want a shorter version ( Dr. Groopman's stated aim was to write a book for layman's consumption) of the key issues with cognitive errors in medical diagnosis, here is an excellent article by Dr. Donald Redelmeier.
Groopman discusses a topic of considerable personal interest and one that I have blogged about now and again. The topic of how cognitive mechanisms such as heuristics serve us well most of the time but can also lead us down a very wrong end is well is illustrated by Groopman with clinical histories, sometimes of his own medical adventures and misadventures. Placing the abstract concepts with real life clinical vignettes give them limbic valence.
Pattern recognition seems to be very important in the diagnostic acumen of experts and a well functioning pattern recognition system which develops over time and with experience seems to be a major distinguishing feature of the expert from the novice. It is useful but not perfect based as it is based on generalizations and abstractions. Generalizations are generally right but not always- so that even with optimal functioning of pattern recognition mistakes can occur.
This pattern recognition system ( a.k.a heuristics, or mental shortcuts) while serving the expert well comes with a dark side, one aspect of which is the phenomenon of "premature closure". This refers to making a diagnosis or an initial impression and then shutting out consideration that the diagnosis may be wrong even as contradictory evidence accumulates.
To mitigate this premature closure,using Groopman's words, the physician needs to:
" repeatedly factor into the analysis the possibility that he is wrong" ... "cogent medical judgments meld first impressions-gestalt-with deliberate analysis." and the physician:
"should be schooled in heuristics-in the power and necessity of shortcuts and in their pitfalls and dangers."
Good diagnosticians need to frequently remind themselves to reconsider the diagnosis as events unfold and test data comes in play asking What else could it be? What have we missed? What is the worst thing it could be?
Basically what we are talking about was nailed by Any Rand when she had her super-heroes say:
"Whenever you think you are facing a contradiction, check your premises, you will find that one of them is wrong." Atlas Shrugged.
For physicians who might want a shorter version ( Dr. Groopman's stated aim was to write a book for layman's consumption) of the key issues with cognitive errors in medical diagnosis, here is an excellent article by Dr. Donald Redelmeier.
Tuesday, March 20, 2007
Dueling ethical views in Archives Internal Medicine re: "tiered" health care systems
In the March 12,2007 issue of the Archives of Internal Medicine, we find two differing views on the ethical status of a tiered medical care system. A one tiered system is exemplified by the Canadian system in which patients are forbidden to purchase care outside of the governmental sanctioned system. ( At least in Canada, they can still medically escape to the U.S.)In England, a private medical insurance scheme thrives, existing along side of the National Health Service.
Dr. Ezekiel Emanuel and Benjamin Krohmal argue in their article that a tiered system (i.e. one with more than one tier) is "just in principle and ..just in practice". They justify their position in part by reference to Rawls principles of justice, the first of which is that "all have the right to the greatest individual liberties compatible with the same liberties for others." Since some medical goods or services must go without public funding, justice protects the liberty of individuals to pay for medical options that the public (government) fails to provide.
In a companion editorial , Dr. Allan S. Brett takes a different point of view. He argues that a second tier may not be necessary and is problematic from an ethical point of view. He says that if we eliminated administrative waste and unnecessary medical interventions then people could then receive comprehensive medical care without a second back up , paid -by the-patient- tier. Since he also recommends a single payer system-i.e government-the "if" in eliminating administrative waste become a very big "if" and then we face the issue of who decides what is "unnecessary".
Further, he suggests that "effective evidence-based interventions should be included in the first tier, and ineffective or unproven interventions should not be provided in any tier."
His use of the term "should not be provided" glosses over what he is saying.What he is saying is that purchasing services not provided in the first tier will not be allowed, i.e will be made illegal. Phrasing this in the more candid way makes his claim that his view is not antithetical to American values empty.
Dr. Brett does not elaborate on what the process would be to decide which interventions are or are not effective but one can assume that would not be done by the individual physician in consultation with the individual patient.Those decisions would be made by committees appointed by the one party payer (which Dr. Brett favors) either directly or indirectly. Ironically, the egalitarian one tier patient system would establish a two tier physician system in which the higher tier would be the elite physicians who decide what should be "provided" and in the lower tier will be the rest of the physicians who will explain to patients what they will be not allowed to have.
Dr. Ezekiel Emanuel and Benjamin Krohmal argue in their article that a tiered system (i.e. one with more than one tier) is "just in principle and ..just in practice". They justify their position in part by reference to Rawls principles of justice, the first of which is that "all have the right to the greatest individual liberties compatible with the same liberties for others." Since some medical goods or services must go without public funding, justice protects the liberty of individuals to pay for medical options that the public (government) fails to provide.
In a companion editorial , Dr. Allan S. Brett takes a different point of view. He argues that a second tier may not be necessary and is problematic from an ethical point of view. He says that if we eliminated administrative waste and unnecessary medical interventions then people could then receive comprehensive medical care without a second back up , paid -by the-patient- tier. Since he also recommends a single payer system-i.e government-the "if" in eliminating administrative waste become a very big "if" and then we face the issue of who decides what is "unnecessary".
Further, he suggests that "effective evidence-based interventions should be included in the first tier, and ineffective or unproven interventions should not be provided in any tier."
His use of the term "should not be provided" glosses over what he is saying.What he is saying is that purchasing services not provided in the first tier will not be allowed, i.e will be made illegal. Phrasing this in the more candid way makes his claim that his view is not antithetical to American values empty.
Dr. Brett does not elaborate on what the process would be to decide which interventions are or are not effective but one can assume that would not be done by the individual physician in consultation with the individual patient.Those decisions would be made by committees appointed by the one party payer (which Dr. Brett favors) either directly or indirectly. Ironically, the egalitarian one tier patient system would establish a two tier physician system in which the higher tier would be the elite physicians who decide what should be "provided" and in the lower tier will be the rest of the physicians who will explain to patients what they will be not allowed to have.
Friday, March 16, 2007
More data showing why P4P will not work-planners undaunted
A recent (free without subscription) article in the NEJM presents data that indicate that the reality of medical care in the U.S. is such that the P4P will not work. Many Medicare patients- and I am sure this applies to non-Medicare patients as well- do not have their medical care provided by a single practitioner.
One problem that policy-wonk, medical planners have is they are dealing with people who live in a free country who typically exercise their choice about a lot of things including who they see when they are ill. If a person is not happy with their doctor-for whatever reason-they change doctors and sometimes they change doctors even if they are happy with the current physician.
In the course of a year a so a person may see several different doctors. This poses a problem for the P4P advocates-namely who should the patient be "assigned to" in terms of the rewards or the penalties of the pay for performance system. The study authors doubt how effective P4P will be in improving quality-for those of you who believe that is about quality. They also suggest maybe we need to assign patients to a given doctor.
The authors may want to review section 1802 of the Medicare bill which said:
" Any individual entitled to insurance benefits under this title may obtain medical services from any institution,agency or person qualified to participate."
Although we can find little comfort in that assurance since the government stopped paying any attention to section 1801 of that bill long ago:
"Nothing in this tittle shall be construed to authorize any federal official or employee to exercise any supervision or control over the practice of medicine..."
Of course, the way that medical care is actually"delivered" is only an inconvenient truth to the planners-something that needs to be restructured to better fit their plans for what everyone should do. That pesky freedom thing does have a way of interfering with central planing.The companion editorial-by Karen Davis, a PhD economist and currently President of the Commonwealth Foundation- suggests ways to changes things so P4P could work. Somehow, we could encourage doctors and patients to participate in a system more like that in which P4P might work and encourage the growth of large integrated systems. Then those systems could reap the rewards of a P4P arrangement. She then admits that P4P at best would be a intermediate step-an interim program- until the day when their bigger and better plan could be realized.Stay turned for details of what that might be.
