EHR ED's in New South Wales. Will the Problems Magically "Disappear?"

It occurs that one could look at Prof. Jon Patrick's recent health IT forensic analysis as a kind of "indictment" of the industry.

He can be seen as suggesting the industry needs to be "put on trial" (figuratively) regarding "crimes" (again, figuratively speaking) they've committed with regard to IT robustness and reliability. The latter translate directly to patient safety.

In a lawsuit such as a medical malpractice trial, obvious as well as potential evidence is put under "legal hold." For instance, if an EHR defect is suspected, metadata, audit trails, and patient data are asked (or should be asked) to be frozen or archived in the state they were in at the time of the alleged accident.

It can take a page or three (or more) of specifications simply to define what information, exactly, needs to be put on legal hold. My former staff were frequently required to place myriad materials on legal hold at Merck Research Labs, for example, baed on the lawsuit du jour.

Once frozen, discovery and forensic analysis of these now-static data can then proceed. In fact, cases can be lost on the basis of evidence of an archiving omissions, destruction or tampering when information holds are requested.

It occurs to me that Prof. Patrick has given the industry a detailed look into factors they could start to remediate, without publicity and without telling anyone. While this would be a net plus for patients, it might result in less of a learning experience to the industy than that industry needs, to motivate the industry to avoid future product engineering and quality issues and put quality (not simply margin) as priority #1.

I therefore would believe a "hold" put on the present state of these ED EMR systems, or a "snapshot" of their current state (i.e., an evaluation environment mirrored from the present operational one) would allow a careful evaluation of the impact of the issues noted in the study.

Such an evaluation would be far more difficult with a cybernetic moving target.

The "snapshot" idea would allow evaluation of system risk levels, intermittent "glitches", interference with workflows, etc. in a controlled testing environment, using mock data or data drawn from actual cases.

The "snapshot" approach would also allow incremental remediation of the "live" system that comes out of safe, controlled testing, rather than sticking with what exists now until the studies could be completed on the as-is system, and then applying all the fixes as one or more large "upgrades."

I, for one, would be interested in studying this "built by software professionals" system and comparing it to health IT systems we "academic nerds" were authoring, say, 10-15 years ago.

-- SS

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A Brief Primer on Health IT Problems

I have noted that numerous policy makers I've spoken with freely admit their knowledge of healthcare IT is zero, or limited to what they've seen and heard in the press (i.e., mainly marketing messages in disguise).

Since most of these officials have little time to study the issues about health IT in depth, I've created a zipped archive of four articles I consider key. The articles can serve as a primer on health IT problems:

1. Joint Commission Health IT Sentinel Events Alert, 2009.

2. FDA Internal Report on Adverse Events Involving Health IT. ("Not intended for public use" - but obtained by the press last year, presumably via FOIA), 2010.

3. ECRI Institute Top 10 Health Technology Hazards of 2011 - see hazard #5.

4. Hoffman/Podgurski, Case Western Reserve School of Law: E-HEALTH HAZARDS: PROVIDER LIABILITY AND ELECTRONIC HEALTH RECORD SYSTEMS - comprehensive article, one of a series, 2009.

The zipped file can be downloaded from here:

http://www.ischool.drexel.edu/faculty/ssilverstein/HIT_issues_Primer.zip

It is 2.7 Mb in length.

(A compilation of over fifty articles is at http://www.ischool.drexel.edu/faculty/ssilverstein/HITreadinglist.doc, for those with lots of time.)

-- SS

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Electronic Medical Records: Two Weeks, Two Reams

Electronic medical records in the pioneering years were about helping clinicians better understand a patient. They were about easing the clinicians' work in evaluating and caring for a patient, or in performing a consult on a patient being cared for by a colleague.

The commercial electronic medical record is another beast entirely.

Thanks the the imperative to document anything and everything to drive up billing, and due to the "computer as a data warehouse", early 20th century programmable card-tabulator culture of mercantile, manufacturing and management computing specialists (A.K.A. the MIS personnel in most hospitals and health IT vendor development shops), these systems have become a distraction and an error-promoting nightmare.

In the June 20, 2009 Wall Street Journal article "The Myth of Prevention", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed several Wharton professor's doubts about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:

... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the �savings� that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It�s a dangerous and probably an incorrect projection.

In the Feb. 26, 2011 New York Times Op-ed "Treat the Patient, Not the CT Scan", Verghese also observed that:

... the complaints I hear from patients, family and friends are never about the dearth of technology but about its excesses. My own experience as a patient in an emergency room in another city helped me see this. My nurse would come in periodically to visit the computer work station in my cubicle, her back to me while she clicked and scrolled away. Over her shoulder she said, �On a scale of one to five how is your ...?�

The electronic record of my three-hour stay would have looked perfect, showing close monitoring, even though to me as a patient it lacked a human dimension. I don�t fault the nurse, because in my hospital, despite my best intentions, I too am spending too much time in front of the computer: the story of my patient�s many past admissions, the details of surgeries undergone, every consultant�s opinion, every drug given over every encounter, thousands of blood tests and so many CT scans, M.R.I.�s and ultrasound images reside in there.

One of the reasons he and other physicians are spending too much time in front of the computer is because the computer EMR application is poorly engineered, presenting a mission hostile user experience and characterized by "clickorrhea" in order to navigate the perfect storm of informational disarray and chaos. The systems also cannot support clinician's cognitive processes properly, as was the original intent of these systems (See, for example, the 2009 National Research Council report on health IT.)

