Ioannidis et al.: What Happens When Underperforming Big Ideas in Research [such as Healthcare IT Exceptionalism] Become Entrenched?

Some years ago, John P. A. Ioannidis, MD wrote this piece:

"Why Most Published Research Findings Are False", John P. A. Ioannidis, PLoS medicine, 2005 August; 2(8): e124

He wrote:

There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.

In other words, in the all-too-common insufficiently powered studies, and even seemingly robust studies in domains with small effect sizes, financial interests, prejudices and other factors more often than not produce false results.

Ioannidis and co-authors recently took their sword to "underperforming Big Ideas in research" (including the "miracles" touted by hyper-enthusiasts such as in genomics and in cybernetics), via a new JAMA viewpoint piece:

What Happens When Underperforming Big Ideas in Research Become Entrenched?
Michael J. Joyner, MD1; Nigel Paneth, MD, MPH2; John P. A. Ioannidis, MD, DSc3
JAMA. Published online July 28, 2016. doi:10.1001/jama.2016.11076
http://jama.jamanetwork.com/article.aspx?articleid=2541515

For several decades now the biomedical research community has pursued a narrative positing that a combination of ever-deeper knowledge of subcellular biology, especially genetics, coupled with information technology will lead to transformative improvements in health care and human health. In this Viewpoint, we provide evidence for the extraordinary dominance of this narrative in biomedical funding and journal publications; discuss several prominent themes embedded in the narrative to show that this approach has largely failed; and propose a wholesale reevaluation of the way forward in biomedical research.

The key word is "narrative."   As per Hayek, those with little real-world operational experience, i.e., intellectuals and academics, often the uncritical cheerleaders for electronic records despite considerable downsides, have only the "narrative" upon which they base their beliefs in healthcare IT exceptionalism:

It is perhaps the most characteristic feature of the intellectual that he judges new ideas not by their specific merits but by the readiness with which they fit into his general conceptions, into the picture of the world which he regards as modern or advanced. . . . As he knows little about particular issues, his criterion must be consistency with his other views and suitability for combining into a coherent picture of the world. . . . It is the intellectuals in this sense who decide what views and opinions are to reach us, which facts are important enough to be told to us, and in what form and from what angle they are to be presented. Whether we shall ever learn of the results of the work of the expert and the original thinker depends mainly on their decision.

(I can add that blogs have to some small degree ameloriated "whether we shall ever learn of the results of the work of the expert and the original thinker", but only to a small degree.)

The "general conception" in cybernetics is that computers are a silver bullet in any domain, and can only result in massive improvements. 

My experience for the past twenty+ years in the Electronic Medical Records/clinical information technology domain, where quality, safety, usability, confidentiality, and other critical real-world issues have been ignored in favor of EHR hyper-enthusiasm, supports Hayek's observations regarding prevalent unfettered beliefs in healthcare IT exceptionalism.

Ioannidis et al. state the factual situation with EHR technology unapologetically, clearly and succinctly:

... The financial and clinical benefits predicted from shifting to EHRs have also largely failed to materialize because of difficulties in interoperability, poor quality, and accuracy of the collected information; cost overruns associated with installation and operation of EHRs at many institutions; and ongoing privacy and security concerns that further increase operational costs.

I would change "interoperability" to "operability."  Otherwise, they're quite correct.  For example, the "Big Data" hyper-enthusiasts quite irrationally believe data from these systems - as they are today -  will somehow "revolutionize" medicine, while at the very same time the IT industry itself and its pundits ignore fundamental precepts of computer science, information science, biomedical informatics, biomedicine and biomedical research itself. 

Some of the hyper-enthusiasts have made predictions that are astonishingly naive, delusionally grandiose and just plain perverse, e.g., see for instance my Jan. 2014 post "Computers + a few docs can manage 'an entire city', and other cybernetic miracles" at http://hcrenewal.blogspot.com/2014/01/computers-few-docs-can-manage-entire.html . 

The new JAMA paper continues:

... These features make the use of EHRs for research into the origins of disease, as proposed in the Precision Medicine Initiative, highly problematic.No clearly specified targets for either improved outcomes or reduced costs have been developed to assess the performance efficiency of EHRs.

Those targets were never specified, but The Market seems to have corrected for that, e.g., via this Jan. 2015 letter from ~40 different medical societies:

 Full letter to HHS available at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf

The authors continue:

... Although it is difficult to argue for a return to paper records, any claim of future transformation of the medical record should include well-defined accountability and review mechanisms. Otherwise, the health care system may become hostage, wasting increasing resources to continuously upgrade electronic technology without really helping patients.

It is clear to me that the health care system and its clinicians are already hostage to the cybernetic hyper-enthusiasts, as evidenced by letters such as the above and many other sources about the mayhem being caused, e.g., a small sampling on this blog at query links http://hcrenewal.blogspot.com/search/label/glitch, http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20difficulties and http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality.

Finally, I disagree with the authors that "it is difficult to argue for a return to paper records."

Paper has its proper place, and "paperless" is a utopian dream of the hyper-enthusiasts that causes significant damage to the primary role of clinicians - to take care of patients.  I make this argument (with a real-world, highly successful example of my own creation) at my Aug. 9, 2016 post "More on uncoupling clinicians from EHR clerical oppression" at http://hcrenewal.blogspot.com/2016/08/more-on-uncoupling-clinicians-from-ehr_91.html.

In summary, the authors of this JAMA piece clearly and succinctly break through the "narrative" about hyper-enthusiast dominated fields, including clinical information technology and the belief in 
healthcare IT exceptionalism.
 
