Information Technology Makes Healthcare Easier? Is This Industry Trying to Harm Patients? Part 6 of a Series

(Note: Part 1 is here, part 2 is here, part 3 is here, part 4 is here, part 5 is here, part 6 is here, part 7 is here, and part 8 is here.)

This post is part 6 of a series on the stunningly poor human engineering of production healthcare IT from major vendors, in use today at major medical centers. These devices provide a decidedly mission hostile user experience, yet with an almost religious fervor are being touted as cybernetic miracles to cure healthcare's ills.

During the Sunday morning talk show "Roundtable" this morning, I saw an IBM ad touting the fact that they'd surpassed the petaflop mark (built computers that can perform one thousand trillion floating point calculations per second).

They touted how such computers will enable weather prediction, medical advances, solutions to social problems, and other cybernetic miracles. (Some of these miracles have been promised since the days of ENIAC in the late 1940's.)

Now, I am indeed amazed by such machines, and realize their value when utilized by competent domain experts overseeing equally competent analysts and programmers, ideally along with HCI (human computer interaction) experts who can help humans interact effectively with such computational high performance.

One would think, though, in a culture where we can perform one thousand trillion calculations per second on large machines, and where consumer machines can perform pretty fast as well that we could do better in the human interface to healthcare IT:

As of 2008, the fastest PC processors (quad-core) perform over 37 GFLOPS (Intel QX9775) [that's 37 billion calculations per second - ed.] GPUs in are considerably more powerful, for example, in the GeForce 8 Series the nVidia 8800 Ultra performs around 576 GFLOPS on 128 processing elements ... There are now graphics cards such as the ATi Radeon HD 4870X2 which can run at over 2.4 TeraFLOPS [2.4 trillion calculations per second - ed.]

Amazing. I used to support applications running on IBM POWER-based supercomputers far slower than 1000 trillion FLOPS for drug discovery at Merck, and chatted with those who used these supercomputers in molecular modeling, critical to drug discovery. Today's computing advances are indeed remarkable just a few years later.

Here is where my disappointment arises.

Health IT seems to be back in the TRS-80 days in terms of its failure to utilize these levels of computing power to create a mission friendly user experience and safer medical care.

HIT user experience: trapped in the TRS-80 era?

Below is how a major healthcare IT system forces a user to do even a simple task, changing the starting date and time for a common medication.

Let's count the steps required for what used to require one step: putting the instrument below to paper.



Keep in mind, health IT is touted as improving the quality of healthcare, reducing errors, and reducing costs.

Step one in the world of HIT (a world, as I said, of MIS-inspired inventory systems, not clinical tools for use by clinicians) involves hunting for, and then clicking "frequency" on a scrolling list of possible "order details", seen on the left of the screen below:

(click to enlarge)

The user then clicks on the "ellipsis button" at upper right, which produces a popup to display the "standard times" for B.I.D. (twice a day) meds:

(click to enlarge)

On the popup subscreen is a list of "standard medication adminstration times" or SMAT's. Here the BID times are shown as 0900 and 2100 (9 AM and 9 PM).

To override these times, more screens, more clicks and more work is needed. The user must click on a "requested start date and time," which has defaulted by programmer edict to the CURRENT data and time. The user is warned in the "User Guide" about how to perform this function as follows-

CAUTION: If you do not change the [default] requested start data and time, the first dose will be scheduled for the current date and time.

The "current time" here being 11:28 AM as on left:

(click to enlarge)

Fantastic. The user must then change the requested start data and time to match the SMAT (standard medication administration time) for the first dose. Say they want the first dose to be given at 2100 (9 PM) tonight.

In the screen below, the user changed this to 6/5/2006 at 2100 (9 PM) to match the SMAT time. The first dose is to be given at 2100 (9 PM) on the current night.

(click to enlarge)

But they're not done yet!

After signing the order, the clinician making the change (often a nurse) will need to click the eMAR (Electronic Medication Administration Record) tab. They must verify something called the "eMAR time frame setting" to be certain that this "time frame" is set for something called the "clinical range." See below:

(click to enlarge)

This act comes with a warning in the instruction manual:

CAUTION: Never limit the eMAR to your shift or to today only. Limiting your view of the eMAR may cause you to inadvertently create medication errors. (!)

Inadvertently create medication errors? Really? Should be easy to fix with machines capable of trillions of calculations per second, no?

No. The user is advised that if the eMAR timeframe is not set to "Clinical Range", all they need do is:

Close the patient's chart, and log out of the health IT application. When you log on next time, the time frame will default to Clinical Range.

Simple, no? Something we all want our doctors and nurses to be doing day in, day out for just this one simple function, no?

Who designed such an interface? What kind of user experience is this, exactly? One designed to make clinical work easier?

Perhap the HIT designers might seek a brain transplant or some other procedure to restore brain function, and then utilize the amazing computational power of modern IT and the advances in biomedical informatics, computational lingustics, parsers (used in building computer program compilers), etc. to allow a user to type in a command with an easily learned syntax such as:

> change Amoxicillin bid 0900 2100 start 06/05/2006

and have the computer popup a verification window that asks:

Are you sure you want to change Amoxicillin to twice daily, 0900 and 2100 (9 AM and 9PM), starting Monday June 5 (Yes/no)?

Or are such undergraduate level computer science feats beyond what's "a good business case" for the HIT vendors, thereby banking on the cognitive diligence of healthcare providers to make up for HIT stupidities?

Are these vendors aware of fifty+ years of computer science, information science, biomedical informatics, HCI and other research? Who, exactly, is creating, testing and approving the clinician user experiences I am illustrating?

Clinicians as technophobes when we're talking about poor IT such as presented in this series? My a**.

In part 7 and on we shall start to see the "peek a boo, wild goose chase, go find your lab data" screens I've mentioned.

-- SS

"Buried Data," a "Smoke-and-Mirrors Job" and a "Positive Spin" on a "Cursed Study"

Documents produced on discovery and recently unsealed during litigation suggested how AstraZeneca handled clinical research data in the marketing of its atypical anti-psychotic drug Seroquel (quetiapine). As reported by Bloomberg,

AstraZeneca Plc 'buried' unfavorable studies on its antipsychotic drug Seroquel, according to an internal e-mail unsealed as part of litigation over the medicine.

The drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in 'cherry picking' of data from one of those studies for use in a presentation, an AstraZeneca official said in a December 1999 e-mail unsealed yesterday under an agreement between the company and lawyers for patients. The London-based company faces about 9,000 lawsuits claiming it failed to properly warn users that Seroquel can cause diabetes and other health problems.

'The larger issue is how we face the outside world when they begin to criticize us for suppressing data,' John Tumas, an AstraZeneca publications manager, told colleagues in the e-mail.

One unsealed document showed AstraZeneca officials considered Trial 15, one of the studies Tumas described as 'buried,' to be a problem because it didn’t produce favorable results on the issue of weight gain for patients taking the drug. Gaining weight can be a factor in the development of diabetes.

Richard Lawrence, an AstraZeneca official, said in a February 1997 e-mail that the company had engaged in a 'great smoke-and-mirrors job' in dealing with U.S. and Canadian investigators on the trial’s results.

'Adopting the approach Don has outlined should minimize (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study,' Lawrence said in the e- mail. It isn’t clear from the e-mail which person Lawrence is referring to.

In his December 1999 e-mail, Tumas said that AstraZeneca had 'buried trials 15, 31, 56,' and was considering a study listed as COSTAR. Details of the trials weren’t specified in the e-mail.

Tumas chastised colleagues for using favorable data produced by Trial 15 without disclosing the full study results, according to his unsealed e-mail.

'There has been a precedent set regarding ‘cherry picking’ of data,' which was used in “the recent Velligan presentations,' he said. 'Thus far, I am not aware of any repercussions regarding interest in the unreported data.'

The publications manager indicated that AstraZeneca had a favorable reputation for engaging in 'ethical behavior' when it came to disclosing study results on its drugs.

'We must decide if we wish to continue to enjoy this distinction,' Tumas wrote.

'The reporting of the COSTAR results will not be easy,' he added. 'We must find a way to diminish the negative findings. But, in my opinion, we cannot hide them.'

So here we have more evidence about a big pharmaceutical company suppressing and manipulating data from the clinical research when its results proved unfavorable to its product. The unsealed evidence, when added to many other cases we have discussed, suggest that manipulation and suppression of clinical research data to support companies' vested interests is a common practice by commercial health care firms, including but not restricted to pharmaceutical, biotechnology, and device companies.

As we have said before, suppression and manipulation of research amounts to post-hoc abuse of research subjects who volunteered their participation believing that it would advance science and health care.

Furthermore, suppression and manipulation of research can deceive physicians into prescribing tests and treatments that will fail to help, or even harm patients, and deceive patients into thinking that they are getting the best possible tests and treatments, when, again what they are getting is ineffective or even harmful.

In my humble opinion, there is an increasingly strong argument that clinical research should not be controlled, and probably should not be done at all by organizations with vested interests in the research producing results favorable to their products.

See additional comments about the Seroquel litigation on the Clinical Psychology and Psychiatry blog here, and the Carlat Psychiatry Blog here.

ADDENDUM (2 March, 2009) - See detailed comments on the apparent manipulation of a meta-analysis of Seroquel versus a "typical" anti-psychotic, haloperidol, on the Clinical Psychology and Psychiatry Blog.

A Call For Congressional Investigation Of The HIT Industry - Is This Industry Trying to Harm Patients? Part 5 of a Series

(Note: Part 1 is here, part 2 is here, part 3 is here, part 4 is here, part 5 is here, part 6 is here, part 7 is here, and part 8 is here.)

In this installment of illustrating defects in today's contemporary health IT, I was going to present more sketches (since contractual clauses between HIT vendors and hospitals tend to forbid sharing of actual screens or defects) of the "let's play peek a boo" variety.

I will present them in part 6 instead. These are screens in which clinicians must scroll extensively to, say, match an INR with a coumadin dose, FiO2 with oximetry result, match systolic with diastolic blood pressure, search around nearly empty screens to reveal a single value many rows down, enter a few common diagnoses via the "clickorrhea" of almost fifty clicks, and other patent absurdities from technology touted as "improving medicine."

I am using part 5 to present another issue: A call for investigation of the HIT device industry, its development, marketing, talent management, contracting, QC, and information sharing practices on bugs and defects.

I have now become aware of organizations with defects/clinician complaint lists for contemporary HIT including CPOE, EHR etc. amounting to well over a hundred pages in one case, and well over a thousand individual items in another, and numerous unquantified but relevant in-betweens.

I recently also received this from a correspondent with expertise in user interaction design:

A funny story [that is actually not funny at all - ed.]

When I managed Operating room systems for a hospital the vendor was [major vendor, name redacted].

The UI was awful. Though the implementation had many problems (prior to my taking the job) circulating nurses were livid. Some actually filed a complaint with the state's department of health claiming the new system endangered patient safety. Alas, the "inspection" ruled it was not endangering patients. [I'm sure the inspectors had significant healthcare IT and informatics domain expertise. Well, no, actually - ed.]

One day I was talking to a representative from [major vendor]. I mentioned their peculiar UI and the guy just didn't get it. He went on to tell me how a single programmer designed and developed the UI all by himself in about a month!!! He thought this was really impressive! I realized in horror, the UI we were seeing every day represented the limited mind of a single technology obsessed programmer who applied his sense of architecture and programming to the patient care routines of operating rooms all across the country.

The electronic chart contained the same fields as old papers forms, but the forms took about 3 minutes to fill while the electronic version took 15 AND while that is somewhat acceptable for long cases [I'd say a doable waste of time, not "acceptable" -ed.], many cases are short, from 15 to 30 minutes and that with the new system the nurse had even less time to take care of the patient - their major responsibility.

This is simply stunning. I might also add "frightening."

The following comes from a person with interest in usability:

I am working at the [name redacted] University Hospital. I asked several [another major HIT vendor] reps about their screen design and why they do not implement better ones. They said there is not a business case to spend the money upfront to do a proper Information Architecture Plan.