Another is due to the computer technician and billing department's fetish with massive detail.

All of these issues are easily illustrated via one picture:

Two weeks of hospitalization of one patient generated about 1000 pages, or two reams of paper (one ream = 500 pages, as sold at office supply stores everywhere) that another physician who sent this photo needed to wade through:

Two weeks, two reams. More stunning full-sized. Click to enlarge.

The content of these reams, rather than being learned medical prose, is what can be more accurately referred to as "legible gibberish." These "records" have all the fluency of a computer programmer's grasp of Shakespeare, or, as one commenter here colorfully put it, "cloistered coding gnomes."

It could have been worse. In my own mother's case, just over two and a half weeks of the initial phase of her hospitalization for an EMR-caused medical catastrophe generated approximately 2,900 pages of legible gibberish - six reams (or three reams, double-sided) for which I had to pay about $1000 to obtain.

This 'paper-orrhea', needless to say, is reckless and a medical information science absurdity. It is crazy stuff.

... Anyone who thinks these systems in their present form benefit clinical medicine needs to have their head examined. Preferably, by a psychiatrist not suffering from irrational exuberance himself or herself, and not taking notes into a computer facing away from the examination couch.

Perhaps a psychiatrist like this?

[/satire off]

-- SS

Addendum: it occurs to me I may have selected the wrong body part for examination. Those who gleefully and uncritically push this experimental technology for national rollout, even in the face of literature such as I aggregated at "An Updated Reading List on Health IT", perhaps (metaphorically speaking) should have the contents of their hip pocket or purse examined:


-- SS

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BLOGSCAN - Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality

From the blog of Dr. Sanjay Gupta at CNN health:

Electronic health records no cure-all

Electronic medical records, also known as EHRs, often touted as a powerful antidote for uncoordinated and ineffective medical care, do little to help patients outside the hospital, according to a new study.

Researchers from Stanford University analyzed federal data on more than 255,000 patients, about a third of whom had health information carried electronically. The researchers compared the care of those patients to the care of patients without EHRs, on 20 different measures of quality � for example, whether proper medication was prescribed for patients with asthma or simple infections, or whether smokers were counseled on ways to quit. On 19 of the 20 measures, there was no benefit from having an EHR. The one exception was dietary advice: Patients at high-risk for illness were slightly more likely to receive counseling on a proper diet.

The U.S. Department of Health and Human Services has pushed hard to encourage the adoption of electronic medical records, including $19 billion worth of incentives for doctors and hospitals. A move to EHRs is one of the less controversial aspects of health care reform, and the shift is often touted by President Obama.

But skeptics say there are serious risks to an overreliance on EHRs, from missing information to simple computer crashes. A report last month from the ECRI Institute, a respected organization that studies science and health issues, listed �data loss and system incompatibilities� as one of ten �Top 10 Health Technology Hazards for 2011.�

Jeffrey C. Lerner, president and chief executive officer of the ECRI Institute, said the new findings are no surprise. "It is reasonable to assume that electronic health records will ultimately help the cause," he told CNN in an email, "but new technology has a learning curve. [Somehow, this "new technology" that dates back decades is having one hell of a long learning curve - ed.] Think of your smart phone. Improving quality will remain a tough challenge, but avoiding technology use doesn�t sound like an alternative.�

To examine whether better technology might help, the Stanford team also looked at whether care was better when physicians used a computer system to help guide them through treatment options. It barely made a difference.

The project was started by Max Romano, an undergraduate at the time who now studies medicine at Johns Hopkins University. The final paper was co-written with Dr. Randall Stafford, a professor at the Stanford Prevention Research Center.

"Our initial hope was that we would see a correlation between electronic health records and quality, and when we looked at the subset of patients whose doctors got help from the clinical decision support systems [decision-making software], we'd see an even stronger relationship," says Stafford. "Perhaps we need to re-examine the naive assumption that just putting in place an EHR system will make a huge difference." [That's called "technological determinism" - ed.]

While praising federal efforts to standardize and streamline EHRs, Stafford said the findings raise serious questions about the scope and speed of the $19 billion campaign. "There is a need to question investing that much societal resource in electronic health records when we really don�t know the answer of what effects those are going to have. Having made that decision, it's incumbent for us to demand exactly what we have gotten out of the investment."

Post by: Caleb Hellerman - CNN Medical Senior Producer

Once again, as I pointed out here, you've seen these questions raised long ago at Healthcare Renewal and at a much older site on health IT difficulties the authors may not be aware of, specifically here.

The CNN post describes results reported online in the Archives of Internal Medicine:

Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality
Max J. Romano, BA; Randall S. Stafford, MD, PhD
Arch Intern Med. Published online January 24, 2011. doi:10.1001/archinternmed.2010.527

More on the primary article later.

I'm busy managing the medical care of my mother's EHR-related May 2010 injuries.

-- SS

Addendum:

My followup post on the primary article is here.

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The Impact of eHealth on the Quality and Safety of Health Care: You Heard Much of This First On Healthcare Renewal ...

A PLoS article was recently published on health IT's impacts on healthcare quality and safety. In the article, a form of meta-research was performed; systematic review articles were collected and then reviewed systematically.

