Showing posts with label JAMA. Show all posts
Showing posts with label JAMA. Show all posts

Monday, August 15, 2016

Stanford authors: Evolutionary Pressures on the Electronic Health Record - "Deimplementing the EHR could actively enhance care in many clinical scenarios"

A brief post.  In this new JAMA article by Stanford authors:

Evolutionary Pressures on the Electronic Health Record
http://jama.jamanetwork.com/article.aspx?articleid=2545405 
Donna M. Zulman, MD, MS1,2; Nigam H. Shah, MBBS, PhD3; Abraham Verghese, MD4

I note the passage:

... Deimplementing the EHR could actively enhance care in many clinical scenarios. Simply listening to the history and carefully examining the patient who presents with a focused concern is an important means of avoiding diagnostic error.7 Many phenotypic observations (the outline of a cigarette packet in a shirt pocket, or spotting neurofibroma, fasciculation, or rash) change the diagnostic algorithm and are easy to miss when work revolves around the computer and not the patient.

I predict pushback against such a bold and contrarian "de-implementation" assertion (contrarian to the hyper-enthusiast and industry narratives, that is).

The authors continue:

There is building resentment against the shackles of the present EHR; every additional click inflicts a nick on physicians’ morale. Current records miss opportunities to harness available data and predictive analytics to individualize treatment. Meanwhile, sophisticated advances in technology are going untapped. Better medical record systems are needed that are dissociated from billing, intuitive and helpful, and allow physicians to be fully present with their patients.
 
I also wrote the primary author with a link to an alternate solution to de-implementation that can "allow physicians to be fully present with their patients", namely, 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
 
-- SS

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

Saturday, April 30, 2016

JAMA LAYS AN EGG

JAMA LAYS AN EGG 

Three months ago I took JAMA to task over a Viewpoint opinion piece about conflict of interest. The authors proposed dancing around the reality of financial conflict of interest in medicine by talking instead about confluence of interest. I countered with a proposal for the term competing interests, which would not paper over the problem. In that post I also included a letter I had sent to JAMA in response to the opinion piece, but which JAMA had declined to publish. I questioned whether JAMA had deep sixed all the critical replies it received.

Now I can report that, in the April 26, 2016 print edition, JAMA has finally published one critical letter and a replyfrom the original authors. So JAMA didn’t deep six everything. This new correspondence appears 174 days after print publication and 214 days after on-line publication of the original Viewpoint article. That glacial delay is problematic – it disables meaningful dialogue.

The new critical letter is from a group in Europe, and it thoughtfully discusses weaknesses in the Viewpoint authored by Cappola and FitzGerald. These Viewpoint authors did not do justice to the critical letter in their reply. Moreover, they disclosed multiple potential competing interests, but they did not follow their own advice by clarifying why we should disregard those obvious competing interests. As we all know, the mere disclosure of competing interests does not by itself remove the problem. It can be a device for hiding in plain sight. Substantively, the reply from Cappola and FitzGerald is mostly hand waving and restatement of biased opinion, without real analysis or incisive thought.

The closing sentences of their reply letter illustrate these issues: “Everyone has biases. Rather than present these pejoratively, as a clash of values that undermines validity, it seems more constructive to mine the complexity of these biases, present them in an accessible fashion, and seek to determine whether they are confluent with the interests of patients, scientists, and regulators who might base their decisions on the results of a given piece of work.” The reference to complexity of biases concerns the matter of nonfinancial bias like fame and careerism in science. The reference to presenting biases in an accessible fashion concerns the ill-considered proposal to include a bias heat map on patients’ consent forms. This idea rightly was panned by the European critics. Meanwhile, where did the compromised and disgraced key opinion leaders disappear to in all this wishful thinking? Where did the corrupt corporations disappear to? They paid billions of dollars in penalties for felony crimes and plea-bargained settlements. They have been airbrushed out of the Cappola-FitzGerald narrative. These authors come across like Bambi confronting Godzilla.


If this is the best that an associate editor of JAMA and a fellow of the Royal Society can do then JAMA needs a fix. This effort is too little and much too late.

UPDATE 05-03-2016
Apparently the link to my earlier post is inoperative. My apologies. Here is a link that should work.
http://hcrenewal.blogspot.com/2016/01/jama-jumps-shark.html 

Sunday, January 24, 2016

JAMA JUMPS THE SHARK


JAMA JUMPS THE SHARK

Medical journals are supposed to promote professional values – scientific, social, and ethical. Quality matters, in each of these domains. Lately, however, highly ranked journals are failing in respect of ethics commentaries. Some editors seem happy to publicize or even to co-author commentaries that are dismissive of current ethics initiatives – like transparency of data reporting and disclosure of conflicts of interest (COI). That’s one way for journals to jump the shark in the race for ratings. They surely get attention and applause in some quarters – but those stunts are net negatives for the journals. Here is one example.

