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More on "Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality"

I wrote earlier at "<a href="http://hcrenewal.blogspot.com/2011/01/blogscan-electronic-health-records-and.html">BLOGSCAN - Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality</a>" that: <blockquote>More on the primary article later. I'm busy managing the medical care of my relative's EHR-related 2010 injuries.</blockquote> Now that I have some time, here are my thoughts on the article, and on a critique of that article published at the same time. The article itself is at: <a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.527">Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality </a> Max J. Romano, BA; Randall S. Stafford, MD, PhD Arch Intern Med. Published online January 24, 2011. doi:10.1001/archinternmed.2010.527 and the critique is at: <a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.518v1">Clinical Decision Support and Rich Clinical Repositories: A Symbiotic Relationship: Comment on "Electronic Health Records and Clinical Decision Support Systems"</a> Clement McDonald and Swapna Abhyankar Arch Intern Med. 2011;0(2011):20105181-2 [note - I know Dr. McDonald personally - ed.] I restrict my comments to commercially available healthcare IT from traditional for-profit health IT merchants. These comments may not apply, or may not apply as directly, to open source EMR's (such as VistA and VistA-based products e.g., WorldVista). First, I find the article's first major result not very surprising: <blockquote>In only 1 of 20 indicators was quality greater in EHR visits than in non-EHR visits (diet counseling in high-risk adults, adjusted odds ratio, 1.65; 95% confidence interval, 1.21-2.26)</blockquote> This is consistent with my belief that the primary problems in healthcare quality are not in the domain of record keeping, whether paper or computerized. Thus, as I wrote at "<a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">Is Healthcare IT a Solution to the Wrong Problem?</a>", EMR's alone are a 'solution to the wrong problems.' They may solve bookkeeping issues, but they don't help clinicians, and in fact probably impair more than aid them due to the <a href="http://www.tinyurl.com/hostileuserexper">mission hostile user experience</a> they often present. The second major conclusion is more debatable: <blockquote>Among the EHR visits, only 1 of 20 quality indicators showed significantly better performance in visits with CDS [clinical decision support -ed.] compared with EHR visits without CDS (lack of routine electrocardiographic ordering in low-risk patients, adjusted odds ratio, 2.88; 95% confidence interval, 1.69-4.90)</blockquote> This result is more debatable due to the nature of, and limitations within, the study. CDS "done well" (two simple words behind which lay massive, perhaps <a href="http://en.wikipedia.org/wiki/Wicked_problem">wicked problem</a>-level sociotechnical complexity) might actually improve guideline adherence by ambulatory care physicians. The major challenge is in "doing it well" (both EHR and CDS) and getting the good data required to do CDS well under the substantial impediments posed by a dysfunctional health IT ecosystem as I wrote about <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem">here</a>, and an oppressive environment for medical practitioners forcing them to "do more in less time" in the interests of money, often due to governmental interference in care. These observations suggest that before tackling national EMR and CDS, we should be tackling the dysfunctions of the health IT industry and ecosystem. The article did utilize some of the best data available to researchers: <blockquote>DATA SOURCE We used the most recent data available from the National Ambulatory Medical Care Survey (NAMCS, 2005-2007) and the National Hospital Ambulatory Medical Care Survey (NHAMCS, 2005-2007), both conducted by the National Center for Health Statistics (NCHS, Hyattsville, Maryland). These surveys gather information on ambulatory medical care provided by nonfederal, office-based, direct-care physicians (NAMCS)<a href="" name="RREF-IOI05178-21"></a><a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.527#REF-IOI05178-21">21</a> and provided in emergency and outpatient departments affiliated with nonfederal general and short-stay hospitals (NHAMCS).<a href="" name="RREF-IOI05178-22"></a><a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.527#REF-IOI05178-22">22</a> These federally conducted, national surveys are designed to meet the need for objective, reliable information about US ambulatory medical care services.<a href="" name="RREF-IOI05178-23"></a><a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.527#REF-IOI05178-23">23</a> These data sources have been widely used by government and academic research to report on patterns and trends in outpatient care.</blockquote> I don't believe the findings can be challenged on the basis of faulty data. The quality of care indicators chosen also were well thought out: <blockquote>QUALITY-OF-CARE INDICATORS Our analysis of quality of care used a selected set of 20 quality indicators that had previously been used to assess quality using NAMCS/NHAMCS<a href="" name="RREF-IOI05178-26"></a><a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.527#REF-IOI05178-26">26</a> but that had been updated to reflect changes in clinical guidelines. Each indicator represents a care guideline whose adherence can be measured using the visit-based information available from NAMCS/NHAMCS visit records. The indicators were developed using broad criteria established by the Institute of Medicine (clinical importance, scientific soundness, and feasibility for indicator selection) and specific criteria based on the NAMCS/NHAMCS data sources. The indicators fall into 5 categories: (1) pharmacological management of common chronic diseases, including atrial fibrillation, coronary artery disease, heart failure, hyperlipidemia, asthma, and hypertension (9 indicators); (2) appropriate antibiotic use in urinary tract infection and viral upper respiratory infections (2 indicators); (3) preventive counseling regarding diet, exercise, and smoking cessation (5 indicators); (4) appropriate use of screening tests for blood pressure measurement, urinalysis, and electrocardiography (3 indicators); and (5) inappropriate prescribing in elderly patients (1 indicator).</blockquote> It should be recalled that this article is in many ways a follow up to the article "Electronic Health Record Use and the Quality of Ambulatory Care in the United States (Arch Intern Med. 2007;167:1400-1405, link to abstract <a href="http://archinte.ama-assn.org/cgi/content/short/167/13/1400">here</a>). The article's authors: <blockquote>... performed a retrospective, cross-sectional analysis of visits in the 2003 and 2004 National Ambulatory Medical Care Survey. We examined EHR use throughout the United States and the association of EHR use with 17 ambulatory quality indicators. Performance on quality indicators was defined as the percentage of applicable visits in which patients received recommended care.