More Cause for Hope - After Novartis Chairman's Rescinded Golden Parachute, Swiss Voters Give Control of Hired Executives' Salaries Back to Owners

Recently, we discussed the latest stupefyingly big golden parachute given to a departing pharmaceutical executive.  Former Novartis CEO and outgoing chairman Daniel Vasella was to be given more than $75 million, after making multiple millions previously, ostensibly so he would not go to work for a competitor.  After a public outcry, the company cancelled the plan, and Vasella admitted a "mistake."  This was the only instance in recent memory in which a big health care organization pulled back some huge executive pay package due to public protest.

Swiss Voters Give Control of Pay of Hired Executives Back to Company Owners

Now Swiss voters have approved a referendum which would actually let the owners of public companies, the stockholders, decide how much to pay hired executives.  As summarized by the New York Times,

Swiss citizens voted Sunday to impose some of the world’s most severe restrictions on executive compensation, ignoring a warning from the business lobby that such curbs would undermine the country’s investor-friendly image.

 The vote gives shareholders of companies listed in Switzerland a binding say on the overall pay packages for executives and directors. Pension funds holding shares in a company would be obligated to take part in votes on compensation packages.

In addition, companies would no longer be allowed to give bonuses to executives joining or leaving the business, or to executives when their company was taken over. Violations could result in fines equal to up to six years of salary and a prison sentence of up to three years. 

The new rules in Switzerland would be unprecedented in the current era.  

Those who are Ostensibly Pro-Business Defend Hired Executives, not Owners

Despite the fact that the new rules would give control over one type of hired employees, hired executives, back to the shareholders, the owners of companies, spokespeople for big companies, but presumably really for their top executives, claimed that the rule would be bad for shareholders.

 

Ahead of the vote, [the Swiss business federation] EconomieSuisse and Mr. Minder’s other opponents warned of dire consequences if the referendum passed, notably in terms of keeping Switzerland attractive to foreign companies and investors. 

But [chief proponent of the new rules] Mr. Minder argued that Switzerland would benefit if it gave shareholders control over the companies in which they invested.

Furthermore, the Guardian reported, 

Minder says the massive sums demonstrate that company boards have lost control of pay and prefer to fork out 'astronomical' salaries rather than pay dividends to shareholders.

Minder told the Swiss daily Le Temps that the only solution was to give shareholders the power to set pay.

 A Bloomberg article suggested that driving the vote were how the Swiss are

 worried about how long they can fend off the crisis that has engulfed the rest of Europe, and dissatisfied with a feeling of being ripped off by their elites.

'It is scandalous. No one deserves to be paid such monstrously high salaries, especially when their employees get paid not much in comparison,' Marianne Lecoultre, a pensioner who lives in a modest flat on the outskirts of Geneva, told me. 

The Germans are Thinking of Making Hired Executives More Accountable

The German media outlet Deutsche Welle reported that there is now more interest in returning control of hired executive pay to company owners there as well.

 After Swiss citizens voted Sunday to impose controls on executive pay, a similar debate has started in Germany. 

Furthermore,

Joachim Poß, the parliamentary leader of the opposition Social Democratic Party, told the daily Neue Osnabrücker Zeitung that the outcome of the referendum was an important step towards restricting the money-grabbing prevalent in corporate management,

He noted that the referendum was encouragement for an initiative at the EU level, and added that 'people do no longer accept perverted bonus systems, neither in banks nor in the real economy.'

Summary: Ripped Off by Health Care Elites

I can start to imagine how supposedly pro-business people in the US will dismiss actions taken by European countries as anti-business and probably "job killing," even though these actions actually gave more control of publicly held business to their owners, not to government, which would seem to be fully in support of capitalism.  Again, maybe some people making the loudest pro-business noises are really sympathetic to, if not paid by, the hired managers of businesses who have put their enrichment ahead of the interests of other employees, customers, clients or patients, the business owners (stockholders, that is), and the public at large. 

Enormous compensation of hired health care executives, out of all proportion, if related at all to whether their work had any positive effect on patients' or the public's health, has long been a concern on Health Care Renewal.  For example, back in 2006, we posted repeatedly (look here for links) about the billion dollar plus fortune amassed by the then CEO of UnitedHealthcare which vividly contrasted with the company's avowal to "make health care more affordable."  That seemed to be an example back then of a rip off by a member of the health care elite.  Now the notion that our top elites have been generally ripping us off is becoming more widespread.

In my humble opinion, the perverse incentives generated by a system that allows top executives to make almost unlimited amounts, regardless of all other considerations, has been a major reason for US and global health care dysfunction.  Making executive compensation less perverse, and ultimately making health care leaders accountable for the effects of what they do on patients' and the public's health may be an absolutely necessary step to make our health care system more functional.  Now at least there is some precedent, admittedly from Europe, for making top hired managers more accountable. 


As Pierre Briancon wrote in Reuters,

 Corporate boards had better take notice: public outrage at what looks like persistent and unapologetic greed in the most severe economic slump in decades is forcing governments to step in. Throughout Europe, indignation at private excess has become a policy problem for administrations trying to explain the need to cut public spending.

In addition,

Self-moderation doesn’t work and self-interest continues to prevail. Throughout the Western world, corporate boards have paid lip service to the need to take into account public opinion, and nothing much has changed either in the banking industry – the symbol of immoderation – or in the wider corporate world. In desperation, governments are taking more forceful action – sometimes reluctantly: the Swiss referendum followed a failure by the country’s parliament to heed to public indignation.

Government intervention can often be clumsy, and it is fraught with the risk of unintended consequences. But it is the right of governments to legislate on social ills – and excessive and provocative private-sector pay has become one. Meanwhile the lobbies promising economic apocalypse have failed to make their case – and to scare anyone with warnings that 'talent' – as they call it – may relocate to friendlier countries. It would be in the interest of all if they stopped turning a deaf ear to calls for decency emanating even from countries like Switzerland, which is hardly a hotbed of Soviet-style command economics.

Even though the final impetus for the overwhelming majority vote on the Swiss referendum came from a ridiculous golden parachute from a pharmaceutical company, the discussion so far has not centered on health care.  So I get to close with something I have repeated on and on, now with a little hope that it may not be considered so extreme....

 Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior.