I other words, if this is true (and I believe it is from my own experiences with numerous vendors), an HIT company's profits override the issues of a mission hostile user experience and cognitive overload of clinicians. The "business case" means "their profit." Looked at another way, physicians and other clinicians' cognitive energies serve as a bank for HIT vendor deficiencies and unwillingness to develop an appropriate and acceptable user experience.

How many patients and clinicians subject to these devices know about these issues?

I am going to go out on a limb here, similar to 1998 when I became one of the first (to my knowledge) to publicly stick my neck out with what at that time was a controversial website on HIT failures. Its title was "Medical Informatics and leadership of clinical computing", now here under a new title. I had hoped that the HIT field's problems would diminish with the passage of time and with very direct exposure that all was not well.

Instead, it appears the HIT industry and products have gotten worse.

The existence of lists of a thousand+ HIT defects in major healthcare organizations, some resulting in clinician complaints about patient endangerment, and unshareable due to contractual gag clauses common in this industry, is simply intolerable. I am told many of these defects will likely never be fixed. I have only scratched the surface in reporting on these issues, being forced to do generic screen sketches, at my series here .

There is no spin, no excuse, no dialog that can forgive such a situation. One must ask how products with thousands of defects could get into production. The existence of such lists is prima facie evidence that this industry is itself defective and that these devices are experimental - with clinicians and patients as unconsenting participants.

Further, the shielding of the industry from liability on the "learned intermediary" basis is prima facie evidence of misuse of such laws. Even "learned clinicians" are being cognitively taxed and overloaded by these devices; they do not have unlimited cognitive capacity to deal with these defects.

I believe this scenario is likely far worse than any practice I saw in pharma.

It is becoming more clear to me and a number of my like minded colleagues that, as in pharma and the other medical device industries:

• A congressional investigation of the HIT industry's development, marketing, talent management, contracting, QC, and information sharing practices (on bugs, UI problems and other defects) is warranted;

• These defect lists need to be public record so the public can evaluate whether their consent to be subjects of these devices is warranted;

• Vendors should not be immune to liability for defects caused by cavalier IT development, testing and talent management practices; the article "Failure to Provide Clinicians Useful IT Systems: Opportunities to Leapfrog Current Technologies", Methods Inf Med 2008; 47: 4–7, by Ball et al. (PDF here) spells out some of these issues;
  

• A societal process needs to be set up in parallel to those other two biomedical industries, pharma and [physical] medical devices, of staged clinical trials, validation, and regulation of HIT [virtual] devices by impartial bodies with appropriate, unconflicted expertise on board. "Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems", Harvard Journal of Law & Technology 2008 vol. 22, No. 1, by Hoffman and Podgurski (PDF here) presents a case for oversight;

• The evaluation needs to go far beyond the CCHIT features and functionality check, an almost useless evaluation criteria in my mind, directly to usability and effectiveness. For a good summary of CCHIT's deficits see p. 132-134 (p. 30-32 of the PDF) in the Harvard Journal of Law & Technology article above. The major problem in HIT seems not absence of features, but a mission hostile user experience.
  

From the latter Harvard Journal of Law & Technology article:

The benefits of EHR systems will outweigh their risks only if these systems are developed and maintained with rigorous adherence to the best software engineering and medical informatics practices and if the various EHR systems can easily share information with each other. Regulatory intervention is needed to ensure that these goals are achieved. Once EHR systems are fully implemented, they become essential to proper patient care, and their failure is likely to endanger patient welfare.

Indeed.

Mine may sound like a radical position, but it is not. The existence of such secretive lists and lack of transparency is a highly significant problem. There is no other industry I know of that can push devices with hundreds or thousands of defects, some safety critical and others enhancing risk, onto the public, while preventing dissemination of defect lists.

Imagine an aircraft industry where planes in the sky or air control devices have thousands of defects, some potentially leading to collisions or crashes. Pharma is being pushed to release negative trials results, for example.

These issues need to be addressed in Washington before we dump $20 billion+ into a defective industry, instead of providing those funds for needed patient care of the poor and uninsured.

-- SS

Dietary Fiber and Mineral Availability

Mainstream health authorities are constantly telling us to eat more fiber for health, particularly whole grains, fruit and vegetables. Yet the only clinical trial that has ever isolated the effect of eating a high-fiber diet on overall risk of death, the Diet and Reinfarction Trial, came up with this graph:



Oops! How embarrassing. At two years, the group that doubled its fiber intake had a 27% greater chance of dying and a 23% greater chance of having a heart attack. The extra fiber was coming from whole grains. I should say, out of fairness, that the result wasn't quite statistically significant (p less than 0.05) at two years. But at the very least, this doesn't support the idea that increasing fiber will extend your life. I believe this the only diet trial that has ever looked at fiber and mortality, without also changing other variables at the same time.

Why might fiber be problematic? I read a paper recently that gave a pretty convincing answer to that question: "Dietary Fibre and Mineral Bioavailability", by Dr. Barbara F. Hartland. By definition, fiber is indigestible. We can divide it into two categories: soluble and insoluble. Insoluble fiber is mostly cellulose and it's relatively inert, besides getting fermented a bit by the gut flora. Soluble fiber is anything that can be dissolved in water but not digested by the human digestive tract. It includes a variety of molecules, some of which are quite effective at keeping you from absorbing minerals. Chief among these is phytic acid, with smaller contributions from tannins (polyphenols) and oxalates. The paper makes a strong case that phytic acid is the main reason fiber prevents mineral absorption, rather than the insoluble fiber fraction. This notion was confirmed here.

As a little side note, polyphenols are those wonderful plant antioxidants that are one of the main justifications for the supposed health benefits of vegetables, tea, chocolate, fruits and antioxidant supplements. The problem is, many of them are actually anti-nutrients. They reduce mineral absorption, reduce growth and feed efficiency in a number of species, and the antioxidant effect seen in human plasma after eating them is due largely to our own bodies secreting uric acid into the blood (a defense mechanism?), rather than the polyphenols themselves. The main antioxidants in plasma are uric acid, vitamin C and vitamin E, with almost no direct contribution from polyphenols. I'm open to the idea that some polyphenols could be beneficial if someone can show me convincing data, but in any case they are not the panacea they're made out to be. Thanks to Peter for cluing me in on this.

