Friday, November 4, 2011

Preserving the Art of Medicine, When The Science is Paint-By-Numbers

The art of medicine, the ability to be therapeutic in your relationship with your patient's is rarely discussed as fundamental to the modern practice of medicine. Medicine is reputed to be a scientific discipline and the driver for evidence based medicine the desire to control costs by standardizing evaluations, treatments, and outcomes.

What if medicine were truly more an artistic endeavour than a scientific one? While my practice is grounded in clinical science and a rational world view, I find as I have matured in my art, I am more artistic and artful in practice than scientific. I am a great believer in the usefulness of patient relevant clinimetrics and the power of the clinical trial of n=1. Medicine practiced scientifically is all about careful serial observation of the patient in response to thoughtful and physiologically justifiable therapy.

However, increasingly I feel as if I were Vincent Van Gogh forced at the height of my powers to only produce Governmentally sanctioned color-by-the numbers artwork. The defining characteristic in my view of the 'Velvet Elvis' is it's quintessential mechanical reproducibility. Having seen one, you have seen them all. While a Van Gogh has stylistic similarities, family characteristics that make it recognizable as his art, it is hardly mechanistic nor predictable nor kitsch.

Do patient's really wish to have their medical care delivered as an industrial product, or do they instead wish to have an experience with their doctor more akin to a romance than an encounter? I of course do not mean a romance in the conventional fashion, erotic in nature, but rather an emotionally satisfying experience in which rapport amplifies the therapeutic efficacy of the drug or treatment prescribed.

This is then the art of medicine, the development of rapport and the transmission of genuine concern and interest in the patient and the patient's outcome. This is the sole requirement to keep Evidence Based Medicine from an inevitable trajectory that leads to a dystopia as envisioned in Alan E. Nourse's science fiction classic 'The Blade Runner.' (http://www.sf-encyclopedia.com/entry/nourse_alan_e).

The recent recall of Xigris is only the most recent example of the unhappy result of having the science of medicine become tainted by the business of medicine. (http://saltycurrent.blogspot.com/2011/10/corporate-ethics-xigris-example.html) When an ever increasing proportion of medical research is funded by Pharmaceutical and Device companies, the objectivity of clinical scientists becomes more suspect. In particular Xigris, was explicitly and prominently recommended for use in patient's with Apache II scores of > 25. The fall out from this affair is only the latest in a series of scandals that periodically highlight the problems with mindlessly and diffidently accepting the evidence behind the evidence based medicine movement. Recall the outrage attendant to the revelation that some data used in the National Surgical Adjuvant Breast and Bowel Project was fabricated. (http://articles.latimes.com/1994-04-14/news/mn-45830_1_breast-cancer-research)

Along this line, a truly valuable and profound meta-analysis 'How Many Scientists Fabricate And Falsify Reserach? Systematic Review and Meta-Analysis of Survey Data' (http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0005738) suggests a lower limit of 14% for falsification of data and a 72% rate for 'questionable research practices.' Given these rates of self-admitted intellectual dishonesty as demonstrated by anonymous surveys, it behooves the artistic medical man to be relentless in questioning today's evidence based guidelines especially if they fly in the face of his practice experience or the grounded basis of well established scientific principles.

That is not to say that guidelines are not in their own right a useful intellectual exercise, a convenient way to summarize and encapsulate a broad body of relevant clinical research, and useful tools in the pursuit of superior outcomes. But they are tools and guides not an end in themselves.

High quality medicine and superior outcomes involves not slavish adherence to a possibly irrelevant guideline, but the intelligent and active elucidation of the patient's true problem(s) combined with a creative and artistic pursuit of an optimal individualized treatment plan for a unique and vulnerable human being. While perfection is never realized in medical practice, it is practice after all, there is never in this writers viewpoint ever a justification for giving less than your all for your patient. It is never justifiable ethically to argue that your human fallibility is a justification for an adverse outcome. Ultimately, the sense of responsibility for the individual outcome, is in my view the best way to assure a positive outcome.

This then, a sense of artistic integrity, the sense of being true to your own best impulses and the altruism that for millennia has characterized the profession of medicine is ultimately the engine for superior outcomes and a satisfying career in medicine.

Sunday, October 2, 2011

Fly "Hospital" Airlines.......

The aviation industry is extolled in the patient safety literature as a pre-eminent example of highly reliable organizations. They are used to provide a model to be emulated in order to enhance safety within medical practice.

This paper from the BMJ discusses the results of anonymous survey's and attitudes related to errors,perceived stress, and teamwork between aircrews and various medical teams (surgical and ICU).
( http://www.bmj.com/content/320/7237/745.full.pdf )

Not surprising, the aircrews are more sensitive to their own stresses and more willing to admit the effects of fatigue on their decision making and eye hand coordination, etc. While there may be valuable insights derived from this comparative study, the essential differences between the work environments of the aircrew member and the physician member of a health care team are profound and underestimated in these comparative surveys.

However, my intention today is not to critique the patient safety movement, but rather to comment on the more profound issue of the effects of the focus on industrial reliability and its unintended effects on therapeutic effectiveness.

I am now working most of the time as a hospitalist in a local hospital. I was discharging a patient who I had episodically followed for some days, but who was originally admitted by my colleague, the medical director of the local hospitalist organization. The patient asked if he was going to see my colleague, and he confessed he was confused as too who I was in the delivery of his care. The patient had a life threatening episode of pulmonary embolism for which my boss did a bang up good job of penetrating to the threat and promptly began thrombolysis of his clot. The patient knew perfectly well that his life had been completely dependent on this excellent practitioners excellent care. However, he was a patient on a hospitalist service and therefore the doctor safeguarding his life literally changed every 12 hours and often times every day he was cared for by another physician, many times, especially during the nocturnalist covering his care, his identity totally unknown to the patient.

He was perplexed, initially to understand that he was in database lingo in a 1:many relationship when his previous understanding and experience of medical practice was that he was in a 1:1 relationship to his primary care physician.

It occurred to me at this time, as it has any other number of occasions that hospitals would prefer if our relationships to patients was identical in character to that of the Captain of an aircraft to the passengers within that aircraft. Essentially anonymous, assumed to be competent, but indifferent to the actual natures and characters or characteristics of the passengers and vice versa.

