Washington Post Article: Electronic medical records not seen as a cure-all

Regarding the very well done Sunday Oct. 25, 2009 story in the Washington Post "Electronic medical records not seen as a cure-all" by staff writer Alexi Mostrous - signup may be required for access - I have several observations.

(Not including the observation that Mr. Mostrous probably deserves an award for being the first major newspaper reporter to broach this topic in a serious and balanced manner.)

First, I believe healthcare IT can live up to all the predictions made about its benefits - but only if done well. There is massive complexity behind those two words "done well", and that is HIT's key stumbling block in 2009. I believe we are only in the adolescent stage of knowing how to "do health IT well."

Second, I should point out that the intended consequences of health IT include, among many other things, the following "hiding in plain sight" (i.e., not often verbalized) intended consequences:

• The improvement of medicine ... in the context of protection of patient rights established over centuries of development of modern medicine.

• The improvement of IT itself through cross disciplinary collaboration between IT and medicine, of the science of IT (computer science), the social aspects of computerization ("sociotechnical issues"), and improvement of the our understanding of the intersection of medicine and computers.

Instead, we largely have the opposite. Patients' rights are trampled, and hostility and territoriality has arisen between clinicians (including medical informaticists) and IT, groups that rarely if ever interacted in hospitals ten or twenty years ago.

Of concern, when scientific study sections evaluate NIH grant proposals calling for testing of new IT that involves patients, patient protections and informed consent processes are a paramount concern since such activities are considered research. Yet, in implementing large clinical IT system in a hospital with new features, there are no formal regulations, and I'm not sure there's even IRB involvement in most cases. Patients do not get the chance to give informed consent to the use of these IT devices mediating their care. Why the difference?

The unintended results of computerization efforts have also included suppression of research on sociotechnical issues and on informatics, which must include study of the downsides of HIT, and of the failures in addition to the study of the successes. That is scientific fact - there is no room for debate, no room for spin on the need for careful study of the downsides of any mission critical domain. One would think there to be a vibrant literature on these issues, Yet searches on massive biomedical databases such as PubMed on, say, "cerner electronic health record" (or other vendors as well) are disappointing to say the least. Further, my own website on HIT difficulties remains nearly unique (PPT) after ten years online. That is not bragging; it is a disturbing finding to me - symptomatic of an industry that somehow has managed to avoid serious scrutiny.

In a field with downsides, there are:

1) those who know about the problems but fail to speak,
2) those who see the problems but fail to act, and
3) those who see, know and speak/write/research the problems.

That said, now on to the Washington Post article:

... bipartisan enthusiasm has obscured questions about the effectiveness of health information technology products, critics say. Interviews with more than two dozen doctors, academics, patients and computer programmers suggest that computer systems can increase errors, add hours to doctors' workloads and compromise patient care.

I would include the bipartisan enthusiasm under the subject header of "irrational exuberance", which itself falls under the header of "lack of domain knowledge." That itself is a consequence of both failure to study the issues, and suppression of those issues by those with an interest in doing so.

health IT's effectiveness is unclear.

The literature is indeed conflicting, and the need for rigorous scientific study has never been more essential considering the commitment of tens of billions of dollars towards health IT. The time for story telling, marketing based on opinion, name calling, leap-of-faith extrapolations of light year dimensions, and other forms of pseudoscience and non-science are over. The time for objective study is now.

The Senate Finance Committee has amassed a thick file of testimony alleging serious computer flaws from doctors, patients and engineers unhappy with current systems.

Being the ranking member of that committee, Sen. Grassley has a fiduciary responsibility to protect Medicare and Medicaid patients (and one might argue, to protect all patients since those programs often serve as models for private insurers). In that regard, the investigation he has initiated is part of his responsibility as a ranking member of Congress. Politics aside (and there are those who will resort to ad hominem "political witch hunt" arguments), he would have been negligent if he had not initiated an inquiry.

Sen. Grassley has taken on the pharma industry and the government's Food and Drug Administration itself, such as in this recent article "FDA fails to follow up on unproven drugs" where he concluded from a GAO study he ordered that "FDA has fallen far short of where it should be for patient safety." He seems quite serious about medical safety.

If only others in Congress had done their job similarly regarding national finance, we might now not be in the worst economic crisis since '29 with many major industries failing.

David Blumenthal, the head of health technology at the Department of Health and Human Services, acknowledged that the systems had flaws. "But the critical question is whether, on balance, care is better than before," he said. "I think the answer is yes."

This sounds uncomfortably like how a pharmaceutical company might respond to doubts about drug effectiveness and safety. In reality it's really irrelevant what he "thinks." Where's the data? Is this a political statement, a personal belief, or a statement backed up by scientific fact that is not cast into doubt by other research results? Our own National Research Council, Joint Commission, and other international organizations have written about their doubts and concerns about HIT [as that IT is designed and implemented in 2009]. If there is rigorous, systematic research weighing pro's and con's to back this assertion, I wish it would be published.

