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

A PLoS article was recently published on health IT's impacts on healthcare quality and safety. In the article, a form of meta-research was performed; systematic review articles were collected and then reviewed systematically.

Black AD, Car J, Pagliari C, Anandan C, Cresswell K, et al. (2011) The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview. PLoS Med 8(1): e1000387. doi:10.1371/journal.pmed.1000387.

A text version can be seen at this link and a PDF downloaded at this link.

I will reproduce only the abstract here, and then make a few comments (over and above the hundreds of posts on these issues I've authored at this blog since 2004):

The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview.

Ashly D. Black¹, Josip Car¹, Claudia Pagliari², Chantelle Anandan², Kathrin Cresswell², Tomislav Bokun¹, Brian McKinstry², Rob Procter³, Azeem Majeed⁴, Aziz Sheikh^2*

1 eHealth Unit, Department of Primary Care and Public Health, Imperial College London, London, United Kingdom, 2 eHealth Research Group, Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, United Kingdom, 3 National Centre for e-Social Science, University of Manchester, Manchester, United Kingdom, 4 Department of Primary Care and Public Health, Imperial College London, London, United Kingdom

Abstract

Background

There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. [I believe it would be more accurate to write "always at considerable cost, with generous profits being made by the IT merchants, implementers and consultants"- ed.] In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care.

Methods and Findings

We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment strategies are lacking.

Conclusions

There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. [You've heard that here before - ed.]

In addition, there is a lack of robust research on the risks [I believe it would be more accurate to say there's been a suppression of research and/or of publicity on the risks - ed.] of implementing these technologies and their cost-effectiveness has yet to be demonstrated [in other words, healthcare IT is an experimental technology. You've heard that here before, too - ed.], despite being frequently promoted by policymakers and “techno-enthusiasts” as if this was a given.

[In other words, there's an irrational - or contrived - exuberance. You've heard that here before, too - ed.]

In the light of the paucity of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, it is vital that future eHealth technologies are evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle. [You've heard that here before, too - ed.]

Such evaluation should be characterised by careful attention to socio-technical factors to maximise the likelihood of successful implementation and adoption.

[You've heard that here before, too, as well as at my site "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties", as a matter of fact previously entitled "Sociotechnologic Issues in Medical Informatics...", started in 1999 - ed.]

I can add these additional comments:

• The findings of this study were of no surprise to me or likely to readers of this blog. I've been writing on these issues since the 1990's, and on this blog since 2004.

• In the main article itself it is stated "... there remains a disparity between the evidence-based principles that underpin health care generally and the political, pragmatic, and commercial drivers of decision making in the commissioning of eHealth tools and services." In other words, the rigor of medical science itself is lacking in healthcare IT. I've written that repeatedly here and elsewhere. I ask again: how can IT "transform" ot "revolutionize" healthcare when the culture of IT itself is in need of reform?

• Also stated in the article's body was this: "Risks largely went ignored apart from anecdotal evidence of time-costs associated with recording of data due to both end-user skill and the inflexibility of structured data, increased costs of EHRs, and a decrease in patient-centeredness within the consultation." See my prior post "MAUDE and HIT Risks: Mother Mary, What in God's Name is Going on Here?" for what I find as deeply concerning ("hair-raising") revelations regarding risk that you should think about next time you find yourself in a computerized hospital or doctor's office.

• Also in the article body: "Our major finding from reviewing the literature is that empirical evidence for the beneficial impact of most eHealth technologies is often absent or, at best, only modest. While absence of evidence does not equate with evidence of ineffectiveness, reports of negative consequences indicate that evaluation of risks – anticipated or otherwise – is essential. Clinical informatics should be no less concerned with safety and efficacy than the pharmaceutical industry. [Having worked in both sectors, hospital and pharma , you've read that here before - ed.] Given this, there is a pressing need for further evaluations before substantial sums of money are committed [as you've read here in numerous posts, that's BEFORE, NOT DURING OR AFTER - ed.] to large-scale national deployments under the auspices of improving health care quality and/or safety." Are governments listening, I ask?
  

• Study methodology and source material limitations were noted. However, also noted was this: "Our greatest cause for concern was the weakness of the evidence base itself. A strong evidence base is characterised by quantity, quality, and consistency. Unfortunately, we found that the eHealth evidence base falls short in all of these respects. In addition, relative to the number of eHealth implementations that have taken place, the number of evaluations is comparatively small." In my view, national re-engineering programs involving a large portion of the economy and a critical societal function should not be undertaken when the evidence base is weak and the number of evaluations is small. Further, national leaders should not be making statements of certainty such as made by the HHS ONC office as I wrote about at "Science or Politics? The New England Journal and The 'Meaningful Use' Regulation for Electronic Health Records" and at "Blumenthal on health IT safety: nothing to see here, move along."

• This article might be compared to the Dec. 2009 Milbank Quarterly article "Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London. I wrote about that article at this link. It was also a meta-analysis; its major conclusion was that "the tensions and paradoxes revealed in this study extend and challenge previous reviews and suggest that the evidence base for some EPR programs is more limited than is often assumed."

Read the entire PLoS article at the links above.

-- SS

Dr. Extormity's Testimony at Healthcare IT Hearing

At "Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith" I reproduced a physician's testimony on "Meaningful Use" of Health IT.

I thought his testimony illustrated the issues quite well.

However, Dr. Monteith's been outdone, this time by Dr. Extormity. Click to play:

Dr. Extormity's Testimony at Healthcare IT Hearing - click to play.