In this model of the hospital, the hospital provides the nurses/stewardesses and pilots/physicians and controls the interactions within the hospital and just as on the airways a commercial interaction rather than a human interaction occurs.

However, the human in pain, disease, and fear is not the equivalent to the excited pleasure or the bored business traveler with respect to customer relationship management. The patient deserves, desires, and requires the ministrations of a real person with therapeutic intent and therapeutic will.

Among my strongest held beliefs are that in the field of medicine, there are some, too few perhaps, who are gifted with a therapeutic personality. That the practice of good medicine taps the depths of the souls of those who serve the patients best interest. That shamanistic power exists in many and perhaps most successful practitioners, and those without this ability to tap the pre-technological wellsprings of healing are ineffective in transforming their patient's into healed and whole human beings.

These dimensions of medicine, the cultural and mystical/spiritual dimensions are increasingly ignored, marginalized, and minimized in the 'practice' of medicine to the detriment of the patient and the practitioner.

In my discussions with the young patient who I was helping too process through his trip to the healthcare factory, I was deprived of the true sense of gratification and sense of personal healing power that comes from being on the spears point, and invoking the skills I spent a lifetime in acquiring, renewing, and enhancing by being their for his personal crisis and leading him out of the valley of death. That joy belonged to my partner. However, for him that gratifying experience was transformed into a technical exercise of correct decision making, bereft of the truest reward in medicine, the sincere thanks of the saved patient. And the patient was left thanking my partner only in the third person as I was to relate his deep gratitude to my colleague.

In the maturity of my practice, my field once so exciting and rewarding, one in which I was sure I was immune to 'burnout' now has transformed to the point that I am virtually as anonymous to patient's as the highly qualified, highly talented, highly skilled aviators who take off and land our planes.

I wished ultimately to grow old with my patient's and too drink of the well of shared experiences, now my draught is bitter, cold, and unappealing... the dregs of a warmed, heady, vaguely sweet grog now gone cold, bland, and nauseating in its uniformity.

Intensity Is A Four-Letter Word or In The World of the Bland, The Half-hearted Rule....

In the summer of life,
I exhausted myself in the struggle,
heroic, in my eyes,
life and death, dependent upon
my own
strength as well as the patient's will to live,
and clinical wisdom and the joy of selflessness
came effortlessly as my just reward.

Thursday, September 8, 2011

I Have Seen The Future, And I Weep....

I recently returned from a temporary ED assignment in a city to remain nameless. As part of the 'system' in the ED, the hospital had implemented a Computerized Provider Order Entry System (CPOE).

I have used such systems in the USAF and for a one year stint in which I worked as a contract cardiologist for the VA. As such, I thought I had seen as much mischief as the systems could cause. For example, in the VA system, using a computerized order entry from the ICU for a "STAT" order could result in total loss of awareness of the order. That is depending on the amount of distractions facing the pharmacy significantly longer delays until time of delivery of the medicine could occur. When the nurse is in the loop, there are repetitive pings built into the order delivery system. These did not occur in the system I was using at that time. And until I penetrated to the possibility that a STAT order could be misplaced by those required to implement the order, several near misses occurred.

However, last weeks CPOE was a new low in process engineering. I favor and support CPOE for high risk areas such as medication ordering. However in this intermediately busy ED, ALL ORDERS had to be entered into the system by the physician. Thus, if I wanted one of the nursing staff to put a splint on an injured limb or if I wanted a wound irrigated I had to enter it into the CPOE system. The net result was that I was functioning as the unit clerk. And furthermore I was exposed to an entirely new set of distractions, as harassed and harried nursing staff were 'pinging' me to enter orders for them into the system at the times of their convenience and not those of my own choosing. This was distracting to say the least.

What is in the mind of those who profess to make our profession a highly reliable enterprise such as aviation? I routinely work in an environment in which intense concentration on ones work and thought is impossible. The party never ends at the nursing stations of some hospitals in which I have worked. And there is generally no place reserved for the physician to work. Now perhaps for many of my colleagues they don't need to think about their tasks and it is a matter of charting a few throw away lines for their note and signing a few standard orders. But if this is the case for some of them, than it is an exception, however, from my standpoint, I think it remains the exception.

However, for me, there is always a great deal of thinking about a case with intense concentration required for the specific orders required for the specific patient in front of me. Thus concentration and being relatively undistracted is an important thing for me.

Imagine how safe an airplane trip would be if the pilot on short final was subject to cell phone cold sales calls or an irate passenger walking into the cockpit demanding that his in-grown toe nail be dealt with ..... NOW. And yet this type of behavior happens routinely in my daily practice(s). There is little planning in hospitals for appropriate work spaces for physicians or for dedicated computer terminals or computer systems for the physicians who work in the hospitals.

Sunday, August 21, 2011

Rashomon, M.D.

Apropos of a case, which looks different based upon your perspective.

I was several years ago, working within my Emergency Medicine Avatar when I overheard the ED scanner call out the approach of a Code III chest pain. I turned to my partner and told him I would see the patient as she entered the ED. I was standing next to a work space finishing out a 'T-sheet' when the patient, a 72-year old female who had undergone angioplasty the week previously was brought into a cardiac bed for evaluation. As the EMS gurney passed my vantage point to the patient I noted that she was literally writhing in pain on the gurney. I ordered a 12-lead EKG, reviewed the tracing when done (no infarction, no ischemia), walked into the room, gently pushed on the L-3rd rib-sternal joint while listening to her heart. No murmurs or other auscultatory abnormalities, but the patient complained even more bitterly of pain. I then injected 10 cc of a 50% by volume mixture of KENALOG™ for inter-articular injection and 1% lidocaine into the patient's easily defined trigger point. 5-minutes later she was free of pain and released from the ED. Total time within the ED was approximately 15 minutes, during a peak time interval for the facility and for which all were grateful (patient's/nursing staff/my partner) for the prompt flow evaluation, timely therapy, and rapid disposition.

As you may know, Rashomon, the brillant film by Akira Kurosawa explores the nature of subjective truth and perception. It is our theme today, in the analysis of my mundane clinical vignette. The problem in front of us relates once again to the current notions of quality in health care. Was this a high quality clinical encounter? or simply efficient? or simply cavalier and reckless care?

