Dr. RW's post referencing Dr. Herb Fred's editorial in the Texas Heart Journal generated several negative responses in KEVINMD's march 30.2006 blog following his reference to that piece.
Several ad hominem comments accused Dr. Fred of being basically a disgruntled, out of date, grumpy old doc who-in the words of one such writer-never practiced in the real world. Ad hominem arguments are -well -just that and usually do not warrant detailed refutation.
Unlike some of the commenters' suggestions, Dr. Fred seems quite aware of the calling-the-shots nature of managed care and the time restriction brought about by the third party payers' domination. He says that the HMOs force physicians to care for a maximum number of patients, in a minimum number of minutes for the lowest number of dollars.
His rant is about the decline of clinical skills and the factors responsible.He believes that values and priorities are not what they used to be.
When he trained in the mid-1950s ( and also when I trained in the 1960s) :
"... hard work,self pride,devotion to duty, strict accountability and pursuit of excellence were the norms" .
To expand on that-Things were framed in the relationship between the individual doctor and the individual patient.We did not speak about or -except in extreme circumstances-consider the " greater good" or conservation of some abstract and apparently collectively owned "resources".It seems that the core competencies of the ACGME do espouse-at least in part-values other than the one-on-one doctor patient relationship.
The ACGME core competences speak of :
..Responsiveness to the needs of patients and society
...practice cost effective health care and resource allocation
...understand how their patient care and other prorfessional practices affect...the health care organization, and...the larger society.
If I were managing an HMO, those "values" are certainly those that I would have inculcated into the doctors who are allocating my resources.
Friday, March 31, 2006
Tuesday, March 28, 2006
Not enough time for medical training-A problem in Europe as well?
The restriction of work hours for residents has lead to complaints from several fronts and concerns from both sides of the Atlantic.
Aggravated Docsurg has recently discussed the issue and quotes an interesting article in the American Journal of Surgery. The article reveals that 89% of surgery residents who completed an anonymous survey reported they "cheated" on the 80 hour work restriction rule. That is- they worked longer but did not report the hours correctly. This also occurred in 74% of non-surgery residents.
The authors of the article seemed to be alarmed that surgery residents were placing their allegiance to the concept of individual responsibility for patient care above a team approach and to adhere to the rules. When did individual responsibility stop being a core value of being a physician or -in current jargon- a major element of professionalism ? Recent apparent revisions in the expressed views of ACME seem to point in that direction. I have written about that before. In 2003 the ACME eliminated the statement that is a touchstone of interning training:
"Physicians...Must recognize their obligation to patients is not discharged at any given time or any given day".
Are there competing visions- the individual responsibility physician versus the shift work doctor.?
The new work hour restrictions in Europe have generated concern that there is not enough time to properly train specialists.Summer's Radiology Site references an article in which British gastroenterologists report trainees no longer have time to perform the necessary number of endoscopies to become proficient due to the duty time restrictions. This lead to the following comments by one of the GI docs involved in a training program:
"You can't shoehorn more training and other work into less and less time and expect the same quality of training."
This statement echos the opinion of the training program directors quoted above who said:
"There is simply insufficient time to educate the internal medicine residents in the present regulatory environment."
This transatlantic meeting of the minds is sobering. The folks who make the rules (ACGME in the U.S.) and whoever in Europe ought to listen to the real life experiences of those program directors and the trainees who have to live by their rules before we have a generation of less well trained specialists who will go home at 5 p.m.
Aggravated Docsurg has recently discussed the issue and quotes an interesting article in the American Journal of Surgery. The article reveals that 89% of surgery residents who completed an anonymous survey reported they "cheated" on the 80 hour work restriction rule. That is- they worked longer but did not report the hours correctly. This also occurred in 74% of non-surgery residents.
The authors of the article seemed to be alarmed that surgery residents were placing their allegiance to the concept of individual responsibility for patient care above a team approach and to adhere to the rules. When did individual responsibility stop being a core value of being a physician or -in current jargon- a major element of professionalism ? Recent apparent revisions in the expressed views of ACME seem to point in that direction. I have written about that before. In 2003 the ACME eliminated the statement that is a touchstone of interning training:
"Physicians...Must recognize their obligation to patients is not discharged at any given time or any given day".
Are there competing visions- the individual responsibility physician versus the shift work doctor.?
