The surprisingly small benefit of some very (expensive) Big Ideas

Last week, JAMA published online a Viewpoint provocatively titled, “What Happens When Underperforming Big Ideas in Research Become Entrenched?” The overarching Big Idea to which the article refers is the “narrative positing that a combination of ever-deeper knowledge of subcellular biology, especially genetics, coupled with information technology will lead to transformative improvements in health care and human health.”

The article highlights three technologies that are integral to the Big Idea but that have not lived up to their promise. The first is genetics/genomics; as an example of unfulfilled promise, the authors trenchantly observe, “Sixty years after the discovery of the genetic defect, no targeted therapy has emerged for sickle cell anemia” — one of the simplest genetic diseases, caused by a single gene. The second is stem-cell therapies; the authors point out one analysis of studies of stem cell therapies, in which the supposed effectiveness of the therapy was directly proportional to the number of factual discrepancies in the published study. The third is electronic health records (EHRs), which have cost billions, but have not realized either the improved care and cost savings that were their major selling point.

Despite the lack of evidence of real benefit, these three technologies have received vast amounts of NIH and government monies. The article recommends changes such as the “NIH should fund many more high-risk, unconventional ideas instead of supporting the same familiar highly funded research fronts.” It also calls for accountability for funded studies to show real benefit.

The article’s title asks what happens when underperforming big ideas become entrenched — vast amounts of money and energy are wasted — and suggests solutions. But the article does not address why those Big Ideas have become entrenched in the face of all evidence, and this must be addressed before solutions can work. I do not pretend to have a definitive answer. But I think there is an even Bigger Idea that overlies all of these lesser ideas: the idea that more technology is inherently good, and in higher-tech medicine will be our salvation.

For example, look at those things that have been shown to make “transformative improvements” in mortality, morbidity, and life expectancy: Quitting smoking. Getting off the couch and doing a bit of exercise. Eating your fruits and veggies. Getting immunized.

Now, which sounds more exciting for research funding: stem cells that we confidently assert can cure Parkinson’s even though we can’t quite prove but it’s pretty obvious that they should, or finding ways to get more grocery stores into poor neighborhoods whose most affordable food source has golden arches in front of it?

The End of Meaningful Use: A Meaningful Opportunity

The Centers for Medicare and Medicaid Services (CMS) Acting Administrator Andy Slavitt said Monday that 2016 would likely see the end of the meaningful use program. Meaningful use is a carrot-and-stick government program designed to get medical providers to use electronic health records (EHRs) and to set standards for using them. The carrot: medical providers who show compliance with meaningful use regulations get incentive payments from the government. The stick: those who do not are assessed financial penalties (257,000 received penalties in 2015).

***

The latest Mayo Clinic study on physician burnout shows that in 2014, 54.4% of physicians admitted to at least one symptom of burnout. This is up from 45.5% in 2011. In the non-physician population, the number is about 25%.

***

Why the burnout? Lots of reasons, but a major one is that many doctors are spending a lot of time doing things that are not just peripheral to what we went into medicine for, but inimical to it.

When I decided to go into medicine almost thirty years ago, I wanted to do work that didn’t involve sitting in front of a computer all day. My father was a computer systems analyst, and while he brought home cool stuff from the office, I wanted to work with people. So I chose medicine. And somewhere along the way, something changed.

Like many doctors, over the years I found myself spending more and more of my patient care time staring into a computer screen. This in and of itself might not have been so bad, except that it was time taken away from the time I used to spend looking at my patients: looking them in the eye, observing the subtleties of their body language, watching how they breathe or fidget or tremor. And increasingly, the time in the computer was spent doing things that satisfied “Meaningful use” standards, but in no meaningful way improved the care I was providing to the person in the room; in fact, it detracted from care by taking the finite resource of the time I spend with patients and wasting it on irrelevancies. Instead of serving patients, doctoring began to feel like serving the machine, responding to its needs in preference to the needs of patients. Unsurprisingly, a lot of doctors feel this way.

Serving machines instead of people: a good recipe for burnout. The CMS may finally be figuring that out.

Meaningful use was based in part on the blind faith that technology is good, so more must be better. That’s why, in Andy Slavitt’s words, it “reward[ed] doctors for the use of technology.” Think about that: a program that rewards doctors not for improving patient care, or fostering better patient-physician relationships, or making contributions to medicine, but for . . . using technology. Might as well pay us for using smart phones.

