The April 24, 2006 issue of the Archives of Internal Medicine published a study from Australia that examined the effects of a twice daily supplement of 600 mg. of calcium carbonate on fracture rates and bone density.
This was a 5 year, double blind, placebo-controlled trial of 1660 women older than 70 years of age.
They found:
1.Using an intention-to-treat analysis, supplementation did not significantly reduce fracture rate.
2.But, of the 56.8% of the study participants who actually took the calcium, there was a reduced fracture rate ( hazard ratio 0.66) and improved bone density measurements.
So when viewed from a "public health perspective" it was not effective. However, calcium seems to work if you take the pills.
These results are similar to those of the recently published Woman's Health Study which also demonstrated that pills only work when you take them. Unlike the U.S. study this one did not find an increase in kidney stones. The misread and sometimes mis-reported results of the WHS may have lead some to stop their calcium in the belief that calcium supplemention does not help.
It does seem to decrease risk of fracture and it may even reduce the risk of colon polyps.
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Friday, April 28, 2006
More on bribing doctors to do their job
I recently posted on Dr. Faith Fitzgerald's principaled stand against pay for performance(P4P).
Ironically in the same issue of Internalmedicinenew.com, as Dr. Fitzgerald's article Dr. Christine K Cassel is featured promoting the ABIM scheme to tie "voluntary" reporting of quality data to obtain points to be used to obtain internist recertification and alleged future remuneration from Medicare.
The measurement of quality indicators is part of the ABIM's Practice Improvement Models (PIMs).
Dr. Cassel is trying to sell all of this because the collected quality data can be used"for multiple purposes."
Dr. Fitzgerald talked about "tipping doctors"for doing their duty.So far as regards CMS,there is just a promise of possible tipping in the future. ABIM seems to be making "an offer you can't refuse" by the threat of non-re certification for docs who don't play their quality game.
Some of us remember Dr. Cassel's commentary in the Annals of Internal Medicine in which she supported a flawed Annals article which bashed older docs in which she took the opportunity to promote the ABIM recertification dicta. See here for Dr. Roy Poses's comments regarding that issue. Promoting physician autonomy and the individual doctor patient relationship clearly is not part of the ABIM mission.
Ironically in the same issue of Internalmedicinenew.com, as Dr. Fitzgerald's article Dr. Christine K Cassel is featured promoting the ABIM scheme to tie "voluntary" reporting of quality data to obtain points to be used to obtain internist recertification and alleged future remuneration from Medicare.
The measurement of quality indicators is part of the ABIM's Practice Improvement Models (PIMs).
Dr. Cassel is trying to sell all of this because the collected quality data can be used"for multiple purposes."
Dr. Fitzgerald talked about "tipping doctors"for doing their duty.So far as regards CMS,there is just a promise of possible tipping in the future. ABIM seems to be making "an offer you can't refuse" by the threat of non-re certification for docs who don't play their quality game.
Some of us remember Dr. Cassel's commentary in the Annals of Internal Medicine in which she supported a flawed Annals article which bashed older docs in which she took the opportunity to promote the ABIM recertification dicta. See here for Dr. Roy Poses's comments regarding that issue. Promoting physician autonomy and the individual doctor patient relationship clearly is not part of the ABIM mission.
Thursday, April 27, 2006
Another argument against pay for performance (P4P) Should doctors be tipped?
Dr. Faith Fitzgerald,professor of Medicine at UC Davis,speaks out against P4P in the April 13,2006 issue of Internal Medicine News.(www.internalmedicinenews.com)
She makes two major points.
1)recommendations by "expert"panels are subject to reversal due to the fragile and provisional nature of medical conventional wisdom. Physicians feel bad when they make certain recommendations ( e.g. HRT for postmenopausal women) and later learn they may have harmed their patients, but at least they thought they were doing the right thing based on the information available at the time. However, with P4P, " Shall we have the same solace if we make these decisions,not because we think they are right but for money?
2"...the very concept of pay for performance for doctors,especially we when collaborate in the creating of the concept:Pay for performance embodies the tacit assumption that if we are not delivering it, it is because we are not being paid enough."...it[P4P] corrodes the conception of self-governance and correction that is part of the definition of professional. ...We must not servilely accept gratuities for doing our duty."