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Solutionism: are all healthcare issues transparent and self-evident processes that can be easily optimized, if only the right algorithms are in place?

I've ordered this book:  "To Save Everything, Click Here: The Folly of Technological Solutionism" by Evgeny Morozov.

I've read some excerpts prior to its delivery and find them fascinating.  Emphases mine:

... Alas, all too often, this never-ending quest to ameliorate—or what the Canadian anthropologist Tania Murray Li, writing in a very different context, has called “the will to improve”—is shortsighted and only perfunctorily interested in the activity for which improvement is sought. Recasting all complex social situations either as neatly defined problems with definite, computable solutions or as transparent and self-evident processes that can be easily optimized—if only the right algorithms are in place!—this quest is likely to have unexpected consequences that could eventually cause more damage than the problems they seek to address.

I call the ideology that legitimizes and sanctions such aspirations “solutionism.” I borrow this unabashedly pejorative term from the world of architecture and urban planning, where it has come to refer to an unhealthy preoccupation with sexy, monumental, and narrow-minded solutions—the kind of stuff that wows audiences at TED Conferences—to problems that are extremely complex, fluid, and contentious. These are the kinds of problems that, on careful examination, do not have to be defined in the singular and all-encompassing ways that “solutionists” have defined them; what’s contentious, then, is not their proposed solution but their very definition of the problem itself. Design theorist Michael Dobbins has it right: solutionism presumes rather than investigates the problems that it is trying to solve, reaching “for the answer before the questions have been fully asked.” [Such as, how risk-prone are paper records, exactly, and how might the risks be ameloriated without spending hundreds of billions of dollars on healthcare IT? - ed.] How problems are composed matters every bit as much as how problems are resolved.

Solutionism, thus, is not just a fancy way of saying that for someone with a hammer, everything looks like a nail; it’s not just another riff on the inapplicability of “technological fixes” to “wicked problems” (a subject I address at length in The Net Delusion). It’s not only that many problems are not suited to the quick-and-easy solutionist tool kit. It’s also that what many solutionists presume to be “problems” in need of solving are not problems at all; a deeper investigation into the very nature of these “problems” would reveal that the inefficiency, ambiguity, and opacity—whether in politics or everyday life—that the newly empowered geeks and solutionists are rallying against are not in any sense problematic. Quite the opposite: these vices are often virtues in disguise. [Such as - paper charts that are rapid to produce and browse, redundancies in healthcare processes that can help prevent errors of omission, ambiguities in decision making that take into account that not everyone fits a guideline, etc.? - ed.] That, thanks to innovative technologies, the modern-day solutionist has an easy way to eliminate them does not make them any less virtuous.

It occurs to me that what I've been calling "the syndrome of inappropriate overconfidence in computing" or "healthcare IT hyper-enthusiasm that ignores the downsides" -- or that which authors such as Nemeth/Cook might call a blindness to complexity that is "hiding in plain sight" and "HIT techno-fantasies" -- and similar ideas, may all be the same thing.

"Solutionism" may be a good umbrella label for these ideas.   Thus, those who challenge these ideas in healthcare and call for caution and restraint are not anti-health IT, not anti-technology, but anti-Solutionism, or maybe 'temperate solutionists' as opposed to 'extremist solutionists' or 'radical solutionists.'

And the reason the pushback is so vicious at times may be that we are attacking not just an industry but a broad philosophy or ideology - "a systematic body of concepts especially about human life or culture."

The current culture promotes solutionism - the belief that there's a technocratic (technological & bureaucratic, i.e., management of society by technical 'experts') solution to every problem as "solutionism" is defined elsewhere.  I think a vast majority of people, including the 'intellectuals', have bought into it.  

It doesn't help that "radical solutionism" is exceptionally profitable for its proponents....

Solutionism may be applicable to, say, domains where numbers or logistical matters predominate (e.g., banking and FedEx), but not to "messy" domains such as medicine.  Or at least not to all of medicine's component parts, such as the parts that clinicians perform using hard-earned expertise, judgement and ethics.

Finally, I ask:

Why can't be cure mental illness, or ensure perfect outcomes in cardiac surgery, or prevent wars, with the appropriate computer apps?

After all, with the appropriate tools, why can't we easily perform nuclear fission on our kitchen tables?

More after I read the book.

-- SS

Comments by Dr. Reed Gelzer on RAND Health IT Report and Op-Ed in Pittsburgh Post Gazette

A 2005 RAND Corporation report predicted that health IT could save the U.S. healthcare system $81 billion a year. Since then, however, annual health spending has increased by almost a trillion dollars, and quality and efficiency have not budged much, even with an increase in health IT adoption, according to researchers Arthur L. Kellerman and Spencer S. Jones in a Jan. 2013 RAND study published in Health Affairs.  Kellermann is chair in policy analysis, and Spencer Jones is an information scientist..

A new Op-Ed by Kellerman and Jones entitled "IT in health care is MIA" appeared on Mar. 3, 2013 in the Pittsburgh Post-Gazette.

They wrote:

Because information technology has so quickly transformed people's daily lives, we tend to forget how much things have changed from the not-so-distant past. Today, millions of people around the world regularly shop online; download entire movies, books and other media onto wireless devices; bank at ATMs wherever they choose; and self-book travel while checking themselves in at airports electronically.

But there is one sector of our lives where adoption of information technology has lagged conspicuously: health care.

Some parts of the world are doing better than others in this respect. Researchers from the Commonwealth Fund recently reported that some high-income countries, including the United Kingdom, Australia and New Zealand, have made great strides in the use of electronic medical records among primary-care physicians. Indeed, in those countries, the practice is now nearly universal.

Yet some other high-income countries, such as the United States and Canada, are not keeping up.

Of course, the U.K. recently suffered a rather severe blow, on the order of 13 billion Pounds' worth, to its National Programme for Health IT in the NHS (NPfIT).  Australia is not exactly an "Emerald City" in terms of health IT, either, as can be seen from numerous links at the blog of Sydneysider Dr. David More, Australian Health Information Technology.

The RAND authors throw in some boilerplate grandiose predictions of certainty about health IT, which seems to have become a common phenomenon in newspapers and even scientific publications of late:

 ... The U.S. government is trying to help. In 2009, Congress passed the Health Information Technology for Economic and Clinical Health Act. HITECH has undeniably accelerated IT adoption, yet the problems of usability and interoperability persist.

