Wednesday, May 29, 2013

Massachusetts Law 2012.224.108


Wow. Think this idea will spread?

Commenter on THCB, where a post about this appeared.


Notwithstanding that I am a veteran Health IT advocate, this Section 108 law is a serious overreach. What if I'm a demonstrably competent and successful cash-only "concierge" clinician (they exist) who has no need of an MU certified EHR system?
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SBM SOUNDS OFF ON "PATIENT PARTICIPATION IN DECISION-MAKING"

“Patient-Centered” decision-making is a new buzz-word in medicine. It is a metaphor for a general approach to care that puts the patient’s experience and needs at the center, as opposed to the needs of the physician or the system.

While this is an effective marketing term, and a useful principle as far as it goes, as a guide to medical practice it is a bit simplistic. It needs to be viewed in the context of the overall medical infrastructure and the net effect specific practices have on the cost and effectiveness of medical care...


The optimal balance between the doctor, the patient, and third parties has been a longstanding debate within medicine. Thoughtful engagement on this issue, it seems, has resulted in real progress. The old paternalistic model, in which the patient simply did as they were told without meaningful consultation, has largely been replaced with a more cooperative model and one that properly grants to the patient informed consent.

Unfortunately, complexity intrudes on this comfortable relationship. We have to recognize that we are somewhat at cross-purposes. Optimal medical practice would maximize several outcomes simultaneously — the patient experience, doctor and patient autonomy, medical outcomes, and cost effectiveness, to name the most important. The problem is, you can’t always get all of these things to an optimal degree at the same time...
As usual, SBM commenters are astute across the breadth of perspectives.
There are all kinds of doctors, patients, and interactions between them. Some of the old so-called paternalistic docs of my childhood and early adulthood were wonderful, in the way Robert Young was wonderful as the father that knew best (even when he was being very paternalistic), and some of the new “patient centered” ones come off as automatons reading you your rights.

Now that my medical center is converting to electronic health records (which I thought I welcomed), all the docs just sit at the terminal and type, type, type, during the entire visit–no eye contact after the “hello”. I’m trying to adjust, and once asked her to just take notes and do it later. She complied but never did it again, so I try not to fuss.
..
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More to come...

Tuesday, May 28, 2013

If I knew then what I know now... pondering the Naked Emperor


Recall, from our prior post,

"Let's Admit the Emperor Has No Clothes- It's Time to Redesign EHRs to Improve Patient Care"

Aside from the fact that time travel and its 20/20 hindsight cognitive fruits are only possible in Hollywood, it's not clear from the Healthcare Innovation Council REBOOT response precisely who is this "Emperor." HHS Secretary Sebelius? CMS Administrator Tavenner?


Yeah, I know, it's likely not aimed specifically at anyone in particular, it's probably just a "witty and original" totemic pejorative metaphorical allusion expressing frustration with bureaucracy. Quite fashionable these days, to be sure.


Anyone who has followed this blog knows by now that I am no reflexive HHS/CMS/ONC cheerleader (far from it), but this unevenly composed letter is so chock full of empty, repetitive echo chamber chants, blinding glimpses of the motherhood-and-apple-pie obvious, a buffet serving of red herrings, and outright misstatements of fact as to compel me into a bit of prefatory snark and Photoshop mockery.

Serious item-by-item critical pushback to ensue shortly. Stay tuned.
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UPDATE
"We believe that the root cause reasons why EHRs aren't delivering on their promises include:
  • [1] EHR design issues: EHRs, to date, have been fundamentally designed to create electronic versions of paper medical records. EHRs focus on data collection mostly for regulatory compliance and financial reporting, not to assist physicians, nurses and other clinicians in providing higher quality more efficient patient care. As a result, the EHRs are not designed to reflect or facilitate the way in which providers deliver patient care, and thus disrupt, rather than enhance, patient care; and
  • [2] EHR implementation issues: EHR implementations are often led as IT "projects" by teams that do not obtain robust, meaningful, future-focused input / involvement from nurses, physicians, pharmacy and other clinicians who provide patient care. The end result typically is that EHR implementations don't make life better for EITHER the clinician or the patient. Sadly, more often than not physicians, nurses and other clinicians find EHRs make it more, rather than less, difficult to provide better patient care."
Bullet 1: While still true to a degree with respect to Big Iron "legacy systems" (such as -- hel-LO? -- the ones they cited as data sources from their interviews) that is a dated argument. It becomes less true, more dated with each passing month. Newer EHR developers are working furiously to come up with workflow-compatible applications.

Bullet 2: Any organization large enough to have an "IT department" has to deal with this internal political problem whatever the hardware and software systems being deployed. This, too, is old news. See my July 2010 post wherein I cite the Haugen-Woodside book "Beyond Implementation: A Prescription for Lasting EHR Adoption."
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Continuing...
"The following themes emerged from those discussions, which question the ability of the current breed of EHRs to improve patient care and question the implementation methodology used by many providers that doesn’t have sufficient focus on improving patient care:
  • [3] Improving patient care should have been the primary focus for EHR planning/implementation, as directed by Congress in the ARRA. Instead, CMS’ and healthcare providers’ focus has been to "just get EHRs up and running" in a way that meets CMS’ “meaningful use” requirements so that they can get “meaningful use” dollars, without regard to how that affects patient care. CMS should change its “meaningful use” requirements to require measureable improvements in patient care in the short-term.
  • [4] The primary caregivers, nurses, were often not involved in EHR planning or had limited involvement with boundaries and limitations when nurses identified specific patient care needs.
  • [5] EHR planning was primarily from the IT perspective, not from the clinical care perspective.
  • [6] The EHR was not designed to provide a longitudinal view of the patient’s story over a period of time, with trending capabilities for improved decision making.
  • [7] The EHR is cumbersome and requires too many clicks to obtain needed patient information.
  • [8] The EHR does not facilitate patient knowledge, education or input.
  •  [9] Quality of documentation has decreased, not increased, after EHR implementation.
  • [10] The EHR is primarily an electronic documentation tool that unfortunately also isn’t, but could be, a "brain partner" decision support tool that aids clinicians in providing and improving patient care.
  • [11] EHRs should be interoperable so that EHR patient records are accessible to all care givers (subject to appropriate security and privacy), which was another direction to CMS by Congress in the ARRA.
  • [12] The efficiency and effectiveness of care delivery business processes need to be reviewed and  re-engineered prior to, not after, commencement of the EMR implementation."
Bullet 3. First, you should noted the repeated confusion of the roles of ONC and CMS in this letter. to wit:
‘‘SEC. 3001. OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY.

‘‘(b) PURPOSE.—The National Coordinator shall perform the duties under subsection (c) in a manner consistent with the development of a nationwide health information technology infrastructure that allows for the electronic use and exchange of information and that—
‘‘(1) ensures that each patient’s health information is secure and protected, in accordance with applicable law;

‘‘(2) improves health care quality, reduces medical errors, reduces health disparities, and advances the delivery of patient- centered medical care;

‘‘(3) reduces health care costs resulting from inefficiency, medical errors, inappropriate care, duplicative care, and incomplete information;

‘‘(4) provides appropriate information to help guide medical decisions at the time and place of care;

‘‘(5) ensures the inclusion of meaningful public input in such development of such infrastructure;

‘‘(6) improves the coordination of care and information among hospitals, laboratories, physician offices, and other entities through an effective infrastructure for the secure and authorized exchange of health care information;

‘‘(7) improves public health activities and facilitates the early identification and rapid response to public health threats and emergencies, including bioterror events and infectious disease outbreaks;

‘‘(8) facilitates health and clinical research and health care quality;

‘‘(9) promotes early detection, prevention, and management of chronic diseases;

‘‘(10) promotes a more effective marketplace, greater competition, greater systems analysis, increased consumer choice, and improved outcomes in health care services; and

‘‘(11) improves efforts to reduce health disparities. [ARRA pg 116]
While both ONC and CMS are agencies under the HHS umbrella, CMS's role is more purely administrative -- i.e., managing the disbursement of the Medicare and Medicaid Incentive funds. It is ONC that is charged with setting and guiding HIT policy priorities under ARRA. The phrase "National Coordinator" is found 70 times across 26 pages of the law, and the combined "Medicare" "Meaningful Use" is found 19 times across 8 pages.

