Friday, September 19, 2014

Are pediatric football concussions different from high school and college head trauma?

It would be nice to think so and a 2012 study by Maugans et al provides some data ( see here for full text) which suggests it may be the case. Eight young football players  (in a study of 12 athletes ) were studied early post concussion and at two subsequent times.The football players ages were : two 12 year olds,one thirteen year old,three 14 years olds and 2 aged 15.

Multiple Imaging techniques were used . The diffusion tensor imaging (TDI) tests were normal  as were conventional MRIs,and proton Magnetic resonance spectroscopy.

 This is in contrast to two o studies in college and two studies in high school football players, none of whom experienced a concussion ,which showed decreased fractional anisotropy (FA) in certain white matter tracts and/or functional MR  abnormality in the dorso-lateral frontal cortex.See here for Talavage's article regarding functional MR changes in high school players.

.Further one study (Bazarian,  (see here for full text)) showed persistence of the TDI changes six months after the college football  season ended. Here is the authors' summary:

" we have demonstrated that a single football season of RHIs  [ repeated head impacts]without clinically evident concussion resulted in WM changes on DTI. These DTI changes correlated with multiple helmet impact measures and persisted despite 6 months of no-contact rest. This lack of WM recovery could potentially contribute to progressive, cumulative WM damage with subsequent RHI exposures. If this relationship is confirmed in longitudinal studies, efforts to limit the development of RHI-related WM changes by monitoring helmet impact measures, and further elucidation of modifiable factors that may influence WM recovery, could mitigate the long-term risk of CTE [chronic traumatic encephalopathy]."

Maugan's group did demonstrate decrease in  cerebral blood flow ( CBF) in the concussed subjects which tended to return to normal over a few weeks.The authors' conclusion;

"Pediatric SRC [sports related concussion] is primarily a physiologic injury, affecting CBF significantly without evidence of measurable structural, metabolic neuronal or axonal injury."

What might account for the apparent differences in brain scan results in the college and high school players and the younger athletes studied by Maugan.

Possibly the younger players have a  threshold for CNS symptoms given a head blow  that is lower that the  threshold for whatever tissue changes takes place that are manifest in DTI findings.

While it has been shown that   some head  impact levels ( as measured by accelerometers in helmets) in  youth football may approach those demonstrated in high school and college they are on average lower.(see here for full text of article by Cobb, 2013 for detailed data of head impact forces ) Further the total number of impacts in a season of high school or college practice and game time may be considerably more than in a season of youth football and it may be the cumulative effects is what drives the DTI changes and whatever underlying tissue changes.Also as the years pile up, youth football and then high school and then college and then for a few professional football the total  number of head impacts grows and it may be the long term cumulative effect of multiple sub-concussive plus the occasional concussive blow that  leads to CTE in a minority of football participants. 

Although parents may feel some reassurance from Maugan's research, there is little to be reassured about in  the brain imaging studies of high school and college football players following a concussion free season as well as those studies on players with concussions.There is certainly little reassurance offered in this lengthy and detailed  article from Rolling Stone.

Thursday, September 18, 2014

Is the "triple aim of health care" analogous to the dual mandate of the Federal Reserve

Well, it can be argued that they are both unachievable and the execution of their aims and goals will require wise men such as the "Men of system" discussed by Adam Smith.

In 1977,  Congress, having accepted at least part of the theory of Keynesian economics, amended The Federal Reserve Act, with the passage of the Humphrey-Hawkins Act, stating the monetary policy objectives of the Federal Reserve as:

"The Board of Governors of the Federal Reserve System and the Federal Open Market Committee shall maintain long run growth of the monetary and credit aggregates commensurate with the economy's long run potential to increase production, so as to promote effectively the goals of maximum employment, stable prices and moderate long-term interest rates."

In other words, the Federal Reserve System is tasked by law to control inflation and maximize employment in spite of the fact, given the tools to which the system has access, that the two mandates might be incompatible.

Dr Don Berwick speaks of medicine's "triple aim"  ( as envisioned by the Institute for Health Care Improvement)  : Population health,the patient's experience and the per capita cost.The collective medicinal "we" should strive  to improve population health,the individual patient's experience and reduce the per capita cost.