</blockquote> That article's authors reached what to many was a counterintuitive conclusion. The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators. They concluded that “as implemented, EHRs were not associated with better quality ambulatory care.” (To medical informaticists, the key phrase that explains these findings is “as implemented”, to which I would also add “as designed”, i.e., badly.) In the latest article, obvious confounding variables appear to have reasonably been taken into account: <blockquote>Performance on each quality indicator was defined as the proportion of eligible patients receiving guideline-congruent care so that a higher proportion represents greater concordance with care guidelines. Attention was paid to excluding those patients with comorbidities that would complicate guideline adherence (eg, asthma in assessing the use of β-blockers in coronary artery disease). Also, in some instances, care was adherent to the quality indicator if a similar therapy was provided (eg, warfarin rather than aspirin in coronary artery disease).</blockquote> With regard to the authors' comments: <blockquote>In a nationally representative survey of physician visits, neither EHRs nor CDS was associated with ambulatory care quality, which was suboptimal for many indicators.</blockquote> As I mentioned, the first part of this statement represents a more solid a conclusion than the second. However, one must ask why the first conclusion (EHR's without CDS not associated with better ambulatory care quality) might be so. <ul><li>Was the study flawed in some way? As per the previous paragraphs, I don't think so.</li><li>Were factors in the real world clinical environment not amenable to cybernetic intervention responsible? This seems likely, such as harried and/or poorly trained physicians, pressured visit time limitations, and other factors that make EHR's a band aid at best.</li><li>Were EHR's a solution to the wrong problem? If documentation issues are not a significant factor in ambulatory care quality (physicians and patients do speak to one another, after all), then EHR's would not be expected to have much additional impact. This also seems likely.</li><li>Were the EHR's suboptimal? <a href="http://www.tinyurl.com/hostileuserexper">Mission hostile IT</a> certainly should not be expected to have a large positive effect on the behavior of users.</li></ul> Regarding the finding that even EHR's with CDS do not make a significant difference in compliance with treatment guidelines, one might also ask (as the authors of the critique did) if: <ul><li>the CDS of the clinical IT in use did not cover the indicators measured. The indicators, however, are not particularly unusual or esoteric. It would therefore surprise me if there were few or no major intersections. (If this was the case, it would speak poorly of the commercial HIT merchants and their products.)</li><li>The CDS implementation itself were mission hostile, making it difficult for users to carry out the recommendations in their harried, time limited visits.</li></ul>Either issue goes back to my point about correcting the IT ecosystem before rolling out this technology at a cost of hundreds of billions of dollars. The authors state: <table border="0" cellpadding="0" cellspacing="0"><tbody></tbody></table><blockquote> While our findings do not rule out the possibility that the use of CDS may improve quality in some settings, they cast doubt on the argument that the use of EHRs is a "magic bullet" for health care quality improvement, as some advocates imply.</blockquote> Yes, right up to the POTUS and the HHS ONC office such as: <blockquote dir="ltr" style="margin-right: 0px;"><div dir="ltr">... The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice. (ONC Chair Blumenthal in the NEJM).</div></blockquote><div dir="ltr"> </div> <div dir="ltr">and this:</div><blockquote dir="ltr" style="margin-right: 0px;"><div dir="ltr"> </div><div dir="ltr">“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.</div></blockquote> As I wrote at "<a href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html">Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>", no, we don't know that. The assertion about "every study and consensus process" is demonstrably false. I think anyone still believing in IT as any type of "magic bullet" needs to be disqualified from involvement in healthcare. On a matter of my own critique of the article, there's this: <blockquote>Several anecdotal articles describe how CDS can disrupt care and decrease care quality; however, further empirical research is needed.<a href="" name="RREF-IOI05178-35"></a><a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.527#REF-IOI05178-35">35</a>-<a href="" name="RREF-IOI05178-36"></a><a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.527#REF-IOI05178-36">36</a> In the absence of broad evidence supporting existing CDS systems, planned investment should be monitored carefully and its impact and cost evaluated rigorously.</blockquote> As in my posts "<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>", "<a href="http://hcrenewal.blogspot.com/2011/01/ehr-problems-no-theyre-merely.html">EHR Problems? No, They're Merely Anecodotal</a>" and "<a href="http://hcrenewal.blogspot.com/2010/09/health-it-on-anecdotalism-and.html">Health IT: On Anecdotalism and Totalitarianism</a>", there's that shibboleth term "<a href="http://hcrenewal.blogspot.com/2011/01/ehr-problems-no-theyre-merely.html">anecdotal</a>" again. The "anecdotal" articles do not include the work of <a href="http://jama.ama-assn.org/content/293/10/1197.abstract">Koppel</a>, <a href="http://www.stanforddaily.com/2010/05/11/computerized-system-may-reduce-hospital-mortality/">Hahn</a> or others who did extensive empirical research and found major problems and increased risks of error created by CPOE and bar coding, to name two variations of clinical IT thought to be "slam dunks" for improved care delivery. Further, the "anecdotes" of HIT malfunction <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">in sites such as the FDA's MAUDE database</a> are alarming to me due to the obvious risk to patients they reflect - whether injuries occurred or not (there is a <a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">patient death account</a> in MAUDE as well), but apparently not to the academic community or ONC, which is chaired by an academic: <div dir="ltr"></div><blockquote dir="ltr" style="margin-right: 0px;"><div dir="ltr"><a href="http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented">http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented</a> ... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said. (Also see <a href="http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html">http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html</a>).