Having noted that, it is a fair point to observe that the Meaningful Use program did indeed glom onto a "Body Count" focus to a great degree (I have to confess to our having recruited some duds early on at my REC). Nonetheless, to a significant extent this signup focus was strategic and in keeping with ARRA intent (aiming for tipping point "Network Effect"). Recall this emblematic "Bend The Cost Curve Graphic"?


It is premature to expect much in the way of "improved clinical outcomes" yet, in light of the magnitude of the huge scope of such a transformative project. Even for complex patients seeing their doctors, say, 4 times a year, any emergent outcomes trends for better or worse are unlike to be evident at this point. This expectation was baked into the HITECH planning assumptions. Criticizing the lack of "improved outcomes" in 2013 is either disingenuous or naive.

Bullet 4: I assume the interview data on this lament came from inpatient settings. It is probably true. Bullet 5: Redundant. See my response to #2. Bullet 6: At least in outpatient settings, longitudinal flowsheets are by now EHR staples, so this is to a great degree a misstatement of fact. Even Vista does flowsheets.


Bullet 7: "The EHR is cumbersome and requires too many clicks" Which "EHR"? There are as of today (May 28th) 1,947 ONC "complete" certified EHR systems. Did HIC collect data on this complaint? Say, how many workflow clicks for each num/denom MU measure, stratifed by EHR product?

I rather doubt it.

Bullet 8: Building in patient education / input functionality is in fact part of the ONC plan. Stage 1 functionality necessarily focused on data capture health care clinicians and staff.

Bullet 9: That allegation is so vague as to be worthless. And, is likely not true.

Bullet 10: The "brain partner" thing. Premature to expect at this point, I would think. Not that's it's not a desirable function. See my various postings (Down in the Weeds') on Messrs Weeds' "Medicine in Denial."

Bullet 11: The "Interoperability" misnomer. Yes, I agree, and have posted so repeatedly. But, here we bump up against the inevitable for-profit market conundrum: Margin = Opacity.

Bullet 12: It's not (workflow/BPM) a before or after thing. To the extent that it's "before," we really just mean that it has to be part of the HIT project planning. We've known this for a long time (e.g., DOQ-IT, 2005 - 2008).
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Continuing...

Bullet points 13 through 19 comprise a (cherry-picked?) summary of studies critical of the effort. I observed in my prior post: 
In meta-analytic fashion, they cite seven studies [bullet points 13 - 19] critical of Health IT deployment, but only allude to aggregate concerns contained in these reports. Seven critical reports across four years? Is that unusual for any large government initiative of comparable complexity and magnitide?
Bullet point 20 simply involves some speculative hand-wringing regarding the recent ONC de-certification of two EHR products and its potential for disruption in the industry should more vendors get decertified. That concern is to an extent reasonable (though I bet HHS is gonna march lockstep carefully past that minefield). My views on the shallowness of the ONC CHPL certification methodology are well known by now to regular blog readers.

The final bullet points
"Strong nurse, physician and clinician EHR involvement will help achieve the following patient care improvement objectives:
  • [20] Improved focus on EHR design and implementation that starts by mirroring the way care is actually delivered by nurses, doctors and other clinicians. This basic design then would move to new, information enhanced processes that not only help clinicians do their jobs easier, but measurably improve patient care safety and quality.
  • [21] Discovery and integration of ways to enable a richer, more engaged and meaningful patient/caregiver relationship versus one that requires increased clinician time for record keeping instead of patient care.
  • [22] Redesigned EHR processes that ensure nothing falls through the cracks in care transitions (e.g., medication reconciliation,) which are a major source of patient safety issues.
  • [23] Rethinking, redesigning and re-engineering nurse, physician and clinician workflows to take full advantage of the capabilities of the new (and evolving) EHR tools to result in improved healthcare processes and care experiences."
In reading through this entire piece, I couldn't help but notice one or another permutation of the phrase "nurses, doctors and other clinicians" occurring repeatedly -- 15 times to be exact (in an 8 page proffer). "Clinician(s)" specifically 22 times.

Roger that. 10-4. We got ya. These are hardly original thoughts. Repeating them multiple times doesn't serve to strengthen the argument.

Bullets 20 and 23: Well, in #20 we're gonna re-design HIT to align to the way clinicians actually work (see #1 also), but in #23 we'll be modifying ("redesigning and re-engineering") clinical workflows to align them with HIT capabilities. Okee-Dokee.

Truth is, it has to be a PDSA improvement mix of tactics. We've known that for quite some time. See, e.g.,  the substantial AHRQ.gov workflow document repository. It goes back at least 20 years.Truth is, "the way clinicians actually work" is not cast in granite; it has to change with the technological times. Health care is not unique in this regard.

Finally,

Bullets 21 and 22: Well, NO ONE is arguing against any of that. The HIT literature of the past decade is full of such recommendations.
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IN CLOSING;
A FEW SUMMARY BROAD CONCERNS I HAVE WITH THIS LETTER
  • Who, precisely is is to be in placed charge of "re-designing EHRs" to produce the functionalities recommended by the HIC? The authors don't say. SOMEONE, SOME ENTITY will have to be in charge. And, while the tone here could not be more transparently anti-government, the private market imperative is fraught with its own adversities. Again, opacity (coupled with barriers to entry) = margin. That is simply an upshot of Efficient Markets 101. Transparency is the inverse linear correlate of Margin. And, it's worth noting in this regard, that Transparency would not beget us 1,945 ONC "Meaningful Use Certified" proprietary EHR systems (and 2 Open Source products, Vista, and Open EMR).
  • Yeah, "frictionless, intuitive, Steve Jobs-ian" usability would be swell. Plug 'n Play. No Training Required. Total Ease of Use for the Busy Clinician. What's not to love?

    But it's a weak analogy. Jobs gave us great entertainment-oriented consumer products (and no one is a bigger "Mac Snob" than me), and, while there is in fact a smidgeon of emerging convergence, the kids now getting $3-5 million in Series A VC IPO money in the Bay Area for their cute small-footprint tablet and smartphone apps are not going to do squat about the industrial-strength IT architectural needs of clinical ambulatory and (especially) in-patient HIT. I've been hanging around the Health 2.0 crowd for nearly a year. I'm mostly seeing a euphoric DotCom Bubble v2.0.

    There are again investors to be fleeced. Google "Built to Flip."

    apropos, from The New Yorker (05/27/13):

    Evgeny Morozov,, in his new book "To Save Everything, Click Here," calls this belief [health care salvation via Health 2.0] "solutionism." Morozov, who is twenty-nine and grew up in a mining town in Belarus, is the fiercest critic of technological optimism in America, tirelessly dismantling the language of its followers. "They want to be 'open,' they want to be 'disruptive,' they want to 'innovate'...You might not be able to pay for health care or your insurance, but if you have an app on your phone that alerts you to the fact that you need to exercise more, or that you aren't eating healthily enough, they think they are solving the problem." [Changing the World, George Packer, pg 50]
    Hear, Hear.
  • "...spend the remainder of the “meaningful use” funds on providing financial incentives for hospitals and other providers that demonstrate “meaningful improvements in patient care” through whatever means they choose, and leave it to the healthcare providers, not our federal government, to choose the most effective means to improve patient care."

