Our cat "Sweetie" counteracts the deleterious effects of stress and thereby saves lives. This is self evident.Sweetie is the oldest known name for a cat, as it was found in an Egyptian tomb along with the embalmed cat that went by that name. Our Sweetie has expressed a preference for cremation.
Google hits for evidence based governance: 5,320, vs 2,250,000 for evidence based medicine. I'd like to see more interest in evidence based governance. But I'll write on Evidence Based Medicine this time.
The Great Health Care Debate grinds on. And on and on . . . Let us hope that our congress and president will turn out to be like the "mills of God (that) grind slow, but they grind exceeding fine." Health Care is obviously a right of the citizen in an advanced society. Get sick in Italy and you are taken to an Italian hospital, and cared for. You will not even meet the billing/admission officer (who is the first person you will see in our American hospitals). My wife just spent a week in Cardiac Intensive Care in hospitals in Sorrento and Sarno, regio di Napoli. I am a doctor and noticed the difference between our way and the Italian way. We left the hospital without any bill or statement whatsoever. Medicines for a month cost 40 USD. One of the same medicines cost 189 USD a month later, back home--I switched that one to a generic equivalent c/o Walmart and asked Walgreens to refund the money. I told Walgreens they should have told my wife that the Italian version of an ACE inhibitor was prohibitively expensive but that inexpensive alternatives were available here in America. (Some of our high cost is avoidable, but then not all Americans are physicians or spouses of physicians.)
The Great Health Care Debate grinds on. And on and on . . . Let us hope that our congress and president will turn out to be like the "mills of God (that) grind slow, but they grind exceeding fine." Health Care is obviously a right of the citizen in an advanced society. Get sick in Italy and you are taken to an Italian hospital, and cared for. You will not even meet the billing/admission officer (who is the first person you will see in our American hospitals). My wife just spent a week in Cardiac Intensive Care in hospitals in Sorrento and Sarno, regio di Napoli. I am a doctor and noticed the difference between our way and the Italian way. We left the hospital without any bill or statement whatsoever. Medicines for a month cost 40 USD. One of the same medicines cost 189 USD a month later, back home--I switched that one to a generic equivalent c/o Walmart and asked Walgreens to refund the money. I told Walgreens they should have told my wife that the Italian version of an ACE inhibitor was prohibitively expensive but that inexpensive alternatives were available here in America. (Some of our high cost is avoidable, but then not all Americans are physicians or spouses of physicians.)
Well, until we come to grips with the high cost of medication, the high cost of medical technology, the high cost of defensive medicine, and the high cost of life styles deleterious to one's health, we and our Great Debate will grind on without ginding exceeding fine. Let's look at the matter of Evidence Based Medicine--small "p" panacea for Health Care savings in the current planning.
Evidence Based Medicine is an attempt to upregulate the science of medicine and downregulate the art of medicine. This makes good sense and fits our modern mind set in the Age of Information. Add translational research and the widespread use of high quality medical studies and we will answer the perennial questions one by one, and save time and money by getting the diagnosis and proper, effective treatment on the first try. It used to be that medicine was described as an art and a science. The aim of Evidence Based Medicine is to hasten the day that medicine is described as a science.
There are some problems inherent in this venture. For one thing, even though we humans have a scant 30,000 genes and seem to constitute a single species with nearly identical DNA--we are within a percent or two of having the same DNA as chimpanzees--we do not react the same to threats, external or internal; toxins, medicines, the passage of time, diet, and so forth. Everyone has heard of someone's grandfather who smoked like the proverbial chimney for eighty years and died in his sleep at ninety-two. And who never went to a doctor, either. My mother was in her ninetieth year when she told me that she did not like to see doctors because all the people doing so were ill. Structuring what we call randomized prospective high quality studies that have sufficient intrinsic statistical power to resolve clinically important questions is easy on paper. Conducting the study without breaks in protocol because either the patient or the clinician departed from the script is difficult. The studies of cancer treatment must span years and years to accrue enough patients to yield solid answers to the original question. But treatments and styles change over time and so does the cast of investigators. Such basic questions as "does screening men for possible prostate cancer save lives? or does such screening translate to early diagnosis? and does early diagnosis of prostate cancer save lives?" seem straight forward enough. Maybe intelligent lay persons doubt a need to study such questions. Humor me, those issues and thousands of others have not been laid to rest.
Evidence Based Medicine is an attempt to upregulate the science of medicine and downregulate the art of medicine. This makes good sense and fits our modern mind set in the Age of Information. Add translational research and the widespread use of high quality medical studies and we will answer the perennial questions one by one, and save time and money by getting the diagnosis and proper, effective treatment on the first try. It used to be that medicine was described as an art and a science. The aim of Evidence Based Medicine is to hasten the day that medicine is described as a science.