Also see my May 2008 post "SEEDIE, the Society for Exorbitantly Expensive and Difficult to Implement EHR’s" for more on Dr. Extormity's fine work.

Note: this was a "medical humor break" of the kind Residents need to stay sane on the battlefield.

(Hat tip to ducknetweb.blogspot.com).

-- SS

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

As I wrote at my last post "Healthcare IT Delirium":

The field of health IT has become delirious.

On top of an irrational exuberance (see this blog query) largely unsupported by the literature (e.g. here), the technology is experimental, its rollout is a grand national experiment in social re-engineering of medicine, there is no patient informed consent, nobody is in control, and nobody is taking responsibility for regulating the domain despite known risks. The results will very likely reflect the Wild West free-for-all that is now extant.

It's worse.

Some time ago I posted on a number of cases of health IT malfunction from the FDA's MAUDE (Manufacturer and User Facility Device Experience) database of medical device risks. See posts on MAUDE here and here.

MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.

Either I missed a Titanic boatload of cases, or MAUDE has been appended since my posts, because MAUDE links such as this , this and this are now returning a Mother Lode of cases, at least from one vendor where these events are reported (other vendors' products suffer similar problems).

Examples just from light browsing cause the hair to stand up on my head (there are many, many more at the MAUDE links above):

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1584195
CERNER MILLENIUM CPOE, POWER CHART
Event Type Injury Patient Outcome Life Threatening;
Event Description

The cpoe system serves and documents all transactions of communication pertaining to the patient's care. Orders are entered and delivered to an anticipated recipient and the action ordered is executed. The device-recipient interface has been unreliable with specific etiologies for failure not yet resolved or understood. Examples include orders to transfer patient from icu to a non-icu bed. Patient is moved to another bed but recipient care team does not receive communication and was not aware patient was under their charge. Patient had seizures on floor for hours throughout the night. Other patients had orders for lab tests, chemical tests on body fluids, cytological analysis of body fluids, cultures on body fluids, pathology on or specimen, and others that are not executed by the recipient, leaving the patient undiagnosed after having taken risks for a procedure. Such interface failures have been known by the vendor for years as reported by its own support team.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581240
CERNER MILLENIUM CPOE, POWERCHART Back to Search Results
Event Type Injury Patient Outcome Life Threatening; Hospitalization Disability
Event Description

The displays, formats, layouts, and interfaces of the cpoe tools at this institution contain elevated degrees of user unfriendliness. This toxic effect on the user is manifested by, to mention a few, more than 20 electronic silos in which orders are stored and extensive wordiness using descriptors that are highly irrelevant to the task of the care of pts with critical illness. This manifests itself in several ways, one of which is the ordering of duplicate medications and treatments, some of which get to the pt. These should be reported to pharmacopoeia data bases but often are not. This pt was being infused both total parenteral nutrition and a concentrated dextrose solution, the combined rate of which and cumulative dose caused pulmonary edema.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577753
CERNER MILLENIUM CPOE Back to Search Results
Event Type Injury Patient Outcome Life Threatening; Hospitalization Disability
Event Description

Stress test orders are ambiguous. An example of the order states "stress test adenosine/dobutamine w/imaging nm -stress test adenosine nm-". Order displays on 4 lines on the screen. The type of test that the doctor intended to be performed is unclear, resulting the risk of incorrect pharmacological modalities being used. This caused life threatening acute asthma attack in patient with background asthma who incorrectly received an infusion of adenosine. All patients ordered pharmacological stress tests become subject to said risk.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1578421
CERNER MILLENIUM CPOE Back to Search Results
Event Type Injury Patient Outcome Life Threatening; Other
Event Description

When a pt having been in the hospital preoperatively, begins its post-operative course in the recovery room or intensive care unit, post op orders are electronically entered by deleting the unneeded orders that have been active, leaving the orders that are still needed, and adding new ones. There can be upwards of 300 lines of "active" orders on a complicated pt. Precise and safe post-operative ordering requires a time consuming line by line review of each order, counter-intuitively canceling those that are not needed. This does not always occur for any number of reasons, not the least of which is that the task is time consuming and user-unfriendly. The incidence of commingling the pre and post op orders in a hospital with cpoe instruments of care is unk, but not uncommon. At least one pt was placed at risk when the clean post operative abdomen was irrigated based on the pre-op order.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1574909
CERNER MILLENIUM CPOE Back to Search Results
Event Type Injury Patient Outcome Life Threatening;
Event Description

This cpoe product allows doses to be ordered that are not a multiple-s- of the pill size. A representative example is 20mg atenolol po daily. Pill size is 25mg. This feature facilitates dosing errors and enables dangerously absurd dosing without warning. When the reports such dose having been given, the clinician is left to wonder, what dose was given, actually.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570802
CERNER MILLENIUM CPOE, POWER CHART Back to Search Results
Event Date 07/11/2006
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description

Hospital wide breakdown of system of electric charts and electric order gadgets resulted in confusion, neglect, failed communications and delayed treatments in the days immediately following the surgery, leaving patient with permanent musculoskeletal disability and mental anguish. Breakdowns of this magnitude endanger hundreds of patients simultaneously.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1665473
CERNER MILLENIUM CPOE, POWER CHART Back to Search Results
Event Date 10/09/2006
Event Type Malfunction Patient Outcome Other;
Event Description

