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But, for the moment, I am stuck on the piece that is, to me, the most fundamental lesson from this story, and unfortunately many similar stories in the industry-funded clinical trial literature that fills our journals. The authors of this study did not function as physicians, clinicians, scientists, or even authors. Some were there because of their previous credentials. Others were there to build up future credentials. But they weren’t there to do what they presented themselves as doing. Researchers are practicing medicine too. I might be seen as naive to see this as the center of this story. If that’s the case, I’ll go to my grave being naive. Medicine has been my life, and this isn’t Medicine.However, despite the seriousness of these concerns, and their corroboration in the Justice Department document that pushed GSK to settle for so much money, my alma mater, Brown University, where Dr Martin Keller, the lead author of Study 329, was Chair of Psychiatry, has consistently refused to revisit the study, and consistently failed to publicly refute the accusations against Dr Keller, nor to accept them and take appropriate action. The University supposedly conducted an internal investigation of the matter, but has not seen fit to make it public. When asked again about this, Brown's new President, Christina Paxson, referred the inquiry to the public relations people:
There’s no place or tradition for physicians, particular physicians in high places, taking part in this kind of bullshit – particularly all the while claiming otherwise. The fact that it has been a widespread practice isn’t an excuse. That’s also an even stronger indictment. There are many principled neuroscientists working in this difficult area of medical science who’ve been tarnished by this kind of pseudoscience. There are many psychiatrists and other practitioners who’ve actually trusted these deceitful articles. And there are untold numbers of patients who’ve been medicated un-necessarily or even directly harmed by this and other capricious advise coming out of these studies – this one in particular. Rather than functioning as the advisers of ill people, these were physicians who actively participated in capitalizing on patients’ illness.
'The recent announcement by the U.S. Department of Justice did not suggest that any further reviews of the paper by the university are immediately warranted,' Darlene Trew Crist said in a written response. 'We have no further statement to make at this time.'
The mission of Brown University is to serve the community, the nation, and the world by discovering, communicating, and preserving knowledge and understanding in a spirit of free inquiry, and by educating and preparing students to discharge the offices of life with usefulness and reputation.the logic of the administration's refusal to have a public discussion of this case escapes me. As I have said before (in 2008!), the appearance of continued stonewalling, now going on for years, can easily be interpreted to imply that the institution has something really big and bad to hide.
Something terrible happened in psychiatry, an alliance between the pharmaceutical industry and a number of our leaders who allowed their academic credentials to be used for commercial purposes. It happened on a large scale, and in the process shamed all of us, whether we were involved or not. Many of the people we looked to to guide us fell into the role of key opinion leaders – a marketing term that meant that they could influence what we did and how we practiced. And in that new role, medical degrees, academic positions, the methods of science, and psychiatric experience became little more than marketing tools in a commercial campaign. Such was the case with Study 329 – an article that has become exemplary because it is now so painfully well known – a symbol for the failings of an era. It needs to be retracted simply because it was wrong on purpose – and we all know it. And yet no involved person, institution, or organization highlighted in that last paragraph has swallowed their pride, or guilt, or denial, or arrogance and called for retraction.[Italics and bold typeface added for emphasis]
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Epic not only submitted MU Stage 2 comments to ONC, it even helpfully distributed them to their customers so they could submit the same comments under their own names. David Clunie noticed this and lists the hospitals who sent in the boilerplate, including University of Miami, which submitted the same comments five times without noticing the “Remove Before Submitting” headline that prefaced Epic’s explanation of why its customers should share its opinions with Uncle Sam.
