CASE IN POINT -COMPARISON OF WARFARIN AND ASPIRIN FOR INTRACRANIAL STENOSIS (THE WASID TRIAL)
The March 31 issue of NEJM published the WASID trial.In summary, warfarin was not superior to high dose asa ( meaning 4 of the 325 mg tablets a day).Because there was more hemorrhage and no fewer ischemic strokes in the warfarin group the authors conclude "aspirin should be used in preference to warfarin in patients with intracranial stenosis"
We all eagerly await a reason not to give warfarin, so is the issue settled ? It may be that warfarin would be better if we could control the INR better but with current practices even in a RCT we apparently cannot.
The editorialist, Dr. W.J.Koroshetz makes interesting comments.The warfarin patients were in "therapeutic target " range of an INR of 2-3 only 63% of the time, which we are told is pretty good for trials of warfarin and probably higher than that achieved typically in real life outside of trials.For those with a less than 2 INR the rate of ischemic stroke was 25 per 100 patient years versus 5 per 100 patient years if IRN was in the 2-3 range. It seems that warfarin "works" to decrease ischemic stroke if it is done right but it hard to get it right. So,if INRs could be kept at 2-3, perhaps warfarin would be judged to be superior to asprin in ischemic stoke reduction with less of the hemorrhage concern.There is some data to indicate that home monitoring of INRs may be better and with Ximelagatran, which is in the wings, no monitoring is needed.
Dr. Koroshetz states that the WASID data does not necessarily mean not to use warfarin or some anticoagulant at all. He suggests possibly LMWH early on and still suggests a role for warfarin in those patients with have more clinical ischemic events while on aspirin.
There is also the issue of Aggrenox- the extended release dipyridamole-aspirin combination which was shown to be better than aspirin alone in the European stroke trial.In the ESPS2 trial the 2 year stroke risk in the placebo group was 15%,12.5 % for aspirin and 9.5% for the aspirin-dipyridamole capsule.
Also consider the issue of how much stroke risk reduction will occur in similar patients when their LDL is lowered (to less than 70??), and their BP is well controlled. Hopefully it will be lower than the 22 % 2 year risk reported in the aspirin group.
Thursday, March 31, 2005
Tuesday, March 29, 2005
Pay for Performance, Part 2, watch the Medicare Payment Advisory Commission
MedPAC is the acronym for the Medicare Payment Advisory Commission.Physicians need to listen to what they are saying. "Physicians are ready for a pay-for-performance program " said Karen Milgate, a MeDPAC research director at a recent meeting which precedes the March report to Congress.Ms.Milgate offered no data to support her statement.
MeDPAC's web site has the biographies of the Commission.The commission has its share of attorneys (who better to determine how medicine will be practiced.)The American College of Physicians is represented.Their envoy, Dr. Alan Nelson is quoted in the March 15, 2005 issue of Internal Medicine News "...the insistence of payers for incentives to promote quality is something that cannot be ignored." (Practicing physicians know well that payers are all about promoting quality,not about saving money at least in the world where pigs will fly.)There are 3 attorneys on the commission and the VP of Humana,CEO of a medical supply company (DeRoyal) and the Executive Director of the Permanente Federal of Medical Groups,and assorted medical policy and public health wonks.
Ms. Milgate suggests linking prescription data with physicians claims to determine whether the patients received "appropriate pharmaceutical care".Here's a new term to me, "pharmaceutical care ".I'll wager if this very coarse grain analysis concludes that care was not appropriate, it will be the fault of the physician not the drug store employee.
One Commissioner,Dr.Nicholas Wolter,who seems to be the only person on the panel in private practice said "pay for performance might be another irritation,rather than an incentive" and added in regard to whether physicians are ready "I'm not sure that's true".Dr.Wolter seems to be a master of the understatement.
The commission report is available on line on the MeDPAC site. The recommendations include "radiologists meet quality standards as a condition for medicare payment" and "measuring the resource use" of physicians treating medicare patients.I did not notice any radiologists on the commission and there appeared to be only one doctor who might actually treat medicare patients.
MeDPAC's web site has the biographies of the Commission.The commission has its share of attorneys (who better to determine how medicine will be practiced.)The American College of Physicians is represented.Their envoy, Dr. Alan Nelson is quoted in the March 15, 2005 issue of Internal Medicine News "...the insistence of payers for incentives to promote quality is something that cannot be ignored." (Practicing physicians know well that payers are all about promoting quality,not about saving money at least in the world where pigs will fly.)There are 3 attorneys on the commission and the VP of Humana,CEO of a medical supply company (DeRoyal) and the Executive Director of the Permanente Federal of Medical Groups,and assorted medical policy and public health wonks.
Ms. Milgate suggests linking prescription data with physicians claims to determine whether the patients received "appropriate pharmaceutical care".Here's a new term to me, "pharmaceutical care ".I'll wager if this very coarse grain analysis concludes that care was not appropriate, it will be the fault of the physician not the drug store employee.
One Commissioner,Dr.Nicholas Wolter,who seems to be the only person on the panel in private practice said "pay for performance might be another irritation,rather than an incentive" and added in regard to whether physicians are ready "I'm not sure that's true".Dr.Wolter seems to be a master of the understatement.