The new work hour restrictions in Europe have generated concern that there is not enough time to properly train specialists.Summer's Radiology Site references an article in which British gastroenterologists report trainees no longer have time to perform the necessary number of endoscopies to become proficient due to the duty time restrictions. This lead to the following comments by one of the GI docs involved in a training program:
"You can't shoehorn more training and other work into less and less time and expect the same quality of training."
This statement echos the opinion of the training program directors quoted above who said:
"There is simply insufficient time to educate the internal medicine residents in the present regulatory environment."
This transatlantic meeting of the minds is sobering. The folks who make the rules (ACGME in the U.S.) and whoever in Europe ought to listen to the real life experiences of those program directors and the trainees who have to live by their rules before we have a generation of less well trained specialists who will go home at 5 p.m.
Monday, March 27, 2006
Archives Internal Medicine article-some good news about the third heart sound and practice
The March 27,2006 issue of the Archives of Internal Medicine published an article that happily tended to confirm some of my biases. ( "Relationship between Accurate Auscultation of a Clinically Useful third heart sound and Level of experience." Marcus,G et al. Arch Int Med. vol 166,March 27, 2006 p.617-622)
The authors studied the auscultatory prowess in regard to detection of a third heart sound (S3))of docs at various levels of experience-from intern to cardiac fellow to attending cardiologist) by having them examine 100 patients shortly after cardiac cath and constructed correlations with LV ejection fraction, BNP and echocardiography.
Findings include:
The finding of a S3 by auscultation is very specific for heart failure (HF).In other words a S3 goes a long way to ruling in heart failure but it is not very sensitive- so not great at ruling out HF.
A cardiologist's perception of an S3 is as good as a phonocardiogram.
And here is the one I really like -Cardiologists and cardiology fellows do better than interns and residents in internal medicine. Who would have thought?
Yes Virginia, practice and experience matter and sometimes the physical exam may be of value.
We speak now of third sounds-in an earlier era we talked more about " gallops " and "gallop rhythms". Dr. George Burch in his 1953 text " A Primer of Cardiology" says a " protodiastolic gallop rhythm is present when the gallop sound occurs early in diastole"..It is due to an exaggerated third heart sound and is common in congestive heart failure."
The medical language of the 1950s did not include the words sensitivity and specificity but the cardiologists and internists of the day knew that a gallop usually ruled in heart failure.
Practice and experience do matter and Dr. David L Simel who wrote the editorial discussing the article wondered if the current trend in reduced house staff training time will be counterproductive in creating an environment wherein that practice and repetition can take place. I think the answer is obvious, of course it will- absent some major effort on the part of the training program to remedy that,given the recent history of ACGME to pile more and more new requirements to be carried out in less and less time.
The authors studied the auscultatory prowess in regard to detection of a third heart sound (S3))of docs at various levels of experience-from intern to cardiac fellow to attending cardiologist) by having them examine 100 patients shortly after cardiac cath and constructed correlations with LV ejection fraction, BNP and echocardiography.
Findings include:
The finding of a S3 by auscultation is very specific for heart failure (HF).In other words a S3 goes a long way to ruling in heart failure but it is not very sensitive- so not great at ruling out HF.
A cardiologist's perception of an S3 is as good as a phonocardiogram.
And here is the one I really like -Cardiologists and cardiology fellows do better than interns and residents in internal medicine. Who would have thought?
Yes Virginia, practice and experience matter and sometimes the physical exam may be of value.
We speak now of third sounds-in an earlier era we talked more about " gallops " and "gallop rhythms". Dr. George Burch in his 1953 text " A Primer of Cardiology" says a " protodiastolic gallop rhythm is present when the gallop sound occurs early in diastole"..It is due to an exaggerated third heart sound and is common in congestive heart failure."
The medical language of the 1950s did not include the words sensitivity and specificity but the cardiologists and internists of the day knew that a gallop usually ruled in heart failure.
Practice and experience do matter and Dr. David L Simel who wrote the editorial discussing the article wondered if the current trend in reduced house staff training time will be counterproductive in creating an environment wherein that practice and repetition can take place. I think the answer is obvious, of course it will- absent some major effort on the part of the training program to remedy that,given the recent history of ACGME to pile more and more new requirements to be carried out in less and less time.
Friday, March 24, 2006
Physicians' " Guild" breakup and the alleged move to free markets
I believe everyone should read HEALTH CARE RENEWAL everyday but a recent post exceeds that blog's high standards. The article is entitled " The consequences of Breaking the Physicians' "Guild" ".
