healthy4u

Those Big Doors Keep Revolving

A few months ago, we <a href="http://hcrenewal.blogspot.com/2010/12/former-nih-director-spins-trhough.html">discussed</a> the revolving door that seems to connect US government leadership positions and leadership positions of commercial health care firms. There are other such revolving doors, like two recently discovered just north of here. State Government to For-Profit Hospitals As <a href="http://www.bostonherald.com/business/healthcare/view.bg?articleid=1321146&format=text">reported</a> by the Boston Herald: <blockquote>David Morales, a longtime trusted adviser to [Massachusetts] Gov. Deval Patrick, became the latest official to leave the administration as he stepped down from a top health-care post for a private sector gig. Morales resigned abruptly yesterday to take a position with Steward Health Care System.</blockquote> Furthermore, <blockquote>Morales worked as a top adviser during the governor’s first term before taking a $128,000-a-year post in 2009 as commissioner of the Division of Health Care Finance and Policy. His resignation was effective yesterday.</blockquote> Note that we have previously <a href="http://hcrenewal.blogspot.com/2011/02/send-mercenaries-guns-and-money.html">discussed</a> the Steward Health Care System, the new name given to the Caritas Christi system after it was bought out by private equity firm Cerberus Capital Management. Steward's aggressive plan to stamp out "leakage" raised concerns that the new movement to make practicing physicians employees could push them to do what is best for the company's bottom line rather than for patients. We previously suggested that deals that turn previously non-profit health systems and physicians' practices into for-profit corporations deserve considerable scrutiny. After Caritas became Steward, state government officials promised close oversight. Now Steward has acquired a new executive who has friends in state government. Non-Profit Health Insurance/ Managed Care by Way of a Political Campaign to Health Care Venture Capital This story also <a href="http://www.bostonherald.com/jobfind/news/healthcare/view/2011_0302charlie_baker_a_health-care_catalyst_for_cambridge_vc_firm/srvc=home&position=also">came from</a> the Boston Herald: <blockquote>Four months after his failed Massachusetts gubernatorial bid, Charlie Baker has landed a private-sector job at a Cambridge venture capital firm. The former Harvard Pilgrim Health Care CEO is now an 'executive in residence' for General Catalyst Partners. He’ll focus on working with small and midsize health-care services companies for the VC firm, which has $1.7 billion under management across five funds.</blockquote> In addition, <blockquote>Health-related companies already in General Catalyst’s portfolio include iWalk, a Cambridge developer of orthotic and prosthetic devices, and North Carolina-based TearScience, which specializes in diagnostic and treatment devices for evaporative dry eye in addition to several still in stealth mode.</blockquote> Note that managed care was originally touted as a way to control health care costs, and that the commercial health care insurance companies/ managed care organizations claim to be doing all they can to control costs. Such a focus on cost control would imply that they ought to be able to vigorously negotiate at arms' length with health care providers and drug and device companies.  Now some device companies have acquired a new venture capital overseer who has friends in insurance and managed care. Summary Not only are there revolving doors connecting the national government and large commercial health firms, but also connecting state government and regional hospital systems, and non-profit health care insurers/ managed care organizations and device companies. This is just some more evidence that people in the leadership of large health care organizations have more in common with each other, even if their organizations are supposed to be competing or negotiating at arms length, than they have with patients, clients, customers and the public at large.  The various revolving doors appear not to align the interests of leaders of health care organizations with their organizations' stated missions, or with promoting the health of patients.  To truly reform health care, we need to expose these doors to more sunlight, and then think about retarding their spin or even locking them in place.

Those Big Doors Keep Revolving

A few months ago, we discussed the revolving door that seems to connect US government leadership positions and leadership positions of comm...