The commission report is available on line on the MeDPAC site. The recommendations include "radiologists meet quality standards as a condition for medicare payment" and "measuring the resource use" of physicians treating medicare patients.I did not notice any radiologists on the commission and there appeared to be only one doctor who might actually treat medicare patients.
Monday, March 28, 2005
Pay For Performance, the latest bogus proposal from Third party "Players"
The latest buzz phrase seems to be "Pay for Performance" (PFP). Articles that discuss the topic often are ambiguous about what PFP means. How will performance be measured? That's the rub. Typically, studies which purport to measure "quality" measure the degree to which certain guidelines are adhered to, wherein quality equals conformance, begging the question are the guidelines even valid. "Performance" will, likely , in part, be "measured" in the same way.
Dr. Charles Francis, president of American College of Physicians, recently participated in a Pro & Con section in Internal Medicine News. The question was " would pay for performance result in better care" He was Pro. He implies that the market is demanding PFP to ensure high quality performance. The third payers are demanding it. How many patients have you heard express the idea that they are very interested in physicians being payed in part by their "quality" of care"? Patients are interested in the physician taking care of the problem at hand. Does anyone deny that the insurance companies, and Medicare are primarily interested in cutting costs? Follow the money. Don't judge a plan or activity by its purported mission, but ask what incentives and restraints does that entity operate under. The incentive of third party payers is to decrease costs.
Dr. Francis's opponent in this quasi-debate was Bruce Vladeck, former administrator of the Health Care Financing Administration. Mr. Vladeck , a non-physician,and he had the most cogent insight expressed by either participant. He said in part about physicians "To change behavior through relatively modest economic incentives is much less powerful than targeting the activities that make professions feel good about themselves-where their identity is closely tied"
While Mr. Vladeck does not explain how to do this, at least he realizes what , I think, most doctors are really about, our identity is tied strongly to doing a good job for our patients.
Unfortunately, to my ears, Dr. Francis's comments sounded like what an administrator of a insurance plan would say ( "...fragmented care,....helping to raise the bar on quality.. foster continuous quality improvement..to meet or exceed evidence based standards." The ACP seems to be the "Newest best friend" of managed care and the powers that be that hold the medical purse strings.
Dr. Charles Francis, president of American College of Physicians, recently participated in a Pro & Con section in Internal Medicine News. The question was " would pay for performance result in better care" He was Pro. He implies that the market is demanding PFP to ensure high quality performance. The third payers are demanding it. How many patients have you heard express the idea that they are very interested in physicians being payed in part by their "quality" of care"? Patients are interested in the physician taking care of the problem at hand. Does anyone deny that the insurance companies, and Medicare are primarily interested in cutting costs? Follow the money. Don't judge a plan or activity by its purported mission, but ask what incentives and restraints does that entity operate under. The incentive of third party payers is to decrease costs.
Dr. Francis's opponent in this quasi-debate was Bruce Vladeck, former administrator of the Health Care Financing Administration. Mr. Vladeck , a non-physician,and he had the most cogent insight expressed by either participant. He said in part about physicians "To change behavior through relatively modest economic incentives is much less powerful than targeting the activities that make professions feel good about themselves-where their identity is closely tied"
While Mr. Vladeck does not explain how to do this, at least he realizes what , I think, most doctors are really about, our identity is tied strongly to doing a good job for our patients.
Unfortunately, to my ears, Dr. Francis's comments sounded like what an administrator of a insurance plan would say ( "...fragmented care,....helping to raise the bar on quality.. foster continuous quality improvement..to meet or exceed evidence based standards." The ACP seems to be the "Newest best friend" of managed care and the powers that be that hold the medical purse strings.
Saturday, March 26, 2005
NEJM Perspective "Quiet in the Library" Nails it
The knowledge explosion and the internet are part of the forces transforming medicine, a major part. Another is the control that managed care exerts over physicians' activities.The fact that we use the term "managed care" exemplifies the degree to which we are controlled by third parties.(the term itself is an insurance industry term to define the discussion by using language to achieve the interests of particular group)
The more I think about it the clearer it is to me that what physicians and students set out to be a generation ago is not possible. Dr. Thomas H Lee in the March 17, NEJM says is simply "There is simply too much to know". As if The too-much-to-know condition is not enough, there is also the constraint that various managed care entities exerts sometimes leading to the untenable situation where the doctor knows what should be done but finds it cannot be done. Certainly for the generalist, there is too much to know. I think a specialist, a pulmonologist or endocrinologist or urologist might, but a general internist or a family practioner..I think not.
The more I think about it the clearer it is to me that what physicians and students set out to be a generation ago is not possible. Dr. Thomas H Lee in the March 17, NEJM says is simply "There is simply too much to know". As if The too-much-to-know condition is not enough, there is also the constraint that various managed care entities exerts sometimes leading to the untenable situation where the doctor knows what should be done but finds it cannot be done. Certainly for the generalist, there is too much to know. I think a specialist, a pulmonologist or endocrinologist or urologist might, but a general internist or a family practioner..I think not.