One problem that policy-wonk, medical planners have is they are dealing with people who live in a free country who typically exercise their choice about a lot of things including who they see when they are ill. If a person is not happy with their doctor-for whatever reason-they change doctors and sometimes they change doctors even if they are happy with the current physician.
In the course of a year a so a person may see several different doctors. This poses a problem for the P4P advocates-namely who should the patient be "assigned to" in terms of the rewards or the penalties of the pay for performance system. The study authors doubt how effective P4P will be in improving quality-for those of you who believe that is about quality. They also suggest maybe we need to assign patients to a given doctor.
The authors may want to review section 1802 of the Medicare bill which said:
" Any individual entitled to insurance benefits under this title may obtain medical services from any institution,agency or person qualified to participate."
Although we can find little comfort in that assurance since the government stopped paying any attention to section 1801 of that bill long ago:
"Nothing in this tittle shall be construed to authorize any federal official or employee to exercise any supervision or control over the practice of medicine..."
Of course, the way that medical care is actually"delivered" is only an inconvenient truth to the planners-something that needs to be restructured to better fit their plans for what everyone should do. That pesky freedom thing does have a way of interfering with central planing.The companion editorial-by Karen Davis, a PhD economist and currently President of the Commonwealth Foundation- suggests ways to changes things so P4P could work. Somehow, we could encourage doctors and patients to participate in a system more like that in which P4P might work and encourage the growth of large integrated systems. Then those systems could reap the rewards of a P4P arrangement. She then admits that P4P at best would be a intermediate step-an interim program- until the day when their bigger and better plan could be realized.Stay turned for details of what that might be.
Wednesday, March 14, 2007
Momentum builds for use of aromatase inhibitors in estrogen positive breast cancer
A recently published clinical trial provides more reason to prefer the aromatase inhibitors to tamoxifen in the treatment of estrogen positive breast cancer.
There are currently three aromatase inhibitors (AIs) approved for breast cancer treatment in hormone positive breast cancer:
Anastrazole (Arimidex)
Letrozole (Femara)
Exemestane (Aromasin)
Here is a NCI website with an annotated bibliography of some of the major clinical trials involving these drugs. The role of AIs seems most clear in high risk patients (large tumors,positive lymph nodes,higher grade histological changes) while the more severe estrogen depletion side effects makes its putative superiority over tamoxifen less clear in those breast cancer patients with low risk of recurrence.
Probably more than any other internal medicine sub specialists, oncologists have been obliged to plow through and attempt to master the deluge of clinical trials and try and determine how to translate those studies into the real life, day to day, medical management of patients with cancer. Two months ago, I had the opportunity to attend a 2 hour seminar on treatment of breast cancer given by a local private practice oncologist and by a local academic oncologists. The mastery of the trial data and their advice regarding practical application to treatment decisions that these two physicians demonstrated reminded me of one of the reasons that some of us went into internal medicine -the pleasure and sense of accomplishment of mastery (or as close as one can come to that with the moving target of medical advances and the accumulation of data contradicting older data) of complicated ideas and multiple facts and putting it all together into the care of sick patients.
There are currently three aromatase inhibitors (AIs) approved for breast cancer treatment in hormone positive breast cancer:
Anastrazole (Arimidex)
Letrozole (Femara)
Exemestane (Aromasin)
Here is a NCI website with an annotated bibliography of some of the major clinical trials involving these drugs. The role of AIs seems most clear in high risk patients (large tumors,positive lymph nodes,higher grade histological changes) while the more severe estrogen depletion side effects makes its putative superiority over tamoxifen less clear in those breast cancer patients with low risk of recurrence.
Probably more than any other internal medicine sub specialists, oncologists have been obliged to plow through and attempt to master the deluge of clinical trials and try and determine how to translate those studies into the real life, day to day, medical management of patients with cancer. Two months ago, I had the opportunity to attend a 2 hour seminar on treatment of breast cancer given by a local private practice oncologist and by a local academic oncologists. The mastery of the trial data and their advice regarding practical application to treatment decisions that these two physicians demonstrated reminded me of one of the reasons that some of us went into internal medicine -the pleasure and sense of accomplishment of mastery (or as close as one can come to that with the moving target of medical advances and the accumulation of data contradicting older data) of complicated ideas and multiple facts and putting it all together into the care of sick patients.
Wednesday, March 07, 2007
Internists doing fewer traditonal internist procedures
The results of a survey sent to 2500 general internist members of the American College of Physicians and replied to by 1389 indicate that internists are doing fewer of the procedures that traditionally had been done by that speciality.This report was published in a recent issue of The Annals of Internal Medicine.
The authors compared the results with those of a survey done in 1986. Here are some of the data.
In 1986, 66% did thoracentesis versus 23 % in 2004, for abdominal paracentesis-60% dropped to 23%, bone marrow aspiration from 27% to 8 %, flex sig dropped from 42% to 20%, insertion of central line 39% to 16%.Interestingly skin biopsies increased as did cryosurgery for skin lesions . Gram stain of the sputum decreased from 50% to 5%.
The increased numbers of IM sub-specialists,tighter credentialing procedures at hospitals,the advent and proliferation of hospitalists were some of the reasons suggested by the authors behind the changes.
Of interest to me was the companion article-an editorial from the American Board of Internal Medicine (ABIM)- regarding what procedures should be taught to physicians in training to become internists.The authors distinguished between the types of procedures residents would be taught to do versus those that they would be taught about.In regard to the latter, we are told that for certain procedures, only what the ABIM refers to as "cognitive competence" will be required. This interesting pedagogic, linguistic construct apparently means that the resident must be shown to be competent in discussing the indications,contraindications, complications etc related to the procedure and be able to obtain an informed consent for the procedure-apparently that someone else will do. Included in the set of procedures are several that many of us older internists consider basic internist activities: thoracentesis, abdominal paracentesis, naso gastric intubation and lumbar puncture.
Internists in training will be required to actually learn how to do ( as opposed to learn how to talk about) the following: venous and arterial access,pap test, endocervical culture and the basic elements of ACLS including intubation.
As best, I could determine from web sources, family practice residency programs continue to teach a wide variety of procedures including those that internists now only have to be able to talk about including thoracentesis, lumbar puncture and abdominal paracentesis.
The authors compared the results with those of a survey done in 1986. Here are some of the data.
In 1986, 66% did thoracentesis versus 23 % in 2004, for abdominal paracentesis-60% dropped to 23%, bone marrow aspiration from 27% to 8 %, flex sig dropped from 42% to 20%, insertion of central line 39% to 16%.Interestingly skin biopsies increased as did cryosurgery for skin lesions . Gram stain of the sputum decreased from 50% to 5%.
The increased numbers of IM sub-specialists,tighter credentialing procedures at hospitals,the advent and proliferation of hospitalists were some of the reasons suggested by the authors behind the changes.
Of interest to me was the companion article-an editorial from the American Board of Internal Medicine (ABIM)- regarding what procedures should be taught to physicians in training to become internists.The authors distinguished between the types of procedures residents would be taught to do versus those that they would be taught about.In regard to the latter, we are told that for certain procedures, only what the ABIM refers to as "cognitive competence" will be required. This interesting pedagogic, linguistic construct apparently means that the resident must be shown to be competent in discussing the indications,contraindications, complications etc related to the procedure and be able to obtain an informed consent for the procedure-apparently that someone else will do. Included in the set of procedures are several that many of us older internists consider basic internist activities: thoracentesis, abdominal paracentesis, naso gastric intubation and lumbar puncture.