According to Dictionary.com a guild is "An association of persons of the same trade or pursuits, formed to protect mutual interests and maintain standards "
In it, Dr. Poses ( about whom we have to wonder when he sleeps) talks about Alain Enthoven's managed competition and his strategy to break up the physicians guild which- in Enthoven's view- is the main reason why medicine costs so much and is of such poor quality in this country. We also hear about the consequences of this strategy.
You would be wrong if you thought Enthoven's views on prepaid group practice, universal coverage and managed competition went away with the demise of Senator Clinton's health care task force.
In the same piece, Dr. Poses give a chilling rendition of the transformation of the pharmaceutical marketing landscape including comments about the new drug reps aka Drug Ken and Drug Barbie.
I'll admit I must have slept though most of the 1980s and 1990s ignorant of the Jackson Hole group and the "intellectual" verbiage that feed the HMO movement, my hat is off to Poses and the other contributors to HCR. They are doing us all a great service.
According to Dictionary.com a guild is "An association of persons of the same trade or pursuits, formed to protect mutual interests and maintain standards "
In it, Dr. Poses ( about whom we have to wonder when he sleeps) talks about Alain Enthoven's managed competition and his strategy to break up the physicians guild which- in Enthoven's view- is the main reason why medicine costs so much and is of such poor quality in this country. We also hear about the consequences of this strategy.
You would be wrong if you thought Enthoven's views on prepaid group practice, universal coverage and managed competition went away with the demise of Senator Clinton's health care task force.
In the same piece, Dr. Poses give a chilling rendition of the transformation of the pharmaceutical marketing landscape including comments about the new drug reps aka Drug Ken and Drug Barbie.
I'll admit I must have slept though most of the 1980s and 1990s ignorant of the Jackson Hole group and the "intellectual" verbiage that feed the HMO movement, my hat is off to Poses and the other contributors to HCR. They are doing us all a great service.
Monday, March 20, 2006
NEJM article on who is at greatest risk of poor quality health care
The March 16, 2006 issue of NEJM published an article reporting the results of applying RAND's Quality Indicators ( some 439 of them) for 30 medical conditions based on telephone interviews followed by review of medical records for those participants who gave permission.
The quality indicators were chosen by a nine member multispeciality "expert panel" using the RAND-UCLA modified Delphi method. The degree to which physicians "comply" with these opinions of what is good care is the measure of quality.
One could haggle with how to measure quality in this type study but nevetheless some of results will give ammunition for health policy wonks of almost any persuasion.
Those who believe a single payer (government) system is best will have to gloss over the authors' sentence that says:
" In the United Kingdom,with universal coverage, a study using our methods found that the overall proportion of recommended health care that was received was similar to what we have reported"
and what they report in this article is that the " problems with quality of care are indeed widespread and systemic and require a system wide approach."
You have to wonder what approach they would recommended as they seem to say both the single payer and the current U.S. set up give equally unacceptable results.
Surprisingly they found that :
"..Blacks had higher scores than whites for the quality of heath care".
This differs markedly from what many other studies have shown.
They also found that
"...health insurance status was largely unrelated to the quality of care".
So is all this concern about the large number of uninsured people misdirected?
This is not outcome data. We have no idea from this study what effect these alleged non-compliances have on the health outcomes. This is process data collected by a method prone to bias ( telephone interviews),using a huge list of quality indicators some of which are evidence based and some expert based. If the medical record did not document a given medical act it is counted as it it did not occur. Further, we are not told in the article what sort of infractions occured and how serious they may be. It is like being told there were 17,242 crimes in a given state over a given time period and we are left in the dark as what types of crimes were documented and how many in each category.
I'll bet we will see a flurry of letters to the editor attacking various aspects of this article.
The quality indicators were chosen by a nine member multispeciality "expert panel" using the RAND-UCLA modified Delphi method. The degree to which physicians "comply" with these opinions of what is good care is the measure of quality.
One could haggle with how to measure quality in this type study but nevetheless some of results will give ammunition for health policy wonks of almost any persuasion.
Those who believe a single payer (government) system is best will have to gloss over the authors' sentence that says:
" In the United Kingdom,with universal coverage, a study using our methods found that the overall proportion of recommended health care that was received was similar to what we have reported"
and what they report in this article is that the " problems with quality of care are indeed widespread and systemic and require a system wide approach."
You have to wonder what approach they would recommended as they seem to say both the single payer and the current U.S. set up give equally unacceptable results.
Surprisingly they found that :
"..Blacks had higher scores than whites for the quality of heath care".