Black AD, Car J, Pagliari C, Anandan C, Cresswell K, et al. (2011) The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview. PLoS Med 8(1): e1000387. doi:10.1371/journal.pmed.1000387.

A text version can be seen at this link and a PDF downloaded at this link.

I will reproduce only the abstract here, and then make a few comments (over and above the hundreds of posts on these issues I've authored at this blog since 2004):

The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview.

Ashly D. Black¹, Josip Car¹, Claudia Pagliari², Chantelle Anandan², Kathrin Cresswell², Tomislav Bokun¹, Brian McKinstry², Rob Procter³, Azeem Majeed⁴, Aziz Sheikh^2*

1 eHealth Unit, Department of Primary Care and Public Health, Imperial College London, London, United Kingdom, 2 eHealth Research Group, Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, United Kingdom, 3 National Centre for e-Social Science, University of Manchester, Manchester, United Kingdom, 4 Department of Primary Care and Public Health, Imperial College London, London, United Kingdom

Abstract

Background

There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. [I believe it would be more accurate to write "always at considerable cost, with generous profits being made by the IT merchants, implementers and consultants"- ed.] In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care.

Methods and Findings

We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment strategies are lacking.

Conclusions

There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. [You've heard that here before - ed.]

In addition, there is a lack of robust research on the risks [I believe it would be more accurate to say there's been a suppression of research and/or of publicity on the risks - ed.] of implementing these technologies and their cost-effectiveness has yet to be demonstrated [in other words, healthcare IT is an experimental technology. You've heard that here before, too - ed.], despite being frequently promoted by policymakers and �techno-enthusiasts� as if this was a given.

[In other words, there's an irrational - or contrived - exuberance. You've heard that here before, too - ed.]

In the light of the paucity of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, it is vital that future eHealth technologies are evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle. [You've heard that here before, too - ed.]

Such evaluation should be characterised by careful attention to socio-technical factors to maximise the likelihood of successful implementation and adoption.

[You've heard that here before, too, as well as at my site "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties", as a matter of fact previously entitled "Sociotechnologic Issues in Medical Informatics...", started in 1999 - ed.]

I can add these additional comments:

• The findings of this study were of no surprise to me or likely to readers of this blog. I've been writing on these issues since the 1990's, and on this blog since 2004.

• In the main article itself it is stated "... there remains a disparity between the evidence-based principles that underpin health care generally and the political, pragmatic, and commercial drivers of decision making in the commissioning of eHealth tools and services." In other words, the rigor of medical science itself is lacking in healthcare IT. I've written that repeatedly here and elsewhere. I ask again: how can IT "transform" ot "revolutionize" healthcare when the culture of IT itself is in need of reform?

• Also stated in the article's body was this: "Risks largely went ignored apart from anecdotal evidence of time-costs associated with recording of data due to both end-user skill and the inflexibility of structured data, increased costs of EHRs, and a decrease in patient-centeredness within the consultation." See my prior post "MAUDE and HIT Risks: Mother Mary, What in God's Name is Going on Here?" for what I find as deeply concerning ("hair-raising") revelations regarding risk that you should think about next time you find yourself in a computerized hospital or doctor's office.

• Also in the article body: "Our major finding from reviewing the literature is that empirical evidence for the beneficial impact of most eHealth technologies is often absent or, at best, only modest. While absence of evidence does not equate with evidence of ineffectiveness, reports of negative consequences indicate that evaluation of risks � anticipated or otherwise � is essential. Clinical informatics should be no less concerned with safety and efficacy than the pharmaceutical industry. [Having worked in both sectors, hospital and pharma , you've read that here before - ed.] Given this, there is a pressing need for further evaluations before substantial sums of money are committed [as you've read here in numerous posts, that's BEFORE, NOT DURING OR AFTER - ed.] to large-scale national deployments under the auspices of improving health care quality and/or safety." Are governments listening, I ask?
  

• Study methodology and source material limitations were noted. However, also noted was this: "Our greatest cause for concern was the weakness of the evidence base itself. A strong evidence base is characterised by quantity, quality, and consistency. Unfortunately, we found that the eHealth evidence base falls short in all of these respects. In addition, relative to the number of eHealth implementations that have taken place, the number of evaluations is comparatively small." In my view, national re-engineering programs involving a large portion of the economy and a critical societal function should not be undertaken when the evidence base is weak and the number of evaluations is small. Further, national leaders should not be making statements of certainty such as made by the HHS ONC office as I wrote about at "Science or Politics? The New England Journal and The 'Meaningful Use' Regulation for Electronic Health Records" and at "Blumenthal on health IT safety: nothing to see here, move along."

• This article might be compared to the Dec. 2009 Milbank Quarterly article "Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London. I wrote about that article at this link. It was also a meta-analysis; its major conclusion was that "the tensions and paradoxes revealed in this study extend and challenge previous reviews and suggest that the evidence base for some EPR programs is more limited than is often assumed."

Read the entire PLoS article at the links above.

-- SS

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An MD hospitalist on EHR's: I might have inadvertently skipped something during the mayhem

At "Clinicians Going for a Swim and Drowning in Information" I commented on a NY Times article about how information and cognitive overload can lead to deadly consequences in warfare. My implication was that medical care (e.g., the ED) bears some similarities.

I received this reply from a clinician hospitalist I know, who also is well versed in Medical Informatics:

Wow, great piece, but a little too close to home for me right now.