For his statement is really saying "we don't really know how many systems have flaws, we know some do, and we don't really know the full extent of the impact of those flaws, but because there can be some benefits, let's spend $50+ billion before we know the extent of the problems and fix them." I point out research from Harvard forty years ago, when Harvard informatics pioneer Dr. Octo Barnett published the "Ten Commandments of HIT." Two of those commandments were:

... 8. Thou shall be concerned with realities of the cost and projected benefit of the computer system [i.e., ROI - ed.]

10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.

The full set is in this post. Somewhere in the past 40 years, the rigorous ROI evaluations (which also must include systematic evaluations of risk, as any businessperson knows) and the fundamental skepticism seem to have gotten lost.

Over the next two months, Blumenthal will finalize the definition of "meaningful use," the standard that hospitals and physicians will have to reach before qualifying for health IT stimulus funds.

This is an example of putting the cart before the horse, and is a semantically-based, self contained logical fallacy of sorts. If a health IT system is harmful, the term "meaningful use" is itself Orwellian. If we don't know if HIT is beneficial, or have doubts, then such as term presupposes that health IT is inherently beneficial. A better term would have been "good faith use" - use based on the faith or hope that health IT will have an overall positive effect. The term "meaningful use" jumps the gun and is more a political slogan than a "meaningful term."

"If you look at other high-risk industries, like drug regulation or aviation, there's a requirement to report problems," said David C. Classen, an associate professor of medicine at the University of Utah who recently completed a study on health IT installations.

This is obvious, the reasons for it are obvious, and the reasons why health IT needs a requirement for problems reporting (one aspect of post-marketing surveillance, the "Phase IV" study as it is known in pharma) is obvious. Yet in 2009, no such requirement exists (see my post "Our Policy Is To Always Have Unabashed Faith In The Computer" for more on why we need reporting requirements.) Why do these requirements simply not exist in HIT?

"It's been a complete nightmare," said Steve Chabala, an emergency room physician at St. Mary Mercy Hospital in Livonia, Mich., which switched to electronic records three years ago. "I can't see my patients because I'm at a screen entering data." Last year, his department found that physicians spent nearly five of every 10 hours on a computer, he said. "I sit down and log on to a computer 60 times every shift. Physician productivity and satisfaction have fallen off a cliff."

The industry in the past has called such physicians "luddites", "resistant to change", "stubborn" etc. However, argumentum ad hominem is a fallacious mode of argument that has no place in a scientific field such as biomedicine. There also seems to be quite a lot of such concerns expressed by a large number of physicians, nurses, etc., and dismissing their concerns with a wave of the hand is cavalier in the extreme - again, these are first principles, without room for argument or debate. Let's study the issues rigorously and scientifically before resorting to ad hominem.

Other doctors spoke of cluttered screens, unresponsive vendors and illogical displays. "It's a huge safety issue," said Christine Sinsky, an internist in Dubuque, Iowa, whose practice implemented electronic records six years ago.

See my eight part series on mission hostile clinical IT here for examples of what Dr. Sinsky is referring to.

She emphasized that electronic records have improved her practice. "We wouldn't want to go back," she said. "But EHRs are still in need of significant improvement."

Yes, not cancellation, but improvement. And, quite importantly, before tens of billions of dollars are spent. Hospitals and physician offices are not an IT development laboratory, since the users of these facilities (patients) have very special rights and the clinicians, very special obligations and responsibilities.

Legal experts say it is impossible to know how often health IT mishaps occur. Electronic medical records are not classified as medical devices, so hospitals are not required to report problems.

That after decades of HIT development, sales and implementation we cannot know with certainty how often mishaps occur is, quite simply, a scandal of major proportions. Quoting an old House of God law, #10: "if you don't take a temperature, you can't find a fever." Another applicable aphorism seen on another discussion board: "you can only be so negligent or craven before the only remaining rationale is that you intended the result."

"Doctors who report problems can lose their jobs," Hoffman said.

I've taken risks with my own career in criticizing health IT, as have my colleagues. Hoffman is not exaggerating.

"Hospitals don't have any incentive to do so [speak out about problems with HIT] and may be in breach of contract if they do."

Imagine the outcry if the same prevailed regarding drugs or medical devices. The cemeteries would be lined with people whose epitaph could read "we bury our mistakes."

While orange-shirted vendor employees "ran around with no idea how to work their own equipment," the internist said, doctors struggled to keep chronically ill patients alive. "I didn't go through all my training to have my ability to take care of patients destroyed by devices that are an impediment to medical care."

This gets to issues I first raised in my website on HIT difficulties: who are these IT personnel, and what are their qualifications, exactly, to be working in mission critical medical environments? How is their competence evaluated?

I think these are questions that need to be answered.

-- SS