... The sky is the limit when it comes to potential gains from health IT ... The payoff will be worth it. Indeed, as with the adoption of IT elsewhere, we may soon wonder how health care could have been delivered any other way.

Read the whole Op-Ed at the Gazette.

(My mother, an unwitting expert with significant experience on health IT adverse effects, is unavailable for comment, as she is dead due to a HIT-related accident.)

However, another expert is available:

Reed D. Gelzer, MD, MPH is an EHR/HIT systems and policy analyst for private and Federal agency clients, primarily in program integrity and clinical quality support.  In clinical practice for 11 years before transitioning into health IT, he also co-chairs the HL7 Records Management and Evidentiary Support (RMES) Workgroup.  He served US Navy Medicine’s Data Quality Office, various private insurers, as well as three years on CCHIT workgroups.  He was the Prevention Workgroup Chair for the 2007 ONC study on mitigation of EHR mediated waste fraud and abuse.

I find his opinions posted at the Gazette comment board of interest.  Some of the themes are very familiar. His comments are reproduced here with just a few comments of mine interjected:

Good afternoon Mr. Kellerman and Mr. Jones,

Thank you for the recitation of the arguments for HIT. I am particularly pleased that you note that a principle block to advancing HIT in the US is the fact that systems are not standardized.

One of the reasons many of our Industrialized Nation peers are far ahead of us is that they, in effect, standardized their systems by having one customer, a government entity operating health care. I assume you are not proposing that. If not then what, in the absence of regulation, will achieve your proper objective of standardizing HIT?

Well, we could simply let the market decide among the current non-standardized, non-regulated systems by accepting the accompanying burdens of cost, patient harms, and highly variable to unreliable data, and so on, in a nationwide experiment using the citizens of the U.S. as the test subjects [without informed consent or opt-out provisions, I might add - ed.] . A free market though would necessitate an absence of market-corrupting subsidies and transparency on comparing products, so that we can all equally hear when systems don't work as expected or cause problems for users, clinics, hospitals, and patients. No subsidies, no advantage to legacy vendors, and publicly available information about system problems, defects, and harms for a free market in HIT seems as unlikely as a single payer, government run system in the U.S., so what other options do we have?

We could say, we as a country want to improve this faulty and expensive industry, and so that is what we will hold providers responsible for. Doctors, hospitals, nurses, clinics, everybody -You have a duty to achieve better.  IT is a means, not the end. Purchase and apply the tools you decide you need to fix the problems you see. If you find you cannot do it, then close your doors and go to work for someone who can.

In support of this, as we do with drugs, we do not expect doctors, hospitals, nurses, clinics to independently research what is safe, what is usable in medications, in lab and imaging equipment and medical devices. We make sure that the tools available are safe, reliable, and do what they are intended to do. We do not de-regulate pharmaceuticals to speed innovation [due to the common claim by HIT hyper-enthusiasts that regulation would harm IT innovation, one might surmise they presumably would support pharma deregulation as well - ed.], we regulate minimum requirements of safety and efficacy so that such tools of medicine can be delivered to the bedside without the clinicians having to spend hours worrying about whether they're even fit for use.

Improving the safety, value, and effectiveness of patient care is not dependent on HIT.  Fit HIT is an indispensable enabler of KNOWING that we are doing our best and KNOWING where we are falling short and where improvements can best be directed.

Meanwhile, there can be no doubt that we will increasingly regulate HIT simply because it is the only way we can ever have non-anecdotal and systematic reporting on what HIT actually does (or doesn't do) for benefiting patients. Otherwise we will continue to be stuck where we are now: between a defective government policy that has bought the vision and promise (and there's a "no return" policy) without evidence, and the accumulating evidence of the difficulty, complexity, costs, and harms rendered by the current national experiment. [This evidence is often ignored or denied by the hyper-enthusiasts - ed.]

Again, thank you for reiterating the necessity of standardization. This should progressively elevate the attention to the vast library of HIT standards existent (and still evolving) that remain unused by vendors. Not just vendors, though. Standards also remain unused by doctors, nurses, hospitals, and clinics (and their organizational advocates) who still, amazingly do little, if any due diligence on the fitness of HIT to their use as patient care tools and records thereof.  [This is known as "negligence" and perhaps "gross negligence" - ed.]  Given that Meaningful Use has lowered the Certification bar so much lower than it was in 2009 and since subsidies have made it a Sellers market (and a race to avoid penalties) it is hard to imagine how the geometric progression of risk of non-standardized [systems] untested for safety, usability, or fitness will not assure pain and suffering of many kinds for years to come.

I look to you RAND to project your dynamic model for how Standardization will be achieved. In the meantime, of course this means that, among other things, they are not standardized for fitness in use for patient care.

RDGelzer, MD, MPH.

These are good thoughts.

I repeat my warnings that until sanity and caution is restored to the health IT sector (or started, as it may never have  existed) it is not likely that "we may soon wonder how health care could have been delivered any other way."

-- SS

Wisdom from the Medical Journal of Oz: "Good HIT and bad HIT"

The recognition and partitioning of "good health IT" from "bad health IT" is now a mainstream meme.  I have few comments about this new article; it reflects views frequently expressed here at Healthcare Renewal (indeed, one of its references is to this blog and this author):

Good HIT and bad HIT
Jon D Patrick and Susan Ieraci
Medical Journal of Australia 2013; 198 (4): 205.

First and foremost, do no harm. Second, do some good

One of the key issues for high-volume, high-risk workplaces like hospital emergency departments (EDs) is the struggle of conflicting aims. While hospital managers need information systems for data collection and storage, clinicians need efficient clinical documentation, data retrieval and order-entry systems that save time rather than steal it from the patient. The work of clinicians is aided by reliable data but impaired by the delays of real-time input, difficult system navigation, suboptimal presentation of information, and other problems in the user experience of health information technology (HIT).1

Mohan and colleagues’ study of the impact of an electronic medical record information system on ED performance had some limitations.2 It was retrospective and unable to control for all confounders, and therefore could only show a correlation with ED delays, not causation. However, the premise for the study delivers an important message — the work required to use the information system was perceived by the ED staff to directly conflict with time spent with patients.