This differs markedly from what many other studies have shown.
They also found that
"...health insurance status was largely unrelated to the quality of care".
So is all this concern about the large number of uninsured people misdirected?
This is not outcome data. We have no idea from this study what effect these alleged non-compliances have on the health outcomes. This is process data collected by a method prone to bias ( telephone interviews),using a huge list of quality indicators some of which are evidence based and some expert based. If the medical record did not document a given medical act it is counted as it it did not occur. Further, we are not told in the article what sort of infractions occured and how serious they may be. It is like being told there were 17,242 crimes in a given state over a given time period and we are left in the dark as what types of crimes were documented and how many in each category.
I'll bet we will see a flurry of letters to the editor attacking various aspects of this article.
Wednesday, March 15, 2006
New Orleans Charity hospital- Dead? But not forgotten
Having grown up medically in halls and wards of Big Charity, news items and blocs about it attract me immediately.
The March 15,2006 issue of JAMA has a poem by a physician, Dr. Wayne F. Larrabee, Jr. who trained there. The poem states in part:
"Charity Hospital, New Orleans 1735-2005 ...Generations climbed her stone steps, disappeared for years inside gray walls, learned to live thirty-six hour days and then to sleep without dreams...
Our hands remember though how to wield a knife, separate good tissue from bad, preserve vessel and nerve and something more- how to touch a dying patient whisper a wordlessly benediction and receive a blessing in return. "
The Haversion Canal blog, authored by a Tulane med student is keeping us current on a planned rally at Charity to save the hospital which has sat unoccupied since Katrina and it seems the state of Louisiana has determined it cannot be repaired and must close permanently.
The featured speakers include LSU and Tulane faculty. I wish I could be there and I wish there were some hope to salvage the institution. It is impossible to think of LSU Medical School and Tulane Medical School without thinking of Charity. I think the med students and house officers who trained there all received a " blessing in return ".
The March 15,2006 issue of JAMA has a poem by a physician, Dr. Wayne F. Larrabee, Jr. who trained there. The poem states in part:
"Charity Hospital, New Orleans 1735-2005 ...Generations climbed her stone steps, disappeared for years inside gray walls, learned to live thirty-six hour days and then to sleep without dreams...
Our hands remember though how to wield a knife, separate good tissue from bad, preserve vessel and nerve and something more- how to touch a dying patient whisper a wordlessly benediction and receive a blessing in return. "
The Haversion Canal blog, authored by a Tulane med student is keeping us current on a planned rally at Charity to save the hospital which has sat unoccupied since Katrina and it seems the state of Louisiana has determined it cannot be repaired and must close permanently.
The featured speakers include LSU and Tulane faculty. I wish I could be there and I wish there were some hope to salvage the institution. It is impossible to think of LSU Medical School and Tulane Medical School without thinking of Charity. I think the med students and house officers who trained there all received a " blessing in return ".
Caveats regarding carotid sinus massage
The March 12, 2006 issue of the Archives of Internal Medicine has an interesting article on the issue of syncope and carotid sinus hypersensitivity and a useful related editorial.
The editorialist make a good point about the contraindications for carotid sinus massage (CSM) as a diagnostic maneuver. The presence of a bruit has traditionally been considered a contraindication but because of the limited diagnostic value of listening over the neck arteries Dr. Neil Coplan suggests it would make more sense to do a carotid ultrasound first if there is concern about the presence of carotid artery disease. And in an elderly patient with a history of syncope you would almost always have that concern and the suggestion is that the absence of a bruit may not be sufficient reassurance.
The article, itself,showed that among community dwelling older folks in England, carotid sinus hypersensitivity was seen in 35 % of the sample ( n=1,000) who did not have a history of falls, syncope or even dizziness. So the point is that a positive result on CSM does not necessarily mean that the patient with syncope has carotid sinus hypersenstivity as the cause and other causes still need to be ruled out. How do you determine if the hypersensitivity is the causative? Basically you check out the other likely suspects and make a clinical judgment.
Since carotid sinus hypersensitivity may be fairly common in the older population, a comment regarding safe use of stethoscope seems in order. At some point in time, which so far has not been accurately pinpointed by medical historians, a sea change occurred in the way stethoscopes are worn. Older docs may still place the ear pieces around the back of the neck while younger ones drape the instrument around the neck with the ear pieces dangling on one side of the chest and the heads of the instruments on the other. Why or when this important cultural change occurred is unclear and the ergonomic issues need to be discussed but older docs need to shift to the modern method if for no other reason than to avoid syncope. This link shows the safe way to carry your stethoscope when not in use and on this link we see Dr. Kildare with the style of another stethoscope era.. Another reason that it is good to keep current.
