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Held Hostage To Health IT? Here Is What Physicians Have To Put Up With Instead Of The Paper Chart...

I might have titled this post "Transforming simplicity in medicine into complexity." It's a wonder clinicians can get clinical work done at all any more. The following material makes the reports of poor alignment of EHR's to clinical needs, clinician distraction, and the slowing of clinician productivity more understandable by laypeople. The following are PDF's from a real healthcare organization, publicly accessible (at present), some with actual screen shots of the applications. How about a 90-page guide simply for entering orders, incidentally grossly mislabeled as "Medical Informatics Physician Education Program" instead of "CPOE application training program" suggesting the authors do not know what <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC400513/pdf/167.pdf">Medical Informatics actually is</a> - and also labeled as "Session 1": <ul><li><a href="http://www.methodistmd.org/pdf/cpoe_training/MASTER%20CPOE%20Physician%20Session%20One%20Final%20030308.pdf">Managing Patient Care Using CPOE</a> (1.2MB PDF)</li></ul> Here's what it takes to simply discharge a patient: <ul><li><a href="http://www.methodistmd.org/pdf/HWD%20Depart%20Physician%20DC_01Apr2009_v3.pdf">House Wide Discharge (Depart Process) training manual </a> (1 MB PDF) - 30 page training manual </li></ul> "Depart Process" is apparently a new buzzword. (Borrowed from the airline industry?) In the B.C. era (before computers), discharge required no 30 page training manual. I find the introduction to the 30 page "Depart Process Training Manual" interesting: <blockquote> Good News! The discharge process has been revised and will be a smoother, less complex process for all. The new process will be to use the House Wide Discharge (HWD) Process, (Depart) when discharging your inpatients.</blockquote> "Less" complex? One can imagine what the "Depart Process" was like before this 30 page training manual. Here's what it takes to enter or review a note: <ul><li><a href="http://www.methodistmd.org/pdf/Using%20Clinical%20Note070207%20ver%203.pdf">Electronic Documentation –Clinical Notes</a> (12 MB PDF)</li></ul> Holy complexity, Batman! Entering a clinical note used to involve opening a chart and applying pen to the right paper. Here is what medical professionals have to contend with when even a minor change is made: <a href="http://www.methodistmd.org/pdf/Tab%20ChangesoneChart%20Updates.pdf"> </a><ul><li><a href="http://www.methodistmd.org/pdf/Tab%20ChangesoneChart%20Updates.pdf">Tab Changes in the Power Chart</a> (150kb PDF)</li></ul> Here's what happens if physicians don't complete their H&P's in 24 hours with the EHR system: <ul><li><a href="http://www.methodistmd.org/pdf/15_H&P_letter3_12-10-2009.pdf">Suspension</a> (31kb PDF)</li></ul> I especially find the introduction to this "H&P suspension" letter of interest: <blockquote>You may remember earlier this year when we started immediate suspensions for H&Ps missing at 24 hours as outlined in our Rules and Regulations. Many of you were caught off guard by this and resented being called after you had already missed the deadline and were suspended [I'll bet - ed.]. We certainly heard your complaints [doctors are simply "complainers" - ed.] and stopped the immediate suspensions until we could create a better process. Since then we have been working on ways to achieve the goal of 100% H&Ps present within 24 hours. We have met repeatedly and received recommendations from HIM [Health Information Management a.k.a. Medical Records - ed.] directors, administration, and senior medical staff leaders. Final proposals have been approved by the Medical Executive Committee and are presented to you here. Beginning January 4, 2010, we will again begin suspending at 24 hours if an H&P is not available on the chart. The stopwatch will start at the time of the admit order. We will make every ["every?" - ed.] effort to contact the physician as the 24 hour deadline grows near. For the few physicians who have had multiple late H&Ps this past year, you will be contacted separately and required to formulate an action plan to present to administration and senior leadership. Repeatedly late H&Ps will trigger recommendation for a shortened reappointment. Additional measures have been proposed by senior leadership for adoption, if necessary. These include limiting service sizes, stopping all admissions for suspended physicians (not just elective admits) or required use of a nurse practitioner (for a charge) to complete the H&P. [In fact, perhaps physicians should be charging hospitals for their time in being forced to use IT such as this - ed.] </blockquote> Mussolini could not have done better in getting the trains out on time. At least trains were not experimental technology. (I'd thought it was deplorable as an internal medicine intern in the early 1980's at the now-defunct Hospital of the Medical College of Pennsylvania when our penurious paychecks of about $300 per week were merely withheld if we had not completed our discharge summaries.) I've commented in the past that physicians and other clinicians are now held hostage to needlessly complex and difficult to use health IT (see my eight part series on the HIT mission hostile user experience <a href="http://tinyurl.com/hostileuserexper">here</a>). I don't see anything here to make me change my mind. Needless to say, being a Medical Informaticist I am not against health IT: I am pro-health IT. What I do oppose is bad health IT - ill conceived, poorly implemented, mission hostile HIT designed with little thought to, or willful ignorance of, real world side effects in the clinic, office and subspecialty area. Health IT can be designed to be far better than most commercial HIT from major vendors is now, of which the above links show but one example. This requires, however, that HIT be viewed not as computer projects that involve clinicians, but as medical projects that involve computers. From that view flows the need for a major shift in HIT power structures and an educational and certification process for IT personnel (such as recommended by the ONC director Dr. Blumenthal that I highlighted in the post "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">ONC Defines a Taxonomy of Robust Healthcare IT Leadership</a>"). For sake of comparison, from the same hospital system as above, here's what physicians must go through to be found competent: <ul><li><a href="http://www.methodistmd.org/pdf/Privilege%20Criteria%20Grid.pdf">Privilege Criteria Grid</a> (120kb PDF)</li></ul> Here's what IT personnel must currently go through to earn the privilege of designing the tools clinicians must use, and of working in healthcare settings: <div style="text-align: left;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiUIswYEZ6UoSj-qK-zzBnav92DI6yWqOPxzpXOzOb4EkL-s0rcqRtbDqgP7QVzZXKsuqTdo7eIpzKVFoUCcRok6TouMjI32bjPMMTqtJg3W3lYgqValRJKlg4jd_Pe-SfgkhO-oTqDgU6W/s1600-h/FC_NullSet_41726_lg.gif"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5422624423186855298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiUIswYEZ6UoSj-qK-zzBnav92DI6yWqOPxzpXOzOb4EkL-s0rcqRtbDqgP7QVzZXKsuqTdo7eIpzKVFoUCcRok6TouMjI32bjPMMTqtJg3W3lYgqValRJKlg4jd_Pe-SfgkhO-oTqDgU6W/s320/FC_NullSet_41726_lg.gif" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 68px; height: 91px;" /></a> The same symbol applies to oversight of such tools themselves by accepted biomedical regulators such as FDA who regulate drugs and tangible medical devices. As I have written before, HIT is a virtual medical device, but a medical device nonetheless. It is a device that by the admissions of its own producers is entirely capable of effecting major impacts on and alterations to clinical care, although the makers rarely admit to adverse impacts. These discrepancies are astonishing. </div> -- SS