Last fall, JAMA went splashy with a sappy Viewpoint articleon conflict of interest by Anne R. Cappola and Garret A. FitzGerald. Anne Cappola is also an associate editor of JAMA– what a coincidence! The article was a Pollyanna piece by these two professors at Penn, promoting pushback on perceived pharmascolds, but really just papering over the problem of COI. The sappy formula? They declared conflict of interest to be a pejorative term that should be replaced by confluence of interest. This casuistry was backed up by wishful thinking and hortatory hand waving, weakly argued. Mostly, it gave the impression that the authors, presuming to speak for investigators generally, were offended by the increasing regulations for managing COI. Those developments have occurred at the Federal, institutional, and publication levels. Worse, the authors ignored the reality of recent corruption that led to those new regulations. That uncomfortable fact was airbrushed out of their discussion. In response, one critic of confluence of interest, writing on the COI blog, aptly raised a comparison to Wall Street: “The phrase also reminds me of a statement by then king-of-the-hill securities analyst Jack Grubman: “What used to be a conflict is now a synergy.” (Three years later Grubman was fined $15 million dollars and barred from the industry for life for what were apparently still considered COIs.)”

The Viewpoint article appeared on-line September 24, 2015, and four days later I sent a critical reply to JAMA. The printed version of the Viewpoint article appeared November 3, 2015, and on 4 December, 2015 I was notified that JAMA chose not to publish my letter to the editor. During the following six weeks, now nearly five months since it appeared, JAMA published no replies whatsoever to the Viewpoint article. Could it be that JAMA has deep sixed all the responses? That’s one way to manage bad publicity, but it is inconsistent with the standards we expect of a journal like JAMA. Here is the text of my letter to the editor of JAMA. Keep in mind that there is only so much one can say within a limit of 400 words and 5 references.


LETTER TO EDITOR, JAMA 09-28-2015            Text word count 389
                                                                                5 references

TITLE: CONFLICT OF INTEREST

In their recent Viewpoint (1), Anne Cappola and Garret FitzGerald recommended replacing the term conflict of interest (COI) with confluence of interest, declaring a pejorative connotation of the term conflict. A better suggestion would have been competing interest, which already is in wide use (2) and which does not paper over the problem. The authors did not frankly acknowledge the gravity of recent COI scandals that led to the situation they decry. Sadly, there are real, common, serious, and unacceptable conflicts of interest. Boundaries are needed, and the authors’ effort to weaken the boundaries is misguided.
Their case for re-framing COI more benignly as a confluence of interests is weakly argued. For instance, they warned of concern that current policies on COI “… might restrain innovation and delay translation of basic discoveries to clinical benefit.” (1) They produced no evidence for that speculative assertion, though they said it was a key reason for their endeavor. Moreover, COI policies do not demonize collaboration with industry. We once had an honorable tradition of interacting with industry while retaining our integrity as clinical scientists. That tradition broke down when academic investigators in many specialties were coƶpted as key opinion leaders (KOLs) by the marketing departments of corporations. There followed an era of corruption in corporate-funded and KOL-managed continuing medical education and journal supplements; of experimercials disguised as KOL-initiated clinical trials (3); of rampant, biased ghostwriting, commissioned by corporations and often with cynical honorary KOL authorship; and of selective analyses of clinical trials data designed to exaggerate benefits, minimize harms, and maximize markets (4). We can readily agree with the Viewpoint authors that these practices had the effect of “biasing the interpretation of results, exposing patients to harm, and damaging the reputation of an institution and investigator” (1). Inevitably, those practices and individuals were exposed, which led to Congressional action and to staggering legal penalties (over $3 billion in the case of GlaxoSmithKline) (5). In response, COI policies were strengthened at the Federal and institutional levels and, of course, they now inconvenience everybody. Such is the way of bureaucracies. As we survey the aftermath, we should direct our annoyance to the many opportunistic investigators who entered into those compromised relationships with industry. It makes no sense now to shoot the messengers or to use sophistry in an attempt to define the problem away.

ACKNOWLEDGEMENTS
The author declares no competing financial interest or other conflict of interest.

REFERENCES

(1) Cappola AR, FitzGerald GA. Confluence, not conflict of interest: Name change necessary. JAMA. Published online September 24, 2015. doi:10.1001/jama.2015.12020.
(2) James A, Horton R, Collingridge D, McConnell J, Butcher J. The Lancet's policy on conflicts of interest––2004. Lancet. 2004; 363 (9402):2-3.
(3) Carroll BJ. Sertraline and the Cheshire cat in geriatric depression. American Journal of Psychiatry. 2004; 161(6): 1145-1146.
(4) LeNoury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.
(5) U.S. Department of Justice, Office of Public Affairs. GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. July 2, 2012. http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report Accessed 09-25-2015.


So, yes, Virginia, there is real COI and there is real corruption in medical science. You cannot make them go away by wishing them away. And, JAMA, if you allow your editors to promote divisive, weak, and problematic ethics positions, at least have the decency to allow debate.

Bernard Carroll.