</div></blockquote> [2011 Addendum:  A definitive response to the "anecdotes" issue is at this Aug. 2011 post:  "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things",  <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html</a>] It has occurred to me that this "what - me worry?" polyanna attitude may reflect an academic bias or over-zealotry regarding peer review and retrospective event descriptions - as opposed to risk. By way of career history, I often lunched with the Director of System Safety of the regional transit authority I once worked for, and accompanied him on site visits; it was amazing how fast he could identify potential risks in sites we visited, both within and outside the authority (e.g., external drug testing laboratories). He identified risks based on personal expertise and experience, and did not seek peer review of his assessments. He sought (and received) action. He thought, and I, partially as a result of this exposure, think proactively in terms of risk, not retrospectively in terms of confirmed, peer reviewed accident reports. On that basis, the 1999 appearance of my site on health IT problems and the commentary initially received, still online at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/informaticsmd/opinions1.htm">this link</a>, should have resulted in significant concern from the HIT academic community, were it not for the aforementioned "lensing effect" of their stations in the domain. Its being passed off as of little more than "anecdote" (a critique I still hear about the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">modern site</a>) was a disappointment for someone of my heterogeneous background. I expressed my views on this issue in a <a href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html?showComment=1285778752781#c9179497987287096166">comment</a>: <blockquote>I am quite fed up with the positivist-extremist academic eggheads whose views are so beyond common sense regarding 'anecdotes' of health IT harm from qualified users and observers, that they would find 'anecdotal stories' of people being scalded when opening hot car radiators as merely anecdotes, and do likewise. These people have been part of the crowd that's led to irrational exuberance on health IT at a national level. As Scott Adams put it regarding the logical fallacy known as: 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. </blockquote> I think that summarizes the "academic lensing effect" regarding risk of HIT. I can also critique the near lack of mention of EHR quality issues: <blockquote>At the same time, our findings may suggest a need for greater attention to quality control and coordinated implementation to realize the potential of EHRs and CDS to improve health care.</blockquote> My comment to this is: you don't say? As I've often written, healthcare will not be reformed until health IT itself is reformed. Finally, on the published critique of the article, I find this passage remarkable: <blockquote> Regardless of the differences, we know from multiple randomized controlled trials that well-implemented CDS systems can produce large and important improvements in care processes. What we do not know is whether we can extend these results to a national level. The results of Romano and Stafford's study suggest not. However, we suspect that the EHR and CDS systems in use at the time of their study were immature, did not cover many of the guidelines that the study targeted, and had incomplete patient data; a 2005 survey of Massachusetts physicians supports this concern.<a href="" name="RREF-IIC05061-5"></a><a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.518v1#REF-IIC05061-5">5</a> On the other hand, we are not surprised that EHRs without CDS do not affect guideline adherence, because without CDS, most EHRs function primarily as data repositories that gather, organize, and display patient data, not as prods to action.</blockquote> It's remarkable in several aspects: <ul><li>First, the refrain of "immature systems" or, expressed more colloquially, a "versioning problem" seems to come up when health IT is challenged. One survey of physicians in one state aside, the fact that more fundamental issues of health IT fitness for purpose and usability are usually not mentioned is striking, as here.</li><li>If the systems were indeed "immature" just several years ago, this speaks poorly for the health IT merchants and their products (as well as the buyers), and back we go to the issue of remediating the HIT ecosystem before we attempt to remediate medicine with its products.</li><li>The final statement about EHR's lacking CDS not being "prods to action" raises the question: why were extraordinary claims made for EHR's in the past several decades, and why were so many organizations buying EHR's without equally extraordinary evidence?</li></ul> Regarding the following assertion in the critique: <blockquote>Although EHRs without CDS may not improve adherence to clinical guidelines, they are (1) a necessary precondition for having CDS (without electronic data, there can be no electronic support functions); (2) valuable for maintaining findable, sharable, legible, medical records; and (3) when they are amply populated (ie, they contain at least 1 or 2 years of dictations, test results, medications, and diagnoses/problems), physicans love them because there are no more lost charts or long waits on the telephone for laboratory results. </blockquote> I make the following observations: <ul><li>Re (1): could extra support staff markedly increase "decision support" at the point of care using paper methods, at a fraction of the cost of health IT?</li><li>Re (2): legible, yes; useful, perhaps not. The near 3000 pages generated by a fraction of my relative's long hospitalization due to HIT-related injury, covering only the first two and a half week hospitalization, were very legible. Very legible; very filled with legible gibberish, unfortunately; and very useless to most humans needing to review her case and render additional care. This problem once again goes to the need to address problems within the HIT ecosystem.</li><li>Re: (3) I would like a reference for the statement about "physicians loving their EHR." Due to the extra efforts and expense involved, it would seem even under the best of circumstances to be a love-hate relationship. Surveys like this one (<a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">link</a>) support that notion.</li></ul> Still more on physicians "loving" EHR's: <blockquote><a href="http://www.healthdatamanagement.com/news/survey-reform-ehr-physicians-41764-1.html">Survey: Docs Skeptical of EHRs, Hate Reform</a> Health Data Management, January 20, 2011 A recent survey of nearly 3,000 physicians shows high levels of displeasure with the Affordable Care Act--and a lot of them don't like electronic health records either. Of the 2,958 physicians surveyed in September, only 39 percent believe EHRs will have a positive effect on the quality of patient care. Twenty-four percent believe EHRs will have a negative effect on quality, and 37 percent forecast a neutral factor. HCPlexus, publisher of the The Little Blue Book reference guide for physicians, developed and conducted the survey with content vendor Thomson Reuters. The survey sample came from physicians in HCPlexus' database. The fax-based survey was done in September 2010, with additional information directly gathered via phone or e-mail from hundreds of the surveyed physicians in December and January.</blockquote> In conclusion, the new Archives article represents yet another data point challenging uncritical assertions of automatic EHR-created medical improvement. I agree with both the article's authors and those who wrote the critique that more reserch is needed (not more fast-paced implementation). As concluded in 2009 by the National Research Council <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">in a study led by several HIT pioneers</a>: <blockquote>Current efforts aimed at the nationwide deployment of health care information technology (IT) will not be sufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause ... In the long term, success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering. </blockquote> These words should not be ignored. -- SS