Internists in training will be required to actually learn how to do ( as opposed to learn how to talk about) the following: venous and arterial access,pap test, endocervical culture and the basic elements of ACLS including intubation.
As best, I could determine from web sources, family practice residency programs continue to teach a wide variety of procedures including those that internists now only have to be able to talk about including thoracentesis, lumbar puncture and abdominal paracentesis.
Thursday, March 01, 2007
Communication between Hospitalist and primary care physicians
It has been so long since I functioned as a officist and a hospitalist-a role known at the time as an internist- that I read with considerable interest an article in JAMA that concluded the current state of information transfer between hospital docs and PCPs was clearly in need of improvement.
Our pulmonary group enjoyed a large referral practice from a fairly wide geographical area of our state and it was thought to be very important to do three things when a patient was discharged from the hospital: 1) give the patient a summary of his/her medications and treatment plan, 2)call the referring physician and 3) write the referring physician and send him a copy of the discharge summary.
The JAMA article extracted data from numerous observational studies and present the reader with typical number of percentages too large to really keep up with. However, here are some:
Direct communication between the hospital physicians and the PCPs occurred only 3-20% of the time. Only 12-34 % of the time was the discharge summary available to the PCP at the time of the first discharge visit. In 2-40% of the time the discharge summary did not have information about the discharge medications.
While this article puts some worrisome numbers to one aspect of the current paradigm shift of the hospitalist phenomenon, there is more insight and enjoyable reading found in a brilliant 1999 NEJM article by Dr.Farrin A. Marian, to whom I believe we must give credit for the term "officist".He defines officist as a general internist who sees patients only in the office as long they remain relatively healthy.
The economic forces at work when I was a part time hospitalist gave us incentives to maintain close and mutually beneficial relationships with our referring physicians part of which was being sure they were kept well informed about what transpired with their patients. The economic forces now at work at least in some practice setttings may be a bit different.
I have been giving thought to the question "why do we have hospitalists anyway?" I am leaning to the conclusion that this is the result of physician fees price controls put into place in 1992 for Medicare patients and the controls placed on hospital charges for Medicare patients in efforts to control the rising cost of medical care for the elderly. Hopefully more on that later.
Our pulmonary group enjoyed a large referral practice from a fairly wide geographical area of our state and it was thought to be very important to do three things when a patient was discharged from the hospital: 1) give the patient a summary of his/her medications and treatment plan, 2)call the referring physician and 3) write the referring physician and send him a copy of the discharge summary.
The JAMA article extracted data from numerous observational studies and present the reader with typical number of percentages too large to really keep up with. However, here are some:
Direct communication between the hospital physicians and the PCPs occurred only 3-20% of the time. Only 12-34 % of the time was the discharge summary available to the PCP at the time of the first discharge visit. In 2-40% of the time the discharge summary did not have information about the discharge medications.
While this article puts some worrisome numbers to one aspect of the current paradigm shift of the hospitalist phenomenon, there is more insight and enjoyable reading found in a brilliant 1999 NEJM article by Dr.Farrin A. Marian, to whom I believe we must give credit for the term "officist".He defines officist as a general internist who sees patients only in the office as long they remain relatively healthy.
The economic forces at work when I was a part time hospitalist gave us incentives to maintain close and mutually beneficial relationships with our referring physicians part of which was being sure they were kept well informed about what transpired with their patients. The economic forces now at work at least in some practice setttings may be a bit different.
I have been giving thought to the question "why do we have hospitalists anyway?" I am leaning to the conclusion that this is the result of physician fees price controls put into place in 1992 for Medicare patients and the controls placed on hospital charges for Medicare patients in efforts to control the rising cost of medical care for the elderly. Hopefully more on that later.
Thursday, February 22, 2007
Family Practice may be joining Internal Medicine in identity crisis
This recent commentary in a family practice journal speaks of a major attitudinal change in family practice . Recently trained Family doctors seem to abandoning their "roots".According to the author the rigors, and risks of doing ob is something that only a shrinking number of FP docs choose to do. Other recently minted FP docs seem to be opting to doing fellowships in such areas as geriatrics, sports medicine, OB, and hospital and critical care seemingly abandoning their traditions of generalism just as some one us believe that internists may be abandoning their tradition of the care of complex and critically ill patients for the regular hours of an office practice,doing mainly primary care and punting to the hospitalists (who ironically now may as likely as not be a family practice doc) when someone gets sick.
The forces of increased medical school debt and decreasing payments for physicians-particularly those in primary care- seem to be at work in fostering the turmoil in both FP physicians and IM physicians. As IM and FP docs seem to be spending much of their time doing the same things the other does-at least in an office setting-there seem to be the same trend for both FP and IM docs as they end their residency to further specialize gaining higher pay,shorter hours and probably more prestige.
The author, Dr. James Glazer, argues for the value of maintaining the core values of the FP generalism which he believes is the heritage of the Family Practitioner. We are seeing internists morphing into primary care docs and the classical primary care doc-the family practice physician-morphing into a "generalist specialist".
As best I can tell, neurosurgeons at least, still know who they are .
The forces of increased medical school debt and decreasing payments for physicians-particularly those in primary care- seem to be at work in fostering the turmoil in both FP physicians and IM physicians. As IM and FP docs seem to be spending much of their time doing the same things the other does-at least in an office setting-there seem to be the same trend for both FP and IM docs as they end their residency to further specialize gaining higher pay,shorter hours and probably more prestige.
The author, Dr. James Glazer, argues for the value of maintaining the core values of the FP generalism which he believes is the heritage of the Family Practitioner. We are seeing internists morphing into primary care docs and the classical primary care doc-the family practice physician-morphing into a "generalist specialist".
As best I can tell, neurosurgeons at least, still know who they are .
Tuesday, February 20, 2007
Tight blood sugar control for ICU patients-stay tuned again
Randomized clinical trials work best for discrete outcomes in well defined groups of patients. In studies involving more complicated, heterogeneous groups of patients with multiple variables, results tend to be less clear cut as biases, confounding factors, the play of chance and the problems of squeezing subset analysis to make some sense of it all conspire to often make the conclusions less than satisfying or useful for real life clinical medicine.
A case in point is the recent prematurely stopped trial of tight glycemic control in ICU patients reported here. No advantage in terms of 28 day mortality rate or duration of stay in the ICU was seen in the tighter control group although other trials have suggested that mortality is lowered with stricter glucose control.Two studies from Belgium had been hailed by some as landmark studies ( at least the 2001 surgical ICU study was) and largely on the basis of the 2001 study both the ADA and the AACE issued recommendations regarding tighter control of blood sugar, the former organization targeting glucose values less than 180 and as close as possible to 110. A new standard of care emerged. Here is a thoughtful analysis of the 2001 NEJM paper and a partial review of other data tending to dampen enthusiasm for tight sugar control.
The 2006 medical ICU Belgium study, which I have commented on before, gave intensivists ( a group of physicians who treat very sick patients and used to be called internists) pause for concern in their enthusiasm to "treat to goal" (a recent mantra that makes me wonder what about the old saw about treat the patient not the numbers) as the data had to be tweaked to show a mortality advantage to the tight control group.(One analysis seemed to indicate increased mortality for the first 3 days and then a mortality advantage for the tighter group). There did seem to be less need for dialysis and there was earl er weaning from ventilators in the tight control arm of the study.
