Institute of Medicine Committee on Patient Safety and Health Information Technology, and Thoughts on Social Aspects of Health IT Evaluation

March 2011 addendum: also see my thoughts on Meeting two of the Committee on Patient Safety and Health Information Technology at this link.

The U.S. National Research Council of the National Academy of Sciences issued a report in early 2009 on the state of health IT.

That study's report, led in part by pioneers in Medical Informatics G. Octo Barnett and William Stead, was entitled "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions" (pre-publication PDF available free at this link). The report was announced under the following header:

CURRENT APPROACHES TO U.S. HEALTH CARE INFORMATION TECHNOLOGY ARE INSUFFICIENT

The insufficiencies were largely in the areas of difficulties with data sharing and integration, deployment of new IT capabilities, large-scale data management, and lack of cognitive support by health IT for busy clinicians.

One might reasonably conclude such deficits could affect patient safety.

Recently the Institute of Medicine (the health arm of the National Academy of Sciences) formed a Committee to study health IT safety. It held its first meeting on Dec. 14, 2010 (quite a few years late in my opinion, and only after tens of billions of dollars have been earmarked for health IT, but better late than never):

The Institute of Medicine Committee on Patient Safety and Health Information Technology is holding its first meeting on December 14-15, 2010. The first day, December 14, 2010 beginning at 10:30 am, is open to the public to observe the committee proceedings. The committee will hear presentations by the Office of the National Coordinator and other invited guests. There will also be an opportunity for members of the public and representatives of interested organizations to make a brief statement before the committee. Prior registration is requested for attendees and required for those wishing to make a statement.

Participant lists and materials from that first meeting are available at this link.

This brings to mind some thoughts on the social aspects of health IT evaluation.

At a website by Dr. David Healy (link) on mass over-promotion and clinical trial data irregularities regarding SSRI's, academic abuses towards critical thinkers, and related affairs, I note an interesting observation in the preface. The author states:

"On the face of it, the investigation of possible hazards posed by SSRIs does not seem to have followed the conventional dynamics of science, where anomalies in the data are supposed to spur further investigation. In this case, debate has been closed down rather than opened up. Journals that might have been thought to be independent of pharmaceutical company influence have “managed” not to publish articles and the appropriate scientific forums have “managed” not to debate the issues."

This sounds eerily familiar with regard to another domain in biomedicine - health IT.

Allow me to substitute a few words:

"On the face of it, the investigation of possible hazards posed by clinical information technology does not seem to have followed the conventional dynamics of science, where anomalies in the data are supposed to spur further investigation. In this case, debate has been closed down rather than opened up. Journals that might have been thought to be independent of information technology company influence have “managed” not to publish articles and the appropriate scientific forums have “managed” not to debate the issues."

Only recently do I note this phenomenon starting to lift. I've aggregated a number of reports and articles of recent years that take a critical-thinking attitude about health IT safety, efficacy, and sociopolitical matters such as here and here. I intend to broaden and deepen this aggregation to make it more comprehensive in the coming months.

This is a somewhat personal exercise as my mother was severely injured in May 2010 by health IT interference with clinician communications, as at the banner at top of my longstanding website on HIT difficulties (link).

However, it's also a professional endeavor. I will be presenting at a regional health care attorney's meeting in a few months on health IT risks. In my talk I will undoubtedly recommend aggressive litigation when HIT is implicated in patient injury, and investigations of potential contributions of health IT to medical malpractice when not readily apparent. I am not alone in this stance.

Several weeks ago I also asked the IOM Committee on Patient Safety and Health Information Technology to be allowed to present my mother's case at some point, a tragic and ironic example of a family member of a physician and Medical Informatics specialist (not just a layperson) injured as a result of health IT. I have not yet received a reply.

Evaluation of health IT will likely become more than an academic endeavor in the next few years. Those engaged in it might find themselves called as expert witnesses - or as defendants.

I see a legal storm approaching in health IT. This is a domain I am somewhat familiar with, as pre-informatics I was a medical officer in public transit making safety-related medical decisions on transit authority/DOT-related matters, at a time when nationally-mandated random drug testing in the industry had recently begun. The legal implications of such work can be quite unexpected - and profound, especially when interfered with by outside sources with conflict of interest (e.g., labor unions). Train wrecks - literally, accompanied by litigation through the roof.

To those involved in health IT, this is not a scientific opinion, and thus feel free to ignore it.

At your own peril IMO.