Sadly, theirs is almost a single voice in a wilderness dominated by the hyper-enthusiasts - and the profiteers.

-- SS

Transparency International Asks Health Care Professionals About Health Care Corruption

Transparency International, the global NGO that studies and fights corruption, seeks information from health care professionals about health care corruption.  The details are in the official announcement below.  If you are a health care professional, please consider responding to this survey. 

Invitation to participate in a corruption in healthcare survey
Transparency International’s health programme has commenced a new research project to identify the major types of corruption in the health sector. We feel that this research piece will contribute to understanding the corruption vulnerabilities in the health sector and ultimately improve the availability and use of health information to hold governments accountable.

This will feed into the World Health Summit in October, where Transparency International has been invited to run the opening session. We'll also be displaying results from the research on our website and will feature interviews with people about their experiences.

As part of our research, we're keen to hear from as many healthcare professionals as possible. This is to enable us to hear about your experiences of corruption and what you consider corruption to be.

At this stage, we do not want to influence your thoughts - more capture them. A survey has gone online and we would be grateful if you could fill it in and distribute to your peers. 

The survey contains ten questions and can be completed in ten minutes. The survey will run until the end of September.

Given the sensitivity of the subject, the survey is anonymous unless you would like to talk to someone about your experience. At the end of the survey there is an option to leave your contact details.

We're looking forward to hearing your thoughts.

Best wishes,

Michael

Michael Petkov
Programme Officer
Pharmaceuticals & Healthcare Programme
Transparency International UK
michael dot petkov at transparency dot org dot uk

The link to the survey is here.

How the System is Rigged - Johnson and Johnson Board Member Pretends to be Independent Brookings Institution Scholar

Fears that "the system is rigged" may cause the lack of trust marring this year's political season. These fears are not baseless.

Dr McClellan of the Brookings Institution on Drug Prices

A recent series in the New York Times focused on the biases of the think tank "independent scholars" whose work is used to justify much policy making.  An article entitled "Think Tank Scholar or Corporate Consultant? - It Depends on the Day" actually provided a health care example that was much worse than what the title implied.

It noted that

Dr. McClellan, a former commissioner at the Food and Drug Administration who until January was a senior fellow at Brookings, has been a go-to expert for the federal government as it debates how to cope with surging costs of prescription drugs.

In particular, Dr McClellan has opined on the increasingly recognized problem of ever-rising drug prices, and on one class of drugs that we have discussed on Health Care Renewal.

At public events, Dr. McClellan emphasized the extraordinary progress by the pharmaceutical industry in coming up with treatments for diseases like diabetes, H.I.V. and hepatitis C.

'Lots of diseases have been transformed,' Dr. McClellan said at a hearing in November sponsored by the Department of Health and Human Services. He ran through a series of slides prominently stamped with Brookings’s name. He also argued that even though these drugs were very expensive, they were worth it given the improvement in a patient’s quality of life.

'They are, over all, a pretty good deal,' Dr. McClellan said, referring to treatments for hepatitis C. One such drug, manufactured by Johnson & Johnson, generated $2.3 billion in sales in its first full year, representing about 7 percent of the company’s overall drug sales in 2014. The pills cost $66,000 for a standard 12-week regimen.

Little Evidence that New Drugs for Hepatitis C Represent "Extraordinary Progress?"


Note that despite Dr McClellan's enthusiasm, there is no good data from clinical trials that show that the new drugs for hepatitis C have long-term clinical benefits.  As we wrote here last month....

In fact, starting in March, 2014, we have posted about the lack of good evidence from clinical research suggesting these drugs are in fact so wondrous.  The drugs are now touted as "cures," at least by the drug companies, (look here), and physicians are urged to do widespread screening to find patients with asymptomatic hepatitis C so they can benefit from early, albeit expensive treatment.

However, as we pointed out (e.g., here and here)
-  The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.
-  There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
-  There is no clear evidence that "sustained virologic response," (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure. 
-  While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.

Furthermore, health care professionals and researchers with heftier credentials in clinical epidemiology and evidence based medicine than mine have since published similar concerns.  These included
- a report from the German Institute for Quality and Efficiency in Health Care (the English summary is here)
- an article in JAMA Internal Medicine from the Institute for Clinical and Economic Review (1)
- a report from the Center for Evidence-Based Policy (link here)
- an article in Prescrire International (2)

These publications and your humble scribe noted that the clinical trials or other types of clinical research about new hepatitis C treatment published in the most prominent journals had numerous methodologic problems that all seemed likely to make the new drugs look better, perhaps intentionally.  (See posts here,  here, and here.)

In July, 2016 we had written about the enthusiasm for these drugs expressed by Mr Bill Gates, chairman of the Gates Foundation.  Maybe one can somewhat excuse Mr Gates, who is hardly a clinical research expert, for this unjustified enthusiasm.  (Although maybe someone at his foundation, given its emphasis on global health, should have briefed him to the contrary.)

Why Was Dr McClellan So Unjustifiably Enthused?

Give Dr McClellan's background, why was he not more skeptical about the the supposed miraculous properties of hepatitis C drugs?.  His biography, provided for the US Department of Health and Human Services Pharmaceutical Forum, suggested he ought to know something about clinical research.  It stated,  

Mark McClellan, MD, PhD, is a senior fellow and director of the Health Care Innovation and Value Initiative at the Brookings Institution. Within Brookings, his work focuses on promoting quality and value in patient centered health care, and he leads the Richard Merkin Initiative for Payment Reform and Clinical Leadership.