Wednesday, March 23, 2005
Retired Doc's Suggestion for Medical Curriculum,Part 5
Medical and non-medical authors decry the amount of money spent on health care in the US. We cannot afford this and we cannot afford that. We are admonished that we spend more than is spent per capita in Europe or Canada as if that comparison should be the gold standard.Medical students not only read this criticism but likely hear it from their professors, at least from those who are of the left leaning persuasion. Medical students should not graduate into a profession that they perceive is a drain on the country's economy. They need to be aware of the "other side of Healthcare Expenditures" This- in fact- is the title of an excellent piece in the Johns Hopkins Advanced Studies In Medicine for Ferurary 2005. (This article would be required reading for the medical students course in basic economics as it impacts medicine) The main point of the article is so obvious that one wonders why it even has to be made. (It has to be made because there has been so much nonsense to the contrary said and published that a major misconception has become part of "conventional wisdom"). Dr. Hough, the article's author, speaks correctly of the healthcare "industry" as a powerful job creator, a major economic force, a high productivity, high tech industry with above average wages as well as being low polluting and relatively insensitive to the business cycle. In short, this is the kind of business you would expect government to encourage and celebrate. Hough quotes one study which estimated that 1.9 billion dollars was directly created by Hopkins to Maryland in 2002. And that money percolates through the economy. He quotes other impressive figure from various areas in the country. Money spent on health care is no more a drain on the economy that is money spent on automobiles or housing or food or cosmetics. The bogus nature of statements such as " the society cannot afford so many MRIs ( or whatevers) should be apparent not only to medical students but to everyone. Medical students, or physicians for that matter, should not be ashamed that there are more MRIs in Houston that in Canada. Canadians should be.
Tuesday, March 22, 2005
AMA News (3-21-05) Misses the same point that an Earlier annals Int Med article did
In the Professional issues section of AMA news, there is an article claiming the answer to the managing-test-result issue is "information technology".They quote the Annals article on "fumbled handoffs" by Dr. Gandhi about which I posted earlier pointing out that the disaster recounted there was not so much an IT issue as it was an issue of ignorance and lack of accountability. It may surprise those who never knew a world without computers but physicians did keep up with lab tests in the 1960s, and 1970s and earlier with notes and cards but mainly with the imperative that they were responsible for the patient and the labs and the xray reports.The reporter also quotes someone who worked on the Joint commission Journal on Quality and Patient Safety who opined "More Government funding is needed" but at least admitted "technology alone won't be the answer".I can personally testify that well run practices have for years done excellent jobs with cards,reminders and calenders and even D-bases on 286 computers in managing lab tests.Apparently they did not need government funding at all for that.
Monday, March 21, 2005
The Doctors at Cedai-Sinai Reject computerized entries
Kevin,MD calls attention to the failure of the computerized medical record system at the Los Angeles hospital.As pointed out in the newspaper account, the problem seemed to be the forcing of the docs to enter notes, etc into a Procrustean system not in the docs using the system to extract information (labs,etc).I have first hand information of a similar situation at a large VA hospital in which the physician's entries into the computer were so time consuming that the surgeons revolted there and said they would not use it.As usual the surgeons had their way but the non-surgeon doctors' complaints were ignored. Computers are supposed to save time-even for physicians-so why not computerized voice recognition dictation with real time turn around.I know that has been talked about for years;is it ready for prime time?
Saturday, March 19, 2005
Even the Masters of Evidence Based Medicine at McMasters Cannot keep up with the 55 new RCTS per day
An editorial in the March/April issue of the ACP journal Club(evidence-based medicine for better patient care) states that each year Medline indexes 560,000 new articles and Cochrane Central adds 20,000 new trials per year.(this is about 55 per day).The editorialists,Glaszious and Haynes, depress us further by revealing that the Cochrane group can only include less than 10% of the trials in their reviews and that a review of guidelines for treatment of atrial fibrillation showed that for twenty reviews "most" were not evidence based.They continue and quote a JAMA article that seems to show that guidelines don't follow guidelines.(JAMA 1999;281;1900-5,"Are guidelines following guidelines?" By Shaneyfelt TM et al)
And then the same issue of the journal itself-in a wierd self referential way- shows how impossible it is to keep up by publishing a review of a meta-analysis of estrogen use in urinary incontinence-claiming that estrogen helps-in their March/April issue even though JAMA in a Feb.issue published the WHI data (a RCT- which,of course, always trumps a meta-analysis)that showed estrogen makes incontinence worse.
Obviously,the issue went to press before the JAMA article was published but the whole thing struck me as ironic or illustrative of what general internists face with the imperative of trying to keep up in the face of too much to keep up with.The ACP Journal CLub publication does typically help in that effort, an occasional oversight notwithstanding.
And then the same issue of the journal itself-in a wierd self referential way- shows how impossible it is to keep up by publishing a review of a meta-analysis of estrogen use in urinary incontinence-claiming that estrogen helps-in their March/April issue even though JAMA in a Feb.issue published the WHI data (a RCT- which,of course, always trumps a meta-analysis)that showed estrogen makes incontinence worse.
Obviously,the issue went to press before the JAMA article was published but the whole thing struck me as ironic or illustrative of what general internists face with the imperative of trying to keep up in the face of too much to keep up with.The ACP Journal CLub publication does typically help in that effort, an occasional oversight notwithstanding.
Wednesday, March 16, 2005
Hopes for vitamin E protective value dashed by HOPE trial.