I believe P4P is wrong on so many levels. Thanks to Dr. Fitzgerald for emphasizing the aspect of how P4P is antithetical to physicians' professional identity.
She makes two major points.
1)recommendations by "expert"panels are subject to reversal due to the fragile and provisional nature of medical conventional wisdom. Physicians feel bad when they make certain recommendations ( e.g. HRT for postmenopausal women) and later learn they may have harmed their patients, but at least they thought they were doing the right thing based on the information available at the time. However, with P4P, " Shall we have the same solace if we make these decisions,not because we think they are right but for money?
2"...the very concept of pay for performance for doctors,especially we when collaborate in the creating of the concept:Pay for performance embodies the tacit assumption that if we are not delivering it, it is because we are not being paid enough."...it[P4P] corrodes the conception of self-governance and correction that is part of the definition of professional. ...We must not servilely accept gratuities for doing our duty."
I believe P4P is wrong on so many levels. Thanks to Dr. Fitzgerald for emphasizing the aspect of how P4P is antithetical to physicians' professional identity.
Tuesday, April 25, 2006
JAMA article:more on why single disease guidelines don't work for multi disease and frail patients
Thankfully,more and more authors of medical journal articles are pointing out the obvious-single disease guidelines applied by role to complicated patients is not a good thing. Clinical judgment is actually required.
In the April 26.2006 issue of JAMA, Dr. Samuel C. Durso writes about the issues involved in using clinical guidelines for older patients with diabetes and complex health status.He referenced an article called "Guidelines for Improving the Care of the Older Person with Diabetes Mellitus." The JAMA article and by reference the "guidelines" he discusses seem to really be a permission to deviate from various single disease guidelines as the physician and patient attempt to do what seems best for the patient taking into consideration prioritizing goals and the patient values and wishes reminding me of Dr. Norton Hadler's "clinical truth".
There have been earlier articles critical of the rote use of single disease guidelines in patients with multiple diseases and this article's focus in on older diabetic patients and highlights problems in frail patients with short life expectancies.
Here are some quotes from Durso's article:
"Most clinical guidelines for common conditions are disease-focused and do not provide guidance for prioritizing multiple medical conditions including geriatric syndromes that are common in older adults."
"Nor do most guidelines make explicit provisions for addressing a patient's health care preferences when they differ from guideline recommendations."
The closing sentence is interesting:
"Clinicians also must be trained in complex decision making"
It that not what internists had been trained to do over the years?
I am a bit taken back that he seems to be talking about " guidelines for guidelines"(I do not believe there can be an algorithm for everything) but there is clear value in recognizing the importance of placing guidelines in the overall clinical picture and knowing when to hold them and when to fold them.
In the April 26.2006 issue of JAMA, Dr. Samuel C. Durso writes about the issues involved in using clinical guidelines for older patients with diabetes and complex health status.He referenced an article called "Guidelines for Improving the Care of the Older Person with Diabetes Mellitus." The JAMA article and by reference the "guidelines" he discusses seem to really be a permission to deviate from various single disease guidelines as the physician and patient attempt to do what seems best for the patient taking into consideration prioritizing goals and the patient values and wishes reminding me of Dr. Norton Hadler's "clinical truth".
There have been earlier articles critical of the rote use of single disease guidelines in patients with multiple diseases and this article's focus in on older diabetic patients and highlights problems in frail patients with short life expectancies.
Here are some quotes from Durso's article:
"Most clinical guidelines for common conditions are disease-focused and do not provide guidance for prioritizing multiple medical conditions including geriatric syndromes that are common in older adults."
"Nor do most guidelines make explicit provisions for addressing a patient's health care preferences when they differ from guideline recommendations."
The closing sentence is interesting:
"Clinicians also must be trained in complex decision making"
It that not what internists had been trained to do over the years?
I am a bit taken back that he seems to be talking about " guidelines for guidelines"(I do not believe there can be an algorithm for everything) but there is clear value in recognizing the importance of placing guidelines in the overall clinical picture and knowing when to hold them and when to fold them.
