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Monday, October 6, 2014

"We really aren't taking care of 'records,' we're taking care of PEOPLE" Lawrence Weed, MD, 1971

0:33: What I’d like to do is go at this problem not from the point of view of the record — I mean, we really aren’t taking care of the records, we’re taking care of people, and we’re trying to get across the idea that this record cannot be separated from the care of that patient. This is not something — the practice of medicine over here, and, and the record over here. This [holds up chart binder] IS the practice of medicine. It’s intertwined with it, it determines what you do in the long run. You’re a victim of it, or you’re a triumph because of it. The human mind simply cannot carry all the information about all the patients in a practice without error, and so, the record becomes part of your practice...
@10:44: "So, a source-oriented record is essentially useless, from the point of view of a rigorous audit. And, if you cannot audit a thing for quality, it means that you do not have the means by which to produce quality.
They're inextricably intertwined also.
If you can't evaluate what you're doing, then there's a very serious possibility you do not know what you're doing, and that you've never defined your goal..."
Music to my ears. See POMR (Problem-Oriented Medical Record). Watch all 54 minutes.

The issue to which he refers is not unique to medicine. My wife is Corporate Director of Quality for Gilbane Federal (formerly ITSI, a construction and environmental remediation firm). I played this clip for her. Physicians are not the only ones who think their expertise and consequent putative professional "autonomy" exempts them from the drudgery of complete, accurate, and timely documentation (digital or otherwise), and that all mandates governing "auditability" are irritating, nonsensical interference by those "who have never treated a patient" (or built a building).

Cheryl is unfazed. She wears a pink hardhat on the job sites (seriously). Many a Bubba has come to rue the day he locked horns with that Skirt. :)

Below, from the Weeds' seminal "Medicine in Denial" which I have cited repeatedly on this blog.
“A culture of denial subverts the health care system from its foundation. The foundation—the basis for deciding what care each patient individually needs—is connecting patient data to medical knowledge. That foundation, and the processes of care resting upon it, are built by the fallible minds of physicians. A new, secure foundation requires two elements external to the mind: electronic information tools and standards of care for managing clinical information. 

Electronic information tools are now widely discussed, but the tools depend on standards of care that are still widely ignored. The necessary standards for managing clinical information are analogous to accounting standards for managing financial information. If businesses were permitted to operate without accounting standards, the entire economy would be crippled. That is the condition in which the $2½ trillion U.S. health care system finds itself—crippled by lack of standards of care for managing clinical information. The system persists in a state of denial about the disorder that our own minds create, and that the missing standards of care would expose.

This pervasive disorder begins at the system’s foundation. Contrary to what the public is asked to believe, physicians are not educated to connect patient data with medical knowledge safely and effectively.” [pg. 1]...
Medical decision making requires sorting through a vast body of available information to identify the limited information actually needed for each patient.  That individually-relevant information must be applied reliably and efficiently, without unnecessary trial and error. This requires highly organized analysis. Educated guesswork is not good enough...
Any system of care that depends on the personal knowledge and analytic capacities of physicians cannot be trusted. And even if basic information processing by physicians could somehow be improved to the point where it is trustworthy, the supply of physicians would remain scarce and expensive. It is a utopian fantasy to think that health care will ever be universally reliable, affordable, and accessible if highly educated, highly compensated physicians are always essential to its delivery. 
The traditional concept of the learned physician is not workable. The concept is that applying advanced medical science requires practitioners who have passed through an extraordinarily prolonged and expensive ordeal of  education, apprenticeship and credentialing. But precisely the opposite is the case. Medical training in its current form is not only unnecessary but incompatible  with scientific rigor. Applying complex medical science to unique patients in all their infinite variety under real-world time constraints demands information processing beyond the capacity of anyone, no matter how gifted, well schooled or experienced. And that would be true even in a best-case scenario where all physicians performed at their peak. Many physicians perform at less than their peak, not only those who succumb to depression and substance abuse but also those who are coping with impossible burdens... [pp. 28-30]
I would make Medicine in Denial required reading in the first year of medical school.
The religion of medicine is not feats of intellect. The religion of medicine is helping to solve the problems of patients, and the compassion involved in the very act of care. But helping patients in the name of caring or compassion may do more harm than good, if the help is not competent. And competence in the face of complexity requires practitioners to use external tools, tools “that are dumb, but speak.” [pg 31]
Props to Art Papier, MD, for the heads-up and the link. Below, a video pitch piece about Dr. Papier's company VisualDx.