A doctor and economist by training, he also has a highly distinguished record in public service and in academic research. Dr. McClellan is a former administrator of the Centers for Medicare & Medicaid Services (CMS) and former commissioner of the U.S. Food and Drug Administration (FDA), where he developed and implemented major reforms in health policy. These include the Medicare prescription drug benefit, the FDA’s Critical Path Initiative, and public-private initiatives to develop better information on the quality and cost of care. Dr. McClellan chairs the FDA’s Reagan-Udall Foundation, is co-chair of the Quality Alliance Steering Committee, sits on the National Quality Forum’s Board of Directors, is a member of the Institute of Medicine, and is a research associate at the National Bureau of Economic Research. He previously served as a member of the President’s Council of Economic Advisers and senior director for health care policy at the White House, and was an associate professor of economics and medicine at Stanford University.

From time to time, McClellan advises U.S. government officials on health care policy issues. In his capacity as a health policy expert, he is the co-director of the Bipartisan Policy Center’s Leaders’ Project on the State of American Health Care; co-chair of the Robert Wood Johnson Foundation Commission to Build a Healthier America; and chair of the FDA’s Reagan-Udall Foundation. McClellan is also co-chair of the Quality Alliance Steering Committee, sits on the National Quality Forum’s Board of Directors, is a member of the Institute of Medicine of the National Academy of Sciences, and is a research associate at the National Bureau of Economic Research.

McClellan holds an MD from the Harvard University–Massachusetts Institute of Technology (MIT) Division of Health Sciences and Technology, a PhD in economics from MIT, an MPA from Harvard University, and a BA from the University of Texas at Austin. He completed his residency training in internal medicine at Boston’s Brigham and Women's Hospital, is board-certified in Internal Medicine, and has been a practicing internist during his career.

However, that biography left out one important item.  Per the NY Times article,

There was no mention in a video of the event that Dr. McClellan joined Johnson & Johnson’s board of directors in October 2013, or that he earned nearly $530,000 over the past two years in overall compensation from the company. That is in addition to his salary at Brookings, where he is one of the top-paid scholars, with $353,145 in wages and other compensation from the think tank in 2014, tax records show.

I suspect that most attendees at the conference had not read our 2013 post on Health Care Renewal that noted Dr McClellan's transit through the revolving door that ended up with his position on the Johnson & Johnson board.

Dr McClellan's Chronic Failure to Disclose His Johnson and Johnson Board Membership

Despite the fact that Dr McClellan's position on the Johnson & Johnson board of directors is public, as are the identities of all the members of US publicly held corporations, Dr McClellan has seemingly made a point of avoiding its mention when he assumes the persona of health care policy expert.

For example, he did not disclose it in some recent publications on aspects of health policy that likely would relate to Johnson & Johnson's interests.  These included:
- a 2014 Brookings report entitled "Improving Health Care While Reducing Cost Growth: What is Possible?"(3) in which he is only described as "Director, Health Care Innovation and Value Initiative, Senior Fellow, Economic Studies; The Brookings Institution."
- a 2014 article on "Health Reform and Physician-Led Accountable Care" in JAMA(4) which simply noted Dr McClellan came from the Brooking Institution, and which contained the assurance that all authors completed "the ICMJE Forum for Disclosure of Potential Conflicts of Interest and none were reported."
- a 2015 article on increasing "pharmaceutical innovation" in Health Affairs(5) which similarly only described Dr McClellan as "senior fellow and director of the Health Care Innovation and Value Initiative at the Engelberg Center for Health Care Reform at Brookings."

Furthermore, Dr McClellan's new employer, Duke University, currently provides a biography which also omits any mention of his position on the Johnson & Johnson board.

Dr McClellan Denies any Conflict of Interest

The NY Times article suggested that Dr McClellan may think his position at Johnson & Johnson is irrelevant to his day job as health policy expert.

Dr. McClellan, in a statement, disputed any suggestion that he might have had a conflict.

'My entire career in academics, government and public policy has focused on evidence-based ways to improve health and restrain costs for consumers, and my extensive track record speaks for itself,' he said.

I suppose that Dr McClellan might have justified his failure to disclose his membership on the Johnson & Johnson board of directors by his perception that this membership caused no conflict of interest.

How Board Membership May Cause Severe Conflicts of Interest

I will omit detailed discussion of all the evidence that even receiving small gifts may affect thinking and actions through the social obligation to reciprocate.  Yet Dr McClellan did not just receive small gifts.  He is a member of a corporate board of directors.

 In 2006, we first noticed that leaders of academic medicine also were serving as board members of large for-profit health care corporations.  The first example we discussed was that of Marye Anne Fox, Chancellor (equivalent to president) of the University of California - San Diego, and hence the person to whom the University of California, San Diego School of Medicine and its academic medical center report. The conflict was between this position, and her service as a member of the board of directors of Boston Scientific, a medical device manufacture, and the board of directors of Pharmaceutical Product Development Inc., a contract research organization.

Later that year, we discussed a "new species of conflict of interest."  At that time we wrote:

Medical schools and their academic medical centers and teaching hospitals must deal with all sorts of health care companies, drug and device manufacturers, information technology venders, managed care organizations and health insurers, etc, in the course of fulfilling their patient care, teaching, and research missions. Thus, it seems that service on the board of directors of a such public for-profit health care company would generate a severe conflict for an academic health care leader, because such service entails a fiduciary duty to uphold the interests of the company and its stockholders. Such a duty ought on its face to have a much more important effect on thinking and decision making than receiving a gift, or even being paid for research or consulting services. Furthermore, the financial rewards for service on a company board, which usually include directors' fees and stock options, are comparable to the most highly paid consulting positions. What supports the interests of the company, however, may not always be good for the medical school, academic medical center or teaching hospital.