    That begs a host of questions, starting with "what will constitute 'meaningful improvements in patient care'?" In science, someone -- in a position of some legitimate authority -- has to determine in advance what will constitute a "significant" improvement above baseline (for each clinical outcome measure of priority concern). These authors are utterly silent on the specifics here. We get instead gauzy Apple Pie sentiments.
I have agree that the "mad race for 'meaningful use' dollars" is real and unhelpful -- though that money chase incentive has peaked on the Medicare side (you'd have needed to attest for year one stage one in 2012 to preserve full 5-year $44k reimbursement potential, and 2013 attesters have additionally gotten hit with a 2% "sequester" cut).
ONE TEENY EDITORIAL NIT

"And thus far the Centers for Medicare & Medicaid Services (CMS) has spent over $12.7 billion of EHR stimulus monies." [page 1]

"These indictments of both our current breed of EHRs and the way in which EHRs are being implemented cry out for change in direction of the “meaningful use carrot” in CMS’ program that has already cost taxpayers $12.8 billion..." [page 3]

Emphasis mine. Was this not subjected to any proofreading prior to submission?
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I have no reason to doubt the sincerity of these HIC people with respect to the envisioned widely-shared ends they proffer. But, I have good reason to be skeptical of their argument as it is set forth in their letter. Maybe they do in fact have detailed operational plans for implementing their vision. They failed to cite any here (nor does this response provide any links to such detail).

CODA

Who/what is the Healthcare Innovation Council, really? Let's begin with Mr. Kneipper.

He's a lawyer, not a clinician.


He's a Health IT/Ops Mgmt vendor. Co-founder, interim CEO of Anthelio. From the corporate website:
EMR Services

Hospitals and physicians are rapidly implementing electronic medical records (EMRs) in order to obtain the "meaningful use" EMR funding under the American Recovery and Reinvestment Act of 2009. EMRs, if properly implemented and utilized, have the potential to improve the quality, efficiency and safety of healthcare delivery.

Though the number of healthcare providers implementing EMRs continues to rise, they are still struggling with the complexity of implementations. We at Anthelio Healthcare understand that the providers may not realize the full value of their EMR implementations due to numerous challenges such as scarcity of skilled resources, interoperability issues and the lack of end-user adaptation.

Anthelio Healthcare, with its proven implementation methodology and its expertise with the leading EMR applications, is a valuable partner for hospitals to lead and support the EMR implementation. We provide EMR solutions for the leading vendors: McKesson, Epic, Cerner, GE, Meditech and Healthland. Our EMR service offerings focus on assisting healthcare organizations create an operationally optimized EMR environment...
Implementations Services

Anthelio Healthcare provides end-to-end implementation services for all leading EMR applications. Based on our extensive experience with EMR implementations, we have developed a propriety [sic] "HeLIX" methodology for implementation...  
"propriety"?

Essentially, they're a VAR for some legacy HIT products.

I found it curious that this Anthelio "Independent Council" has no independent web presence (it resides in a sub-folder on the Anthelio website). Haven't yet looked to see whether they've filed 501(c)(3) or 501(c)(4). Anyone want to guess?


No Trademark declaration (not even "TM" common law).

I could cybersquat all of those domains for about 50 bucks. And then mount one of them, with just some basic homepage content, for about $100 a year.
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Wednesday, May 22, 2013

"If I knew then what I know now, what would I do differently?"

"If I knew then what I know now,
what would I do differently?"

A fender-bender of a sentence, that interrogative. Well, past-present grammatical pedantry aside ("what would I have done differently?"), a couple of my favorite aphorisms are "experience is that which you get immediately after you really needed it" and "judgment comes from experience, and experience comes from bad judgment."

Interesting bit of news popped up in the Google search today.
Healthcare Innovation Council Cites 2 Reasons Why EHRs Fail to Deliver

The Healthcare Innovation Council, an independent group of healthcare experts  has urged Congress to re-examine the direction of the Meaningful Use program, stating that it is not improving patient care. The commentary entitled, “Lets Admit the Emperor has No Clothes-It’s Time to Redesign EHRs to Improve Patient Care” was submitted by six US Senators in response to a report released by six Republican senators on April 16th...
Given that it's in the public domain, I will reproduce it in its entirety for your consideration. Read it all closely.
[Note: I am adding bracketed numbers on all of the bullet points for reference during the argument assessment phase].
MAY 26TH UPDATE

For your convenience (and my edification), I have transcribed the HIC Reponse Letter into verbatim mp3 audio (29 minutes), embedded here (you may need to get the free Adobe Flash plugin for embedded A/V html content). It is also located at my KHIT Podcast page.Just click on "start arrow" icon on the audio bar. You can then scroll up and down at will while the audio plays.

Note that they released their response commentary 11 months in advance of the Senate "REBOOT" report. Oops.
(image added by blogger -BG)
Let's Admit the Emperor Has No Clothes- It's Time to Redesign EHRs to Improve Patient Care
 
A public commentary from Anthelio's Healthcare Innovation Council

Anthelio’s Healthcare Innovation Council is an independent group of healthcare experts
that generates and publicly shares innovative ideas about how U.S. hospitals and
healthcare providers can meet escalating quality and financial pressures
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Abstract: Congress allocated $30+ billion of taxpayer monies to stimulate adoption of electronic health records (“EHRs”) by hospitals and physicians in order to improve healthcare quality. With nearly half of those monies spent, EHRs have not produced meaningful improvements in patient care and instead have made it more, rather than less, difficult for clinicians to provide patient care. It is time to redo the “meaningful use” EHR stimulus program to ensure that EHRs are designed and implemented in ways that help them improve patient care quality, safety and efficiency. Unless that is done, we then urge Congress to halt CMS’ “meaningful use” EHR program and spend the remainder of the “meaningful use” funds on providing financial incentives for hospitals and other providers that demonstrate “meaningful improvements in patient care” through whatever means they choose.
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There's always wisdom in asking the question "if I knew then what I know now, what would I do differently?" This question might be particularly instructive in looking at the substantial amount of resources- both dollars and people- we have invested in electronic health records (EHRs) over recent years and the EHR promise to deliver better patient care.

In 2009 Congress allocated $30+ billion of our taxpayer monies in the American Recovery and Reinvestment Act (ARRA) to stimulate adoption of EHRs and create a nationwide health information technology (HIT) infrastructure. The stated purpose of the HIT infrastructure was "to improve the quality of health care, such as by promoting the coordination of healthcare and improving the continuity of health care among providers by reducing medical errors, improving population health, reducing health disparities, reducing chronic illness, and advancing research and education.” The lofty goals for these EHR stimulus monies also included providing clinical decision support, supporting physician order entry, capturing/querying healthcare quality information, and exchanging/integrating such information among healthcare providers.


Whew! Lofty goals indeed! And thus far the Centers for Medicare & Medicaid Services (CMS) has spent over $12.7 billion of EHR stimulus monies.


Are we getting our money's worth from such a huge investment of taxpayer dollars? 
Why are we, both as healthcare providers AND as consumers of healthcare (as well as taxpayers), not seeing noticeable improvements in quality, coordination, continuity and improved process from providers who have implemented EHRs? Instead what we are seeing is a massive disruption of providers’ patient care focus as they chase “meaningful use” dollars; increased burdens on physicians, nurses and clinicians since EHRs as currently designed require more, not less, of their time and effort; and an unprecedentedly huge expenditure by providers on EHR hardware and software at a time when providers are under severe financial pressures.
HAVE WE LOST TRACK OF THE PLOT? IS IT TIME FOR A DO-OVER?