As we warp and deform the encounter into a series of Rashomonian perspectives let us look at the case from the standpoint of the quality manager. This patient with known coronary artery disease who had undergone a recent angioplasty failed to undergo conventional cardiac risk stratification with serial cardiac biomarkers and serial EKG tracings. The nearly mandatory overnight hospitalization was not done and the patient released prior to absolute exclusion of AMI or unstable angina had occurred as directed by all relevant cardiovascular disease protocols and practice guidelines. (See the following pdf document for a relatively standard chest pain protocol- http://www.mssm.edu/static_files/MSSM/Files/Departments/Emergency%20Medicine/Manual/SUB52.pdf)

Seen from the perspective of the clinical performance measures and through the eyes of the clinical performance measures monitor, the case falls out. I am once again required to document and justify my deviation from the quality measures which are mandated by the patient's chief complaint of chest pain. No ASA, no beta-blockers, etc, etc.


If I had a medical educator look at the case, I was guilty of inadequate and substandard care. I literally asked the patient one question, 'does it hurt when I push here?' It is well known, and I agree with this dictum that history suggests or makes the diagnosis in over 80% of cases. Therefore, my encounter with this patient is suspect due to its abbreviated nature.

I coded the case as chest pain with a sub diagnosis of costochondritis. If the case had been reviewed by medicare, I would have been guilty of medicare fraud, since the diagnosis of undifferentiated chest pain is a high complexity type diagnosis that would justify with appropriate documentation of medical data elements a high complexity payment. However, if I coded the diagnosis with costochondritis as the initial diagnosis I would have been paid for a low or moderate complexity diagnosis. Furthermore, if I recall the case properly I probably coded the case as high complexity and probably failed to capture all data elements required for this charge.

If the case was reviewed by the hospitalizations utilization manager, I might well have been subtly or not too subtly harassed since this was a medicare beneficiary, i.e., an adequately insured patient and I deprived the hospital of the DRG attendant to medical observation for a chest pain rule out protocol while obtaining for the hospital only the initial payment for the Emergency Department evaluation of the patient. Furthermore, since the patient was in the ED settings, all advanced imaging charges would have been born by the payor, unlike imaging accomplished after hospitalization which results in reduced profit margin for the patient. Therefore, failure to do a Chest CT with IV contrast to 'rule out' a pulmonary embolism deprived the hospital of some not insignificant revenue. Apropos of this point, I am aware of an ED medicine group who are literally tracked by their administration to keep medicare beneficiary ED admissions at a given rate with respect to numbers of ED presentations. What I mean by this, is if 80 medicare beneficiaries are seen in 24 hours than X% of those patients are required to be admitted. This is done to preserve hospital revenue streams and the percentage is directed by administration to the ED group. The not too subtle implication is that if they can't find a reason to admit at this rate, another ED group can be found that will be compliant to this informal guidance.

If this patient with the known presence of CAD had sustained sudden cardiac death or an acute myocardial infarction anytime in the 6 to 12 months of her release from the ED, the grieving family of this patient would have been able to find probably 1,000 'domain experts' who would have been overjoyed to testify that my practice was substandard, reckless, and cavalier resulting in avoidable death or injury to my patient. The case is many years distant now, so I think I can say with some certainty that the patient did not sustain a myocardial infarction anytime over the period of reasonable observation since my own ED evaluation of the patient. However, from the perspective of the retrospectoscope I would have been guilty of medical malpractice due to my failure to do what other similarly trained and experienced practitioners would have done.

Now as we face the question, was this enlightened practice or bad practice which of the Rashamon-esque perspectives should we adopt, which is the real situation.

From my perspective, the thought process and the situation is as follows. I was heavily influenced in my clinical evaluation of chest pain during my own internal medical training by the following now classical article:

Ruling Out Acute Myocardial Infarction: A Prospective Multicenter Validation of a 12-Hour Strategy For Patients at Low Risk. Lee et al. NEJM, 34(18) 1239-1246,1991.



The flow chart is difficult to see at this magnification but the solitary physical examination finding predictive of low probability for underlying ischemia is a defined costo-sternal trigger point that exactly reproduces or amplifies the patient's pain. Furthermore, while 20% of anterior wall MI's are recognized to have accompanying chest wall pains, total resolution of the pain with local injection of Lidocaine reliably distinguishes the chest wall pain associated with AMI from costochondral pain.

When the patient passed me at the nursing station en route to her room I noted the colicky nature of her pain, i.e., she could not get comfortable and she writhed and twisted on the EMS gurney trying to find a spot where she was comfortable.

True ischemic chest pain and infarction pain is never colicky, the patient in this setting acts like an insect preserved on a board with a needle stuck in the middle of its chest. There is no movement, because the patient feels as if they are being crushed into the gurney. The sole exception to this rule of thumb is the patient with myocardial rupture which is also an intense pain with a colicky character but for which time rapidly triages the patient into the critically ill group.

So,from my perspective of the case, the patient by Gestalt had costochondritis, the exquisite sensitivity of the chest to the light palpitation pressure resulting from auscultation of the left sternal border, the presence of a non-ischemic EKG, and the rapid and complete extermination of her severe 10/10 chest pain with 10-cc of 1% Lidocaine all made for a defensible diagnosis of costochondritis.

The patient was happy, I was happy, my partner was happy, the nursing team was happy, the biller/coder for the ED group was happy as I could bill for 2 or 3 more high complexity patient's over this hour.

Was this a high quality encounter, or not? Was it sensitive to the goals of EBM practice or not? Am I or should I be paid for the quality of my documentation or the quality of my care, or more heretically for being right or at a minimum being prudent?

What is wrong with health care today, that this trivial patient encounter can engender so many potentially negative viewpoints and reviews? In fact with a case base of over 60,000 unique patient encounters my clinical expertise is and should be well in advance of EBM. Why do I personally feel harassed and hassled by a health care system designed to educate others in things I already know? Why am I subjected on a daily fashion and why are my practice habits being subverted by perverse incentives? Why is it that as someone always in the pursuit of excellence and growth in my skills and my knowledge do I find the new Galenism so repugnant and offensive? Why do I get the feeling that my goals and professional needs and more importantly the needs and goals of my patient are irrelevant in the land of health bureaucracy and health care mediocrity? Why am I not paid for expertise rather than slavish adherence to guidelines that often times do not fit the clinical scenario? Or rather why does my expertise not de facto trump the guidelines? Why should I have to work harder to do the right thing rather than mindlessly follow a guideline which as I have noted often times does not suit the clinical situation? Why should I follow guidelines targeted to chief complaints rather than validated diagnoses? Most irritatingly, why should someone with less training and experience and judgement be able to trump my own clinical impressions based on their position or title, i.e., clinical practice monitor/coordinator?