The editorialist make a good point about the contraindications for carotid sinus massage (CSM) as a diagnostic maneuver. The presence of a bruit has traditionally been considered a contraindication but because of the limited diagnostic value of listening over the neck arteries Dr. Neil Coplan suggests it would make more sense to do a carotid ultrasound first if there is concern about the presence of carotid artery disease. And in an elderly patient with a history of syncope you would almost always have that concern and the suggestion is that the absence of a bruit may not be sufficient reassurance.
The article, itself,showed that among community dwelling older folks in England, carotid sinus hypersensitivity was seen in 35 % of the sample ( n=1,000) who did not have a history of falls, syncope or even dizziness. So the point is that a positive result on CSM does not necessarily mean that the patient with syncope has carotid sinus hypersenstivity as the cause and other causes still need to be ruled out. How do you determine if the hypersensitivity is the causative? Basically you check out the other likely suspects and make a clinical judgment.
Since carotid sinus hypersensitivity may be fairly common in the older population, a comment regarding safe use of stethoscope seems in order. At some point in time, which so far has not been accurately pinpointed by medical historians, a sea change occurred in the way stethoscopes are worn. Older docs may still place the ear pieces around the back of the neck while younger ones drape the instrument around the neck with the ear pieces dangling on one side of the chest and the heads of the instruments on the other. Why or when this important cultural change occurred is unclear and the ergonomic issues need to be discussed but older docs need to shift to the modern method if for no other reason than to avoid syncope. This link shows the safe way to carry your stethoscope when not in use and on this link we see Dr. Kildare with the style of another stethoscope era.. Another reason that it is good to keep current.
Monday, March 13, 2006
Homocysteine- three randomized trials suggest maybe everyone will not benefit from supplementation with b12 and folate
A pre-publication release from the NEJM on line gives us the results of 2 randomized trials (RCTs) which investigated the effects of treating patients with known cardio-vascular disease with folic acid and B12. These trials known as the HOPE 2 trial and the NOVIT trial join the previously published VISP trial.
Overall, there was no benefit in terms of the composite end point of recurrent myocardial infarction,stroke or sudden cardiac death. In HOPE 2, there was a statistically significant reduction in stroke among treated patients versus placebo. In all 3 trials the treatment did reduce the homocysteine levels. The concept of using composite end points is interesting and leaves me a bit puzzled. What is the rational of adding up cases of MI and strokes? Is not each outcome an important concern per se? How do authors decide to lump or split outcomes?
These trials do not provide evidence against the practice of attempting to lower elevated homocysteine levels in patients with CV disease as the trial treated all comers , not just those with elevated levels. What about patients with elevated levels and no history of CV disease?
I cannot leave this topic without noting a meta-analysis quoted by the editorialist in the same NEJM issue as the two articles quoted above. That article "determined" that a 25% reduction in the serum homocysteine levels was associated with an 11 % lower risk of ischemic heart disease. The fact that we now have 3 RCTs that contradict a Meta-analysis should no longer be noteworthy as we see that more than occasionally. My point is that to imply such precision exists in how much benefit will accrue from a given therapeutic manipulation based on a meta-analysis is not warranted and approaches the threshold for silliness. When authors do that it applies a coat of "apparent validity" paint to a structure held together by a complex collection of assumptions.
After I use up my current supply of b12 I guess there is no reason to buy any more.
Overall, there was no benefit in terms of the composite end point of recurrent myocardial infarction,stroke or sudden cardiac death. In HOPE 2, there was a statistically significant reduction in stroke among treated patients versus placebo. In all 3 trials the treatment did reduce the homocysteine levels. The concept of using composite end points is interesting and leaves me a bit puzzled. What is the rational of adding up cases of MI and strokes? Is not each outcome an important concern per se? How do authors decide to lump or split outcomes?
These trials do not provide evidence against the practice of attempting to lower elevated homocysteine levels in patients with CV disease as the trial treated all comers , not just those with elevated levels. What about patients with elevated levels and no history of CV disease?