We believe that the root cause reasons why EHRs aren't delivering on their promises include: 
  • [1] EHR design issues: EHRs, to date, have been fundamentally designed to create electronic versions of paper medical records. EHRs focus on data collection mostly for regulatory compliance and financial reporting, not to assist physicians, nurses and other clinicians in providing higher quality more efficient patient care. As a result, the EHRs are not designed to reflect or facilitate the way in which providers deliver patient care, and thus disrupt, rather than enhance, patient care; and
  • [2] EHR implementation issues: EHR implementations are often led as IT "projects" by teams that do not obtain robust, meaningful, future-focused input / involvement from nurses, physicians, pharmacy and other clinicians who provide patient care. The end result typically is that EHR implementations don't make life better for EITHER the clinician or the patient. Sadly, more often than not physicians, nurses and other clinicians find EHRs make it more, rather than less, difficult to provide better patient care. 
So, from the "if I knew then, what I know now perspective”, we've had numerous conversations with a wide array of clinicians from multiple hospital, academic and provider practices, all of whom are using EHR systems from the leading EHR vendors (e.g., Epic, Cerner, Siemens, McKesson, Meditech etc.). The following themes emerged from those discussions, which question the ability of the current breed of EHRs to improve patient care and question the implementation methodology used by many providers that doesn’t have sufficient focus on improving patient care:
  • [3] Improving patient care should have been the primary focus for EHR planning/implementation, as directed by Congress in the ARRA. Instead, CMS’ and healthcare providers’ focus has been to "just get EHRs up and running" in a way that meets CMS’ “meaningful use” requirements so that they can get “meaningful use” dollars, without regard to how that affects patient care. CMS should change its “meaningful use” requirements to require measureable improvements in patient care in the short-term.
  • [4] The primary caregivers, nurses, were often not involved in EHR planning or had limited involvement with boundaries and limitations when nurses identified specific patient care needs.
  • [5] EHR planning was primarily from the IT perspective, not from the clinical care perspective.
  • [6] The EHR was not designed to provide a longitudinal view of the patient’s story over a period of time, with trending capabilities for improved decision making.
  • [7] The EHR is cumbersome and requires too many clicks to obtain needed patient information.
  • [8] The EHR does not facilitate patient knowledge, education or input.
  •  [9] Quality of documentation has decreased, not increased, after EHR implementation.
  • [10] The EHR is primarily an electronic documentation tool that unfortunately also isn’t, but could be, a "brain partner" decision support tool that aids clinicians in providing and improving patient care.
  • [11] EHRs should be interoperable so that EHR patient records are accessible to all care givers (subject to appropriate security and privacy), which was another direction to CMS by Congress in the ARRA.
  • [12] The efficiency and effectiveness of care delivery business processes need to be reviewed and  re-engineered prior to, not after, commencement of the EMR implementation.
These indictments of both our current breed of EHRs and the way in which EHRs are being implemented cry out for change in direction of the “meaningful use carrot” in CMS’ program that has already cost taxpayers $12.8 billion and cost healthcare providers tens of billions.
ESCALATING VIEW THAT THE EMPEROR HAS NO CLOTHES
A growing chorus of experts is beginning to question whether CMS’ EHR program is misdirected and not likely to achieve its objectives within a reasonable period of time. Consider the following:
  • [13] The first significant voice to challenge the direction of EHRs came way back in December 2010 when President Obama’s Council of Advisors on Science and Technology called for a change in the direction for EHRs since “[s]everal identifiable barriers in the healthcare system currently discourage innovation and vigorous competition in the market to create effective health IT systems”, including that “most current health IT systems are proprietary applications that are not easily adopted into the workflow of a clinician’s day, and whose proprietary data formats are not directly exchangeable from one system to another.” The Council bluntly urged a major change in CMS’ HITECH approach to stimulate the widespread adoption of EMRs/EHRs, which it said “creates a danger that EHR adoption during early stages of meaningful use may exacerbate the problem of incompatible legacy systems.”
  • [14] A 2011 letter to the ONC from 39 different physician professional organizations raised serious concerns regarding EHRs and interoperability technology issues: “Asking physicians to do more within an environment that is still not largely interconnected, and in which commercially available products cannot perform the required functions reliably, will simply result in additional financial and administrative burdens, including the use of time-consuming dual processes--paper and electronic….”
  • [15] In January 2011 Stanford University researchers Max J. Romano, BA, and Randall S. Stafford, MD, PhD. published a paper that also challenged the CMS push for EHRs since they found no evidence that EHRs would have any meaningful impact on healthcare quality: “despite the promise of better quality, the clinical benefits of EHRs and CDS [clinical decision support] are not evident in our quality indicators…our results raise doubts about past implementation of costly EHR technologies nationally. While EHRs offer substantial administrative efficiency over paper records, current patterns of EHR and CDS use do not appear to translate into better outpatient quality of care.”
  • [16] In November 2011, the Institute of Medicine released its latest report entitled “Health IT and Patient Safety: Building Safer Systems for Better Care” that bluntly stated that “the current state of safety of health IT must not be permitted to continue….Evidence suggests that existing health IT products in actual use may not yet be consistently producing the anticipated benefits, indicating that health IT products, in some cases, can contribute to unintended risks of harm…Health professionals require technologies that make this work easier and safer, rather than more difficult…Many health information systems used today provide poor support for the cognitive tasks and workflow of clinicians….This can lead to clinicians spending time unnecessarily identifying the most relevant data for clinical decision making, potentially selecting the wrong data, and missing important information that may increase patient safety risks.”
  • [17] In January 2013, the RAND Corporation released an updated report on EHRs that was a stunning reversal of its earlier report (skeptics allege that the earlier report was biased in favor of EHRs since it was financed by EHR software companies): "Health Information Technology systems must be engineered to aid the work of clinicians, not hinder it. Systems should be intuitive, so they can be used by busy health care providers without extensive training. Doctors and other healthcare providers should be able to easily use systems across different health care settings, much as consumers easily drive various makes and models of automobiles."
  • [18] On January 14, 2013 the American Medical Association (“AMA”) challenged the ONC’s ongoing rush to incentivize/force adoption of EHRs: “While the AMA shares the Administration’s goal of widespread EHR adoption and use, we are extremely concerned with the recommended approach to move full speed ahead without a comprehensive evaluation of the program and resolving existing barriers, including Health IT infrastructure flaws.”
  • [19] In 2013 CRICO, a patient safety and medical professional liability company owned by and serving the Harvard medical community, stated that that traditional EMRs don’t help clinicians improve patient care quality: “Traditional EMRs, evolved from hospital billing systems, provide a wealth of information and data, but fall short of helping clinicians streamline significant administrative requirements or process the vast amounts of information needed to care for patients. Nor do they reduce risk by helping avoid the types of oversights that can lead to an adverse event.”
  • [20] On April 25, 2013 ONC announced that it had revoked the certifications of two EHR products that previously had been certified under the “meaningful use” program. This is the first time that has happened and has caused huge concerns among hospitals and physicians about the possibility that more de-certifications could follow and disrupt EHR implementations and “meaningful use” funding.
It’s clearly time for Congress to reconsider whether CMS’ “meaningful use” program is furthering Congress’ explicit ARRA goal to employ EHRs to improve patient care. When Congress decided to rely on CMS and ONC to promulgate rules to achieve that goal, Congress was warned that it ought to exercise ongoing oversight to ensure that the federal ARRA stimulus monies would be used to improve patient care and quality. Specifically, on June 26, 2009 a Congressional Health Care Caucus panel presentation moderated by Representative Michael Burgess, M.D., Chair of the Caucus, with the following panel participants, stated that EHRs were not focused on improving patient care and quality, and thus urged that Congress not allow CMS to pay “meaningful use” funds to implement those EHRs without a focus on patient care and quality—the panel participants included Dr. Herbert Lin, Chief Scientist at the National Research Council and Editor of its report entitled “Computational Technology for Effective Health Care—Immediate Steps and Strategic Directions”; Tevi Troy, former Deputy Secretary of HHS; and Rick Kneipper, Co-Founder of Anthelio Healthcare Solutions and a member of Anthelio’s Healthcare Innovation Council.
Unfortunately, that warning wasn’t heeded, but fortunately some in Congress are starting to listen to the rising crescendo of concerns about CMS’ “meaningful use” EHR program since on April 16, 2013 Senators Thune, Alexander, Roberts, Burr, Coburn and Enzi issued a report entitled “Reboot: Re-Examining the Strategies Needed to Successfully Adopt Health IT” that stated as follows:
“[W]hile promoting the use of health IT is a laudable goal, a growing body of objective analysis and empirical data suggests that the [HITECH “meaningful use” stimulus] program needs to be recalibrated to be effective. Congress and the administration need to work together to ‘reboot’ the program to accomplish the aims of meaningful use and interoperability and ensure appropriate stewardship of taxpayer dollars in the process.”
REDESIGNING EHRS TO IMPROVE PATIENT CARE

