Australian ED EHR Study: An End to the Line "Your Evidence Is Anecdotal, Thus Worthless?"

At my Sept. 2010 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" I lamented that while my early mentor in biomedicine Victor P. Satinsky MD taught the wise credo "critical thinking always, or your patient's dead" in the 1970's, our culture had become so perverse that this credo had been largely supplanted with:

"Critical thinking anytime, and your career's dead."

That post was in reaction to continued heckling on a professional mailing list, the American Medical Informatics Association (AMIA) Clinical Information Systems Working Group (cis-wg). On this list, Oregon Health Sciences University professor William Hersh expounded on how the evidence of health IT dangers was largely "anecdotal" therefore to be discounted, and how I, specifically, "didn't know the literature on health IT."



In that post I put the lie to the latter figment. On the former prevarication Dr. Jon Patrick, author of the recent thorough dissection of problems with the ED EHR system being rolled out in public hospitals in New South Wales, Australia (see my Mar. 5, 2011 post "On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts"), hit the ball out of the park:

Prof. Patrick to AMIA cis-wg:



I think such defences are particularly unuseful especially with respect to the dismissal of personal stories and experiences as "anecdotes", hence committing them to the realm of folklore. I offer these notions as a counterpoint.



Discounting Anecdotes:



1. Is a perfidious and specious act.



2. It denies early warning signs of problems.



3. It denies a voice and disempowers the working clinical community who have to operationalise decisions made by others.



4. It denies a route to process improvement within an institution - which is most important for EBM and incremental review of local processes.



5. It defends software manufacturers from fault rectification - cuts off even a need to deliberate on it. Critics of the value of anecdotes are squarely on the side of the faulty and deficient manufacturer.



6. A rule of project management is that projects consist of 3 components, cost, quality and time and if their needs to be a compromise it has to be on quality. Anecdotes are early warning signs of such a compromise.

Prof. Patrick had to once again put the lie to this refrain at a comment on the HISTalk blog yesterday, where the anonymous proprietor had written in a review of Patrick's EHR study:

... On the other hand, I wouldn’t say it’s [Prof. Patrick's Cerner FirstNet study] necessarily unbiased, it focuses on implementation of a single department application that didn’t go well for a variety of reasons (despite many successful FirstNet implementations elsewhere), it uses the unchallenged anecdotal comments of unhappy users who make it clear they liked their previous EDIS better, and it nitpicks (I wasn’t moved to find a pitchfork when I learned that the primary keys in the Millennium database aren’t named consistently).



[Considering the complexity and changeability of healthcare and the corresponding software lifecycle, I duly note that that latter attitude about 'failing to find pitchforks' regarding breaches of sound software engineering practices seems to be a symptom of the larger health IT disease that Prof. Patrick writes about - ed.]

Dr. Patrick then knocked the ball out of the Southern Hemisphere with a comment of his own about anecdotalism and a link to an expansion of the aforementioned ideas he'd shared on "discounting anecdotes":

Prof. Patrick to HISTalk owner:



Your Comment “it uses the unchallenged anecdotal comments of unhappy users ” is not only unfair but unreasonably inaccurate. The comments made by the users are the Directors of 7 EDs and so they have a right to carry authority by virtue of the experience but also the number of 6 out 7 presenting a view of Firstnet as unfit for purpose has numeric validity, which they justify with about 20+ pages of their comments – see Part 2 Appendix 2.



I would also point readers to my editorial about the role of personal experiences being the most useful information to understand the nature of socio-technical failures. http://aci.schattauer.de/en/contents/archive/issue/1124/manuscript/15463/show.html

The essay at that link, "The Validity of Personal Experiences in Evaluating HIT", is an editorial in Johns Hopkins informaticist Chris Lehmann's brilliant new journal "Applied Clinical Informatics."



The editorial is available free, and is a must-read for anyone in a decision-making or managerial role in mission critical domains, including our elected representatives.