The March 16, 2005 issue of JAMA published the results of the large, long RCT that gave 400 U. Of Vitamin E to the study participants. (The HOPE and HOPE TOO trials)
No protection for heart disease or cancer was evident. The promising biological plausibility of Vitamin E as an anti-oxidant has been countered with very strong data indicating it does not protect against the diseases that we thought it might. I remember telling patients it looked like a good play and I have bought many bottles myself. At worse it seemed harmless. It may be harmless but the HOPE trialists report data that suggest possible increased risk of heart failure. The data there seems about as weak as the data we used to tout E in the past, so I don't plan to scare anyone with that.
But if true is this still another example of how we get things just backwards?. We recommended HRT to decrease heart attack risk and later learned it increases risk of another vascular disease, stroke. We knew that if you gave a person with CHF beta-blockers it would make it worse and now they are required treatment of CHF. We excluded anti-cholinergics for COPD ex cathedra because they would make secretions too thick. The list of "getting things backwards" is so easy to make that it is not fun anymore. All of this needs to be included in the "anti-hubris" lectures to medical students.
No protection for heart disease or cancer was evident. The promising biological plausibility of Vitamin E as an anti-oxidant has been countered with very strong data indicating it does not protect against the diseases that we thought it might. I remember telling patients it looked like a good play and I have bought many bottles myself. At worse it seemed harmless. It may be harmless but the HOPE trialists report data that suggest possible increased risk of heart failure. The data there seems about as weak as the data we used to tout E in the past, so I don't plan to scare anyone with that.
But if true is this still another example of how we get things just backwards?. We recommended HRT to decrease heart attack risk and later learned it increases risk of another vascular disease, stroke. We knew that if you gave a person with CHF beta-blockers it would make it worse and now they are required treatment of CHF. We excluded anti-cholinergics for COPD ex cathedra because they would make secretions too thick. The list of "getting things backwards" is so easy to make that it is not fun anymore. All of this needs to be included in the "anti-hubris" lectures to medical students.
Monday, March 14, 2005
Boil the Oceans,Goedel's Theorem and the Medical Knowledge-application Gap
Will Rogers, when asked about the solution to the German U-boat problem during WW I said "Boil the oceans.That'll force all the subs to the surface" When asked, How, he dismissed the issue as "mere details".
Much has been made of the explosion of medical information and the lack of application of same to the trench-dwelling docs.Fontelo and Ackerman posting on the 9/21/04 issue of Medscape in an article entitled "Evidence Based Medicine needs easy-to-use handheld tools for universal application" propose a solution.
A clinician would ask a question ( Dx, Rx, prognosis, whatever) on his PDA and a remote computer would take over. The literature would be reviewed,software would scan the articles,apply algorithms and "rules of EBM",evaluate it all and provide a conclusion back to the doctor.When I read this I thought are we really close to having an "expert system" that would replace the experience and expertise of human expert in various medical disciplines and be able to solve problems in general? ( I realize there are various "limited" (specific application) expert systems in existence but the authors seems to be talking about a general problem solver.) Could we ever have such a thing? It turns out that there is considerable difference of opinion regarding the second question.
In 1928 David Hilbert challenged the mathematical world to devise a procedure to devise the truth or falsity of every arithmetic statement.In 1931, Kurt Goedel demonstrated that this could not be done. A simplified version of Goedel's theorem is "arithmetic is not completely formalizable". The work of Turing and Chaitin enlarged this thought to " There is no systematic way of deciding if a given proposition is decidable or not".
Goedel showed that a system as relatively simple as arithmetic could not be axiomatized or made into a set of rules or algorithms to prove all of the truth within the system.
There is a persuasive body of thought that extrapolates from that. Roger Penrose has said human insight cannot be reduced to an algorithm. William Barrett ( Author of the Illusion of Technique) has argued that if the rules for a relatively simple system such as arithmetic are not adequate to determine the truth of some true statements, how much more inadequate must be rules be for a more complex system. He says we cannot escape the contingencies of life by an all encompassing algorithmic system, (such as a system that could do all the proposed off site computer would do for the inquiring physician's questions.)Maybe the findings of Goedel et al do not preclude what the authors propose and maybe I don't understand what they hope for.But it seems like what they write about leads us to a consideration of what IT can do, ie artificial intelligent systems(AI) or expert systems and we then run head on into the arcane debate over strong and weak AI, an area where I have no credentials.
Already computers have revoluntionized medicine and there is more to come.PDAs are great,having the PDR and drug interactions, and antibiotics guidelines and the ATP risk equations really have made my work easier and better and who can practice without ready access to Google.Wireless systems in hosptials are already giving staff real time access to lab data etc.But the day when you can simply ask your PDA what to do and a computer program will do what the Cochrane group does now (by using computers and humans) and much more is not here yet and some of us believe that even in theory it will never be.It is a quantum leap from computers regurgitating pre-digested guidelines and searching for articles to "reading" articles, analyzing them and answering questions in real time.Knowledgeable, intelligent savy humans are currently needed for that job and they would be not be able to provide the instant answers that they authors imply would be part of their scheme.Will they someday be smart enough to design machines that can replace them?