Eerily similar to / descriptive of my experience last night in the hospital: processing multiple information sources related to multiple different problems for a new admission (patient, family, ED staff, disjointed EMR - some documents in the Documents tab of the [major EHR vendor name redacted - ed.] system but most others in the hospital system Portal requiring a separate lookup, some radiology studies available through the EMR on any workstation but others requiring accessing the PACS system directly on scarcer dedicated workstations - plus paper record components, including EKGs, progress notes) ... all while various drone-equivalents are channeling information regarding multiple other admissions in the wings and/or patients decompensating on the floors or in the ICU.

Oh yeah, and then there's the "12 hour shift" thing. Oops, gotta run... Just slept all day after my night shift and have to head back to hospital for the next one. Still haven't submitted any charge tickets, btw, even for last week's shifts (I'm carrying around paper face sheets with scribbled notes on the back; I'm supposed to fax them to the billing office once I figure out what CPT / visit intensity code I want to use.)

Gosh, I hope I remembered to touch on 10 bullet points related to ten organ systems for my ROS for each of my admissions; might have inadvertently skipped something during the mayhem...

PS. I'd love to be wearing one of those brain wave contraptions mentioned in the article to see what my theta wave activity was.

This is not atypical of IT's effects on healthcare today.

-- SS

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New York Times: The Doctor vs. the Computer Fool

"Wise men learn more from fools than fools from wise men." - Chinese proverb

A stunning story was published in the New York Times entitled "The Doctor vs. the Computer."

A more appropriate title would have been "The Doctor vs. the Computer Fool."

The computer is simply a tool and is not the doctor's opponent; rather, the people under whose auspices the IT was designed and implemented are the physician's foes here:

New York Times
December 30, 2010, 10:19 am
The Doctor vs. the Computer

By DANIELLE OFRI, M.D.

Electronic medical records promise efficiency, safety and productivity in the switch from paper to computer. But there are glitches, as a patient of mine recently brought to light.

My patient needs prostate surgery. It is my job, as his internist, to estimate the risks this surgery poses, decide whether he can proceed with the surgery and make recommendations for his medical management before and after the operation.

He is an extremely complicated patient. His hypertension requires three concurrent medications. He�s taking pills for diabetes, but he really should be giving himself insulin injections. His kidneys are wending their way toward dialysis. A few years ago he had a reaction to a diabetes medication that caused congestive heart failure. His aortic valve is narrowed � not severely, but enough to keep me on edge.

Estimating my patient�s surgical risk and planning for his operative care is not a straightforward process.

The complexities are anything but linear and deterministic, and judgment borne of experience is essential. No algorithm will replace this process in my lifetime, I suspect.

After our physical exam, I sit down to write a detailed evaluation, because I want the surgeons and anesthesiologists to fully understand the complexity of his situation.

In medicine, if you don't know your patient and their history, your patient's dead.

As I type away, I feel like I�m doing the right thing, explicating my clinical reasoning rather than just plugging numbers into a formula. I�m midway into a sentence about kidney function when the computer abruptly halts.

I panic for a moment, fearful that the computer has frozen and that I�ve lost all my work � something that happens all too frequently. But I soon realize that this is not the case. Instead, I�ve come up against a word limit.

It turns out that in our electronic medical record system there is a 1,000-character maximum in the �assessment� field. [Brilliant! - ed.] While I�ve been typing, the character number has been counting backward from 1,000, and now I�ve hit zero. The computer will not permit me to say anything more about my patient.

I see no reason for any degree of politeness or sensitivity regarding this mission hostile "feature" of a clinical documentation system. The person(s) who either designed the system this way and/or set constraints such as this were fools - on first principles - for imposing such a limitation.

... In desperation, I call the help desk and voice my concerns. �Well, we can�t have the doctors rambling on forever,� the tech replies.

"We" can't?

Yes, I guess "we", a.k.a. the computer Einsteins who've invaded clinical medicine (or more precisely, who've been permitted to invade clinical medicine), a domain in which they are most often manifest laypeople, cannot let the doctors "ramble."

Uses up too many electrons - or something.

Case closed.

In a way this story reminds me of capricious, mission hostile IT limitations I heard about ca. 2002 or '03. I was demonstrating the Saudi Arabia-Yale Genetics Research Database (SAYGR) I'd authored in 1993-5 to world-class AIDS researcher Emilio Emini, in my role as Director of Scientific Information Resources, Research Information Systems division, Merck Research Labs where Dr. Emini was employed at that time.

SAYGR by design placed no artificial limitations on the number of descriptors for an entity, nor on the number of user-defined entities (such as lab test results and descriptors of the results) that could be created, even out in the field, by an enduser. Yet I'd developed it with early 1990's relational database technology.

Emini remarked that SAYGR was much more advanced than the database tools he was provided by the research IT dept., which fixed the number of descriptors to five or perhaps ten per item (probably thus avoiding the need to set up relational tables to make the programmer's job easier). This limitation was often insufficient for the needs of his advanced AIDS research. Again, brilliant.

I will add that there are many good jobs awaiting arrogant computer fools -- if only they'd be thrown out of the medical arena and replaced with IT personnel of a service mentality, who understand the limitations of lack of clinical knowledge and experience, and the asymmetric responsibilities, obligations and liabilities of clinicians compared to their own banal data processing jobs.