Whole grains would be a good source of water-soluble vitamins and minerals, if it weren't for their very high phytic acid content. Even though whole grains are full of minerals, replacing refined grains with whole grains in the diet (and especially adding extra bran) actually reduces the overall absorption of a number of minerals (free text, check out table 4). This has been confirmed repeatedly for iron, zinc, calcium, magnesium and phosphorus. That could well account for the increased mortality in the DART trial.

Refining grains gets rid of the vitamins and minerals but at least refined grains don't prevent you from absorbing the minerals in the rest of your food. Here's a comparison of a few of the nutrients in one cup of cooked brown vs. unenriched white rice (218 vs. 242 calories):

Brown rice would be quite nutritious if we could absorb all those minerals. There are a few ways to increase mineral absorption from whole grains. One way is to soak them in slightly acidic, warm water, which allows their own phytase enzyme to break down phytic acid. This doesn't seem to do much for brown rice, which doesn't contain much phytase.

A more effective method is to grind grains and soak them before cooking, which helps the phytase function more effectively, especially in gluten grains and buckwheat. The most effective method by far, and the method of choice among healthy traditional cultures around the world, is to soak, grind and ferment whole grains. This breaks down nearly all the phytic acid, making whole grains a good source of both minerals and vitamins.

The paper "Dietary Fibre and Mineral Bioavailability" listed another method of increasing mineral absorption from whole grains that I wasn't aware of. Certain foods can increase the absorption of minerals from whole grains high in phytic acid. These include: foods rich in vitamin C such as fruit or potatoes; meat including fish; and dairy.

Another point the paper made was that the phytic acid content of vegetarian diets is often very high, potentially leading to mineral deficiencies. The typical modern vegetarian diet containing brown rice and unfermented soy products is very high in phytic acid and thus very low in absorbable minerals. The more your diet depends on plant sources for minerals, the more careful you have to be about how you prepare your food.

Dietary Fiber and Mineral Availability

Mainstream health authorities are constantly telling us to eat more fiber for health, particularly whole grains, fruit and vegetables. Yet the only clinical trial that has ever isolated the effect of eating a high-fiber diet on overall risk of death, the Diet and Reinfarction Trial, came up with this graph:



Oops! How embarrassing. At two years, the group that doubled its fiber intake had a 27% greater chance of dying and a 23% greater chance of having a heart attack. The extra fiber was coming from whole grains. I should say, out of fairness, that the result wasn't quite statistically significant (p less than 0.05) at two years. But at the very least, this doesn't support the idea that increasing fiber will extend your life. I believe this the only diet trial that has ever looked at fiber and mortality, without also changing other variables at the same time.

Why might fiber be problematic? I read a paper recently that gave a pretty convincing answer to that question: "Dietary Fibre and Mineral Bioavailability", by Dr. Barbara F. Hartland. By definition, fiber is indigestible. We can divide it into two categories: soluble and insoluble. Insoluble fiber is mostly cellulose and it's relatively inert, besides getting fermented a bit by the gut flora. Soluble fiber is anything that can be dissolved in water but not digested by the human digestive tract. It includes a variety of molecules, some of which are quite effective at keeping you from absorbing minerals. Chief among these is phytic acid, with smaller contributions from tannins (polyphenols) and oxalates. The paper makes a strong case that phytic acid is the main reason fiber prevents mineral absorption, rather than the insoluble fiber fraction. This notion was confirmed here.

As a little side note, polyphenols are those wonderful plant antioxidants that are one of the main justifications for the supposed health benefits of vegetables, tea, chocolate, fruits and antioxidant supplements. The problem is, many of them are actually anti-nutrients. They reduce mineral absorption, reduce growth and feed efficiency in a number of species, and the antioxidant effect seen in human plasma after eating them is due largely to our own bodies secreting uric acid into the blood (a defense mechanism?), rather than the polyphenols themselves. The main antioxidants in plasma are uric acid, vitamin C and vitamin E, with almost no direct contribution from polyphenols. I'm open to the idea that some polyphenols could be beneficial if someone can show me convincing data, but in any case they are not the panacea they're made out to be. Thanks to Peter for cluing me in on this.

Whole grains would be a good source of water-soluble vitamins and minerals, if it weren't for their very high phytic acid content. Even though whole grains are full of minerals, replacing refined grains with whole grains in the diet (and especially adding extra bran) actually reduces the overall absorption of a number of minerals (free text, check out table 4). This has been confirmed repeatedly for iron, zinc, calcium, magnesium and phosphorus. That could well account for the increased mortality in the DART trial.

Refining grains gets rid of the vitamins and minerals but at least refined grains don't prevent you from absorbing the minerals in the rest of your food. Here's a comparison of a few of the nutrients in one cup of cooked brown vs. unenriched white rice (218 vs. 242 calories):

Brown rice would be quite nutritious if we could absorb all those minerals. There are a few ways to increase mineral absorption from whole grains. One way is to soak them in slightly acidic, warm water, which allows their own phytase enzyme to break down phytic acid. This doesn't seem to do much for brown rice, which doesn't contain much phytase.

A more effective method is to grind grains and soak them before cooking, which helps the phytase function more effectively, especially in gluten grains and buckwheat. The most effective method by far, and the method of choice among healthy traditional cultures around the world, is to soak, grind and ferment whole grains. This breaks down nearly all the phytic acid, making whole grains a good source of both minerals and vitamins.

The paper "Dietary Fibre and Mineral Bioavailability" listed another method of increasing mineral absorption from whole grains that I wasn't aware of. Certain foods can increase the absorption of minerals from whole grains high in phytic acid. These include: foods rich in vitamin C such as fruit or potatoes; meat including fish; and dairy.

Another point the paper made was that the phytic acid content of vegetarian diets is often very high, potentially leading to mineral deficiencies. The typical modern vegetarian diet containing brown rice and unfermented soy products is very high in phytic acid and thus very low in absorbable minerals. The more your diet depends on plant sources for minerals, the more careful you have to be about how you prepare your food.