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The Future Pathways for e-Health in NSW

Prof. Patrick has now added a new section to his <a href="http://hcrenewal.blogspot.com/2011/03/on-emr-forensic-evaluation-from-down.html">report on health IT in NSW Australia</a>, entitled "The Future Pathways for e-Health in NSW." It is available <a href="http://sydney.edu.au/engineering/it/%7Ehitru/essays/Things%20we%20should%20change%20in%20NSW-v4.pdf">at this link</a> (PDF). It inoculates against most of the 'Ten Plagues' that bedevil health IT projects (such as the IT-clinical leadership inversion, lack of transparency, suppression of defects reporting, magical thinking about the technology, and lack of accountability of the bureaucrats). Emphases mine: <blockquote>In Short Term ( 0-3 months) 1. Halt further rollouts of Firstnet or other CIS systems. The current roll-out programs use significant efforts in training staff for a system that is counterproductive to patient well being. 2. Complete a full and thorough risk assessment analysis and usability of the software. The CIS report indicates there are a number of risks in the current software that are not likely to have been assessed in the past. 3. Address the current problems before doing anything else. There are a number of problems that appear solvable in the short term that would improve the situation for current users, such as providing needed reports. 4. Create the NSW IT Improvement Panel composed of ED Directors, IT-savvy clinical and quality improvement staff responsible for advising on the preparedness and process of the rollout. 5. Create an effective error and bug reporting mechanism that is viewable by all ED directors and with the display of the priority of each entry and expected completion time. 6. Initiate a high profile campaign to encourage staff to lodge fault records on anything they discover wrong, problematic or inefficient in using the system. In the longer term (3-12 months) 1. Review the Health Support Services and make it clinically accountable by appointing a clinical head with an IT education. 2. Create a culture change in the HSS. The current operation of the HSS seems to be devoid of influence from the clinical community. 3. All NSW CIS system procurement should be guided by an IT Advisory Board of IT experienced clinical, academic and medical software industry experts. 4. Create pathways for hospitals that wish to be early adopters and take a lead role in the development of new methods for using and deploying IT systems. 5. Support innovation within the Australian medical software communities that contribute to a culture of innovation and continuous quality improvement. 6. Adopt transparency rules in all new healthcare information acquisitions. Secrecy has bedevilled the efforts of staff and management to get improvements in the CIS systems and hold service agents accountable for their failure to comply to service level agreements. All agreements about a signed contract should be available to the ED Directors. 7. Replace the State Based Build policy with a policy of providing a technology to match the technology experience of the individual departments so that leaders are not dragged backwards with inappropriate technology installation </blockquote>The de facto "National Program for IT in the HHS" here in the United States needs a similar inoculation. I can only add that our own ONC office (Office of the National Coordinator for Health IT of the Dept. of HHS) had more granular recommendations about expertise levels required for leadership roles in such undertakings. I wrote about them at my Dec. 2009 post "<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">ONC Defines a Taxonomy of Robust Healthcare IT Leadership</a>." --SS

The Future Pathways for e-Health in NSW

Prof. Patrick has now added a new section to his report on health IT in NSW Australia , entitled " The Future Pathways for e-Health in ...

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Are Those Sockpuppers From Down Under?