As Steve Jobs taught the world, design simplicity should be linked to making products easy to use—“The main thing in our design is that we have to make things intuitively obvious.” The problem is that EHRs as currently designed are neither simple to use nor intuitive, and in fact make patient care more difficult and time consuming.


If we rethink design from the users' perspective, we believe it is essential that physicians and nurses, who are widely recognized as the primary caregivers and serve as 24X7 advocates in coordinating care across the team of providers, take a more central and meaningful role in the selection, design, implementation and operation of EHRs. In the day of manual records, nursing notes, for example, would be stored away in the Medical Records Department, and, for the most part, ignored except for necessary discharge planning. The electronic record is changing that equation. Increasingly, data stored electronically will become available to identify population health patterns of care and outcomes for large groups of people. In order to deliver improved population health, it is critical that nurses and doctors take an active EHR design role, both for care and for research and outcome improvement. Nurses are where the proverbial rubber meets the road in patient care. If EHRs are designed and implemented to simply and conveniently deliver what nurses need and when they need it, patient care, along with patient experience, would be dramatically improved. Unfortunately, more often than not, nurses are not meaningfully tapped for a strong EHR design or implementation role, and neither are other caregivers, including  physicians, pharmacists etc. This is a missed opportunity that needs to be remedied. Healthcare is a relationship business first and foremost. Technology should enable and enhance that relationship- not inhibit or replace it.


Strong nurse, physician and clinician EHR involvement will help achieve the following patient care improvement objectives:
  • [20] Improved focus on EHR design and implementation that starts by mirroring the way care is actually delivered by nurses, doctors and other clinicians. This basic design then would move to new, information enhanced processes that not only help clinicians do their jobs easier, but measurably improve patient care safety and quality.
  • [21] Discovery and integration of ways to enable a richer, more engaged and meaningful patient/caregiver relationship versus one that requires increased clinician time for record keeping instead of patient care.
  • [22] Redesigned EHR processes that ensure nothing falls through the cracks in care transitions (e.g., medication reconciliation,) which are a major source of patient safety issues.
  • [23] Rethinking, redesigning and re-engineering nurse, physician and clinician workflows to take full advantage of the capabilities of the new (and evolving) EHR tools to result in improved healthcare processes and care experiences.
It is important to recognize that EHR design does not end with implementation. Nurses and other clinicians should continue to play an active role in continually optimizing the EHR tool based on experience gained from its use. The vision of the EHR should be tempered by its use, and refined and enhanced as needed. That is the only way to ultimately deliver on the lofty promises made and demonstrate the full value of the tool to clinicians and patients.

TIME TO REDEFINE MEANINGFUL USE


The flaws of designing EHRs to capture data without improving patient care could be addressed if CMS “reboots” by refocusing its “meaningful use” stimulus monies to ensure that EHRs are designed and implemented in ways that demonstrate improved patient care, improved caregiver efficiency and improved patient experience. This is what CMS was charged to do by both Congress and the ARRA. We believe that CMS’top priority should be requiring that EHRs provide real and measurable benefit to users and make a positive difference to patient care. Let's count what counts- not merely what we can count.


Actual patient care improvement and better patient care process are not, but need to be, key parts of CMS’ “meaningful use” criteria. Increased nursing and physician clinical input will improve EHR design, acceptance and outcomes, as well as improve resource utilization and effectiveness of patient care resources. In order to ensure this clinician input, “meaningful use” criteria should require, and measure, (i) the involvement of caregivers, nurses and physicians in the EHR design, implementation and utilization processes and (ii) the post-implementation effects of the EHR on achieving meaningful patient care improvement. This would change CMS’ “meaningful use” standard to a “meaningful use in improving patient care” standard in order to achieve a continuous patient care, quality, safety and outcomes process improvement.


SUCCESS


It’s time to reassess the mad race for “meaningful use” dollars that CMS has fostered. CMS’ program is not resulting in EHRs that improve patient care, as mandated by Congress when it created and funded the program. CMS needs to change its “meaningful use” criteria to ensure that providers implement EHRs in ways that improve patient care. Moreover, requiring providers to move from one EHR project to another EHR project at breakneck speed does not allow for the optimization of what was just finished before attention goes to the next big thing, and has resulted in huge numbers of EHRs that are “in the ditch” and interfering with, not facilitating and improving, patient care. And CMS’ rush for EHRs does not appropriately recognize the overwhelming need for healthcare providers to concentrate on the multiplicity of unprecedented financial, clinical and political challenges they are facing today.
We squander and disrespect the wisdom of our users when we treat them solely as operators of our electronic tools. Steve Jobs did not do that— there's magic in that wisdom. Our users, medical professionals, are hungry for ways to improve patient care quality, efficiency and costs, and it’s time to redo the “meaningful use” EHR stimulus program to ensure that EHRs are designed and implemented in ways that help them improve patient care quality, safety and efficiency. It’s time to “reboot” before all of the “meaningful use” monies are spent and make that happen. Unless that is done, then we urge Congress to halt CMS’ “meaningful use” EHR program and spend the remainder of the “meaningful use” funds on providing financial incentives for hospitals and other providers that demonstrate “meaningful improvements in patient care” through whatever means they choose, and leave it to the healthcare providers, not our federal government, to choose the most effective means to improve patient care.
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Anthelio’s Healthcare Innovation Council members are:
  • Robert Burns, PhD, MBA: Chair of the Health Care Management Department at Wharton School, University of Pennsylvania; Director of the Wharton Center for Health Management and Economics
  • Hud Connery, MHA: CEO of iVantage, a healthcare data analytics company; former
    founder and CEO of Essent Healthcare, a for profit hospital company
  • Kevin Hickey: Founder and Principal with HES Advisors, a consultancy to healthcare
    growth companies; former executive roles with Oxford Health Plans, Aetna, Lincoln National and MetLife
  • Julie Klapstein: Former founding CEO and Vice Chair of Availity, a health information network; board member of Annies Organics, Standard Register, Dominion Diagnostics and Akal
  • Rick Kneipper: CEO (Interim), Chief Strategy and Innovation Officer, and Co-Founder of Anthelio Healthcare Solutions
  • Jack Lord, MD: Former COO of University of Miami Health System; former CEO,
    Navigenics; former SVP and Chief Innovation Officer, Humana Inc.; and former COO,
    American Hospital Association
  • John McConnell, MD: CEO, Wake Forest Baptist Medical Center; EVP for Health Affairs, Wake Forest University; Professor of Urology, Wake Forest University School of Medicine; former EVP for Health System Affairs at University of Texas Southwestern Medical Center; elected to Institute of Medicine of the National Academy of Sciences
  • Sharon Riley: Former CEO of University of Texas Southwestern Medical Center University Hospitals; former COO of Anne Arundel Medical Center; former COO of University of Nebraska Medical Center; Board member of Heska Corp.; Senior Advisor to DigiWorks
  • MaryAnn Stump, RN, MBA: Former SVP, Chief Strategy and Innovation Officer, Blue
    Cross and Blue Shield of Minnesota; External Advisory Board, Yale College of Nursing; Robert Wood Johnson Foundation Executive Nurse Fellow National Advisory Board
With special thanks to Jack Kowitt, Executive Vice President of Anthelio Healthcare Solutions (former CIO of Parkland Health and Hospital System), who participated in the preparation of this commentary.**
** I searched out and added the links to all of these people, wanting to read up on them prior to engaging in any analysis of this proffer. Rather impressive crew.
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"Given that we now know what we did not in 2009 with the passage of ARRA/HITECH, what should we now do differently?"