Epic via University of Michigan Health System Meaningful Use Workgroup also the same Epic comments from University of Miami (who liked them so much they submitted it twice and then a third time and then a fourth and fifth time) and again from the Martin Health System and Metro Health Hospital and The Methodist Hospitals and Fairview Health Services and Sutter Health and Parkview Health System and the Everett Clinic and Dayton Childrens' and UMDNJ and NYU Langone Medical Center and Hawaii Pacific Health and finally as submitted by Epic themselves - others like the Community Health Network just stated they had read and agreed with Epic's comments - Imaging - concur that DICOM is not needed for that objective and PACS images do not need to be duplicated - concerned about single sign on if two systems - View, Download and Transmit to 3rd Party - images are not in the EHR but the PACS - patients would need DICOM viewers - size of the images is a problem - disks are better (also if you look at some copies of this, there are some pretty funny "remove before submitting to ONC" notes that say things like which versions support what and how much it would cost to retrofit, etc.; how embarrassing, both for Epic and their lackeys at these institutions)
... Focus certification on the minimum floor set of capabilities required to complete meaningful use objectives.
Informational Comments for Organizations Using Epic (remove before submitting to ONC)
We’ve heard your requests for a chart search feature, and our desire to see this certification criterion removed does not mean we don’t want to develop such a feature. In a future version of Epic, we want to develop the best possible chart search feature based on your input. However, if this criterion stays in the Final Rule, we worry we’ll have to divert attention from future chart search features you’ve requested to focus on a simplified, less valuable version of the feature to meet certification.
Under pressure from investors unhappy with the health insurer's performance and direction, WellPoint Inc. Chief Executive Angela Braly resigned Tuesday, and the company's board said it would begin a search for a permanent replacement.
The abrupt shift came as the board's leadership had been meeting with major investors in the wake of a disappointing second-quarter earnings report that sharpened concerns about Ms. Braly and the company's strategy
In its statement, the board signaled that WellPoint's direction might not change dramatically. Ms. Ward said that the board 'continues to believe that time will prove the wisdom of potentially transformative actions taken under Angela's leadership…But now is the right time for a leadership change.' She also said the board believes 'the remaining executive team is dynamic and strong, with great potential to drive WellPoint's future success.'
Details about her exit package were not released Tuesday, but under her contract, she is entitled to at least $7.7 million if terminated without cause.
a series of stumbles over the past few years, including an unexpected earnings hit last year tied largely to problems with a Medicare plan in California. In 2010, the company scaled back a proposed rate increase in California that had become a lightning rod in the policy debate over a health overhaul, leading to a loss.
Many blame Braly and her team for putting The Affordable Care Act over the top in Congress after Wellpoint’s Anthem Blue Cross plan in California two years ago raised rates nearly 40 percent on individual policyholders before the increase was tamed. Many at the time say that provided President Obama and Sebelius political momentum and ammunition to tell the story of excessive rate increases by the loathed insurance industry.
became corporate royalty, with all the absurd arrogance, disconnections from reality, ego poisoning, and cults of personality thereby implied.
... When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):
- Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "disruptive physician" and/or or being subjected to sham peer review (link).
- Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)
- Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at http://www.jointcommission.org/report_a_complaint.aspx . Also consider writing the JC senior officers (link to officer's list), whose awareness of HIT issues I can personally attest to via our correspondences.
- Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. An example of such an adverse event report I filed myself (when the involved hospital refused) is at this link in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.
- Inform the State Medical Society and local Medical Society of your locale.
- Inform the appropriate Board of Health for your locale.
- If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "Quality Insights of PA."
- Inform a personal attorney.
- Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.
- As clinicians are often forced to use health IT, at their own risk even when "certified" (link), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:
"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]
We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice.
With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at http://www.jointcommission.org/assets/1/18/SEA_42.PDF, the IOM report on HIT safety at http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, and the FDA Internal Memorandum on H-IT Safety Issues at http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology.
CMO __________ (date, time)
CIO ___________ (date, time)
CMIO _________ (date, time)
General Counsel ___________ (date, time)
etc."As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.
- If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.
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There's no truly robust evidence of generalizable benefit, no randomized trials, there's significant evidence to the contrary, there's risk to safety that this disruptive technology causes in its present state (but the magnitude is unknown, see quotes from 2012 IOM study here) that MU and "certification" do not address, there's a plethora of hair-raising defect reports from the only seller that reports such things, but CMS justifies the program [starting at p. 18 in the Final Rule for Meaningful Use Stage 2 at this link - ed.] with the line:"Evidence [on benefits] is limited ... Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs ... There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs."