Much has been made of the explosion of medical information and the lack of application of same to the trench-dwelling docs.Fontelo and Ackerman posting on the 9/21/04 issue of Medscape in an article entitled "Evidence Based Medicine needs easy-to-use handheld tools for universal application" propose a solution.
A clinician would ask a question ( Dx, Rx, prognosis, whatever) on his PDA and a remote computer would take over. The literature would be reviewed,software would scan the articles,apply algorithms and "rules of EBM",evaluate it all and provide a conclusion back to the doctor.When I read this I thought are we really close to having an "expert system" that would replace the experience and expertise of human expert in various medical disciplines and be able to solve problems in general? ( I realize there are various "limited" (specific application) expert systems in existence but the authors seems to be talking about a general problem solver.) Could we ever have such a thing? It turns out that there is considerable difference of opinion regarding the second question.
In 1928 David Hilbert challenged the mathematical world to devise a procedure to devise the truth or falsity of every arithmetic statement.In 1931, Kurt Goedel demonstrated that this could not be done. A simplified version of Goedel's theorem is "arithmetic is not completely formalizable". The work of Turing and Chaitin enlarged this thought to " There is no systematic way of deciding if a given proposition is decidable or not".
Goedel showed that a system as relatively simple as arithmetic could not be axiomatized or made into a set of rules or algorithms to prove all of the truth within the system.
There is a persuasive body of thought that extrapolates from that. Roger Penrose has said human insight cannot be reduced to an algorithm. William Barrett ( Author of the Illusion of Technique) has argued that if the rules for a relatively simple system such as arithmetic are not adequate to determine the truth of some true statements, how much more inadequate must be rules be for a more complex system. He says we cannot escape the contingencies of life by an all encompassing algorithmic system, (such as a system that could do all the proposed off site computer would do for the inquiring physician's questions.)Maybe the findings of Goedel et al do not preclude what the authors propose and maybe I don't understand what they hope for.But it seems like what they write about leads us to a consideration of what IT can do, ie artificial intelligent systems(AI) or expert systems and we then run head on into the arcane debate over strong and weak AI, an area where I have no credentials.
Already computers have revoluntionized medicine and there is more to come.PDAs are great,having the PDR and drug interactions, and antibiotics guidelines and the ATP risk equations really have made my work easier and better and who can practice without ready access to Google.Wireless systems in hosptials are already giving staff real time access to lab data etc.But the day when you can simply ask your PDA what to do and a computer program will do what the Cochrane group does now (by using computers and humans) and much more is not here yet and some of us believe that even in theory it will never be.It is a quantum leap from computers regurgitating pre-digested guidelines and searching for articles to "reading" articles, analyzing them and answering questions in real time.Knowledgeable, intelligent savy humans are currently needed for that job and they would be not be able to provide the instant answers that they authors imply would be part of their scheme.Will they someday be smart enough to design machines that can replace them?
Sunday, March 13, 2005
Good News for skeptics of Disease management Programs
Dr.Autumn Galbreath, of University of Texas Medical School in San Antonio, presented a paper at the American Heart Association meeting which gave little for advocates of these programs to be pleased about.
For the beginning I thought this "movement" was basically fluff and hype and a plan for managed care organizations to make money by saving money for the large insurers and HMOs.Drug companies also promoted these programs which seemed to me to be a thinly disguised promotion program for various of their products.
Dr.Galbreath's findings indicate that there is no savings.This study was large and was a Randomized trial, attributes that apparently most if not all of previous papers that hyped the programs did not share.
There was no difference in hospitalizations,procedures, office or ER visits or medication cost.There was a slightly longer survival in the disease management group versus the control group in this 18 month study involving 1,069 patients. The mechanism by which this occurred is not known.I suppose if some physicians were not aware of the state of the art treatment, then contact with the case manage nurse might have brought about a beneficial alteration in some patient's care.But this type study is too coarse grained to tease out that level of detail.
When and if I get CHF or asthma or Parkinsons disease, I want to be managed by a experienced cardiologist,pulmonary doc, or neurologist whose time I don't want wasted by phone call from a nurse manager armed with guidelines and flow sheets and a good telephone voice.
For the beginning I thought this "movement" was basically fluff and hype and a plan for managed care organizations to make money by saving money for the large insurers and HMOs.Drug companies also promoted these programs which seemed to me to be a thinly disguised promotion program for various of their products.
Dr.Galbreath's findings indicate that there is no savings.This study was large and was a Randomized trial, attributes that apparently most if not all of previous papers that hyped the programs did not share.
There was no difference in hospitalizations,procedures, office or ER visits or medication cost.There was a slightly longer survival in the disease management group versus the control group in this 18 month study involving 1,069 patients. The mechanism by which this occurred is not known.I suppose if some physicians were not aware of the state of the art treatment, then contact with the case manage nurse might have brought about a beneficial alteration in some patient's care.But this type study is too coarse grained to tease out that level of detail.
When and if I get CHF or asthma or Parkinsons disease, I want to be managed by a experienced cardiologist,pulmonary doc, or neurologist whose time I don't want wasted by phone call from a nurse manager armed with guidelines and flow sheets and a good telephone voice.