Sunday, April 23, 2006
Medscape offers pro and con discussion re" P4P
I have to give credit to Medscape for publishing arguments against pay for performance (P4P) in the form of a point-counterpoint piece.
Dr. Robert M Centor, professor at University of Alabama and president elect of the Society of General Internal Medicine (and well known blogger) presented a well reasoned discussion pointing out concerns and problems regarding P4P.I believe internists and family physicians who populate the real world of patient care will be heartened by the position he presented.
Dr. Michael S.Barr,one of the vice presidents of the American College of Physicians, was assigned the job of delivering the ACP party line and what appeared to me to be a rather luke warm defense of P4P-"Many physicians have indicated significant concerns about P4P, and rightly so."
Barr does not address the points made by Centor(in fairness this was not a debate with time for rebuttals) but relies on giving a version of recent history of the issue which as usual begins with a mandatory reference to the seemingly-above-challenge "Crossing the Quality Chasm " authored by the IOM and advice to physicians to "reframe their thinking."
No doubt, there are thoughtful physicians and others who believe the P4P will improve quality but I cannot but think that the major driver for this movement is to reduce costs. The major players in that regard are the government, insurance and HMOs and with their resources seem to dominate the debate and have largely defined the universe of discourse regarding the issue.(Note-even I have given up bothering to put quotes around the word quality.)
Dr.Centor, in his role at the Society of General Internal Medicine,does have a forum to express his views and I applaud his efforts and hope others can join the fray.
Dr. Robert M Centor, professor at University of Alabama and president elect of the Society of General Internal Medicine (and well known blogger) presented a well reasoned discussion pointing out concerns and problems regarding P4P.I believe internists and family physicians who populate the real world of patient care will be heartened by the position he presented.
Dr. Michael S.Barr,one of the vice presidents of the American College of Physicians, was assigned the job of delivering the ACP party line and what appeared to me to be a rather luke warm defense of P4P-"Many physicians have indicated significant concerns about P4P, and rightly so."
Barr does not address the points made by Centor(in fairness this was not a debate with time for rebuttals) but relies on giving a version of recent history of the issue which as usual begins with a mandatory reference to the seemingly-above-challenge "Crossing the Quality Chasm " authored by the IOM and advice to physicians to "reframe their thinking."
No doubt, there are thoughtful physicians and others who believe the P4P will improve quality but I cannot but think that the major driver for this movement is to reduce costs. The major players in that regard are the government, insurance and HMOs and with their resources seem to dominate the debate and have largely defined the universe of discourse regarding the issue.(Note-even I have given up bothering to put quotes around the word quality.)
Dr.Centor, in his role at the Society of General Internal Medicine,does have a forum to express his views and I applaud his efforts and hope others can join the fray.
Wednesday, April 12, 2006
What could be better than a Randomized Clinical Trial?
What would be better than a RCT? Answer- a RCT that makes a comparison between realistic alternatives. This issue was the subject of a insightful editorial in the April 12, 2006 issue of JAMA.(Recent Trials in Hypertension-compelling science or commercial speech;JAMA, vol 295, no. 14, p1704-1706)
Three researchers well known for their expertise in this area authored the piece,B.M. Psaty,N.S. Weiss and C. D Furberg.
Full text requires subscription. Here are some highlights.
We are all becoming increasingly aware that a RCT comparing two drugs does not mean squat if the comparator drug is given in too low a dose or is one that no one (or hardly anyone) would choose anyway.
Is one treatment superior to another? Lets do a RCT. O.K. but " a fundamental principle of active treatment-controlled trials is the scientific obligation to use the best available treatment in the control group."
The editorialists were addressing the issue of blood pressure active treatment trials (an active treatment trial compares one drug with another- not with a placebo) and point out that in the ASCOT trial, low dose diuretics were not used in 45% of the atenolol group.Further,the ASCOT investigators acknowledged that possibly atenolol was not the appropriate comparator drug
for contemporary BP treatment. (Atenolol has fallen into some disrepute in that regard)
One point is that one could argue that low dose diuretics would have been a more appropriate comparator drug and atenolol is not the best beta-blocker to use as well.
