European health care systems are already awash in “big data.” The United States is rushing to catch up, although clumsily thanks to the need to corral a century’s worth of heterogeneity. To avoid confounding the chaos further, the United States is postponing the adoption of the ICD-10 classification system. Hence, it will be some time before American “big data” can be put to the task of defining accuracy, costs and effectiveness of individual tests and treatments with the exquisite analytics that are already being employed in Europe. From my perspective as a clinician and clinical educator, of all the many failings of the American “health care” system, the ability to massage “big data” in this fashion is least pressing. I am no Luddite – but I am cautious if not skeptical when “big data” intrudes into the patient-doctor relationship.
The driver for all this is the notion that “health care” can be brought to heel with a “systems approach.”
This was first advocated by Lucien Leape in the context of patient safety and reiterated in “To Err is Human,” the influential document published by the National Academies Press in 2000. This is an approach that borrows heavily from the work of W. Edwards Deming and later Bill Smith. Deming (1900-1993) was an engineer who earned a PhD in physics at Yale. The aftermath of World War II found him on General Douglas MacArthur’s staff offering lessons in statistical process control to Japanese business leaders. He continued to do so as a consultant for much of his later life and is considered the genius behind the Japanese industrial resurgence. The principal underlying Deming’s approach is that focusing on quality increases productivity and thereby reduces cost; focusing on cost does the opposite. Bill Smith was also an engineer who honed this approach for Motorola Corporation with a methodology he introduced in 1987. The principal of Smith’s “six sigma” approach is that all aspects of production, even output, could be reduced to quantifiable data allowing the manufacturer to have complete control of the process. Such control allows for collective effort and teamwork to achieve the quality goals. These landmark achievements in industrial engineering have been widely adopted in industry having been championed by giants such as Jack Welch of GE. No doubt they can result in improvement in the quality and profitability of myriad products from jet engines to cell phones. Every product is the same, every product well designed and built, and every product profitable.
If patients were widgets, if care givers were production workers, and if caring conformed to “six sigma” principals, even slight deviations from standards of care would be as easy to recognize, those responsible could be singled out for improvement, and remedies would be obvious. This is the mantra of the quality agenda that drives health policy. In a corollary exercise in linguistic determinism, health economists and hospital administrators are wont to speak of patients as “units of care”, physicians as “providers”, and clinical demand as “throughput.” But manufacturing cell phones or producing fast food has little in common with managing the care of patients in all their variability and with all their unpredictability. No clinical metric conforms to a six sigma standard; we in medicine are barely comfortable defining “normal” with a 95% confidence interval and we are fully aware that “outliers” can be clinically normal and those in the normal range can be abnormal. Forcing the clinic into the six sigma paradigm is worse than an exercise in futility; it is an exercise in iatrogenicity. To wit:
It was the end of a long day in clinic a couple of weeks ago. I found myself sitting next to a colleague, a young, talented and well-read academic orthopedic surgeon. Each of us was staring at a computer screen displaying our “Physician’s Dashboard”, the gateway to the granularity-generating Electronic Medical Record (EMR) purveyed by EPIC. EPIC is a privately-held, exceedingly profitable company that dominates the multi-billion dollar EMR marketplace. Both of us are novitiates with the interface; UNC Hospitals only recently “went live” with EPIC at great cost in terms of personnel time and in terms of hundreds of millions of dollars. I was grumbling as I fought with the program to create a clinically useful medical record for the sake of the patients I had been seeing that day. My surgical colleague urged me to create templates and “smart sets”; he found EPIC easily manageable thanks to these short-cuts to record keeping which took advantage of any and all aspects of patient care that were stereotypical.
First, I took him to task on behalf of my patients. I explained that for a rheumatologist like me, and all others who are labeled “cognitive” specialists, the care of the patient revolves around the “granularity” of the narrative. I needed to listen actively to my patient to understand the particular idioms that populate any narrative of distress. And I need to communicate the approach the patient and I would take to sorting out the illness and formulating management to all involved in this patient’s care. It is an exercise that takes advantage of individual differences and idiosyncrasies rather than pummeling narratives into common denominators. I never assume the average, nor do I ever presume the outcome. Templates and “smart sets” are anathema.
Next, I took him to task on behalf of his patients. Most “interventionalist” physicians and surgeons think in terms of the average, the usual, and presume the outcome. It’s the old adage about having a hammer. However, this is a mindset that is a disservice to patients seeking elective orthopedic solutions. One of the greatest advances in clinical medicine in my 45 years as a physician is not a product of laboratory science or translational research; it’s a product of life-course (“social”) epidemiology. We are now advantaged by a rich literature addressing the experience of “health”. It turns out that many a person in the community is coping effectively with the same physical predicaments that others find so overwhelming as to feel the need to seek medical advice. That’s true of heartache, headache, heartburn, and so much more including the experience of regional musculoskeletal pain, which are the most frequent complaints voiced in the primary care setting and the reason for most orthopedic consultations. I coined the term “regional musculoskeletal disorders” 30 years ago to denote localized musculoskeletal discomfort and impairment experienced by working-age adults who were otherwise well and who suffered no traumatic precipitant. Regional musculoskeletal disorders are intermittent predicaments of life. If one goes a year without an important episode of low back pain, that’s abnormal. For knee or neck/shoulder/arm regional disorders, we should not be surprised by an episode during the course of 3 years. It was clear even 30 years ago that a central, often the central clinical issue was not the region that hurts, but what is it about this episode that proved so overwhelming that this person chose to be a patient?
This perspective has revolutionized our understanding of the illness that presents as back pain. However, I chose knee pain as the object lesson for my colleague. We’ve long known that elderly women with regional knee pain who remain people cannot be distinguished from similar women who choose to be patients with knee pain by the quality of the pain, the consequent incapacity, or by features discerned on physical or radiologic examinations. Affective challenges are far more likely the distinguishing features. There is a prominent case report that is relevant to this insight. It is tucked into the August 13, 2012 issue of the New Yorker, in “Big Med,” an article written by Atul Gawande. I have had numerous interchanges with Atul going as far back as his earliest article in the New Yorker in 1998, an article titled “The Pain Perplex.” Atul is a distinguished endocrine surgeon, a brilliant student of health policy as it relates to surgical practice, and an outstanding commentator. In “Big Med” he calls for standardization of medical practice, particularly surgical practice, in a fashion he likens to the line chefs in the Cheesecake Factory restaurant chain. He offers an example of the value of such standardization: the way he chose the orthopedist to operate on his recently widowed mother’s painful knee. No doubt, the procedure was performed in a technically exemplary fashion. Need I say more?
That brings us to the “forest” that is missed in any exercise that demands one parse clinical predicaments to create the granularity required to harvest “big data.” Nothing about this granularity can obviate the need for the person who chooses to be a patient to be advantaged by a discussion with the physician in the context of an empathic therapeutic relationship. “Big data” does not recognize or serve this relationship. It may facilitate invoicing, it certainly creates a new, self-serving industry, but it is a hazard for patient care.