As Robert AG Monks put it, board members must "demonstrate unyielding loyalty to the company's shareholders" [Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]  (Of course, after the global financial collapse of 2008 made us sadder and a little wiser, we realized that many board members actually seem to have unyielding loyalty to their cronies among top management.)  However, in any case, the stated or actual interests of a member of the board of a health care corporation, like a pharmaceutical company or medical device company, could be very different and at odds with the mission of not only academic medical institutions, but of think-tanks professing to provide unbiased policy relevant research.

Presumably, were Dr McClellan in a situation in which he had an opportunity to promote Johnson & Johnson's interests, such as speaking at an influential conference about drug prices, and failed to uphold the company's interests, stockholders could consider legal action against him for failing in his fiduciary responsibilities.  Thus the mind boggles at how Dr McClellan could believe that his role as a corporate director does not pose a conflict of interest for him in his better publicized role as think tank and now academic health care policy expert.

Discussion

It is hardly news that US health care is broadly dysfunctional, that it suffers from ever rising costs, and questionable quality, while access has only somewhat improved after the 2009 Affordable Care Act.  The big question is why these problems seem so intractable.

Our latest case illustrates that the problem may be that health policy making is dominated by people with conflicts of interest.  In the current case, one of the more influential voices on health care policy turns out not to have just a garden variety conflict of interest.  He actually has a duty to uphold the corporate interests of one of the biggest US drug, biotechnology and device companies.  Could one really expect such a man would have a serious interest in controlling health care costs, especially those driven by the prices charged by drug, biotechnology, and device makers?

A system in which the top "independent" health policy experts may have conflicts of interest, may even be members of boards of directors of health care corporations, certainly suggests a system that has been rigged. 

As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  Furthermore, this web is now strong enough to have effectively transformed US health care into an oligarchy or plutocracy.  Health care is effectively run by a relatively small group of people, mainly professional managers plus a few (lapsed?) health care professionals, who simultaneously run or influence multiple corporations and organizations.

For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. Health care professionals who care for patients, those who teach about medicine and health care, clinical researchers, and those who make medical and health care policy should do so free from conflicts of interest that might inhibit their abilities to put patients and the public's health first.

Health care professionals ought to make it their highest priority to ensure that the organizations for which they work, or with which they interact also put patients' and the public's health ahead of private gain, especially the private gain of the organizations' leaders and their cronies.


 References

1. Ollendorf DA, Tice JA et al. The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection. JAMA Intern Med 2014;174(7):1170-1171. Link here.
2. Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete. Prescrire Int 2015; 24: 5- 10. Link here.
3.  McClellan M, Rivlin AM. Improving Health Care While Reducing Cost Growth: What is Possible?
Engelberg Center for Health Care Reform at Brooking; 2015.  Link here.
4.  Mostashari F, Sanghavi D, McClellan M. Health reform and physician-led accountable care: the paradox of primary care physician leadership. JAMA 2015; 311: 1855-56.  Link here.
 4.  Daniel GW, Caze A, Romine MH, Audibert C, Leff JS, McClellan M. Improving pharmaceutical innovation by building a more comprehensive database on drug development and use.  Health Aff 2015; 34: 319-327.  Link here.

More on uncoupling clinicians from EHR clerical oppression

At my August 6, 2016 post (link) I wrote of my belief that "best practices" for EHR evolution call for:

... a return to paper (specialized forms depending on the setting) for clinical data capture by busy doctors and nurses, and data entry into a computer via clerical personnel.

I presented a late 1990's real-world experiment in creating such a system for invasive cardiology in the Delaware hospital system, Christiana Care Health System, where I was CMIO at that time.

As at the links http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story and https://web.archive.org/web/20140316024627/http://cci.drexel.edu/faculty/ssilverstein/scotsilv/invascard.htm (the latter a May 2002 article in the journal "Advance for Health Information Executives" written by myself and the project executive sponsor at the time), the "experiment" was a deliberate move away from the "doctors as clerical employees" article-of-faith of the health IT enthusiasts.

Enthusiasts seem to ignore the downsides and emphasize a (seemingly) sensible strong belief about efficiency, one of whose principles is that paper must be abolished in medicine.  Is work towards that end beneficial, or deleterious, to the clinical mission?

In fact, an attempt to implement such a paperless system, "Apollo" as the commercial system was known, in a cath lab performing 6,000 procedures/year proved impossible.  The busy clinicians, doctors, nurses and technicians simply did not have enough time to enter data directly into a computer.  Maneuvering around a computer application, dealing with its designber-centric menus, drop-downs, icons, widgets, annoying messages, input limitations, outright crashes with data loss, etc. was both inappropriate, and in fact impossible, in such a setting.

In 2016, one of the largest complaints of hundreds of thousands of U.S. physicians and nurses is that they spend more time interacting with the computer than with patients.  Patients complain they cannot get eye contact from clinicians - who are tethered to a computer screen entering data - during "live" encounters.

It is my belief there is no solution to this problem other than, where appropriate and advantageous, decoupling clinicians from data input and returning to paper for data entry, that is, specialized forms as in the aforementioned post.  Data input needs to be returned to clerical personnel as in the aforementioned invasive cardiology system.