In the editorial Dr. Patrick concludes. similarly to his earlier AMIA mailing list opinion:

... the denial of recounted personal experiences in discussion and analysis of HIT is biased and specious and has the effect of:



1. Denying early warning signs of problems.



2. Denying a voice for the working clinical community who have to operationalise decisions made by others and thus disempowers them.



3. Denying process improvement within an institution – which is most important for Evidence Based Medicine and incremental review of local processes.



4. Discourages staff from engaging in any form of process improvement hence worsening the sense of disenchantment.



Every legitimate personal experience of a HIT deserves to be considered on its merits lest we wish to retreat from process and product improvement. Mechanisms of censorship both implicit due to contrived processes of disinformation and disempowerment or explicit due to contractual specifications will lead to more waste, lost productivity, contempt for the providers, and distress among frontline staff rather than increased productivity and improved patient health and safety as we all desire.

In my view, the drivers or motivators for the "anecdotalist" accusation are these, singly or in combination:

• Too much "education" to see the nose on one's face, as in, to think zebras and unicorns instead of horses when hearing hoofbeats outside one's midwest U.S. abode (eggheads);
  
  
• Too little common sense (fools), as in Scott Adams' example: "IGNORING ALL ANECDOTAL EVIDENCE - Example: I always get hives immediately after eating strawberries. But without a scientifically controlled experiment, it’s not reliable data. So I continue to eat strawberries every day, since I can’t tell if they cause hives";
  
  
• Too much concern for the possible interruption of flow of money or power in one's direction (gonifs).
  
  

In conclusion, the anecdotalist refrain of "your evidence is anecdotal" [therefore of little or no value] when used repetitively against competent observers is the refrain of eggheads, fools and gonifs.



In healthcare, the end result is "your patient's dead."



My "anecdotal relative" injured in a mid-2010 HIT mishap is sadly an example.



[June 2011 addendum: my relative, after much suffering, has now died of complications of the "anecdotal HIT mishap" - ed.]



As for myself, I am a Markopolist (see my Sept. 2010 post "Health IT: On Anecdotalism and Totalitarianism").



-- SS

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Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT

I am both surprised and pleased to read the new report of an American Medical Informatics Association (AMIA) task force, in the form of an AMIA Board Position Paper released today entitled:

"Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force." Goodman, Berner, Dente, Kaplan, Koppel et al. for the AMIA Board of Directors. J Am Med Inform Assoc (2010). doi:10.1136/jamia.2010.008946.

A free PDF is available at this link.

This report may be part of a trend. As I wrote recently at this link:

I was somewhat taken aback by the appearance of the article by Karsh et al. entitled "Health information technology: fallacies and sober realities" (covered at Healthcare Renewal here) in the Oct. 2010 Journal of the American Medical Informatics Association (JAMIA).

I was taken aback since the article rains heavily on the academic memes of healthcare IT as a benign and deterministic solution to healthcare's ills, and of health IT-related adverse outcomes being mere "anecdotes."

It appears that the views on healthcare IT safety, ethics, management practices, etc. appearing on the Healthcare Renewal blog and on my once-controversial academic health IT website "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" (started in 1999) are now becoming mainstream.

Most of the issues in this new AMIA Position Paper have been written about at this blog since 2004, and at my aforementioned academic HIT website since 1999. I will reproduce the abstract of the paper below, but download and read the entire paper (emphases mine):