Deciding on lifeboat capacities for the Titanic, gas tank safety measures for the Ford Pinto, fail-safe systems for the Chernobyl nuclear power plant, and final launch decisions on the Space Shuttle Challenger in cold weather come to mind.

-- SS

1/4/11 addendum:

To those who might think a 1000-character text field limitation of a modern EHR is to save storage space that would have to be "reserved" or set aside to hold longer comments, just consider that your hard disk does not "reserve space" a priori to hold long files. The operating system allocates space dynamically as needed, up to rather massive limits per file set via internal OS and microprocessor addressing characteristics.

My aforementioned SAYGR application, initially developed with early 1990's relational technology, limited comment and impression fields as well - but to appx. 65,535 (64k) characters maximum. The workstations it ran on in the field had precisely 16 megabytes of RAM and 500 megabyte hard drives. (Yes, mega-, not giga-.)

I believe health IT vendors in 2011 can do far better than 1000-character impression fields.

Others have commented on possible workarounds to this limit. To them, I remind them of this simple wisdom I first posted at my series on mission hostile health IT:

"You should not have to work around something that is not in the way."

-- SS

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BLOGSCAN - Are electronic medical records a health care cure or a disease?

This doctor writing at Cleveland.com really doesn't like EMR:

... Our practice implemented EMR about three months ago, and it has not been a downhill sleigh ride thus far. Here's the scorecard.

� It saves time. It doesn't.

� It saves money. It hasn't.

� It promotes office flow and efficiency. Hardly.

� It improves staff morale. Are you joking?

� Patients prefer it. None that I know.

� It's been a bonanza for document-scanning companies. Bingo!

What I find most troubling about EMR is that it is "point and click" medicine. It radically disrupts the doctor-patient relationship. Taking the patient's medical history -- the bedrock of doctoring -- is reduced to a sterile data-entry process. Taking the history, the conversation that physicians and patients have had since Hippocrates tended to the sick, is our opportunity to reach out and bond with our patients. During this time, we forge human-to-human connections with patients who are seeking our help. This is the scaffold upon which a sturdy doctor-patient relationship develops. EMR is taking a chainsaw to this structure.

Those who champion the technology are usually not practicing physicians. They are the insurance industry, billing personnel, medical coding specialists, the government, various bean counters and, of course, EMR vendors. Because these folks are not physicians, they do not appreciate how EMR affects doctoring at ground zero in our exam rooms ...

Read the whole thing.

-- SS

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Study highlights 'lurking question' of measuring EHR effectiveness: The science in Medical Informatics is dead

The science in Medical Informatics is dead.

I'm not going to even use academic fabric softener in my assertion, e.g., "may be", "appears to be", or "is it?" (as a question) dead.

It's dead.

When HIT experts recommend changing the study goalposts when existing studies don't give results they'd like to see, rather than first and foremost critically and rigorously examining why we're seeing unexpected results, science is dead.

Study highlights 'lurking question' of measuring EHR effectiveness

December 22, 2010 | Molly Merrill, Associate Editor

WASHINGTON � Hospitals' use of electronic health records has had just a limited effect on improving the quality of medical care nationwide, according to a study by the nonprofit RAND Corporation.

The study, published online by the American Journal of Managed Care, is part of a growing body of evidence suggesting that new methods should be developed to measure the impact of health information technology on the quality of hospital care.

[In other words, we're not getting the results we thought and hoped we'd get with "Clinical IT 1.0", so let's alter the study methodologies and endpoints --- rather than using the results we have to identify the causes and improve the technology to see if we can do better with "Clinical IT 2.0."

Further, it's not as if there's no other data on why health IT might not work as hoped - ed.]

Most of the current knowledge about the relationship between health IT and quality comes from a few hospitals that may not be representative, such as large teaching hospitals or medical centers that were among the first to adopt electronic health records.

[This implies "other" "representative" hospitals are either not doing it right, or the technology is ill suited for them and may never work. Which is it? We really need to know before we proceed with hundreds of billions more in this "Grand Experiment" - ed.]

The RAND study is one of the first to look at a broad set of hospitals to examine the impact that adopting electronic health records has had on the quality of care.

The research included 2,021 hospitals � about half the non-federal acute care hospitals nationally. Researchers determined whether each hospital had EHRs and then examined performance across 17 measures of quality for three common illnesses � heart failure, heart attack and pneumonia. The period studied spanned from 2003 to 2007.

The number of hospitals using either a basic or advanced electronic health records rose sharply during the period, from 24 percent in 2003 to nearly 38 percent in 2006.

[How many billions of dollars diverted from patient care needs does that represent? - ed.]

Researchers found that the quality of care provided for the three illnesses generally improved among all types of hospitals studied from 2004 to 2007. The largest increase in quality was seen among patients treated for heart failure at hospitals that maintained basic electronic health records throughout the study period.

However, quality scores improved no faster at hospitals that had newly adopted a basic electronic health record than in hospitals that did not adopt the technology.

[In other words, the improvements or lack thereof had little to do with electronic vs. paper record keeping - ed.]

In addition, at hospitals with newly adopted advanced electronic health records, quality scores for heart attack and heart failure improved significantly less than at hospitals that did not have electronic health records.

[In other words, the clinical IT was probably impairing doctors compared to simpler paper methods and good HIM personnel - ed.]

EHRs had no impact on the quality of care for patients treated for pneumonia.