-- SS

Paleolithic Diet Clinical Trials, Part V

Dr. Staffan Lindeberg's group has published a new paleolithic diet paper in the journal Nutrition and Metabolism, titled "A Paleolithic Diet is More Satiating per Calorie than a Mediterranean-like Diet in Individuals with Ischemic Heart Disease" (1).

The data in this paper are from the same intervention as his group's 2007 paper in Diabetologia (2). To review the results of this paper, 12 weeks of a Paleolithic-style diet caused impressive fat loss and improvement in glucose tolerance, compared to 12 weeks of a Mediterranean-style diet, in volunteers with pre-diabetes or diabetes and ischemic heart disease. Participants who started off with diabetes ended up without it. A Paleolithic diet excludes grains, dairy, legumes and any other category of food that was not a major human food source prior to agriculture. I commented on this study a while back (3, 4).

One of the most intriguing findings in his 2007 study was the low calorie intake of the Paleolithic group. Despite receiving no instruction to reduce calorie intake, the Paleolithic group only ate 1,388 calories per day, compared to 1,823 calories per day for the Mediterranean group*. That's a remarkably low ad libitum calorie intake in the former (and a fairly low intake in the latter as well).

With such a low calorie intake over 12 weeks, you might think the Paleolithic group was starving. Fortunately, the authors had the foresight to measure satiety, or fullness, in both groups during the intervention. They found that satiety was almost identical in the two groups, despite the 24% lower calorie intake of the Paleolithic group. In other words, the Paleolithic group was just as full as the Mediterranean group, despite a considerably lower intake of calories. This implies to me that the body fat "set point" decreased, allowing a reduced calorie intake while body fat stores were burned to make up the calorie deficit. I suspect it also decreased somewhat in the Mediterranean group, although we can't know for sure because we don't have baseline satiety data for comparison.

There are a few possible explanations for this result. The first is that the Paleolithic group was eating more protein, a highly satiating macronutrient. However, given the fact that absolute protein intake was scarcely different between groups, I think this is unlikely to explain the reduced calorie intake.

A second possibility is that certain potentially damaging Neolithic foods (e.g., wheat and refined sugar) interfere with leptin signaling**, and removing them lowers fat mass by allowing leptin to function correctly. Dr. Lindeberg and colleagues authored a hypothesis paper on this topic in 2005 (5).

A third possibility is that a major dietary change of any kind lowers the body fat setpoint and reduces calorie intake for a certain period of time. In support of this hypothesis, both low-carbohydrate and low-fat diet trials show that overweight people spontaneously eat fewer calories when instructed to modify their diets in either direction (6, 7). More extreme changes may cause a larger decrease in calorie intake and fat mass, as evidenced by the results of low-fat vegan diet trials (8, 9). Chris Voigt's potato diet also falls into this category (10, 11). I think there may be something about changing food-related sensory cues that alters the defended level of fat mass. A similar idea is the basis of Seth Roberts' book The Shangri-La Diet.

If I had to guess, I would think the second and third possibilities contributed to the finding that Paleolithic dieters lost more fat without feeling hungry over the 12 week diet period.


*Intakes were determined using 4-day weighed food records.

**Leptin is a hormone produced by body fat that reduces food intake and increases energy expenditure by acting in the brain. The more fat a person carries, the more leptin they produce, and hypothetically this should keep body fat in a narrow window by this form of "negative feedback". Clearly, that's not the whole story, otherwise obesity wouldn't exist. A leading hypothesis is that resistance to the hormone leptin causes this feedback loop to defend a higher level of fat mass.

Some Call it "Tyranny" - Top Leaders of University of California (Including Leaders of Academic Medicine) Demand Bigger Pensions for Themselves

The state of California, and its flagship university system, the University of California, have been under extreme financial pressure lately. 

The 36 Executives' Demands

However, that apparently has not decreased the University's hired managers' and executives' sense of entitlement.  They are threatening to sue if their pensions are not increased.  As reported by the San Francisco Chronicle,

Three dozen of the University of California's highest-paid executives are threatening to sue unless UC agrees to spend tens of millions of dollars to dramatically increase retirement benefits for employees earning more than $245,000.

'We believe it is the University's legal, moral and ethical obligation' to increase the benefits, the executives wrote the Board of Regents in a Dec. 9 letter and position paper obtained by The Chronicle.

'Failure to do so will likely result in a costly and unsuccessful legal confrontation,' they wrote, using capital letters to emphasize that they were writing 'URGENTLY.'