The output side (with, of course, significant user-centered redesign) can remain computerized; as long as the paper forms are also made available via document imaging.

The forms for invasive cardiology looked like this, and were subject to revisions as needed.

Physician's data collection form, side 1.  Click to enlarge.

Physician's data collection form, side 2

Cath technician/nurse's data collection form, side 1

Cath technician/nurse's data collection form, side 2

The EHR itself was freed from "legacy" limitations regarding rapid customization, essential in medicine.  It was designed with the ability to rapidly incorporate changes and modifications to the dataset as needed, matching the changes to the forms.

Below I am showing some of the reports that this system produced regularly, as designed by the team of programmers, executives and cardiologists, under my medical informatics leadership. I used to do "real" informatics, e.g., leading the data modeling of entire clinical subspecialty domains and developing advanced IT based on those models, until seeing that the commercial sector was damaging the field of HIT, and medicine itself, with horribly bad health IT leading to letters such as the January 21, 2015 letter to HHS at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf.  It was then, in the early 2000s, that I turned my attention to writing about the industry's deficits.

The major advantage of the cardiology reports shown below concerned accuracy, including the case report itself whose language and organization was also developed for optimal clinical organization and  readability -- unlike the reams of "legible gibberish" that emanates from commercial EHRs then and today.  See my post "Two weeks, two reams" at lhttp://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html for more on that issue.

Quality data input into the system, being freed from the accuracy-impairing aspects of busy clinicians as clerical employees, and the resultant reports saved the organization close to $1 million in the first year and led to a better understanding of what worked and what didn't in treating blocked coronary arteries.

Click to enlarge:

Some statistical reports, and sample computer-generated case report front page

An evaluation of the project by the national organization, the Society for Cardiac Angiography and Interventions, was that the accomplishments were "exceptional."

All this was achieved without direct clinician data entry - and deliberately so due to the distractions of that process having failed in the same setting in prior organizational attempts, without medical informatics expertise.  Perhaps, more accurately, I should say "medical informatics expertise in someone who also thinks critically about all issues involved, including adverse effects, of IT."  Clinicians could supplement each section of the forms data if needed via dictation, which was directly transcribed by humans into the cardiology server.

"Clerical work for clerical employees, clinical work for clinicians" was the theme of the project.

Breaking from the belief that paper is to be abolished at all costs was the key to creating really useful and well-accepted health IT, even in this exceptionally busy critical care setting.  It was still being used over a decade later, ca. 2008 and may still be now.  I have not been back for a visit since then.

One argument might be made that hospitals cannot afford enough clerical employees to do all the data input.  I maintain that, with hospitals spending upwards of $100 million for EHRs, and with the data being used and sold profitably by a wide variety of stakeholders who contribute nothing for the medical data they obtain (EHR makers, insurers, regulators to name just a few), transcriptionists could be afforded.

Of course:

Physicians with simply too much free time on their hands - the majority, it might seem, based on the behavior of some of the EHR enthusiasts and government pundits - and who enjoy giving away the fruits of their labor for others' profits could still enter data directly into the computer.  If they want to.

I note that if physicians really were empowered, the current status quo of clinicians as (unpaid) data-input personnel for those who profit from the data likely would never have come to pass.

Entering orders would still be done by clinicians, although that process and the process of alerts and reminders also needs a major reworking, such as use of advanced NLP to allow a more natural input of orders.

In summary, in the late 1990s the mantras of eliminating paper from medicine, and of clinicians needing to perform clerical work, were challenged and shown to be injurious to health IT progress in a critical care setting, invasive cardiology.

The lessons learned are more valuable today as they were then, considering that the health IT "experiment" is facing significant opposition today, with significant clinician rancor.  The CEO of the American Medical Association perhaps summed it up best when he referred to HIT as "the digital snake oil of the early 21st century" as at http://www.ama-assn.org/ama/pub/news/news/2016/2016-06-11-a16-madara-address.page.

These are unfortunate and undesired positions for the AMA CEO, and for the aforementioned medical society leaders as expressed in the letter to HHS to express, but this development has its real-world reasons.

Correction calls for modifying/softening cybernetic-enthusiast ideas like "paperless" and a more appropriate allocation of computer-related tasks.  Refocusing on "Clerical work for clerical employees; clinical work for clinicians" would be a good start.

-- SS

Weird emails from Independence Blue Cross via its IT outsourcing partners: showing yet more health IT industry trust-destroying incompetence

In the past week I've received two emails that made me highly suspicious of medical/insurance identity theft.

The emails came from Independence Blue Cross, ibx.com, into the email account I receive normal mailings from them, and seemed to indicate someone had created an unauthorized user account (I redacted my email address below):

Aug. 5, 2016:

From: noreply@ibx.com
Date: Fri, Aug 5, 2016 at 7:19 PM
Subject: User Created
To: [my email address redacted]

User Created With UserId - userId20392, Password - password20392

July 27, 2016: 

From: noreply@ibx.com
Date: Wed, Jul 27, 2016 at 1:59 PM
Subject: User Created
To: [my email address redacted]

User Created With UserId - userId1546, Password - S04bd9u3tR

These userid's and passwords did not work at ibx.com's website, but my concern was that, if these were false accounts, the creator could have logged in and changed the password.

After the first email I left a message with the IBX fraud line, but heard nothing in response.