Current EHRs have been designed (from all appearances, without knowledge of what physicians actually do in the office) to facilitate increased billing  and to meet meaningful use. Getting rid of meaningful use is an opportunity to completely redesign EHRs — using what physicians actually do as a guide — to make them a useful adjunct to the practice of medicine, rather than a burnout-promoting waster of colossal amounts of time; to enhance (or, at the very least, not detract from) the patient-physician relationship; and to put the patient rather than the technology back at the center of what physicians do.

This may require hefty changes, the complete rethinking and redesigning (maybe scrapping) of current EHR systems. This could be disruptive; but sometimes, when you make a mistake, the best thing to do it to go back and erase it and start over. And if change resulted in doctors getting back to being doctors, I think most of us would welcome it. As Slavitt said on Monday, “We have to get the hearts and minds of physicians back. I think we’ve lost them.” Using this opportunity to completely rethink and overhaul EHR systems is a good way to see that happen.

 

 

 

Bioethics Exam

In keeping with the evaluation-obsessed spirit of the time, here is a little bioethics test. No multiple-choice fill-in-the-bubbles here, no simple true/false; but bioethics usually isn’t so simple, is it? So it’s OK if you don’t have a No. 2 pencil, you can still take today’s exam!

_______________________

1. The patient-physician relationship depends on trust, and close observation, and appreciating subtleties, and giving one’s full attention to another person. So, who thought that making the doctor spend the office visit typing into a computer was actually a good idea???

2. Why does the NRA know better than physicians in Florida what they should be saying to their patients in the exam room?

3. What is just and right about a medical insurance system in which people have to stay in jobs they hate because of the fear of getting sick, and which bankrupts many people who get a serious illness? Give examples to support your answer.

4. If doctors have huge malpractice premiums, which they pay for by charging patients more for medical care, then essentially patients are paying doctors so the doctors can protect themselves from patients. Does this make sense? Explain.

5. Compare and contrast: Why should taking one’s own life be considered a more dignified death than any other? Is there really any dignity in death itself, or is it in the way that we face it?

6. Why should doctors be trusted more than anybody else with the right to kill someone?

7. If all of these prenatal genetic tests weren’t developed and marketed for specifically eugenic purposes, then just what were they developed and marketed for?

8. Is there any evidence that “evidence-based medicine” (aka statistic-based medicine) is better than whatever we did before?

9. Is abortion the problem, or is it the symptom of a lot of other problems?

10. In the DSM-V (the latest version of the official guidebook to diagnosing psychiatric illness), grief over the death of a loved one that lasts longer than two weeks can now be considered a disease and treated with medications. What will be the next normal human experience to be turned into a disease?

EXTRA CREDIT:

11. What does it mean to be human? Who gets to decide?

*  *  *

Since this is an ethics blog, you’re on your honor to score yourself fairly. Good providence!

Meaningful Use and Justice

As part of the 2009 economic stimulus bill, Congress passed the Health Information Technology for Economic and Clinical Health (HITECH) Act. Among other things, this act sought to increase the adoption of Electronic Health Records (EHRs) by providing financial incentives to adopters of certified EHRs who met certain benchmarks by a certain timeline. These benchmarks are known as “Meaningful Use.” To receive the financial incentives — up to $63,750 over six years beginning in 2011 — “providers” must attest to compliance with Meaningful Use. That this is a much larger task than originally assumed was demonstrated by the decision last month of the Center for Medicare & Medicaid Services to push back the timeline for reaching compliance with Stage 2 of Meaningful Use, acknowledging problems with the implementation of the required technology.

Last week a report on the progress of Meaningful Use showed that practices which serve primarily minority populations, and practices in areas with the highest levels of poverty, were least likely to have attested to Meaningful Use — and thus least likely to receive any financial incentives.

The cost for startup of an EHR is substantial– estimated to be at least $40,000 to $100,000 per provider. The cost for training, upkeep, upgrades, etc., are never-ending. The time involved in learning and maintaining such systems is also significant.

Areas with higher minority populations and higher rates of poverty are some of the most medically underserved areas as well. There is less money flowing than in more affluent areas, and there is less flexible time in the schedule, as there are fewer physicians seeing greater numbers of patients.

Therefore it appears that one of the unintended consequences of the Meaningful Use program is that those practices that have the least resources to spend on an EHR are the least likely to receive any financial stimulus, while those practices that have the resources to pour into purchasing and upgrading EHRs and training people to use them are more likely to receive financial aid. Those that need it the most don’t get it.

The Federal Government is pushing hard for EHRs (next year, Medicare will start penalizing physicians who don’t use them). It has set up a benchmark program that financially rewards those who are most financially well off, thus increasing existing disparities. It should restructure this program in such a way that it at least does not tend to increase disparities.