It has been discovered that the medication review screen consisting of a list of the medications on the left most column and a grid indicating the number of doses administered in each time period. The defect manifests itself in the representation of exactly what medication was administered. For pts who are taking two or more forms of the same pharmacological agent, eg nitroglycerin in the paste form, sub lingual form, and pill form, the name of the medication is represented as "nitroglycerin" on the list. The number of times it was administered is confusingly listed as a number in parentheses without clarity on which form of the medication was administered, creating confusion in the clinician and risk to the pt.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1726923
CERNER MILLENIUM CPOE, POWER CHART
Event Date 04/03/2010
Event Type Injury Patient Outcome Life Threatening; Other
Event Description

The computerized physician order entry instruments were deployed. Pleural fluid specimen were obtained. Chemical and cytological analysis was ordered on the specimen using the cpoe instruments. The specimen was not analyzed as ordered. Cytology results did not become available. Similar dysfunction appeared in more than 6 patients. The hospital has resorted to paper forms to clarify the dysfunction of this cpoe instrument. The patients may have cancer causing the fluid build up. This will not be known until time passes. There may be resultant delay in diagnosis of chest organ cancer.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1766892
CERNER MILLENIUM CPOE
Event Date 07/08/2010
Event Type Injury Patient Outcome Life Threatening;
Event Description

The active and active prn medication list had 7 potassium doses and routes, 2 tylenol doses and routes, 3 magnesium doses, 3 narcotic medications and doses, and 6 sodium chloride and sodium phosphate orders. The defects in the device and human factors at the interface enabled duplicate, triplicate, and more medications, enabling the nurse to potentially decide the treatment for this pt. The exact incidence of medication duplication from (b)(4) systems is unk, but common.

Some examples of mere "malfunctions", again just from random browsing of the MAUDE data:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=358222
Model Number RELEASE 500
Event Date 10/03/2001
Event Type Malfunction Patient Outcome Other;
Event Description

Please see initial report.

Event Description

A user entered an order during the order entry process, with a frequency of every 8 hours and then used the ad hoc scheduling feature to modify the defaulted administration times for that frequency. After this was done, the user changed the frequency of the order to a 12-hour frequency without modifying the ad hoc administrations times. The software did not clear the previously entered ad hoc administration times to adjust to the default times for the new frequency. This resulted in a patient receiving a medications 3 times a day as opposed to 2 times a day. The drug was carbamazepene. This incorrect order frequency was repeated for 3 days, ultimately resulting in the patient receiving of total of 3 extra doses over a 3-day period (1 extra dose per day). On the fourth day, the nurse caring for the patient noticed the inconsistency in the order and conducted a further investigation with the pharmacist. The patient was discharged on time; no extended stay was necessary as a result of the overmedication. The patient's carbamazepene levels were checked during a follow-up visit that occurred 5 days after discharge, and were noted as normal at that time.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1365512
Model Number 2007.01 - 2007.17
Event Date 12/30/2008
Event Type Malfunction Patient Outcome Other;
Event Description

The issue involves cerner millennium powerchart message center inox. When the results folder is filtered by event set and the event set display and event set name are different, result filtering may not function correctly. If the result filter is in message center and is an inclusive filter, results may be filtered out incorrectly. The impact associated with this issue is that patient care may be delayed or missed as follow-up may not occur. Cerner has not received communication on any adverse patient events as a result of this issue.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1247673
Model Number 2007
Event Date 10/30/2008
Event Type Malfunction
Manufacturer Narrative

Cerner distributed a priority review flash notification on nov 13, 2008 to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. A software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the software correction is available.

Event Description

This issue involves the overview with reminder functionality on powerchart and affects sites that use cerner millennium powerchart (powerchart. Exe). If a currently open pt chart is replaced with another pt chart, and reminders are subsequently viewed in the detail pane of this visit, the incorrect patient's reminder may de displayed. Pt care could be adversely affected, as clinical decisions could be based on the wrong pt info. Cerner has not received communication of any adverse pt events as a result of this issue.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1097561
Model Number 2007.13
Event Date 06/30/2008
Event Type Malfunction
Event Description

The issue involves the task list functionality in carenet, and affects users that utilize the task list to view and document pt activities. When encounter security is turned on and the user documents an activity in task list, utilizing the previous or next arrows to select another pt chart, the single pt task list displays tasks for incorrect pt. Clinicians may view and document a pt's activity in another pt's record. Pt care may be affected as clinical decisions could be based on incomplete, invalid, or inappropriate info. Cerner has not received communication of an adverse pt event as a result of this issue.

Cerner has distributed a priority review flash notification july 30, 2008, to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. A software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the modification is available. Additional model #: 2007. 16.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1051313
Model Number 2001 THROUGH 2007
Event Date 04/23/2008
Event Type Malfunction
Manufacturer Narrative

Cerner has distributed a priority review flash notification may 23, 2008 to all potentially impacted clients sites. The notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. User documentation is being updated to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the documentation is available.

Event Description

The issue involves the order entry formats in powerorders and affects sites that use powerorders and medication profile. When creating the volume dose detail in the order entry formats (oef), the strength order formats require the volume dose to have an "=" sign as a prefix label. Failure to adhere to this build can result in an inpatient prescription order converted to produce an outpatient prescription that may be misleading. This only occurs when the inpatient order used is verified with a pharmacy product and the formulation used does not exactly match the dose. A formulation factor of more or less than one is used to achieve the volume and the order is then converted to a prescription. For example, 500 mg = 1 tab or 250 mg times 2 tabs = 500 mg. Patient care could be adversely affected, as a patient could receive either more or less of a medication therapy than intended. Cerner has received communication of order discrepancies discovered during a chart review as a result of this issue.