The metadata (IP headers) of the messages looked like this (I redacted my email address):

Delivered-To: [my email address redacted]
Received: by 10.237.44.68 with SMTP id f62csp1992388qtd;
        Fri, 5 Aug 2016 16:20:27 -0700 (PDT)
X-Received: by 10.36.77.145 with SMTP id l139mr7340323itb.19.1470439227798;
        Fri, 05 Aug 2016 16:20:27 -0700 (PDT)
Return-Path: 
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User Created With UserId - userId20392, Password - password20392

After the second, I called IBX.  I was told it is a "malfunction", that these emails were not anything nefarious, other subscribers were affected, and that it "would be corrected soon."

I had already looked up the "Received from" header cnxsgusgma01.cnxuat.com [216.183.110.200]:

# ARIN WHOIS data and services are subject to the Terms of Use
# available at: https://www.arin.net/whois_tou.html
#
# If you see inaccuracies in the results, please report at
# https://www.arin.net/public/whoisinaccuracy/index.xhtml
#
#
# The following results may also be obtained via:
# https://whois.arin.net/rest/nets;q=216.183.110.200?showDetails=true&showARIN=false&showNonArinTopLevelNet=false&ext=netref2
#

Connecture, Inc. INFLOW-7524-7780 (NET-216-183-110-192-1) 216.183.110.192 - 216.183.110.255
Inflow Inc. INFL-AR-1 (NET-216-183-96-0-1) 216.183.96.0 - 216.183.127.255

Other IP's in the header appear to be of local (internal) workstations at the companies involved.

Who are these mysterious companies from which these emails seem to have originated?


Connecture, Inc:

http://www.connecture.com/the-connecture-difference/

Health insurance has entered the consumer age. Be ready. (We are.)

While there is almost universal agreement that health insurance will predominantly be distributed online in the near future, few American consumers have yet to experience it. In fact, most Americans have very little experience shopping for health insurance at all – let alone while making sense of numerous and often deceptively similar plans.

All of that is changing. Reform, the health insurance industry’s efforts to become more efficient, and Americans’ affinity for doing business online are all converging in the form of health insurance exchanges that present users with unprecedented freedom of choice.

Choice, of course, leads to questions. Which plans does my doctor participate in? Do they address my health needs? What about my family and my children? What happens if I need to go to the emergency room? How much will it cost – not just this month but year round? Am I eligible for a subsidy, and if so how much? In short, what’s the best plan for me and my family?

In health insurance, there are no cookie-cutter answers. That’s why health insurance exchanges and online distribution systems must do far more than enable consumers to enroll for coverage.

That’s where we come in. For more than 15 years we’ve focused on a singular goal: To create online systems and exchanges that empower Americans to choose the right health insurance plan online with confidence the first time, and every time.

Inflow Inc.

http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=105889

As of January 4, 2005, Inflow, Inc. was acquired by SunGard Availability Services, Inc. Inflow, Inc. provides facilities-based information technology outsourcing solutions to companies with critical business and network applications. The company offers its services in three primary lines: application hosting and management, business continuance and disaster recovery, and enterprise data-center management. Its application hosting and management services include application hosting and colocation, multi homed internet access, security services, application and infrastructure management, and network and system development. The company’s business continuance and disaster recovery services consist of business continuance planning/consulting, managed storage services, and content distribution services. Inflow’s enterprise data-center management services comprise onsite data-center management, operational support system management, data-center development, data-center audit services, data-center migration assistance, and business process documentation. Inflow, Inc. was founded in 1997 and was based in Thornton, Colorado.

Emphases mine.

So, perhaps millions of Independence Blue Cross customers are receiving emails that would reasonably cause suspicion in this day and age for identity theft, from companies that gloriously promise:

To create online systems and exchanges that empower Americans to choose the right health insurance plan online with confidence the first time, and every time.

To provide facilities-based information technology outsourcing solutions to companies with critical business and network applications

Confidence is the last thing the emails I received on behalf of ibx.com inspire in me.

If this information is being spilled (to the subscriber's own email account, but who knows where else?), I can only fear that other information is not quite secure, and wonder if these "ghost accounts" are just a glitch, or insiders spying on PHI, or other effects of either massive bugs or hacker attacks.

IT companies and companies that outsource their critical IT to others (including health IT makers and health IT buyers such as hospitals) - and the IT service providers themselves - need to really, really get their houses in order.

They need to stop beta-testing buggy software upon their customers (or live patients in the case of clinical IT).

Problems like this reflect significant and trust-busting incompetence, at best.

-- SS

NIST workshop "The Role of Standards in Preventing & Mitigating Health IT Patient Safety Risks" perhaps should be titled "The Role of Common Sense in Preventing & Mitigating Health IT Patient Safety Risks Before Rolling Out Bad Health IT Nationally"

Ready, fire, aim.

As I wrote in 2010-12 at "Cart before the horse" posts at http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html and http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html, rolling out health IT nationally before having a firm grasp of its risks was an abrogation of medical ethics and long standing treatises on medical experimentation, including the need for informed consent, dating back to the post-WW2 period.

Ready, fire, aim:  let's roll out health IT nationally, then figure out how to make it safe...

Now we have this "workshop" to be held September 7, 2016:

http://www.nist.gov/healthcare/usability/the-role-of-standards-in-preventing-and-mitigating-health-it-patient-safety-risks-workshop.cfm

The Role of Standards in Preventing & Mitigating Health IT Patient Safety Risks

Purpose:
Health IT Community Technical Workshop for all Stakeholders: Learn and Share Industry Best Practices.