Researchers say the mixed results may be attributable to the complex nature of healthcare.

[That is likely true, but maybe the mixed results are also -- and even more likely in major part -- due to poorly designed and/or poorly implemented IT - ed.]

Focusing attention on adopting EHRs may divert staff from focusing on other quality improvement efforts.

[That speaks to poor EHR overkill, poor usability, unfitness for purpose, and other issues that may or may not be remediable in short or even long term - ed.]

In addition, performance on existing hospital quality measures may be reaching a ceiling where further improvements in quality are unlikely.

[That speaks to a low ROI or even negative for the hundreds of billions of dollars being diverted to the IT sector - ed.]

"The lurking question has been whether we are examining the right measures to truly test the effectiveness of health information technology," said Spencer S. Jones, the study's lead author and an information scientist at RAND. "Our existing tools are probably not the ones we need going forward to adequately track the nation's investment in health information technology."

["Probably" not the ones we need? How can the authors know this? This is not science, it is speculation. Further, I'd say the scientific imperative before we design "the right measures" to "truly" test the effectiveness of HIT is to understand why the measures we're using now are not showing the desired results, because perhaps they are perfectly adequate and are revealing crucial flaws, overestimations and false assumptions that need to be dealt with, now, not after another round of billions is spent - ed.]

New performance measures that focus on areas where EHRs are expected to improve care should be developed and tested, according to researchers.

[In pharma clinical trials, this is akin to what is known as "changing the study methodologies and endpoints" - a form of manipulating clinical research, usually with the true ultimate endpoint of money - ed.]

For example, EHRs are expected to lower the risk of adverse drug interactions, but existing quality measures do not examine the issue.

[I believe the studies that have been done of CPOE have not been consistently supportive, and in fact show CPOE might create new med errors - ed.]

"With the federal government making such a large investment in this technology, we need to develop a new set of quality measures that can be used to establish the impact of electronic health records on quality," Jones said.

[This is truly putting the cart before the horse as I wrote here. The studies showing the benefit should have long preceded the "large investments" that were decided upon - ed.]

Support for the study was provided by RAND COMPARE (Comprehensive Assessment of Reform Efforts). RAND developed COMPARE to provide objective facts and analysis to inform the dialogue about health policy options. COMPARE is funded by a consortium of individuals, corporations, corporate foundations, private foundations and health system stakeholders.

Other authors of the study are John L. Adams, Eric C. Schneider, Jeanne S. Ringel and Elizabeth A. McGlynn.

The overarching assumption is that the metrics are wrong, not the quality and fitness for purpose of the technology, the 'wrongness' of which is painfully obvious from the aforementioned other literature, e.g., link, link, link, and the many posts at this blog referring to other literature. Are the authors unaware, one might ask? I know they are not. (Or - blinded? That is, could there be external pressures affecting the thought processes? The arguments might not unreasonably be construed to be skewed from that perspective.)

Recognizing the atrocious user experience and mission hostile nature of the technology (link), how disruptive it is (link, link), how poorly implemented it is often by domain amateurs to support financial battles of the payers, not cognitive processes of clinicians, I am amazed there's any signs of improvement at all, not outright deterioration. (That there is not outright deterioration of care displays if anything the results of the hard mental labor and ingenuity of clinicians to work around the technology's deficits.)

I note that the last time RAND looked at such matters there were problems with pro-health IT bias, among other issues (see my Feb. 2009 post "Heartland Institute Research & Commentary: Health Information Technology").

Carl Sagan wrote that science is a candle in the dark in a demon haunted world.

It seems the demons are winning.

-- SS

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Why I find the healthcare IT industry so disappointing

At "Background On The 'Ecosystem' of Commercial Healthcare IT" I wrote:

... In reading about HIT difficulties it is important to understand the �ecosystem� of commercial health IT, that is, the identity and nature of the principal constituents and stakeholders, and their interrelationships. Familiarity with this environment is useful in order to place the social and organizational issues affecting HIT diffusion in the proper context.

By implication, I made the case that the commercial HIT ecosystem was far from healthy.

Recently at Healthcare Renewal and at another blog I visit, HISTalk, frequented largely by IT industry workers and officials, I've noted an uptick in comments from anonymous commenters that resort to ad hominem, strawman arguments, or other forms of logical fallacy in a fairly clear cut attempt not to seriously debate the issues but to de-legitimize serious arguments. I generally respond to such comments, but a few have been so debased here that I have simply deleted them.

Here is an example of a duplicitous strawman argument recently posted at the aforementioned other site with regard to my HC Renewal post "21st century EMR experiments: screwing around with people's lives in a broke city, while not having a clue what you're doing":

... Jumping to conspiracy theories about cover-ups whenever there is an IT problem acknowledged by an organization does not really help improve the state of health IT.

I find the sicknesses of the commercial health IT ecosystem very disappointing and, in fact, revolting due to the implications for patients.

Perhaps a little background as to why I feel that way is in order.