We at Healthcare Renewal have had experience with the healthcare sock puppets. They are shills, a person or group working on behalf of a company or other special interest. They attempt to use distraction, ad hominem, misdirection and other psyops tactics to attack points of view they don't like. They also plant memes they or their sponsor deem desirable. They are universally anonymous in their postings. One got careless and got nailed via IP forensics, as at my Jan. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">More on Perversity in the Healthcare IT World: Is Meditech Employing Sockpuppets?</a>" and my semi-satirical followup post a few days later, "<a href="http://hcrenewal.blogspot.com/2010/01/socky-meditech-sockpuppet-on-vacation.html">Socky the Meditech Sockpuppet on Vacation?</a>" after he/she disappeared after exposure. A Healthcare Renewal reader with an MBA at that time non-anonymously related the following (emphases mine): <blockquote>In reading this thread of comments I have to believe IT Guy [the Sock puppet - ed.] is a salesperson. My only question is: Were you assigned this blog or did you choose it? We had this problem a number of years ago where a salesperson was assigned a number of blogs with the intent of using up valuable time in trying to discredit the postings. In my very first sales class we learned to focus on irrelevant points, constantly shift the discussion, and generally try to distract criticism. I would say that HCR is creating heat for IT Guy’s employer and the industry in general. I find it sad that a company would allow an employee to attack anyone in an open forum. IT Guy needs to check with his superiors to find out if they approve of this use of his time, and I hope he is not using a company computer, unless once again this attack is company sanctioned. Steve Lucas</blockquote> It seems this foul type of creature is starting to crawl out of the woodwork regarding Prof. Jon Patricks' analysis of an ED EHR system mandated by the state's government of NSW for public hospitals, as I wrote about in my posts such as on Mar. 5, 2011 at "<a href="http://hcrenewal.blogspot.com/2011/03/on-emr-forensic-evaluation-from-down.html">On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts.</a>". They may be corporate, they may be government. They likely have a financial stake in the ED EHR project as well. For instance, the sockpuppet/shill comments are starting to appear at the Australian Health Information Technology blog of Dr David More MB, PhD, FACHI at <a href="http://aushealthit.blogspot.com/">http://aushealthit.blogspot.com</a>: <blockquote>This blog has only three major objectives. The first is to inform readers of news and happenings in the e-Health domain, both here in Australia and world-wide. The second is to provide commentary on what seems to have become the lamentable state of e-Health in Australia and to foster improvement. The third, sadly, is now to try and force accountability for the actions of, and the funds spent, by NEHTA. [National E-Health Transition Authority <a href="http://www.nehta.gov.au/about-us/contact-us">as at this link</a> - ed.] </blockquote> (Sounds like a kindred mission relative to HC Renewal.) For instance at Dr. More's post "<a href="http://aushealthit.blogspot.com/2011/03/prof-patrick-has-really-hit-bullseye-it.html">Prof Patrick Has Really Hit the Bullseye It Would Seem. Lots of Supportive Comments From All Over!</a>" we see the following sock puppet-like comments rearing their holey (not holy) woven head: <blockquote>... It seems that the heuristic axiom of Ockham’s Razor (as presented by Jon) is the design criteria by which Jon thinks NSW Health should have selected their CIS ... unbelievable! Unfortunately Jon has not proposed any practical alternatives in his papers. His papers are full of opinions, unfounded claims and incorrect facts (not to mention the countless flaws in his research methodologies). </blockquote>and <blockquote>Dr Patrick - you are so misinformed. There are so many untruths in what you report. Why is this? Because you interviewed 7 people. Being Directors, what is the likelihood they are hands on with the system? Minimal I would say from experience in the EDs. Call yourself a researcher - huh! It is a totally biased report which reflects the opinions of those with an axe to grind. Why don't you talk to some nurses,clerical staff and junior doctors? There are hundreds of them working in EDs across the state. Their opinion should matter as they are the ones caring for our patients. You should be ashamed of yourself! I certainly would not hire you to do a research project if this is the biased and blatantly incorrect rubbish that you come up with. Shame on you!! </blockquote> and the ever-so-common refrain of: <blockquote> Has Dr Patrick ever completed (or even been involved in) an implementation of an EMR (at all or of any scale)? Can someone tell us what makes him an authority the subject? [I, OTOH, have done so, authoring, implementing, managing for hospitals and major pharma - ed.] ... His view is unbalanced and his paper is clearly bias. How Sydney University tolerates papers of such poor quality and biasness (being published by their professors) is beyond me. [Paper is 'clearly bias'? Biasness? This person needs a grammar lesson - ed.] </blockquote> Ink is never put to specifics of the supposed transgressions in these largely <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">ad hominem</a>, anonymous attacks. If those who wrote them had the fortitude to identify themselves, perhaps they might be somewhat credible. However that rarely if ever is the case. In my humble opinion, such comments are risible, not even worth the electrons they're written with. Except for amusement: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg3DtCGREf4I9i7ZUFKWW3kCq2yWxsrw3okOy0YckEIFo4dqu0qNZkdqiOwcKXBoV3ptTR9LjEJ3yg5dBmYoDv9qBXxNd8hFXNWAKUsUb8xEG4keQovVddB6Oj0ZWsvlFynC5Keh5eqlxJG/s1600/sockpuppet2.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5581573263825574290" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg3DtCGREf4I9i7ZUFKWW3kCq2yWxsrw3okOy0YckEIFo4dqu0qNZkdqiOwcKXBoV3ptTR9LjEJ3yg5dBmYoDv9qBXxNd8hFXNWAKUsUb8xEG4keQovVddB6Oj0ZWsvlFynC5Keh5eqlxJG/s320/sockpuppet2.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 129px; height: 148px;" /></a>Socky the Health IT Sockpuppet. Click to enlarge. </div> p.s. an ED EHR-injured relative of mine has a message to the sockpuppets of the world. It's not fit for a public site, but it has to do with travel to a very hot, deep, sulfurous place in the earth. -- SS

Are Those Sockpuppers From Down Under?