I'm not touting it at this point, just citing it (uncompensated and unsolicited). Investigate and make up your own mind

apropos, from MedScape (requires free registration):
Can Our Brains Handle the Information Age?
...By some estimates, the amount of scientific and medical information produced in the last 25 years is equal to all of the information in all of human history up to that point.
The human brain can really only attend to a few things at once, so I think we are reaching a point where we have to figure out how to filter information so that we can use it more intelligently and not be distracted by irrelevant information...
Medscape: It's a common concern that physicians are becoming overreliant on technology to access information. Do you think the fact that doctors no longer have to memorize, say, dosages does a disservice to patients? Or might externalizing information to computers and smartphones free up valuable neurologic resources that could be used for something else? 

Dr Levitin: I see it as a good thing—I don't want to rely on a doctor's memory. It's not that doctors have bad memories, it's that we all have bad memories. It has been shown many, many times that memory is fallible. I want to be able to rely on my doctor as having an exquisitely tuned pattern recognition system so that when I walk in the door and he sees a cluster of symptoms, he puts it all together in a pattern-matching algorithm in his brain and says, you know, I think we should run this test, and you might have this, and this is what I think is going on from a diagnostic standpoint...
I just downloaded Dr. Levitin's new book, and will study and report on it.

We humans have a long history of pursuing neural enhancement— ways to improve the brains that evolution gave us. We train them to become more dependable and efficient allies in helping us to achieve our goals. Law schools, business schools, and medical schools, music conservatories and athletic programs, all strive to harness the latent power of the human brain to deliver ever higher levels of achievement, to provide an edge in a world that is increasingly competitive. Through the sheer force of human ingenuity, we have devised systems to free our brains of clutter, to help us keep track of details that we can’t trust ourselves to remember. All of these and other innovations are designed either to improve the brain we have, or to off-load some of its functions to external sources...

Finished reading. Another fine book.
Quick excerpt:
The biopsy analysis involves human judgment and what amounts to a “Does it look funny?” test. The pathologist or histologist examines the sample under a microscope and notes any regions of the sample that, in her judgment , are not normal. She then counts the number of regions and considers them as a proportion of the entire sample. The pathology report may say something like “5% of the sample had abnormal cells” or “carcinoma noted in 50 % of the sample.” Two pathologists often disagree about the analysis and even assign different grades of cancer for the same sample. That’s why it’s important to get a second opinion on your biopsy— you don’t want to start planning for surgery, chemotherapy, or radiation treatment until you’re really sure you need it. Nor do you want to grow too complacent about a negative biopsy report.

To stick with the prostate cancer example, I spoke with six surgeons at major university teaching hospitals and asked them about the risks of side effects from prostate biopsy. Five of them said the risk of side effects from the biopsy was around 5%, the same as what you can read for yourself in the medical journals. The sixth said there was no risk —that’s right, none at all. The most common side effect mentioned in the literature is sepsis; the second most common is a torn rectum; and the third is incontinence. Sepsis is dangerous and can be fatal. The biopsy needle has to pass through the rectum, and the risk of sepsis comes from contamination of the prostate and abdominal cavity with fecal material. The risk is typically reduced by having the patient take antibiotics prior to the procedure, but even with this precaution, there still remains a 5% risk of an unwanted side effect...
Two of the physicians sheepishly admitted that they deliberately withhold this information. As one put it, “We don’t mention these complications to patients because they might be discouraged from getting the biopsy, which is a very important procedure for them to have.” This is the kind of paternalism that many of us dislike from doctors, and it also violates the core principle of informed consent...
Plugging these numbers into the binomial calculator, we find that if you have five biopsies, the probability of having a side effect at least once is 23%.
Of the five surgeons who acknowledged that there was a 5% risk of side effects from the prostate biopsy, only one understood that the risk increased with each biopsy. Three of them said that the 5% risk applied to a lifetime of having biopsies— you could have as many as you want, and the risk never increased.