Held Hostage To Health IT? Here Is What Physicians Have To Put Up With Instead Of The Paper Chart...

I might have titled this post " Transforming simplicity in medicine into complexity ." It's a wonder clinicians can get clini...

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What the November, 2009, Breast Cancer Screening Argument Obscured

In November, 2009, a rancorous argument about screening mammography for women aged 40-49 was touched off by the publication of updated guidelines(1), supported by a systematic literature review(2) by the US Preventive Services Task Force (USPSTF).  The guidelines suggested that yearly mammographic screening for women in that age group should not be automatic, but a decision made for individual patients after discussion between the patients and their doctors.  This was based on a critical review of the best available data which suggested that the benefits of screening acrue to only a few patients.  1904 women would have to start screening and continue for multiple rounds to prevent one cancer death over 11-20 years of follow-up.  These benefits had to be balanced against a number of potential risks, including the risks of treatment of cancers that might never behave malignantly, and the at least theoretical risk of generating new cancers through radiation exposure from mammography.  These seemingly reasonable recommendations generated heated responses.  The debate, to be charitable, seemed to be at its core about how one should weigh benefits and harms in making individual and health policy decisions.  Since different people value different outcomes differently, I was not sure at the time how to make a meaningful contribution to this debate, or whether the debate had to do with the issues we usually discuss on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>. I should note that the USPSTF guidelines never said "do not screen" women under age 50, or that the government should not pay for such screening.  They did say "the decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take pateint context into account, including the patient's values regarding specific benefits and harms."  It is hard to see how anyone could argue with that as an expression empowering patients' choices and values.  (For further discussion about how the recommendations were actually modest and reasonable, see Partridge and Winer.)(3) Now that the dust has settled, it may be useful to reflect further on this.  Doing so suggests that the rancorous US debate mainly obscured rather than illuminated the major issues regarding mammography screening, particularly about our lack of clear evidence from clinical research needed to make the best individual and  policy decisions about mammography.  It seems to me that the main questions one must answer to make an individual or policy decision about screening mammography are: Does it improve longevity? This is not the same as asking whether mammography reduces mortality from breast cancer.  It is theoretically possible that while decreasing mortality due to breast cancer, screening and its downstream consequences increases mortality from other causes.  At least in theory, screening may detect small tumors that would never grow or metastasize.  Treating such tumors could sometimes lead to premature death due to complications of surgery, radiation, or chemotherapy.  Furthermore, screening also involves periodically exposing large numbers of women to radiation, which may sometimes cause new tumors.  So reducing breast cancer mortality does not automatically mean that overall longevity would be improved. There have been eight major trials of breast cancer screening which included women younger than 50. (See reference 2.)  None demonstrated a statistically significant increase in overall survival (that is, an increase unlikely to have been due to chance alone) due to screening. Does it reduce suffering, improve functioning or generally improve quality of life? To my knowledge, no major trial attempted to answer this question.  No such data is mentioned in the USPSTF systematic review. Do the above benefits outweigh all its potential harms and risks? So we cannot answer this question, because the benefits that might be most meaningful to patients (overall survival, symptom reduction, functional improvement, overall quality of life improvement) have not been clearly measured. A Lack of Relevant Evidence So the USPSTF guidelines, like other relevant guidelines, were based on the evidence that is available.  Since the evidence did not directly answer the most important questions, the guideline writers were left doing the best they could with evidence that only indirectly addressed the main issues.  No wonder they ended up unable to make a clear recommendation, and leaving the decisions to individual discussions, and individual discussions that would necessarily hinge on guesses about the unknown.  One would think that a big point of discussion about breast cancer screening would be why after eight trials enrolling a total of about 350,000 patients reported over 20 years we still cannot answer the big clinical questions.  A related point for discussion in the US is why only one, and the earliest trial was conducted here.  If we here in the US think breast cancer screening is such a major concern (and we should think so), why have we been unable to mount a single important trial of it since the HIP trial conducted more than 30 years ago? Instead, the rancorous debate in the US included... Anecdotes, Some Irrelevant The press found a number of women who said they would not be alive were it not for screening mammography before age 50.  With all due respect, one cannot tell whether an individual whose tumor was found on screening mammography would still have been diagnosed early enough for succesful treatment in the absence of screening mammography.  (And also with all due respect, we have no idea whether there also are cases of women who died as a result of treatments of tumors that never would have progressed, or cases of women who died of tumors caused by radiation from multiple mammograms.)  Reasoning from single cases when people, diseases, and treatment results vary so much is likely to mislead.  It is somewhat ironic that some of the cases cited were of women who had breast cancer diagnosed before age 40, even though the debate was supposedly about screening from ages 40-49.  For example, in an inflammatory article that suggested that some "oncologists" might want the USPSTF sent to the prison at Guantanamo Bay, Washington Post editorialist Dana Milbank cited cancer activist Nancy Brinker, who mentioned her sister "whose breast cancer was found with a mammogram at age 37," (and apparently who tragically is no longer alive).