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The Meaning of “Value” in Health Care

Paul KeckleyThere are terms in healthcare circles that get thrown around as if there’s a common and widely accepted definition.

Consider “quality:” every hospital touts its quality, every physician confidently affirms their delivery of high quality care, and every trade and professional sector in healthcare has its own definition that aligns with attributes of quality they deem most important. “Quality” is touted on every website and in every boardroom, but rarely is it defined and measured consistently.

“Outcomes” is another. Most ascribe positive outcomes in their performance, but the indicators on which they’re based and the time periods over which they’re captured—days, weeks, months, or years—varies from user to user. Valid and reliable measures are ephemeral: process measures are used more frequently because they’re easier for regulators, policymakers and payers to monitor; i.e. “advising a patient to stop smoking or lose weight” but these may have little to do with the actual outcome.

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On the Preventability of Lethal Errors: A Response to Dr. Koka

In my opinion, the title of Dr. Koka’s post (“Very Bad Numbers“) is far too inflammatory for a subject that needs to be taken seriously. Dr. Koka’s summary of the approach I took in my JPS study is a reasonable summary, minus a few key points. Preventability of lethal errors is the problematic issue. The nine authors of the Classen paper did postulate that virtually all serious adverse events they found are preventable; I did not pull this out of the air. Preventability is a highly subjective area. A few years ago everyone assumed that hospital acquired infections were simply the cost of doing business. Now we know that the majority of infections can be prevented. The major difference Dr. Kota and I have is that he wants to rely exclusively on the Landrigan study, which is an excellent and large study, but it is not representative of the nation. It represented hospitals in North Carolina. That state was chosen because it was much more aggressive in efforts to reduce medical harm than the average state in the nation. The OIG study (2010) was in fact an attempt to be representative of the Medicare population across the country, but it is just Medicare beneficiaries. As I noted in my paper, none of the four studies can stand alone, not even the Landrigan paper.Continue reading…

The Healthcare System Link in the San Bernardino Shootings

Screen Shot 2015-12-02 at 4.08.30 PMAnother day, another mass shooting. At this point the news reports say nearly 30 down, 14 or more dead, multiple perps, at a banquet for the San Bernardino, California, Department of Public Health.

And instantly the argument is all about the guns. I understand that, and I’m not even saying that it’s not about the guns.

And instantly we want to say these folks are crazy and of course that’s true. It doesn’t matter if they frame their reasons around Allah or “no more baby parts” or Obama’s impending takeover of the U.S. using ISIS fascist armies disguised as Syrian refugees pouring over the border from Mexico, doesn’t matter. Anyone who turns a gun on other human beings in a school, a clinic, a public street is we can safely say, nuts, if “nuts” has any real meaning any more.

But there are crazy people in every culture, and we have always had crazy people in ours. The percentage of people who are crazy does not scale across societies and across time with the number of people walking into theaters, malls, and bus stations with guns blazing.

Even the number of guns per capita, or the caliber and size of magazines people can buy, or the rules around buying them do not scale directly with mass violence. There is something else going on here.

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Rethinking our Thinking about Diagnostic tests: There is nothing Positive or Negative about a Test result

Making a diagnosis is easy if the test we use to make the diagnosis defines the disease. These sorts of tests, called “reference-standard” tests, when present at any level of the test’s result, make the diagnosis. A spinal fluid culture growing listeria or opioids in the urine are examples.

Using reference-standard tests in clinical medicine, however, is not the norm. The reason for this is that reference-standard tests often don’t exist and if they do they may be dangerous, difficult to obtain, and costly. Hence, we use most often non-reference standard tests that can only raise or lower the likelihoods of diseases. There is nothing particularly new in these comments. Every reader will know such concepts as, the “sensitivity and specificity” of a test. Every reader will remember hearing about, or be able to construct, 2X2 tables showing the sensitivity of a test; the corresponding false negative percent; the specificity of the test; the corresponding false positive percent.

But, despite the ever-present teaching of how tests ‘work”, it is my experience that physicians and patients have difficulty using the measures of a test’s value in clinical care. This difficulty is manifest in the observation that diagnosis mistakes may be common and the perceived mistake is the inciting event in up to 40% of malpractice cases. If the conceptual ideas for appropriate test characteristics are so clear and well taught, why is there so much difficulty in using tests to make a correct diagnosis? I contend that the way we teach and understand testing has not allowed us to advance an ideal, numerate approach to accurately making a diagnosis. I claim, also, that the concept of a single “sensitivity and specificity” for a test is actually suspect, even incorrect.

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Very Bad Numbers

flying cadeuciiThe date is July 17th, 2014. It is 10am in the Dirksen Senate building, and the congressional subcommittee on health and aging is about to focus on patient harm. The educating will be done by some of the leaders in the medical field, Ashish Jha and Tejal Gandhi from Harvard, Peter Pronovost from Johns Hopkins. The star of the proceedings is John James, a toxicologist, a PhD from Texas, and the founder of Patient Safety America.

The tone is set from the beginning by none other than Bernie Sanders. In somber tones, he relays that hospitals can make patients worse, and that a recent study suggests medical errors is America’s third leading cause of death behind only heart disease and cancer. Hospitals are killing patients, and something needs to be done about it. The panelists then go on to speak strongly about the ongoing epidemic of patients dying in hospitals, and re-enforce the staggering numbers introduced by Bernie Sanders.