Comparing drugs or sequences of drugs in hypertension trials is not simple.Many- if not most- patients require two or more medications to achieve control and the protocols in active comparisons trials may not reflect the way BP is really treated in the non-RCT world in which real physicians live. The highly hyped and highly criticized ALLHAT trial has also been accused of that fault.
The authors point out that although atenolol does not have a great track record in decreasing cardiovascular disease mortality in treated hypertensive patients, 3 large recent industry-sponsored trials used atenolol as the comparator drug.
The editorial quotes a recommendation of the National Heart,Lung and Blood Institute Working Group proposing a comparison of several drugs in patients who were receiving low dose diuretics, i.e. adding on an ARB, or an ACEi, or a CCB or a beta-blocker (but not atenolol) and doing a head-to-head comparison.
Three researchers well known for their expertise in this area authored the piece,B.M. Psaty,N.S. Weiss and C. D Furberg.
Full text requires subscription. Here are some highlights.
We are all becoming increasingly aware that a RCT comparing two drugs does not mean squat if the comparator drug is given in too low a dose or is one that no one (or hardly anyone) would choose anyway.
Is one treatment superior to another? Lets do a RCT. O.K. but " a fundamental principle of active treatment-controlled trials is the scientific obligation to use the best available treatment in the control group."
The editorialists were addressing the issue of blood pressure active treatment trials (an active treatment trial compares one drug with another- not with a placebo) and point out that in the ASCOT trial, low dose diuretics were not used in 45% of the atenolol group.Further,the ASCOT investigators acknowledged that possibly atenolol was not the appropriate comparator drug
for contemporary BP treatment. (Atenolol has fallen into some disrepute in that regard)
One point is that one could argue that low dose diuretics would have been a more appropriate comparator drug and atenolol is not the best beta-blocker to use as well.
Comparing drugs or sequences of drugs in hypertension trials is not simple.Many- if not most- patients require two or more medications to achieve control and the protocols in active comparisons trials may not reflect the way BP is really treated in the non-RCT world in which real physicians live. The highly hyped and highly criticized ALLHAT trial has also been accused of that fault.
The authors point out that although atenolol does not have a great track record in decreasing cardiovascular disease mortality in treated hypertensive patients, 3 large recent industry-sponsored trials used atenolol as the comparator drug.
The editorial quotes a recommendation of the National Heart,Lung and Blood Institute Working Group proposing a comparison of several drugs in patients who were receiving low dose diuretics, i.e. adding on an ARB, or an ACEi, or a CCB or a beta-blocker (but not atenolol) and doing a head-to-head comparison.
Senator raises questions about the quality of Quality Improvement Organizations ( QIOs)
Probably most people and likely many physicians have never even heard of QICs. Here is their website where we learn that the QIC program is directed by CMS and consists of 53 QICs who are tasked "to make sure patients get the right care at the right time."
Senator Chuck Grassley is asking for changes in this program because- according to a recent news blurb in the Capital Health Call section in JAMA of "questionable expeditures,potential conflicts of interests and lack of effectiveness." He raises questions about the quality of the program purported to ensure quality of medical care.
The American Health Quality Association, which is described as a QIC trade organization seems to admit that the program need changes-probably they would favor more funding- but blames the problems on poorly written laws.
Purportedly, there was a need for these QICs because physicians left to their own devices would not deliver "quality care", so it would seem reasonable that what we need now is another layer of quardians who can watch over and insure the quality of the organizations that were to insure the quality of care., but ,of course, they will have to be audited.
Senator Chuck Grassley is asking for changes in this program because- according to a recent news blurb in the Capital Health Call section in JAMA of "questionable expeditures,potential conflicts of interests and lack of effectiveness." He raises questions about the quality of the program purported to ensure quality of medical care.
The American Health Quality Association, which is described as a QIC trade organization seems to admit that the program need changes-probably they would favor more funding- but blames the problems on poorly written laws.
Purportedly, there was a need for these QICs because physicians left to their own devices would not deliver "quality care", so it would seem reasonable that what we need now is another layer of quardians who can watch over and insure the quality of the organizations that were to insure the quality of care., but ,of course, they will have to be audited.