I am deeply impressed by the level of rigorous science here. We are truly in a golden age of science. [That is obviously satirical - ed.]
3. Summary of Costs and Benefits
This final rule is anticipated to have an annual effect on the economy of $100 million or more, making it an economically significant rule under the Executive Order and a major rule under the Congressional Review Act.
Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the final rule. The total Federal cost of the Medicare and Medicaid EHR Incentive Programs between 2014 and 2019 is estimated to be $15.4 billion (these estimates include net payment adjustments for Medicare providers who do not achieve meaningful use in 2015 and subsequent years in the amount of $2.1 billion).
In this final rule we have not quantified the overall benefits to the industry, nor to EPs, eligible hospitals, or CAHs participating in the Medicare and Medicaid EHR Incentive Programs. Information on the costs and benefits of adopting systems specifically meeting the requirements for the EHR Incentive Programs has not yet been collected and information on costs and benefits overall is limited.
Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs, including reductions in medical recordkeeping costs, reductions in repeat tests, decreases in length of stay, increased patient safety, and reduced medical errors. There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs.
"Evidence [on benefits] is limited ... Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs ... There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs."
You see a horrific train wreck in the making, with all your coworkers contributing to it. But they are all making a fortune, and their manager - who is your boss too - is making even more money by keeping it going. Quite obviously, they're going to keep doing it whether you participate or not; so even if you refuse to participate, the firm will be dead anyway. You can try to stop it by going over your boss's head to the CEO; but your boss won't like that at all, and he and the entire department will tell the CEO whatever they need to tell him in order to keep it going. And if - speaking purely hypothetically - your CEO is an oblivious, selfish, obnoxious egomaniac nearing retirement age, heavily focused on his golf game and art collection, with a few hundred million in cash already stashed away, scheduled to rake in another $50 million this year, whose contract guarantees him another $100 million if he loses his job - well, then he probably won't be very sympathetic to you either. You could try going to the board of directors, but even if you could reach them, it will turn out that they are old pals of the CEO, often stunningly clueless, picked largely so that they won't rock the boat.
So if you try to stop the party, you'll probably get marginalized or fired, as happened to a number of serious, ethical people who tried to warn their management and curtail unethical and illegal conduct in Merrill Lynch, Lehman, Citigroup, AIG and elsewhere. So you'd gain nothing by acting ethically - quite the contrary, you'd ostracize yourself and lose your chance to build (or rather, transfer to yourself) some real personal wealth - possibly once-in-a-lifetime opportunity.
Dr. Scot Silverstein travels the country attending conferences [and other countries as well - ed.], speaking on panels and voicing concerns about health care's headlong rush into a reliance on electronic medical record systems.
"Older and younger physicians alike are increasingly concerned about the poor design and poor usability of clinical IT," Silverstein said.
The Drexel University College of Information Science and Technology faculty member calls "EMR" an anachronistic term from a time when the systems were merely storage tools for records. "What is meant in 2012 is not just an innocuous 'filing cabinet,' but an enterprise clinical resource management and workflow control system - not just storing records, but regulating and governing all clinical behavior and action," Silverstein said.
Silverstein contends such systems are inappropriate for some health-care environments, such as emergency rooms and intensive-care units. "They slow down and distract clinicians due to their generally poor user interfaces, in the worst possible setting, and disrupt clinician cognition," he said.
... These devices are not appropriate for high-risk, high-intensity environments such as ED's, ICU's etc. They slow down and distract clinicians due to their generally poor user interfaces, in the worst possible setting, and disrupt clinician cognition. But don't take my word for it. See the 2012 report from the Institute of Medicine on healthcare IT safety (I wrote about it at http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html), the National Institute of Standards and Technology report on clinical IT usability (http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html) and the literature I collated at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist.
Silverstein defines such cognition as the decision making and problem solving necessary to provide quality health care.