We at Healthcare Renewal have had experience with the healthcare sock puppets. They are shills, a person or group working on behalf of a co...

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EHR ED's in New South Wales. Will the Problems Magically "Disappear?"

It occurs that one could look at Prof. Jon Patrick's recent <a href="http://hcrenewal.blogspot.com/2011/03/on-emr-forensic-evaluation-from-down.html">health IT forensic analysis</a> as a kind of "indictment" of the industry. He can be seen as suggesting the industry needs to be "put on trial" (figuratively) regarding "crimes" (again, figuratively speaking) they've committed with regard to IT robustness and reliability. The latter translate directly to patient safety. In a lawsuit such as a medical malpractice trial, obvious as well as potential evidence is put under "legal hold." For instance, if an EHR defect is suspected, metadata, audit trails, and patient data are asked (or should be asked) to be frozen or archived in the state they were in at the time of the alleged accident. It can take a page or three (or more) of specifications simply to define what information, exactly, needs to be put on legal hold. My former staff were frequently required to place myriad materials on legal hold at Merck Research Labs, for example, baed on the lawsuit du jour. Once frozen, discovery and forensic analysis of these now-static data can then proceed. In fact, cases can be lost on the basis of evidence of an archiving omissions, destruction or tampering when information holds are requested. It occurs to me that Prof. Patrick has given the industry a detailed look into factors they could start to remediate, without publicity and without telling anyone. While this would be a net plus for patients, it might result in less of a learning experience to the industy than that industry needs, to motivate the industry to avoid future product engineering and quality issues and put quality (not simply margin) as priority #1. I therefore would believe a "hold" put on the present state of these ED EMR systems, or a "snapshot" of their current state (i.e., an evaluation environment mirrored from the present operational one) would allow a careful evaluation of the impact of the issues noted in the study. Such an evaluation would be far more difficult with a cybernetic moving target. The "snapshot" idea would allow evaluation of system risk levels, intermittent "glitches", interference with workflows, etc. in a controlled testing environment, using mock data or data drawn from actual cases. The "snapshot" approach would also allow incremental remediation of the "live" system that comes out of safe, controlled testing, rather than sticking with what exists now until the studies could be completed on the as-is system, and then applying all the fixes as one or more large "upgrades." I, for one, would be interested in studying this "built by software professionals" system and comparing it to health IT systems we "academic nerds" <a href="http://ycmi.med.yale.edu/trialdb/">were authoring</a>, say, 10-15 years ago. -- SS

EHR ED's in New South Wales. Will the Problems Magically "Disappear?"

It occurs that one could look at Prof. Jon Patrick's recent health IT forensic analysis as a kind of "indictment" of the indu...

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Getting Out of Our RUC - "An Open Letter To Primary Care Physicians"