Their demand comes as UC is trying to eliminate a vast, $21.6 billion unfunded pension obligation by reducing benefits for future employees, raising the retirement age, requiring employees to pay more into UC's pension fund and boosting tuition.

The fatter executive retirement benefits the employees are seeking would add $5.5 million a year to the pension liability, UC has estimated, plus $51 million more to make the changes retroactive to 2007, as the executives are demanding.

The executives fashioned their demand as a direct challenge to UC President Mark Yudof, who opposes the increase.

'Forcing resolution in the courts will put 200 of the University's most senior, most visible current and former executives and faculty leaders in public contention with the President and the Board,' they wrote.

Background to the Case
Here is the relevant background:

The roots of the pension dispute go back to 1999, five years after the IRS limited how much compensation could be included in retirement package calculations. But even after the IRS granted UC's waiver in 2007, nothing changed.

University executives were having troubles of their own that year.

President Robert Dynes resigned in 2007 after it was discovered that UC was awarding secret bonuses, perks and extra pay to executives. State auditors also found that UC's compensation practices were riddled with errors and policy violations.

UC officials also had become aware of another big problem: UC's pension obligations were about to outstrip its ability to pay retirees. Neither UC nor its employees had paid into the fund since 1990.

It took until this year for UC to act. In September, a retirement task force offered Yudof several options for closing the $21.6 billion gap - and one to widen it: increasing executive pensions.

Health Care Executives Included

Note that in addition to a bunch of finance officers and portfolio and asset managers, the demanding executives included quite a few leaders of the medical schools, and academic medical centers, including:

UC System's Central Office
Dr. Jack Stobo, senior vice president, health services and affairs

UCSF
Dr. Sam Hawgood, vice chancellor and dean, School of Medicine
Ken Jones, chief operating officer, medical center
Mark Laret, CEO, medical center
Larry Lotenero chief information officer, medical center
John Plotts, senior vice chancellor

UC Davis
William McGowan, CFO, health system
Dr. Claire Pomeroy, CEO health system, vice chancellor/dean, School of Medicine
Ann Madden Rice, CEO Medical Center

UCLA
Dr. David Feinberg, CEO of the hospital system; associate vice chancellor
Dr. Gerald Levey, dean emeritus
Virginia McFerran, chief information officer of the health system
Amir Dan Rubin, chief operating officer of the hospital system
Dr. J. Thomas Rosenthal, chief medical officer of the hospital system; associate vice chancellor
Paul Staton, chief financial officer of the hospital system

UC San Diego
Dr. David Brenner, vice chancellor for health sciences; dean of the School of Medicine
Tom Jackiewicz, CEO, associate vice chancellor of the health system
Dr. Thomas McAfee, dean for clinical affairs

UC Irvine
Terry Belmont, CEO, Medical Center

The Outraged Reaction
The executives' demands sparked anger on campus.

Dissenting members of the task force said it would be unseemly' to expand executive pensions. Tuition had just been increased by 32 percent this fall, and the regents were poised to raise it another 8 percent for fall 2011. They also voted to shift more money into the retirement fund from employees' pockets, as low-wage workers worried about retiring into poverty.

'I think it's pretty outrageous that this group of highly compensated administrators of a public university are challenging the president and the chair of the Board of Regents, said Daniel Simmons, chairman of UC's Academic Senate and a law professor at UC Davis.

'What outrages me the most is that these 36 people are blind to the fact that this is a public entity in dire straits,' said Simmons, who also served on the retirement task force and opposed the higher pensions.

The demands prompted outrage from politicians and editorialists. A few choice samples:

- The executives are "tarnishing the university's name with greed," editorial (UCLA) Daily Bruin.

- "Very out of touch," by Governor Elect Jerry Brown; "truly living in an ivory tower...." while "people are suffering in the rest of the state and losing their homes," by Assemblyman Jerry Hill, D- San Mateo (per the San Francisco Chronicle)

- "Uncaring and divisive," "undercuts public support for one of California's most treasured institutions," "sending out its own special-interest message: what's in it for me," - editorial, San Francisco Chronicle.

- "despicable threat," the California Regents (UC board of trustees) should not "claim that lavish pension may be needed to recruit good people to UC. Good people don't threaten lawsuits against a cash-strapped sate to enrich themselves." editorial, Sacramento Bee.

- Governor-Elect B4rown should issue an executive order "to eliminate any position in the University of California system paying $245,000 a year or more," (thus effectively firing all the 36 complaining executives); "free taxpayers and students alike from the tyranny of those whose main objective during any time - tough or otherwise - is to keep milking the state for every penny the can squeeze out," editorial, Manteca Bulletin.