The recently reported study (European Glucontrol trial) found no mortality difference for the 536 patients treated to a blood glucose of 80-110 as compared to a group of 546 who glucose was maintained in the 140-180 range.One of the investigators, Dr. Presier from Belgium, is quoted as saying that there is no reason to recommend the use of 110 mg as a target and that 140 or 150 would be wise.
I think we have learned that elevated blood sugars should not be ignored in the critically ill patient but that we can go the way of "too much of a good thing" in attempting to impose a blood glucose of 80-110 particularly in light of recent evidence of lack of clear cut benefit and the very real increased risk of hypoglycemia about which I am just old-fashioned enough to believe it is not a good thing. In the Glucontrol trial of those with a serious hypoglycemic the mortality was 18% versus 11.6 % in those without such a reaction. For those of us still optimistic enough to believe a bigger better randomized trial will show the way, we can wait for the results of the Nice-Sugar trial.
A case in point is the recent prematurely stopped trial of tight glycemic control in ICU patients reported here. No advantage in terms of 28 day mortality rate or duration of stay in the ICU was seen in the tighter control group although other trials have suggested that mortality is lowered with stricter glucose control.Two studies from Belgium had been hailed by some as landmark studies ( at least the 2001 surgical ICU study was) and largely on the basis of the 2001 study both the ADA and the AACE issued recommendations regarding tighter control of blood sugar, the former organization targeting glucose values less than 180 and as close as possible to 110. A new standard of care emerged. Here is a thoughtful analysis of the 2001 NEJM paper and a partial review of other data tending to dampen enthusiasm for tight sugar control.
The 2006 medical ICU Belgium study, which I have commented on before, gave intensivists ( a group of physicians who treat very sick patients and used to be called internists) pause for concern in their enthusiasm to "treat to goal" (a recent mantra that makes me wonder what about the old saw about treat the patient not the numbers) as the data had to be tweaked to show a mortality advantage to the tight control group.(One analysis seemed to indicate increased mortality for the first 3 days and then a mortality advantage for the tighter group). There did seem to be less need for dialysis and there was earl er weaning from ventilators in the tight control arm of the study.
The recently reported study (European Glucontrol trial) found no mortality difference for the 536 patients treated to a blood glucose of 80-110 as compared to a group of 546 who glucose was maintained in the 140-180 range.One of the investigators, Dr. Presier from Belgium, is quoted as saying that there is no reason to recommend the use of 110 mg as a target and that 140 or 150 would be wise.
I think we have learned that elevated blood sugars should not be ignored in the critically ill patient but that we can go the way of "too much of a good thing" in attempting to impose a blood glucose of 80-110 particularly in light of recent evidence of lack of clear cut benefit and the very real increased risk of hypoglycemia about which I am just old-fashioned enough to believe it is not a good thing. In the Glucontrol trial of those with a serious hypoglycemic the mortality was 18% versus 11.6 % in those without such a reaction. For those of us still optimistic enough to believe a bigger better randomized trial will show the way, we can wait for the results of the Nice-Sugar trial.
Monday, February 19, 2007
Medical Knowledge Self Assesment Program (MKSAP) -one more time at least
MKSAP 14 has been available for over a year and I finally could resist it no longer and ordered a hard copy of it.I have enjoyed/suffered through all of the previous editions.Even though I am no longer in practice I felt compelled to spend the hours reading the texts and taking the tests-perhaps it gives me a bit of a illusion of still doing what I used to do.
One of the major additions in recent versions of MKSAP is a very large booklet entitled "General Internal Medicine". This section seems to me in part to be the manifestation of the doctrine "Why can't an internist be more like a family doctor?"
There are sections on contraception and abnormal uterine bleeding. When I trained and when I was in practice women who wanted advice about contraception and who had abnormal uterine bleeding were referred to their gynecologist.Very few of the women I saw as patients did not have a gynecologist.
Does the American College of Physicians (ACP) believe and encourage that internists should be adequately expert and trained to go through the vagaries of abnormal uterine bleeding complete with ordering ultrasound and doing a endometrial biopsy? Some of the questions seem to imply just that. Are IM residents trained in this now? At best we internists might be sort-of well read novices in this area and should we not as a matter of professional ethics refer our patients to the specialists who are best able and most expert? Some of the questions in this section seem to assume internists should be able to manage these maters.
I have recently encountered some younger internists who have carved a pseudo-niche in "women's health".These, in my limited experience are mainly female internists, who among other things do the annual paps and help their patients "manage menopause" and offer contraceptive advice. As I have commented on before this is not why I became an internist.Expanding the services I offer perhaps to compete with family doctors and NPs was not something I choose to do.
Internists seemingly are also expected to be able to diagnose and treat various skin disorders including the papulosquamous problems as well as lice and scabies. A section on corneal abrasions implies internists need fluorescein strips and Wood's lights in their office as the expectation is that not only will such patients be evaluated by the internist but treated and the internists will have the patients come back for follow up observation to see if a referral to an opthalmologist is needed.This sounds like the days of gate keeping when every referral needed approval by the insurance clerk.
In spite of the apparent theme that internists need/should/might do many of the things dermatologists and gynecologists do the, MKSAP is a great exercise in reviewing the ever increasing panorama that internal medicine has become. Plus it is probably the only time you will "see" or at least answer a question about a case that turns out to be Whipple's Disease.
One of the major additions in recent versions of MKSAP is a very large booklet entitled "General Internal Medicine". This section seems to me in part to be the manifestation of the doctrine "Why can't an internist be more like a family doctor?"
There are sections on contraception and abnormal uterine bleeding. When I trained and when I was in practice women who wanted advice about contraception and who had abnormal uterine bleeding were referred to their gynecologist.Very few of the women I saw as patients did not have a gynecologist.
Does the American College of Physicians (ACP) believe and encourage that internists should be adequately expert and trained to go through the vagaries of abnormal uterine bleeding complete with ordering ultrasound and doing a endometrial biopsy? Some of the questions seem to imply just that. Are IM residents trained in this now? At best we internists might be sort-of well read novices in this area and should we not as a matter of professional ethics refer our patients to the specialists who are best able and most expert? Some of the questions in this section seem to assume internists should be able to manage these maters.
I have recently encountered some younger internists who have carved a pseudo-niche in "women's health".These, in my limited experience are mainly female internists, who among other things do the annual paps and help their patients "manage menopause" and offer contraceptive advice. As I have commented on before this is not why I became an internist.Expanding the services I offer perhaps to compete with family doctors and NPs was not something I choose to do.
Internists seemingly are also expected to be able to diagnose and treat various skin disorders including the papulosquamous problems as well as lice and scabies. A section on corneal abrasions implies internists need fluorescein strips and Wood's lights in their office as the expectation is that not only will such patients be evaluated by the internist but treated and the internists will have the patients come back for follow up observation to see if a referral to an opthalmologist is needed.This sounds like the days of gate keeping when every referral needed approval by the insurance clerk.
In spite of the apparent theme that internists need/should/might do many of the things dermatologists and gynecologists do the, MKSAP is a great exercise in reviewing the ever increasing panorama that internal medicine has become. Plus it is probably the only time you will "see" or at least answer a question about a case that turns out to be Whipple's Disease.