Another study has shown that the same electronic medical record information system is perceived to have had a negative impact on the care of patients, as well as the productivity and morale of staff, in six EDs in New South Wales.3 The need to be hypervigilant about the accuracy of the information supplied by the electronic health record compounds an already stressful clinical environment, which in turn leads to resentment towards the technology and the people who have imposed it. This makes it “bad” HIT. Unless this is corrected, HIT efforts will overuse precious health care resources, will be unlikely to achieve claimed benefits for many years to come, and may actually cause harm.4,5

The large HIT corporations produce a type of technology that is best categorised as enterprise resource planning (ERP), which has its roots in the manufacturing industry. It is based on the idea that all processes within an organisation can be standardised, and that all processes of the same type should have their information modelled and processed in the same manner. If this high degree of standardisation were considered the best way to process and model information derived from clinical activity, then ERP would be a favoured technology to adopt, as has happened in many places.

However, there is an alternative, almost contradictory, perspective on the nature of clinical work: that it is non-deterministic and performed by a group of diverse staff working in an ecologically stable network of people that has to respond to diverse medical needs and diseases. The ecology model accommodates staff joining and leaving the process, with differing needs emerging at different times, so that the other individuals in the network have to adapt and modify their behaviour and improvise in an unpredictable manner. Amid all this variability is the ever-demanding imperative to improve the processes of care and attention to the patient, while also increasing staff productivity.6

Where the ERP model has been imposed in the clinical setting, staff may be coerced into an approach to their work that is at odds with established best practices. This could only be considered “good” HIT if it brought greater staff productivity with at least no loss (and, preferably, improvement) of patient safety and services and staff morale.

It is not enough just to identify problems: effort must be invested in transforming bad HIT into good HIT. This process must identify and optimise all the operative factors: human behaviour, system design, equipment performance, skills of the IT participants, and the operational policy framework.7 Good HIT should include clinician control of the interface design for content, dataflow and workflow. It includes the ability to change the system in real time, and it incorporates inbuilt data analytical capability, natural language processing, and native interoperability and clinical coding.8 Finally, there must be an appropriate opportunity to test systems for useability, effectiveness and suitability before their release.

There must be a move away from standardised processing models and towards improving the user experience in the clinical setting. Clinicians should not have to shoehorn their activity into predefined, externally imposed work processes that do not reflect actual activity and will not improve efficiency. A true patient-focused system aligns all its components towards the same aim. Like a good clinician, good HIT does no harm — to patients or staff.

American medical / HIT journals are perhaps a bit too beholden to industry to directly commit such health IT heresy.  Thank the stars those Down Under are a bit more bold.

-- SS

Michael Millenson and "the adamant refusal by hospitals and doctors to adopt electronic records no matter what the evidence"

Over at Health Beat by Maggie Mahar appears a piece critical of NYT reporter Julie Creswell's Feb. 20, 2013 article "A Digital Shift on Health Data Swells Profits in an Industry."  (The piece was also cross-posted at The Health Care Blog.)  There have been several responses highly critical of the NYT article recently in various venues.

The Health Beat piece "The Health IT Scandal the NY Times Didn’t Cover" is by Michael L. Millenson, president of Health Quality Advisors LLC in Highland Park, IL, and the author of the critically acclaimed book, Demanding Medical Excellence: Doctors and Accountability in the Information Age published in 2000.

I bought and read that book at the time.

The posting at Health Beat contains the following statement:

The actual scandal is more complicated and scary. It has to do with the adamant refusal by hospitals and doctors to adopt electronic records no matter what the evidence. 

I am profoundly disappointed by this statement in view of issues (frequently written about here and elsewhere) such as:

• The conflicting literature by credible and responsible parties on health IT's real-world value and risks as it exists today;  
• Fiduciary obligations of hospital executives to maintain safe operating conditions; 
• Legal and ethical obligations of physicians to resist technology they find or believe harmful without rigorous proof of its beneficence and efficacy (which includes the absence of major evidence conflicts); 
• The evidence of major and frequent flaws, bugs and "glitches", some of which are alarming;

not to mention:

• The 500+ reader comments in response to Creswell's article, many by clinicians describing why they don't like today's health IT; 
• Examples of unintended adverse consequences such as here (plus at least 5 other IT-related crippling injuries and/or deaths of infants I know of but cannot speak about), and here, and here;
• Other factors as at this blog and at my teaching site here.

I am trying to find a polite term for the statement, and struggling to do so in view of the author's prior work, which I admired.

The statement really is saying:

... It [the "scandal"] has to do with the adamant refusal by hospitals and doctors to adopt electronic records no matter what the evidence ... which is all exceptionally robust and positive, leaving no room whatsoever for reasonable doubt or caution.

Regrettably, here is the most polite term I can come up with describing the statement:

Preposterous.

If anyone takes offense to that term, please suggest a more precise one.

Perhaps a book needs to be written entitled "Demanding Information Technology Excellence: Health IT and Accountability in the Information Age."

-- SS

Mar. 4, 2013 addendum:

In a response to a reader's comment to the cross-posting of this piece at The Health Care Blog (link), Millenson responds:

"platon20: my point, that EMRs were available in the 1970s but never changed their interface because doctors never cared enough to demand it, is not refuted by your argument, but confirmed."

This is bizarre and inconsistent with my experience and that of other Chief Medical Informatics Officers I've mentored or spoken with.  Since my entry into the domain of Medical Informatics 21 years ago I've heard many physicians, myself included [1], demand that health IT sellers and/or hospital IT departments "improve the user interface", among other areas for improvement. 

Based on my own observations and that of others (e.g., via reader comments at my teaching site dating to at least 1999), these pleas have often fallen on the deaf - and in some cases ill-informed and/or incompetent - ears of hospital senior and IT executives and industry pundits.  The latter have often responded by accusing the physicians of being "Luddites" or technophobes, and the advocates for change such as myself "anti-health IT."

The most stunning example regarding this phenomenon is the industry pushback against Prof. Jon Patrick at U. Sydney, and the ignoring of his work (on both the user experience and the fundamental software engineering quality) sitting on a University server for several years now, regarding a major U.S. ED EHR slated for rollout in an entire state of Australia.  

With usability issues now being forced of the industry for reconsideration by HHS via NIST, the industry response has been to claim that "usability is in the eye of the beholder" and other frivolous claims, up to and including interference in the the public comments period on Meaningful Use via ghostwriting, and possibly outrageous statements (although that issue became anechoic), to get their way, which is to do little or nothing on that score.