More on "Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality"

I wrote earlier at " BLOGSCAN - Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Qua...

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BLOGSCAN - Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality

From the blog of Dr. Sanjay Gupta at CNN health: <blockquote><a href="http://pagingdrgupta.blogs.cnn.com/2011/01/24/electronic-health-records-no-cure-all/">Electronic health records no cure-all</a> <div class="cnnBlogContentPost"> Electronic medical records, also known as EHRs, often touted as a powerful antidote for uncoordinated and ineffective medical care, do little to help patients outside the hospital, according to a new study. Researchers from Stanford University analyzed federal data on more than 255,000 patients, about a third of whom had health information carried electronically. The researchers compared the care of those patients to the care of patients without EHRs, on 20 different measures of quality – for example, whether proper medication was prescribed for patients with asthma or simple infections, or whether smokers were counseled on ways to quit. On 19 of the 20 measures, there was no benefit from having an EHR. The one exception was dietary advice: Patients at high-risk for illness were slightly more likely to receive counseling on a proper diet. The U.S. Department of Health and Human Services has pushed hard to encourage the adoption of electronic medical records, including $<a href="https://www.cms.gov/ehrincentiveprograms/">19 billion worth of incentives</a> for doctors and hospitals. A move to EHRs is one of the less controversial aspects of health care reform, and the shift is <a href="http://money.cnn.com/2009/01/12/technology/stimulus_health_care/">often touted by President Obama</a>. But skeptics say there are serious risks to an overreliance on EHRs, from missing information to simple computer crashes. A report last month from the ECRI Institute, a respected organization that studies science and health issues, listed “data loss and system incompatibilities” as one of ten “<a href="https://www.ecri.org/Press/Pages/Top-10-Health-Technology-Hazards-List-2011.aspx">Top 10 Health Technology Hazards for 2011</a>.” Jeffrey C. Lerner, president and chief executive officer of the ECRI Institute, said the new findings are no surprise. "It is reasonable to assume that electronic health records will ultimately help the cause," he told CNN in an email, "but new technology has a learning curve. [Somehow, this "new technology" that dates back decades is having one hell of a long learning curve - ed.] Think of your smart phone. Improving quality will remain a tough challenge, but avoiding technology use doesn’t sound like an alternative.” To examine whether better technology might help, the Stanford team also looked at whether care was better when physicians used a computer system to help guide them through treatment options. It barely made a difference. The project was started by Max Romano, an undergraduate at the time who now studies medicine at Johns Hopkins University. The final paper was co-written with Dr. Randall Stafford, a professor at the Stanford Prevention Research Center. "Our initial hope was that we would see a correlation between electronic health records and quality, and when we looked at the subset of patients whose doctors got help from the clinical decision support systems [decision-making software], we'd see an even stronger relationship," says Stafford. "Perhaps we need to re-examine the naive assumption that just putting in place an EHR system will make a huge difference." [That's called "technological determinism" - ed.] While praising federal efforts to standardize and streamline EHRs, Stafford said the findings raise serious questions about the scope and speed of the $19 billion campaign. "There is a need to question investing that much societal resource in electronic health records when we really don’t know the answer of what effects those are going to have. Having made that decision, it's incumbent for us to demand exactly what we have gotten out of the investment." </div> <div class="cnnPostFooter"> <table border="0" cellpadding="0" cellspacing="0"> <tbody> <tr> <td class="cnn_padb20 cnn_author_info" valign="top">Post by: <a href="http://pagingdrgupta.blogs.cnn.com/tag/caleb-hellerman-cnn-medical-senior-producer/" rel="tag">Caleb Hellerman - CNN Medical Senior Producer</a> </td></tr></tbody></table></div></blockquote> Once again, as I pointed out <a href="http://hcrenewal.blogspot.com/2011/01/you-heard-most-of-this-first-on.html">here</a>, you've seen these questions raised long ago at Healthcare Renewal and at a much older site on health IT difficulties the authors may not be aware of, specifically <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">here</a>. The CNN post describes results reported online in the Archives of Internal Medicine: <a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.527"> Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality </a> Max J. Romano, BA; Randall S. Stafford, MD, PhD Arch Intern Med. Published online January 24, 2011. doi:10.1001/archinternmed.2010.527 More on the primary article later. I'm busy helping managing the medical care of my relative's 2010 EHR-related injuries. -- SS Addendum: My followup post on the primary article is <a href="http://hcrenewal.blogspot.com/2011/01/more-on-electronic-health-records-and.html">here</a>.

BLOGSCAN - Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality

From the blog of Dr. Sanjay Gupta at CNN health: Electronic health records no cure-all Electronic medical records, also known as EHRs, of...

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St Jude Medical Settles Again

Here we go again to kick off the week, legal settlements, cardiac devices, alleged kickbacks, manipulated research, as <a href="http://www.bloomberg.com/news/2011-01-21/st-jude-agrees-to-pay-16-million-to-settle-government-kickback-probe.html">reported</a> by Bloomberg: Another Legal Settlement by St Jude Medical <blockquote>St. Jude Medical Inc. agreed to pay $16 million to settle a U.S. government probe of claims the company paid kickbacks to doctors who implanted its heart devices in patients. The accord resolves a five-year investigation of St. Jude’s marketing practices for defibrillators and pacemakers. </blockquote> This was not even the first recent settlement by this particular company: <blockquote>In June, St. Jude agreed to pay the federal government $3.7 million to resolve a separate whistleblower case over claims that it made illegal payments to hospitals in Kentucky and Ohio that used the company’s heart devices. </blockquote> Our relevant post about that previous settlement was <a href="http://hcrenewal.blogspot.com/2010/06/st-jude-medical-settles.html">here</a>. Kickbacks, Manipulated Research <blockquote>The $16 million settlement stemmed from a case filed by Charles Donigian, a former St. Jude technician from St. Louis, who accused the company of using kickbacks to market products. The kickbacks, which ranged as high as $2,000 per patient, came in the form of 'sham fees' for phony clinical-research studies on the devices, Donigian said in his suit. </blockquote> There was slightly more detail in a <a href="http://www.theheart.org/article/1175639.do">report</a> in TheHeart.org: <blockquote>According to the DoJ, the company used postmarketing studies and a registry as vehicles to reward physicians participating in those studies to implant the devices. 'In each case, St Jude paid each participating physician a fee that ranged up to $2000 per patient,' a statement from US Attorney Carmen M Ortiz notes. 'The United States alleges that St Jude solicited physicians for the studies in order to retain their business and/or convert their business from a competitor's product.' The statement also observes: 'Although St Jude collected data and information from participating physicians, it knowingly and intentionally used the studies and registry as a means of increasing its device sales by paying certain physicians to select St Jude pacemakers and ICDs for their patients.'</blockquote> Summary It all is getting so old, isn't it? Yet another pharmaceutical, biotechnology or device company settles a case alleging payments to physicians to induce them to use its products. The twist here is that the form of the payment allegedly also manipulated the clinical research process. There have been other cases of manipulation or suppression of research about cardiac devices. For example, see our <a href="http://hcrenewal.blogspot.com/2011/01/guidant-boston-scientific-gets.html">recent post</a> about how Guidant, now a subsidiary of Boston Scientific, was put on probation for its actions in another such case. The allegations amounted to serious external threats to physicians' professionalism: payments to promote use of health care products whether or not their implantation was in patients' best interests, and manipulation of clinical research that could have further corrupted the clinical evidence base, and presumably could have broken the trust of clinical research subjects. Left unsaid in the brief articles is how willingly the physicians gave in to these threats to their professionalism for the dollars involved. Yet despite the apparently corrosive quality of the bad behavior, the penalties to the company were trivial. Per St Jude Medical's <a href="http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-fundsnapshot">most recent financial profile</a>, its yearly revenue was over $4.5 billion.  Two settlements totaling less than $20 million amount to a relatively small cost of doing business.  And note that St Jude Medical is not admitting it did anything wrong.  Per TheHeart.org, its statement was: <blockquote>We are pleased to have reached a settlement agreement with the DoJ that fully resolves the postmarket-study matter in Boston. The company maintains that its postmarket studies and registries are legitimate clinical studies designed to gather important scientific data, and St Jude Medical does not admit liability or wrongdoing by entering into this agreement. The company entered into a settlement agreement to avoid the potential costs and risks associated with litigation. This settlement brings the previously reported postmarket-study investigation to a close.</blockquote> So it all gets so tiresome. The continuing <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements </a>like this do provide evidence of how professionalism and evidence-based medical practice are under threat. However, as we have said ad infinitum, such settlements are likely to do nothing to alleviate that threat. To repeat the conclusion of our last post about St Jude Medical, the usual sorts of legal settlements we have described do not seem to be an effective way to deter future unethical behavior. Even large fines (and the one described above would be peanuts to a large health care corporation) can be regarded just as a cost of doing business. Furthermore, the fine's impact may be diffused over the whole company, and ultimately comes out of the pockets of stockholders, employees, and customers alike. It provides no negative incentives for those who authorized, directed, or implemented the behavior in question. My refrain has been: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

St Jude Medical Settles Again

Here we go again to kick off the week, legal settlements, cardiac devices, alleged kickbacks, manipulated research, as reported by Bloomber...