Again, there are many, many more examples like these in MAUDE, and I haven't even looked for data from other mfg's yet.

My mother was nearly killed last year by this technology due to issues like these, the risks of which I've been writing about for more than ten years now.

Alert to Sarah Palin:

"Death panels?" Who needs death panels when technology like this is mediating our care and is planned for "urgent" national rollout with "meaningful use" rules and Medicare extortion - er, gentle coercion - directed towards healthcare organizations and clinicians?

I repeat, from the title of this post:

Mother Mary, What in God's Name is Going on Here?

and:

U.S. government, where the he** are you?

-- SS

Jan. 21, 2011 addendum:

One wonders if the EHRevent site I wrote about at "EHRevent.org: Web Site to Collect EHR Safety Reports" and at "EHRevent: survey amateurism, bias, or something else?" will be as frank as MAUDE.

Healthcare IT Delirium

The delirium surrounding healthcare IT seems to be worsening.

In an Aug. 2010 post "EPIC's outrageous recommendations on healthcare IT project staffing" I wrote that health IT company Epic, one of the largest, seemed to not care about healthcare or IT education or experience in its recommendations to hospitals on staffing of safety critical projects (i.e., the implementation of safety critical clinical cybernetic devices):

Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say.

The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores.

Based on a presentation by the company at my university, they apparently they mean it:

Career Presentation: Epic Systems Corporation - TONIGHT

The Drexel Women in Computing Society (WiCS) will organize a career presentation by Epic Systems Corporation tonight, January 19, 2011, from 6 to 7 p.m. at University Crossings, room 149 (32nd and Market Streets).

Epic Systems Corporation, located in Madison, Wisc., creates software for the healthcare industry and is hiring for many positions. They are recognized nationally as a leader in moving healthcare organizations from paper medical records to completely electronic ones. Epic hires from all majors, all degrees and all experience levels, and requires no software experience. [Or, as is obvious from this solicitation, healthcare experience - ed.] The presentation will include an overview of Epic's industry work, corporate philosophy and role-specific expectations.

This presentation is open to all graduate and undergraduate students at Drexel University. Pizza will be provided and resumes will be accepted after the presentation.

Other health IT merchants will probably soon follow suit.

As I also wrote at the aforementioned post:

Medical environments and clinical affairs are not playgrounds for novices, no matter how "smart" their grades and test scores show them to be, and these practices as described, in my view, represent faulty and dangerous advice.

The advice also is at odds with the taxonomy of skills published by the Office of the National Coordinator I outlined at the post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership."

This talent management ideology is also alien to medicine (at least since the Flexner Report of 1910), and at odds with critical thinking and common sense.

Then there's this, an attempt by Medical Informatics researchers of the American Medical Informatics Association (AMIA) to ex post facto put a scientific veneer on the troublesome and extremely costly "Meaningful Use of health IT" criteria mandated by the US Government. Those criteria were largely arrived at through "off-the-top-of-their heads" committee meetings (see "Meaningful Use and the Devil in the Details: A Reader's View" on this blog and "The MU Hearings: DrLyle Goes to Washington 1/18/11" at the HIStalk site):

On behalf of the CISWG Leadership Team [AMIA Clinical Information Systems work group - ed.]

In light of the HITECH Act and subsequent Meaningful Use objectives, it is imperative for the informatics community to consider the current science behind clinical information systems and to identify areas requiring further research. In keeping with this, the CISWG leadership is interested in developing a white paper, “The Science Behind the Meaningful Use Criteria”.

The purpose of this paper will be to synthesize the existing literature regarding each of the meaningful use criteria and develop recommendations for future research. We are requesting your assistance in this work.

We ask you, as experts in the field, to help identify current literature and subject matter experts for EACH of the meaningful use criteria. In addition, please state if you (1) believe there is evidence for the objective, and (2) if the evidence is supporting of the objective. Please do not delete other’s input but rather add your comments directly to the document (even if in conflict with others).

The document should result in a great asynchronous discussion. Please provide your input by the 7th of February. We appreciate any input you are able to provide. Thank you for your assistance and we look forward to sharing the results of this work in the future

My contribution will probably be that it's probably better to examine the science in a domain before putting it into national policy, not after ...

I'd also observed at "Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?" and at the followup post "Cart before the horse, again: IOM to study HIT patient safety for ONC" that a focus on "meaningful use" before a focus on health IT "meaningful usability" and health IT safety was putting the cart before the horse.

Recklessly so, in fact.

How not to do health IT: by putting the cart before the horse on usability and safety

Finally, in light of the recent experiences of a medical informatics-skilled hospitalist as I posted at "An MD hospitalist on EHR's: I might have inadvertently skipped something during the mayhem" ...

[The NY Times article on information overload in the military causing deaths] was eerily similar to / descriptive of my experience last night in the hospital: processing multiple information sources related to multiple different problems for a new admission (patient, family, ED staff, disjointed EMR - some documents in the Documents tab of the [major EHR vendor name redacted - ed.] system but most others in the hospital system Portal requiring a separate lookup, some radiology studies available through the EMR on any workstation but others requiring accessing the PACS system directly on scarcer dedicated workstations - plus paper record components, including EKGs, progress notes) ... all while various drone-equivalents are channeling information regarding multiple other admissions in the wings and/or patients decompensating on the floors or in the ICU.