Since 2007, we have been <a href="http://hcrenewal.blogspot.com/search/label/RUC">writing</a> about the secretive RUC (RBRVS Update Committee), the private AMA committee that somehow has managed to get effective control over how Medicare pays physicians.  The RUC has been accused of setting up incentives that strongly favor invasive, high technology procedures while disfavoring primary care and other "cognitive medicine."  Despite the central role of (perverse) incentives in raising health care costs while limiting access and degrading quality, there has been surprisingly little discussion about the pivotal role played by the RUC.  Now there is a movement afoot to <a href="http://replacetheruc.org/">replace the RUC</a>.  In a new post <a href="http://careandcost.com/2011/03/05/an-open-letter-to-primary-care-physicians/">on the Care and Cost blog</a>, and <a href="http://replacetheruc.org/2011/03/05/an-open-letter-to-primary-care-physicians/">the Replace the RUC site</a>, Paul M. Fischer and Brian Klepper urged four approaches: 1. Make the public aware of the RUC’s role and urge the primary care societies to stop “enabling” the RUC through their participation. 2. Recruit experts who can credibly calculate the economic impacts of the RUC’s actions, and who can devise alternative payment methodologies. 3. Demonstrate the unlawfulness of CMS’ (and HCFA’s) two-decades long reliance on the RUC. 4. Develop a collaboration between primary care and non-health care business. They are also urging three specific actions: <blockquote>1. Contact your primary care society to demand that they withdraw from the RUC. 2. Broaden awareness of what we’re doing and why by rebroadcasting to your primary care colleagues. 3. Get in touch to help us with resources, relationships or approaches that can strengthen this project.</blockquote> They have set up an <a href="http://www.ipetitions.com/petition/quittheruc/">electronic petition</a> that people can use to urge the three major medical societies that represent primary care physicians to quit the RUC. On Health Care Renewal, we have been trying to make the systemic problems with with the leadership of health care organizations less <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> in the hopes that greater realization that these problems exist would lead to actions to solve them. The regulatory capture by the RUC of Medicare's payment setting mechanism is one problem that really cries out for a solution. In 2007, I <a href="http://hcrenewal.blogspot.com/2007/05/more-on-disparities-between.html">called for</a> "an unbiased re-evaluation of the components of the RBRVS by people who are dedicated to doing it fairly, not benefiting one group of physicians, or the organizations that benefit from the increased use of procedures"; and "an unbiased investigation of what went awry with the process used by Medicare to determine physician payments."  Your heard it here first on Health Care Renewal.  It is nice to now have such distinguished company.  I urge our readers to consider the actions urged above.  True health care reform will require a transparent, honest, fair process for governments to decide on how they will pay for physicians' care and other health care services and goods.

Getting Out of Our RUC - "An Open Letter To Primary Care Physicians"

Since 2007, we have been writing about the secretive RUC (RBRVS Update Committee), the private AMA committee that somehow has managed to ge...

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Dr. Scott Monteith on "The Best Compromise" on Physicians and Use of Troublesome Health IT