Just a Reminder

I will not tolerate comments that are disrespectful or threatening to other commenters or myself. Feel free to disagree with anyone here, including me, in a courteous tone. I enjoy the intelligent discussions we have here, and I don't want them to degenerate into troll wars.

Just a Reminder

I will not tolerate comments that are disrespectful or threatening to other commenters or myself. Feel free to disagree with anyone here, including me, in a courteous tone. I enjoy the intelligent discussions we have here, and I don't want them to degenerate into troll wars.

Are Health IT Designers, Testers and Purchasers Trying to Harm Patients? Part 4 of a Series

(Note: Part 1 is here, part 2 is here, part 3 is here, part 4 is here, part 5 is here, part 6 is here, part 7 is here, and part 8 is here.)

Electronic health records, or electronic death records?

In this fourth installment of a series whose subtitle could well be "hospitals are paying tens of millions of dollars to healthcare IT (HIT) companies for clinical IT designed as if by rank amateurs, while shortchanging the poor and uninsured", we see yet more screens that create a mission hostile user experience to physicians, nurses and other clinicians trying to take care of patients.

These hellish user experiences are causing clinician cognitive overload, distracting and tiring them, and due to violations of fundamental good practices in information display, actually promoting error.

Perhaps part of the problem is the contractual lack of vendor accountability for bad patient outcomes resulting from defects (i.e., as if "learned intermediaries" have unlimited cognitive energy to deal with a poor user experience), and contractual gag orders on sharing actual screen shots. This forces me to draw mock ups to illustrate the problems.

I am aware of major medical centers with lists of HIT user experience problems in recently acquired systems that are 100+ pages long. What percentage of these issues present possible patient risk is not known to me, but I will venture that it is a considerable percentage. Who is designing such medical devices? Who is testing these devices before release for use on patients?

Here is my next mockup. This is of a patient medication list from an HIT system from a major vendor:

(click to enlarge)

The user experience good practices violations that are committed here are numerous and inexcusable.

There is repetition, extraneous information, lack of focus and clarity, lack of any symbolic or diagrammatic representations, and general clutter.

When I write that HIT is designed by business computing personnel as if it were an inventory system, not a clinical device, this exemplifies what I mean.

Imagine clinicians forced to perform their work via screens like this on many patients, each day, day in and day out, and having to make critical decisions on medication orders based upon them. Imagine an on-call physician at 3 in the morning, with more admissions in the ED, interacting with ill conceived screens like this. Madness.

Remember, the purpose of HIT is to facilitate clinicians, not tire them and make them drink information from a firehose.

It would not have been difficult to condense and organize this presentation into a coherent, focused display that could be used at a glance by a clinician to understand a patient's medication profile.

A competent grad student or informatics postdoc in could design such a screen. I know that, because I helped postdocs do such things.

Now, how about screens that force clinicians to resort to use of physical digits instead of virtual ones - i.e., their fingers! - to keep track of what's what?

See this labs viewing screen (note: values and ranges are fictitious)

(click to enlarge)

The clinician user now scrolls to the right and down to see more values and sees this:

(click to enlarge)

Note the row and column headers have scrolled away. The user must hold a finger on the screen to keep track of headings. It is not too diffcult to imagine mistaking one test's value for another.

The amount of coding it would take to maintain fixed row and column headers is far less than the amount of cognitive effort clinicians must expend to use such screens. It is certainly less than the efforts spent in making amends for unfortunate patient outcomes such philistine and mission-hostile IT devices create. Such design problems are inexcusable on prototypes, let alone production systems.

Where are our government watchdogs on these issues?

More violations of simple first principles of providing a good user experience in part 5.

-- SS

Three Troubled Device Companies: ArthroCare, Stryker, AM2PAT

It was quite a week in the medical device business.

Arthrocare

Last week we discussed the shenanigans at ArthroCare Corporation here. Since then, more information has come out about in the Austin Business Journal provided more information about these improper practices:

While the internal review, being conducted with the assistance of outside counsel Latham & Watkins LLP, is not yet complete, the ArthroCare’s audit committee has reviewed evidence that indicates that the company’s spine unit engaged in and may have caused others to engage in improper practices in certain instances by:

* seeking separate reimbursement from insurers for company products in connection with procedures which were contractually reimbursed on a global basis;
* making inaccurate statements in claims submitted to insurers regarding the place where particular procedures were performed;
* providing physicians and insurers with descriptions of company technologies which had the effect of circumventing payor policies that did not cover such technologies;
* recommending and advocating to physicians the use of a Current Procedural Terminology code to identify its coblation nucleoplasty technology that was not approved by the American Medical Association and may have not properly described the procedure that was performed.

These improper practices identified so far may have occurred since at least 2006.

Investigators were informed that certain sales and marketing personnel within the spine unit provided physicians and their billing staff with merchandise and administrative services at no charge potentially in exchange for their utilization of the company’s products. The audit committee has determined that company personnel at all levels lacked adequate health care compliance training and that company billing personnel lacked adequate training and supervision in insurance reimbursement requirements. In addition to considering and implementing remediation efforts, the committee is undertaking a review of such practices in other business units.

Stryker

Meanwhile, the New York Times reported about Stryker:

A Justice Department inquiry into Stryker’s marketing of human bone growth products has resulted in guilty pleas by former company sales representatives.

One former sales official pleaded guilty two weeks ago, and another one did in November, court documents show.

Stryker, a leading maker of medical devices, and the United States attorney’s office in Boston, which is conducting the inquiry, declined to comment. A spokeswoman for the attorney’s office said the investigation was continuing.

The inquiry, which began last year, involves several issues, according to court papers and Stryker filings with the Securities and Exchange Commission. The questions include whether Stryker abused a federal exemption that authorized it to sell only limited quantities of its bone growth products for 'humanitarian' reasons, according to the documents.

The two former sales officials pleaded guilty to charges that they had promoted off-label use of the products even though they knew that such use had earlier caused problems in some patients.

The products in question are used by surgeons to aid the growth of bones that fail to heal properly.

This case is not the only one raising ethical questions about Stryker's management.