I cannot leave this topic without noting a meta-analysis quoted by the editorialist in the same NEJM issue as the two articles quoted above. That article "determined" that a 25% reduction in the serum homocysteine levels was associated with an 11 % lower risk of ischemic heart disease. The fact that we now have 3 RCTs that contradict a Meta-analysis should no longer be noteworthy as we see that more than occasionally. My point is that to imply such precision exists in how much benefit will accrue from a given therapeutic manipulation based on a meta-analysis is not warranted and approaches the threshold for silliness. When authors do that it applies a coat of "apparent validity" paint to a structure held together by a complex collection of assumptions.
After I use up my current supply of b12 I guess there is no reason to buy any more.
Wednesday, March 08, 2006
Physicians deal with individuals not with averages
I blogged previously that a key maxim that medical students should have branded into their brains is "Every one does not react in the same way to treatment".
There is more to it than that. Everyone with the same illnesses does not present in the same way,everyone with same illness does not always have the same results on lab tests or imaging and everyone does not accept a physician's recommendation in the same way.
I came across a memorable quote that captures all of that in an eloquent way and needs to be appended to the hypothetical handout for med students of the very important Milbank Quarterly article by RL Kravitz which is entitled "Evidence-based medicine;heterogeneity of treatment effects and the trouble with averages"
The author is Dr. Leon Eisenberg,the reference "Medicine-Molecular,Monetary, or More than Both", JAMA july 26,1995-vol 272, no. 4 p 331" While I do not agree with all he said the following is dynamite"
"...Medicine deals with phenotypes,not genotypes. Between genotype and phenotype, a lifetime of individual experience has fashioned what began as an envelope of stochastic probabilities into a singular personal embodiment: the patient who faces us.
In clinical practice, it is the particularities and idiosyncrasies of the individual patient that challenge the physician. The same disease never presents in quite the same way in successive patients.
Complaints vary: severity varies, response to treatment varies. Nondisease, that is, nonorganic disease, mimics "real disease" with remarkable fidelity"
In short, there is heterogeniety of almost everything and possibly why Hippocrates noted that experience was treacherous along with judgment being difficult.
There is more to it than that. Everyone with the same illnesses does not present in the same way,everyone with same illness does not always have the same results on lab tests or imaging and everyone does not accept a physician's recommendation in the same way.
I came across a memorable quote that captures all of that in an eloquent way and needs to be appended to the hypothetical handout for med students of the very important Milbank Quarterly article by RL Kravitz which is entitled "Evidence-based medicine;heterogeneity of treatment effects and the trouble with averages"
The author is Dr. Leon Eisenberg,the reference "Medicine-Molecular,Monetary, or More than Both", JAMA july 26,1995-vol 272, no. 4 p 331" While I do not agree with all he said the following is dynamite"
"...Medicine deals with phenotypes,not genotypes. Between genotype and phenotype, a lifetime of individual experience has fashioned what began as an envelope of stochastic probabilities into a singular personal embodiment: the patient who faces us.
In clinical practice, it is the particularities and idiosyncrasies of the individual patient that challenge the physician. The same disease never presents in quite the same way in successive patients.
Complaints vary: severity varies, response to treatment varies. Nondisease, that is, nonorganic disease, mimics "real disease" with remarkable fidelity"
In short, there is heterogeniety of almost everything and possibly why Hippocrates noted that experience was treacherous along with judgment being difficult.
Monday, March 06, 2006
Required reading" Aggravated Docsurg's post onThe AMA,Pay for peformance (P4P)
I have written about P4P before and am more concerned than ever about it in light of AMA recent apparent support of it.
Aggravated Docsurg has an excellent post of this topic replete with great links to well written and thoughtful essays pointing out what a bad idea P4P is. I can add nothing to his comments and those he references. The P4P may well work out to be even worse than managed care if that is even possible.
Aggravated Docsurg has an excellent post of this topic replete with great links to well written and thoughtful essays pointing out what a bad idea P4P is. I can add nothing to his comments and those he references. The P4P may well work out to be even worse than managed care if that is even possible.
The latest Holly Grail Test for bacterial infection? -Procalcitonin
"Use less antibiotics" has become a common theme. Antibiotics are expensive, pneumonia is a very big ticket item for CMS and hospitals and then there is the often invoked specter of antibiotic resistant in regard to which the conventional wisdom is that overuse of antibiotics is one of the causal elements. Recently, I referenced an article that suggested that effective "education" about overuse of antibiotics might have negative health effects because of underuse.
Procalcitonin, (PCT) as the name implies, is a precursor to the thyroid hormone calcitonin. Normally this substance is found in the thyroid glands but in some conditions,notably bacterial infections-but maybe not viral-blood levels rise.