I have posted two guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at the Jan. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/01/dr-monteith-hit-testimony-to-hhs.html">Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith</a>" and the Dec. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/12/meaningful-use-and-devil-in-details.html">Meaningful Use and the Devil in the Details: A Reader's View</a>". Here is another, with his permission. He is responding to a talking point from a health IT commentary website that was distributed among the AMIA evaluations special interest group readership. Dr. Monteith asks some very probing questions. He writes: <blockquote>I would like to respond to what I see as being one of the most important and challenging “real-life” issues confronting clinicians, and is captured in this excerpt [below, from the multi-vendor sponsored site HISTalk - ed.]: <blockquote> HisTALK: ... Somewhere between “we vendors are doing the best we can given a fiercely competitive market, economic realities, and slow and often illogical provide procurement processes that don’t reflect what those providers claim they really want” and “we armchair quarterbacks critics think vendors are evil and the answer is free, open source applications written by non-experts willing to work for free under the direct supervision of the FDA” is the best compromise.</blockquote> That is, this excerpt performs the helpful task of framing “the best compromise” somewhere between two extreme viewpoints. It would be helpful (at least for me) if this group could discuss what “the best compromise” actually ‘looks like’ in practice. How does one actually understand and live within “the best compromise”? Let’s start with a relatively simple scenario: What should clinicians do when they are working with EHRs that have known “problems” that are putting patients at risk, and the problems are not being immediately addressed, either directly or indirectly through, for example, an acceptable “work around,” or other adjustments to the EHR or local business processes? Should the clinician continue to use the EHR and… <ul><li> assume that others (e.g., vendor, IT department, administration, etc.) will fix the problem(s)?</li></ul><ul><li> report the problem(s)? Once? Twice? Three or more times? (How many?) To whom?</li></ul><ul><li> inform the patient of the known problem(s) (if the problem(s) apply to the patient)?</li></ul><ul><li>inform the patient that we do not have a good understanding of how to balance or even understand the risks posed by the EHR, given the dearth of peer-reviewed literature and algorithms? (What is “acceptable risk” for a given EHR problem? Does the EHR-related problem’s risk/benefit analysis change if the patient is in the hospital for a simple, nonlife-threatening problem vs. a complex, life-threatening problem)?</li></ul><ul><li> give the patient the option to NOT use the EHR? (Note that we almost always give patients the choice to refuse other “risky ventures” such as diagnostic procedures and treatments.)</li></ul><ul><li> inform their medical malpractice insurance company of the EHR-related problems?</li></ul><ul><li> submit the problem(s) to the organization’s ethics committee, if there is one?</li></ul><ul><li> report the problem(s) to the organization’s risk management staff?</li></ul><ul><li> report the problem(s) in writing or verbally?</li></ul><ul><li> stop using the EHR?</li></ul> Etc. (including some combination of things). Can providers (especially physicians) legitimately rationalize, given our ethical (to patients and our colleagues) and legal obligations (to patients and the state where we are licensed), the use of tools that are posing risks to patients and providers, when those risks are not spelled-out, not well understood, not peer-reviewed, etc.? (Obviously everything we do has risks, but we are obligated to revel and discuss those risks as noted above. Further, the risks/benefits of a given diagnostic or treatment intervention are the product of peer-reviewed algorithms. Are patient’s aware of the risks associated with their doctor’s or hospital’s EHR?) Again, the above excerpt suggests that there is a “ best compromise.” But what is/are “the best compromise(s)”? I joke with friends that I am a “radical moderate” – that is, I usually find myself committed to the “middle ground” in most complex and thoughtful discussions. But when it comes to EHRs, I am finding it difficult to define or understand what a “moderate” or an acceptable “best compromise” looks like. Given the current EHR exuberance driven by ONC’s incentive dollars and vendor profits (or hoped-for profits), we all know that the “politically correct” approach is to “go along” and be an “early adopter” (without too many protests). But is the politically correct approach really the “best compromise,” especially in light of our ethical and legal obligations? I am anxious to hear what other people think about this matter. I am sincerely seeking help in better understanding a sensible, real-life “best compromise” for those of us in the trenches. Note that if we cannot define “the best compromise,” then what does that say about us? How can we justify “getting on board” with patient care tools (e.g., EHRs, eRx’ing, etc.) that are posing risks (known and unknown), with no clear processes for informing patients, not giving patients their choice to use these e-tools, no clear evidence-based risk/benefit analyses, etc.?</blockquote> My own pithy, initial responses are as follows: <blockquote>Re: Given the current EHR exuberance driven by ONC’s incentive dollars and vendor profits (or hoped-for profits), we all know that the “politically correct” approach is to “go along” and be an “early adopter” (without too many protests). But is the politically correct approach [i.e, "go along to get along" - ed.] really the “best compromise,” especially in light of our ethical and legal obligations?</blockquote> No, for the reasons after your comma. [i.e., in light of our ethical & legal obligation - ed.] One should look to the past for lessons in what the "compromises" might be. How about the <a href="http://en.wikipedia.org/wiki/Flexner_Report">Flexner Report of 1910</a> as a start? The treatises on human research protections penned largely after the <a href="http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment">Tuskegee experiments</a> and the horrors of WW2, such as these as listed on an NIH web page "<a href="http://ohsr.od.nih.gov/guidelines/index.html">Office of Human Subjects Research, Regulations and Ethical Guidelines</a>" might also shed some light: <ul><li><a href="http://ohsr.od.nih.gov/guidelines/45cfr46.html">45 CFR 46</a> Protection Of Human Subjects</li></ul> <ul><li><a href="http://ohsr.od.nih.gov/guidelines/GrayBooklet82404.pdf">Guidelines for Conduct of Research Involving Human Subjects at NIH (Gray Booklet) (pdf file)</a></li></ul> <ul><li><a href="http://ohsr.od.nih.gov/guidelines/belmont.html">The Belmont Report</a> Ethical Principles and Guidelines for the Protection of Human Subjects of Research</li></ul> <ul><li><a href="http://ohsr.od.nih.gov/guidelines/nuremberg.html">Nuremberg Code</a> Directives for Human Experimentation</li></ul> <ul><li><a href="http://ohsr.od.nih.gov/guidelines/helsinki.html">World Medical Association Declaration Of Helsinki</a></li></ul>I further opine:<blockquote>Re: How can we justify “getting on board” with patient care tools (e.g., EHRs, eRx’ing, etc.) that are posing risks (known and unknown), with no clear processes for informing patients, not giving patients their choice to use these e-tools, no clear evidence-based risk/benefit analyses, etc.?</blockquote> Perhaps with the line that "I never make mistakes ... everything I do is an experiment." The technology is experimental. Perhaps the best way forward is to treat it as such. In medicine I think there's a rich history of how to conduct proper (and improper) experimental research. Again, Dr. Monteith raises some critical questions that need to be answered. Or, more correctly, needed to be answered a long time ago, and long before planned national rollouts of healthcare information technology. -- SS