The inquiry poses new complications for Stryker, which is already operating under federal oversight as a result of an earlier Justice Department investigation of kickbacks paid by makers of artificial hips and knees to doctors.

We posted about this previous issue, first here, most recently here.

AM2PAT

Last, but most assuredly not least, was a story, (here reported by Newsday) about AM2PAT:

Federal authorities are hunting the mastermind behind a 'horrific case' in which bacteria-laden syringes shipped from an Angier, N.C., plant sickened hundreds of people and killed five.

Two men pleaded guilty Monday in U.S. District Court in Raleigh for their roles in ignoring sterility standards at the former AM2PAT Inc. plant. The court heard of conditions at the plant more consistent with a Third World textile factory than a pharmaceutical facility.

The men - plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma - were each sentenced to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace. They were rewarded with a relatively light sentence in exchange for information about chief executive Dushyant Patel, whose company sold $6.9 million worth of heparin and saline syringes in 2006-07 that did not undergo proper sterility testing.

Dushyant Patel, indicted late last week on 10 charges that include fraud and selling adulterated medical devices, has not been arrested. Authorities think he may have fled to his homeland in India and are seeking help from Interpol.

Syringes from AM2PAT were pulled from the market early last year, and the Angier plant shuttered after an outbreak of Serratia, a bacterial infection, hit patients in Colorado, Texas, Illinois, Florida and other states.

On Monday, prosecutors laid out a scheme before Judge Terrence Boyle in which the plant's operators routinely failed to follow sterility rules to keep production running faster. The drugs were not produced at the plant, but were loaded into syringes there, then shipped.

The plant was subject to U.S. Food and Drug Administration requirements for its production. The syringes were supposed to be loaded in a 'clean room,' with employees in caps and gowns and air carefully ventilated to keep germs from spreading.

A photograph entered into evidence Monday shows a 'clean room' refreshed with a common window fan held together with duct tape. In another photo, women work on an assembly line under lamps, surrounded by what look like green plastic recycling bins.

Once the syringes were loaded with drugs, each batch was required to be held for two weeks, while employees tested for bacteria and other contaminants. If bacteria were cultured from the medicines, the whole batch should have been held back. That wasn't happening, court documents show.

Batches of syringes went straight from the production line into the marketplace, with Sharma falsifying manufacturing dates to make it appear to regulators that requisite quality tests had been done. And when tests were done, results were ignored.

Note first that none of these cases was isolated, in that each of these companies had questions raised about management behavior before (at Arthrocare, about accounting; at Stryker, about marketing and payments to doctors; at AM2PAT, raised by health care professionals about quality of its products.)

In the US, we are undergoing yet another great debate about health care reform. Two big issues are the high cost and questionable quality of our health care. All three of these cases involved behavior that could have raised costs. Two may have had indirect effects on quality. One may have directly caused patient death and disease.

Yet, even after executive arrogance, misbehavior, self-interest, and corruption have lead to the global financial meltdown, we are still not really addressing such behavior as a cause of our global health care crisis.

NextGen and Vendor/Doctor Dialog: Yet Another Patronizing EHR Company of Certified HIT Experts?

Note 6/9/09:

To those reading this post via a link in an email from CCHIT's Mark Leavitt, see this June 7th post "Open Letter to Mark Leavitt" first.

The link you are at now is several months old, one of many posts I've written over the years about the scarcity of leadership-level Medical Informatics-trained professionals in the health IT vendor world. I consider that issue contributory to EHR's often mission hostile user experience (my series on that topic is here), and ultimately deleterious to patient well-being. I also believe the HIT industry has put its own interests ahead of that of patients in its inattention to HIT safety and rejection of accountability.

Additional views on the recent CCHIT NJ Bill are at ePatients.net at "David Kibbe & Mark Leavitt:Openness vs. Opacity" and "Dossia, Microsoft HealthVault & Google Health: Illegal in NJ?". There are some now-familiar themes regarding CCHIT civility in those posts.

6/10: As a result of a link sent by a commenter, I am adding the post "The Kibbe/Leavitt Rumble in the High Tech Jungle!" to the list of interesting views in the note above.

-- SS

My early medical mentor, cardiothoracic surgery pioneer Victor P. Satinsky, MD, believed in public embarrassment (a.k.a. "sunlight") as a tool to fight bureaucracy and discrimination. I quote him on that. He wanted his NSF summer science training progam (SSTP) 10th grade students at Hahnemann Hospital to actually picket a clothing distributor, for example, when that distributor did not deliver our white coats nor a refund in a timely manner. He also was highly politically incorrect, for example having gay activists speak to our group of 200 high school students about bias and discrimination, at a time in the early 1970's when such talks were frowned upon. He took grief for that. Yet fairness and "critical thinking always, or your patient's dead" were his mantras.

Dr. Satinsky must be rolling in his grave at what has become of medicine due to the type of bureaucracy we cover here at Healthcare Renewal. He would probably be a healthcare blogger himself were he still alive.

At "A Vendor/Doctor Dialog On Healthcare IT?" I wrote that

In response to my recent post to the American Medical Informatics Association's clinical information systems (CIS-WG) and organizational issues (POI-WG) workgroups about my WSJ letter to the editor, Charles Jarvis, an AVP of Healthcare Industry and Government Relations at HIT vendor Nextgen.com thoughtfully suggested I "come and listen to how the government, providers, insurers and yes- HIT providers- can work together for the common good before drawing such strong conclusions." (Soothing blue font original - ed.)

Dialog is a useful idea. I am always open to listening.

However, dialog must be among equals in an atmosphere of complete transparency. Otherwise it is not dialog, it is politics.

How can there be "dialog" in an environment where one side is able to squelch open discussion of the issues?

... p.s. in late 2003 after the collapse of Merck's pipeline, I wrote to your [NextGen's - ed.] CEO and HR department in Horsham about my availability to help in their EHR efforts. This was prior to the bulk of my writings on HIT difficulties. I did not so much as even get a response or inquiry, although I live thirty minutes away.

Perhaps you could explore why your company showed no interest in perhaps the only formally trained medical informaticist in this area, and former CMIO of a major hospital in the region (Christiana Care).

More on this below.