Wednesday, February 14, 2007
The efficacy-effectiveness phenomenon stirkes again-this time with drug eluting stents
Our old friend,the efficacy-effectiveness phenomenon (EEP) can be found in the drug eluting stent (DES) controversy.The NEJM electronic issue hit the ether on 2/14/07 presenting 4 meta-analyses, two editorials and the well publicized Swedish registry study which alarmed cardiologists and patients. Subscribers also could listen to an audio segment in which Dr. Steve Nissen of Cleveland Clinic debated Dr. Donald Baim of Boston Scientific. Nissen recommended that a RCT be done to compare DES with bare metal stents while Dr. Baim announced that a trial was already underway to compare DES with coronary artery bypass surgery (CABG).The DES which seemed to have solved the problem of early stent restenosis stand accused of leading to late stent thrombosis and increased coronary events-trading short term gain for long term harm. Data and conflicting interpretations and opinions fly back and forth.
The term EEP refers to the often striking differences in outcomes that occur when an intervention shown to be very efficacious and safe in a RCT is applied to a broader group of patients as the intervention moves from the very controlled world of a trial to the more chaotic settings of real clinical practice.
Some of the difference is due to the fact that the intervention is now being used to treat patients who may vary in many important-and outcome determining-ways from the treatment group in the trial. A recent article in the Archive of Internal Medicine suggest that a more subtle mechanism may be at work as well.Results may also be less impressive when the intervention is applied to patients with the identical characteristics as the treatment group in the trial an effect speculated by the Archives article authors to be due at least in part to general greater care in their treatment and more uniform and consistent application of other generally accepted and recommended aspects of care. Further. there may well be differences in trial subjects related to the fact that they agree to be in a trial.
Safety issues are more likely to become evident in the observational data that accumulate as the intervention becomes widely used. RCTs are relatively small and generally recognized not to be the method of choice to determine if less common side effects occur. Observational data as they accumulate develop much more statistical power for short term effects and because observation can continue much longer the longer term outcomes become evident.So we clearly need to rely on observational data but the rub occurs in interpretation of the data. The groups that are compared in observational data are not randomized and while various statistical techniques are applied to try and compensate for the biases that plaque non-randomized comparisons there is a thick messy residue of doubt and controversy. The techniques seem an attempt to make observational data more like controlled trials which of course they aren't.
When DES were approved by the FDA the striking fact impacting the minds of interventional cardiologist was that the restenosis rate ( the main problem with bare stents) was about 20% and that seen in the DES trials for the coated stents was about 10%. Of course, cardiologists were anxious to apply that technology to their coronary artery patients and very quickly DES took over and by a year after approval about 80% of the percutaneous interventions involved use of DES. Not only were they applied to patients who were exactly like those in the trials ( basically short lesions and large arteries in a non acute setting) but also to patients with more complicated lesions and those in the middle of an acute coronary syndrome.
From a mechanistic point of view, it seems that the addition of drugs to the stents worked to prevent the over-exuberant growth of intimal cells onto the stents causing early restenosis ( in the six month time frame) but also may have overdone it in some patients leading to inadequate neointimal coverage of the DES and late thrombosis of the stent. Some cardiologists have suggested that the late thrombosis event coincided with stopping Plavix and have suggested continued use of Plavix for three or more years rather than the one year now commonly recommended.
The FDA's position seems to be that for the on label indications for DES, there appears to be no real issue with late thrombosis and that there is an increased risk of late thrombosis in patients with more complicated lesions and those with renal disease and diabetes. . How long to take anti-platelet drugs is an unsettled question as is the use of DES in patients whose coronary artery disease features do not confrom with the current on-label indications.
When a RCT is published and publicized and the results appear to be really great the best advice may be -as Bob Dylan said- "don't speak too soon, the wheel's still in spin"
addendum: 3/23/07.I have revised the next to last paragraph as somehow the original published version was garbled .
The term EEP refers to the often striking differences in outcomes that occur when an intervention shown to be very efficacious and safe in a RCT is applied to a broader group of patients as the intervention moves from the very controlled world of a trial to the more chaotic settings of real clinical practice.
Some of the difference is due to the fact that the intervention is now being used to treat patients who may vary in many important-and outcome determining-ways from the treatment group in the trial. A recent article in the Archive of Internal Medicine suggest that a more subtle mechanism may be at work as well.Results may also be less impressive when the intervention is applied to patients with the identical characteristics as the treatment group in the trial an effect speculated by the Archives article authors to be due at least in part to general greater care in their treatment and more uniform and consistent application of other generally accepted and recommended aspects of care. Further. there may well be differences in trial subjects related to the fact that they agree to be in a trial.
Safety issues are more likely to become evident in the observational data that accumulate as the intervention becomes widely used. RCTs are relatively small and generally recognized not to be the method of choice to determine if less common side effects occur. Observational data as they accumulate develop much more statistical power for short term effects and because observation can continue much longer the longer term outcomes become evident.So we clearly need to rely on observational data but the rub occurs in interpretation of the data. The groups that are compared in observational data are not randomized and while various statistical techniques are applied to try and compensate for the biases that plaque non-randomized comparisons there is a thick messy residue of doubt and controversy. The techniques seem an attempt to make observational data more like controlled trials which of course they aren't.
When DES were approved by the FDA the striking fact impacting the minds of interventional cardiologist was that the restenosis rate ( the main problem with bare stents) was about 20% and that seen in the DES trials for the coated stents was about 10%. Of course, cardiologists were anxious to apply that technology to their coronary artery patients and very quickly DES took over and by a year after approval about 80% of the percutaneous interventions involved use of DES. Not only were they applied to patients who were exactly like those in the trials ( basically short lesions and large arteries in a non acute setting) but also to patients with more complicated lesions and those in the middle of an acute coronary syndrome.
From a mechanistic point of view, it seems that the addition of drugs to the stents worked to prevent the over-exuberant growth of intimal cells onto the stents causing early restenosis ( in the six month time frame) but also may have overdone it in some patients leading to inadequate neointimal coverage of the DES and late thrombosis of the stent. Some cardiologists have suggested that the late thrombosis event coincided with stopping Plavix and have suggested continued use of Plavix for three or more years rather than the one year now commonly recommended.
The FDA's position seems to be that for the on label indications for DES, there appears to be no real issue with late thrombosis and that there is an increased risk of late thrombosis in patients with more complicated lesions and those with renal disease and diabetes. . How long to take anti-platelet drugs is an unsettled question as is the use of DES in patients whose coronary artery disease features do not confrom with the current on-label indications.
When a RCT is published and publicized and the results appear to be really great the best advice may be -as Bob Dylan said- "don't speak too soon, the wheel's still in spin"
addendum: 3/23/07.I have revised the next to last paragraph as somehow the original published version was garbled .
Tuesday, February 06, 2007
A patient as "a fellow creature in pain"
A reprint of a no longer recent " A Piece of My Mind" section of JAMA should be handed out to all medical students. The title- "The importance of the Right Heart" by Dr. Lawrence J. Hergott. (reference-JAMA Feb.,7,2007 vol. 297, no 5 p 447)
He speaks about making judgments "beyond the medical judgment". Much is being written about the diseases that are "self inflicted " and the blame that physicians may place on those patients which may well be manifest as "an attitude that would be difficult to conceal from such people they treat."Obesity, diseases closely associated with cigarette use and excess alcohol and "unsafe" sex come to mind. We have all seen that attitude manifest as comments about patients who are obese or who abuse themselves with drugs and alcohol and I remember hearing and making those comments from the time I was a medical student and intern. Who has not tended to treat with " greater feeling" the blameless patients, perhaps a young mother ravaged by cancer than the street bum reeking of alcohol and dirt dumped in your hospital while you are on call.