Dr. Scott Monteith on "The Best Compromise" on Physicians and Use of Troublesome Health IT

I have posted two guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at the Jan. 2011 post " Interesting HIT Testimony to...

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

At my Sept. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html">The Dangers of Critical Thinking in A Politicized, Irrational Culture</a>" I lamented that while my early mentor in biomedicine Victor P. Satinsky MD taught the wise credo "critical thinking always, or your patient's dead" in the 1970's, our culture had become so perverse that this credo had been largely supplanted with: <blockquote>"Critical thinking anytime, and your career's dead." </blockquote>That post was in reaction to continued heckling on a professional mailing list, the American Medical Informatics Association (AMIA) Clinical Information Systems Working Group (cis-wg). On this list, Oregon Health Sciences University professor <a href="http://www.billhersh.info/">William Hersh</a> expounded on how the evidence of health IT dangers was largely "anecdotal" therefore to be discounted, and how I, specifically, "didn't know the literature on health IT." In that post I put the lie to the latter figment. On the former prevarication Dr. Jon Patrick, author of the recent thorough dissection of problems with the ED EHR system being rolled out in public hospitals in New South Wales, Australia (see my Mar. 5, 2011 post "<a href="http://hcrenewal.blogspot.com/2011/03/on-emr-forensic-evaluation-from-down.html">On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts</a>"), hit the ball out of the park: <blockquote>Prof. Patrick to AMIA cis-wg: I think such defences are particularly unuseful especially with respect to the dismissal of personal stories and experiences as "anecdotes", hence committing them to the realm of folklore. I offer these notions as a counterpoint. Discounting Anecdotes: 1. Is a perfidious and specious act. 2. It denies early warning signs of problems. 3. It denies a voice and disempowers the working clinical community who have to operationalise decisions made by others. 4. It denies a route to process improvement within an institution - which is most important for EBM and incremental review of local processes. 5. It defends software manufacturers from fault rectification - cuts off even a need to deliberate on it. Critics of the value of anecdotes are squarely on the side of the faulty and deficient manufacturer. 6. A rule of project management is that projects consist of 3 components, cost, quality and time and if their needs to be a compromise it has to be on quality. Anecdotes are early warning signs of such a compromise. </blockquote><blockquote> </blockquote>Prof. Patrick had to once again put the lie to this refrain at a comment on the HISTalk blog yesterday, where the anonymous proprietor <a href="http://histalk2.com/2011/03/06/monday-morning-update-3711/">had written in a review of Patrick's EHR study</a>: <blockquote>... On the other hand, I wouldn’t say it’s [Prof. Patrick's Cerner FirstNet study] necessarily unbiased, it focuses on implementation of a single department application that didn’t go well for a variety of reasons (despite many successful FirstNet implementations elsewhere), it uses the unchallenged anecdotal comments of unhappy users who make it clear they liked their previous EDIS better, and it nitpicks (I wasn’t moved to find a pitchfork when I learned that the primary keys in the Millennium database aren’t named consistently). [Considering the complexity and changeability of healthcare and the corresponding software lifecycle, I duly note that that latter attitude about 'failing to find pitchforks' regarding breaches of sound software engineering practices seems to be a symptom of the larger health IT disease that Prof. Patrick writes about - ed.] </blockquote> Dr. Patrick then knocked the ball out of the Southern Hemisphere with a <a href="http://histalk2.com/2011/03/06/monday-morning-update-3711/#comment-14097">comment of his own</a> about anecdotalism and a link to an expansion of the aforementioned ideas he'd shared on "discounting anecdotes": <blockquote>Prof. Patrick to HISTalk owner: Your Comment “it uses the