Oh yeah, and then there's the "12 hour shift" thing. Oops, gotta run... Just slept all day after my night shift and have to head back to hospital for the next one. Still haven't submitted any charge tickets, btw, even for last week's shifts (I'm carrying around paper face sheets with scribbled notes on the back; I'm supposed to fax them to the billing office once I figure out what CPT / visit intensity code I want to use.)

Gosh, I hope I remembered to touch on 10 bullet points related to ten organ systems for my ROS for each of my admissions; might have inadvertently skipped something during the mayhem...

PS. I'd love to be wearing one of those brain wave contraptions mentioned in the article to see what my theta wave activity was.

... and the injury of my mother in May 2010 due to interference of healthcare IT in clinician-clinician communications (including, but not limited to, me communicating with those caring for my mother, and them communicating among themselves and with the technology itself), all I can say is:

The field of health IT has become delirious.

On top of an irrational exuberance (see this blog query) largely unsupported by the literature (e.g. here), the technology is experimental, its rollout is a grand national experiment in social re-engineering of medicine, there is no patient informed consent, nobody is in control, and nobody is taking responsibility for regulating the domain despite known risks. The results will very likely reflect the Wild West free-for-all that is now extant.

This is crazy stuff.

Running off the rails. We seem to be going out of our way looking for this with HIT, sending it out full speed ahead on far too short a track ...

There's very little else I can do about it at this point, having tried writing, speaking, and political venues.

This will affect your healthcare, not just mine (at least I know what to look out for).

I suggest litigators stay closely attuned to hospital morbidity and mortality incidence (and incidents).

-- SS

An MD hospitalist on EHR's: I might have inadvertently skipped something during the mayhem

At "Clinicians Going for a Swim and Drowning in Information" I commented on a NY Times article about how information and cognitive overload can lead to deadly consequences in warfare. My implication was that medical care (e.g., the ED) bears some similarities.

I received this reply from a clinician hospitalist I know, who also is well versed in Medical Informatics:

Wow, great piece, but a little too close to home for me right now.

Eerily similar to / descriptive of my experience last night in the hospital: processing multiple information sources related to multiple different problems for a new admission (patient, family, ED staff, disjointed EMR - some documents in the Documents tab of the [major EHR vendor name redacted - ed.] system but most others in the hospital system Portal requiring a separate lookup, some radiology studies available through the EMR on any workstation but others requiring accessing the PACS system directly on scarcer dedicated workstations - plus paper record components, including EKGs, progress notes) ... all while various drone-equivalents are channeling information regarding multiple other admissions in the wings and/or patients decompensating on the floors or in the ICU.

Oh yeah, and then there's the "12 hour shift" thing. Oops, gotta run... Just slept all day after my night shift and have to head back to hospital for the next one. Still haven't submitted any charge tickets, btw, even for last week's shifts (I'm carrying around paper face sheets with scribbled notes on the back; I'm supposed to fax them to the billing office once I figure out what CPT / visit intensity code I want to use.)

Gosh, I hope I remembered to touch on 10 bullet points related to ten organ systems for my ROS for each of my admissions; might have inadvertently skipped something during the mayhem...

PS. I'd love to be wearing one of those brain wave contraptions mentioned in the article to see what my theta wave activity was.

This is not atypical of IT's effects on healthcare today.

-- SS

Why is Johnson and Johnson "Spinning Out of Control?"

Last week, a New York Times article by Natasha Singer and Reed Abelson cataloged some of the problems afflicting the giant health care corporation Johnson and Johnson. 

Little red flags jut out from the shelves at a CVS drugstore in suburban Boston, alerting shoppers to shortages of nearly a dozen Johnson & Johnson products. Among them are Motrin, Rolaids, children’s Tylenol liquid and adult Tylenol, Mylanta, Pepcid AC and even some Neutrogena skin care products.

'Looking for Tylenol pain relief products?' asks one of the signs. The notices at CVS serve as a stark reproof to Johnson & Johnson, whose brands have for more than a century been synonymous with quality. Some of its products are in short supply at drugstores and supermarkets because the McNeil Consumer Healthcare unit of J.& J. last year recalled about 288 million items, including about 136 million bottles of liquid Tylenol, Motrin, Zyrtec and Benadryl for infants and children.

Johnson & Johnson has had to recall such a variety of products because of quality-control problems across product lines, in multiple factories and in several units last year. Some of its consumer products, for instance, may have contained bits of metal. Others came in bottles with a moldy smell. And some products have gone missing from stores with hardly an explanation. All of this has put the company and its manufacturing under the intense scrutiny of lawmakers and officials at the Food and Drug Administration.

'It looks like a plane spinning out of control,' says David Vinjamuri, a former J.& J. marketing employee who now trains brand managers at his company, ThirdWay Brand Trainers.

The article noted how the current widespread manufacturing problems at J+J seem to contradict the company's famous credo.

dating from 1943, saying that the company owed its first responsibility to the mothers and fathers, doctors, nurses and patients who use its products.

The article noted that the company's problems

have not been limited to its over-the-counter products, which could suggest that the company may suffer from even broader problems. Last year, its DePuy medical device unit recalled two kinds of hip implants, affecting tens of thousands of patients worldwide. Its vision care unit recalled millions of soft contact lenses sold abroad.

In fact, the company also has had major ethics problems. We noted here, for example, that last October J&J and Ortho-McNeil Janssen, a Johnson and Johnson subsidiary,were found by a jury to have defrauded the Lousiana Medicaid system by minimizing safety problems with the atypical anti-psychotic drug Respirdal, with a penalty of over $250 million.

