healthy4u: medical pragmatism

One manner by which Healthcare's core values are usurped is via distortions and slander about physicians and other clinicians. At "<a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-irrational.html">Health IT: Ddulites and Irrational Exuberance</a>" and related posts (<a href="http://hcrenewal.blogspot.com/search/label/Ddulite">query link</a>) I've described the phenomenon of the: <blockquote>'Hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.'</blockquote> I have called this personality type the "Ddulite", which is "Luddite" with the first four letter reversed. I have also pointed out that the two are not exact opposites, as the Luddites did not endanger anyone in trying to preserve their textile jobs, whereas the Ddulites in healthcare IT do endanger patients. Yet, in the 20 years I've been professionally involved in health IT, I have frequently heard the refrain, usually from IT personnel and their management, that "Doctors resists EHRs because they are [backwards, technophobic, reactionary, dinosaurs, unable/unwilling to change, think they are Gods, ..... insert other slanderous/libelous comment]. I've heard this at Informatics meetings, at medical meetings, at commercial health IT meetings (e.g., Microsoft's Health Users Group, and at <a href="http://www.himss.org/ASP/index.asp">HIMSS</a>), at government meetings (e.g., <a href="http://www.gs1.org/healthcare/about">GS1 healthcare</a>), and others. The summary catchphrase I've heard and seen (even in the comments on this blog) is that doctors are "Luddites" while IT personnel are forward-thinking, know better than doctors, and are "Modernists." This slander and libel of physicians and other clinicians needs to stop, and the entire issue needs to be reframed. Doctors are pragmatists. When a new technology is rigorously shown to be beneficial to patients, and (perhaps more importantly) rigorously shown not to be of little benefit or worse, significantly harmful, doctors will embrace it. There are countless examples of this that I need not go into. They also have responsibilities, obligations, ethical considerations, liabilities, and other factors to consider in their decisions: <blockquote><a href="http://www.merriam-webster.com/dictionary/pragmatism">Pragmatism</a> (Merriam-Webster): : a practical approach to problems and affairs <tried a="" and="" balance="" between="" pragmatism="" principles="" strike="" to=""> </tried></blockquote> The reality is not: <blockquote>Luddite doctors <---- are in tension with ----> Modernist IT personnel</blockquote> but is: <blockquote>Pragmatist doctors <---- are in tension with ----> Ardent technophiles (Ddulites) </blockquote> The technophiles' views may be due, on the one hand, to ignorance of medicine's true complexities and "innocent" overconfidence in technology. Unfortunately, it is a gargantuan leap of logic to go from "well, computers work in tracking FedEx packages and allowing me to withdraw money from my U.S. bank when I'm abroad, to "therefore with just a little work they will transform medicine." Anyone familiar with even the most fundamental issues in Medical Informatics is aware of this. (This is the problem with "generic management" of healthcare IT - healthcare amateurs are unfamiliar with these issues.) Due to the complex, messy social, scientific, informational, ethical, cultural, emotional and other issues relatively unique to medicine, that leap from banking/widget tracking/mercantile computing --> medicine is probably more naive than the leap in logic, for instance, that would have a person believe since a hot air balloon can go high in the sky, it can take a person to the moon, as I observed <a href="http://hcrenewal.blogspot.com/2009/01/wsj-waste-feared-in-digitizing-patient.html">here</a>. On the other hand the technophile's expressed views can also be a territorial ploy with full awareness of, and reckless disregard for, the consequences of technology's downsides. (The CIO where I was a CMIO was well-known to be an aficionado of Sun Tzu's "<a href="http://en.wikipedia.org/wiki/The_Art_of_War">Art of War</a>" in his corporate politics - the polar opposite of a 'team player.' I might add that the doctors were fully expected to be 'team players'.) Part of the struggle between the health IT industry and medical professionals has also been control of information flow about HIT. This has been brought to the fore by my observation of the almost uniformly negative comments on today's HIT at the physician-only site <a href="http://www.sermo.com/">Sermo.com</a>. Sermo is populated, I might add, not by computerphobes but by physicians in a wide variety of specialties using computers for social networking. These comments will hopefully soon be published. (They are not dissimilar to the many comments I reported in my Jan. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">An Honest Physician Survey on EHR's</a>", although some might call the sponsor of the latter survey, <a href="http://www.aapsonline.org/">AAPS</a>, biased. I do not think the same can be said of Sermo.com, an open site for all physicians.) I have mentioned on this blog the numerous impediments to flow of information about health IT's downsides, and these impediments are well described, for example, in the Joint Commission Sentinel Events Alert on Health IT (<a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF">link</a>), the FDA Internal Memorandum on H-IT Safety (<a href="http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology">link</a>) and elsewhere (such as at <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">link</a>, <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20safety">link</a>). The Institute of Medicine of the National Academies noted this in their <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">late 2011 study on EHR safety</a>: <blockquote>... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk. Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.[IOM (Institute of Medicine). 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press, pg. S-2.] </blockquote> Also in the IOM report: <blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect. More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”</blockquote> I note that the 'impediments to generating evidence' effectively rise to the level of legalized censorship, as observed by Koppel and Kreda regarding gag and hold-harmless clauses in their JAMA article "<a href="http://jama.ama-assn.org/content/301/12/1276.extract">Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians</a>", JAMA 2009;301(12):1276-1278. doi: 10.1001/jama.2009.398. Pragmatist physicians are quite rightly very wary of the technology as it now exists. Ultimately, even when information on HIT risks or defects does surface, it is highly inappropriately labeled as "anecdotal" (see <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">this post on anecdotes</a> for why this behavior is inappropriate). This "anecdotalist" phenomenon occurs right up to the HHS Office of the National Coordinator for Health IT (ONC), as I described in my post "<a href="http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html">Making a Stat Less Significant: Common Sense on 'Side Effects' Lacking in Healthcare IT Sector</a>" and elsewhere. Therefore, another part of reframing the pragmatism vs. technophilia issue is for clinicians to put an end to censorship of HIT adverse experiences. I have the following practical suggestions, used myself, to start to accomplish the latter goal. These suggestions are in the interest of protecting public health and safety: When a physician or other clinician observes health IT problems, defects, malfunctions, <a href="http://www.tinyurl.com/hostileuserexper">mission hostility</a> (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting): (DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.) <ul><li>Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "<a href="http://www.jpands.org/vol9no3/huntoon.pdf">disruptive physician</a>" and/or or being subjected to sham peer review (<a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">link</a>).</li></ul><ul><li>Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal"> at this link</a>. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger <a href="http://hcrenewal.blogspot.com/search/label/Dr.%20Scott%20Monteith">Dr. Scott Monteith</a> in a comment to me about this post.)</li></ul><ul><li>Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at <a href="http://www.jointcommission.org/report_a_complaint.aspx">http://www.jointcommission.org/report_a_complaint.aspx</a> . Also consider writing the JC senior officers (<a href="http://www.jointcommission.org/about_us/joint_commission_officers.aspx">link to officer's list</a>), whose awareness of HIT issues I can personally attest to via our correspondences.</li></ul><ul><li>Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at <a href="https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm">https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm</a>. An example of such an adverse event report I filed myself (when the involved hospital refused) is <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1729552">at this link</a> in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.</li></ul><ul><li>Inform the State Medical Society and local Medical Society of your locale.</li></ul><ul><li>Inform the appropriate Board of Health for your locale.</li></ul><ul><li>If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "<a href="http://www.qipa.org/Home.aspx">Quality Insights of PA</a>."</li></ul><ul><li>Inform a personal attorney.</li></ul><ul><li>Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.</li></ul><ul><li>As clinicians are often forced to use health IT, at their own risk even when "certified" (<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">link</a>), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:</li></ul><blockquote>"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.] We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice. With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at <a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF" style="font-style: italic;">http://www.jointcommission.org/assets/1/18/SEA_42.PDF</a>, the IOM report on HIT safety at <a href="http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF" style="font-style: italic;">http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF</a>, and the FDA Internal Memorandum on H-IT Safety Issues at <a href="http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology" style="font-style: italic;">http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology</a>. CMO __________ (date, time) CIO ___________ (date, time) CMIO _________ (date, time) General Counsel ___________ (date, time) etc."</blockquote><ul><li>If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.</li></ul><ul><li>As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.</li></ul> These measures can help "light a fire" under the decision makers, and "get the lead out" of efforts to improve this technology to the point where it is usable, efficacious and safe. -- SS