(4)  Going Well Beyond the Evidence As noted above, no trial has shown that screening mammography for women under 50 increases overall longevity.  We all hope it does, but so far, there is no clear evidence that it does.  Yet multiple media reports included assertions that screening mammography saves lives.   For example, the breast cancer activist mentioned above said, "mammography saves lives," apparently including mammography under age 50.(4)  An op-ed column by Dr Alan Kaye, chairman of radiology at Bridgeport Hospital, asserted "large, multinational research studies have shown that mammography saves lives in all age groups covered by the current guidelines."(5)  I would challenge him to show me a single such study that found a statistically significant increase in overall survival for patients under 50.  A Texas radiologist stated, "I diagnosed a 40-year old woman with breast cancer last week.  If she had waited 10 years, with pre-menopause breast cancer she would have been dead."(6)  Unfortunately, since she was just diagnosed, how can he be certain that she will survive any given amount of time?  How could he know that the cancer might not have become manifest, absent that single mammogram, later while still treatable?  I do not want to be too hard on patients who do not appreciate that the outcomes of testing and treatment for breast cancer are not certain.  However, one would hope that physicians would be able to deal with this uncertainty. Conflicted Opinions Some of the more strident discourse came from those who may have had financial vested interests in promoting screening mammography.  Fugh-Berman and Bell pointed out numerous "fact-free emotionally charged statements" made by people who appeared to "reading from the same script-book."(7)  They identified that many of the loudest critics of the USPSTF guidelines were affiliated with not-for-profit organizations with impressive names, but also with substantial financial support from corporations that make products used in mammography.  Also, some had personal financial relationships with such corporations.  An op-ed article by former US Food and Drug Agency (FDA) commissioner Dr Andrew von Eschenbach and Ms Nancy Desmond distorted the USPSTF guidelines to mean "most women should delay screening until they are 50," and claimed that was based on cost concerns, not clinical evidence.(8).  Desmond is the CEO of and von Eschenbach is now a senior advisor to the Center for Health Transformation.  The Center's <a href="http://www.healthtransformation.net/cs/our_members">members</a> include numerous pharmaceutical and device manufacturing corporations, including several that make mammography equipment (e.g., GE Healthcare and Siemens). Summary Cancer, especially breast cancer, has major emotional connotations, and can be a difficult issue to deal with from many people.  The conflicting emotions cancer brings out in many patients may understandably affect their physicians, as well as friends and family.  Nonetheless, physicians, other health policy professionals, and health policy experts can serve patients better if they do not allow the patients' understandable affective responses cloud their understanding of the clinical and scientific issues.  Yet the late 2009 debate in the US about screening mammography included many responses in which emotion seemed to overwhelm reason.  It may also be that some such responses came from people who had vested interests, or whose employers had vested interests that supported the emotional, rather than the reasoned approach.  Meanwhile, no one seemed to acknowledge that a big reason we are still debating this topic is that we have not made the effort or expended the resources to do good trials of sufficient size to answer the questions that need answering.  Of course, such trials might provide answers that would upset some people, or threaten others' incomes.  (As one news article pointed out, mammography is now a $5 billion a year industry in the US.)(6) So my end of annus horribilis 2009 message on Health Care Renewal is to better serve our patients, from 2010 onward we health care professionals need  to try harder to put evidence and logic ahead of our own emotions, and certainly ahead of our financial self-interest.   Note that numerous bloggers have taken on this topic, so see posts on <a href="http://scienceblogs.com/insolence/2009/11/really_rethinking_breast_cancer_screenin.php">Respectful Insolence</a>, <a href="http://www.gooznews.com/node/3173">GoozNews</a>,  <a href="http://healthcareorganizationalethics.blogspot.com/2009/11/death-panel-plots-and-mammogram.html">Health Care Organizational Ethics</a>, and the <a href="http://www.evidenceinmedicine.org/2009/11/uspstf-mammography-and-grading-recommendations.html">Evidence in Medicine blog</a>. References 1. US Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement.  Ann Intern Med 2009; 151: 716-726. [link <a href="http://www.annals.org/content/151/10/716.full">here</a>] 2. Nelson HD, Tyne K, Naik A et al. Screening for breast cancer: an update for the U.S. Preventive Services Task Force.   Ann Intern Med 2009; 151: 727-737.  [link <a href="http://www.annals.org/content/151/10/727.full">here</a>] 3. Partridge AH, Winer EP. On mammography - more agreement than disagreement.  N Engl J Med 2009; 361: 2499-2501. [link <a href="http://content.nejm.org/cgi/content/short/361/26/2499">here</a>] 4. Milbank D. Feeling farther from the finish.  Washington Post, Nov 24, 2009.  [link <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/11/23/AR2009112303145.html">here</a>]  5. Kaye A. An alarming retreat on early detection.  Hartford Courant, Nov 25, 2009 [link <a href="http://www.courant.com/news/opinion/editorials/hc-kaye-healthcare1125.artnov25,0,2479096.story">here</a>] 6.  Jacobson SJ. Dallas-area clinics ignore proposed rules, still push for mammograms. Dallas News, Nov 27, 2009.  [link <a href="http://www.dallasnews.com/sharedcontent/dws/dn/latestnews/stories/112709dnmetmammograms.3f4c9cb.html">here</a>] 7. Fugh-Berman A, Bell A. Mammography and the corporate breast.  Bioethics Forum, Nov 24, 2009.  [link <a href="http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4194">here</a>] 8. von Eschenbach A, Desmond N. Government panels can't put price on human life. Associated Press, Nov 24, 2009.  [link <a href="http://www.healthtransformation.net/cs/opeds_news?pressrelease.id=3509">here</a>]

What the November, 2009, Breast Cancer Screening Argument Obscured

In November, 2009, a rancorous argument about screening mammography for women aged 40-49 was touched off by the publication of updated guide...