Thursday, July 28, 2011

Genesis (Of The Statistical Medievalist)

It may seem strange to the reader that this post details the genesis of The Statistical Medievalist but I take as my model for this unorthodox temporal sequencing, as well as explicitly stealing the posts title from Have Gun Will Travel, my all time favorite TV series. In Episode 1 of the 6th and final season entitled Genesis, it is revealed how Paladin was transformed from a man with 'feet of clay' into a heroic champion for hire.

So along those lines, and in keeping with the spirit of the 'Knight Without Armour' it seems to be the right time to describe the genesis of The Statistical Medievalist.

Having been trained in medicine at the end of the last century, at a time when the medieval Guild system was in authority and in near complete control of the education of medical professionals, I am very much intellectually rooted in the times of the mage, the maven, and the master guildsman. However, in the pursuit of the science of medicine, and as someone with an undergraduate major in Mathematics, I have always been drawn to the meta-theoretic areas of medicine, i.e., the theory of medical practice including as I have said in introduction to the blog, biostatistics.

These then have been the two enduring lines of thought and exploration that I have traversed over my entire medical career. In this way, going back to my idolization of Paladin, I know what is too live in two worlds, such as he does in San Francisco (Dandified and Elegant Man of Letters) or the Gun For Hire (Solitary Warrior in pursuit of justice for his client).

In my own case, those worlds are the intellectual pursuit of mathematical truth, insight, or rigor in decision making existing in dynamic tension with the need for immediate and often dramatic action in pursuit of the best outcome for my 'client' usually with action being impelled with incomplete knowledge and understanding.

Thus, while I treasure the medieval values and power of the Medical Education Guild system, I find I must embrace fully and without contradiction the necessity to balance the medieval logical world view best epitomized by Aristotelian Syllogistic logic in contradistinction to the multi-valued 'fuzzy' logical systems of thought inherent in the modern quantum views of reality and implicit in the use of statistical methodologies for analysis of medical therapies.


Furthermore in another but related sense, I am attracted to the medieval view of medicine as I  live through the transformation of my profession. No longer am I a Master Guildsman who owns a unique job shop, I am being transformed into a well compensated technician laboring in an implicit medical assembly line in which statistical defined outputs and control limits are valued more than the unique outcomes of the individual patient. To better define and understand these transformational forces I would reference you gentle reader to the following graphic which illustrates the so-called Product-Process Matrix, a fundamental tool for understanding Process Architectures.


I had the experience of working as a Consulting Cardiologist at the now defunct Internal Medicine Branch of the Aeromedical Consultation Service at the USAF School of Aerospace Medicine, a job in which on a busy week, I would exhaustively evaluate, consul, and more often than not perform heart catheterizations on 4 active duty military aviators. Thus,  I understand at a visceral level the medieval job-shop practice environment. These 'clients' were all worth up to or more than $12 million dollars per copy to the USA military with respect to costs to replace them at the most important time in their careers, i.e., Major to Colonel ranks. Therefore, a highly individualized process was appropriate to their needs as well as the needs of the US military.

However, I also had the contemporaneous experience of working in an Urgent Care Clinic, in which on the heaviest day of my practice in that environment I evaluated, counseled, and treated (together with my 'team') 80 patient's in 16 hours of operations. This aberrancy was fueled by the need of the clinic to meet throughput demands driven by cash flow considerations. The 'on the hoof' value of the 'clients' was hard to judge, but certainly no one had invested multi-10's of millions of dollars in their training and upkeep. Their issues were usually more mundane than that of my military aviators, but honestly was there any humanistic justification for an almost 200:1 disparity in face time with your doctor?

It is in this sense of Medieval that I find my truest sense of despair with the transformation of my guild into a humanistically irrelevant set of processes designed to separate 'clients' or their 'payors' from the maximum amount of wealth with the minimal cost or thought possible.

And so it is in this other, darker, blacker, but more realistic sense that I am the Statistical Medievalist, an obsolescent guild master fighting a delaying but ultimately hopeless rear-guard action against relentless opponents wielding a metaphorical mace, statistical control theory.


The awful truth of statistical control theory, is that perfection lies at the 'golden' mean.  In this sense, mean-ing the greatest return for the least investment of gold. Immodestly as someone who believes he is operating well above the upper control limit, I know that those process improvement forces designed to move practitioners from below the lower control limit into the mean, must by the laws of statistics and reality also force me to drop below the upper control limit into the range of the average (meaning in my world view, thoughtless) practitioner.

So in conclusion and to be amplified at a later date, recall the talismanic power of  TANSTAAFL! 

     

Tuesday, July 26, 2011

The Case For Case Based Reasoning


Case-based reasoning has been formalized for purposes of computer reasoning as a four-step process[1]:
  1. Retrieve: Given a target problem, retrieve cases from memory that are relevant to solving it. A case consists of a problem, its solution, and, typically, annotations about how the solution was derived.  
  2. Reuse: Map the solution from the previous case to the target problem. This may involve adapting the solution as needed to fit the new situation.
  3. Revise: Having mapped the previous solution to the target situation, test the new solution in the real world (or a simulation) and, if necessary, revise.  
  4. Retain: After the solution has been successfully adapted to the target problem, store the resulting experience as a new case in memory.  
The complexities associated with programming and implementation of a knowledge management system based on case histories is both non-obvious and difficult, but ironically this is the actual process that an expert physician uses in his day to day clinical work.

As always I am struck by the central ironies of the practice of 'scientific medicine' in the 1st decades of the 21st Century. The central thrust of the evidence based medical movement, a movement that I am sympathetic too with respect to its articulated central goal of improving clinical practice, involves the notoriously difficult challenge of adopting and adapting clinical trial data to the individual case. However, too often the proponents of 'EBM' in their enthusiasm and zeal for the movements global goals prefer mindless execution of the guidelines if or if not the individual patient before you conforms to the patient characteristics of the clinical trial from which the 'evidence' is derived.