Moreover, the NY Times summary is already out of date. The Los Angeles Times just reported yesterday even more recalls.

Why does the company seem to be in a tail-spin? Ms Singer and Mr Abelson listed several possible causes:

The reasons for McNeil’s woes remain unclear. Some critics, including former employees, say Johnson & Johnson has lost sight of its credo, while others suggest that the company decentralized its oversight of manufacturing and quality control in error.

Others say it was simply a matter of cost-cutting. The December lawsuit, for example, cited two unnamed former employees who contended that the company failed to address the manufacturing problems at McNeil because it was trying to save money.

Other former employees who are not involved in the lawsuit say that J.& J. seemed to hesitate in recent years to invest in new manufacturing equipment.

'It takes a lot of money to buy equipment and maintain quality,' says Patrick Bols, who left Johnson & Johnson’s pharmaceutical division in the late 1990s and owns stock in the company.

Why, however, would the company lose sight of its sacred credo? Why would it excessively cut costs in a way that would diminish its ability to carry out its most basic function, to produce pure and unadulterated drugs?

I submit that one clue can be found in a recent news article in Nature Biotechnology about the march of drug and biotechnology companies forced into legal settlements. [Ratner M. Crossing the line. Nature Biotech 2010; 12: 1232-1235. Link here.]

People are rewarded for improving a firm's financial performance - right up the chain to the CEO, [former US Department of Justice and current Vogel, Slade & Goldstein attorney Ms Shelley] Slade says. 'Their concerns are pleasing Wall Street and shareholders, and bonuses are driven by financial performance. There's a real conflict between what the compliance folks want them to do and what's in their immediate financial self-interest. Sometimes the compliance people don't get the full story from the people in operations.

So what we have here is another argument for the importance of perverse incentives as drivers of health care dysfunction. It is likely that all the management of nearly all health care organizations are driven, not by mythic credos or high-minded mission statements, but by the impetus for short-term revenues driven by desire to earn big bonuses and keep their total compensation in six- through eight-figures. These sorts of incentives will predictably lead to excess cost-cutting, unethical behavior, and outright crime.

So, to repeat like a broken record (if anyone remembers what that means, a broken vinyl audio recording skipping due to surface scratches) - if we really want health care reform, if we really want to lower costs, improve access, and improve quality, we need to abolish the perverse incentives that drive managers of health care organizations.  Somehow we need to make the leadership of health care organizations accountable for fulfilling their credos, mission statements, and really their basic responsibilities.  The patients' interests need to come first.  Drug companies must make pure, unadulterated drugs, and promote them honestly and ethically, and their leaders must first be accountable for doing so.

BLOGSCAN - Why Problems at Local Marquee Hospitals May be Anechoic

We have often discussed how the shortcomings of leadership of big health care organizations may be anechoic.  (See this post for a recent example.) 

Now, on the HealthBeat blog, Maggie Mahar discussed how journalists often fail to look closely at the actions of large, well-known local hospitals.  She noted some possible causes:
- "Hospitals, after all, are major advertisers."
- "the marquee hospital’s patrons tend to be powerful local figures."
- " most readers really don’t want to hear that their local academic medical center is having problems...."
She also summarized just how unhealthy relationships among the news media and marquee hospitals can become, but also provided some examples of incisive investigative reporting.  As they say, read the whole thing.

"I'm Not Here to Sell Drugs" - Then Why Use Company Provided "Correct" Slides?

In October, 2010, we discussed a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharmaceutical companies to thousands of doctors.  Industry often claims that they only pay the best and the brightest physicians and academics to provide education relevant to their products.  However, the ProPublica et al report suggested that they mainly recruited physicians who already showed their favor to their products by prescribing them often, but soothed their consciences by dubbing them "thought leaders" or "key opinion leaders."  While some of the physicians were well-known academics, others had notably blemished records. 

Since then, news media around the US have looked into interactions among local physicians and academic medical institutions and the seven pharmaceutical companies.  In November, 2010, here we discussed cases that suggested that pharmaceutical companies like physician speakers because they are more "believable" than pharmaceutical representatives, and choose physicians who already are prolific prescribers of the drug to be promoted, and that suggested that some physicians realized that speaking for pharmaceutical companies influenced their own prescribing.

Since then, more investigations of local physicians' interactions with pharmaceutical companies have appeared that reinforced contrasts between rationalizations that physicians and drug companies use to support continued payments for "drug talks," and what these talks are really about.

"Leaders in Their Field" vs Sanctions and Crimes

 Many pharmaceutical (and other health care corporations) have repeated the mantra that the physicians they hire to give talks are the best and the brightest.  The physicians who give the talks sometimes get to believe this.  For example, a ProPublica follow-up report[1] on discrepancies between data the pharmaceutical companies put on the web and gave to state regulators noted:

Pfizer, for example, told the state it paid Dr. Randy Schapiro $1,770 last year. But on the firm’s website, it reported spending $43,827 on him in the second half of 2009 alone.

It then quoted Dr Schapiro:

Schapiro said the doctors paid by pharmaceutical companies are 'leaders in their fields,' and patients should want to see their physician among them. 'If their doctor is not on the list,' he said, 'maybe they should look for a different doctor.'