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On Automobile, and Health Care Companies Run by Finance People

The New Republic published "<a href="http://www.tnr.com/article/economy/wagoner-henderson">Upper Mismanagement</a>" about what happens when businesses are run by people who do not understand their companies' businesses.  Although the article was focused on the decline of manufacturing in the US, its applicability to health care is obvious: <blockquote>Harvard business professor Rakesh Khurana, with whom I discussed these questions at length, observes that most of GM’s top executives in recent decades hailed from a finance rather than an operations background. (Outgoing GM CEO Fritz Henderson and his failed predecessor, Rick Wagoner, both worked their way up from the company’s vaunted Treasurer’s office.) But these executives were frequently numb to the sorts of innovations that enable high-quality production at low cost. As Khurana quips, “That’s how you end up with GM rather than Toyota.” How did we get to this point? In some sense, it’s the result of broad historical and economic forces. Up until World War I, the archetypal manufacturing CEO was production oriented—usually an engineer or inventor of some kind. Even as late as the 1930s, business school curriculums focused mostly on production. Khurana notes that many schools during this era had mini-factories on campus to train future managers. After World War II, large corporations went on acquisition binges and turned themselves into massive conglomerates. In their landmark Harvard Business Review article from 1980, 'Managing Our Way to Economic Decline,' Robert Hayes and William Abernathy pointed out that the conglomerate structure forced managers to think of their firms as a collection of financial assets, where the goal was to allocate capital efficiently, rather than as makers of specific products, where the goal was to maximize quality and long-term* market share. By the 1980s, the conglomerate boom was reversing itself. Investors began seizing control of overgrown public companies and breaking them up. But this task was, if anything, even more dependent on fluency in financial abstractions. The leveraged-buyout boom produced a whole generation of finance tycoons—the Michael Milkens of the world—whose ability to value corporate assets was far more important than their ability to run them. The new managerial class tended to neglect process innovation because it was hard to justify in a quarterly earnings report, where metrics like “return on investment” reigned supreme. 'In an era of management by the numbers, many American managers … are reluctant to invest heavily in the development of new manufacturing processes,' Hayes and Abernathy wrote. 'Many of them have effectively forsworn long-term technological superiority as a competitive weapon.' By contrast, European and Japanese manufacturers, who lived and died on the strength of their exports, innovated relentlessly </blockquote> Furthermore, <blockquote>The business schools had their own incentives to channel students into high-paying fields like finance, thanks to the rising importance of school rankings, which heavily weighted starting salaries. The career offices at places like Harvard, Stanford, and Chicago institutionalized the process—for example, by making it easier for Wall Street outfits and consulting firms to recruit on campus. A recent Harvard Business School case study about General Electric shows that the company had so much trouble competing for MBAs that it decided to woo top graduates from non-elite schools rather than settle for elite-school graduates in the bottom half or bottom quarter of their classes. No surprise then that, over time, the faculty and curriculum at the Harvards and Stanfords of the world began to evolve. 'If you look at the distribution of faculty at leading business schools,' says Khurana, '“they’re mostly in finance. … Business schools are responsive to changes in the external environment.' Which meant that, even if a student aspired to become a top operations man (or woman) at a big industrial company, the infrastructure to teach him didn’t really exist. </blockquote> If business schools did little to teach about manufacturing, they did almost nothing to teach about health care. But at the same time the finance people were taking over manufacturing, health care organizations were pushed to turn over their leadership to business people to improve efficiency and <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-breaking-physicians.html">break the physician's "guild." </a>Would there be any reason to expect that a finance background would be better preparation to run a health care corporation than to run an automobile company? For the latest thought- and wince-provoking example of how leaders of health care corporations seem to know almost nothing about the actual health care their companies provide, see a <a href="http://www.dailyfinance.com/story/ceos-corner-why-health-care-reform-makes-dialysis-firm-davita/19274801/">DailyFinance interview</a> with Mr Kent Thiry, CEO of DaVita, a for-profit corporate provider of dialysis services. According to the <a href="http://phx.corporate-ir.net/phoenix.zhtml?c=76556&p=irol-governance">company web-site</a>, "prior to working for Vivra, Mr. Thiry was a partner at Bain & Company, an International management consulting company. He earned his BA degree, with distinction and Phi Beta Kappa, in Political Science from Stanford University in 1978, and his MBA, with honors from Harvard Business School in 1983"  So he got his MBA from an elite US business school at the time in which finance was becoming dominant as described above.  Asked to explain his business model, Mr Thiry responded: <blockquote>Most of us have a couple of kidneys. These kidneys are amazing organs -- some of the most complex, sophisticated organs in the human body, which is why they've been so difficult to replicate compared to other organs like the heart and lung and others. And when the kidney fails, you need to go on dialysis, unless you're one of the fortunate few to get a transplant. And we operate the centers that people come to if their kidney fails and they can't get a transplant. And what we do in our centers is take care of these people typically three times a week -- four hours each time -- where we take their blood out of their body, clean out all the toxins that they would normally clean out themselves through the act of urinating. But you don't do that anymore once you've lost your kidney function. And we take that part out, take the toxins out and then put the blood back in with some other nutrients. </blockquote> To be charitable, I do not think that would merit a "C" on a high school biology test. [Medical science cannot "replicate" hearts or lungs. Kidney function is not the same thing as "urinating." The functions of the kidney are far more complex than "cleaning out toxins."] Does it make any sense to put someone who obviously understands so little about kidneys in charge of a kidney dialysis company?  (On the other hand, see<a href="http://hcrenewal.blogspot.com/2009/07/turning-patients-into-dialysis-dollars.html"> this post</a> on accusations that DaVita's ruthless business practices treat patients like "dialysis dollars.") So, if putting finance people in charge of automobile companies turned out to be a recipe for bankruptcy, why should we expect from putting finance people in charge of dialysis companies, or hospitals, or drug, biotechnology or medical device companies, or health care insurance companies, or health care information technology companies? The CEOs of big health care organizations, most of whom have business, not health care backgrounds, have mainly been good at paying themselves and their cronies well. (For example, according to the <a href="http://ccbn.10kwizard.com/xml/download.php?repo=tenk&ipage=6292362&format=PDF">2009 DaVita proxy statement</a>, in 2008, Mr Thiry owned over 2 million shares of stock, 1.9% of all shares outstanding, and received more than $11 million in total compensation.  Clearly, he was not paid according to his knowledge of kidney biology.)  Meanwhile, health care costs rise, access falls, and quality degrades. If we really want to reform health care, maybe we should take a lesson from Toyota. Put the car guys and gals in charge of car companies. And put the health care guys and gals in charge of health care.