Dr. Hergott's current essay is only available by subscription but an earlier JAMA submission is full text available here and is more than worth the reading time.Here he speaks of the difference between reputation and character.Another essay entitled "Playing the Moonlight Sonata from Memory" is found in a 2002 issue of JAMA and in it he writes eloquently about the anguish a physician experiences when a patient dies because of what the physician did and the extremely long half life that anguish possess. All of his essays would be valuable to medical students and all resonate with physicians who have been there and done that for a while.
Near the end of his current manuscript he quotes part of the Oath of Maimonides:
May I never see in the patients anything but a fellow creature in pain.
Not as someone who deserves his dyspnea because of cigarette use defying years of advice to quit, not as someone whose ascites is his just due from profligate use of alcohol, not as someone who should not be in this country at all, not as someone who would not be having the myocardial infarction at all if he had done what his doctors told him to do and not as someone who is taking "scarce medical resources" from someone who deserves them more or for whom the treatment could be more cost effective but as a fellow human whose is in need of what physicians spent so many years of their lives preparing themselves to be able to offer.
The oath should remind us that being face to face with a fellow human in need
..makes judgment beyond the biomedical not only unnecessary but inappropriate.
He speaks about making judgments "beyond the medical judgment". Much is being written about the diseases that are "self inflicted " and the blame that physicians may place on those patients which may well be manifest as "an attitude that would be difficult to conceal from such people they treat."Obesity, diseases closely associated with cigarette use and excess alcohol and "unsafe" sex come to mind. We have all seen that attitude manifest as comments about patients who are obese or who abuse themselves with drugs and alcohol and I remember hearing and making those comments from the time I was a medical student and intern. Who has not tended to treat with " greater feeling" the blameless patients, perhaps a young mother ravaged by cancer than the street bum reeking of alcohol and dirt dumped in your hospital while you are on call.
Dr. Hergott's current essay is only available by subscription but an earlier JAMA submission is full text available here and is more than worth the reading time.Here he speaks of the difference between reputation and character.Another essay entitled "Playing the Moonlight Sonata from Memory" is found in a 2002 issue of JAMA and in it he writes eloquently about the anguish a physician experiences when a patient dies because of what the physician did and the extremely long half life that anguish possess. All of his essays would be valuable to medical students and all resonate with physicians who have been there and done that for a while.
Near the end of his current manuscript he quotes part of the Oath of Maimonides:
May I never see in the patients anything but a fellow creature in pain.
Not as someone who deserves his dyspnea because of cigarette use defying years of advice to quit, not as someone whose ascites is his just due from profligate use of alcohol, not as someone who should not be in this country at all, not as someone who would not be having the myocardial infarction at all if he had done what his doctors told him to do and not as someone who is taking "scarce medical resources" from someone who deserves them more or for whom the treatment could be more cost effective but as a fellow human whose is in need of what physicians spent so many years of their lives preparing themselves to be able to offer.
The oath should remind us that being face to face with a fellow human in need
..makes judgment beyond the biomedical not only unnecessary but inappropriate.
Tuesday, January 30, 2007
New Guidelines for Thromboembolic disease
New guidelines for DVT and PE are appearing in the Feb. Annals Internal Medicine and the Journal of Family Practice and a overview of is found here.
Here are some of the highlights.
1.Low molecular weight heparin (LMWH) is preferable to unfactionated heparin (UFH). UFH is history for that application.
2.It is o.k. to treat DVT as an outpatient.Not everyone , of course, but for those patients who have the wherewith all to do the necessary things, such as take the LMWH injections and travel to where ever to get INRS-(coumadin and LMWH typically started simultaneously), etc. Further, in selected patients maybe you can treat PEs as out patients. This may give older docs a little heartburn and again this is not for all patients.
3.Three to six months is probably long enough for a provoked DVT.
4.For recurrent DVT -more than 12 months is recommended.
5.Use of Prediction Rules ( like the Wells Rule) is encouraged. Caveat-this is for uncomplicated cases, i.e. younger patients without co-morbidities.I have expressed my reservations about decision "rules" before.
6.The D-dimer is ready for prime time and with low pre-test probability ( probably as indicated by a prediction rule) and a negative high sensitivity D-dimer, further testing can be eliminated. Caveat-this may not apply to older patients with co-morbidities.
7.A negative ultra sound does not rule out a calf DVT.Ultra sounds do better for proximal DVTs.
8.Compression stockings are important in an effort to decrease the likelihood of post thrombosis syndrome.Begin use within one week and continue for a year.
Here are some of the highlights.
1.Low molecular weight heparin (LMWH) is preferable to unfactionated heparin (UFH). UFH is history for that application.
2.It is o.k. to treat DVT as an outpatient.Not everyone , of course, but for those patients who have the wherewith all to do the necessary things, such as take the LMWH injections and travel to where ever to get INRS-(coumadin and LMWH typically started simultaneously), etc. Further, in selected patients maybe you can treat PEs as out patients. This may give older docs a little heartburn and again this is not for all patients.
3.Three to six months is probably long enough for a provoked DVT.
4.For recurrent DVT -more than 12 months is recommended.
5.Use of Prediction Rules ( like the Wells Rule) is encouraged. Caveat-this is for uncomplicated cases, i.e. younger patients without co-morbidities.I have expressed my reservations about decision "rules" before.
6.The D-dimer is ready for prime time and with low pre-test probability ( probably as indicated by a prediction rule) and a negative high sensitivity D-dimer, further testing can be eliminated. Caveat-this may not apply to older patients with co-morbidities.
7.A negative ultra sound does not rule out a calf DVT.Ultra sounds do better for proximal DVTs.
8.Compression stockings are important in an effort to decrease the likelihood of post thrombosis syndrome.Begin use within one week and continue for a year.
Monday, January 29, 2007
Are SSRIs bad for the bones?
In the January 22, 2007 issue of the Archives of Internal Medicine, Dr. J.B. Richards et al have written a paper providing evidence that SSRI use is associated with increased falls, increased number of fractures and decrease in bone density measurements in a group of patients age fifty and over.
This was a prospective, multi- institutional study which selected 5008 adults fifty years of age and older and followed them for five years for incident fractures. They found a hazard ratio of 2.1(C.I. 1.3 to 3.4)for fragility fractures. There was a dose effect noted and there is some animal experimental data which provides some degree of biological plausibility.There are functional serotonin receptors in bone and some data suggesting decrease bone mass in mice administered SSRIs.
I have frequently harped about the growing tendency in medical publications to overemphasive the significance of small increases in relative risks or odds ratios (i.e. less than 2). Here we have a fairly credible number for the OR and some biological plausibility but the authors indicate that previous analyses of this possible relationship failed to show an association. So the case is not proven but it is reasonable to consider SSRI use as a possible risk factor in the context of osteoporosis and falls and to have a quicker trigger finger to do BMD measurements and to emphasize the value of adequate amounts of vitamin D and calcium to older patients who take SSRIs.
This was a prospective, multi- institutional study which selected 5008 adults fifty years of age and older and followed them for five years for incident fractures. They found a hazard ratio of 2.1(C.I. 1.3 to 3.4)for fragility fractures. There was a dose effect noted and there is some animal experimental data which provides some degree of biological plausibility.There are functional serotonin receptors in bone and some data suggesting decrease bone mass in mice administered SSRIs.
I have frequently harped about the growing tendency in medical publications to overemphasive the significance of small increases in relative risks or odds ratios (i.e. less than 2). Here we have a fairly credible number for the OR and some biological plausibility but the authors indicate that previous analyses of this possible relationship failed to show an association. So the case is not proven but it is reasonable to consider SSRI use as a possible risk factor in the context of osteoporosis and falls and to have a quicker trigger finger to do BMD measurements and to emphasize the value of adequate amounts of vitamin D and calcium to older patients who take SSRIs.