Stated coherently, it's a fair question (though I would add the qualifier "what, if anything...").

Fundamental to PDSA, is it not? You PLAN, you DO, you STUDY the upshot, and then you ACT -- in a controlled, scientific manner -- based on the initial results.

MORNING UPDATE

apropos of the topic, this arrived in my email inbox this morning:




Healthcare IT is challenged by seemingly opposing needs - the clinician's need for fast and intuitive data capture, and the enterprise need for structured and encoded data. The latter is needed to optimize care plans, drive decision support, quality reporting and appropriate billing. Through the government's Meaningful Use of EHRs program, healthcare institutions are incentivized to adopt certified EHR technology meant to achieve those data needs. However, this direct approach of capturing healthcare data via structured templates and drop-down menus in today's EHR user interfaces comes at the expense of lost physician productivity and isn't working in practice. On top of that, the intended benefit of widespread interoperability of healthcare data has not yet been achieved either.

Clinicians prefer the more efficient and more expressive unstructured narrative to capture a patient's story, and this mode of clinical documentation persists in most hospitals and practices for that reason. At first glance, it doesn't look like the goals of Meaningful Use and interoperability efforts can be achieved based on unstructured narrative. However, recent technology advances have propelled this mode of clinical documentation to the forefront as a viable alternative to structured data entry that helps to address current EHR deficiencies and provide physicians a more familiar experience for creating digital records. In this webinar, we will review a closed-loop clinical documentation approach based on Speech Understanding™ and Natural Language Understanding technologies, and will discuss how a strategy of incrementally capturing and structuring just the relevant data can achieve the goals of Meaningful Use and interoperability without significantly impacting physician productivity or quality of documentation. This approach received widespread attention when it was demonstrated at the last HIMSS conference as part of the HealthStory Interoperability Showcase.

During this webinar, you’ll learn:

  • How recent technology advances help address current EHR deficiencies by allowing physicians to continue to capture and use the full patient story
  • How to achieve the goals of Meaningful Use and interoperability without disrupting the physicians documentation workflow or the quality of the documentation
  • How closed-loop clinical documentation approaches use Speech Understanding™ and Natural Language Understanding technologies to structure the relevant data from the narrative and support Meaningful Use.
 Interesting. Register here. I just did.



ALSO ON-TOPIC
HHS announces electronic health record adoption more than doubled in 2013
May 23, 2013


More than 50% of medical professionals and 80% of hospitals have received Medicare or Medicaid incentive payments related to meaningful use of electronic health records, a more than twofold increase since 2012.

The Department of Health and Human Services (HHS) announced it has exceeded its goal for 2013 due to physicians, hospitals and other eligible providers adopting meaningful use of electronic health records (EHRs).

“We have reached a tipping point in adoption of electronic health records,” Kathleen Sebelius, HHS secretary, stated in a press release. “More than half of eligible professionals and 80% of eligible hospitals have adopted these systems, which are critical to modernizing our health care system. Health IT helps providers better coordinate care, which can improve patients’ health and save money at the same time.”...
No accident, the timing of that news, 'eh? Link to the HHS press release here.

Humor me. Work with me here. I'm fixin' to proffer an analogy, imperfect as it may be.

Also apropos...

SAN FRANCISCO, Calif. — Before health care providers can handle “big data,” they first need to learn how to deal with small data.

That’s the frank assessment of Sean Cassidy, a vice president with Premier Data Alliance, a group purchasing organization that helps coordinate the health care provided by 2,800 hospitals, 56,000 non-surgical healthcare facilities, and 34,000 doctors’ offices.


He focused on the data needs of accountable care organizations, or ACOs, which aim to control costs while improving health  care outcomes by basing reimbursements to providers on the effectiveness of the care they provide. To do so, an ACO incorporates a network of physicians, hospitals, and other providers with a wide range of specialties, to ensure that patients can get the services they need within the network. That’s where technology comes in.


“I need tools to coordinate their care,” Cassidy said, speaking from the perspective of a healthcare provider in the ACO context. He was speaking onstage today at VentureBeat’s HealthBeat conference, a two-day event focused on health IT. (That’s Cassidy, above, on the right, speaking with VentureBeat CEO Matt Marshall.)


“The game is, keep folks in the ambulatory setting, keep them out of the ER setting, and that’s how we’re going to dramatically control costs.”


But to make that work, Cassidy says, ACOs need better data. Right now, much of the data available comes from medical claims, data that is “a mile wide and an inch deep,” Cassidy quipped.


Electronic medical records systems (EMRs) would offer much deeper data on each patient’s condition and needs, enabling much more effective large-scale analysis and coordination — but EMRs are hard to work with. That’s a fact acknowledged by many of the speakers today.
“We have had trouble getting data out of EMRs,” Cassidy said. “We have had trouble with closed systems, and with walls being put up.”


For example, Cassidy said, the database records and reporting provided by Epic, one of the largest EMR providers, lacks the flexibility and the transparency that he needs to make it truly interoperable with other systems. Other EMR systems are similarly limited.


That presents a huge opportunity for startups that can help break down those walls and increase the interchange of data, he said.
“What we’d like to see is standards emerge,” Cassidy concluded. “Then everybody, let’s innovate on top of that platform, and let the best companies win.”
 “What we’d like to see is standards emerge. Then everybody, let’s innovate on top of that platform, and let the best companies win.”

Indeed. What have I been saying? See my April 25th, 2013 post. I'm still waiting for someone to substantively challenge me on my asserted facts and my logic.
___

UPDATE: MR. KNEIPPER WILL HAVE A COW

WHAT YOU SHOULD BE DOING AS A SMALL PRACTICE

As a small practice looking to buy that first EHR or trying to correct the mistakes of the first purchase by switching, it would be prudent to remain unmoved by the current Epic-Non-Epic drama being played out.  Both segments of the market have very good reasons to exist, and as an EHR customer what you should be mainly concerned about is the suitability of the product to your practice.