On Automobile, and Health Care Companies Run by Finance People

The New Republic published " Upper Mismanagement " about what happens when businesses are run by people who do not understand thei...

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The $20 Million Dollar Journal Editor

Last week, the Milwaukee Journal-Sentinel <a href="http://www.jsonline.com/watchdog/watchdogreports/80036277.html">reported</a> on a royally paid journal editor: <blockquote>In 2002, Thomas Zdeblick, a University of Wisconsin orthopedic surgeon who has pocketed millions of dollars in royalties from the spinal device maker Medtronic, took over as editor-in-chief of a medical journal about spinal disorders. It would be the beginning of a beautiful friendship. In the years to come, Zdeblick would receive more than $20 million in patent royalties from Medtronic for spinal implants sold by the company. And the medical journal he edited would become a conduit for positive research articles involving Medtronic spinal products, a Journal Sentinel analysis found. Zdeblick took over editorship of the Journal of Spinal Disorders & Techniques seven years ago. Since then, studies involving Medtronic spinal products or that were funded by Medtronic appeared in the journal at least once per issue, on average. Dozens of studies that mentioned Medtronic products have been published while Zdeblick has been editor. But in issue after issue, readers of the journal were not told that he was receiving millions of dollars in royalty payments from Medtronic at the same time. Most of the time the articles, including some co-authored by Zdeblick himself about devices for which he gets royalties, had good things to say about the Medtronic products. Only on a small number of occasions did the articles find major problems with Medtronic devices. And often the articles did not disclose financial ties the authors had to Medtronic. </blockquote> Here are some specifics: <blockquote>From 2003 through 2007, Zdeblick got more than $19 million in royalty payments for spinal devices from Medtronic, according to a January 2009 letter by U.S. Sen. Charles Grassley (R-Iowa), who has been investigating payments to orthopedic surgeons by Medtronic. In 2008, Zdeblick got another $2 million from Medtronic from royalties and working as a consultant, according to UW records. To assess the relationship, the Journal Sentinel reviewed every article published in the journal since Zdeblick became editor. The journal is published seven or eight times a year and typically has a dozen or so articles. The articles were searched to see if Medtronic products were used as a part of the study or if the study was funded by Medtronic. At least 70 such articles were found in 56 issues of the journal from 2002 through October 2009. • A 2005 study by researchers in France found favorable preliminary results with Medtronic's Maverick artificial disc. In 2007, Medtronic paid Zdeblick $144,000 in royalties for the Maverick disc, according to Grassley's letter. •  In August 2009, Zdeblick co-authored a study that involved Medtronic's Premier Anterior Cervical Plate as well as the plate of another company, Synthes. The study involved using two different kinds of bone grafts with the plates. Zdeblick got $654,000 in Premier royalties from Medtronic in 2007. •  Zdeblick also co-authored three articles, in 2002, 2003 and 2005, involving Medtronic's BMP-2 and the LT-Cage, a device that paid him $1.4 million in royalties in 2007. None of those studies disclosed that he received millions of dollars in royalties from Medtronic. Often articles in the journal had good things to say about Medtronic products: •  In the 2002 study, Zdeblick and the co-authors concluded that BMP-2 and the LT-Cage led to a solid union and high fusion rates. In the 2003 study they found that BMP-2 may become 'the new gold standard.' •  In a 2006 study, a different group of authors concluded that BMP-2 when used with a hip bone graft significantly improved the success of the fusion surgery with minimal risk to the patient. The 2005 French study of Medtronic's Maverick artificial disc that did not involve Zdeblick concluded it was a 'promising therapeutic technique.' </blockquote> Dr Zdelblick declined to comment for the Journal-Sentinel, but: <blockquote>In a statement, a spokesman for the spinal journal said Zdeblick has disclosed his financial relationship with Medtronic to the company that publishes the journal, Wolters Kluwer Health/Lippincott Williams & Wilkins. All manuscripts submitted to the journal go through a rigorous review process using reviewers who have an objective viewpoint, Robert Dekker, director of communications with Philadelphia-based Wolters Kluwer Health & Pharma Solutions, said in a statement. 'Thanks to our strict peer review policies and processes, we have no concerns about the existence of this relationship,' Dekker said in an e-mail. Dekker declined to provide a list of the reviewers used by the journal or information about their financial relationships with device companies. He also declined to comment on how Zdeblick made decisions about manuscripts and reviewers. </blockquote> Of course, as the Journal-Sentinel pointed out, editors can make publication decisions independent of the recommendations of peer-reviewers. They also are free to select peer-reviewers who might have a particular viewpoint about a manuscript, its topic or authors, and to make and enforce editorial suggestions for changes in manuscripts.  It is beyond me what good that disclosure of conflicts of interest to a for-profit publishing corporation does in the absence of further disclosure.  Keep in mind also that the division of Wolters Kluwer that publishes the journals, <a href="http://www.wolterskluwer.com/WK/About+Us/Divisions/HealthPharmaSolutions/">Wolters Kluwer Health & Pharma Solutions</a>, not only publishes journals and textbooks, but "provides marketing and publications services, business intelligence products, and advanced analytical tools and services" to pharmaceutical corporations. Furthermore, <blockquote>'It's absolutely a conflict,' said Richard Smith, the former editor of the British Medical Journal. At a minimum, Zdeblick's conflict should be fully disclosed by his journal whenever a study involving a Medtronic product is published, said Smith, the author of 'The Trouble with Medical Journals.' However, because he makes so much money from Medtronic royalties, he really should not be editing the journal at all, Smith said. </blockquote> Just to add icing to the cake, Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=20313">pointed out</a> on her University Diaries blog that Dr Zdeblick is not only a journal editor, but a Professor and <a href="http://www.orthorehab.wisc.edu/sportsmedicine/research/zdeblick.shtml">Chairman of Orthopedics and Rehabilitation</a> at the University of Wisconsin.  In addition, his web-page at the University notes that he is on the <a href="http://journals.lww.com/spinejournal/Pages/EditorialBoard.aspx">editorial board</a> of another orthopedics journal, Spine, also published by Wolters Kluwer Health.  So here we go again.  How should we assess the objectivity of an ostensibly scholarly medical journal whose editor was made rich by royalties from a company whose devices were often evaluated in the articles published in the journal?  How should we assess the honesty of a journal editor who received millions in royalties from Medtronic, but who only deigned to disclose as an author in his own journal, "One or more of the author(s) has/have received or will receive benefits, (e.g., royalties, stocks, stock options, decision making position) for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript." (as in Zdelblick TA, Phillips FM. Interbody cage devices.  Spine 2003; 28: S2-S7.)  (Note that this sort of disclosure seems to be standard operating procedure for orthopedic surgeons who make millions from royalties and consulting fees, e.g. see <a href="http://hcrenewal.blogspot.com/2008/06/more-multi-million-dollar-orthopods.html">this post</a>.) Prof Zdelblick had numerous opportunities to influence his colleagues, trainees, and students in his roles as journal editor, journal editorial board member, author of scholarly articles, and professor and chair of orthopedics.  At the very least, the people who read his journal or his articles, listened to his lectures, or participated in his clinical teaching should have at least had the opportunity to judge for themselves whether being paid over $20 million might have just biased what he wrote and said a tiny bit.  But can anyone doubt that $20 million dollars would profoundly influence one's thinking?  Can anyone doubt that an inventor who got rich from royalties might not be more enthused about the use of the devicesthat generated the royalties than would an academic whose salary is unrelated to the use of any device?   It seems to be an abuse of entrusted power for a journal editor, professor, and department chairman not to clearly disclose such huge conflicts of interests to readers, learners and colleagues. This is just the latest vivid example of the conflicts of interest that permeate health care.  When multi-million dollar men pretend to be unbiased editors and professors, is it any wonder that we regularly overuse and overvalue the devices and drugs that they are selling? ADDENDUM (6 January, 2010) - See also comments <a href="http://spineblogger.blogspot.com/2009/12/old-news-is-well-old-news.html">on the Spine Blogger</a>, and by Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2010/01/increasing-price-of-medical-journal.html">on the Hooked: Ethics, Medicine and Pharma blog</a>.