I am reminded of a series of  articles in JAMA in 199 4by Dr. David Eddy ( "Rationing resources while improving quality" ) in which he promised to provide a means to improve quality of medical care and reduce costs. This was to be done by utilizing a utilitarian cost calculus.The idea was to do what was best for the group,the health care collective statistically, even though he admitted that in such a system there would be winners and losers but the utility to the former would out way the dis utility to the minority. Of course in this scheme quality had to be defined or redefined as  what is better for the aggregate. At least Eddy was candid about there being losers,in Berwick's utopian visions in the picture he paints there seem only to be winners.The population will do better, the individual patient's experience will improve and "we" will spend less money per patient. Everyone will do better and it will even cost less.What could possibly be wrong with that?

I believe that IHI's policy recommendations are basically Eddy's prescription adorned with a layer or two of management-speak verbiage dumped on the top to obfuscate what is really happening. When you improve population health care or outcome and simultaneously  decrease per capital costs, you essentially are doing a cost effectiveness analysis based on a statistical benefit to some group ( e.g. those covered lives in an ACO or HMO) regardless of what determent might befall some other  individuals in the group making the third aim of improving the  patient's experience little more than a fraudulent claim. This is population medicine dressed up in polite euphemisms designed to flimflam the members of the health care collective.

Both Dr. Robert Berenson and Dr. Harold Sox,former president of the American College of Physicians, are  perhaps more candid about about their visions for medical care in the country.

Berenson writing in 1998 in the Annals of Internal Medicine said.

"We propose that devotion to the best interests of each individual be replaced with an ethic of devotion to the best interests of the group for which the physician is personally responsible.

Berenson makes it clear that the individual's interest shoudl be trumped by the group's interest.

Dr Harold Sox, former president of the American College of Physicians, in his commentary regarding "population medicine"  made it clear that in shifting funds from managing one disease to another would involve for at least a few generations results in some not receiving treatment so others might enjoy some type of preventive measures. That would be quite an "experience" for those who might have to forgo some treatment.

Quoting Sox's  November 12, 2013 JAMA commentary:

 "Planning to optimize population health will mean determining the frequency,causes and consequences of he common medical conditions in a population and devising strategies for dealing with them over a lifetime. "...
resources must be allocated across program to prevent,detect and treat disease and its risk factors. "...One reasonable principle to move resources from groups of patients less likely to benefit to groups more likely to benefit...

With the application of this utilitarian calculus there will be winners and losers which Sox seems to admit implicitly the following paragraph.

"It will take several generations to realize the benefit of investments in disease prevention.In the short run, these investments may draw resources away from the tests and treatment of some sick people.In the long run, diseased prevention and better low-cost technology could reduce the outlay for treatment."

If Berwick's, triple aim is something other than  the utilitarian approach of Eddy,Berenson and Sox I wish someone would explain. It is the old wine in newly labeled bottles, this time labeled "enhanced patient experience" and the platitudinous "patient centered care" when really it is the greatest good for the greatest number as judged by cost effectiveness calculation and the real winners are the third party payers and their fellow travelers. . 

Sunday, August 31, 2014

The effects of multiple sub-concussion head blows in football

Two research  groups have demonstrated brain imaging findings in collegiate football players over the course of a season.Importantly these abnormal finding occurred in players who did not experience a concussion..While concussions occurring at all levels of football competition has finally attracted some long overdue attention,more recently the significance of so called " sub-concussive" head blows is under scrutiny.

Bazarian et al studied 10 college football players over the course of one season. ( "Persistent Long Term cerebral White Matter Changes after Sports related Repetitive Head Impacts. Plos one 9(4),e94737)

 Head impacts were recorded and measured by helmet accelerometers and brain imaging was done preseason, immediately post season and six months after the end of the season. Imaging was done by the diffusion tensor technique (DTI).This MR technique can demonstrate abnormalities in the white matter and can visualize connections of fiber tracts between different parts of the brain.Current theory regarding traumatic brain injury is that axons are stretched with resultant micro damage.These changes are not detectable by conventional MR while DTI is capable of detecting abnormalities associated with so-called mild brain trauma.