This is not a trivial problem. No one has captured the complexities of medical practice, and the dynamic tension that exists between data and experience, reflection and action, tincture of time vs the need to act with incomplete knowledge than the first and greatest of all scientific physicians Hippocrates.

Recall the 1st aphorism of Hippocrates, recall it and burn it into your brain and your heart.....

"Life is short, the art is long, opportunity fleeting, experience delusive, judgment difficult."

The first aphorism of Hippocrates eloquently captures the crux and flux of modern medical practice as precisely today as it did in classical Greece. In spite of 2000 years of continuous and relentless advances Medicine remains more art than science. The complexity of human biology, an intractably unique human psychology, complex and poorly understood or characterized social forces, the enigmatic dimension of spirit, and the variegated interplay of human cultural forces and beliefs act in concert to make each ‘patient’ bewilderingly unique.


The statistical analysis of groups is an inductive process; i.e., reasoning from specific cases to a
general case or rule. Conversely, logical analysis of the individual is deductive; reasoning from general cases to a specific instance. Thus, at the most fundamental level, there are operational and philosophical impediments to the application of fundamentally inductive conclusions in solving the problems of the individual case of human disease.

The power of the randomized controlled trial, is the extraction of the essential commonalities between large numbers of cases and the experiences of individual patients. The power of the method lies in teasing out beneficial effects between competing treatments. However, in that extraction of treatment effects, the individual case is sacrificed for the sake of the power of the data extraction.

However, often lost in the blind pursuit of the RCT, are the serious methodological limitations and caveats related to its use:
(i) The study of rare diseases is difficult or impossible since studies may not have sufficient statistical power to detect clinically significant therapeutic benefits.
(ii) Referral bias is endemic to this form of clinical research and results are often not broadly generalizable to nonacademic centers.
(iii) Large multi-center trials of common illnesses can demonstrate statistically significant differences
between treatment groups, independent of any genuine operational treatment differences.
(iv) The process of clinical trial design involves conscious and implicit constraint of the patient population. So- called exclusion criteria act to select for the ‘purest cases’ of any given illness. This explicit attempt to limit patient heterogeneity is scientifically justifiable in order to increase the confidence that variations in dependent variables are statistically attributable to the study treatment rather than be due to intrinsic biological variability of the study population. However, this same process also seriously undermines the ability to generalize study results to the more diverse and unselected natural patient
populations. Ironically, generalization of experimental results is the true purpose of all clinical experiments.
(v) Placebo controlled double blind studies are increasingly prohibitively expensive, and increasingly funded by 'industry' rather than having government funding. This sometimes makes it difficult to separate science from marketing. Furthermore, the ever expanding role of industry in study design and funding constrains the universe of potential studies and potential problems being studied.
(vi) Double blind studies are seriously constrained by resource and time constraints and important even vital clinical questions may not be approached with this methodology. Many perhaps most important clinical questions require time frames of experimentation that are not practical for clinical scientists to study. For example basic science research in pirion diseases was originally unusually slow due to the experimental models available and the necessity to wait for 5-6 years to see evidence of infection in the animal models used in their study.
(vii) Knowledge and technology is not static, even in those cases where long term follow up is available, technological changes in diagnosis and therapeutics threatens to make results irrelevant even at the time
of their publication. For example the original BARI trial concluded that PCI was an inferior strategy to CABG for treatment of multi vessel coronary artery disease in patients with diabetes treated with oral agents. However, over the 5.4 years of average follow up accomplished in the trial, STENT technology advanced from bare metal to various drug eluting STENT's making the conclusions of the trial irrelevant to the 'state of the art' at the time publication of the trial results.

The power of Case Based Reasoning lies in the practical realization that each case presents the expression of a common etiological factor(s) in interaction with a biologically complex and often times unique individual. Therefore, the method has the ability to extract commonality, i.e., how one case resembles another case, when that 'resemblance' is that of a family resemblance in its sense as articulated by Ludwig Wittgenstein in the Philosophical Investigations,  Familien√§hnlichkeit, that is a resemblance more subliminal than precisely defined. Just as we recognize Johnny as vaguely similar to his third youngest brother Jack, we might well be stymied to detail precisely how they actually seemed to have a common family origin. In the same way, one case of psittacosis may not be identical, but reminiscent to another case of our own experience or existing within the literature. Therefore, central to the method and fundamental to the recognition of the case, is the 5th and ultimately the 1st case-based R-step, recognition of the case as a case of 'x.' The case based method uses analogy of solution successes to determine the best solution set from a database of cases. But fundamental to this method, is the recognition of the commonality of cases. Again not a trivial issue.

However, for me the real philosophical attraction of case based reasoning, is the realization that with the passage of time, while the knowledge inherent in RCT methodologies can become irrelevant or superceded by time and events, case based knowledge always builds upon its previous foundation becoming deeper, richer, and more relevant with the passage of time. To the mature practitioner this is a comfort and a validation of the life time of learning involved in becoming an expert practitioner of medicine.

While not precisely congruent with respect to the issues I am raising in this essay, the following recent Perspective Article from the New England Journal Of Medicine makes an analogous point, that an ugly case makes an enormous impact on our clinical practice, and promotes clinical wisdom. (Level IV Evidence — Adverse Anecdote and Clinical Practice. Alison M. Stuebe, M.D. N Engl J Med 2011; 365:8-9July 7, 2011- http://www.nejm.org/doi/full/10.1056/NEJMp1102632).  The central message of this thoughtful essay can be summarized by what I call the 1st Law of Surgery: Good surgical judgement comes from experience, and experience comes from bad surgical judgement.    

Saturday, July 16, 2011

The New Galenism




The term Galenism in this essay has the usual pejorative sense of a pernicious influence, which grants that while Galen transformed medicine in late antiquity, he yet so dominated its thought that subsequent thinking and innovation was stifled by his authority.

In the defense of Galen, his own personal ideal of the physician is one that I can enthusiastically subscribe to, and is best captured by the title of his treatise "That the best Doctor is also a Philosopher" (Galen On The Ideal Physician. P Brain. South African Medical Journal, 52:936-938, 1977)(Original Source - Claudii Galeni Opera Omnia. ed. C.G. Kuhn, Lepzig Cnobloch. 1821-1833. Reprinted, 1964: Hildesheim, Olms. The work translated is in vol I, pp. 53-63.) 