Headlining the proceedings is an unassuming gentleman named John James. He has a Ph. D in pathology, and he worked as a Chief Toxicologist at NASA. He is at the congressional proceedings, and is one of the lead activists in patient safety because of personal tragedy. His 19 year old son died in the summer of 2002 due to “uninformed, careless, and unethical” care by cardiologists. He proceeded to write a book, “A Sea of Broken Hearts” that details the errors he believes cardiologists made in his son’s care that lead to his death. Of note 2 cardiologists that were sought by Dr. James’ lawyers believe the care his son got did not violate the standards of care. A further 2 appeals to the Texas Medical Board also rendered two opinions from two other separate cardiologists that the standards of care in this case were not only met, but exceeded. Dr. James, armed with information he has carefully selected from a number of different sources, strongly disagrees.

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A Home for Orphan Wearables

How many people do you know who’ve bought a Fitbit or similar device to track their exercise patterns–who have then let the whole venture lapse? The Fitbit now resides comfortably and peacefully in their drawer!

Well, there’s a useful way to recycle them, offered by Tufts University professor Lisa Gulatieri. As noted in this article:

Gualtieri started RecycleHealth in April with the goal of giving unused activity trackers — mostly Fitbits so far, but RecycleHealth accepts all devices — a second life. The company has collected about 20 devices so far and has plans to donate them to the Montachusett YMCA in Fitchburg, Massachusetts, where they will be used to help older and lower income individuals have access to devices, as well as to learn about how those populations interact with activity trackers.

Check out the Facebook page for stories on how the idea is spreading, plus more information, including how to get free mailing labels.

 Paul Levy is the former CEO of BIDMC and blogs at Not Running a Hospital, where an earlier version of this post appeared. 

A Usability Conundrum: Whether it is EHRs or Hospital Gowns, One Size Never Fits All…

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Building clinical care systems that intimately support clinical work has to begin with the acknowledgement that clinicians perform many tasks within the context of a patient encounter, and those tasks very in type, number, and sequence.   Everyone knows this. So, one might ask, if this is common knowledge, why are there so many problems with EHR usability? The answer is very simple.   EHR systems are designed to be one-size-fits-all.

One-size-fits-all (OSFA) is such a fundamental precept of EHR design that no one even questions it.   Instead, there is a pursuit of every possible means of fixing EHR systems, while allowing them to remain OSFA. Why? Because it is a design assumption carried over from past software design/development limitations.   Achieving the highest possible level of usability requires dumping deeply-ingrained OSFA thinking.

How did OSFA become so entrenched in EHR designs? Here are the main reasons.

 Poor choice of design metaphor
Paper charts are the inspiration for current EHR systems.   Charts are OSFA. No clinician was allowed to customize the chart to fit his/her personal work habits or information needs. Every hospital or practice has strict rules about chart organization and use. There are legal rules that dictate how charts must be stored and what they must contain. There is an entire profession dedicated to charts. Charts are designed to be standardized information repositories; they are not designed to aid in care delivery. Paper charts are a means to an end, and I have never heard anyone gush over how wonderful a paper chart was or how it made their lives so much better. However, since paper charts are (were) a fact of life, one simply adapted to them, like it or not.

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Venrock headlines Health 2.0’s Digital Health Investor Conference, WinterTech 2016

Health 2.0’s WinterTech conference on January 13, 2016 at the Julia Morgan Ballroom in San Francisco, CA showcases the latest in digital health investing featuring leaders from Venrock, Canvas Venture Fund, Helix, Doximity, Grand Rounds, Livongo, Omada Health, and more. Learn about the latest financing and market trends of digital health and hear directly from the start-ups creating the biggest waves in the industry.

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Cost, Value & Tools

Peter PronovostLike a pro golfer swears by a certain brand of clubs or a marathon runner has a chosen make of shoes, surgeons can form strong loyalties to the tools of their craft. Preferences for these items — such as artificial hips and knees, surgical screws, stents, pacemakers and other implants — develop over time, perhaps out of habit or acquired during their training.

Of course, surgeons should have what they need to be at the top of their trade. But the downside of too much variation is that it can drive up the costs of procedures for hospitals, insurers and even patients. When a hospital carries seven brands of the same type of product instead of one or two, it’s not as likely to get volume discounts. Moreover, if hospitals within a health system negotiate independently of one another, they may pay drastically different prices for the exact same item.

Carrying many brands of a given item may also increase risks for error and patient harm. Staff members need to be trained and competent in a variety of tools; the greater the number of tools, the greater the risk for error.

These physician preference items are no small contributor to health care costs. Around the year 2020, medical supplies are expected to eclipse labor as the biggest expense for hospitals, according to the Association for Healthcare Resource and Materials Management. Higher costs for physician preference items are major drivers of this increase.Continue reading…

Closing the Loop on The Need for Better Telemedicine


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I’ve had the great privilege of presenting our virtual care company, CirrusMD, to potential customers and investors at some of the premier health technology conferences this fall, making the cut for both the Health 2.0 Traction event and this week in the finals of the mHealth Summit and HIMSS Venture+ event. (Breaking: we won the mHealth Summit and HIMSS Venture+ mature startup company award!)

Still, we often get an initial response, “Who needs another telemedicine company with the likes of Teladoc and American Well raising big rounds this year?” One writer even went so far as to share the thought in Forbes on the fragmentation of the digital health landscape after Health 2.0.

I want to take the opportunity to use an analogy to explain why were are different from other telemedicine offerings on the market, and why we are getting such great traction and recognition. In fact, we’re working to “unfragment” the healthcare landscape by closing up some very loose ends that occur in a typical telemedicine experience.

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