White matter changes were noted in these players none of whom sustained a clinically evident concussion.
The changes in most players,but not all, were also seen in the six month followup images. Evidently in some cases the 6 month period with no head impacts allowed recovery or at least return to the pre season scan pattern.. There was a correlation between number of head impacts and DTI findings. The DTI changes were not correlated with changes in cognitive testing or tests of balance.The authors state that it is not known whether the changes noted represented damage per se or recovery and beneficial plasticity. The number of head impacts ranged from a low of 431 to 1850.Multiple head impacts occur regularly in lineman while quarterbacks and wide receivers are more at risk for more severe single hits and concussions.

A possibly encouraging  finding in the Bazarian study  is that none of players demonstrated any scan abnormalities at the beginning of the season.One would expect that if these findings were to persist for very long periods of time (longer than 6 months) that these players who likely played football for a number of years by this time would have shown some abnormality from repeated head blows.

Another TDI imaging study was published by TW McAllister ( Effect of head impact of diffusivity measures in a cohort of collegiate contact sports athletes, Neurol. 10:1212/01Dec 11 2013.) There was at least one important difference from Bazarian's results. Quoting the authors from this study which involved 80 varsity football and ice hockey players and 79 non contact sports participants:

 "The magnitude of change in corpus callosum MD (mean diffusivity) was associated with poorer performance on a measure of verbal learning and memory."

What are the underlying tissue changes corresponding to the DTI patterns? No one knows whether they represent damage to the axon and or the myelin  sheath and/or edema. See here for a comprehensive discussion of the DTI technique and findings in head trauma.

Regardless of the exact relationship between imaging findings and the tissue changes, it is difficult  to argue that subjecting (allowing) young brains to sustain multiple hits can be anything other than potentially harmful.Although recent emphasis on concussion and chronic traumatic encephalopathy (CTE) has lead to some rule changes in the direction of limiting to some degree head blows and rules regarding management of concussions ( when to be allowed to return to play etc) ,every Friday night tens of thousand of young men hit each other repeatedly in the head and are cheered on by hundred of thousands of football fans and parents. For now the dogs continue to bark while the caravan moves on.

Much to no one's surprise a similar study has been published involving measurement of head impact forces and DTI changes in a high school football team over the course of a season. (Devenport,EM et al, "Abnormal white matter integrity related to head impact exposure in a season of high school varsity football"
J of Neurotrauma 2014 Jul 14, published ahead of print) .There was a significant linear relationship between their measure impact force and DTI changes as well as relationship between DTI measurements and changes in a memory test.

Wednesday, August 13, 2014

What would happen if Choosing Wisely became the medical "law of the land"?

Choosing Wisely (CW) is an initiative or campaign lead by the American Board of Internal Medicine Foundation (ABIMF) to change the thinking of physicians and patients so that the choice of  medical tests and treatments are chosen  wisely in such a way as to greatly reduce waste of resources and harm to the patient.

It began as an apparent low-key program to simply have the physician and her patient sit down together and have conversation about what needed to be done in a particular patient's case and it continues in part to be marketed as such. So, if for example that a given test, e.g. MR of the lumbar spine,might not be ordered if it were the case that an MR in that stylized scenario had not been shown to be helpful.The patient would be subject to possibly harm of a false positive tests and the possible cascade of more testing,etc etc.

However in the two years since the launching of CW ( at the time of this writing) several policy experts and wonks have envisioned a much more full bodied, authoritative and coercive role  for the pronouncements announced under the CW brand.  It is this expanded role for CW that I refer to as the medical law of the land.. From simply reducing waste and  harm a second wave of CW is to reducing "low value" services,however that may be defined

So based on some of these experts' recommendations, what would the medical landscape look in the era in which the decisions of Choosing Wisely ,would be much more than the suggestions or recommendations,which is how they are sometimes presented  and  instead be  determinative in regard to the reimbursements of third party payers, private and public as well being used in decisions regarding maintenance of certification and other mechanisms to decrease medical costs.