The $20 Million Dollar Journal Editor

Last week, the Milwaukee Journal-Sentinel reported on a royally paid journal editor: In 2002, Thomas Zdeblick, a University of Wisconsin or...

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Finnish EHR's Clumsy, Mission Hostile, Consume Doctors' Precious Time

It seems common wisdom in the U.S. that the "Europeans are way ahead of us" in computerized medicine. Perhaps the common wisdom is not so wise. This from Finland: <blockquote>HELSINGIN SANOMAT INTERNATIONAL EDITION - HOME <a href="http://www.hs.fi/english/article/Clumsy+computer+systems+consume+doctors%E2%80%99+time/1135251678391"> Clumsy computer systems consume doctors’ time</a> When Arto Virtanen, a doctor at a public health clinic, wants to access the information of a young patient, 12 windows of different sizes open up on different parts of his computer screen. Virtanen has to deal with each of them every time a patient visits him for routine postnatal care. “It used to be that a municipal doctor would see six or seven patients in an hour, when documentation was not at its present level”, Virtanen says. “Then there came more paperwork, and four patients were seen in an hour. Now if a doctor wants to read all the information about a patient in the information system, there would only be time for consultations with, say, two patients in an hour.” Clumsy computer systems are already seen as a danger to patient security, says Tiina Lääveri, a member of the board of the Finnish Medical Association, who has acquainted herself with the various systems. Clumsy retrieval of data is one source of danger. Important information can disappear into the nooks and crannies of the software. “There can be 100 pages of text without any summary, out of which a doctor should find information in a couple of minutes." In hospitals, the systems do not separately tell nurses about changed dosages of medicines. “The information is there, mixed in the mass of all of the rest of it, where it gets lost.” In addition to causing outright dangers, computer systems waste precious working hours. In addition to actual medical data, the computer requires the recording of various items of statistical information. Patients can see the problem as well. Up to 43 per cent of time reserved for a patient with an appointment to see a public health doctor can be spent dealing with a computer, according to a study published earlier this year in Lääkärilehti, the publication of the Finnish Medical Assotiation. A national health archive now under development would not help things, as data would still be handled with existing software. “Software companies have started to become interested in listening to users only in recent years”, Lääveri says. Virtanen in Rajamäki would like to see more compatibility between systems. “There could be a common database, which should be easily accessible by a network browser”, Virtanen says. “It might also be constructed according to what this working process really is.” [You don't say? - ed.] </blockquote> Can health IT be any more mission hostile than this? (Unfortunately, the answer to what started as a rhetorical question is probably "yes." See <a href="http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html">this post</a> on the US military's EHR AHLTA, and see my eight part series "Are Health IT Designers, Testers and Purchasers Trying to Harm Patients?" on mission hostile commercial HIT <a href="http://www.tinyurl.com/hostileuserexper">starting here</a>.) Reports of difficulty in EHR Utopia have leaked out of other European countries such as <a href="http://articles.icmcc.org/2009/01/23/dutch-ehr-postponed-are-they-in-good-company/">the Netherlands and Germany</a>, not to mention <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">the UK</a>. The most startling observation is that “software companies have started to become interested in listening to users only in recent years." What manner of cavalier simpletons and opportunists populate such health IT companies? -- SS Addendum: It appears AHLTA may be a bad as it is due in part to "politics as usual" a.k.a. corruption. See "<a href="http://www.nextgov.com/nextgov/ng_20090729_5415.php">Company won earmarked funds for work on military health records</a>." If such conduct has been commonplace during AHLTA'a tortured history, it could explain just how AHLTA became as terrible as the senior military officials describe it in the linked article above.

Finnish EHR's Clumsy, Mission Hostile, Consume Doctors' Precious Time

It seems common wisdom in the U.S. that the "Europeans are way ahead of us" in computerized medicine. Perhaps the common wisdom is...

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Are Dissmissive Industry and Government Reactions to Physician Concerns about EHR's and other Clinical IT Simply Perverse?