ABSTRACT
The current commercial health information technology (HIT) arena encompasses a number of competing firms that provide electronic health applications to hospitals, clinical practices, and other healthcare-related entities. Such applications collect, store, and analyze patient information. Some vendors incorporate contract language whereby purchasers of HIT systems, such as hospitals and clinics, must indemnify vendors for malpractice or personal injury claims, even if those events are not caused or fostered by the purchasers. Some vendors require contract clauses that force HIT system purchasers to adopt vendor-defined policies that prevent the disclosure of errors, bugs, design flaws, and other HIT-software-related hazards. [The "gag clauses." These are exceptionally unethical, in my view, regarding the use of an experimental technology, healthcare IT, on unsuspecting, unconsented patients unaware of health IT risks - ed.] To address this issue, the AMIA Board of Directors appointed a Task Force to provide an analysis and insights. Task Force findings and recommendations include: patient safety should trump all other values [I've been writing and saying this for many years now - ed.]; corporate concerns about liability and intellectual property ownership may be valid but should not over-ride all other considerations; transparency and a commitment to patient safety should govern vendor contracts; institutions are duty-bound to provide ethics education to purchasers and users, and should commit publicly to standards of corporate conduct; and vendors, system purchasers, and users should encourage and assist in each others’ efforts to adopt best practices. Finally, the HIT community should re-examine whether and how regulation of electronic health applications could foster improved care, public health, and patient safety. [Regulation has been another issue I have focused upon, especially after holding a management role in Big Pharma - ed.]

Also notable was this proclamation:

... “Hold harmless” clauses in contracts between Electronic Health Application vendors and purchasers or clinical users, if and when they absolve the vendors of responsibility for errors or defects in their software, are unethical. [I note that, somewhat remarkably, this is not the more typical hedged academic "may be unethical" statement- ed.] Some of these clauses have stated in the past that HIT vendors are not responsible for errors or defects, even after vendors have been informed of problems.

Unethical, indeed, as per my JAMA letter of July 22, 2009 on that issue entitled "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" (link) and per my more detailed essay at my Drexel HIT website (link).

Also remarkable were these statements:

... For-profit manufacturers of healthcare products are bound by values which may at times conflict. For instance, as entities in a marketplace, they are duty-bound to provide a financial return to those investors who have contributed resources in anticipation of their success. Yet, as developers and manufacturers of products that affect the health of people, they are no less obligated to ensure, to the extent possible, that their products are safe and effective, and beneficially support patients [that goes without saying - ed.] and those who treat and care for them. [That is, clinicians, who through their unpaid hard work using oft ill-designed HIT systems are currently used as beta testers and, through 'hold harmless' clauses, as an insurance company and, quite frankly, as cannon fodder - ed.]

... Contracts should require that system defects, software deficiencies, and implementation practices that threaten patient safety should be reported, and information about them be made available to others, as appropriate. Vendors and their customers, including users, should report and make available salient information about threats to patient safety [I've also been writing this for years; it's common sense - ed.] resulting from software deficiencies, implementation errors, and other causes. This should be done in a way easily accessible to customers and to potential customers. This information, when provided to customers, should be coupled with applicable suggested fixes, and should not be used to penalize those making the information available. [There should be as little fear of reporting HIT problems as in reporting medication problems - ed.]

... If appropriate for their size and mission, vendors and client institutions contribute to the growth of biomedical knowledge by conducting HIT research [including research on how to remediate the HIT itself and the IT industry creeds, customs and traditions that cause suboptimal design and implementation in the first place - ed.] … authors of scientific reports should not be prevented from identifying devices, tools, and systems by name in publications.

… There are situations in which HIT vendors pursue joint marketing agreements with institutions that adopt vendors’ products and by which these institutions become a part of the vendors’ marketing program [I believe that hospitals should never allow themselves to become IT marketing and promotion operations - ed.], often in exchange for discounts, payments, stock options, or favorable treatment by the vendor. In at least some cases, these agreements include provisions whereby healthcare institutions that serve as demonstration sites for particular products receive compensation when other institutions adopt products from the same vendor. The Task Force notes that such agreements might place the “referring” institutions in a conflict of interest [a common topic on this blog -ed.], and therefore recommends that:

• Any such conflicts should be eliminated or managed, including disclosure, according to current standards.

• Where such agreements are made, they should include a provision whereby any payment or other compensation contingent on the sale of a system to another party must be disclosed to that other party.