On the other hand, several of the local news articles focused on physicians who were paid drug company speakers despite having chequered backgrounds, shall we say. In the Elmira Star Gazette[2]:

Tulio Ortega, a Rochester psychiatrist who made $144,548 from Eli Lilly and AstraZeneca for speaking to groups of peers during the last two years - was put of [sic] probation for two years in 2008 and ordered to pay a $7,500 fine after being sanctioned for negligence and incompetence.

Also,

Lilly also paid Yonkers physician Ali Sherzoy $4,334 in the first two quarter of this year, even though he had his license suspended in New York and New Jersey earlier this year after pleading guilty to a count of criminal sexual contact in 2008.

Sherzoy told ProPublica the incident involted his family's nanny and had nothing to do with his ability to practice medicine.

Other New York doctors were sanctioned for incidents ranging from deficiencies in handling controlled substances to being convicted of tax evasion.

Another article by the same author[3] noted two more cases:

In 1991, Johnson City doctor Louis Mateya was charged with professional misconduct after a 22-year-old woman accused him of unzipping his pants and fondling himself during an examination.

Mateya admitted guilt to the charge. The State Board for Professional Medical Conduct suspended his license for two months, followed by a 58-month probationary period, during which he was monitored by a psychiatrist and a health professional selected by the board.

During the last nine months of 2009, GlaxoSmithKline paid Mateya, an internist at United Health Services, $1,750 to speak on behalf of Lovaza, Glaxo's prescription omega 3 fish oil, according to an e-mail from a United Health Services spokeswoman.

Also,

A second Southern Tier physician, Robert Douenias, of Corning, was also paid by Glaxo: $20,000 during the same time frame to deliver speeches, even though he received sanctions in 1992.

According to the Office for Professional Medical Conduct (OPMC) records, Douenias lied about a previous criminal conviction on his application for a New York medical license. He received a censure and reprimand from the OPMC, was ordered to perform 200 hours of public service and was placed on probation for two years. Douenias said on his application he had never been convicted of a crime in any state or country, even though he had a previous conviction, according to OPMC records.

Note that the original ProPublica reporting from their database emphasized cases of physicians paid to speak by pharmaceutical companies who also had been sanctioned by medical boards or the criminal justice system (see post here).

Although drug marketers like to tell physicians they are selected as "thought leaders" because of their brilliance, it appears that the selection of such "key opinion leaders" is not necessarily based on sterling character.

"I'm Not There to Sell a Drug," But Then Why Use the Company's Slides?

A number of the reports featured physicians who asserted their independence, at least from marketing goals. 

For example, as reported by the Duluth (MN) News Tribune[4],

A Duluth psychiatrist has received more than $525,000 since 2002 in payments from pharmaceutical companies, far more than any other Northland doctor, an analysis by the News Tribune shows.

Dr. Tracy Tomac of St. Luke’s hospital was paid by the companies to give presentations on health and drug issues.

Furthermore,

'I’m there as an educator and resource,' she said. 'I’m not in business to do a sales pitch. I’m not a salesperson.'

Also,

In 2007, [Dr] Tomac said her presentations included content that was screened and approved by the FDA,....

However, other reporting suggested that content "screened and approved by the FDA" was content provided by the pharmaceutical companies.

For example, The Tennessean noted[5]:

Dr. Jan Brandes heads the Nashville Neuroscience Group, a clinic that's now part of Nashville-based Saint Thomas Health Services. She made $111,150 in outside income over the past two years, largely in speaker fees paid by drug company GlaxoSmithKline, which markets a wide array of brand-name drugs, literally from A to Z.

Dr Brandes also asserted,

'The real point is I'm not there to sell a drug,' Brandes said. 'I'm there to interpret trial results, talk about disease states and help physicians understand where this research might fit in the context of their practice.'

However,

Most drug companies now require physicians to use the company's slides and presentations if they pay them to speak at an event. The industry says that is to ensure that all U.S. Food and Drug Administration rules are met and that physicians don't wander off into discussing uses for a particular product that haven't been approved by regulators.

Also, an article in the Alexandria (VA) Gazette Packet[6] noted:

Whistleblower lawsuits filed in recent years have accused firms of using doctors to push pills for unapproved uses during dinnertime talks, prompting at least 10 firms to settle cases for nearly $7 billion in the last three years. Since that time, pharmaceutical companies have tightened control over what happens during presentations given on their dime. Last year, for example, GlaxoSmithKline instituted a new policy prohibiting doctors from using their own slides during presentations. Starting in 2010, all doctors giving speeches sponsored by GlaxoSmithKline must use slides presented by the pharmaceutical company in the order specified.

'We want to make sure that everything is correct,' said Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline. 'The best way to do that is to have our team prepare the slide.'

Note that Dr Brandes above was paid mainly by GlaxoSmithKline, who presumably also provided all her slides and made sure that everything she said was "correct," at least in terms of what GlaxoSmithKline thought was correct.

And one more example per MyFoxAtlanta[7]:

Some of Georgia's highest paid physicians? .... and Roswell psychiatrist Dr. Michael Banov: over $68,000, also from Lilly.

Dr Banov asserted:

We don't sell medications. We simply educate physicians about data, and they make their own mind up.

However,

Banov says, the drug company - not him - creates the materials used in his speeches, and he says there's a reason for that.

'We are only able to present the data. We're not able to present our personal opinions. Our personal preferences, how we use the medication off label. any of that. So we're held to a very tight standard by the FDA,' said Banov.

Drug companies may say they make their paid physician speakers use slides provided by the company to prevent them from talking about "off-label" uses.  However, there is no reason for a physician-educator not to talk about "off-label" uses, and physicians can prescribe any legal drug for whatever purpose they see fit, whether or not the drug is on or "off label." 