Thursday, March 10, 2005
Women's Health Study,low dose aspirin, revisted
In my March 8th blog I questioned whether the AHA asa guidelines were still appropriate in light of the WHS's less than positive findings regarding primary prevention of cardiovascular disease with aspirin. Overall, there was no reduction in heart attack risk.Table 1 in the NEJM article indicates that only 3.9% of study participants had a Framingham Risk Score of 10% or higher which is the AHA threshold for recommendation for aspirin. So most of the participants would not have been recommended aspirin according to AHA guidelines. 84 % of women had a risk score of less than 5 %. The finding of of no decrease in risk in a group of women the majority of which did not "need" asa according to AHA, if anything, tends to validate the AHA recommendations.The article's tabulations do not display the percentage of women with a Framingham risk from 6-10%, but 11.8 % were from 5.0 to 9.9, so somewhere around 10% would have been recommended aspirin according to the more proactive USPHS guidelines. A similar argument seems to apply to those guidelines.
My spin on this is that the WHS study should not invalidate the AHA guidelines.In younger women, whose risk profile is less than 5%, I believe they should be counseled that the WHS study did show a fairly small decrease in stroke risk but that would have to be balanced by the demonstrated increase in GI bleeding.
My spin on this is that the WHS study should not invalidate the AHA guidelines.In younger women, whose risk profile is less than 5%, I believe they should be counseled that the WHS study did show a fairly small decrease in stroke risk but that would have to be balanced by the demonstrated increase in GI bleeding.
Wednesday, March 09, 2005
JAMA article:Computerized doctor order system shown to facilitate errors
The March 9, 2005 issue of JAMA published an article with evidence that CPOE (Computerized physician order entry) systems may actually have the effect of increasing mediations errors. The authors investigated the effects of a particular system at one teaching hospital. Ordering medication in a hospital is a complex, multi-faceted process and reliance on a system that oversimplifies and does not capture important subtleties and particulars is likely to cause more harm than good.The authors describe numerous, potentially harmful, glitches in the system (they describe 22 situations in which the system increased the likelihood of error and instances of house staff and nurses having to "work around" the system).
An editorial has an excellent discussion on the conceptual disconnect between clinical work and CPOE and decision support systems. It suggests that what clinicians really do is "sense making"-i.e. making sense of the clinical picture rather than simplified, conceptualized "decision making".It is not easy to devise a computer system to "make sense" of complex,often ambiguous clinical elements if for no other reason than it is hard to make sense of any given particulars let alone make an abstract meta-plan to solve clinical problems generally.
One aspect not mentioned is the tendency of people to abdicate their responsibility for the activity to the computer system. For example, if they believe a program is monitoring drug dose, drug interactions, drug appropriateness etc, there is a tendency to ignore and not take control of those considerations.
The editorial's subtitle is "Waiting for Godot". If we believe that all of the problems of medicine can be managed by computer programs, we will be waiting for something that never arrives like the tramps in Beckett's play.
An editorial has an excellent discussion on the conceptual disconnect between clinical work and CPOE and decision support systems. It suggests that what clinicians really do is "sense making"-i.e. making sense of the clinical picture rather than simplified, conceptualized "decision making".It is not easy to devise a computer system to "make sense" of complex,often ambiguous clinical elements if for no other reason than it is hard to make sense of any given particulars let alone make an abstract meta-plan to solve clinical problems generally.
One aspect not mentioned is the tendency of people to abdicate their responsibility for the activity to the computer system. For example, if they believe a program is monitoring drug dose, drug interactions, drug appropriateness etc, there is a tendency to ignore and not take control of those considerations.
The editorial's subtitle is "Waiting for Godot". If we believe that all of the problems of medicine can be managed by computer programs, we will be waiting for something that never arrives like the tramps in Beckett's play.
Tuesday, March 08, 2005
Women's Health Study: Low dose aspirin-No overall decrease in myocardial infarctions,modest decrease stroke risk and increased risk of GI bleeding
Until yesterday it was generally believed that aspirin decreased heart attack risk and did little to primarily prevent stroke.But that wisdom was derived from trials in which the subjects were predominately men.The most recent data from the WHS seems to say the reverse is true in women-well not exactly. Overall no decrease in MI in women, except for those 65 or older in whom there was a 34 % decrease.Overall there was a 17 % decrease in stroke relative risk (RR).The changes in RR were small in general. The largest deviation from a RR of 1 was in the side effects side of the ledger with GI bleeding that required transfusion having a RR of 1.4.
If we consider magnitude of RR and biological plausibility as determinants of significance, the most significant finding of the trial may be that even low dose aspirin (100 mg every other day) can cause significant GI bleeding. This coupled with no decrease in heart attack risk ( which is largely why many women take aspirin and were told to take aspirin) and only a modest possible decrease in stroke risk (RR =0.83,p=0.04) leads me to question whether the current guidelines of the AHA and the PHSTF should still be -as the lawyers say-" good law". It seems reasonable to still be somewhat proactive for asa prophylaxis in women 65 and over who meet the risk assessment criteria of either group. Once again we see why guidelines are written on paper and not granite.Once again we see if we judge docs on whether they adhere to guidelines as opposed to being more current that the guidelines we convict them on faulty evidence.