Saturday, January 27, 2007
Is endurance exercise bad for the right ventricle?
For someone who recently finished his 50 th marathon, (with a - modestly put- incredible comeback from a mysterious orthopedic disability) the last thing I wanted to hear about is this article presenting evidence that all that running may be setting me up for a problem with my heart, specifically my right ventricle.
As a non-cardiologist I struggled to try and make sense ( and to try and deny the implications of) the observations made. Here they are:
1.22 patients, endurance athletes, with rhythm problems were referred to Dr. Hein Heidbuchel, a cardiologist in Belgium.
2.In 6 the diagnostic criteria for arrhythmogenic right ventricular dysplasia (ARVD) were met.
(ARVD diagnostic criteria can be found here It is a rare cardiac condition,a cardiomyopathy with fatty degeneration and fibrous replacement of the right ventricular wall, tendency to ventricular tachycardia and often a positive family history.The EKG may show inverted t waves in right sided leads and the so-called epsilon waves.)While rare in the U.S., Apparently this entity is significantly more common in parts of Europe (according to the Wikipedia article on ARVD).
3.In 82% of the 22 the criteria for the diagnosis of ARVD were not met but there was some abnormality showing up on testing-i.e. either the ekg,echo or morphology.The summary did not detail exactly what the findings were.
4.In the 5 who had right ventricle biopsies, none had light microscopy evidence of ARVD.
The authors postulate that the volume overload put greater stresses on the thin-walled right ventricle and might be causing ARVD. On the other ( and more reasonable hand), it has been recognized that a cause of arrhythmia in athletes is ARVD.Since these were athletes referred for rhythm problem it is not surprising that some had findings suggestive of ARVD since that condition seems to be fairly well known as a cause of rhythm problems in athletes,at least in parts of Europe.
There is evidence that in the early hours after a marathon or following a full or half Ironman distance triathlon there may occur elevations of troponin in the range seen in myocardial infarctions and there have been reported echocardiographic changes that could be described as cardiac "fatigue". The changes were those of altered relaxation characteristics and a decreased contractility all of which, along with the elevated troponins returned to normal in 48 hours.I am hoping that all of this is just analogous to the sore leg muscles and raised total CK values that remit in a few days and is of as little consequence. On the other hand, here is a paper that uses rather weak and indirect evidence to argue that long term cycling may be harmful to the heart. Also a recent NYT article quotes another study showing increased troponin levels after a marathon and briefly discussed some other tepid voices of concern that have been raised.
In the late 1970s, a pathologist,Dr. Tom Bassler put forth the overblown thesis that running marathons provided virtual immunity to coronary artery disease. The saga of Jim Fixx and the published data of Dr. Tim Noakes proved that wrong. Maybe some of us keep on running distances that are probably too long to make much sense-and much more than makes sense from a protect-the-heart point of view- still carry some of that bogus notion with as we slog along.
As a non-cardiologist I struggled to try and make sense ( and to try and deny the implications of) the observations made. Here they are:
1.22 patients, endurance athletes, with rhythm problems were referred to Dr. Hein Heidbuchel, a cardiologist in Belgium.
2.In 6 the diagnostic criteria for arrhythmogenic right ventricular dysplasia (ARVD) were met.
(ARVD diagnostic criteria can be found here It is a rare cardiac condition,a cardiomyopathy with fatty degeneration and fibrous replacement of the right ventricular wall, tendency to ventricular tachycardia and often a positive family history.The EKG may show inverted t waves in right sided leads and the so-called epsilon waves.)While rare in the U.S., Apparently this entity is significantly more common in parts of Europe (according to the Wikipedia article on ARVD).
3.In 82% of the 22 the criteria for the diagnosis of ARVD were not met but there was some abnormality showing up on testing-i.e. either the ekg,echo or morphology.The summary did not detail exactly what the findings were.
4.In the 5 who had right ventricle biopsies, none had light microscopy evidence of ARVD.
The authors postulate that the volume overload put greater stresses on the thin-walled right ventricle and might be causing ARVD. On the other ( and more reasonable hand), it has been recognized that a cause of arrhythmia in athletes is ARVD.Since these were athletes referred for rhythm problem it is not surprising that some had findings suggestive of ARVD since that condition seems to be fairly well known as a cause of rhythm problems in athletes,at least in parts of Europe.
There is evidence that in the early hours after a marathon or following a full or half Ironman distance triathlon there may occur elevations of troponin in the range seen in myocardial infarctions and there have been reported echocardiographic changes that could be described as cardiac "fatigue". The changes were those of altered relaxation characteristics and a decreased contractility all of which, along with the elevated troponins returned to normal in 48 hours.I am hoping that all of this is just analogous to the sore leg muscles and raised total CK values that remit in a few days and is of as little consequence. On the other hand, here is a paper that uses rather weak and indirect evidence to argue that long term cycling may be harmful to the heart. Also a recent NYT article quotes another study showing increased troponin levels after a marathon and briefly discussed some other tepid voices of concern that have been raised.
In the late 1970s, a pathologist,Dr. Tom Bassler put forth the overblown thesis that running marathons provided virtual immunity to coronary artery disease. The saga of Jim Fixx and the published data of Dr. Tim Noakes proved that wrong. Maybe some of us keep on running distances that are probably too long to make much sense-and much more than makes sense from a protect-the-heart point of view- still carry some of that bogus notion with as we slog along.
Wednesday, January 24, 2007
Hand off problems or lack of personal responsibility by physician
Here is an interesting and alarming story of what went wrong at teaching hospital allegedly because of problems in the system of "handing off" patients.Handing off or "signing out" has become a hot topic since the increased restrictions on house staff working hours has brought about more time doctors have a shift change and hand off their patients to the next shift.
Here is a much truncated version of what happened.
A 83 year old had a pacemaker inserted without incident and his post procedure chest x ray revealed no pneumothorax.Since he was on a "non-house staff" service" a nurse practioner (NP) apparently was the "doctor" in charge of care of the patient in the recovery unit. Noting increasing dyspnea a floor nurse called the doctor which is now a nurse practioner (NP) but it was after hours and apparently interns cover for the NP. At the floor nurse's suggestion a chest x-ray was ordered but never seen by the intern as before that could occur he signed out on the "night float resident". Ultimately someone recognized the pneumothorax, a chest tube was inserted almost a day after the onset of dyspnea and the patient probably suffered no long term ill effects.
The article's author then described steps taken to improve the system of handoffs which may well be a well designed and worthwhile project but...
Although there are obvious problems that occur with handoffs, my take on this situation is that the story would not have evolved as it did if the procedure doctor took responsibility for the post procedure care of his patient. When we did procedures-bronchoscopies, pleural biopsies, etc we would write on the order sheet, "Call me if there are questions or if problems arise". Just as surgeons- at least in my day- were in charge of the post op care, so were procedural internists in charge of and responsible for the patients after the procedure.
Apparently at this hospital after a procedure the patient goes to recovery where the NP is the "doctor" in charge of care- at least until their shift ends. This seems to be so much the usual way things are done that the author did not even consider why the cardiologist was not called.This is not surprising as the author, a young hospitalist, has likely never known any other way than their current system.
We seem to be replacing personal physician responsiblity with "systems".
What lessons are being implicitly taught to the house staff? The procedure doc seems to have no post procedure responsibility but is content to delegate care to a NP. In that environment how surprised could you be to learn the intern signs out without seeing the chest x-ray. End of shift-end of responsiblity.End of procedure-end of responsibility.