Tuesday, April 11, 2006
More on Disease Mongering
Health Care Renewal recently referenced a symposium on Disease Mongering (DM) and the full text essays are now available on the PLOS website.
In recent months,I have written about certain aspects of the promotion of the diagnosis and treatment of two conditions,bipolar disorder and restless legs syndrome (RSL) as having features of the DM phenomenon.
Let me attempt to preempt one line of possible criticism by stipulating that Bipolar Disease is a very serious psychiatric disorder and warrants treatment by qualified physicians and that RLS can be in some patients a very disturbing disorder with definite morbidity relief from which could be very worthwhile.
However, I had questioned the drug company initiative to round up primary care doctors to seek out and take on the often daunting task of managing a bipolar patient,an enterprise in which psychiatrists really earn their fee.(I will admit that in No-trees Texas type locations the PCP may have to take on the job as the region may be bereft of psychiatrists).I also questioned the wisdom of screening for RLS with a drug company sponsored questionnaire with the objective of offering treatment with a dompamine agonist for positive screenees.
The PLOS symposium essay on RLS is worth reading as it takes up several aspects of this matter with much greater development of the issues than my gut feeling sense of it that I posted. Hats off to Doctors Steven Woloshin and Lisa M. Schwartz of Dartmouth Medical School .
Another article questions the evidence or lack of it underpinning the whole issue of diagnosis and treatment of bipolar disorder.
It can be argued that the marketers manipulate the motivations of physicians and various support groups . The physicians are obviously an essential element in the equation. It is their desire to foster the welfare of their patient and do the right thing that is necessary for the DM process to flourish. I believe the "shame of being ignorant" is branded into the limbic cortex of medical students .Hats off to the ever insightful author of the blog PURRY GUD (tomwaitsatemyaby.blogspot.com) who used that phrase recently.
Physicians-many at least-are haunted by the fear that we will harm someone or fail to help someone because of something we do not know (there are certainly other ways we can harm also). This motivation to know what we need to know allows marketers to direct our energies to detection of new illness and to accept wider definitions of disease . Medications are not prescribed because we like the free food or notepads or pens even if we like the free food. Free lunches are not really the problem. The marketers not only manipulate the physcians' hypertrophied sense of duty but the prestige of evidence based medicine as well with all the tricks and traps one can squeeze into a randomized trial to give the veneer of solid science to something that may be no more than a comparison of their drug with one no one would use anyway.
The good news here, if there is any, is that we are catching on. The DM symposium is evidence of that.
We are getting more skeptical about what we read.We are realizing there is more to a RCT than the fact is randomized and blinded. With Google and other search engines it is easier to more quickly confirm or deny material from various promotional efforts. (The bad news is who has time to check and analyze everything that appears in print)
But even as our duty pushes us to strive even harder to figure out what it is we should do to do the right thing we learn of still another tactic to thwart and divert our efforts.
In recent months,I have written about certain aspects of the promotion of the diagnosis and treatment of two conditions,bipolar disorder and restless legs syndrome (RSL) as having features of the DM phenomenon.
Let me attempt to preempt one line of possible criticism by stipulating that Bipolar Disease is a very serious psychiatric disorder and warrants treatment by qualified physicians and that RLS can be in some patients a very disturbing disorder with definite morbidity relief from which could be very worthwhile.
However, I had questioned the drug company initiative to round up primary care doctors to seek out and take on the often daunting task of managing a bipolar patient,an enterprise in which psychiatrists really earn their fee.(I will admit that in No-trees Texas type locations the PCP may have to take on the job as the region may be bereft of psychiatrists).I also questioned the wisdom of screening for RLS with a drug company sponsored questionnaire with the objective of offering treatment with a dompamine agonist for positive screenees.
The PLOS symposium essay on RLS is worth reading as it takes up several aspects of this matter with much greater development of the issues than my gut feeling sense of it that I posted. Hats off to Doctors Steven Woloshin and Lisa M. Schwartz of Dartmouth Medical School .
Another article questions the evidence or lack of it underpinning the whole issue of diagnosis and treatment of bipolar disorder.