Note:

I believe my background is not too dissimilar from the background of many physicians, who have had similar experiences. The following is therefore not so much about me, but about the challenges of medical training and practice in general and the life experiences imparted:

Pre- informatics, while a resident at Abington Memorial Hospital in Pennsylvania and then as a Manager in a regional transit authority�s medical department, I handled situations such as these:

• Being admitting officer in the ED in the busiest night, ever, in the hospital�s history to that time, New Years Eve 1985-6, having to see perhaps a hundred patients and admit ~ 30. The ED staff needed to -- and did -- perform flawlessly after participating in the highly upsetting and depressing, unsuccessful resuscitation effort of a medical colleague shot in the chest in his home (link) around midnight. It was I who performed heart massage on him -- open-chest style -- with my gloved hands after the surgeons on the trauma team cracked his chest;
  

• Running three near-simultaneous cardiac arrests in the ICU�s during family visiting hours, while being trailed by a Mennonite minister-in-training as an observer. Dealing with the patients' crises and their families was not easy and in fact was extremely stressful. The minister-in-training at the end of it all after several hours stated he was amazed at how I and the intern I was overseeing kept our cool during the affair;
  

• Not telling an intern colleague on the telephone whose mother I�d just declared deceased in the MICU that she had died, because his call was coming from his father�s funeral. His father had died a few days before in the CCU right next door, previously healthy but having had an MI from the stress of his wife's condition. (The intern later thanked me for not telling him about his mother's death until after dad's funeral).

• Repairing a malfunctioning GE CT scanner's computer to get it up and running late one Sunday might ca. 1986, which permitted a life-saving CT scan of the head of an unidentified young man brought in in a delirious state. A repairman left near midnight and said it was fixed, but it was not, and service, I was told, was unavailable between midnight and 7 AM Sun-Mon. so he could not be called back. I'm not sure if this was a vendor policy or a contractual issue (either of which would reflect Titanic lifeboat-like stupidity, since people need CT scans 24x7), but due to radiology training and computer expertise I knew what the problem was and fixed it, going above and beyond the call of duty of an internal medicine resident.
  

• Dealing strongly and firmly with militant labor union leaders and drug-troubled vehicle and train operators as Mgr. of Medical Programs and drug testing in a large regional transit authority. I was very firm in my stance about keeping these operators off the street, and getting them help, to protect the public from possible catastrophe. I was threatened more than once, including being threatened with my life, by operators I had to put out of service.

• Standing up to a police officer and a FOP union official regarding what I believed was gross exaggeration of a minor injury, with no objective findings to substantiate the reported symptoms, multiple inconsistent findings on exam (indicative of 'acting'), and ongoing injury-clinic (a.k.a. fraud-factory) hot pack and massage "treatments" for more than a year, to take advantage of the injury compensation system. This type of activity was unfair to truly injured personnel, to the city that had to pay for these activities at the expense of other needed services, and to the taxpayer.
  

Experiences such as this impart a sense of the fragility of life, of responsibility, obligation, and an understanding of the need for critical thinking and serious and uncompromising attitudes where patients are concerned into physicians of good character.

(Somehow, the hospital, pharmaceutical and medical device executives written about at Healthcare Renewal seem to have missed those points in their own life experiences.)

Most serious, critical-thinking physicians thus would find irrational arguments coming from the HIT industry, marketing spin, petty character attacks on those who report on HIT difficulties, and other unpleasantries quite unserious and disappointing. I certainly do.

After all, IT industry personnel in large part went through educations far simpler than that of a physician. They generally have bachelor's or masters' degrees, have had no medical school experience, internships, residencies, postdocs, etc. They have what are essentially comfortable desk jobs, no liability for patient harm, and compared to most physicians, a cakewalk in their professional lives.

On the other hand, as a physician who had such experiences, I�m a serious professional concerned about serious issues that affect people's lives in their time of need.

I expect nothing less from others involved in aspects of healthcare that can be life or death (as my own mother recently experienced via EHR-initiated iatrogenic catastrophe).

From that perspective, I find the commercial HIT ecosystem quite disappointing indeed.

-- SS

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Concerns about adoption of Electronic Health Records, as expressed at a meeting of the U.S. House of Representatives Committee on Science & Technology

Even within the Medical Informatics community, it is not common to hear major real-world issues that must be faced before national health IT can become a (safe, effective) reality presented candidly.

I therefore found this candid presentation by a fellow Medical Informaticist, Dr. Richard Gibson, refreshing. (Dr. Gibson was in Medical Informatics fellowship training at U. Utah at the same time I was in my postdoctoral fellowship at Yale.) He presented on issues related to standards for the most part, but also presented some serious caveats as I reproduce below. The caveats will sound familiar to readers of this blog.

The head of ONC, Dr. Blumenthal, was present at this meeting. I hope he will heed Dr. Gibson's words on the difficulties of health IT and cease to present clinical IT as a deterministic solution to healthcare's ills, including definitive statements on unknowns or debatable topics, and even false statements such as these (released for political reasons, of course):

In the NEJM:

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers� decisions and patients� outcomes [actually, may - we do not yet know - ed.] . Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.


From the HuffPo Investigative Fund:

�We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. [False- ed.] And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,� Blumenthal said when unveiling new regulations in Washington on July 13.

Dr. Gibson's testimony on EHR adoption concerns was as follows:

Medical Informaticist Dr. Richard Gibson on Health IT
U.S. House of Representatives Committee on Science & Technology
Subcommittee on Technology & Innovation
Sept. 30, 2010
(Full PDF transcription here).