I found Mr. Jarvis' patronizing "why don't you come and listen" line, sent in a nice soothing blue font, disturbing, since it's vendors (immune from liability and from intra-organization scrutiny even when events such as this and these occur), not physicians and physician informaticists, who need to do the listening.

However, something else was at the back of my mind, and information saver that I am (I did run Merck Research Lab's science library and historical science archives department, after all), I checked my disk backups.

What I found reflects something I've noted numerous times in the past. Interactions with HIT vendors - both their products and their people - have most often been quite annoying.

Here is Mr. Jarvis' bio:

[Nov. 2011 editor's note - the bio disappeared from the original link; the link now points to archive.org]

Charles Jarvis, Assistant Vice President, Healthcare Industry Services & Government Relations

Charles W. Jarvis FACHE is Assistant Vice President for Healthcare Industry Services and Legislative Affairs – having been in this role since January 2005 [this date becomes relevant as below - ed.] Mr. Jarvis' responsibilities include community and partnership business development including overseeing the company grants and funding procurement program, government relations, new business planning, and educational efforts. Mr. Jarvis is active in the Electronic Health Record Vendor Association (EHRVA), currently holding the position of Chairman of the Government Affairs and Affiliated Organizations Workgroup.Prior to joining NextGen, Mr. Jarvis was in hospital and physician group practice management for 25 years in both the New Jersey and Massachusetts markets.

Mr. Jarvis holds a Masters Degree in Business with a concentration in Health Administration [i.e., he took a few courses in health admin - ed.] from Temple University and a Bachelors Degree in Economics from the Wharton School of the University of Pennsylvania. [Common to the HIT industry and to observations on HC Renewal about HC leadership in general, I note no clinical experience or credentials - ed.] He is also a Fellow in the American College of Health Care Executives and holds the American Medical Informatics Certification for Health Information Technology [what is that? More below - ed.]

Now, it was bad enough my earlier inquiries to the NextGen CEO were ignored. Far worse is the outcome of my application to NextGen for a position as Director of Industry Relations in late 2004:

NextGen Healthcare is currently looking for an individual to manage our Industry Relationships. We are a rapidly growing, publicly held company looking for an aggressive, self-motivated individual who is seeking a challenging position with a top tier healthcare IT company. As the Director of Industry Relations, you will be responsible for managing industry relations. This will include relationship management with the consultant marketplace, medical societies, health plans, and our Value Added Resellers. Qualified candidates will have preferably healthcare IT background either as a project manager, consultant, marketing manager, or sales representative . Applicant must also be career oriented, professional, and organized, possess excellent oral and written communication skills and be detail oriented. Working knowledge of MS Excel, Word and PowerPoint a must. Local and national travel required.

Here is the relevant email thread:

From NextGen:

In a message dated 12/27/2004 9:04:43 A.M. Eastern Standard Time, JWong@nextgen.com writes:

Hello Dr. Silverstein,

We would like to schedule an interview for you the week of January 3, 2005.
Would you please advise your schedule? I will be arranging an meeting with
the president and one of our vice presidents. Please let me know what day
and time are best.

Thank you.

Jennifer Wong
Business Development Coordinator
> NextGen Healthcare Information Systems, Inc.
795 Horsham Road
Horsham, PA 19044
215.657.7010 (p) 215.657.7011 (f)
jwong@nextgen.com
Website - www.nextgen.com


My reply back:


From: ScotSilv@aol.com [mailto:ScotSilv@aol.com]
Sent: Thursday, January 06, 2005 12:44 PM
To: JWong@nextgen.com
Subject: Re: Interview

Hi Jennifer,

I have been away for the New Year. I'm following up on getting an interview schedule set.

I also left a voicemail.

Regards,

Scot


NextGen gets back to me:


In a message dated 1/10/2005 11:47:51 A.M. Eastern Standard Time, JWong@nextgen.com writes:

Hi Dr. Silverstein,

I have forwarded your resume internally to the appropriate persons. Thank you - you should be hearing from someone shortly.

Thank you.

Jennifer Wong
Business Development Coordinator
NextGen Healthcare Information Systems, Inc.
795 Horsham Road
Horsham, PA 19044
215.657.7010 (p) 215.657.7011 (f)
jwong@nextgen.com
Website - www.nextgen.com


My response after waiting, and waiting:

From: ScotSilv@aol.com [mailto:ScotSilv@aol.com]
Sent: Thursday, January 20, 2005
To: JWong@nextgen.com
Subject: Re: Interview

Dear Jennifer,

I still await contact from NextGen. Please advise if this opportunity is still available. I am in conversation with other organizations and want to finalize my schedules.

Sincerely,

Scot

Then ... silence.

I never heard from the company again.

(Dialog? What dialog? There does not appear to have been even fundamental respect.)

In summary, an AVP who may very well have -- hypothetically speaking; I'd never heard of him before he responded to my recent workgroup posts -- made a decision about blowing me off as a Director in 2005 (he started in Jan. 2005) now tells me how I should "come and listen to how the government, providers, insurers and yes- HIT providers- can work together for the common good before drawing such strong conclusions."

I can also add that NextGen did indeed hire a medical informaticist straight away from the same program I trained in, Yale's, sometime after that person's completion of a postdoctoral fellowship in July 2006, as a "physician consultant." I had finished the fellowship in 1994 after a number of years of medical practice and by 2005 had quite a lot of applied and management experience under my belt.

(My current bio does not include my time as Medical Programs Manager for quasi-governmental agency SEPTA, with much interaction with SEPTA Industrial Relations, and with federal regulators DOT, FRA, NIDA and others on health matters in the transportation industry, but it did then.)

So, I was entirely blown off without so much as an explanation in 2005, but a new informatics trainee hired in 2006. This raises a number of questions. Hypothetically speaking, was this due to:

• Lack of recognition of my background, which included extensive clinical, medical informatics and EHR experience and working in a critical role in a quasi-governmental organization with links to several federal agencies?
• Age discrimination? I was in my late 40's at the time.
• Perhaps it was felt I had too much experience for the organization?
  
• Hiring the young and relatively inexperienced on the basis of "cheap?"
• My patient-centric advocacy views on HIT, as in, "the patient must be protected from defective HIT?"