• Payments or gifts to individuals and institutions, including institutional officials, clinicians, etc, should be disclosed. Alternatively, they should be addressed by entities’ internal mechanisms for managing conflicts of interest and commitment, perhaps along the lines of the “rebuttable presumption” standard endorsed by the Association of American Medical Colleges. The goal of the standard is “to ensure that institutions systematically review any financial interest that might give rise to the perception of a conflict of interest, and further, that they limit the conduct of human subjects research by financially interested individuals to those situations in which the circumstances are compelling.

The new AMIA Position Paper and the aforementioned paper on HIT fallacies and realities seem to reflect a welcome transformation or even about-face for AMIA. I am likely considered "radioactive" by some in that organization for espousing similar views dating back to the late 1990's, when expression of such views was uncommon and even frowned upon. Academia has not been highly tolerant of heterodoxy in many domains for quite some time.

One wonders if that stigma will "stick" in view of the increasing realization that such views were not heretical, but forward-thinking along the lines of my early medical mentor, the late Victor P. Satinsky, MD of Hahnemann Medical College and Hospital:

From http://www.upenn.edu/gazette/0298/0298obits.html: Dr. Victor P. Satinsky, C'34, Philadelphia, a cardiovascular surgeon at the old Hahnemann Hospital who helped develop coronary-bypass surgery; September 7 [1997]. He is also credited with 30 major medical innovations and the invention of the Satinsky clamp, now a standard instrument in cardiovascular surgery. He joined Hahnemann (now part of the Allegheny health system [as of 2010 now Drexel College of Medicine - ed.]) in 1946 to do thoracic-surgical research, and from 1961 till his retirement in 1977 he was the research director of its cardiovascular institute. Dr. Satinsky liked to refer to himself on promotional materials as 'the Renaissance Doctor', as he was also a poet, a playwright (some of his plays were produced in London), a painter, a clarinetist, and a fencer; he was known at Hahnemann for practicing his swordsmanship in the halls and classrooms of the hospital. And at the age of 80, he earned a black belt in aikido, and subsequently taught it. Although he had no religious training, during the Second World War he once filled in as a rabbi on a troopship going to Europe when he learned it had chaplains, but no rabbi. He also had taught himself psychiatry and while at Hahnemann developed educational programs for young people; the first, for gifted high-school students, began in 1961. He later added programs for disadvantaged youth, for young people with emotional problems, and one for college dropouts. On retiring, he set up the Satinsky Institute for Human Resource Development to continue this work, which he ran until his death at 84 years.

Dr. Satinsky's short, simple and unyielding credo was:

"Critical thinking always, or your patient's dead."

-- SS

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On AMIA's Jan. 2009 Letter to The Office of President Elect Barack Obama: Something is Missing

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Nov. 11, 2010 note: see the new post on an AMIA Board Position Paper released this day (Nov. 11) entitled "Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT" at this link.
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I was somewhat taken aback by the appearance of the article by Karsh et al. entitled "Health information technology: fallacies and sober realities" (covered at Healthcare Renewal here) in the Oct. 2010 Journal of the American Medical Informatics Association (JAMIA).

I was taken aback since the article rains heavily on the academic memes of healthcare IT as a benign and deterministic solution to healthcare's ills, and of health IT-related adverse outcomes being mere "anecdotes."

(It is ironic that my own relative recently fell victim to healthcare IT's supposed beneficence. They were harmed via health IT-related disruptions in care continuity.)

My blog posting on that Karsh article brought a letter to my attention, authored by AMIA's leadership and sent on Jan. 7, 2009 to the Office of President Elect Barack Obama. The full PDF of the letter is here.