I remind Millenson that "improving the user experience" of health IT cuts into the bottom line.

[1] e.g.,  in a project initiated 20 years ago by the clinicians themselves - in a critical care area no less - in which I had to take over through force of will from the hospital's own IT department and COO and  re-engineer not just the commercial user interface but the entire dataset itself.  The project ultimately proved successful after my intervention, but the mid-level executive who facilitated my takeover to do that, and I, were punished by our superiors for our efforts.

-- SS

JAMIA: Reduction in medication errors in hospitals due to adoption of computerized provider order entry systems

A new article appeared online 20 February 2013 in the Journal of the American Medical Informatics Association entitled "Reduction in medication errors in hospitals due to adoption of computerized provider order entry systems" (link to fulltext) by David C Radley, Melanie R Wasserman, Lauren EW Olsho, Sarah J Shoemaker, Mark D Spranca and Bethany Bradshaw.

The authors performed a meta-analysis of the literature on Computerized Practitioner Order Entry (CPOE) systems in inpatient settings and concluded:

"Processing a prescription drug order through a CPOE system decreases the likelihood of error on that order by 48% (or in  a range of 41% to 55% with ninety five percent confidence).  Given this effect size, and the degree of CPOE adoption and use in hospitals in 2008, we estimate a 12.5% reduction in medication errors, or ∼17.4 million medication errors averted in the USA in one year."

It is important to know the potential benefits of CPOE, as the government has been pushing this technology since the foundation of the Office of the National Coordinator (for health IT) within HHS since 2004.  Indeed, reimbursement penalties on Medicare will start in 2015 for non-adopters of government certified health IT.

It is especially important to get to the truth about CPOE specifically, and health IT in general, in terms of risks, benefits, return on investment, improvements, and alternatives.

Not long before this new JAMIA article appeared, an active study of EHR problems with voluntary reporting by members of the ECRI Institute's Patient Safety Organization (PSO) produced some concerning data.  Namely, that over a 9-week period starting April 16, 2012, and ending June 19, 2012, 171 health information technology-related problems were reported from just 36 healthcare facilities, primarily hospitals. Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths.

Obviously, extrapolating those number to:  1)  a much higher number of hospitals, of which the U.S. alone has approximately 5,700 plus other facilities such as long-term care, and private physician offices; 2)  over a full year, not just 9 weeks;  3) accounting for the perhaps 5% voluntary reporting level (per Koppel) of issues such as medication errors; 4) plus accounting for (per FDA) the issue of lack of recognition of IT as contributing to medical incidents (this list is not all-inclusive) - the results are of concern.

Thus, work such as in this new JAMIA article on CPOE is important.  The article can be downloaded in its entirety as of this writing from the link above.  The article describes a methodology that is quite complex, and obviously a great deal of time and effort was put into it.  It appears to be a valiant effort to get us one step closer to the truth.  This should be applauded.

I was impressed on first reading of this literature meta-analysis and its statistical calculations. (Actually I needed to read it several times to fully grasp the methodologies involved.)

The question arose in my mind, however: can this article's conclusions be true, and the ECRI PSO Deep Dive study be true, at the same time?

Prior to going into an analysis and perhaps detailed critique of the methodology, and knowing the difficulties and contradictions the literature on this topic presents, I decided first to look at the source articles selected from the literature for inclusion in the JAMIA meta-analysis.

In doing so, issues became apparent that shed light on the difficulties of meta-analyses on topics such as this.

The only methodological issue I will mention at this time is that the study used a surrogate endpoint - medication "error" rates before, and after, implementation of CPOE, rather than patient outcomes.  (The reason I put "error" in quotes is that, as the authors describe regarding study limitations, the exact definition varies from site to site and study to study.  They also acknowledge the limitations of using such an endpoint.)  Surrogate endpoints, however, may or may not reflect the actual information being sought regarding outcomes.

As Roy Poses noted in a June 2008 post "Criticism of Surrogate Endpoints in Whose Interests?":

... The problem with surrogate endpoints is that they are surrogates for the real thing. In many cases, a treatment may appear beneficial when measured by its affect on such endpoints, but not turn out to be beneficial when measured by its affect on real clinical outcomes, e.g., alleviation of symptoms, improvement of function, and prolongation of survival. There are many reasons why this may be the case.

This weakens the present study as a basis for social re-engineering.  The authors responsibly acknowledge that via the statement in the conclusion that:

Future research in this area will be critically important to inform policy and funding decisions regarding the development and implementation of CPOE in care delivery.

When I reviewed the studies that were used for the meta-analysis, however, my enthusiasm for the results was diminished.

The authors write:

Using the search terms of Ammenwerth et al, we updated the search using PubMed in February 2009, identifying 390 studies. Each was reviewed by two study authors (MRW and DCR). After applying the a priori inclusion/exclusion criteria, 10 studies were retained. [Listed in footnotes 10–19 - ed.]

Here are the 10 studies retained, as per footnotes #10 - 19.  Short excerpts (I am trying to keep this post relatively short) and my very brief comments about each of them are as follows.  Hyperlinks to the summaries and in some cases to fulltext are present in the online study itself at the full text link at top of this post.

First, I note no randomized, controlled clinical trials, the gold standard of medical research.  That lack is not the fault of the authors; it is a general feature in the domain of healthcare information technology.

That said: 

Included study #1 (footnote 10):

Bates DW, Teich JM, et al, The impact of computerized physician order entry on medication error prevention. Brigham and Women's Hospital, J Am Med Inform Assoc 1999;6:313–21.

... During the study, the non-missed-dose medication error rate fell 81 percent, from 142 per 1,000 patient-days in the baseline period to 26.6 per 1,000 patient-days in the final period (P < 0.0001). Non-intercepted serious medication errors (those with the potential to cause injury) fell 86 percent from baseline to period 3, the final period (P = 0.0003). Large differences were seen for all main types of medication errors: dose errors, frequency errors, route errors, substitution errors, and allergies. For example, in the baseline period there were ten allergy errors, but only two in the following three periods combined (P < 0.0001).  The study periods were as follows: baseline, 51 days, Oct-Nov 1992; period 1, 68 days, Oct-Dec 1993; period 2, 49 days, Nov-Dec 1995; and period 3, 52 days, Mar-Apr 1997.