I am not making accusations in any way, only raising questions. Only the company knows the answers, of course, and it is their right to hire someone or not hire them or even have them in for interview. Even basic courtesy of followup with the professional community is optional.

However, I rest my case regarding the really annoying nature of health IT vendors beyond just their often poorly conceived products, and their inability or unwillingness to tap experienced healthcare informatics professionals as I've written about before on HC Renewal.

Finally, what is the "American Medical Informatics Certification for Health Information Technology?" claimed in Mr. Jarvis' biography?

I have never heard of it before and a Google search seems unrevealing. Could it be an overstated credential to impress stockholders and investors? (We in informatics strive for semantic clarity). AMIA does not "certify" anyone in informatics to my knowledge although they offer a short course in the 10x10 program that awards a "Certificate of Completion in the 10x10 Program." I'm not aware of an American certification board in HIT.

Is it like another Htraesian informatics "certification", CPHIMS, as I described here?

Is it a certificate like this, which students get after completing the intensive 3-course graduate program in an accredited university that I created? Perhaps something you get after completing one of these programs, created and funded by Don Lindberg and other informatics pioneers, that I spent two years of my life in?

Or perhaps it's more like this three day 10 course miracle certification and button? "Consists of 10 course, two and a half days curriculum and CPEHR Certification Examination" [is that like a 10 course meal? - ed.]

Oh, I forgot. In healthcare informatics, everyone's an expert.

Finally, I guess I won't be applying to NextGen again. They might blow me off.

Again.

-- SS

A few thoughts on Minerals, Milling, Grains and Tubers

One of the things I've been noticing in my readings on grain processing and mineral bioavailability is that it's difficult to make whole grains into a good source of minerals. Whole grains naturally contain more minerals that milled grains where the bran and germ are removed, but most of the minerals are bound up in ways that prevent their absorption.

The phytic acid content of whole grains is the main reason for their low mineral bioavailability. Brown rice, simply cooked, provides very little iron and essentially no zinc due to its high concentration of phytic acid. Milling brown rice, which turns it into white rice, removes most of the minerals but also most of the phytic acid, leaving mineral bioavailability similar to or perhaps even better than brown rice (the ratio of phytic acid to iron and zinc actually decreases after milling rice). If you're going to throw rice into the rice cooker without preparing it first, white rice is probably better than brown overall. Either way, the mineral availability of rice is low. Here's how Dr. Robert Hamer's group put it when they evaluated the mineral content of 56 varieties of Chinese rice:

This study shows that the mineral bio-availability of Chinese rice varieties will be [less than] 4%. Despite the variation in mineral contents, in all cases the [phytic acid] present is expected to render most mineral present unavailable. We conclude that there is scope for optimisation of mineral contents of rice by matching suitable varieties and growing regions, and that rice products require processing that retains minerals but results in thorough dephytinisation.

It's important to note that milling removes most of the vitamin content of the brown rice as well, another important factor.

Potatoes and other tubers contain much less phytic acid than whole grains, which may be one reason why they're a common feature of extremely healthy cultures such as the Kitavans. I went on NutritionData to see if potatoes have a better mineral-to-phytic acid ratio than grains. They do have a better ratio than whole grains, although whole grains contain more total minerals.

Soaking grains reduces their phytic acid content, but the extent depends on the grain. Gluten grain flours digest their own phytic acid very quickly when soaked, due to the presence of the enzyme phytase. Because of this, bread is fairly low in phytic acid, although whole grain yeast breads contain more than sourdough breads. Buckwheat flour also has a high phytase activity. The more intact the grain, the slower it breaks down its own phytic acid upon soaking. Some grains, like rice, don't have much phytase activity so they degrade phytic acid slowly. Other grains, like oats and kasha, are toasted before you buy them, which kills the phytase.

Whole grains generally contain so much phytic acid that modest reductions don't free up much of the mineral content for absorption. Many of the studies I've read, including this one, show that soaking brown rice doesn't really free up its zinc or iron content. But I like brown rice, so I want to find a way to prepare it well. It's actually quite rich in vitamins and minerals if you can absorb them.

One of the things many of these studies overlook is the effect of pH on phytic acid degradation. Grain phytase is maximally active around pH 4.5-5.5. That's slightly acidic. Most of the studies I've read soaked rice in water with a neutral pH, including the one above. Adding a tablespoon of whey, yogurt, vinegar or lemon juice per cup of grains to your soaking medium will lower the pH and increase phytase activity. Temperature is also an important factor, with 50 C (122 F) being the optimum. I like to put my soaking grains and beans on the heating vent in my kitchen.

I don't know exactly how much adding acid and soaking at a warm temperature will increase the mineral availability of brown rice (if at all), because I haven't found it in the literature. The bacteria present if you soak it in whey, unfiltered vinegar or yogurt could potentially aid the digestion of phytic acid. Another strategy is to add the flour of a high-phytase grain like buckwheat to the soaking medium. This works for soaking flours, perhaps it would help with whole grains as well?

So now we come to the next problem. Phytic acid is a medium-sized molecule. If you break it down and it lets go of the minerals it's chelating, the minerals are more likely to diffuse out of the grain into your soaking medium, which you then discard because it also contains the tannins, saponins and other anti-nutrients that you want to get rid of. That seems to be exactly what happens, at least in the case of brown rice.

So what's the best solution for maximal mineral and vitamin content? Do what traditional cultures have been doing for millenia: soak, grind and ferment whole grains. This eliminates nearly all the phytic acid, dramatically increasing mineral bioavailiability. Fermenting batter doesn't lose minerals because there's nowhere for them to go. In the West, we use this process to make bread, which would probably be a good food if it weren't for the gluten. In Africa, they do it to make ogi, injera, and a number of other fermented grain dishes. In India, they grind rice and beans to make idli and dosas. In the Phillipines, they ferment ground rice to make puto. Fermenting ground whole grains is the most reliable way to improve their mineral bioavailability and nutritional value in general.

But isn't having a rice cooker full of steaming brown rice so nice? I'm still working on finding a reliable way to increase its nutritional value.