If we consider magnitude of RR and biological plausibility as determinants of significance, the most significant finding of the trial may be that even low dose aspirin (100 mg every other day) can cause significant GI bleeding. This coupled with no decrease in heart attack risk ( which is largely why many women take aspirin and were told to take aspirin) and only a modest possible decrease in stroke risk (RR =0.83,p=0.04) leads me to question whether the current guidelines of the AHA and the PHSTF should still be -as the lawyers say-" good law". It seems reasonable to still be somewhat proactive for asa prophylaxis in women 65 and over who meet the risk assessment criteria of either group. Once again we see why guidelines are written on paper and not granite.Once again we see if we judge docs on whether they adhere to guidelines as opposed to being more current that the guidelines we convict them on faulty evidence.
Monday, March 07, 2005
Retired Doc's Suggestions for Medical Curriculum-Part 4 : anti-hubris course
I do not have all the content of this course prepared yet but I do have the sense of it and some great quotes.
The sense of it is from the writings of Norton Hadler and much of it can be found in his article on various European backache compensation systems (JOM,vol 31, pg 823, 1989). In it he speaks of clinical truth which he distinguishes from scientific truth-although scientific truth must be utilized in obtaining clinical truth-and from legal "truth"-which is incidental to settling the dispute at hand. Clinical truth is or is derived from a contract between a physician and a patient and is based on trust.He said it better than I can and his article would be required reading in this "anti-hubris" course.
Our approaches are provisional and based on fragmentary information and when I think about the algorithms and paradigms that are in our tool boxes, Boris Pasternak's quote appears as an emphatic "yes..but", "What is laid down, ordered, factual, is never enough to embrace the whole truth:Life always spills over the rim of every cup". Karl Popper said " we know a great deal but our ignorance is sobering and boundless...all things are insecure and in a state of flux".
All of this does not mean that we can't pull out the latest guidelines from whomever in our PDA and see if that does or does not apply to the case at hand.But the operative words there are "see if it applies to the case at hand." The experienced physician has one- at least one-advantage over the younger one, he has seen the 180 degree changes in a given algorithm or clinical guideline. Plaintiff attorneys are fond of saying to the expert witnesses ,"Doctor,were you wrong then or are you wrong now" in the situation where there is an apparent contradiction.
Medical students need to know-in regard to the "factual knowledge" imparted to them- that while that material may be the very best that the very best of minds can determine at this time that they need to stay tuned because all of that may change at any time and the physician will have to decide what to do for the patient even before the next authoritative pronouncement is prepared.In that decision she will have to call upon her knowledge,expertise and judgement and the patient's values and views and do her job the way physicians have for many years before guidelines were part of medical language and work with the patient for their particular clinical truth.
addendum: spelling corrections made 6/15/15
The sense of it is from the writings of Norton Hadler and much of it can be found in his article on various European backache compensation systems (JOM,vol 31, pg 823, 1989). In it he speaks of clinical truth which he distinguishes from scientific truth-although scientific truth must be utilized in obtaining clinical truth-and from legal "truth"-which is incidental to settling the dispute at hand. Clinical truth is or is derived from a contract between a physician and a patient and is based on trust.He said it better than I can and his article would be required reading in this "anti-hubris" course.
Our approaches are provisional and based on fragmentary information and when I think about the algorithms and paradigms that are in our tool boxes, Boris Pasternak's quote appears as an emphatic "yes..but", "What is laid down, ordered, factual, is never enough to embrace the whole truth:Life always spills over the rim of every cup". Karl Popper said " we know a great deal but our ignorance is sobering and boundless...all things are insecure and in a state of flux".
All of this does not mean that we can't pull out the latest guidelines from whomever in our PDA and see if that does or does not apply to the case at hand.But the operative words there are "see if it applies to the case at hand." The experienced physician has one- at least one-advantage over the younger one, he has seen the 180 degree changes in a given algorithm or clinical guideline. Plaintiff attorneys are fond of saying to the expert witnesses ,"Doctor,were you wrong then or are you wrong now" in the situation where there is an apparent contradiction.
Medical students need to know-in regard to the "factual knowledge" imparted to them- that while that material may be the very best that the very best of minds can determine at this time that they need to stay tuned because all of that may change at any time and the physician will have to decide what to do for the patient even before the next authoritative pronouncement is prepared.In that decision she will have to call upon her knowledge,expertise and judgement and the patient's values and views and do her job the way physicians have for many years before guidelines were part of medical language and work with the patient for their particular clinical truth.
addendum: spelling corrections made 6/15/15
Thursday, March 03, 2005
Annals Internal Medicine cites need for better information system but ignores ignorance of house staff in published case history
In the March 1, 2005 Annals of Internal Medicine the "Improving Patient Care"section deals with a case in the discussion about which the author emphases the problems associated with lack of follow up by and "hand offs" to physicians. A 70 year old alcoholic presents with cough and weight loss.His chest xray showed "RUL pneumonia with a dense infiltrate with extensive fibronodular disease and upper lobe volume loss. No tb studies were done and the patient was discharged on antibiotic therapy.Through a series of lapses it is some 2 months later and after the patient was sent to and then sent back from a nursing home before the diagnosis of tb was finally made and treatment started, but apparently too late. He died of respiratory failure shortly thereafter.