 

What Makes Doctors Happy

The Rand Corporation recently published a study of determinants of physician professional satisfaction, and their implications for patient care. One of the “most novel and important findings” related to electronic health records (EHRs).

The study found that EHRs affected physician satisfaction both positively and negatively. Physicians like the idea of EHRs, and appreciate their “promise” to improve patient care and thus professional satisfaction. However, the current reality of EHRs significantly detracted from physician satisfaction for multiple reasons,including, “Poor EHR usability, time-consuming data entry, interference with face-to-face patient care, inefficient and less fulfilling work content, inability to exchange health information between EHR products, and degradation of clinical documentation.”

I can personally testify to the validity of these findings. I have had the opportunity as a family practice doc to work extensively with two EHR systems. One is considered the “Cadillac” of EHRs, and the reputation fits: a bloated, lumbering, energy-guzzling EHR with lots of bells and whistles and a hefty price tag. The other one—well, let’s just say that using it, one gets the impression that the programmers made sure there were no physicians within 100 miles of them who might contaminate their EHR design with concepts of how actual physicians function.

Both of these EHRs are certified for something called “Meaningful Use.” This is a set of practices that EHRs must be capable of, and physician offices and hospitals have to implement, in order to receive bonus payments from the federal government and avoid penalties. The practices include things like E-prescribing, providing patients with an electronic copy of their health information, and generating patient lists for specific conditions.

But some things are absent from the requirements for Meaningful Use, like usability, and doesn’t detract from patient-physician interactions. A new report documents what most doctors already feel: that increased use of EHRs means less face-time with patients. For many if not most physicians, it means lots of time gazing into a screen and keyboarding that used to be spent face-to-face with patients. We spend time tending charts that used to be spent tending patients. I can confidently assert that most doctors did not go into the clinical practice of medicine because they prefer data-entry over relationships with patients; but this is what the current generation of EHRs has handed us.

The federal government defines “Meaningful Use” as “Use of EHRs in a way that positively affects patient care.” Positive effects on patient care can (theoretically, at least) come about by the data storage and manipulation capabilities that computers offer. But if they come about at the expense of that which is central to every human relationship—looking into the other’s face, body language that says, “What you are expressing to me is so important that I will give you my complete attention,” not multitasking—then perhaps the negative effects have overbalanced any theoretical positive effects. One of the dangers of EHRs is the old “To a patient with a hammer, everything looks like a nail” conundrum; to a person with a computer, everything looks like data. When we define “Quality medical care” solely in terms of what we can count and measure, when we value data over relationship, then “Meaningful Use” becomes a meaningless slogan.

 

Monitoring the Health IT industry

Should electronic medical records (EMRs) be regulated for safety just like any other medical device?

At first glance, the answer seems to be, “No.” After all, EMRs are just computer versions of the old paper chart, right? Nobody regulated paper charts for safety, so why should we be questioning EMRs?

On closer scrutiny, however, the answer is not so clear, because EMRs are more than simple repositories of clinical data. They are used to enter and transmit orders for things like procedures, tests, and medications, as well as to transmit results back to physicians.  While errors due to bad doctor handwriting have diminished, there is a growing body of data documenting new errors and harms to patients caused by EMRs. The Institute of Medicine (IOM) catalyzed the headlong rush to adopt EMRs with its 1999 report asserting that increasing the use of information technology (IT) would lead to decreased patient errors and increased safety; in 2011 it published a report calling for the formation of an independent federal body to investigate patient deaths and other adverse events caused by health IT.

Now the large industry that has grown up around EMRs is fighting federal regulation that would treat EMRs like any other medical device and monitor their effect on patient safety. As the IOM’s 2011 report points out, the precise effect EMRs have had on patient safety is difficult to quantify because of “contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events . . . these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.”

It appears that the Health IT industry believes that it is not in its best interest to gather data on how its products might adversely affect patients. On the other hand, it appears that gathering such data and using it to improve systems is in the best interests of patients. In this conflict of interests, the patients’ interests should clearly prevail.

This is not to say that it should necessarily be the FDA that regulates the industry. In fact, I believe a transparent and trustworthy private body would be a better option. But the Federal Government has spent literally billions of dollars (our dollars) to induce physicians and hospitals to adopt EMRs. Most of that money is ultimately finding its way into the coffers of the Health IT industry. The government has not only the right to determine what harms that money may be causing, but the responsibility to do so.