Consider the comments of Dr Robert Benson Jr.,President Emeritus of the ABIM and ABIMF  writing on the ABIMF blog with bolding of words added by me:

" CMS, which has the ultimate negotiating position in the form of reimbursement for Medicare services, could only accept negotiated bundled charges. It could also refuse payment for non-compliance with the Choosing Wisely recommendations."...ABIM could require candidates to achieve a perfect score on questions related to costs and redundant care as a requirement for admission to secure exams for initial certification or MOC."

So, a candidate for ABIM certification would have to properly quote the Choosing Wisely rules recommendations before he even gets to take the certification ofrMOC examination.

This recent commentary by Dr N.E. Morden and her co-authors from Yale and Harvard tells the same story.

"..physician-endorsed low-value labels will probably be leveraged to these purposes. [cost containment and quality measures]...We believe that if such efforts are designed and applied carefully they should be embraced as a promising method for reducing low-value services."

...linking the lists ( of tests and procedures not to do ) to specialty specific maintenance of certification act activities such as practice audits and improvement tasks could also advance their dissemination and uptake at very low cost."

"...Choosing Wisely items should also be incorporated into quality-measurement efforts such as Center for Medicare and Medicaid Services Physician Quality Reporting  ...linking low value service use to financial incentives ( translate penalties )  .. should accelerate ...into practice changes."

So payment for physician services,quality ratings,and maintenance of board certification are linked to adherence to the "recommendations" of  CW.

In this proposed choosing wisely world the deciders at CW assume a very powerful position.Various special interest groups stake holders would have great incentive to lobby the CW leaders,to do what they could to direct the "recommendations". Physicians would have to follow the CW guidance or risk loosing certification let alone payment for services. As bound as physicians would be to the  dictates of the CW authority how much trust could a patient have that his physician is acting in his best interests .Making CW the medical law of the land would be a giant step toward the collectivization of medicine and destruction of the traditional physician patient relationship.

Of course, all of those sky-is-falling comments are in stark contrast to what one would read on the websites promoting the CW campaign.. There we hear  marketing phrases such as "ensuring the right care at the right time" and doing reasonable, sensible things and involving the patients in the decision process. Mom and apple pie with ice cream on the pie is the image floating above  the CW advertising efforts, but when one reads the comments of Benson and Morden et al  that outlines what they want to do,a different, darker side of CW is visible.So what is it: an idealized physician-patient collaborative effort or advocacy for  an alarming  level of medical care hegemony lead by select members of the higher echelons of the progressive medical elite who seem to believe that carrots are not enough .The ABIMF and the Robert Wood Johnson Foundation are spending millions of dollars convincing the public and members of the medical profession that Choosing Wisely is a collaborative,thoughtful movement that just wants to ensure that patients get the right care at the right time while the President Emeritus of ABIM(F) and some policy wonks from Yale and Harvard talk a markedly different game.

Today's trial balloons may well become tomorrow's policies and governing rules about how medicine is practiced and it will not be all about the right treatment at the right time.It will be about the most cost effective means of achieving quality adjusted life years as that is valued by someone other than those trying to live those years.

Wednesday, August 06, 2014

The crusade to change medical ethics,custom and practice gains momentum

The mega-thought leaders,the established leadership of some of the major,influential professional medical organizations, and an alarming numbers of fellow travelers are on a quest to change the thinking of the worker-bee physicians,and the general public (who are either now patients or potential patients) from the long established model of the physician as an advocate and fiduciary to the patient to one in which the physician is a steward  of "scarce medical resources" which are characterized as being owned by society.But the physicians who are tricked into acting in that way are not preserving "society's resources" but rather they are boosting the bottom line of some vertically integrated health care entity.

Early explorations  and exhortations of this theme in the major medical literature are exemplified by one article in the Annals of Internal Medicine and a series of articles in the Journal of the American Medical Association (JAMA).I chose these articles because the authors were quite explicit about their recommendations.