A recent paper ( reported in the Feb. issue of "Pulmonary Medicine, pg 3, " Procalcitonin can guide antibiotic use in CAP cases) explored its use in community acquired pneumonia, in which the authors claimed that one could use the test to determine duration of antibiotic therapy. For the most part, how long we treat pneumonia is a function of physician preference and reliance on expert opinion.
As a recent journal club discussion of procalcitonin's role in detecting bacterial infections pointed out, already there are a number of "yes,buts" and "howevers". PCT may not always be elevated in bacterial sepsis, and may be elevated in heart failure and cardiogenic shock and I'll bet as time goes by more conditions and medications will be found to effect blood levels.
Appropriate restraint in the enthusiasm for thinking that PCT will always paint a bright line between bacterial and viral infections is expressed in this review by two investigators who have done some of the often quoted research in this area. PCT testing may well evolve into common use as one of the diagnostic elements to consider in evaluating a patient with possible infection.
Procalcitonin, (PCT) as the name implies, is a precursor to the thyroid hormone calcitonin. Normally this substance is found in the thyroid glands but in some conditions,notably bacterial infections-but maybe not viral-blood levels rise.
A recent paper ( reported in the Feb. issue of "Pulmonary Medicine, pg 3, " Procalcitonin can guide antibiotic use in CAP cases) explored its use in community acquired pneumonia, in which the authors claimed that one could use the test to determine duration of antibiotic therapy. For the most part, how long we treat pneumonia is a function of physician preference and reliance on expert opinion.
As a recent journal club discussion of procalcitonin's role in detecting bacterial infections pointed out, already there are a number of "yes,buts" and "howevers". PCT may not always be elevated in bacterial sepsis, and may be elevated in heart failure and cardiogenic shock and I'll bet as time goes by more conditions and medications will be found to effect blood levels.
Appropriate restraint in the enthusiasm for thinking that PCT will always paint a bright line between bacterial and viral infections is expressed in this review by two investigators who have done some of the often quoted research in this area. PCT testing may well evolve into common use as one of the diagnostic elements to consider in evaluating a patient with possible infection.
Friday, March 03, 2006
Annals Internal Medicine article-you can't rely on RCTs alone to determine drug safety
In the Feb.21,2006 issue of the Annals of Internal Medicine, Ioannidis et al have an excellent article on adverse efffects (AEs).(Ioannidis,et al "Adverse effects;The more you search, the more you find", Ann Int Med 144 (4) Feb 21, 2006)
"It is almost always inappropriate to make statments about no difference in adverse rates between groups of non-significant p values....rates of adverse events that are derived from single, modest-sized trials that are not statistically significant typically do not exclude with certainty the possibility of major,clinical important differences in harm between groups"
Randomized trials are often small and designed to test efficacy in patients in which the dosing is well controlled and often patients with co-morbidities are excluded. Only after many more patients are treated do side effects become apparent.
The latest two in what could be a very long list of medications for which serious safety issued arose after RCTs were done and FDA approval issued are Tegrin (gatifloxacin) and Ketex.
The issue with gatifloxacin drug is diabetes and now it seems to be contraindicated in patients with diabetes. Serious liver problems have been noted with Ketex.
Interestingly, gatifloxacin has been associated both with hypoglycemic reactions in diabetics on treatment and hyperglycemia in patients previously not known to be diabetic.One cannot but wonder what the mechanism(s)is/are.
A recent review of gatifloxacin-hyperglycemia cases found most were associated with decreased renal function. That the blood sugar effects are not limited to just gatifloxacin is suggested by another recent review that showed approximately equal numbers of "dysglycemias" with gatifloxacin and levofloxacin.Still another review study demonstrated a greater risk of blood sugar alterations with gatifloxacin.
Even though the RCT rests on the top perch in the party-line version of the heirarchy of the evidence used in evidence based medicine, we have to fall back on the lowly case report and observational studies to alert us to serious drug side effects. We have to realize RCTs may be best to determine efficacy not the risk of adverse effects.
"It is almost always inappropriate to make statments about no difference in adverse rates between groups of non-significant p values....rates of adverse events that are derived from single, modest-sized trials that are not statistically significant typically do not exclude with certainty the possibility of major,clinical important differences in harm between groups"
Randomized trials are often small and designed to test efficacy in patients in which the dosing is well controlled and often patients with co-morbidities are excluded. Only after many more patients are treated do side effects become apparent.