With so much rhetoric about instilling professionaism in medical students and house officers how can individual responsiblity be given such short shrift? In 2003 the ACGME eliminated the following statement from their pronouncements:
Physicians must recognize their obligation is not discharged at any given time or any given day.
No, that is not a typo -they eliminated the fundamental principle of the doctor-patient relationship,that the physician is responsible for his patient.
It is not coincidental that the ACGME 2003 general core competencies statement mentions "systems" or "system" seven times but saw fit not to include the above quoted sentence. To my reading the authors of the competencies seems much more concerned with team play, group dynamics,system blather, and conserving society's resources than inculcating physician responsiblity for their individual patients, which is what I thought it was all about.
Here is a much truncated version of what happened.
A 83 year old had a pacemaker inserted without incident and his post procedure chest x ray revealed no pneumothorax.Since he was on a "non-house staff" service" a nurse practioner (NP) apparently was the "doctor" in charge of care of the patient in the recovery unit. Noting increasing dyspnea a floor nurse called the doctor which is now a nurse practioner (NP) but it was after hours and apparently interns cover for the NP. At the floor nurse's suggestion a chest x-ray was ordered but never seen by the intern as before that could occur he signed out on the "night float resident". Ultimately someone recognized the pneumothorax, a chest tube was inserted almost a day after the onset of dyspnea and the patient probably suffered no long term ill effects.
The article's author then described steps taken to improve the system of handoffs which may well be a well designed and worthwhile project but...
Although there are obvious problems that occur with handoffs, my take on this situation is that the story would not have evolved as it did if the procedure doctor took responsibility for the post procedure care of his patient. When we did procedures-bronchoscopies, pleural biopsies, etc we would write on the order sheet, "Call me if there are questions or if problems arise". Just as surgeons- at least in my day- were in charge of the post op care, so were procedural internists in charge of and responsible for the patients after the procedure.
Apparently at this hospital after a procedure the patient goes to recovery where the NP is the "doctor" in charge of care- at least until their shift ends. This seems to be so much the usual way things are done that the author did not even consider why the cardiologist was not called.This is not surprising as the author, a young hospitalist, has likely never known any other way than their current system.
We seem to be replacing personal physician responsiblity with "systems".
What lessons are being implicitly taught to the house staff? The procedure doc seems to have no post procedure responsibility but is content to delegate care to a NP. In that environment how surprised could you be to learn the intern signs out without seeing the chest x-ray. End of shift-end of responsiblity.End of procedure-end of responsibility.
With so much rhetoric about instilling professionaism in medical students and house officers how can individual responsiblity be given such short shrift? In 2003 the ACGME eliminated the following statement from their pronouncements:
Physicians must recognize their obligation is not discharged at any given time or any given day.
No, that is not a typo -they eliminated the fundamental principle of the doctor-patient relationship,that the physician is responsible for his patient.
It is not coincidental that the ACGME 2003 general core competencies statement mentions "systems" or "system" seven times but saw fit not to include the above quoted sentence. To my reading the authors of the competencies seems much more concerned with team play, group dynamics,system blather, and conserving society's resources than inculcating physician responsiblity for their individual patients, which is what I thought it was all about.
Tuesday, January 23, 2007
Heuristics invaluable but need to be understood and monitored
I was impressed by and wrote about an article by Dr. Croskerry who has studied how physicians think and how they can think better diagnostically when they understand their basic human tendency to think by using ad hoc rules of thumb, cognitive shortcuts or heuristics. DB's MEDICAL RANTS recently (jan. 22, 2007) referenced a great article by Jerome Groopman entitled "What's the Trouble?" which draws upon Coskerry's insights.
A more detailed treatment of these thoughts can be found here in an 2005 article by Croskerry.
I came across another related article entitled "Diagnosing Diagnostic Mistakes" which also talks about diagnostic "errors" and make the interesting and , I think, valid, point that everything called an error might not be.
Dr. Clement J. McDonald authored an excellent article over ten years ago in the Annals of Internal Medicine entitled Medical Heuristics,The silent Adjudicators of Clinical Practice",
It is available in full text on line and well worth reading.
McDonald talks about common medical heuristics some of which have been codified into aphorisms, For example Occams razor which advises to choose the simplest hypothesis (or a single disease process)to explain a set of observations.Contrasted to this is the less well know Hickam's Dictum which says a patient can have as many diagnoses as he darn well wants. Another is " treat the patient not the numbers. This adage which was quasi-dogma in my house officer days has been diluted by the development of various lines of evidence that we should in fact treat the numbers, at least when we are considering blood sugar in diabetes and blood pressure values and- at least for secondary prevention of coronary artery disease-the cholesterol level.
A more recent article by Dr. Donald Redelmeier also appears in the Annals, "The Cognitive Psychology of Missed Diagnoses"
He speaks of common heuristics: The availability heuristic-we judge the likelihood of a case by how easily examples spring to mind. The anchoring heuristic-we tend to stick with our initial impression ( this runs counter to the well established scientific principle of checking for evidence that would disprove our working hypothesis).This is also called premature closure.
Humans may well have biologically ancient neurological mechanisms that organize incomplete data into a sensible whole ( our visual system seems to do a great job of that) and gives us an reassuring sense of control and an illusion of a more accurate and more complete understanding of a given situation that we sometimes really have. These and other heuristics have survived perhaps because they do work reasonably well much of time but the missed diagnoses are reminders that much of the time is not all of the time and hopefully awareness of their existence and their potential fallibility will enable us to mentally over ride them when appropriate. This could be a simple as reconsidering the diagnosis as more clinical data becomes available.
A more detailed treatment of these thoughts can be found here in an 2005 article by Croskerry.
I came across another related article entitled "Diagnosing Diagnostic Mistakes" which also talks about diagnostic "errors" and make the interesting and , I think, valid, point that everything called an error might not be.
Dr. Clement J. McDonald authored an excellent article over ten years ago in the Annals of Internal Medicine entitled Medical Heuristics,The silent Adjudicators of Clinical Practice",
It is available in full text on line and well worth reading.
McDonald talks about common medical heuristics some of which have been codified into aphorisms, For example Occams razor which advises to choose the simplest hypothesis (or a single disease process)to explain a set of observations.Contrasted to this is the less well know Hickam's Dictum which says a patient can have as many diagnoses as he darn well wants. Another is " treat the patient not the numbers. This adage which was quasi-dogma in my house officer days has been diluted by the development of various lines of evidence that we should in fact treat the numbers, at least when we are considering blood sugar in diabetes and blood pressure values and- at least for secondary prevention of coronary artery disease-the cholesterol level.
A more recent article by Dr. Donald Redelmeier also appears in the Annals, "The Cognitive Psychology of Missed Diagnoses"
He speaks of common heuristics: The availability heuristic-we judge the likelihood of a case by how easily examples spring to mind. The anchoring heuristic-we tend to stick with our initial impression ( this runs counter to the well established scientific principle of checking for evidence that would disprove our working hypothesis).This is also called premature closure.
Humans may well have biologically ancient neurological mechanisms that organize incomplete data into a sensible whole ( our visual system seems to do a great job of that) and gives us an reassuring sense of control and an illusion of a more accurate and more complete understanding of a given situation that we sometimes really have. These and other heuristics have survived perhaps because they do work reasonably well much of time but the missed diagnoses are reminders that much of the time is not all of the time and hopefully awareness of their existence and their potential fallibility will enable us to mentally over ride them when appropriate. This could be a simple as reconsidering the diagnosis as more clinical data becomes available.
Subscribe to:
Comments (Atom)