A series of articles was published in 1995 in JAMA authored by Dr. David Eddy that discussed the metrics and merits of decision analysis which he hailed to be a mechanism to increase the quality of medical care while reducing costs. Eddy defined quality as the greatest medical good for the greatest number within the eco-medical collective (aka HMO now this might be an ACO) It did not go unnoticed to the skeptical reader that Dr. Eddy listed his affiliation as "Kaiser Permanente of Southern California")

In 1998 M.A. Hall,a law professor, and Dr. Robert A. Berenson writing in the Annals of Internal Medicine said that "the traditional ideal" [the prime duty to the patient ] was "not compatible with the role that existing insurance contracts and manged care arrangements define for physicians."
"We propose that devotion to the best interests of each individual be replaced with an ethic of devotion to the best interests of the group for which the physician is personally responsible."

Berenson and Hall  justified this  ethical sea change because the role that insurance contracts would  define for the physicians.Medical ethics must change to accommodate the bottom line of the third party payers.If traditional ethics were in the way,just change the ethics and that is exactly what the ACP and the ABIMF are attempting to do.Never mind that for the most part one of the characteristics of a profession is that it and not a third party defines its ethics.They seemed to either rewrite the definition of a profession or declare that the practice of medicine was not really a profession at all.

 Dr.Berenson Joined HCFA in 1998.His biography found at the ECRI website indicates that from 1987 to 1997 he was a Vice President at the Lewin Group.Lewin is part of Ingenix which is owned by United Health Care Group.Ingenix changed its name to Optuminsight in early 2011.(See here for details.)He is a fellow at the Urban Institute and in  2010 he became vice of  the Medicare Payment Advisory Commission (MEDPAC)

 In a recent NEJM roundtable, Dr. Atul Gawande, summed it up with this reference to "a new culture in practicing medicine"  in which physicians will "prioritize our responsibilities as shepherds of scare social resources  to the same extent that we've historically prioritized our responsibilities for providing benefits to our specific patients"  This, or course, is nothing new. The American Board of Internal Medicine Foundation (ABIMF) and the ACP has been promoting this notion of  physicians as stewards of resources as part of the new Medical Professionalism which debuted in prime time in 2002 in a well funded campaign. ABIMF received some $ 13 million from the ABIM  which apparently represented receipts well in excess of costs of the various testing programs ABIM administers to internists. Another $ 5 million was in the form of a grant from the Robert Wood Johnson Foundation,

 The Choosing Wisely campaign is well funded and is in part funded ironically by thousands of internists who sent off their checks to take a certification exam not to support a political, philosophical campaign  whose mission appears to be to usher in the medicine of the collective.

It gets ever worse.Consider the following comments of Dr. John Benson Jr,former CEO of ABIM and ABIMF: (my underlining)

" ABIM could require candidates to achieve a perfect score on questions related to costs and redundant care as a requirement for admission to secure exams for initial certification or MOC."

If a candidate does not learn the Choosing Wisely catechism or some other subjective view of what is and is not high value to the letter she would not even be "allowed" to take the certification exam. 

 You have to wonder  how the typical patient would  feel if he knew that his physician  was devoted to the best interests of some statistical aggregate, perhaps those who found themselves in some or other ACA or HMO or being treated in some large hospital system.It is not clear to me how many physicians have adopted that perverse devotion but it is clear that the caravan of the medical progressives is expending much effort and money to that end and I am afraid while some dogs  are barking objections the caravan will move on.

I still remember the elation and pride that I had when I learned I has passed the Internal Medicine examination ( I became board certified so long ago there was still a written and a oral exam). Now as I look at the efforts of the ACP and the ABIM to destroy the traditional medical ethics of devotion to the patient, pride is not the emotion I feel.

Friday, August 01, 2014

Is "low value [medical] care like Justice's Stewart's definition of pornography?

In a 1964 obscenity case, Supreme Court Justice Potter Stewart admitted that he might not be able to specifically define the parameters of pornography but " I know it when I see it".

I wonder if a similar situation exists with the concept of low value medical care (LVC) which is  a main talking point in a campaign spearheaded by the American Board of Medicine Foundation (ABIMF).

Surely this term is not just a floating abstraction. I thought I had  simply missed the definition in reading about LVC. Off to Google to enter "definition of Low value care". Neither Google nor Bing lead me to a generally accepted definition of low value care or for that matter value in health care in general.