Here are relevant excerpts about which I will make only a single comment:

January 7, 2009

Dear Mr. President-Elect,

On behalf of the more than 4,000 physicians, nurses and other members of the American Medical Informatics Association (AMIA) who use health information and communications technology (HIT) to improve the quality, efficiency and safety of healthcare, I am writing to applaud and encourage your commitment to investing in a genuine transformation of our nation’s healthcare system. Properly deployed and supported, HIT can be part of broad health care reform and, importantly in this time of economic challenge, a significant economic multiplier that will encourage the creation of new jobs and real improvements in patient care, public health and life sciences research.

... If we are to develop a national infrastructure for the use of health information to benefit individuals and our entire population, the United States must –

• Develop mechanisms, including grants, loans and financial incentives for physicians, nurses, and healthcare organizations to deploy, implement successfully, and widely disseminate electronic health records (EHRs);
• Develop and support local, regional and national health information exchange to ensure that accurate, secure health information is available whenever and wherever needed by those authorized to access such information;
• Develop and support programs to address the need for a prepared health information technology workforce, with training and continuing education of physicians, nurses, health information managers and others;
• Develop more effective ways to address the health needs of underserved populations, including providing equitable access to health information and communications technology;
• Develop and assure compliance with standards, policies and practices that support effective sharing of health information, while fostering security, confidentiality and transparency, and building trust with the public;
• Develop and maintain health terminologies and classifications that will allow health data to be not only useful, but uniform and consistent, and enable interoperability across myriad information systems;
• Develop proper means to link information related to individuals in order to ensure the validity and integrity of health data used to inform care and research;
• Develop proper means for authentication of the identity of individuals and caregivers and any others authorized to access identifiable health information;
• Support the development of decision-making and other knowledge-management tools in order to permit the delivery of individualized, evidence-based care;
• Develop and support secure web-portals to link individuals to their caregivers and ensure genuinely patient-centered care;
• Develop appropriate and secure linkages between EHRs and the public health system to ensure safety from bioterrorism, rapidly spreading infectious diseases, and other threats;
• And provide appropriate funding for the development of a robust national health information strategy, with support for continued HIT and informatics research and innovation.

During the Presidential campaign, you demonstrated your boldness and vision by pledging to allocate $10 billion annually for five years to promote the adoption and use of health IT. Such an investment will pay dividends not only in improving health care, but in creating jobs...

These are all laudable and interesting goals for an experimental technology, as tacitly admitted in the above goals (although it would have been more ethical, I believe, to have waited for the technology to have "needed" fewer of these goals as a result of research in constrained settings before boldly promoting expensive national rollouts on live patients).

In any case, however, something very, very important is missing...

There is no mention of healthcare IT safety.

At $10 billion annually, surely the AMIA leadership could have specifically and explicitly recommended that some fraction, even a token % (even a small percentage of $10,000,000,000 is not chicken feed), should have been dedicated to help ensure the disruptions and unintended consequences caused by any new/developing/expanding information and communications technology (ICT) didn't kill or maim patients.

Perhaps through the publication of the aforementioned Karsh study on HIT fallacies and sober realities, the AMIA leadership is subconsciously seeking absolution.

-- SS

Addendum: my own Dec. 7, 2008 "Open letter to President Obama" on healthcare IT took a decidedly different approach, namely, I attempted to make the President-elect aware of numerous HIT "fallacies and sober realities":

... our government has been seduced by the promise, the potential, the Siren Song if you will of HIT, and shielded from information on its true challenges, difficulties, downsides and failures. An "irrational exuberance", a Syndrome of Inappropriate and Uninformed Overconfidence in Computers prevails in healthcare.

... [If HIT itself is not reformed,] billions of precious healthcare dollars that might be spent on “IT misadventure” in a time of unprecedented national financial challenges and hardships might simply be better spent on delivery of needed medical services, health insurance and other "safety net" interventions.

... healthcare’s defects cannot be effectively changed or reformed via healthcare IT, if that healthcare IT itself is defective.

AMIA leadership and I also differed on the issue of health IT regulation, as I posted in July 2009 at "JAMA letter: Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards." On that issue, JAMA published my commentary, not theirs.

-- SS

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