Yes, they are. At the Nov. 10, 2009 essay "<a href="http://hcrenewal.blogspot.com/2009/11/academic-freedom-and-ed-ehrs-down-under_10.html">Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development</a>" and preceding essays linked to it, I wrote about an Australian informatics professor's travails in writing about ED EHR's. He wrote a mixed-method essay about the mission hostile user experiences ED physicians in NSW reported about the EHR's they were being compelled to use, in addition to similar negative commentary from ED physician experts in other lands. The latest version of the paper "A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck" is <a href="http://www.it.usyd.edu.au/%7Ehitru/essays/The%20Story%20of%20the%20Deployment%20of%20an%20ED%20Clinical%20Information%20System6.0.pdf">here</a> (PDF) or accessible from his department's webpage <a href="http://www.it.usyd.edu.au/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">here</a>. The government attempted to censor the paper and likely censure the author, and I speculate the HIT industry was not far behind. Below is an example from my own city on why I found the reactions to the evolving ED EHR paper - reactions that "blamed the doctors" or dismissed what appear to be frequently encountered ED physician concerns - perverse. I use the term "perverse" in the most formal sense of the word: <blockquote>Merriam-Webster dictionary: <a href="http://www.merriam-webster.com/dictionary/Perverse">Perverse</a> (adj). Etymology: Middle English, from Anglo-French purvers, pervers, from Latin perversus, from past participle of pervertere Date: 14th century 1 a : turned away from what is right or good : corrupt b : improper, incorrect c : contrary to the evidence or the direction of the judge on a point of law <perverse> 2 a : obstinate in opposing what is right, reasonable, or accepted : wrongheaded b : arising from or indicative of stubbornness or obstinacy 3 : marked by peevishness or petulance : cranky 4 : marked by perversion : perverted</perverse></blockquote> The very, very last thing patients need is to have ED clinicians slowed down. Concerns expressed by even a minority of ED physicians that EHR's slow them down or reduce their effectiveness ought to set off alarm bells and rigorous government investigations of the kind that would arise if airline pilots started to complain about lax security <a href="http://www.nytimes.com/2009/12/29/us/29terror.html">allowing passengers on board with bombs</a>: <blockquote>Dec 24, 2009 Philadelphia Inquirer <a style="font-weight: bold;" href="http://www.philly.com/philly/health_and_science/80045572.html">Philadelphia ERs seek solutions to crowding</a> By Marie McCullough Inquirer Staff Writer Two of the region's leading medical centers have racked up the city's highest number of "diversions" - periods when ambulances are advised to steer clear because the emergency room is so full. The Hospital of the University of Pennsylvania and Thomas Jefferson University Hospital are working to reduce such diversions as the number of emergency rooms in the city has continued to fall. This year, Penn has reduced the disruptions by 22 percent and Jefferson by 28 percent. As they seek solutions, the hospitals are examining their own practices, reflecting a national shift in efforts to address the perennial crisis of ER overcrowding. Consider Jefferson. This year it reduced diversion hours even though the number of ER patients, the severity of their medical needs, and staffing stayed about the same. Jefferson relieved overcrowding by finding ways to move patients in and out of the ER - and the whole hospital - faster. "That's where I'm focused, on improving efficiencies," said Rex Mathew, hired by Jefferson two years ago for the new job of vice president of emergency medicine clinical operations. This is not to suggest that the nation's emergency medical-care system has been slacking. From 1992 to 2002, the number of annual emergency-room visits increased 23 percent, while the number of ERs decreased 15 percent, studies show. In the Philadelphia region, the contraction has been more dramatic - from 62 ERs in 1993 to 38 now, a 39 percent decrease. The most recent loss was this year's closing of Northeastern Hospital, which had 45,000 emergency visits annually. The impact has been felt at Aria Health-Frankford Campus, where Joaquin Rivera died in the ER while waiting for care on Nov. 28. While there is no evidence that overcrowding played a role in his death, Frankford had nearly as many diversions in November - 121 hours - as all of last year. Emergency departments are beset by growing numbers of the uninsured, the chronically ill, and the aged. Nonetheless, experts say it's time for hospitals to stop blaming ER overcrowding on economic, social, and demographic factors that are beyond their control, and start looking inward. A recent Government Accountability Office report found that even in life-and-death cases, large percentages of ER patients do not see doctors within recommended times. "Many hospitals have done little to address the patient-flow obstacles that lead to overcrowded" emergency rooms, says a report by Urgent Matters, an ER improvement initiative funded by the Robert Wood Johnson Foundation. Jefferson and Hahnemann University Hospital are among six U.S. hospitals using grants from Urgent Matters to develop practical strategies for reducing ER crowding. These will be shared nationally through newsletters, the Web, and conferences. ... Most fixes, however, are neither easy nor obvious. Sick patients may lie on gurneys for hours in ERs, uncomfortable and taking up precious space, while they wait for a hospital bed to become available. ... "The problem is not just physical space but effective space," said Robert McNamara, chair of emergency medicine at Temple University Hospital. "With hospital margins tight, there may be beds, but no staff to cover them. And hospitals try to keep staffing tight to keep costs down." Temple has the city's busiest ER, with 74,000 adult and 20,000 pediatric patients this year - 24 percent of whom were admitted to the hospital, McNamara said. Anticipating a surge in demand following Northeastern's closure, Temple added ER staff and made a concerted effort to speed up testing and discharge procedures, he said. This year, through November, Temple had 118 hours when ambulances were diverted. The Hospital of the University of Pennsylvania, with about 60,000 ER patients and a 26 percent admission rate, was by far the city's leading diverter - more than 1,000 hours through November. ... the crowding conundrum continues to evolve. One question is whether health-care reform - which now seems imminent - may increase ER volume rather than reducing it, as millions more Americans become insured. </blockquote>The situation is actually even worse. A patient recently died of a heart attack, sitting in the waiting room of a hospital where I once rotated during my internship, Frankford Hospital. He was not found until others in the waiting room stole the dead patient-in-waiting's wristwatch. The man <a href="http://cbs3.com/topstories/joaquin.rivera.protest.2.1354721.html">sat unresponsive for nearly an hour</a> in the waiting area of Aria Health Frankford Hospital before a visitor notified security and a doctor arrived. <blockquote>Dec. 1, 2009Philadelphia Inquirer <a href="http://www.philly.com/philly/news/78202702.html?cmpid=15585797">Waiting to be seen at hospital, dying Joaquin Rivera was robbed, police say</a>... According to Philadelphia police, Rivera walked into Aria Health's Frankford Campus, on Frankford Avenue near Harrison Street, about 10:45 p.m. Saturday. He was alone, and apparently had walked from his nearby home on Duffield Street near Foulkrod, his son said. Rivera complained of feeling pain in his left arm and abdomen, and was told to sit in the waiting area, said police spokesman Lt. Frank Vanore. [A middle aged man with left arm and abdominal pain told to 'sit in the waiting room?' One wonders who would qualify for sitting under medical observation - ed.] At some point during the next hour, Rivera, a longtime bilingual counselor at Olney High School, lost consciousness. He inadvertently became a target, Vanore said, to three other people in the waiting room... [One of the other people] signed up to be seen by a doctor, while his two cohorts sat near Rivera. "At some point, [one of the people] is observed taking the victim's watch and passing it to the other man," Vanore said. When a witness ran to notify a security guard of the crime and Rivera's condition, the limping man and his female partner fled, Vanore said. Hospital personnel rushed to Rivera's aid, but it was too late. He was pronounced dead shortly after midnight Sunday. Vanore said police have not yet learned of Rivera's cause of death. The family said he was believed to have died of a heart attack. </blockquote> I reiterate, the very last thing in the world ER clinicians need are ill-conceived and ill-implemented electronic health records systems that slow them down. Instead of attempted censorship and spin control, such concerns should be addressed throughly, impartially and promptly if not immediately. What could one call the arrogance or devil-may-care mindset in the government and health IT industry that dismisses such concerns so cavalierly, other than "perverse?" -- SS