However, the genesis of Galenism owed less to his own habits of thought and investigative methodologies than it did to the mindless acceptance of his successors of his results, and who then embraced him as the ultimate authority in medical practice.  

One can see the current infatuation with practice guidelines as the reintroduction of slavish conformity to 'expert' opinion akin to the forces that kept the western practice of medicine mired in antiquity until the renaissance. 

Take as an example a recent case referred to me by the "Performance Improvement" department in one of the locum tenens hospital sites I am currently working at. The patient was an elderly female who presented with atrial fibrillation with rapid ventricular rate, mild chest pain, focal and severe ST segment changes in the anterior lateral leads of her EKG. She had a troponin I elevation of a significant degree occurring several hours after her initial assessment. Once her heart rate was controlled and once she was back in normal sinus rhythm her chest pain resolved, but her troponin I elevation remained mildly elevated. She had no EKG evidence of transmural infarction, and once she had returned to normal sinus rhythm her focal EKG changes remained but were attenuated compared to those seen initially. 

By the Universal Definition of Acute Myocardial Infarction, (www.escardio.org/guidelines-surveys/.../guidelines-universal-MI-slides.pdf), this patient had a so-called Type II AMI , i.e., rather than the AMI being a consequence of plaque rupture and thrombotic occlusion occurring within the vessel causing focal myocardial injury, the pathophysiological etiology for the myocardial injury signal is due to increased myocardial oxygen demand in combination with inadequate myocardial supply of oxygen and nutrients. Common causes for this pathophysiological state are anemia, arrhythmia (as in this case), hyper- or hypotension, vasoconstriction or arterial spasm. 

I am referred the case, as I did not begin this young lady (75 years of age) on Statin drug therapy since it was a protocol item. The entire implication of a Type II AMI is that is not a consequence of unstable plaque occluding or severely obstructing an epicardial coronary artery. And as such, since it is not the consequence of unstable cholesterol plaque, it is not obvious to a clinical expert in cardiology (that is myself) that statin drug therapy is indicated in this case. That is simply put, anti-cholesterol therapy is not, nor should it be a protocol item for post MI care in the Type II infarct. However, the change in nomenclature and the emphasis on correct pathophysiological characterization of the mechanism of an acute myocardial infarction now threatens the mindless execution of ‘best practices.’


The effect of acute statin therapy on plaque stabilization and prevention of Type I AMI is clear cut and supported by decades of biologically congruent results with powerful clinical data endpoints. Furthermore, because the effects of statins are so immediate in the setting of plaque stabilization, a significant effect of their use is probably related to their anti-inflammatory effects with respect to the vascular system. Thus, the absolute risk:benefit ratio is so highly weighted to treatment that the decision to treat epicardial lesions is virtually axiomatic across all genders and ages of patients. The survival advantage for statin drug therapy with respect to plaque stabilization is immediate and profound and occurs within many studies as soon as 6 months post event.


While the thoughtful use of guidelines to enhance patient care and improve medical outcomes is highly desirable, the mindless pursuit of ‘core measure’ statistics is anathema to the thoughtful physician. By not treating this patient with statin drug therapy I have invoked in my hospital a ream of paperwork designed to ‘improve my practice.’


However, if I had simply followed the guideline my performance would have been ‘perfect’ but my practice thoughtless, flawed, and ‘Galen-istic.’ While statin drugs are for the most part among the safest of all drugs and drug classes there still remain real potential risks with their use.


Since in the patient under discussion the guideline does not apply as the patient has no evidence of unstable plaque as her pathophysiology, could an argument be made for statin drug therapy based on ATP III guidelines?


This particular patient had a lipid profile in which her HDL cholesterol was 54 mg/dl, HDL/Cholesterol ratio was 3.4, and her LDL cholesterol was 119  mg/dl. According to the National Cholesterol Education Program, this patient has a 10 year risk of developing symptomatic CVD (due to epicardial disease - not supply/demand mismatch) of <9%. Furthermore her ATP III LDL goal is <130 mg/dl. Thus, no argument for statin drug therapy can be made based on population normative data and conventional risk assessment.


The PROSPER study (The PROspective Study of Pravastatin in the Elderly at Risk) (Randomized trial of 5,804 seniors age 70-82 years of age) demonstrated an actual cardiovascular death rate of 3.3% among patient’s on statins vs a 4.2% in the placebo group, a 0.9% absolute difference in mortality rate in this age group, with an absolute all-cause mortality rate difference in treatment versus placebo group of 0.2%. As a consequence because of the absence of a clinically significant difference in mortality between treated groups and placebo groups, I find little data to support a cholesterol intervention in this patient based on survival advantage within her age group.


Furthermore, the current patient had advanced COPD, was on home oxygen and is essentially bed-ridden due to her need for continuous oxygen therapy. Echocardiography demonstrates severe pulmonary artery hypertension due to the magnitude of her COPD. Again, we see a patient who is not manifestly obviously directly comparable to or appropriate to treat with guidelines designed to mitigate the effects of elevated cholesterol levels on the survival of predominately middle aged males.


So, in summary, a patient without evidence of unstable coronary plaque, without indication for drug therapy related to a population derived risk assessment, in an age group controversial with respect to absolute survival advantages of statin drug therapy, and with severe co-morbid pulmonary conditions was not treated with statin drug therapy AND the ghost of Galen has pronounced my practice inadequate and deserving of ‘practice improvement.


What is going on here? It seems to me that the more thoughtful your practice, the more headaches will be brought to that practice by those who inexpertly and without art-fullness drive that practice to the 'best practices' if or if not that practice applies to the precise patient in front of you. I am tempted to draw an analogy between the effect of standardization in education methodologies to the attempted standardization in medical treatments. But I will leave that rumination to a future post.   
   

Sunday, June 5, 2011

Babette's Feast Vs McBurger Feast

QUALITY

Webster: "That which makes something what it is; characteristic element; basic nature, kind; the degree of excellence of a thing; excellence, superiority."

OED: "...degree of excellence."

ANSI(American National Standards Institute)/ASQ(American Society of Quality ): "The totality of features and characteristics of a product or service that bears on its ability to satisfy given needs."