The author discusses various methods to ensure followup . He does not mention, however, a well established method of obtaining follow up of lab tests. It is the RPU. This stands for responsible physician unit. The physician caring for the patient is responsible for finding out what the results of the tests.
The clinical picture and chest film shouted r/o tb. The narrative of sequential foul-ups is disturbing and the author's comments about the important of systems to ensure that reports are seen by doctors are appropriate. However, the original "fumble" occurred because of the apparent ignorance of the medicine resident ( I assume they were medical residents). While the subsequent events are alarming-and may be mitigated or eliminated by appropriate systems and safeguards- the lack of basic clinical knowledge demonstrated in this case is astonishing.
I cannot believe even a first year resident would not think "rule out tb" when he encounters an alcoholic with cough, weight loss and a upper lobe infiltrate. (the initial radiologist's report displays a high level of cluelessness also by not mentioning tb as a diagnostic possibility) Even if the resident was ignorant about tb,where was the attending?Not doing tb tests in this type case is comparable to not doing biomarkers for heart damage in er patients with chest pain.
At the county hospital at which I trained that patient's arrival would have lead to the intern, resident and medical student spending the next few hours getting sputum samples and doing AFB stains. Even if the smears were negative the patient would have likely been hospitalized in a contagion unit to rule out tbc given the very high "pre-test" probability of tb.
The author speaks of algorithms for this and algorithms for that. What is the nature of the algorithm to prevent house officers from harming patients based on their ignorance? In a earlier - less politically correct era- in regard to the first house office who saw the patient- we would have asked where did he go to med school.
The author discusses various methods to ensure followup . He does not mention, however, a well established method of obtaining follow up of lab tests. It is the RPU. This stands for responsible physician unit. The physician caring for the patient is responsible for finding out what the results of the tests.
The clinical picture and chest film shouted r/o tb. The narrative of sequential foul-ups is disturbing and the author's comments about the important of systems to ensure that reports are seen by doctors are appropriate. However, the original "fumble" occurred because of the apparent ignorance of the medicine resident ( I assume they were medical residents). While the subsequent events are alarming-and may be mitigated or eliminated by appropriate systems and safeguards- the lack of basic clinical knowledge demonstrated in this case is astonishing.
I cannot believe even a first year resident would not think "rule out tb" when he encounters an alcoholic with cough, weight loss and a upper lobe infiltrate. (the initial radiologist's report displays a high level of cluelessness also by not mentioning tb as a diagnostic possibility) Even if the resident was ignorant about tb,where was the attending?Not doing tb tests in this type case is comparable to not doing biomarkers for heart damage in er patients with chest pain.
At the county hospital at which I trained that patient's arrival would have lead to the intern, resident and medical student spending the next few hours getting sputum samples and doing AFB stains. Even if the smears were negative the patient would have likely been hospitalized in a contagion unit to rule out tbc given the very high "pre-test" probability of tb.
The author speaks of algorithms for this and algorithms for that. What is the nature of the algorithm to prevent house officers from harming patients based on their ignorance? In a earlier - less politically correct era- in regard to the first house office who saw the patient- we would have asked where did he go to med school.
New Crestor warning material-Reason 7988 to not prescribe a medication when it first comes out
I continue to be puzzled how often seasoned physicians prescibe relatively new drugs soon after their introduction. Crestor certainly looked good ( marked lowering of LDl, seemed to offer the muscle safety of Pravachol and less concern with interactions) and for the most part still does but FDA has issued a warning and wants us to know that 1) you have to use less in Asians and 2) there may be something to the kidney toxicity issue .
Wednesday, March 02, 2005
Retired Doc's Suggestions for Medical Curriculum-Part 3, Method acting?
I cannot take credit for this suggestion.E.B. Larson and X. Yao suggested this in the March 2, 2005 issue of JAMA. Method Acting type techniques were suggested to increase empathy in the doctor-patient relationship.I was not fortunate enough to have formal method acting training in med school.Several months ago a patient who I had attended for several years was found to have a large right upper lobe mass. Calling her into the office, to discuss the finding and the options etc was an emotionally draining exercise.I did not have to imagine and practice ahead of the meeting what it would be like to have cancer to feel for that person.(This rehearsal is part of the acting technique according to the authors.) Several years ago, a thoracic surgeon called me in tears to tell me that he was unable to resect a sarcoma that had invaded the kidney and vena cava in a 38 year old man who had two young children.The authors say " teaching acting to physicians also enriches their reservoir of human experience {and} ironically, can help them achieve detachment when they become too engaged in a patent's experience" I guess that means that if the surgeon and I had acting training we could have appeared to really care but not actually "get involved".This article really left me mind-boggled;I would be interested in what other physicians think of this. By the way, I don't really suggest that method acting be added quite yet to med school curriculum. Let us wait on the evidence. I believe there is something in a human's hard wiring or genes or something that makes people( at least those without autism) have empathy. I recall reading that even very young children can distinguish between a real smile and a fake one. The ability of our ancestors to detect emotions in others is part of the survival package that was passed down through the centuries. My recollection of myself and peers as house officers in a large county hospital reveals young people dealing with incredible amounts of human pain and misery and we did develop a shell of callousness and cynicism to survive it all but most of us overgrew that.
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