In fact the literature of health care value is bereft of a general consensus as described in this quote from Dr.Scott D. Ramsey writing in the Oncologist :

"one of the most enduring and controversial topics in medicine is the concept of what constituents value in health care"

The concepts of the business management  guru, Michael E. Porter are widely quoted and for him value is defined as "health outcome per dollar spent" but he spends considerable effort in explicating how elusive and difficult that is to put into meaningful operational use.

Given that the term value lacks a clear definition and defined operational boundaries, how did the American Board of Internal Medicine Foundation (ABIMF) expect many medical professional organization to conjure up a list of low value procedures? That initiative was part of their "Choosing Wisely " Campaign. Yet a list were generated  by some process or processes with some or other operational meaning of low value.I guest these medical thought leaders know it when they see it.

Professor Catherine MacClean of University of Pennsylvania gives this definition of low value health care, which seems to be close to if not on the mark and at least  is more substantive:

"any care for which there exists an alternative form of care this is both equally  effective and lower cost. In this regard no care or watchful waiting is eligible for the designation "alternative form" I wonder how many of the  "Choosing Wisely" campaign's wise choices  meet that definition.

 I think that more than a few writers who talk about low value care may be using  little more than Justice Stewart's ocular  technique.

Wednesday, July 30, 2014

Population medicine approach meets Public Choice theory and practice

What happens with the population medicine approach (PMA) when one considers how thing really work according to the insights of public choice theory (PCT). Spoiler alert-you get much more cronyism,favoritism,and focused benefits and diffused costs with certain special interest groups profiting greatly.

Considering what went on with the writing of ACA what groups would be likely to profit from a governmental run PMA? Big Pharma,big health care insurance , big hospital system,big prescription drug management companies,and lots of consultants who will claim to be able to explain it all.

Recall some of the details of the profitable,magical revolving doors that were prominent  in the creation and the subsequent development   of The Affordable Care act.

 Leading the list has to be Nancy DeParle.See here for Dr Roy Poses's comments on her travels in and out of business and in and out of prominent roles in government.

Senator Max Baucus's chief counsel,Liz Fowler, was singled out by the good senator for her important work in crafting the ACA. See here for my earlier comments about the ins and outs of her moving from health related business to  Baucus' influential  committee and back again.

More recently is the interesting matter of the new deputy administrator of CMS,Andrew Slavitt,who assumed that post fresh from his executive position at Optum/QSSI, a subsidiary of the country's largest medical insurer, United Health Group. Optum was hired by HHS to set up the internet hub for Obamacare.The ethic "rule" that a person leaving a private organization to a governmental agency cannot interact in an official capacity with that firm for one year was waived in the case of Slavitt . See here for details.

 Should anyone be surprised that a deputy administrator of CMS would become chairman of ABIMF Board of trustees.

Glenn M. Hackbarth ,JD was a deputy administrator of Healthcare finance administration (the precursor organization to Center for Medicare Services  and  until recently was the chair of the board of trustees of the American Board of Internal Medicine Foundation (ABIMF).

Should anyone be surprised that Sam Ho, an executive Vice President of United Health Care, severed on an Institute of Medicine Committee that was charged to devise recommendations to the administration regarding what elements should be included in the mandatory health insurance proposed under Obamacare?

Answer to both- of course not.

After all who should know better what coverages should be included in a program that forces everyone to buy health care insurance than the CEO of an insurance company who will make out like crazy when the bill is enacted?

After all why would  one  of  the hierarchy of the largest third party payer ( ie Medicaid and Medicare) not wish to associate with a foundation that strives to conserve the nation's health resources?

No, these are not instances of strange bedfellows but rather folks synchronizing and harmonizing  their mutual interests? All these folks are just dedicated to providing quality health care to everyone while wisely making choices that will preserve our finite medical resources.

Should anyone be surprised that a former vice president of a large medical insurer (WellPoint)  was the key author of the Obamacare bill as it came out of Senator Baucus's committee? Of course not. who would be better qualified for that task than Elizabeth Fowler who was also chosen by the administration to oversee the administration of the statute after it was passed?

So what does all of this have to do with PMA and PCT? The history of the cahoots and cronyism of ACA provides the answer.