I note that this was a highly advanced setting with long-standing Medical Informatics expertise, performed by Medical Informatics experts of the highest caliber.  This was an ideal environment for the implementation of good health IT.  The results may thus not be generalizable to facilities without that level of experience.  

Also, the study was a considerable number of years ago, some of it two decades ago.  While one might assume the technology has improved, the increased commercial sector involvement since the 1990's, and especially after the HITECH incentives of 2009, may be creating an increased occurrence of bad health IT, and/or implementation in facilities with far less (if any) informatics expertise.

Thus, in my view the study's applicability to current times and to all medical organizations is not extremely strong. 

Included study #2 (footnote 11):

Medication Administration Variances Before and After Implementation of Computerized Physician Order Entry in a Neonatal Intensive Care Unit, Pediatrics 2008;121:123–8

... Data on 526 medication administrations, including 254 during the pre-computerized physician order entry period and 272 after implementation of computerized physician order entry, were collected. Medication variances were detected for 19.8% of administrations during the pre-computerized physician order entry period, compared with 11.6% with computerized physician order entry (rate ratio: 0.53). Overall, administration mistakes, prescribing problems, and pharmacy problems accounted for 74% of medication variances; there were no statistically significant differences in rates for any of these specific reasons before versus after introduction of computerized physician order entry.

Here, 'n' is very small, and there is a finding that the CPOE had no effect on administration mistakes, prescribing problems, and pharmacy problems.  Thus, a ringing endorsement for national CPOE implementation this study is (unfortunately) not. 

Included study #3 (footnote 12):

The effect of computer-assisted prescription writing on emergency department prescription errors, Acad Emerg Med 2002;9:1168–75.

Without even a summary, my concern here is that ePrescribing and CPOE are different entities.   Inclusion of ePrescibing in a study of CPOE is not entirely without some risk of conflation of results of one with the other. 

Included study #4 (footnote 13):

Impact of computerized physician order entry on clinical practice in a newborn intensive care unit, J Perinatol. 2004 Feb;24(2):88-93.

This article studies gentamicin dosing and turn around times and found that:

"...the accuracy of gentamicin dose at the time of admission for 105 (pre-CPOE) and 92 (post-CPOE) VLBW infants was determined. In the pre-CPOE period, 5% overdosages, 8% underdosages, and 87% correct dosages were identified. In the post-CPOE, no medication errors occurred. Accuracy of gentamicin dosages during hospitalization at the time of suspected late-onset sepsis for 31 pre- and 28 post-CPOE VLBW infants was studied. Gentamicin dose was calculated incorrectly in two of 31 (6%) pre-CPOE infants. No such errors were noted in the post-CPOE period.

My comments are that a NICU is a specialized environment with a high ratio of clinicians/staff to patients.  Findings in such an environment again may not be generalizable.  Also, one should ask if complex CPOE systems are really needed for dosing calculations and turn around time improvements.  Simpler and cheaper human/technological solutions might have achieved similar or better results.  Thus, again, while not demeaning the results achieved by this study's interventions in 2004, I have my concerns that this study is not strong evidence of generalizability of even the CPOE surrogate measurement, namely decrease of med "errors." 

Included study #5 (footnote 14):

A computer-assisted management program for antibiotics and other antiinfective agents. N Engl J Med 1998;338:232–8.

We have developed a computerized decision-support program linked to computer-based patient records that can assist physicians in the use of antiinfective agents and improve the quality of care. This program presents epidemiologic information, along with detailed recommendations and warnings. The program recommends antiinfective regimens and courses of therapy for particular patients and provides immediate feedback. We prospectively studied the use of the computerized antiinfectives-management program for one year in a 12-bed intensive care unit. RESULTS: During the intervention period, all 545 patients admitted were cared for with the aid of the antiinfectives-management program. Measures of processes and outcomes were compared with those for the 1136 patients admitted to the same unit during the two years before the intervention period. The use of the program led to significant reductions in orders for drugs to which the patients had reported allergies (35, vs. 146 during the preintervention period; P less than 0.01), excess drug dosages (87 vs. 405, P less than 0.01), and antibiotic-susceptibility mismatches (12 vs. 206, P less than 0.01). There were also marked reductions in the mean number of days of excessive drug dosage (2.7 vs. 5.9, P less than 0.002) and in adverse events caused by antiinfective agents (4 vs. 28, P less than 0.02).  [Several other benefits omitted for brevity - they can be seen at the JAMIA footnote hyperlink -  ed.]

My thoughts here are that, while the results were commendable, once again this study took place 15 years ago, and was in a high-staff-to-patient specialized ICU environment.  I also wonder if complex, expensive CPOE is needed to accomplish these tasks as opposed to, say, an online DSS and appropriate workflows and process. 

Included study #6 (footnote 15):

Impact of computerized prescriber order entry on medication errors at an acute tertiary care hospital. Hosp Pharm 2003;38:227–31.

The authors analyzed medication errors documented in a hospital's database of clinical interventions as a continuous quality improvement activity. They compared the number of errors reported prior to and after computerized prescriber order entry (CPOE) was implemented in the hospital. Results indicated that in the first 12 months of CPOE, overall medication errors were reduced by more than 40%, incomplete orders declined by more than 70%, and incorrect orders decreased by at least 45%. Illegible orders were virtually eliminated but the level of medication errors categorized by drug therapy problems remained significantly unchanged. The study underscores the positive impact of CPOE on medication safety and reemphasizes the need for proactive clinical interventions by pharmacists.

This study appears reasonable for inclusion in a meta-analysis, although ideally there might have been accounting for possible influence of non-intervention (computer)-related pre-post interval changes.  The transition to CPOE, training, increased awareness, etc. can influence results, especially short term. 

Included study #7 (footnote 16):

Error reduction in pediatric chemotherapy: computerized order entry and failure modes and effects analysis. Arch Pediatr Adolesc Med 2006;160:495–8.