Summary

We have posted frequently about hired managers and executives of health care organizations receiving compensation and benefits out of all proportion to their apparent performance. The case of the demanding University of California executives is just one of many. However, what is really remarkable about this case is the reaction to it. We are hearing top leaders, including many of the top leaders of the state's medical schools and academic medical centers, called uncaring, greedy, and despicable by well-known politicians and in newspaper editorials, and we are hearing calls that they be fired, en masse.

Maybe we are at a tipping point.

Of course, hired health care managers and executives are not entitled to line their own pockets while patients and their other constituencies suffer during the great recession. They are not entitled to continually drive health care costs up while they enrich themselves.

However, apathy, learned helplessness, and the anechoic effect have let them promote themselves into a de facto new aristocracy (just like the hired managers and executives of some other non-profit organizations, for-profit corporations, and especially financial service corporations have turned themselves into the rest of that aristocracy.)

If we do not reclaim health care from these new oligarchs, we will all end up not just with expensive, difficult to access, mediocre health care, but under their tyranny.

Post-Script

This is just the latest example of the sense of entitlement displayed by the hired managers and executives of the University of California. Outrageous pay and benefits unjustified by any measure of performance for University of California's hired managers and executives has been grist for the Health Care Renewal mill since 2005.  A few samples:
-  The ranks of those paid more than $200 K rose much faster than those paid less, while lower paid employees endured a pay freeze, and the university cut its budget.  Managers got bonuses for extra work, while faculty did not.  Managers got housing allowances, and other perks.  (November, 2005) 
- UC-Irvine managers were paid lavishly while presiding over debacles involving transplant services  (liver transplants, November, 2005; bone marrow transplants, January, 2006; kidney transplants, January, 2006)
- UC - San Diego Chancellor was paid $359 K plus a bonus of $248 K for supposed full time work while serving on ten for-profit corporate and non-profit boards, including directorships of for-profit health care corporations that were conflicts of interest with her role overseeing the medical school and medical center.  This was the first case of what we later called the "new species of conflicts of interest" posted on the blog.  (January, 2006)
- UC - Irvine managers got bonuses while its medical center failed an inspection (January, 2010), as did managers at other UC campuses (January, 2010).

Maybe if these older stories produced more outraged, the current situation would not have occurred.

You heard it first on Health Care Renewal

Hat tip to Prof Margaret Soltan on the University Diaries blog.

BLOGSCAN - Health IT Debacle Down Under?

From the blog "Australian Health Information Technology" by Dr David More MB, PhD, FACHI:

Monday, January 03, 2011

NSW Health Has A Full Blown Health IT Failure on Its Hands. As I Predicted in 2006!

The Healthelink Project, which was to provide a prototype for a Shared EHR for NSW has essentially imploded.

Information provided to this blog confidentially confirms both the number of participants in the project and their information transmission activities have both fallen through the floor over the last 12 months! To protect sources I can’t provide much detail concerning the evidence I have seen, but it is clear and dramatic and confirms what I have been saying for a good while. Sadly HealtheLink is such a badly wounded animal that it really now needs to be helped to pass to a much better place!

Are the national health IT efforts in the US headed in the same direction?

Read the entire post at the link above.

-- SS

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

BLOGSCAN - On Device Company's Obfuscation of the Reasons for Payments to Surgeons

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody analyzed further the case of the huge royalties paid to spine surgeons by Medtronic (see our most recent post here).  He wondered why surgeons would get such sizable payments for "intellectual property" related to devices that they neither seemed to use or to research?  I would note that the lack of clarity about the reason for Medtronic's payments to these surgeons is just part of a larger lack of clarity about most of the payments made to physicians and medical and health care academics for "consulting" or serving on advisory boards.  If such professional-industrial collaboration is so important for "innovation," one wonders why the people engaged in it are almost never willing to disclose the topics of these wonderful interchanges?

BLOGSCAN - Wandering in the Wilderness

On the 1 Boring Old Man blog, "Mickey," the anonymous blogger, a retired academic psychiatrist, posted about how he figured out the extent that health care dysfunction affected psychiatry while wandering the "wildnerness" outside of academic psychiatry.  He proposed that what needs to die is "the shameful mockery many have made of their own rallying cry - 'evidence based medicine'…"  Dr Wally Smith would have called it pseudo-evidence based medicine.   (And thanks for the mention of Health Care Renewal.)