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Is the Executive Branch/HHS Trying to Put Lipstick on a Pig Regarding Health IT?

In another example of executive branch spin on healthcare - this time, the <a href="http://healthit.hhs.gov/portal/server.pt?open=512&objID=1200&mode=2">Office of the National Coordinator of Health IT</a> (ONC) within <a href="http://www.usa.gov/Agencies/Federal/Executive/HHS.shtml">HHS</a> - data that gave an off-narrative message about healthcare IT was initially withheld according to Modern Healthcare's Joseph Conn. The data withholding is reminiscent of the data manipulation practiced in the pharmaceutical industry. Legislative branch, take note: <div style="border: medium none; text-align: left; background-color: transparent; color: rgb(0, 0, 0); overflow: hidden; text-decoration: none;"> <blockquote> <a href="http://www.modernhealthcare.com/article/20110124/blogs02/301249999">Not-so-rosy rumors</a>By Joseph ConnModern Healthcare.com Last week, Dr. David Blumenthal <a href="http://www.modernhealthcare.com/article/20110117/blogs02/301179963">announced the results</a> of two surveys funded by the Office of the National Coordinator for Health Information Technology on hospital and physician participation in the federal electronic health-record incentive programs. But Dr. B left out a few numbers in going over the results of the survey of office-based physicians conducted by the National Center for Health Statistics. On request, the ONC and NCHS released those missing numbers. Docs were asked: "Are there plans to apply for Medicare or Medicaid incentive payments for <a href="http://www.modernhealthcare.com/meaningfuluse">meaningful use</a> of health IT?" Blumenthal reported on their answers in part, noting that 41.1% indicated "yes" and 14% said "no." However, a 44.9% plurality, which he did not mention, chose "uncertain whether we will apply." [<a href="http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html">Nothing to see here</a> ... move along - ed.] Those who answered "yes" were asked a follow-up question: "What year do you expect to apply for the meaningful-use payments?" Of the 41.1% of docs who indicated they were sure they would apply (a figure Blumenthal released), nearly one in five (19.7%, a number he didn’t mention) were unsure as to when. [Must be the Luddite faction - ed.] Additionally, the NCHS asked physicians, "Which incentive payment do you plan to apply for?" Their responses to this question also weren’t mentioned by Blumenthal last week. Not surprisingly, given current eligibility thresholds, 65.1% selected Medicare and just 6.8% chose Medicaid, but again there was considerable uncertainty, with 28.2% choosing "unknown" or leaving the choice blank. [This finding suggests rank confusion to me more than anything else. In case nobody noticed, physicians are rather busy these days taking care of patients, and don't have time to find out what's in lengthy government documents - ed.] </blockquote> Read the whole article. It seems the executive is simply determined to push this technology onto a significantly skeptical physician community - skeptical of the incentives, of MU, of government intentions, and/or of the technology itself. Of course, perhaps they feel that such data on a beneficent technology that will absolutely, positively benefit medicine and patients needs to be withheld - for the greater good, of course, which some people have to suffer to achieve (see the post "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">MAUDE and HIT Risks: Mother Mary, What in God's Name is Going on Here?</a>"). ONC on healthcare IT in recent months: <blockquote><a href="http://healthcarereform.nejm.org/?p=3732&query=home">http://healthcarereform.nejm.org/?p=3732&query=home </a> ... The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice. (Also see <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html</a>). and <a href="http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented">http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented</a> ... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said. (Also see <a href="http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html">http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html</a>). </blockquote> A good number of physicians still appear to possess critical thinking skills. Perhaps the new Congress (i.e., legislative branch) can benefit from physician-style skepticism about health IT as well. -- SS </div>

Is the Executive Branch/HHS Trying to Put Lipstick on a Pig Regarding Health IT?

In another example of executive branch spin on healthcare - this time, the Office of the National Coordinator of Health IT (ONC) within HHS...

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The Impact of eHealth on the Quality and Safety of Health Care: You Heard Much of This First On Healthcare Renewal ...