I explained that each biopsy represented an independent event, and that two biopsies presented a greater risk than one. None of them were buying it. The first of my conversations went like this:
“I read that the risk of serious complications from the biopsy is five percent.”
“That’s right.”
“So if a patient has biopsies five times, that increases their risk to nearly twenty-five percent.”
 “You can’t just add the probabilities together.”
“I agree, you can’t. You need to use the binomial theorem, and you come up with twenty-three percent— very close to twenty-five percent.”
“I’ve never heard of the binomial theorem and I’m sure it doesn’t apply here.""I don’t expect you to understand this. It requires statistical training.”
“Well, I’ve had some statistical training. I think I can understand. What is it you do for a living again?”
“I’m a research scientist— a neuroscientist. I lecture in our graduate statistics courses and I’ve published some statistical methods papers.”
“But you’re not an MD like I am. The problem with you is that you don’t understand medicine. You see, medical statistics are different from other statistics.”

“I’ve had twenty years of experience in medicine. How much have you had? I’m dealing in the real world. You can have all the theories you want, but you don’t know anything. I see patients every day. I know what I’m seeing.”
Levitin, Daniel J. (2014-08-19). The Organized Mind: Thinking Straight in the Age of Information Overload (pp. 244-247). Penguin Group US. Kindle Edition.
Recall? (from SBM) "The three most dangerous words in all of medicine are 'in my experience'."

The issues (opportunities?) are manifold. Health IT simply must be (re?) designed in ways that support effective clinical decisionmaking (see Dr. Carter's EHR Science work), but accurate clinical dx reasoning goes well beyond IT systems to the very pedagogy of medical education itself (not to mention the actual day-to-day in-the-trenches culture of clinical organizations and the non- patient-centered business paradigms within which they must function). Messrs. Weed address many of these issues in substantive detail in Medicine in Denial.

What doctors offer

The fact is that if you have something wrong with you, you don’t go running to a statistics book, you go to a doctor. Practicing medicine is both an art and a science. Some doctors apply Bayesian inferencing without really knowing they’re doing it. They use their training and powers of observation to engage in pattern matching— knowing when a patient matches a particular pattern of symptoms and risk factors to inform a diagnosis and prognosis.

As Scott Grafton, a top neurologist at UC Santa Barbara, says, “Experience and implicit knowledge really matter. I recently did clinical rounds with two emergency room doctors who had fifty years of clinical experience between them. There was zero verbal gymnastics or formal logic of the kind that Kahneman and Tversky tout . They just recognize a problem. They have gained skill through extreme reinforcement learning, they become exceptional pattern recognition systems. This application of pattern recognition is easy to understand in a radiologist looking at X-rays. But it is also true of any great clinician. They can generate extremely accurate Bayesian probabilities based on years of experience , combined with good use of tests, a physical exam, and a patient history.” A good doctor will have been exposed to thousands of cases that form a rich statistical history (Bayesians call this a prior distribution) on which they can construct a belief around a new patient. A great doctor will apply all of this effortlessly and come to a conclusion that will result in the best treatment for the patient.

“The problem with Bayes and heuristics arguments,” Grafton continues, “is they fail to recognize that much of what physicians learn to do is to extract information from the patient directly, and to individualize decision-making from this. It is extremely effective. A good doctor can walk into a hospital room and smell impending death.” When many doctors walk into an ICU room, for example, they look at the vital signs and the chart . When Grafton walks into an ICU room, he looks at the patient, leveraging his essential human capacity to understand another person’s mental and physical state.