Are Dissmissive Industry and Government Reactions to Physician Concerns about EHR's and other Clinical IT Simply Perverse?

Yes, they are. At the Nov. 10, 2009 essay " Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development ...

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Boston Scientific (Again) Settles - This Time, Charges of Kickbacks Disguised as Clinical Studies

One would think that the stories about bad behavior by health care organizations would quiet down just before Christmas, but no... As reported <a href="http://www.google.com/hostednews/ap/article/ALeqM5i6EeKMw1uQyqOJxROb_E5H2vMIeQD9CP8M1O0">by the AP</a>: <blockquote>U.S. attorneys in Boston said Wednesday heart device maker Boston Scientific will pay $22 million to resolve allegations its Guidant division paid kickbacks to doctors to get them to use its heart devices. The U.S. Department of Justice said Guidant paid physicians $1,000 to $1,500 each in 2003 and 2004 to participate in four studies, called RaCE, RaCE II, RaCE III, and MERITS. It said the studies were designed to increase sales of pacemakers and defibrillators. Federal officials said the company targeted doctors who favored products made by other companies, hoping the payments would induce them to use Guidant devices more often. They said Guidant submitted claims for payment on the devices to Medicare. Boston Scientific did not admit wrongdoing as part of the civil settlement. Under the agreement, its cardiac rhythm management division will have to publicly disclose payments to physicians on a Web site. Boston Scientific also entered into a corporate integrity agreement. </blockquote> So here we have an example of a "<a href="http://hcrenewal.blogspot.com/2008/08/article-in-annals-of-internal-medicine.html">seeding study</a>," that is, a marketing effort to persuade physicians to prescribe a product disguised as a clinical research study, but for medical devices, not drugs.  Seeding studies seem to combine multiple kinds of unethical behavior, deceptive marketing and manipulated research.  There had been some question in the past whether seeding studies exist, but this is the second recent example to come to light, suggesting that not only do they exist, but that they are used by device as well as pharmaceutical companies. Note that, as <a href="http://www.bloomberg.com/apps/news?pid=20601103&sid=a0ZPcYxXqf88">Bloomberg reports</a>, this is the third major settlement of allegations of bad behavior made by Boston Scientific, <blockquote>The company agreed last month to pay $296 million to settle a Justice Department probe into Guidant’s handling of heart devices and restated third-quarter results. [See post <a href="http://hcrenewal.blogspot.com/2009/11/boston-scientific-to-plead-guilty-of.html">here</a>.] In 2007, Boston Scientific agreed to pay $240 million to settle more than 8,000 lawsuits claiming Guidant hid defects in defibrillators, which are devices that shock the heart back into regular rhythm. </blockquote>Cataloging legal settlements seems to be a useful way to assess the sorts of bad behavior manifested by large health care organizations (see some posts <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">here</a>). However, as we have said frequently, such settlements, including the "corporate integrity agreements" now frequently attached to them, seem to have done little to deter bad behavior.  Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts will suffer any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. I submit that would-be health care reformers who want to improve care, reduce costs and improve access should advocate for real negative consequences for people who implement, direct or approve the various versions of fraud, kickbacks, and miscellaneous corruption and malfeasance we have discussed on Health Care Renewal. By the way, the <a href="http://www.bostonscientific.com/AboutUs/Leadership.bsci/,,/navRelId/1004.1012/seo.serve">board of directors</a> of Boston Scientific includes two noted academics with leadership roles in academic health care.  Marye Anne Fox is the <a href="http://www-chancellor.ucsd.edu/leadership.html">Chancellor of the University of California - San Diego</a>, and hence the leader of a major medical school and academic medical center.  The <a href="http://www.ucsd.edu/explore/about/index.html">university's mission statement</a>, alongside which sits her picture, proclaims it "strives to maintain a climate of fairness, cooperation, and professionalism." Uwe Reinhardt, Professor at Princeton, is a noted health care economist, and <a href="http://economix.blogs.nytimes.com/author/uwe-e-reinhardt/">blogger on the Economix blog</a> for the New York Times.  Perhaps such august academic personages could tell  us how they are assuring that the company they are paid well to oversee upholds, rather than undermines professionalism and fairness.

Boston Scientific (Again) Settles - This Time, Charges of Kickbacks Disguised as Clinical Studies

One would think that the stories about bad behavior by health care organizations would quiet down just before Christmas, but no... As report...

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