unchallenged anecdotal comments of unhappy users ” is not only unfair but unreasonably inaccurate. The comments made by the users are the Directors of 7 EDs and so they have a right to carry authority by virtue of the experience but also the number of 6 out 7 presenting a view of Firstnet as unfit for purpose has numeric validity, which they justify with about 20+ pages of their comments – see Part 2 Appendix 2. I would also point readers to my editorial about the role of personal experiences being the most useful information to understand the nature of socio-technical failures. <a href="http://aci.schattauer.de/en/contents/archive/issue/1124/manuscript/15463/show.html" rel="nofollow">http://aci.schattauer.de/en/contents/archive/issue/1124/manuscript/15463/show.html</a></blockquote> The essay at that link, "The Validity of Personal Experiences in Evaluating HIT", is an editorial in Johns Hopkins informaticist Chris Lehmann's brilliant new journal "<a href="http://aci.schattauer.de/en/contents/archive.html">Applied Clinical Informatics</a>." The editorial is available free, and is a must-read for anyone in a decision-making or managerial role in mission critical domains, including our elected representatives. In the editorial Dr. Patrick concludes. similarly to his earlier AMIA mailing list opinion: <blockquote> ... the denial of recounted personal experiences in discussion and analysis of HIT is biased and specious and has the effect of: 1. Denying early warning signs of problems. 2. Denying a voice for the working clinical community who have to operationalise decisions made by others and thus disempowers them. 3. Denying process improvement within an institution – which is most important for Evidence Based Medicine and incremental review of local processes. 4. Discourages staff from engaging in any form of process improvement hence worsening the sense of disenchantment. Every legitimate personal experience of a HIT deserves to be considered on its merits lest we wish to retreat from process and product improvement. Mechanisms of censorship both implicit due to contrived processes of disinformation and disempowerment or explicit due to contractual specifications will lead to more waste, lost productivity, contempt for the providers, and distress among frontline staff rather than increased productivity and improved patient health and safety as we all desire. </blockquote> In my view, the drivers or motivators for the "anecdotalist" accusation are these, singly or in combination: <ul><li>Too much "education" to see the nose on one's face, as in, to think zebras and unicorns instead of horses when hearing hoofbeats outside one's midwest U.S. abode (eggheads); </li><li>Too little common sense (fools), as in <a href="http://www.morgantownbrights.com/2009/09/10/you-are-wrong-because/">Scott Adams' example</a>: "IGNORING ALL ANECDOTAL EVIDENCE - Example: I always get hives immediately after eating strawberries. But without a scientifically controlled experiment, it’s not reliable data. So I continue to eat strawberries every day, since I can’t tell if they cause hives"; </li><li>Too much concern for the possible interruption of flow of money or power in one's direction (<a style="font-weight: bold;" href="http://www.thefreedictionary.com/gonif">gonifs</a>). </li></ul> In conclusion, the anecdotalist refrain of "your evidence is anecdotal" [therefore of little or no value] when used repetitively against competent observers is the refrain of eggheads, fools and gonifs. In healthcare, the end result is "your patient's dead." My "anecdotal relative" injured in a mid-2010 HIT mishap is sadly an example. [June 2011 addendum: <a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">my relative</a>, after much suffering, has now died of complications of the "anecdotal HIT mishap" - ed.] As for myself, I am a Markopolist (see my Sept. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/09/health-it-on-anecdotalism-and.html">Health IT: On Anecdotalism and Totalitarianism</a>"). -- SS

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

At my Sept. 2010 post " The Dangers of Critical Thinking in A Politicized, Irrational Culture " I lamented that while my early men...

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