Good doctors talk to their patients to understand the history and symptoms. They elegantly use pattern matching. The science informs their judgments, but they don’t rely on any one test... [ibid, pp. 248-249]


Dr. Papier alerted me to this initiative. I support the intent here. It deserves a permanent link in my right hand links column. They're producing a documentary focused on changing the medical dx paradigm, based in large measure on the pioneering work of Dr. Weed.
From the beginning, physicians are trained to gather and memorize medical knowledge.  And while the doctors’ mind is an essential component to this training, the mind can fail.  It is susceptible to the same limitations, confusion, biases and inaccuracies that plague the rest of us.

Yet, physicians are expected to know what is wrong with us and this impossible challenge leaves patients in great danger and doctors with an incredible psychological burden.

There is an incredible chasm between the amount of knowledge required to practice medicine safely and the capacity of the human mind to process it.  Doctors care deeply about their patients and want to do the right thing.  How can we bridge this gap?

The film was inspired by the life and work of Dr. Larry Weed who is now 89 years old and living in Vermont.  Dr. Weed has been trying to fix the fundamental problems with the practice of medicine for the last 50 years. The road has not been easy.  He shows us that these ideas were first discussed more than 400 years ago by the philosopher Francis Bacon and many others, but they have not gotten any better--at all.  Despite his deep beliefs and convictions, Dr. Weed has met many obstacles in his crusade to fix the system over the last 5 decades.  You will be drawn to the passion and compassion of Larry Weed and amazed by the clarity of his ideas.  As the filmmakers were first inspired to document this story, you will be inspired to learn more.  You will ask, "why have I never thought about this before?" and hopefully, you will never forget the lessons learned in this film.

In the lead up to this project, the filmmakers have worked closely with professors who study diagnostic error, with educators struggling to teach capable students, with physicians who feel the burden of responsibility and have felt the sting of failure, and most importantly with patients and families who have suffered deeply as a result of the problems in the medical system first hand.  The film is about ideas that are much bigger than Larry Weed, the filmmakers, or any of the individuals in the film.  It is a film about real problems in the practice of medicine that may affect you or someone you love soon.
Pay it forward. BTW: For more on my musings on the philosophical history underpinning medical art and science, see my earlier post Philosophia sana in ars medica sana.

This potential for digital information processing to advance medical decision making is obvious. Perhaps less obvious is the potential to advance medical knowledge itself. Just as instruments like the microscope and the telescope revealed whole new worlds for observation in science, so instruments for processing information can radically expand the scope of usable knowledge and data for comprehension in medicine. Increasingly, medical knowledge will encompass not just generalizations about large populations (a form of knowledge relatively accessible to the unaided mind) but also enormously detailed understanding about the infinite variety of unique individuals (a form of knowledge the mind needs external aids to comprehend). Coping with this complexity is becoming more and more essential, as genomics and proteomics are creating detailed new data about every individual and correspondingly intricate bodies of knowledge (see part VII).

The culture of medicine has yet to confront these realities. Physician training, credentialing and functioning remain fundamentally unchanged—even though cognitive error in medicine is now recognized as epidemic, even though consensus has developed on the need for electronic medical records and other “health information technology,” even though health care institutions increasingly use digital technologies for storing, retrieving and communicating information, even though practitioners and patients use the Internet to gain unprecedented access to medical knowledge, and even though health information networks are being developed to permit interoperability among disparate systems and institutions. Despite these advances, the physician’s mind remains heavily burdened with the core function of processing information—applying comprehensive general knowledge to inform selection and analysis of patient-specific data—even as the new technologies accelerate information overload. This is a burden too great for the human mind to bear.
Placing this burden on the mind completely undermines order and transparency in medical decision making. The mind is variable, idiosyncratic, inefficient, unreliable and opaque when attempting to process detailed information on the fly. Unavoidably, the mind introduces disorder... [pg 32]
"Unavoidably, the mind introduces disorder." I will connect up some of these dots with Dr. Levitin's book shortly, once I have finished it. See also my citation of Marx's "Whack-a-Mole: The Price We Pay For Expecting Perfection" (scroll down in the linked post).