Before-and-after study from 2001 to 2004. After CPOE deployment, daily chemotherapy orders were less likely to have improper dosing (relative risk [RR], 0.26; 95% confidence interval [CI], 0.11-0.61), incorrect dosing calculations (RR, 0.09; 95% CI, 0.03-0.34), missing cumulative dose calculations (RR, 0.32; 95% CI, 0.14-0.77), and incomplete nursing checklists (RR, 0.51; 95% CI, 0.33-0.80). There was no difference in the likelihood of improper dosing on treatment plans and a higher likelihood of not matching medication orders to treatment plans (RR, 5.4; 95% CI, 3.1-9.5).

Again, the results appear commendable.  However:  there was no difference in the likelihood of improper dosing on treatment plans, and worse, there was found a higher likelihood of not matching medication orders to treatment plans.

In fact, this article was accompanied by a letter in response entitled "Primum non nocere", David Dickens, MD; Dianne Sinsabaugh, RPh; Brenda Winger, PharmD, Arch Pediatr Adolesc Med. 2006;160(11):1185-1186 (after some digging, text found at http://archpedi.jamanetwork.com/article.aspx?articleid=486317):

Kim et al. demonstrated that in the practice of pediatric oncology, computerized physician order entry (CPOE) reduced improper dosing, missing cumulative doses, and incomplete nursing checklists.  In contrast to these benefits, however, CPOE also resulted in a 5-fold increase in “not matching medication orders to treatment plans.” Although little detail was provided on the nature of these medication order/treatment plan “mismatches,” it implies that chemotherapy ordered through CPOE deviated more often from intended protocol therapy as compared with paper-ordered chemotherapy. While CPOE ostensibly led to more precise chemotherapy dosing, it increased the risk of that chemotherapy being the wrong chemotherapy.

The author did respond: "Mismatches between treatment plan and orders at point of therapy increased, but were intercepted and clarified at POC. [By people - ed.].  No incorrect meds were given.

On its face, this is not an entirely dispositive proof of CPOE beneficence and raises significant concern that, sooner or later, a person might miss the discrepanc(ies) resulting in unintended adverse consequences. 

Included study #8 (footnote 17):

Effects of an integrated clinical information system on medication safety in a multi-hospital setting. Am J Health Syst Pharm 2007;64:1969–77.

This study took place at Lifespan health care system that includes Rhode Island Hospital (RIH), a private, 719-bed, not-for-profit, acute care hospital and academic medical center that has a pediatric division, the Hasbro Children’s Hospital; and The Miriam Hospital (TMH), a 247-bed, not-for-profit, acute care general hospital.

Methods. The integrated systems selected for implementation included computerized physician order entry, pharmacy and laboratory information systems, clinical decision-support systems (CDSSs), electronic drug dispensing systems (EDDSs), and a bar-code point-of-care medication administration system. The indicators for CPOE with inherent CDSSs demonstrated a significant effect of this functionality on reducing prescribing error rates for three of the four indicators measured: drug allergy detection, excessive dose, and incomplete or unclear order. The fourth indicator measured, therapeutic duplication, did not show a significant effect on prescribing error rates. For the rules engine software CDSS, the colchicine indicator did not show a statistically significant effect on prescribing error rate, but a significant decrease in prescribing errors related to metformin use in renal insufficiency was observed after implementation of the rules engine software and integration with CPOE.

Again, these are commendable results, but on its face the technologies involved went far beyond just CPOE, and the results were not uniform.  The actual reduction figures for seven categories were mostly in 50% range, one at 86% (allergy), but the duplicates issue at 8%, not felt statistically significant.

Of more concern, there was this in the news in 2011.  A software bug at this organization led to thousands and perhaps tens of thousands of prescription errors that could have (and without definite proof, despite organization denials I would be concerned did) led to injury and death.  I wrote about the malfunction at http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html.  The bug was not discovered for about a year.

Other organizations, especially those new to CPOE and/or health IT, face similar risks.

Again, this is not a caveat-free endorsement of national CPOE rollout in 2013.

Included study #9 (footnote 18):

Effect of computer order entry on prevention of serious medication errors in hospitalized children. Pediatrics 2008;121:e421–7.

627 pediatric admissions, with 12 672 medication orders written over 3234 patient-days.  The rate of non-intercepted serious medication errors in this pediatric population was reduced by 7% after the introduction of a commercial computerized physician order entry system, much less than previously reported for adults, and there was no change in the rate of injuries as a result of error. Several human-machine interface problems, particularly surrounding selection and dosing of pediatric medications, were identified.

The issues of concern here are bolded and underlined above and need not be restated.

Lastly:

Included study #10 (footnote 19):

Evaluation of reported medication errors before and after implementation of computerized practitioner order entry. J Health Inf Manag 2006;20:46–53.

While a major objective of CPOE is to reduce medication errors, its introduction is a major system change that may result in unintended outcomes. Monitoring voluntarily-reported medication errors in a university setting was used to identify the impact of initial CPOE implementation on medical-surgical and intensive care units. A retrospective trend analysis was used to compare errors one year before and six months after implementation. Total error reports increased post-CPOE but the level of patient harm related to those errors decreased. Numerous modifications were made to the system and the implementation process. The study supports the notion that CPOE configuration and implementation influences the risk of medication errors. Implementation teams should incorporate monitoring medication errors into project plans and expect to make ongoing changes to continually support the design of a safer care delivery environment.

This study appeared more a study reporting unintended outcomes than benefits. The total medication error reports increased post-CPOE but the level of patient harm related to those errors decreased.   (That decrease might have been due to human factors, or to serendipity, both of which cannot be expected to protect forever.)

The reasons for the changes were described this way:

... Contributing causes. To assist in the development of safety interventions, contributing causes were identified for reported errors. The most common contributing cause was noncompliance to policy and procedure, identified in 40 percent of errors. For example, a previous order may not have been discontinued when a new dose change was entered, resulting in two active orders for the same medication with different dosages

 The next most common contributing cause was computer entry errors, seen in 25 percent of mistakes. One example was if a medication order was placed on the wrong patient.  ["Use error" due to confusing user interfaces as recently defined by NIST - as opposed to "user error" - was likely to have contributed to at least some of these errors - ed.]  The next most common error was initial load errors (19 percent). During entry of all current medications on the day of activation, multiple category B errors were made. An example was a written order for sliding scale calcium gluconate “PRN,” which was entered into the CPOE system as “scheduled.”