There are some problems inherent in this venture. For one thing, even though we humans have a scant 30,000 genes and seem to constitute a single species with nearly identical DNA--we are within a percent or two of having the same DNA as chimpanzees--we do not react the same to threats, external or internal; toxins, medicines, the passage of time, diet, and so forth. Everyone has heard of someone's grandfather who smoked like the proverbial chimney for eighty years and died in his sleep at ninety-two. And who never went to a doctor, either. My mother was in her ninetieth year when she told me that she did not like to see doctors because all the people doing so were ill. Structuring what we call randomized prospective high quality studies that have sufficient intrinsic statistical power to resolve clinically important questions is easy on paper. Conducting the study without breaks in protocol because either the patient or the clinician departed from the script is difficult. The studies of cancer treatment must span years and years to accrue enough patients to yield solid answers to the original question. But treatments and styles change over time and so does the cast of investigators. Such basic questions as "does screening men for possible prostate cancer save lives? or does such screening translate to early diagnosis? and does early diagnosis of prostate cancer save lives?" seem straight forward enough. Maybe intelligent lay persons doubt a need to study such questions. Humor me, those issues and thousands of others have not been laid to rest.
But Evidence Based Medicine should answer such questions and let us move on to thornier issues like "do intracoronary stents save lives?" Believe it or not, one can find expert opinion on both sides of the above questions, each of the questions. This is baffling for patients and discouraging for their doctors. There is only one arena in which there is absolute certainty: court of law/medical malpractice/failure to diagnose cancer/late stage prostate cancer. Trial lawyers are not seeking truth, though. They are seeking settlement money. Theirs is all art and no science. But I digress and I apologize.
First let's look at definitions for Evidence Based Medicine. Then let's look at some recent reports in the fine Journal of Evidence Based Medicine.
NHS QIS 2005 (definition courtesy of the National Health Service of Scotland)
Evidence-based clinical practice is an approach to decision-making in which the clinician uses the best evidence available, in consultation with the patient, to decide upon the option which suits the patient best.
NHS Quality Improvement Scotland 2005
Evidence-based practice:
is integration of best research evidence with clinical expertise and patient values
Sackett et al. 2000
First let's look at definitions for Evidence Based Medicine. Then let's look at some recent reports in the fine Journal of Evidence Based Medicine.
NHS QIS 2005 (definition courtesy of the National Health Service of Scotland)
Evidence-based clinical practice is an approach to decision-making in which the clinician uses the best evidence available, in consultation with the patient, to decide upon the option which suits the patient best.
NHS Quality Improvement Scotland 2005
Evidence-based practice:
is integration of best research evidence with clinical expertise and patient values
Sackett et al. 2000
The National Mental Health Association is committed to promoting the appropriate use of medications for all illnesses, including mental illnesses. NMHA subscribes to the common definition of evidence based medicine as the integration of the best research evidence with clinician expertise and patient values, and has grave concerns about public policies and protocols that fail to account for this definition. Below please find links to more information on major research findings on the effectiveness of mental health medications as well as issue briefs on EBM more broadly.
The best available evidence, modified by patient circumstances and preferences, is applied to improve the quality of clinical judgements.
McMaster Clinical Epidemiology Group 1997
Some representative studies in this literature:
Evidence-Based Medicine 2009;14:105; doi:10.1136/ebm.14.4.105
Copyright © 2009 by the Royal Society of Medicine.
THERAPEUTICS
Periodic screening with prostate-specific antigen testing reduced mortality from prostate cancer
The first 150 words of the full text of this article appear below.
STUDY DESIGN
Design:
randomised controlled trial (European Randomised Study of Screening for Prostate Cancer [ERSPC]). Current Controlled Trials ISRCTN49127736 [controlled-trials.com] .
Allocation:
not concealed, at least in part.* In 3 countries, randomisation occurred before consent was obtained; in the other 4 countries, only consenting participants were randomised, but allocation concealment was unclear.
Blinding:
blinded (outcome adjudication committees).*
STUDY QUESTION
Setting:
7 European countries.
Participants:
162 243 men 55–69 years of age (mean age 61 y). Some countries also enrolled men outside of this age range, but they were not included in this analysis. Men with a previous diagnosis of prostate cancer were excluded.
Intervention:
screening, on average, once every 4 years with prostate-specific antigen (PSA) testing (n = 72 890) or usual care (n = 89 353). In most centres, a serum PSA concentration >3.0 ng/ml was considered to be an indication for biopsy or additional diagnostic tests. Men diagnosed with prostate cancer were treated according to local standard practice.
Outcomes:
. . . [Full text of this article]
So, using the readily available blood test, PSA or prostate specific antigen, one can find prostate cancer earlier and the mortality or death rate was reduced. This suggests that there is Evidence available for the Basis of Medical practice of screening men with PSA testing. That should help the clinician with good decision making. Ah, but here comes another article reporting another study aiming at answering the same question:
Evidence-Based Medicine 2009;14:104-105; doi:10.1136/ebm.14.4.104
Copyright © 2009 by the Royal Society of Medicine.