The latest two in what could be a very long list of medications for which serious safety issued arose after RCTs were done and FDA approval issued are Tegrin (gatifloxacin) and Ketex.
The issue with gatifloxacin drug is diabetes and now it seems to be contraindicated in patients with diabetes. Serious liver problems have been noted with Ketex.
Interestingly, gatifloxacin has been associated both with hypoglycemic reactions in diabetics on treatment and hyperglycemia in patients previously not known to be diabetic.One cannot but wonder what the mechanism(s)is/are.
A recent review of gatifloxacin-hyperglycemia cases found most were associated with decreased renal function. That the blood sugar effects are not limited to just gatifloxacin is suggested by another recent review that showed approximately equal numbers of "dysglycemias" with gatifloxacin and levofloxacin.Still another review study demonstrated a greater risk of blood sugar alterations with gatifloxacin.
Even though the RCT rests on the top perch in the party-line version of the heirarchy of the evidence used in evidence based medicine, we have to fall back on the lowly case report and observational studies to alert us to serious drug side effects. We have to realize RCTs may be best to determine efficacy not the risk of adverse effects.
ACP'S " Advanced Medical Home" will that dog hunt?
If you live in Texas, sooner or later you have to say something about "dogs and hunting" and I apologize in advance for seeming to treat a very serious,and I presume thoughtful, set of suggestions from the American College of Physicians in what seems to be a flip manner.
The ACP rightfully claims that primary care medicine is in a crisis mode. I agree. Their proposal called "Advanced Medical Home" (AMH) call for widespread changes in reimbursement, practice mechanics and systems and even medical education.
The proposal recommends:
"Voluntary certification and recognition of primary care and specialty medical practices that provide patient-centered care based on the principles of the chronic care model; use evidence based guidelines, apply appropriate health information technology, and demonstrate the use of best practices to consistently and reliably meet the needs of patients while being accountable for the quality and value of the care provided".
The ACP calls for:
public policy and third party financing changes and changes in medical education and national pilot testing of their proposal.
Reading though the 20 plus pages (plus appendices) I am somewhat discouraged by finding every current buzz word and platitude that are usually used in policy wonk type discussions of health care ( patient centered, value, best practices,etc,etc) but it is clear that primary care is in trouble and the ACP is at least aware of some of the issues. They seem to rely on the hope that evidence based medicine and information technology and the team approach will save the day for primary care and that somehow or other the folks with the check books (CMS,insurance companies) will cooperate with their suggestions.
The model that they proposed is supposed to improve quality and reduce cost and physicians can share in this "system wide" savings. We all know how physicians shared in the cost savings that Managed Care was to bring about. In this era of evidence based medicine where is the evidence of efficacy or safety for what they propose? Where is the evidence that this approach will save money.
Will what they propose matter? Will anyone ( CMS and third party payers)
listen? Does it all make any sense? I would be very interested in what the real doctors out there think about this.
The ACP rightfully claims that primary care medicine is in a crisis mode. I agree. Their proposal called "Advanced Medical Home" (AMH) call for widespread changes in reimbursement, practice mechanics and systems and even medical education.
The proposal recommends:
"Voluntary certification and recognition of primary care and specialty medical practices that provide patient-centered care based on the principles of the chronic care model; use evidence based guidelines, apply appropriate health information technology, and demonstrate the use of best practices to consistently and reliably meet the needs of patients while being accountable for the quality and value of the care provided".
The ACP calls for:
public policy and third party financing changes and changes in medical education and national pilot testing of their proposal.
Reading though the 20 plus pages (plus appendices) I am somewhat discouraged by finding every current buzz word and platitude that are usually used in policy wonk type discussions of health care ( patient centered, value, best practices,etc,etc) but it is clear that primary care is in trouble and the ACP is at least aware of some of the issues. They seem to rely on the hope that evidence based medicine and information technology and the team approach will save the day for primary care and that somehow or other the folks with the check books (CMS,insurance companies) will cooperate with their suggestions.
The model that they proposed is supposed to improve quality and reduce cost and physicians can share in this "system wide" savings. We all know how physicians shared in the cost savings that Managed Care was to bring about. In this era of evidence based medicine where is the evidence of efficacy or safety for what they propose? Where is the evidence that this approach will save money.
Will what they propose matter? Will anyone ( CMS and third party payers)
listen? Does it all make any sense? I would be very interested in what the real doctors out there think about this.
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