Objectives:
Bring together all Health IT stakeholders to share best practices and review the fundamentals of risk prevention and mitigation that apply to Health IT. Health IT standards are part of the foundation needed to deliver high quality, patient-centric care. The industry continues to gain a better understanding of the relationship between managing risk and providing quality care through the safe use of Health IT.

This forum is an opportunity to receive updates on the latest standards development process related to risk prevention and mitigation, quality assurance and safety-related usability, to find out about recent findings from studies conducted on this subject, and to bring industry stakeholders together to share best practice, and define the path forward for risk prevention and mitigation that apply to Health IT.

Agenda:
Final Agenda (http://www.nist.gov/healthcare/usability/upload/NIST-Workshop-Agenda-7_7_16.pdf)

This workshop is an admission that the industry lacked in understanding "of the relationship between managing risk and providing quality care through the safe use of Health IT" at a time when rollout of bad health IT was pushed like a Miracle Cure by government and industry pundits, and became a national mandate,

To all the boneheads who did push this technology out the door prematurely before its risks and safety were reasonably understood, and/or ignored the "iconoclasts" as they were derogatorily known, thanks for harassing doctors and nurses to the point of exhaustion, harming patients via cybernetic experimentation without consent, and wasting billions of dollars of taxpayer money.  (It would have been a very good thing, I note, if efforts like this had been mandated before my mother's demise of care continuity failure precipitated by bad health IT.)

NIST, this workshop is late, but better late than never.

However, I am increasingly of the belief that this technology is unsuitable for busy clinicians, as long as they bear the clerical burdens, and can never be fixed it that arrangement is not drastically changed.

"Best practices", I believe, call for a return to paper (specialized forms depending on the setting) for clinical data capture by busy doctors and nurses, and data entry into a computer via clerical personnel.

Why do I hold this belief?

I designed such a system for invasive cardiology (a highly complex, critical-care medical domain) 20 years ago that was highly successful and popular, even among busy invasive cardiologists, to replace a direct-computer-entry commercial product from hell.  This is written up at this link: http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story

After modeling the dataset for the domain of cardiac catheterization to a high degree of granularity, the forms were designed and tested collaboratively with the invasivist leaders, as seen below.

The physicians recorded real-time onto the forms, or shortly after they de-gloved.  There were also specialized forms for the cath lab technicians and nurses. Click to enlarge.  Each section could be supplemented via dictation if needed, and the text transcribed and sent to the application server for inclusion on the full cath report, via a direct link from central transcription.

No wasting of clinicians' valuable time and limited cognitive energy navigating lousy EHR user interfaces, interacting with a multitude of mind-numbing icons and widgets, and other frustrations looking to enter critical data.

Physician's data collection form, side 1.  Click to enlarge.

Physician's data collection form, side 2

Cath technician/nurse's data collection form, side 1

Cath technician/nurse's data collection form, side 2

Clerical employees were hired to perform data entry from the paper forms and inquire with the doctors when there were questions about data recorded during the cath.

Forms for less specialized medical domains would be significantly simpler.

Addendum:

Ca. 2007, (non-medical) Siemens Healthcare IT executives in Malvern, PA (a Siemens division now bought out by Cerner) were shown this project by me, still in use just a few miles south of them in Delaware, and deemed it "impractical" for commercialization.  I thought that very sadly ironic considering the incredible engineering prowess and accomplishments world-wide of parent company Siemens A.G.

In my direct first-hand experience, non-medical IT executives are one of the biggest impediments to health IT progress (and safety), in both hospitals and the pharmaceutical industry.

http://www.siemens.com/about/en/
About Siemens
Siemens is a global powerhouse focusing on the areas of electrification, automation and digitalization. One of the world’s largest producers of energy-efficient, resource-saving technologies, Siemens is a leading supplier of systems for power generation and transmission as well as medical diagnosis. In infrastructure and industry solutions the company plays a pioneering role. As of September 30, 2015, we had around 348,000 employees in more than 200 countries. In fiscal 2015, they generated revenues of €75.6 billion.

-- SS

A Tenet of Impunity - Tenet Settles Kickback Allegations for $514 Million, No Individual Suffers Any Negative Consequences

Tramp, tramp, tramp.  The march of legal settlements continues.  The latest entry is a corporation that has had a 20 plus year history of legal misadventures, allegations of unethical behavior, and actual crimes.  Here are the basics from the Atlanta Business Chronicle:

Tenet Healthcare Corp. (NYSE: THC) said Monday that it believes it has reached an agreement in principle with the government to resolve a long-running criminal investigation and civil litigation about a kick-back scandal involving an Atlanta medical clinic and three of the company's Atlanta-area hospitals.

Dallas-based Tenet said it has agreed to pay $514 million, has agreed to the appointment by the U.S. Department of Justice of a corporate monitor for a period of three years, and has agreed for two wholly owned subsidiaries that previously operated Atlanta Medical Center and North Fulton Hospital to each plead guilty to a single-count indictment.

In particular, regarding kickbacks,

The company's two subsidiaries will plead guilty to a single count of conspiracy to violate the federal anti-kickback statute and defraud the United States, Tenet reported.

Four hospitals owned by Tenet -- Atlanta Medical Center, North Fulton Hospital, Spalding Regional Medical Center and Hilton Head Hospital -- allegedly paid kickbacks to a Georgia company called Clinica de la Mama for Medicaid patient referrals. Clinica de la Mama operated medical clinics that provided prenatal care to predominantly undocumented Hispanic women in metro Atlanta and Hilton Head, S.C.

The contracts were in effect for various periods from 2000 to 2013 between the four hospitals.