But then sifting through all the arguments and counterarguments to make an informed EHR decision might be too much to ask of a busy provider, already reeling under umpteenth deadlines.  So, the ideal thing to do would be to hand over the mantle of EHR purchase, installation, and support to your medical billing vendor or your EHR support company and let them sift through all the noise, while you continue to provide your fullest attention to your patients.
From "EHR WAR OF THE BIGGIES – THE COMMONWELL PROBLEM"

ANOTHER UPDATE

From the Fort Mill Times.
Healthcare Innovation Council Calls Out CMS’ EHR Program as “Emperor Has No Clothes”

DALLAS (May 20th, 2013) -- An independent group of healthcare experts has called upon Congress to reconsider CMS’ “meaningful use” program to finance electronic health records (EHRs) for hospitals and physicians since it is not furthering Congress’ goal of improving patient care. The Healthcare Innovation Council submitted its commentary entitled “Let's Admit the Emperor Has No Clothes- It's Time to Redesign EHRs to Improve Patient Care” to U.S. Senators Lamar Alexander, Richard Burr, Tom Coburn, Mike Enzi, Pat Roberts and John Thune in response to an April 16, 2013 public invitation and report by such Senators that questioned the current EHR federal funding program and asked for public input...

The Council’s commentary cites numerous examples about how the current breed of EHRs and the method they are being implemented are not improving patient care, as required by Congress when it approved $30+ billion of taxpayer monies for EHRs in the American Recovery and Reinvestment Act...
"The Council’s commentary cites numerous examples about how the current breed of EHRs and the method they are being implemented are not improving patient care."

Really? Where? The commentary asserts that there are "numerous examples" resulting from their "interviews." They don't cite them, nor do they provide any assurance that the data were scientifically obtained rather than being anecdotal and biased in favor of naysayers. In meta-analytic fashion, they cite seven studies [bullet points 13 - 19] critical of Health IT deployment, but only allude to aggregate concerns contained in these reports. Seven critical reports across four years? Is that unusual for any large government initiative of comparable complexity and magnitide?

Pretty sloppy re-write by the Fort Mill Times, I'd say.
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More to come...


Monday, May 20, 2013

How Fragile We Are

I've been driving all day back to LAS from Walnut Creek. Got in to witness this on the news when I got home.

Terrible. Below, a hospital in Moore, Oklahoma.

Wonder if they had EHR with offsite backup and a disaster recovery procedure? More broadly, I wonder how many of the local citizens' docs had EHR with offsite backup and a recovery px? Their REC should be able to tell that from its CRM or environmental scan data.

www.salvationarmyusa.org
MAY 22 UPDATE

Well, the official death toll has been reduced by more than half, down from the fog-of-calamity estimated 51 to 24 today. When you look at the scenes of destruction, it's testament to the locals' preparation and awareness that the death toll wasn't in the hundreds or thousands.


May the rebuilding and healing proceed quickly.
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Thursday, May 16, 2013

Courage


Notwithstanding that some critics found it necessary to criticize from afar the wisdom of Angie's decision, no one can dispute the courage it took to make it and to undergo this radical, life-altering px. And to then go public about it.

I, for one, wish her a full recovery and a long, healthy life to come.
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UPDATE: 

Why Angelina Jolie’s ‘Medical Choice’ Is Likely Not Yours

SUNDAY UPDATE: GUEST CROSS POST

I've been enthusiastically reading Dr. Gurley's columns in the Chronicle for years, and was blessed to finally meet her at Health 2.0 SF last fall. She is heroic in my eyes.

Dr. Gurley has agreed to serve as Chair of the now-assembling Clinical and Policy Advisory Board for my new project, KHIT. Others include Joe Fortuna, MD, Chair of the ASQ Health Care Division, and my former boss Deb Huber, RN, MSHA, Executive Director, HealthInsight Nevada and HealtHIE Nevada HIE. Nomination of others welcomed.

Jan has graciously assented to a linked cross-posting here.


From her blog, "Posts from an Insane Healthcare System".
Booby Traps: Pitfalls along the path of genetic testing and mastectomies
May 16th, 2013, Jan Gurley, MD


The first time I wrestled with the issue of whether to get my breasts cut off, I was in my early forties.  Partners in life, my breasts had done right by me. They delighted me in all their underwhelming adolescent glory. Then they’d been a source of panting, wriggling joy for so much of my adult life. They’d amazed me after pregnancy when I became a fount of Bessie-the-cow milk production. I could have fed a village — or at least a day care. I’d learned to love and laugh about my breasts, like many motherhood-survivors, because when it comes to your own body, the first casualty of giving birth is your dignity. Post-weaning, the second casualty is your cup size. I’d even written about (and claimed) that frustrating and fascinating sagging that occurs with vintage breasts like mine.

But there was a good chance, like for Angelina Jolie, that mine could be harmed by “faulty” gene.

Booby trap #1: When it comes to family history, how bad is bad enough?

The Affordable Care Act mandates that BRCA genetic testing be covered, when you have a higher risk of breast cancer. What is “higher”? That’s actually a tough question to answer. There are many useful risk calculation tools out there (here and here are two). Plugging in what was known at the time of my own genetic testing, my estimated lifetime risks were between 17%-26%. Bad, sure, but that’s a pretty big range, and, probably, a significant underestimate. Why?

First, my family in rural Georgia, like most of America, struggles with getting good consistent health care, as well as dealing with taboos around women’s health. So when I tried to map out a sprawling family history, there were large numbers of women who had or even died of “female troubles.” Where the heck does that go in a risk calculator?

Second, the current calculators don’t include the gamut of risk factors.  Most are focused on breast cancer, with some including ovarian cancer, which are the risks for BRCA1 genes. BRCA2, however, also increases your risk of melanoma and pancreatic cancer. I’d had a nasty early-stage mole taken off while in medical school, and my mother’s mother died of pancreatic cancer. That’s not in a calculator anywhere.

Since I’m a doctor, and was aware of these caveats, I was able to have a detailed discussion with my provider about my risks, and get my genetic testing covered. Many other people with my exact same family history, might be told theirs wasn’t bad enough to qualify for the roughly $3,000 test.

Booby trap #2:   Are you ready to act if your test is bad?

Shouldn’t we just screen everybody? There is an old medical rule-of-thumb: Don’t get a test, if there’s nothing you’re going to do about the result. Is that true, though? After all, isn’t a blood test just a blood test? Well, no. If you get a positive BRCA result, you can’t ever erase that from your mind, your medical record, your family, or even your world view. Just knowing your results can shift the psychological foundations of your life.

I thought I knew my priorities when I had my BRCA test. Like Angelina Jolie, I had young children that needed me. They climb into your bed on a Saturday morning and knee your belly as they crawl across you with their stacks of books, demanding you to “read!” Silky little arms snake around your neck, claiming you, your love, your time. Young children are wonderfully, gloriously oblivious to your importance to them. Hell, if losing my breasts was what was necessary to avoid breast cancer, I figured I was “done” with my breasts. I decided to get genetic testing, and I told everyone who cared that if it came back positive, I’d have both my breasts removed. I thought I was ready for that.

I believe getting tested is an act of claiming your choices and your future. However, I am not a huge fan of home-based testing for lethal-type genes – unless it is the only option. Testing is a difficult process. The pivotal time of pondering, arranging the test, then waiting for results, oppresses with a stagnant emotional turmoil that seethes under the surface. A quicksand of fatalism can drag you so far down you find yourself unable to do the minimum-necessary to care for your health. Partners help. Trained health care support helps. I can’t even begin to imagine having to walk a red carpet, facing the world of Internet trolls, as I grimly pushed ahead, day by day, carrying that burden while I waited for the results.