... Silverstein thinks current clinical IT programs focus too much on raw data and not enough on supporting a physician's decision-making abilities. "As a result, valuable time and energy is spent managing data as opposed to understanding the patient," he said. "Ideally, IT systems would place raw data into context with current medical knowledge to provide clinicians with computer models that depict the health status of the patient, including information on how different organ systems are interacting, epidemiological insight into the local prevalence of disease and potential patient-specific treatment regimens."
... Kay Takes, vice president of patient care services at Mercy Medical Center-Dubuque, said the hospital finds electronic medical records a help in the critical environment of the ICU.
"Specifically in the ICU, in the last 13 months we've gotten enhancements that allow us to download values from the medical equipment - it's automatically pulled into the medical record," she said "It's been fantastic. The availability of the information is enormously valuable. It's been a lot more of a benefit than a hindrance."
... And we do still talk to each other – but even that doesn’t always “work out”, because we’ve lost our operational minds (collectively) – the shared-by-all compact, visually all data in one place, and temporally arranged – i.e., the shared nurse/doc/resp flowsheet [traditionally in an ICU, a long tabular scroll of paper for "at a glance" patient status overview - ed.] – where everybody was looking at the same page, which we no longer are – as the team is slowly discovering.
And which required no logon for sign-over bedside rounding (~40 minutes for 20-30 babies was the allotted time). The flowsheet needed only a 10-15 second glance to spot developing problems; “the computer” is effectively inaccessible in the time allotted for the twice daily sign-n-out “rounds”.
A health IT hazard is a characteristic of any health IT application or its interactions with any other health care system (e.g., the people, equipment and work spaces of an ICU) that increases the risk that care processes will be compromised and patients harmed.
Usability
• Information hard to find
• Difficult data entry
• Excessive demands on human memory
• Sub-optimal support of teamwork (situation awareness)
• Confusing information display
• Inadequate feedback to the user
• Mismatch between real workflows and HIT
• Mismatch between user mental models/expectations and HIT
Data Quality
• IT contributed to entry of data in the wrong patient’s record
• Organizational policy contributed to entry of data in the wrong patient’s record
• Patient information/results routed to the wrong recipient
• Discrepancy between database and displayed, printed or exported data
• Faulty reference information
• Unpredictable elements of the patient’s record available only on paper/scanned documents
• Lost data
• Inaccurate natural language processing
• Virus or other malware
Decision Support
• Excessive non-specific recommendations/alerts
• Faulty recommendation
• Missing recommendation or safeguard
• Inadequate clinical content
• Inappropriate level of automation
Vendor Factors
• Sub-optimal interfaces between applications and devices
• Faulty vendor configuration recommendation
• Unusable software implementation tools
• Non-configurable software
• Inadequate vendor Testing
• Inadequate vendor software change control
• Inadequate control of user access
• Faulty software design (specification)
Local Implementation
• Faulty local configuration or programming
• Inadequate local testing
• Inadequate project management
• Inadequate software change control
• Inadequate control of user access
• Suboptimal interface management
Other factors
• Inadequate training
• Excessive workload (including cognitive)
• Inadequate organizational change management
• Inadequate management of system downtime or slowdown
• Unclear policies
• Compromised communication among clinicians (i.e., during handoffs)
• Interactions with other (non-HIT) care systems
• Physical environment (e.g., hardware location, lighting, engineering)
• Inadequately secured data
• Hardware Failure
• Use error in the absence of other factors
"nemesis" posted at 1:19 pm on Mon, Aug 27, 2012.
He travels the country complaining about existing systems? Perhaps the good prof could spend a little time designing the ideal interface/system and see if he can get anyone interested. Surely his design would win them all over.
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Unfortunately, little evidence exists about how to address this problem. Although extensive literature suggests that contributors include excessive workload, loss of autonomy, inefficiency due to excessive administrative burdens, a decline in the sense of meaning that physicians derive from work, and difficulty integrating personal and professional life, few interventions have been tested. Most of the available literature focuses on individual interventions centered on stress reduction training rather than organizational interventions designed to address the system factors that result in high burnout rates.Previous Studies of Burnout and Dissatisfaction