ISO (International Standards Organization): "The totality of features and characteristics of a product or service that bear on its ability to satisfy specified or implied needs."

The purpose of a blog, or at least this blog is to allow for this 'voice in the wilderness' to HOWL himself hoarse into the vast sea of largely unseen faces and personalities swimming in the contextual richness of the internet. Therefore, until such time as I have posted comments which allow for expansion of my own personal thoughts enriched by the contributions of others, the posts necessarily deal with my own ever expanding set of pet peeves surrounding largely the modern practice of medicine, as medicine is largely all I do.

From this perspective therefore, I am wondering how Quality in medical practice has morphed from the sense of Webster and the OEM  'excellence' to what I take to mean adequate ('...ability to satisfy specified or implied needs.').

When talking about quality as a statistical and medical concept I am fond of what I characterize as the 'Chef Analogy.' If we are talking about food instead of medical care, the corporatist (American Heritage Dictionary: adj Of, relating to, or being a corporative state or system.') as well as the medical practitioner or the patient all understand that a 'quality' meal means a lot more than defined statistical uniformity. For example, take the most exquisite meal you have ever eaten, or re-watch (or watch if you have never seen it) the sublime 'Babette's Feast'  (Babette's Gaestebud) (http://en.wikipedia.org/wiki/Babette's_Feast) (available on NetFlix as a CD). This sense of the gastronomic as art is in my view the true sense of quality.

Now consider the McDonald's Hamburger. If you factor out changes in the McDonald's menu due to the corporatist desire for cultural relevance (increased sales by accommodation to local tastes (http://en.wikipedia.org/wiki/McDonald's_products_(international)); then quality in the McDonald's  paradigm (or the ISO/ANSI paradigm), means you eat the same 'great burger' if you are 'dinning' in San Bernardino, California (McDonald's Corporate Headquarters) or in Puerto Williams, Chile (gateway to Tierra Del Fuego and Anarctica)( http://www.victory-cruises.com/pwilliams.html).

Thus the concept of 'quality'  in the modernist  sense, means ideally extermination or at a minimum limitation of variation necessary to obtain satisfaction of 'the defined needs of the product.' Thus, nutritional needs are minimally met by the McDonald's burger, while maximizing corporatist profit, and the product (the burger) has zero variation in composition, weight, fat content, etc regardless of where it is served. However, in comparison to Babette's Feast, one can't argue that the McBurger Feast is a quality meal, in that sublime human and artistic sense that Babette's Feast is a once in a life time experience.

Quality in medicine should mean exceptional excellence in providing for the emotional, biological, and social needs of the patient. It should be a complex, integrated, and multidimensional dance in which the patient leads in that dance. The quality clinical encounter is based on mutual trust and respect in which the needs of the one, the patient, out way the needs of the many (in direct opposition to the philosophy that societal needs for rationing trump the individuals needs for an optimal life or a stance antithetical to "Gemeinnutz geht vor Eigennutz" - i.e., the welfare of the nation takes precedence over the selfishness of the individual) or the few (the physician and other health care agents). The role of the physician in this model of health care is to provide via appropriate use of superior technical care, humanistic empathy and personal shamanistic therapeutic power a complete healing of the patient or an effective mitigation of the symptom complexes of the patient.

The current paradigm for medical practice equates 'quality' to adherence to defined expert consensus measures of outcome, or in fact, no measures of outcomes at all, but rather conformance to a defined quality measure usually based on a high level and simplified description of a clinical state, i.e., Acute MI, Pneumonia, CHF, etc. Utilizing this practice paradigm, the care is 'quality care' if the guideline is slavishly adhered to. For example, I am aware of a case of acute MI in which the patient presented to the cardiac catheterization laboratory and had an acute intervention with door to balloon time well below the 90 minute target (no longer target, but absolute goal). However, unfortunately for the patient, the operator under the time pressures of meeting the 90 minute guideline target, became disoriented, and stent'ed a tight lesion which was not in fact the infarct related artery. The patient arrested during the stent deployment in the wrong vessel, coded, was reanimated but left the infarct with a trashed ventricle. All guideline mandated treatments were met in the case, all drugs given and the time lines adhered to. The hospital reported the case and maintained its 100% compliance rate with respect to door to balloon time. From the standpoint of the system, the case was high quality, all guidelines were met. However, accuracy of placement of the stent is not a metric followed by the quality mavens nor is it easily  and reproducibly measured by the nonspecialist.

In a related case, another cardiologist in my community, took a patient urgently to the cardiac catheterization laboratory and emergently stent'ed two vessels, based on the ED MD's interpretation of the EKG as meeting EKG criteria for ST elevation MI. All guideline treatments were meet and the case contributed to the 100% 90 minute balloon to door time metric for the hospital. I saw the patient in cross cover for the interventional cardiologist. The EKG was misinterpreted, it failed to meet criteria for ST elevation MI, the troponin I elevation was minimally increased and stayed 'flat' during multiple subsequent measurements; the patient, an 80 year nursing home patient with advanced dementia had acute urosepsis complicated by early and mild sepsis syndrome which resulted in his mild troponin I elevation. The lesions stent'ed in the cardiac catheterization laboratory were 'significantly narrowed' but had no markers suggesting unstable plaque. This, this arguably needless emergency procedure was defined as demonstrating 'quality' care as defined by the statistical mechanics who are tinkering with the medieval guts of medical care.

These aberrations are tolerated because to the statistical re-engineers of health care, they have an implicit philosophical belief that on average, more good than harm will come from slavish adherence to 'guidelines.' They feel this situation will be much better than the current system in which a master guildsman (the physician) does what (s)he think needs to be done in the individual case dependent on biomedical reasoning and case based decisions. In a real sense the belief system of the management gurus, gurus who largely are either non-physicians or who self select to leave clinical practice is similar to that of the trial lawyer who believes that by fully conforming to the advocacy system, and by doing everything one side can do to not search for the truth, but rather effectively advocate for opposed views, that on average, more good than evil occurs. This idea that justice or clinical effectiveness is dependent on the performance of groups is the hallmark of these perverse doctrines and philosophies. I am reminded of the old joke that defines a statistician as a man who would put his right foot in bucket of boiling water and his left foot in a bucket of ice water and then claim that on average he was comfortable.