And then results arrive…

Booby Trap #3: Beware of both optimism and pessimism when you’re playing the numbers game.

In cost-effectiveness analyses, researchers try to put an exact number on how bad is bad. Human minds, however, balk at this concept. For example, if I told you there was a 2% chance you’d get breast cancer, you’d likely feel pretty good. If I said there was a 98% chance you’d never get breast cancer, you’d probably feel even better. But if I said you had a one in fifty chance of getting breast cancer – and to imagine yourself sitting in a room with 49 other people, waiting to see if your name would be called out as the one with the diagnosis, you’d be feeling pretty crummy. Yet all of those are the exact same risk.

When you get something rare, you get it 100%. Some of us probably looked at Angelina Jolie’s estimated 87% risk of breast cancer and thought, well, it’s not 100%. We can project ourselves into the 13% good result. Or we may freak and believe, in our heart of hearts that having the gene means we must already have cancer. Neither is true. So how can we live with this constant risk friction?

After looking at the numbers, I approach the issue in a more qualitative way. One option is the Worst Case Scenario approach. What is worse – having your breasts cut off, or having breast cancer? And, for many people, that answer is enough.

But sometimes you have to dig deeper, to ask questions such as: what if I cut off both my breasts, and I never got breast cancer, how would I feel? Or, what if I had my breasts cut off and I still got breast cancer – how would I feel? Or what if I chose to do nothing, never got breast cancer but lived my life in a state of perpetual fear?

This is an approach I call Drafting The Story. You are the protagonist-hero of your life and these are all drafts, of your story. Which narrative can you live with? Which one can you embrace? Angelina Jolie’s statement that she felt “powerful” was authentic because she chose her narrative.

Sometimes, in health care, it’s not the number-crunchers we need; it’s the story-tellers.

Booby Trap #4: Watch out for when a good result can be a bad result.

So what were my test results? And what happened to my beloved breasts? Things didn’t actually turn out how anyone would have expected.

First, I was BRCA negative.

The exploding relief that I felt should have been a warning sign that maybe I wasn’t quite as ready to cut off my breasts as my hyper-logical, algorithmic brain tried to say I was. But I ignored that warning sign and let myself just revel in the joy – joy for myself and joy for my loved-ones.

Second, so what did this mean for me long term, and for all people with higher risks of breast cancer whose BRCA tests are negative? Is there a risk to having a negative result? Well, as in many aspects of medicine, this question is complex and controversial. Those two forces – complex and controversial – are also warning signs that we, as a health care system, are likely to give inconsistent, suboptimal health care. When I got my negative BRCA test results, I tumbled right into those gaps in care, only to crash-land with an invasive breast cancer diagnosis several years later.

What can you learn about health, statistics, and decision-making from my experience? Stay tuned for Booby Traps, Part 2: Pitfalls of the mastectomy decision.
I eagerly await part 2, as should you.

Doc Gurley speaking at Health 2.0: Refactored, May 13th, 2013.
Photo by BobbyG
I have some observations to contribute regarding clinical assays and statistics. For now, a snip from a post of mine a decade ago on a different topic. There are two principal camps among stats practitioners; the "Frequentists" and the "Bayesians."

Count me squarely in the latter encampment.


My core concerns:
  1. Sensitivity: the ability of an assay to indentify true positives;
  2. Specificity: the power of an assay to eliminate true negatives;
  3. Prevalence: the proportion of true positives in a population of interest;
  4. The upshot of error: the relative consequences of being wrong either way.
And, in addition to Lab QA (both intra- and inter), add to the foregoing what you might call the "Empirical Moving Target" problem. Past may well be significant prologue in many cases (a fundamental necessity of the Bayesian paradigm), but not inexorably.

ON ANALYTICAL "ACCURACY" AND "PRECISION"

From my 1998 grad Thesis:
The terms “accuracy” and “precision” are not synonyms. The former refers to closeness of agreement with agreed-upon reference standards, while the latter has to do with the extent of variability in repeated measurements. One can be quite precise, and quite precisely wrong. Precision, in a sense, is a necessary but insufficient prerequisite for the demonstration of “accuracy.” Do you hit the “bull’s eye” red center of the target all the time, or are your shots scattered all over? Are they tightly clustered lower left (high precision, poor accuracy), or widely scattered lower left (poor precision, poor accuracy). In an analytical laboratory, the “accuracy” of production results cannot be directly determined; it is necessarily inferred from the results of quality control (“QC”) data. If the lab does not keep ongoing, meticulous (and expensive) QC records of the performance histories of all instruments and operators, determination of accuracy and precision is not possible.
I don't claim any expertise with respect to commercial genomic assays. Nonetheless, there are some basics that do in fact apply:
Processing DNA samples requires that humans collect and handle biological samples, which are then subjected to laboratory techniques run by human technicians. DNA testing is only as reliable as are the people overseeing each of these processes, and infallibility simply cannot be achieved. Therefore, forensic scientists must depend on quality control, retesting, troubleshooting, and transparency of every decision made in the process to achieve reliable, trustworthy forensic evidence every time.

Krimsky, Sheldon; Simoncelli, Tania (2010-06-01). Genetic Justice: DNA Data Banks, Criminal Investigations, and Civil Liberties (Kindle Locations 5646-5650). Columbia University Press. Kindle Edition.
apropos of all of the foregoing...

Sometimes, more medical information is a bad thing. The influential United States Preventive Services Task Force recommends against most women getting genetic screenings for their susceptibility to breast cancer. Why? Because the tests are imperfect: for every woman who gets tested for genes associated with onset breast cancer, even more will falsely test positive, leading spooked patients into needless surgery or psychological trauma. Super cheap genetic testing from enterprising health startups, such as 23andMe, have complicated cancer detection for us all by increasing the accessibility of imperfect medical information.

After discovering a mutated BRCA1 gene, known to increase breast cancer 60 to 80%, actress Angelina Jolie’s underwent a radical preventive double mastectomy. Her brave confession in the New York Times brought much needed attention to breast cancer awareness, but it’s dangerous in the hands of a statistically illiterate population...
Link to full article here.
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UPDATE:

"It took less than a day for various quacks to attack Angelina Jolie’s decision, as reasonable and science-based as it was, to undergo prophylactic bilateral mastectomies to prevent breast cancer."

ScienceBasedMedicine.org
I had been debating whether to blog about Angelina Jolie’s announcement last week in a New York Times editorial entitled My Medical Choice that she had undergone bilateral prophylactic mastectomy because she had been discovered to have a mutation in the BRCA1 gene that is associated with a very high risk of breast cancer. On the one hand, it is my area of expertise and was a big news story. On the other hand, it’s been nearly a week since she announced her decision, and the news story is no longer as topical as it was. Also, I’ve already written about it a couple of times on my not-so-super-secret other blog, making the division of blogging…problematic. So, if some of this is a bit repetitive to those who are also fans of my more—shall we say?—insolent persona, I apologize, but try to be patient. I will be doing more than just rehashing a couple of posts from last week (although there will unavoidably be at least a little of that), because there have been even more examples of reactions to Jolie’s announcement that provide what I like to consider “teachable moments.” I will start by asserting quite bluntly that in my medical opinion, from the information I have available, Angelina Jolie made a rational, science-based decision. How she went about the actual mechanics might have had some less than scientific glitches along the way (more about that later), but the basic decision to remove both of her breasts to prevent breast cancer associated with a BRCA1 mutation that she carried was quite reasonable and very defensible from a scientific standpoint...
SBM never disappoints.
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More to come...