It can be argued that the marketers manipulate the motivations of physicians and various support groups . The physicians are obviously an essential element in the equation. It is their desire to foster the welfare of their patient and do the right thing that is necessary for the DM process to flourish. I believe the "shame of being ignorant" is branded into the limbic cortex of medical students .Hats off to the ever insightful author of the blog PURRY GUD (tomwaitsatemyaby.blogspot.com) who used that phrase recently.
Physicians-many at least-are haunted by the fear that we will harm someone or fail to help someone because of something we do not know (there are certainly other ways we can harm also). This motivation to know what we need to know allows marketers to direct our energies to detection of new illness and to accept wider definitions of disease . Medications are not prescribed because we like the free food or notepads or pens even if we like the free food. Free lunches are not really the problem. The marketers not only manipulate the physcians' hypertrophied sense of duty but the prestige of evidence based medicine as well with all the tricks and traps one can squeeze into a randomized trial to give the veneer of solid science to something that may be no more than a comparison of their drug with one no one would use anyway.
The good news here, if there is any, is that we are catching on. The DM symposium is evidence of that.
We are getting more skeptical about what we read.We are realizing there is more to a RCT than the fact is randomized and blinded. With Google and other search engines it is easier to more quickly confirm or deny material from various promotional efforts. (The bad news is who has time to check and analyze everything that appears in print)
But even as our duty pushes us to strive even harder to figure out what it is we should do to do the right thing we learn of still another tactic to thwart and divert our efforts.
Monday, April 10, 2006
Medical news you really can't use
Medical Journals sometimes publish POEMs-which in this context stands for "Patient Oriented Evidence that Matters". The criteria for a study to be elevated to high level on the epistemological food chain are:
1.addresses a question physician face.
2.has measure(s) of outcome and
3.has the potential to change the way doctors practice.
There are several "medical news newspapers" typically distributed without charge to physicians, one example of which is the " Internal Medicine Report",which I usually read if for no other reason than for the excellent essays by Dr.Philip R. Alper . This type of publication has no shortage of information that you really can't use,as well as some you can , the trick being to know the difference.
Here are some of the "unPOEMs" from that publication.
They reference an case control study from Urology (2005,67:73-79,which noted that risk for BPH was increased by eating more cereal,bread, eggs and poultry while risk was decreased by eating more soup,legumes, cooked veggies and citrus fruit. Try putting this factoid into your practice. Mr. Jones, with your BPH- I would recommend you eat less bread and more soup.
Another reference was to a paper presented at meeting of the American Stroke Association in which patients who had endovascular closure of patent foramen ovale (PFO) has less migraine headache than a comparison group that was treated medically.This was a retrospective,nonrandomized study and recall bias was an obvious issue. Again try and put this "observation" into practice.
In the same issue we also "learn" that Sulfonyluea therapy for type 2 diabetes linked to cancer" and "moderate coffee consumption may keep Type 2 diabetes "at bay".
Many of these factoid unPOEMs derive from case control studies that are correctly described as hypothesis generating studies that sometimes alert researchers to apparent associations that lead them to push on with more definitive techniques and sometimes are just statistical noise dead ends.
1.addresses a question physician face.
2.has measure(s) of outcome and
3.has the potential to change the way doctors practice.
There are several "medical news newspapers" typically distributed without charge to physicians, one example of which is the " Internal Medicine Report",which I usually read if for no other reason than for the excellent essays by Dr.Philip R. Alper . This type of publication has no shortage of information that you really can't use,as well as some you can , the trick being to know the difference.
Here are some of the "unPOEMs" from that publication.
They reference an case control study from Urology (2005,67:73-79,which noted that risk for BPH was increased by eating more cereal,bread, eggs and poultry while risk was decreased by eating more soup,legumes, cooked veggies and citrus fruit. Try putting this factoid into your practice. Mr. Jones, with your BPH- I would recommend you eat less bread and more soup.
Another reference was to a paper presented at meeting of the American Stroke Association in which patients who had endovascular closure of patent foramen ovale (PFO) has less migraine headache than a comparison group that was treated medically.This was a retrospective,nonrandomized study and recall bias was an obvious issue. Again try and put this "observation" into practice.