There were also computer design issues that contributed to 10 percent of errors. An example was when the pharmacist received two printouts for methylprednisolone 500 mg IV. He assumed it was a duplicate order, but when he reviewed the CPOE system, he saw that one order was for today and the other was for tomorrow. The dates for these orders were not visible on the order printout from the CPOE system. [This again seems to be 'use error' - ed.]

These issues can and will occur anywhere.  Once again, this is not entirely an article, either by itself or in a meta-analysis, that I find ideal in attempted proof of CPOE effectiveness and beneficence.

In fact, after I reviewed this source, I noted that this study was eliminated from the inclusion set:

... Based on later expert reviewer feedback, we eliminated one additional study that solely used a voluntary reporting method for error detection, leaving nine studies for our final pooled analysis.

It would probably not be hard to convince critical thinkers of the possibility this study was removed for reasons other than stated.

In summary, while one should not and cannot expect perfection in the studies available in a meta-analysis, due to the difficulties in this domain the literature resources utilized were not ideal, and the surrogate endpoint also raises concern.  (I have not reviewed the entire corpus of potential literature myself.)  The authors conducted a difficult and rigorous study, but one cannot turn data "lead" (as in Pb) to gold (as in Au), no matter how hard one works or however good one's intentions are.

The authors did note the limitations of the study, although their conclusion will likely be taken by the industry as a "full steam ahead" signal.   (I do note with some irony the proximity of this article's release to the soon-to-start massive HIMSS 2013 Annual Conference & Exhibition trade show, March 3-7, 2013 in New Orleans, LA.)  While likely a coincidence, my concern is that CPOE vendors will be talking nonstop about these results.

Thus, I agree with the author's conclusion (especially in view of the recent voluntary reporting-based ECRI PSO study) that "future research in this area will be critically important to inform policy and funding decisions regarding the development and implementation of CPOE in care delivery."

From a clinical perspective, "primum non nocere" and the avoidance of gambling billions of dollars applies, at least until a better understanding of the technology's risk/benefit ratio and how to improve it occurs.

A fraction of those billions would pay for more robust, current studies on the scale needed to get closer to the truth, such as formal post-market, mandatory surveillance that measures not surrogate but primary variables - such as outcomes both positive and negative.  As noted by the authors, voluntary reporting has the least sensitivity towards uncovering error: 

... Reviewed studies used various medication error detection methods. Research suggests that the highest error rates are found through direct observation, followed by chart review, then automated surveillance, and voluntary reporting.  [Citations were made to papers by Flynn and Jha regarding these points - ed.]

Formal studies are essential from the basis of medical (e.g., safety and public health), business (e.g., ROI and liability), and social policy perspectives (e.g., are we spending the billions of dollars this technology costs wisely).

-- SS

Addendum:   

I have often been the fire-breathing and über-skeptic iconoclast on matters such as this.  However, I will allow a true international expert to take on that role this time, Dr. Richard Cook, who had a guest post here yesterday (link).  Dr. Cook's opinion on this JAMIA study (again, reproduced here with permission) was this:

A meta-analysis of the literature on the nature of the universe in the mid 1500's would have concluded that the sun revolves around the earth. The data isn't fake, just worthless.  

-- SS

Dr. Richard Cook on the Health IT Sector's Ills

This explanation of the health IT sector's ills comes from Dr. Richard Cook, a physician, educator, researcher, and patient safety expert formerly at the University of Chicago and now Professor of Healthcare System Safety at the Royal Institute of Technology, Stockholm, Sweden.

Dr. Cook was also a member of the U.S. Institute of Medicine panel that studied health IT safety, leading to the 2012 IOM report ("Health IT and Patient Safety: Building Safer Systems for Better Care").

He was also co-author of an article I consider a must-read for anyone in the health IT sector, Hiding in plain sight: What Koppel et al. Tell Us About Healthcare IT, Journal of Biomedical Informatics. 38 (4): 262-3.

Reproduced with his permission:

My views are already on record. [This links to his IOM report dissent where he made the case that health IT is a Class 3 medical device and should be regulated - ed.]

Politically important activities (cynically, things that cost >10B$) are never neutral. HIT techno-fantasies are common and easily commandeered. Claims about the present and future efficacy of HIT have been altered in bewildering patterns to fit the circumstances of the moment.  This is not uncommon for expensive technologies with a few dominant producers and strong government ties (cf. Mackenzie's Inventing Accuracy, MIT Press, 1993). 

The recent history of HIT is dominated by the social construction of several myths.  Although there are technical threads in the history, they are exceptionally frail. There have been myths of safety, of productivity, of economic efficiency, of clarity, of precision, of reliability.  

The truth is that the Obama administration depended, in part, on savings to be obtained from HIT for claims it made prior to the election of 2008 about the savings to be derived from the plan to "reform" healthcare. These interests aligned with those of the industry and a faction from academic medicine and the result was the usual sausage.

A central problem with techno-fantasies is that they are impossible to disprove. They are claims about the future. HIT's cornucopia has been promised repeatedly since the 1960's. Nothing like the promises has materialized.  Indeed, the IOM committee that was commissioned to evaluate the best evidence on this subject found no persuasive evidence that HIT improved patient safety. I know because I was there.

But this is not the point and never has been. Privileged entities marshall arguments in favor of their purposes. The devil can cite scripture to his purpose. The result is what matters to them and the goal here was to get the government to fund private HIT installation in private healthcare facilities by offering first a carrot and then a stick. They steamrollered the opposition -- which was much more nuanced and thoughtful than the attacks on you [Scot Silverstein] make it appear -- and made it happen.

To be clear, there was no conspiracy here. This is not deal done in back rooms by a few executives and cigar smoking pols. Instead it is the entirely predictable result of a confluence of interest among powerful stakeholders to advance their agendas. There is nothing shocking about an inferior, ill-conceived product getting government support, viz. Solyndra. Ultimately, the technical issues serve to the socio-political ones.

It's no better over here.  [That is, in Sweden - ed.] We face the same problems in Sweden that you do in the U.S. We have the advantage of paying about 1/3 of what you do for healthcare and getting, objectively, better medical care and a better life than you do in the U.S.  But we have the same fractionated approach that you do and the same age bulge looming in the next 2 decades and there are plenty of problems with safety and humaneness, just like in your country. 

I present this without any changes that might have occurred when unpleasant truths or opinions undergo peer review in a specialized, non-transparent and highly profitable sector.

-- SS