A PLoS article was recently published on health IT's impacts on healthcare quality and safety. In the article, a form of meta-research was performed; systematic review articles were collected and then reviewed systematically. <blockquote>Black AD, Car J, Pagliari C, Anandan C, Cresswell K, et al. (2011) The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview. PLoS Med 8(1): e1000387. doi:10.1371/journal.pmed.1000387.</blockquote> A text version can be seen at <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387">this link</a> and a PDF downloaded at <a href="http://www.plosmedicine.org/article/fetchObjectAttachment.action;jsessionid=472E204B9D8D4CB5CF520DEB894BFA55.ambra02?uri=info%3Adoi%2F10.1371%2Fjournal.pmed.1000387&representation=PDF">this link</a>. I will reproduce only the abstract here, and then make a few comments (over and above the hundreds of posts on these issues I've authored at this blog since 2004): <blockquote>The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview.Ashly D. Black<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff1">1</a>, Josip Car<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff1">1</a>, Claudia Pagliari<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff2">2</a>, Chantelle Anandan<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff2">2</a>, Kathrin Cresswell<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff2">2</a>, Tomislav Bokun<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff1">1</a>, Brian McKinstry<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff2">2</a>, Rob Procter<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff3">3</a>, Azeem Majeed<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff4">4</a>, Aziz Sheikh<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff2">2</a><a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#cor1" class="fnoteref">*</a><a name="aff1" id="aff1"></a>1 eHealth Unit, Department of Primary Care and Public Health, Imperial College London, London, United Kingdom, <a name="aff2" id="aff2"></a>2 eHealth Research Group, Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, United Kingdom, <a name="aff3" id="aff3"></a>3 National Centre for e-Social Science, University of Manchester, Manchester, United Kingdom, <a name="aff4" id="aff4"></a>4 Department of Primary Care and Public Health, Imperial College London, London, United Kingdom<h2>Abstract<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#top"></a></h2> <h3>Background</h3> There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. [I believe it would be more accurate to write "always at considerable cost, with generous profits being made by the IT merchants, implementers and consultants"- ed.] In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care. <h3>Methods and Findings</h3> We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment strategies are lacking. <h3>Conclusions</h3> There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. [You've heard that here before - ed.] In addition, there is a lack of robust research on the risks [I believe it would be more accurate to say there's been a suppression of research and/or of publicity on the risks - ed.] of implementing these technologies and their cost-effectiveness has yet to be demonstrated [in other words, healthcare IT is an experimental technology. You've heard that here before, too - ed.], despite being frequently promoted by policymakers and “techno-enthusiasts” as if this was a given. [In other words, there's an irrational - or contrived - exuberance. You've heard that here before, too - ed.] In the light of the paucity of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, it is vital that future eHealth technologies are evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle. [You've heard that here before, too - ed.] Such evaluation should be characterised by careful attention to socio-technical factors to maximise the likelihood of successful implementation and adoption. [You've heard that here before, too, as well as at my site "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</a>", as a matter of fact previously entitled "Sociotechnologic Issues in Medical Informatics...", started in 1999 - ed.]</blockquote> I can add these additional comments: <ul><li>The findings of this study were of no surprise to me or likely to readers of this blog. I've been writing on these issues since the 1990's, and on this blog since 2004.</li></ul><ul><li>In the main article itself it is stated "... there remains a disparity between the evidence-based principles that underpin health care generally and the political, pragmatic, and commercial drivers of decision making in the commissioning of eHealth tools and services." In other words, the rigor of medical science itself is lacking in healthcare IT. I've written that repeatedly here and elsewhere. I ask again: how can IT "transform" ot "revolutionize" healthcare when the culture of IT itself is in need of reform?</li></ul><ul><li>Also stated in the article's body was this: "Risks largely went ignored apart from anecdotal evidence of time-costs associated with recording of data due to both end-user skill and the inflexibility of structured data, increased costs of EHRs, and a decrease in patient-centeredness within the consultation." See my prior post "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">MAUDE and HIT Risks: Mother Mary, What in God's Name is Going on Here?</a>" for what I find as deeply concerning ("hair-raising") revelations regarding risk that you should think about next time you find yourself in a computerized hospital or doctor's office.</li></ul><ul><li>Also in the article body: "Our major finding from reviewing the literature is that empirical evidence for the beneficial impact of most eHealth technologies is often absent or, at best, only modest. While absence of evidence does not equate with evidence of ineffectiveness, reports of negative consequences indicate that evaluation of risks – anticipated or otherwise – is essential. Clinical informatics should be no less concerned with safety and efficacy than the pharmaceutical industry. [Having worked in both sectors, hospital and pharma , you've read that here before - ed.] Given this, there is a pressing need for further evaluations before substantial sums of money are committed [as you've read here in numerous posts, that's BEFORE, NOT DURING OR AFTER - ed.] to large-scale national deployments under the auspices of improving health care quality and/or safety." Are governments listening, I ask? </li></ul><ul><li>Study methodology and source material limitations were noted. However, also noted was this: "Our greatest cause for concern was the weakness of the evidence base itself. A strong evidence base is characterised by quantity, quality, and consistency. Unfortunately, we found that the eHealth evidence base falls short in all of these respects. In addition, relative to the number of eHealth implementations that have taken place, the number of evaluations is comparatively small." In my view, national re-engineering programs involving a large portion of the economy and a critical societal function should not be undertaken when the evidence base is weak and the number of evaluations is small. Further, national leaders should not be making statements of certainty such as made by the HHS ONC office as I wrote about at "<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">Science or Politics? The New England Journal and The 'Meaningful Use' Regulation for Electronic Health Records</a>" and at "<a href="http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html">Blumenthal on health IT safety: nothing to see here, move along</a>."</li></ul><ul><li>This article might be compared to the Dec. 2009 Milbank Quarterly article "Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London. I wrote about that article at <a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html">this link</a>. It was also a meta-analysis; its major conclusion was that "the tensions and paradoxes revealed in this study extend and challenge previous reviews and suggest that the evidence base for some EPR programs is more limited than is often assumed."</li></ul> Read the entire PLoS article at the links above. -- SS

The Impact of eHealth on the Quality and Safety of Health Care: You Heard Much of This First On Healthcare Renewal ...

A PLoS article was recently published on health IT's impacts on healthcare quality and safety. In the article, a form of meta-research ...

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Dr. Extormity's Testimony at Healthcare IT Hearing

At "<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>" I reproduced a physician's testimony on "Meaningful Use" of Health IT. I thought his testimony illustrated the issues quite well. However, Dr. Monteith's been outdone, this time by Dr. Extormity. Click to play: <div style="text-align: center;"><a href="http://www.youtube.com/watch?v=mYZwbtNekS8&feature=player_embedded"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5564684296131576562" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgxJvdDACxop8Np7td9Y-Btuj-LVcTu1DFXN8N8OomDi77jtHUotPuYaqk7MWSbMsOOWnRg8xdoa_yoQdrQ_x2JrMWGEaqg2yDbOFIKwJ76zBln3Om_gHEuF7diYgzfkPBE7z7BvQhEfQnI/s320/drextormity.jpg" style="cursor: pointer; display: block; height: 196px; margin: 0px auto 10px; text-align: center; width: 320px;" /></a>Dr. Extormity's Testimony at Healthcare IT Hearing - click to play. </div> Also see my May 2008 post "<a href="http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html">SEEDIE, the Society for Exorbitantly Expensive and Difficult to Implement EHR’s</a>" for more on Dr. Extormity's fine work. Note: this was a "medical humor break" of the kind Residents need to stay sane on the battlefield. (Hat tip to <a href="http://ducknetweb.blogspot.com/2011/01/extormity-ehr-testimony-at-health-it.html">ducknetweb.blogspot.com</a>). -- SS

Dr. Extormity's Testimony at Healthcare IT Hearing

At " Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith " I reproduced a physician's testimo...

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MAUDE and HIT Risks: What in God's Name is Going on Here?