Like many such settlements, this one evoked almost no media coverage, and what coverage there was appeared in the business, not health care news.  For example, the brief Wall Street Journal story focused almost entirely on the financial implications for Tenet of the settlement.  Thus the anechoic effect continues.  

Unpacking the Settlement

Bad Patient Care

First of all, the settlement included guilty pleas to charges of "conspiracy to violate the federal anti-kickback strategy."  The allegations were that the kickbacks were paid "for Medicaid patient referrals."  That means that Tenet was alleged to have paid the operator of medical clinics to send patients to Tenet hospitals.  This goes beyond financial crime.

Physicians swear oathes to put the care of individual patients ahead of all other concerns.  The new American Medical Association Principles of Medical Ethics states:

A physician shall, while caring for a patient, regard responsibility to the patient as paramount.

That means that decisions by physicians to refer patients to specific hospitals, specialists, etc should be based on what referrals would be best for individual patients, and certainly not on payments to the physicians by such hospitals, specialists, etc.  Kickbacks like those described above could send patients to hospitals that were not the most suitable for the patients' needs, thus potentially harming patients.  So this case raises big concerns about bad patient care, not merely unethical money transfers.

Yet in the minimal media coverage of the Tenet settlement, I see nothing about medical ethics, potential harms to patients, etc. 

Impunity

As is typical of such settlements, no individual who might have authorized, directed or implemented the kickbacks suffered any consequences.  While top managers of Tenet might have gotten even bigger bonuses because of the additional revenues supplied by the sorts of behavior discussed above, they  would suffer no financial penalties as a result of this settlement.  In fact, in 2015, the current Tenet CEO,  Mr. Trevor Fetter, who was an officer of the company in 2013, the last year kickbacks covered by the settlement ocurred, received total compensation of $15,354,283 according to the company's 2016 proxy statement.

Although in this settlement there were at least some corporate guilty pleas, allowing this case to be considered criminal, these pleas were not made by Tenet.  Instead they were by its subisidiaries.  This would allow Tenet itself  to avoid any non-financial penalties, such as being barred from participating in US government programs.  While the monetary size of the settlement appeared to be large, it was trivial compared to Tenet's annual earnings, which last year were over $18.6 billion according to Google Finance.

This settlement, like many others, included a corporate integrity agreement.  Such agreements, and conceptually similar deferred prosecution agreements, were heavily promoted, in part through the use of a logical fallacy, by then US Attorney, now Governor of New Jersey Chris Christie.  However, there seems to be little evidence that they deter future bad behavior (look here).  

Recidivism

Tenet actually has a long, dark record of misbehavior.  In 2012, we published our last post on Tenet.  It was about a $42.7 million dollar settlement the company made then of charges it overbilled the Medicare program from 2005-07.  As we wrote then:

While this story appeared briefly and without context in a few business news outlet, it really is part of a much bigger picture.

National Medical Enterprises

Published in 2006, Maggie Mahar's Money Driven Medicine was one of the important early works on health care dysfunction (see post here, the web-site of the documentary film based on it here).  One of the striking cases it discussed was that of Nartional Medical Enterprises.  NME was charged not only with run of the mill offenses like over-billing, but more exotic ones like kidnapping patients. NME eventually settled with federal authorities in 1994 for $379 million, and pleaded guilty to a variety of charges. The results were similar to many more recent cases. No one went to jail, and the CEO walked away with a golden parachute.  Despite the seriousness of the offenses, NME did not go out of business.  It simply changed its name - to Tenet Healthcare.

Legal Problems in the 21st Century

The "new" Tenet continued to have legal issues.  These included a $395 million settlement of the Redding Medical Center unnecessary heart surgery scandal in 2004 (look here), and a $21 million settlement of US government charges of kickbacks (look here), a $7 million settlement with the government of Florida of charges of fraudulent billing (look here), and a $900 million settlement of federal over-billing complaints (look here, and see our post here), all in 2006.  There was an apparent lull, and then in 2011 the company settled a class action suit brought after the deaths of 34 patients in a Tenet facility in New Orleans after Hurricane Katrina (see Bloomberg story here.)

Yet this more than 20 year history of repeated allegations, settlements, and crime did not apparently affect the latest settlement.

Conclusions

Nearly every big US health care corporation now seems to now have a long history of bad behavior, sometimes criminal behavior, that has not stopped the revenues from flowing, and the top managers from becoming millionaires, or billionaires.  Is it any wonder that a few years ago, nearly a majority of US respondents to a Transparency International poll declared our health care system to tbe corrupt (look here)?

Their dark musings may be partially due to their awareness that health care corruption is a taboo topic.  As we wrote about it in 2016 (look here)...

 Essentially, there is so much money to be made through pharmaceutical (and by implication, other health care corruption) that the corrupt have the money, power, and resources to protect their wealth accumulation by keeping it obscure.  In the Transparency International 2016 Report on health care corruption in the pharmaceutical industry,

However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Keep in mind that the money made from corruption does not just go to innocent peoples' retirement funds that are invested in pharmaceutical stocks.  It predominantly goes to top corporate executives and managers, and their cronies who preside over the corrupt practices.

I might as well repeat myself once again.  As I wrote in 2015,

If we are not willing to even talk about health care corruption, how will we ever challenge it? 

So to repeat an ending to one of my previous posts on health care corruption....  if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption.  Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage.  Yet such action cannot begin until we acknowledge and freely discuss the problem.  The first step against health care corruption is to be able to say or write the words, health care corruption.