THERAPEUTICS
Annual screening for prostate cancer did not reduce mortality from prostate cancer.
The first 150 words of the full text of this article appear below.
STUDY DESIGN
Design:
randomised controlled trial (Prostate, Lung, Colorectal, and Ovarian [PLCO] Cancer Screening Trial). ClinicalTrials.gov NCT00002540 [ClinicalTrials.gov] .
Allocation:
{concealed}*.
Blinding:
blinded (outcome adjudication committee).
STUDY QUESTION
Setting:
10 centres in the USA.
Participants:
76 693 men 55–74 years of age. Exclusion criteria included history of PLCO cancer, current cancer treatment, and >1 prostate-specific antigen (PSA) test in 3 years.
Intervention:
annual screening with PSA testing for 6 years and digital rectal examination for 4 years (n = 38 343) or usual care that might include screening (n = 38 350). A serum PSA concentration >4.0 ng/ml was considered to be a positive result. Men and their primary physicians were informed of test results; they decided on further diagnostic evaluation and treatment, according to standard practice.
Outcomes:
incidence of and mortality from prostate cancer at 7 years. {The trial had >90% power to detect a 20% relative reduction in prostate cancer mortality.}*
Follow-up period:
median 12 years.
Participant follow-up:
98% at 7 years (intention-to-screen analysis).
MAIN RESULTS
. . . [Full text of this article]
Steven E Canfield
University of Texas Medical School at Houston, Houston, Texas, USA
So, screening did not reduce mortality of prostate cancer. Opposite conclusions, same issue of the same journal, same clinical question. This illustrates the problem with Evidence Based Medicine: great idea but needs more work.
It is not ready for prime time yet. There is still ample room for art in the "medicine is an art and a science." In fact, look at those definitions again and see if there is not a bit of hedging there. The definitions seem to call for a measure of clinical art of medicine in applying the best available evidence. But perhaps prostate cancer is aiming too high. Let's pick something really basic, like does a vaccination that most young people and many older people get, the pneumococcal vaccine, do any good? This report appeared in the same issue as the two prostate cancer screening reports:
Evidence-Based Medicine 2009;14:109; doi:10.1136/ebm.14.4.109
Copyright © 2009 by the Royal Society of Medicine.
THERAPEUTICS
Review: pneumococcal vaccination is not effective for preventing pneumonia, bacteraemia, bronchitis, or mortality
The first 150 words of the full text of this article appear below.
QUESTION
Is pneumococcal vaccination effective for various clinical outcomes in adults?
REVIEW SCOPE
Included studies compared pneumococcal polysaccharide vaccine with placebo, other vaccines, or no intervention (control). Studies of children; evaluation of antibody responses only or pneumococcal polysaccharide vaccines as a booster after conjugate pneumococcal vaccine; or animal, laboratory, and observational intervention studies were excluded. Outcomes were definitive pneumococcal pneumonia, presumptive pneumococcal pneumonia, all-cause pneumonia, bacteraemia or invasive pneumococcal disease, bronchitis, all-cause mortality, pneumonia mortality, and mortality from pneumococcal infection.
REVIEW METHODS
Medline (1966 to May 2007), EMBASE/Excerpta Medica (1974 to May 2007), Cochrane Central Register of Controlled Trials, Latin American and Caribbean Health Sciences Literature, Indian Medlars Centre, African Index Medicus, and reference lists were searched for randomised controlled trials (RCTs) or quasi-RCTs. 22 trials (n = 101 507) met the selection criteria.
MAIN RESULTS
Meta-analysis showed that pneumococcal vaccination did not differ from control for definitive pneumococcal pneumonia (table). The pneumococcal vaccination group . . . [Full text of this article]
Jennie Johnstone
McMaster University Hamilton, Ontario, Canada
Now, that's definitive and would guide practice. Except that an attending physician who neglected to offer the pneumococcal vaccine to his or her Florida patient would be on the wrong side of expert testimony were something bad to happen to that patient. The doctor would be right not to have offered or counseled for the vaccination but the jury would never see that journal report. We need more than just good clear data, we need to rework the medical litigation system in our country. At least study this problem and its high costs.
Any physician who has practiced medicine long enough to have mastered the art of medicine will welcome more science with open arms, including Evidence Based Medicine. But the present state-of-the-art of Evidence Based Medicine, if I can play on words here, is not sufficient to guide much of what goes on in Health Care, far less promise great savings early on. This is something we should invest in now so that the future will be better for patients and doctors and whoever pays for all this. Don't count on Evidence Based Medicine to save money in today's Health Care.
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