Of additional central relevance apropos of this theme are the works of Jerome Carter, MD at the excellent blog EHR Science:
"Given the troubles that are plaguing EHR vendors in meeting MU stage 2 requirements, this seems like a good time to talk about what goes into building a system that supports clinical care. “Tweaking” a complex software system is not a good approach for adding features. It is sort of in the same category as knocking down a wall to enlarge a room.  Sometimes it’s okay, and sometimes there is a cave-in and a lot of noise. Complex software systems are designed holistically; they have an architecture and are designed to meet a specific set of requirements. Once a system is built, changing the requirements too much, too quickly, or both can cause problems. Imagine what happens when a third floor is added to a building that was designed to support only two.

Creating clinical care systems that support clinical work requires not only a huge up-front effort to determine what the system should do and how it should be structured, but it also requires a design that can accommodate change gracefully (or at least as gracefully as possible). In the case of clinical care systems, this means examining in detail a range of issues from the highest level, such as users, the work they do, and the environments they work in, down to low-level matters, such as data element names and audit trail designs. As I have stated in previous posts, there is not enough public discussion on clinical software design principles, methods, techniques, etc. Public discourse concerning EHR systems needs to move beyond who likes their system and who does not.  It is time to acknowledge the inherent complexity of systems that support clinical work and approach their design and implementation accordingly."


From a "58 stakeholders" letter circulating in Congress (pdf):
Dear Member of Congress:
The undersigned organizations urge Congress to act this year to provide clarity and certainty for appropriate, risk-based oversight of health information technology (IT).

The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 called upon the Administration to provide recommendations to Congress on an appropriate risk-based framework. With the release of the recommendations in April, it is now time for lawmakers to pass legislation that achieves the complementary goals of protecting patients, ensuring safe and effective care, and fostering continued innovation in the rapidly-growing health IT field... 

Considering the vast potential for improved outcomes, enhanced patient safety, and reduced costs, we hope the Administration and Congress will work together to pass legislation this year to clarify the lines of regulatory jurisdiction by updating the law under which health IT is currently regulated. FDASIA clearly lays out a multi-step process consisting of recommendations by the Administration to Congress (the FDASIA Report), followed by Congressional action, informed by those recommendations, to effectuate changes to ensure an appropriate regulatory framework for health IT...
There has long been grumbling about what is viewed in many quarters as inadequate ONC and CMS "regulation" of Health IT, with the more strident, partisan critics calling all EHRs "inherently dangerous unregulated medical devices." Be interesting to see whether this effort gets any traction. I'm a bit skeptical at this point. But, rational, effective regulation is in fact needed, particularly as it pertains to "interoperability" (regarding which I've written at some recurrent length) and the ever-present patient safety concerns.


Props to SearchHealthIT
It's time for billionaire EHR vendors to stop crying poverty, stop hiding behind proprietary data standards, and work together for the benefit of patients. Bake interoperability into the system. Health data should work like the Web works: You make the browser, we own the data. Vendors should be mindful of the fact that no politician, regardless of stripe, loses a vote when standing up for patients. When healthcare costs get reduced in the process, that's double the reason to invoke the long arm of the law and solve health data interoperability once and for all.

Really, the only matter left to resolve is if the EHR vendors who aren't playing well in the interoperability sandbox will come willingly, or if it will take a fight.
Are current expectations for interoperability nearsighted?
Kyle Murphy, PhD,

An uncomfortable truth is that medical mistakes are normal. Errors, like this one in Texas, have occurred since doctors started treating patients. The good news is that technology has made medical care better. No credible person suggests a return to the paper-chart era. Yet, it is still our duty to face mistakes, learn from them, and in so doing, improve future care. Being honest about root causes is necessary.
apropos of my prior post. Props to THCB.

More to come...

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