Ideally the law should embrace the quest for truth not simply certify 'justice' as the product of the most impassioned and effective advocacy. Similarly, medicine in its purist form, is the effective therapy for the individual patient and his circumstances on the day of his clinical encounter.

Quality medical care, as defined by the Statistical Medievalist is excellence of care for the individual, not acceptable care for the masses. It is fundamentally, the right diagnosis at the right time utilizing the right treatment that is tailored to the individual circumstances and individual features of the unique patient at hand. It is always recommended and delivered with respect to optimization of the individuals health not produced or performed with an eye to what will maximize the medical economics for the entire class of patient's with this diagnosis.

In reality, the cheapest care, the most cost effective care, is the null case, i.e., no care at all. It remains for the physician to remain focused on the care of the individual. It is a violation of the Hippocratic Oath and an abandonment of the Maimonidian principles of compassionate medical practice to place society and its needs in advance of the needs of the individual patient.

Friday, May 27, 2011

A Head Code? A Cardiac Code? A Trauma Code? A Human Code?

A principle impediment to effective modern medical practice is our ever increasing addiction to ‘coded data.’

During my own medical informatics training my mentors extolled the virtue of ‘coded data’ and promised a utopian practice when all parts of the medical encounter were based on the hard ‘coding’ of clinical data.

Certainly compared to back then (1997), we have made enormous leaps in taking the stubborn clinical encounter and transforming it into an industrial process complete with abundantly coded clinical data elements. The engine for this transformation has been the payor’s demands for validation of services and medical necessity. Through the insistence of those that pay of the bills all structured, disciplined, reasoned, and principled resistance to ‘hard coding’ of our patient’s has collapsed and the coding is ongoing at an ever accelerating rate.

Somehow in this process we believe, wrongly in my view, that  we have insight into the patient and the patient’s problems. However, I feel this highly unlikely. Having used various electronic medical record systems since the 1980’s, I find for my own part that I am not edified or enlightened by reviewing the list of ‘coded’ diagnoses that are so popular in EMR systems.

In my own practice, at various times, places, and venues I have and do function as a Hospitalist, Internist, Cardiologist, Critical Care Physician, and Emergency Medicine physician. This is a relatively wide set of clinical roles for one physician, but as Winston Churchill was found of saying, ‘a change is as good as a rest.’

All these roles see the patient encounter and the patient through various different prisms. And it has bothered me greatly over the years, with respect to the EM (Evaluation and Management) codes that we are supposed to define our patient encounters along a continuum of interest that deals with ‘simple problems’ to complex problems. And a central purpose of the modern EMR is to help us elucidate the complexity of our clinical actions in a method akin to that of the old vaudeville joke in which you order a Chinese meal by getting ‘one from column A and one from column B.’

Let me make the heretical assertion, there are no ‘simple’ clinical problems and no simple clinical encounters, there are are only simple minded practitioners. Let me provide for you an example which illustrates this principle... I had in the past, seen a simple sore throat, which was seen several hours earlier by a colleague. The mother brought the child for re-evaluation within 6 hours of the first evaluation, risking the ire of the ER staff, because the baby had not yet improved.

I know for those of you who work in Emergency Departments, you can readily hear in the background of your minds eye (forgive the mixed metaphor) that droning Greek chorus of staff voices, decrying the stupidity of the mother for re-evaluation, after all, she just barely picked up the antibiotic and had just barely given the child the first dose.

I entered the room, and found a two month old waif of a child, appearing desperately ill, ice-pale in color, listless and uninvolved in her surroundings. Her abundant and easily palpable lymphadenopathy had the quality and feel of large shooter marbles, locked and immobile in the soft tissues of her neck. Terrifying to find and terrifying to feel. The lymphocyte count astronomical, the platelet count nearly undetectable, she was induced that evening for treatment of her acute lymphocytic leukemia.

I am sure that the time I spent with the child was not much less than that spent by my colleague earlier that day, but my encounter was complex, his was simple. Or was my encounter also simple? And was I guilty of ‘up coding.’ It was the same patient, the same problem, the same exam, the same day. What gives here, should the payor have to pay for the encounter twice? Should they disallow (or did they disallow - I don’t know) the charges for my visit? The widget (the patient) had been processed once that day, why pay for a second look?

In fact, the case illustrates some profound truths about the central depravity of ‘coding.’ I am, you are, any practitioner is paid just as handsomely or poorly as befits your perspective, for being wrong as for being right. Furthermore, as you probably can imagine from your own practice, being wrong is generally more profitable and more expedient and expeditious than being right.

This thought and realization drives me middlingly crazy, that I would be paid as much for being wrong (something that usually takes very little time) as I am for being right. Since being right will take a real history accomplished in partnership with a real human who is generally unaccustomed to medical technical lingo, and a careful and thoughtful physical examination. But so perverted are the incentives in medical care, that to do a careful, systematic, and thorough job of clinical evaluation, prior to the laboratory panels, or imaging studies, dooms yourself to business extinction.

Here is a useful model of medical work....



It is my own extensions to and representation of the classical bio-psycho-social model of medicine. It is the closest thing to which I can profess to believe in with religious intensity. And within that rich gruel-like milieu of my patient and his/her symptoms, lies the interlocking components and interactions of biological (dys)function, psychological (mal)adaptation, social context, spiritual and existential meaning... all swimming in the sea of his/her culture. What is it about this contextually rich, experientially diverse, and philosophically complex phenomena, the patient;  that allows for some to see a ‘simple problem’ definable and solvable in 15 minutes?

I once calculated (forget the methodology) that I have had perhaps 60,000 plus unique patient encounters, God help me if I ever saw any one of them as anything other than what Churchill so eloquently described, “ A Riddle, Wrapped In A Mystery, Inside an Enigma.’ Left to my lifetime, any one of them could have taken my lifetime to describe and to understand.

But the practicalities are we do the best we can not having a life time to study the one. But, let us please stop for a moment and contemplate in full Shakespearean depth and profundity the glory of each individuals life, the uniqueness of their illness and ultimately the loneliness of their passing.

It is in what I call privately the Maimonidesian dimension of medical practice that I struggle to stay focused when being forced to live in a world of clinically based economic ‘reality.‘ For it is the most human part of the practice of medicine to uniformly recall in all ‘patient encounters’ that ultimately the patient is ‘a fellow creature in pain.’