Doctors and EHRs: Reframing the "Modernists v. Luddites" Canard to The Accurate "Ardent Technophiles vs. Pragmatists" Reality

One manner by which Healthcare's core values are usurped is via distortions and slander about physicians and other clinicians. At "...

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In Defense of Psychiatric Diagnoses and Treatments The Boston Globe is out today with a <a href="http://www.boston.com/news/local/massachusetts/articles/2009/04/02/some_who_set_policy_tied_to_industry/?page=1">story</a> about conflicts of interest involving American Psychiatric Association guidelines for treating depression, mania, and schizophrenia – disorders for which the market in medications is said to be $25 billion annually. Conflicts abound, it seems, and the consequent implication is that industry influence has led to guidelines that “focus heavily on medications and give relatively little attention to nondrug treatments.” The lead author of a forthcoming analysis, Lisa Cosgrove from the University of Massachusetts is quoted in the Globe as saying “…the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence." Maybe so, but it’s not just psychiatry. And this new study should not be taken to invalidate psychiatric diagnoses or to undermine the efficacy of psychiatric treatments. The existence of disease is not predicated on having a biological test. It’s nice when we do have one, but there are many disorders throughout medicine, not just in psychiatry, for which there is no conclusively defining biological test. Think migraine. Think multiple sclerosis. Think chronic pain. There is a distinguished tradition of clinical research, going back to the late 1950s, wherein disorders like depression, mania, and schizophrenia were studied for their genetic profiles, their clinically meaningful subtypes, their biological correlates, and their responses to treatments. This bottom-up approach yielded useful theories, which in turn led to better theories and to new treatments for depression, mania, and schizophrenia. Like any other branch of science, clinical science has a self-correcting function that distinguishes it from pseudo-science and propaganda. So, we welcome new theories even though most will not survive, and we welcome new diagnostic proposals and we welcome potential new treatments. All are subject to the test of independent confirmation, and nobody is surprised when many fall away. Since around 1990 that tradition has been corrupted by Pharma and Pharma’s money. There is no shortage of examples regularly in the news. Academic key opinion leaders lost their ethical compass and, with or without a figleaf, devolved into spokespersons for industry. One is reminded of Julien Benda’s term la trahison des clercs. Instead of moving on from undistinguished and problematic new drugs, key opinion leaders work with the marketing departments of Pharma to promote and defend the brand. Remember the <a href="http://www.beforeyoutakethatpill.com/2009/3/psychnet.pdf">PsychNetters</a>? Of course, psychiatry is not the only medical specialty corrupted in this way. Stents, anybody? Orthopedic devices, anybody? Lost in the marketeering and propaganda since around 1990 is the discipline of clinical therapeutics. As one <a href="http://www.margaretsoltan.com/?p=11166">commentator</a> put it, if there is no way to confirm biologically the existence of disease, then “…we cannot confirm with much confidence that this or that treatment treats mental disease.” It actually is possible to identify effective treatments for mental disease. We did it with lithium. We did it with the early antidepressant drugs. And we did it with the early antipsychotic drugs. There was room for improvement in all of these, but make no mistake – they were dramatic positive developments. Most of the work in the past 20 years, however, put marketing first and clinical therapeutics second. Humbug aside, the goal was not to improve the management of depression or mania or schizophrenia but to jump whatever bar the FDA was setting in order to get a product on the market. Indeed, the really hard clinical research issues were studiously avoided. Along the way, the clinical research enterprise became dominated by academic and for-profit contract research organizations in which, to put it gently, standards of recruitment of patients apparently suffered, so that response rates in placebo-treated patients skyrocketed. As a result, proving that a drug does work became harder, and the overall drug advantage over placebo in treating depression <a href="http://www.bmj.com/cgi/content/extract/331/7509/155">came into serious question</a>. In effect, the corruption of clinical research standards has brought us to an epistemologic quagmire about the efficacy of today’s most popular antidepressant drugs. As for the charge that psychiatrists and primary care physicians just throw drugs at mental health problems, that is nothing new. It is a reflection of the professional pragmatism that permeates medical practice. Think back to the 1950s when the new wonder drugs called antibiotics were handed out like Pez, mostly for people who did not really need them and who would not benefit from them. The working principle was misguided simplicity and pragmatism, which minimized and discounted the risks. Even today the over-use of antibiotics remains a public health concern. Just as in the 1950s patients with nonspecific upper respiratory symptoms were “given the benefit of the doubt” and were prescribed an antibiotic on the reasoning that it might help them while probably not hurting them, so today patients with nondescript depressive or anxiety symptoms are prescribed an SSRI drug on the same reasoning. The cost of this approach in wasted money, in unnecessary side effects, and in unproductive clinical management is non-trivial. So, the issues are more nuanced than today’s Boston Globe story would suggest. For good and for ill, psychiatry is not so very different from the rest of medicine. Corruption and compromise respect no subspecialty boundaries. We can have reliable and valid knowledge of disease without a biological test. We can show efficacy of treatments for disorders that lack a biological test. But when simplistic pragmatism and cutting corners dominate in therapeutics and in clinical trials, then we are in trouble.

In Defense of Psychiatric Diagnoses and Treatments

In Defense of Psychiatric Diagnoses and Treatments The Boston Globe is out today with a story about conflicts of interest involving America...

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