As I wrote at my last post "<a href="http://hcrenewal.blogspot.com/2011/01/healthcare-it-delirium.html" style="font-family: arial;">Healthcare IT Delirium</a>": <blockquote style="font-family: arial;">The field of health IT has become delirious. On top of an irrational exuberance (see <a href="http://hcrenewal.blogspot.com/search?q=irrational+exuberance">this blog query</a>) largely unsupported by the literature (e.g. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a>), the technology is <a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment">experimental</a>, its rollout is a grand national experiment in social re-engineering of medicine, there is no patient <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">informed consent</a>, nobody is in control, and <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">nobody is taking responsibility for regulating the domain</a> despite known risks. The results will very likely reflect the Wild West free-for-all that is now extant.</blockquote> It's worse. Some time ago I posted on a number of cases of health IT malfunction from the FDA's <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">MAUDE</a> (Manufacturer and User Facility Device Experience) database of medical device risks. See posts on MAUDE <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=MAUDE">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death">here</a>. Center for Public Integrity Investigative reporter Fred Schulte had also written on the MAUDE reports and other "glitches" at a Nov. 2009 report "<a href="http://www.publicintegrity.org/2009/11/24/7011/switch-electronic-records-getting-mixed-reviews-hospitals-and-clinics" target="_blank">Switch to electronic records getting mixed reviews at hospitals and clinics</a>." <blockquote style="font-family: arial;">MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. </blockquote> Either I missed a Titanic boatload of cases, or MAUDE has been appended since my posts, because MAUDE links such as <a href="http://google2.fda.gov/search?q=maude+cerner+millenium&x=8&y=7&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&ie=UTF-8&access=p&sort=date%3AD%3AL%3Ad1&entqr=3&oe=UTF-8&ud=1&filter=0">this</a> , <a href="http://google2.fda.gov/search?q=Cerner+millenium&x=6&y=7&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&ie=UTF-8&access=p&sort=date%3AD%3AL%3Ad1&entqr=3&oe=UTF-8&ud=1&filter=0&start=50">this</a> and <a href="http://google2.fda.gov/search?q=cerner+powerchart&x=19&y=18&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&ie=UTF-8&access=p&sort=date%3AD%3AL%3Ad1&entqr=3&oe=UTF-8&ud=1&filter=0&start=30">this</a> are now returning a Mother Lode of cases, at least from one vendor where these events are reported (other vendors' products suffer similar problems). Examples just from light browsing cause the hair to stand up on my head (there are many, many more at the MAUDE links above):<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581240"></a> <blockquote face="arial"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1584195" style="font-family: arial;">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1584195</a> CERNER MILLENIUM CPOE, POWER CHART Event Type Injury Patient Outcome Life Threatening; Event Description The cpoe system serves and documents all transactions of communication pertaining to the patient's care. Orders are entered and delivered to an anticipated recipient and the action ordered is executed. The device-recipient interface has been unreliable with specific etiologies for failure not yet resolved or understood. Examples include orders to transfer patient from icu to a non-icu bed. Patient is moved to another bed but recipient care team does not receive communication and was not aware patient was under their charge. Patient had seizures on floor for hours throughout the night. Other patients had orders for lab tests, chemical tests on body fluids, cytological analysis of body fluids, cultures on body fluids, pathology on or specimen, and others that are not executed by the recipient, leaving the patient undiagnosed after having taken risks for a procedure. Such interface failures have been known by the vendor for years as reported by its own support team. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581240">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581240</a> CERNER MILLENIUM CPOE, POWERCHART Back to Search Results Event Type Injury Patient Outcome Life Threatening; Hospitalization Disability Event Description The displays, formats, layouts, and interfaces of the cpoe tools at this institution contain elevated degrees of user unfriendliness. This toxic effect on the user is manifested by, to mention a few, more than 20 electronic silos in which orders are stored and extensive wordiness using descriptors that are highly irrelevant to the task of the care of pts with critical illness. This manifests itself in several ways, one of which is the ordering of duplicate medications and treatments, some of which get to the pt. These should be reported to pharmacopoeia data bases but often are not. This pt was being infused both total parenteral nutrition and a concentrated dextrose solution, the combined rate of which and cumulative dose caused pulmonary edema. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577753">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577753</a> CERNER MILLENIUM CPOE Back to Search Results Event Type Injury Patient Outcome Life Threatening; Hospitalization Disability Event Description Stress test orders are ambiguous. An example of the order states "stress test adenosine/dobutamine w/imaging nm -stress test adenosine nm-". Order displays on 4 lines on the screen. The type of test that the doctor intended to be performed is unclear, resulting the risk of incorrect pharmacological modalities being used. This caused life threatening acute asthma attack in patient with background asthma who incorrectly received an infusion of adenosine. All patients ordered pharmacological stress tests become subject to said risk. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1578421"> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1578421</a> CERNER MILLENIUM CPOE Back to Search Results Event Type Injury Patient Outcome Life Threatening; Other Event Description When a pt having been in the hospital preoperatively, begins its post-operative course in the recovery room or intensive care unit, post op orders are electronically entered by deleting the unneeded orders that have been active, leaving the orders that are still needed, and adding new ones. There can be upwards of 300 lines of "active" orders on a complicated pt. Precise and safe post-operative ordering requires a time consuming line by line review of each order, counter-intuitively canceling those that are not needed. This does not always occur for any number of reasons, not the least of which is that the task is time consuming and user-unfriendly. The incidence of commingling the pre and post op orders in a hospital with cpoe instruments of care is unk, but not uncommon. At least one pt was placed at risk when the clean post operative abdomen was irrigated based on the pre-op order. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1574909"> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1574909</a> CERNER MILLENIUM CPOE Back to Search Results Event Type Injury Patient Outcome Life Threatening; Event Description This cpoe product allows doses to be ordered that are not a multiple-s- of the pill size. A representative example is 20mg atenolol po daily. Pill size is 25mg. This feature facilitates dosing errors and enables dangerously absurd dosing without warning. When the reports such dose having been given, the clinician is left to wonder, what dose was given, actually. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570802">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570802</a> CERNER MILLENIUM CPOE, POWER CHART Back to Search Results Event Date 07/11/2006 Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention Event Description Hospital wide breakdown of system of electric charts and electric order gadgets resulted in confusion, neglect, failed communications and delayed treatments in the days immediately following the surgery, leaving patient with permanent musculoskeletal disability and mental anguish. Breakdowns of this magnitude endanger hundreds of patients simultaneously. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1665473">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1665473</a> CERNER MILLENIUM CPOE, POWER CHART Back to Search Results Event Date 10/09/2006 Event Type Malfunction Patient Outcome Other; Event Description It has been discovered that the medication review screen consisting of a list of the medications on the left most column and a grid indicating the number of doses administered in each time period. The defect manifests itself in the representation of exactly what medication was administered. For pts who are taking two or more forms of the same pharmacological agent, eg nitroglycerin in the paste form, sub lingual form, and pill form, the name of the medication is represented as "nitroglycerin" on the list. The number of times it was administered is confusingly listed as a number in parentheses without clarity on which form of the medication was administered, creating confusion in the clinician and risk to the pt. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1726923">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1726923</a> CERNER MILLENIUM CPOE, POWER CHART Event Date 04/03/2010 Event Type Injury Patient Outcome Life Threatening; Other Event Description The computerized physician order entry instruments were deployed. Pleural fluid specimen were obtained. Chemical and cytological analysis was ordered on the specimen using the cpoe instruments. The specimen was not analyzed as ordered. Cytology results did not become available. Similar dysfunction appeared in more than 6 patients. The hospital has resorted to paper forms to clarify the dysfunction of this cpoe instrument. The patients may have cancer causing the fluid build up. This will not be known until time passes. There may be resultant delay in diagnosis of chest organ cancer. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1766892">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1766892</a> CERNER MILLENIUM CPOE Event Date 07/08/2010 Event Type Injury Patient Outcome Life Threatening; Event Description The active and active prn medication list had 7 potassium doses and routes, 2 tylenol doses and routes, 3 magnesium doses, 3 narcotic medications and doses, and 6 sodium chloride and sodium phosphate orders. The defects in the device and human factors at the interface enabled duplicate, triplicate, and more medications, enabling the nurse to potentially decide the treatment for this pt. The exact incidence of medication duplication from (b)(4) systems is unk, but common. </blockquote> Some examples of mere "malfunctions", again just from random browsing of the MAUDE data: <blockquote> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=358222">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=358222</a> Model Number RELEASE 500 Event Date 10/03/2001 Event Type Malfunction Patient Outcome Other; Event Description Please see initial report. Event Description A user entered an order during the order entry process, with a frequency of every 8 hours and then used the ad hoc scheduling feature to modify the defaulted administration times for that frequency. After this was done, the user changed the frequency of the order to a 12-hour frequency without modifying the ad hoc administrations times. The software did not clear the previously entered ad hoc administration times to adjust to the default times for the new frequency. This resulted in a patient receiving a medications 3 times a day as opposed to 2 times a day. The drug was carbamazepene. This incorrect order frequency was repeated for 3 days, ultimately resulting in the patient receiving of total of 3 extra doses over a 3-day period (1 extra dose per day). On the fourth day, the nurse caring for the patient noticed the inconsistency in the order and conducted a further investigation with the pharmacist. The patient was discharged on time; no extended stay was necessary as a result of the overmedication. The patient's carbamazepene levels were checked during a follow-up visit that occurred 5 days after discharge, and were noted as normal at that time.<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1365512">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1365512</a> Model Number 2007.01 - 2007.17 Event Date 12/30/2008 Event Type Malfunction Patient Outcome Other; Event Description The issue involves cerner millennium powerchart message center inox. When the results folder is filtered by event set and the event set display and event set name are different, result filtering may not function correctly. If the result filter is in message center and is an inclusive filter, results may be filtered out incorrectly. The impact associated with this issue is that patient care may be delayed or missed as follow-up may not occur. Cerner has not received communication on any adverse patient events as a result of this issue. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1247673">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1247673</a> Model Number 2007 Event Date 10/30/2008 Event Type Malfunction Manufacturer Narrative Cerner distributed a priority review flash notification on nov 13, 2008 to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. A software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the software correction is available. Event Description This issue involves the overview with reminder functionality on powerchart and affects sites that use cerner millennium powerchart (powerchart. Exe). If a currently open pt chart is replaced with another pt chart, and reminders are subsequently viewed in the detail pane of this visit, the incorrect patient's reminder may de displayed. Pt care could be adversely affected, as clinical decisions could be based on the wrong pt info. Cerner has not received communication of any adverse pt events as a result of this issue. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1097561"> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1097561</a> Model Number 2007.13 Event Date 06/30/2008 Event Type Malfunction Event Description The issue involves the task list functionality in carenet, and affects users that utilize the task list to view and document pt activities. When encounter security is turned on and the user documents an activity in task list, utilizing the previous or next arrows to select another pt chart, the single pt task list displays tasks for incorrect pt. Clinicians may view and document a pt's activity in another pt's record. Pt care may be affected as clinical decisions could be based on incomplete, invalid, or inappropriate info. Cerner has not received communication of an adverse pt event as a result of this issue. Cerner has distributed a priority review flash notification july 30, 2008, to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. A software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the modification is available. Additional model #: 2007. 16. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1051313">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1051313</a> Model Number 2001 THROUGH 2007 Event Date 04/23/2008 Event Type Malfunction Manufacturer Narrative Cerner has distributed a priority review flash notification may 23, 2008 to all potentially impacted clients sites. The notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. User documentation is being updated to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the documentation is available. Event Description The issue involves the order entry formats in powerorders and affects sites that use powerorders and medication profile. When creating the volume dose detail in the order entry formats (oef), the strength order formats require the volume dose to have an "=" sign as a prefix label. Failure to adhere to this build can result in an inpatient prescription order converted to produce an outpatient prescription that may be misleading. This only occurs when the inpatient order used is verified with a pharmacy product and the formulation used does not exactly match the dose. A formulation factor of more or less than one is used to achieve the volume and the order is then converted to a prescription. For example, 500 mg = 1 tab or 250 mg times 2 tabs = 500 mg. Patient care could be adversely affected, as a patient could receive either more or less of a medication therapy than intended. Cerner has received communication of order discrepancies discovered during a chart review as a result of this issue. </blockquote>Again, there are many, many more examples like these in MAUDE, and I haven't even looked for data from other mfg's yet. My relative was nearly killed last year by this technology due to issues like these, the risks of which I've been writing about for more than ten years now. Alert to Sarah Palin: "Death panels?" Who needs death panels when technology like this is mediating our care and is planned for "urgent" national rollout with "meaningful use" rules and Medicare-penalty extortion - er, gentle coercion - directed towards healthcare organizations and clinicians? I repeat, from the title of this post: What in God's Name is Going on Here? and: U.S. government, regulatory agencies and consumer watchdogs: where are you? -- SS Jan. 21, 2011 addendum: One wonders if the EHRevent site I wrote about at "<a href="http://hcrenewal.blogspot.com/2010/11/ehreventorg-web-site-to-collect-ehr_15.html">EHRevent.org: Web Site to Collect EHR Safety Reports</a>" and at "<a href="http://hcrenewal.blogspot.com/2010/11/emrevent-survey-amateurism-bias-or.html">EHRevent: survey amateurism, bias, or something else?</a>" will be as frank as MAUDE.

MAUDE and HIT Risks: What in God's Name is Going on Here?

As I wrote at my last post " Healthcare IT Delirium ": The field of health IT has become delirious. On top of an irrational exuber...

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