In the same issue we also "learn" that Sulfonyluea therapy for type 2 diabetes linked to cancer" and "moderate coffee consumption may keep Type 2 diabetes "at bay".
Many of these factoid unPOEMs derive from case control studies that are correctly described as hypothesis generating studies that sometimes alert researchers to apparent associations that lead them to push on with more definitive techniques and sometimes are just statistical noise dead ends.
Sunday, April 09, 2006
Carotid endarterectomy-AAN guidelines
The updated and long awaited guidelines from the American Academy of Neurology are available on line in full text. Their previous guidelines were published in 1990.
Two large Class I studies provide good data for their recommendations regarding symptomatic carotid stenosis (CS), the NASCET trial and the ECST. Entry into the studies required a TIA or non-disabling stroke within the previous 6 months.
For symptomatic patients with stenosis greater than 70% ( but less than "near total" occlusion) carotid endarterectomy (CE) is recommended if the surgical stroke or death frequency is believed to be less than 6% and the patient has an expected survival of five years or more. The absolute risk reduction is 16% with a NNT of 6.3.
If the stenosis is less than 50%, surgery is not recommended and medical treatment is preferred.
In regard to asymptomatic patients CE should be considered if the stenosis is 60-99 % and the surgical stroke or death risk is less than 3% and the patient has an expected 5 year or greater survival.
Due to the slow accumulation of big time Class I studies we may have gone about as far as we are likely to go any time soon with learning about CE versus medical treatment, but what about carotid stents? The jury is just beginning to hear the evidence and there are advocates with convincing arguments on each side.
Coronary stents have certainly become worthy rivals of CABGs and catheter treatment of cerebral aneurysms -at least in some clinical situations-may be better than surgical clipping. I believe that increasingly we will see more and more endovascular catheters at work and less classical surgery. I wonder how long it will take for enough data with head to head ( or neck to neck) comparisons between CE and stenting to accumulate to determine the role of catheters versus surgery in this setting.
Two large Class I studies provide good data for their recommendations regarding symptomatic carotid stenosis (CS), the NASCET trial and the ECST. Entry into the studies required a TIA or non-disabling stroke within the previous 6 months.
For symptomatic patients with stenosis greater than 70% ( but less than "near total" occlusion) carotid endarterectomy (CE) is recommended if the surgical stroke or death frequency is believed to be less than 6% and the patient has an expected survival of five years or more. The absolute risk reduction is 16% with a NNT of 6.3.
If the stenosis is less than 50%, surgery is not recommended and medical treatment is preferred.
In regard to asymptomatic patients CE should be considered if the stenosis is 60-99 % and the surgical stroke or death risk is less than 3% and the patient has an expected 5 year or greater survival.
Due to the slow accumulation of big time Class I studies we may have gone about as far as we are likely to go any time soon with learning about CE versus medical treatment, but what about carotid stents? The jury is just beginning to hear the evidence and there are advocates with convincing arguments on each side.
Coronary stents have certainly become worthy rivals of CABGs and catheter treatment of cerebral aneurysms -at least in some clinical situations-may be better than surgical clipping. I believe that increasingly we will see more and more endovascular catheters at work and less classical surgery. I wonder how long it will take for enough data with head to head ( or neck to neck) comparisons between CE and stenting to accumulate to determine the role of catheters versus surgery in this setting.
Tuesday, April 04, 2006
You need more than FEV1 to judge bronchodilator response
Bronchodilator drug trials and often clinical followup have focused on the changes in the forced expiratory volume in one sec (FEV1) to judge therapeutic response. However, it is recognized that exercise intolerance and dyspnea may improve with no significant change in expiratory flow rates.
Improvement in exercise tolerance actually seems to correlate better with indicators of improvement in overinflation,a simple measure of which is the inspiratory capacity (IC).
The IC is the sum of the tidal volume and the inspiratory reserve capacity which is the volume of air inhaled on top of a tidal volume. In COPD the IC is reduced as a result of the hyperinflation ( increased residual volume and functional residual capacity) so that the tidal volume is performed at the upper part of the lung's pressure volume curve which is a region of low compliance and an increased load on the inspiratory muscles.The overinflation present at rest is worsened with increasing airtrapping during exercise with increased respiratory rate and decreased time to exhale and is currently thought to be a major variable that relates to exercise intolerance and the sensation of dyspnea.