... CONCERNS ABOUT ADOPTION OF ELECTRONIC HEALTH RECORDS

Adoption of EHRs is a Prerequisite for Interoperability

We have an enormous effort still ahead of us. Before going on to the specific standards that are the topic of today's hearing, we need to acknowledge that the standards have relatively little application unless individual healthcare providers have electronic health records in the first place. Most of the more than 400,000 Eligible Professionals still need to acquire an electronic health record, and most of that effort will be in small physician offices. CMS has estimated the five-year cost of acquiring an electronic health record for an eligible professional to be $94,000. EHR incentive plans through Medicare and Medicaid will cover 47 to 67% of that estimated cost. As a general rule, EHRs still do not allow providers to see more patients in a day, spend more quality time with their patients, or guarantee better or more consistent health outcomes for their patients. [This raises the question of what then, exactly, do EHR's do? - ed.] In short, even with the generous EHR incentive program, there still may not be a sufficient financial rationale for individual providers or small practices to invest in electronic health records.

Implementing an EHR is Stressful for the Provider

Implementing electronic health records in small physician offices is not like purchasing a copy machine or a fax machine. In addition to the great capital expense, the EHR is markedly disruptive to both the clinical and administrative functions of the office. Every provider, medical assistant, receptionist, and billing staff member needs to change the way they do their work. Even with excellent training, it usually takes 2-12 months before providers are fully comfortable on their new tools. On a new EHR, each office visit takes longer - this means increased waiting times for patients or a fewer number of patients per day for the provider. It is not uncommon for providers on a new EHR, after a full 8-10 hour day of seeing patients, to finish their charts on the computer at home for three or four hours in the evening [potentially introducing inaccuracy into the record as a result of the long delay between visit and documentation - ed.] Even those providers who believe in the patient care benefits of an EHR are exhausted by the process in the first year. [Do exhausted clinicians make more, or less errors? - ed.]

EHRs Viewed Unfavorably by Many Providers Because of Administrative Documentation

Many providers who do not yet have EHRs in their office have commented to me how much they dislike the output received from many other physician office EHRs or from hospital EHRs. They specifically complain about how many pages these EHR reports require and how difficult it is to find the small bit of useful clinical information within. Upon investigation, most of this low-value verbosity comes from physicians documenting specific history and physical exam findings required to support their billing. Also, as medicolegal requirements ratchet up, clinicians feel a need to document with a date-time stamp every single finding and every single item of data that they have reviewed. The existing cumbersome EHR reports impair the clinical process and can put the patient at risk by making important information obscure. Clinicians criticize the EHR for this clumsy reading even though the cause lies with our current payment and administrative systems, and not the EHR itself [I would challenge this assertion; computers generate reports according to human-created scripts, and scripts could be created to generate clinically meaningful reports - ed.] , which is otherwise widely agreed to be highly legible. [An apropos term is "legible gibberish" and I recently paid almost $1000 for appx. 2,800 pages of it from an Eclipsys system, documenting two and a half weeks of care of my EHR-injured mother. The output was simply awful - ed.] Most clinicians would prefer to go back to simpler charting that more closely reflects their thought process. These EHR changes will need to await payment reform.

IT Professionals with Multiple Skills Needed for EHR Implementation

Another challenge in implementing electronic health records in small provider offices is the lack of technical expertise and support for the office. The providers are busy with a full schedule seeing patients. Medical assistants are putting patients in rooms or they are continuously on the phone with patients. Front office staff members are trying to make appointments and handle incoming calls. The billing staff is overwhelmed with insurance paperwork. Most providers and staff, especially those in small practices, don�t have time to become fluent in the use of the new system, much less become expert in training others to use the system. Typical small physician implementations start two to three months before the expected launch date of the software. All current paper-based workflows need to be examined and re-designed for the new software. This requires analysts who are not only familiar with software but familiar with the healthcare office process. [It also requires competent people with a service attitude, further limiting the pool of available personnel - ed.] Bringing the majority of the 400,000 Eligible Professionals up to speed on an EHR in the next several years will be challenged by a lack of IT implementation professionals.

EHR Technical Requirements Can Be Challenging for Smaller Practices

Small physician practices are already spending 40-60% of their net revenue on overhead. Space in small physician offices is at a premium and providing a physically locked computer space within the physician office is difficult. Physician offices do not typically have the technical expertise to manage the computers in the clinical areas as well as the office computer network and the larger computers that act as servers and tape backup for the EHR software. Hosting provider EHRs on centralized servers supporting multiple practices may address this concern, but many of the currently used office EHRs are not yet ready for this step-up in technology. Many small towns do not have local computer hardware professionals to support physician offices. The Regional Extension Centers (RECs) exist to assist physicians in this context but even with generous funding, the RECs will be challenged to meet the enormous demand in the next several years. [Considering the "wicked" nature of health IT and the organizational and social issues involved, I would say the RECs will be "overwhelmed to the point of paralysis" - ed.]

I agree with nearly all of Dr. Gibson's positions. I feel they are very helpful in terms of clarifying others' understanding of some inconvenient truths about HIT.

I am disappointed, however, that we even need such testimony before Congress to clear up misconceptions and irrational exuberance about EHR's in the year 2010, when these issues became obvious to objective and unconflicted observers many years ago.

The culture of HIT appears stagnant. Unfortunately cultural reform takes far longer than technological reform.

Yet HIT cannot reform medicine until HIT itself and our societal attitudes and approaches to it are reformed. Hopefully this speech will be a part of initiating the needed reform.

-- SS

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