In the March 2006 issue of Chest ( subscription required for full text), authors from Holland demonstrated that a long acting bronchodilator (LABA),formoterol plus once a day tioptropium ( a long acting anticholinergic) brought about significant improvement in expiratory flow rates and -probably more importantly from a symptom improvement point of view-a significant increase in the inspiratory capacity.
Scores of bronchodilator trials focused only ( or at least mainly) on FEV1 measurement. ( I was involved in several as a pulmonary fellow) and as we learn more about the pathophysiology and the clinical correlates of lung function measurements we are better able to develop therapeutic measures to improve the disabling exercise intolerance of COPD patients.
It may have taken the surgical lung volume reduction experience to remind lung doctors that we have been doing pharmcologic lung volume reduction therapy all along when we have been using bronchodilators.
Improvement in exercise tolerance actually seems to correlate better with indicators of improvement in overinflation,a simple measure of which is the inspiratory capacity (IC).
The IC is the sum of the tidal volume and the inspiratory reserve capacity which is the volume of air inhaled on top of a tidal volume. In COPD the IC is reduced as a result of the hyperinflation ( increased residual volume and functional residual capacity) so that the tidal volume is performed at the upper part of the lung's pressure volume curve which is a region of low compliance and an increased load on the inspiratory muscles.The overinflation present at rest is worsened with increasing airtrapping during exercise with increased respiratory rate and decreased time to exhale and is currently thought to be a major variable that relates to exercise intolerance and the sensation of dyspnea.
In the March 2006 issue of Chest ( subscription required for full text), authors from Holland demonstrated that a long acting bronchodilator (LABA),formoterol plus once a day tioptropium ( a long acting anticholinergic) brought about significant improvement in expiratory flow rates and -probably more importantly from a symptom improvement point of view-a significant increase in the inspiratory capacity.
Scores of bronchodilator trials focused only ( or at least mainly) on FEV1 measurement. ( I was involved in several as a pulmonary fellow) and as we learn more about the pathophysiology and the clinical correlates of lung function measurements we are better able to develop therapeutic measures to improve the disabling exercise intolerance of COPD patients.
It may have taken the surgical lung volume reduction experience to remind lung doctors that we have been doing pharmcologic lung volume reduction therapy all along when we have been using bronchodilators.
Friday, March 31, 2006
Comments about Deficiency of clinical skills
Dr. RW's post referencing Dr. Herb Fred's editorial in the Texas Heart Journal generated several negative responses in KEVINMD's march 30.2006 blog following his reference to that piece.
Several ad hominem comments accused Dr. Fred of being basically a disgruntled, out of date, grumpy old doc who-in the words of one such writer-never practiced in the real world. Ad hominem arguments are -well -just that and usually do not warrant detailed refutation.
Unlike some of the commenters' suggestions, Dr. Fred seems quite aware of the calling-the-shots nature of managed care and the time restriction brought about by the third party payers' domination. He says that the HMOs force physicians to care for a maximum number of patients, in a minimum number of minutes for the lowest number of dollars.
His rant is about the decline of clinical skills and the factors responsible.He believes that values and priorities are not what they used to be.
When he trained in the mid-1950s ( and also when I trained in the 1960s) :
"... hard work,self pride,devotion to duty, strict accountability and pursuit of excellence were the norms" .
To expand on that-Things were framed in the relationship between the individual doctor and the individual patient.We did not speak about or -except in extreme circumstances-consider the " greater good" or conservation of some abstract and apparently collectively owned "resources".It seems that the core competencies of the ACGME do espouse-at least in part-values other than the one-on-one doctor patient relationship.
The ACGME core competences speak of :
..Responsiveness to the needs of patients and society
...practice cost effective health care and resource allocation
...understand how their patient care and other prorfessional practices affect...the health care organization, and...the larger society.
If I were managing an HMO, those "values" are certainly those that I would have inculcated into the doctors who are allocating my resources.
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.
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.
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