But drug companies are prohibited by law from promoting off-label uses.  Requiring physicians to use drug companies' slides and preventing them from talking about "off-label" uses demonstrates that the physicians are functioning as marketers, not educators. 

Summary

As local reporters look into more cases, it becomes increasingly clear that up to now, pharmaceutical companies have been none too fussy about which physicians they pay to speak about their products. It is self-serving, but inaccurate for both sets of parties to assert that the companies choose only the "best and the brightest." 

Furthermore, it has now become glaringly obvious that the purpose of "drug talks" is, well, to sell drugs.  Some physicians paid by drug companies to speak may bluster about their independence, but if they are using company provided slides, who can deny they are influenced  by the company.  Furthermore, when companies insist not merely on providing slides, but on ensuring that "everything is correct," then it is clear that it is the companies' talks that the physicians are giving.  Physicians giving company talks cannot be speaking independently, and hence must be regarded as company sales personnel, whose disguises as independent doctors or medical academics are now in tatters.

Doctors who still choose to go to "drug talks" should have no illusions that they are being exposed to anything other than marketing.  Thus, I urge my colleagues to forgo the nice meals and the company prepared "correct" slides, and spend the time trying to more critically assess the clinical evidence. 

References


1.  Ornstein C, Weber T. In Minnesota, drug company reports of payments to doctors arrive riddled with mistakes.  ProPublica, Dec 10, 2010.  Link here.
2. Hunter J. Rochester psychiatrist, sanctioned for incompetence, made $144K from drug companies. Elmira Star-Gazette, Dec 4, 2010.
3. Hunter J. Despite sanctions, physicians hired as drug company pitchmen. PressConnects.com, Dec 4, 2010. Link here.
4. Stahl B. Duluth doctor denies payments from drug companies sway decisions.  Duluth News Tribune, Dec 20, 2010.  Link here.
5. Ward G. They say they prescribe based on patients, not Big Pharma. Tennessean, Dec 19, 2010. Link here.
6. Pope ML. Conflict of interest? - Alexandria doctors receive thousands of dollars from Big Pharma.  Alexandia Gazette Packet, Jan 13, 2010.  Link here.
7. Galvin B. Health watch: doctors and drug companies. MyFoxAtlanta, Dec 29, 2010. Link here.

Clinicians Going for a Swim and Drowning in Information

Clinicians these days at computerized facilities are often drinking information from a firehose, and even worse.

Just to make their tasks more difficult, the firehose is difficult to use, it sputters on occasion due to "glitches" in the water pumps, and sometimes even emits fouled water due to problems at the reservoir or connecting pipes, without frequent "workarounds" and mental gymnastics by the clinicians. I've seen it personally in the recent care of my own mother.

This is far from the dream of Medical Informatics, whose specialists viewed IT as a tool to reduce cognitive overload and make healthcare provision more efficient.

Why is information overload a bad thing?

Here's why:

New York Times
In New Military, Data Overload Can Be Deadly
By THOM SHANKER and MATT RICHTEL
January 16, 2011

When military investigators looked into an attack by American helicopters last February that left 23 Afghan civilians dead, they found that the operator of a Predator drone had failed to pass along crucial information about the makeup of a gathering crowd of villagers.

But Air Force and Army officials now say there was also an underlying cause for that mistake: information overload.

At an Air Force base in Nevada, the drone operator and his team struggled to work out what was happening in the village, where a convoy was forming. They had to monitor the drone’s video feeds while participating in dozens of instant-message and radio exchanges with intelligence analysts and troops on the ground.

There were solid reports that the group included children, but the team did not adequately focus on them amid the swirl of data — much like a cubicle worker who loses track of an important e-mail under the mounting pile. The team was under intense pressure to protect American forces nearby, and in the end it determined, incorrectly, that the villagers’ convoy posed an imminent threat, resulting in one of the worst losses of civilian lives in the war in Afghanistan.

“Information overload — an accurate description,” said one senior military officer, who was briefed on the inquiry and spoke on the condition of anonymity because the case might yet result in a court martial. The deaths would have been prevented, he said, “if we had just slowed things down and thought deliberately.”

Data is among the most potent weapons of the 21st century. Unprecedented amounts of raw information help the military determine what targets to hit and what to avoid. And drone-based sensors have given rise to a new class of wired warriors who must filter the information sea. But sometimes they are drowning.

Research shows that the kind of intense multitasking required in such situations can make it hard to tell good information from bad. The military faces a balancing act: how to help soldiers exploit masses of data without succumbing to overload.

Read the entire NY Times piece.

I have no other comments to offer, other than (as the military seems to recognize for its own needs through engaging experts in domains such as neuroscience), the time to "accelerate interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering" as recommended in 2009 by the National Research Council is before the attempted national rollout of hundreds of billions of dollars of technology.

The time to do so is not during - and certainly not after - the HITECH-led medical re-engineering attempt.

Finally, unlike the health IT industry, I don't see the military attributing these issues to "Luddite soldiers."

-- SS

Guidant (Boston Scientific) Gets Probation

The latest in the parade of legal settlements by health care corporations involves a new wrinkle. 

We have been writing about the case of Guidant Corporation's faulty implantable cardiac defibrillators (ICDs) in 2005, almost since the start of the Health Care Renewal blog.  A quick summary, via the Minneapolis Star-Tribune, is:

In 2005 Minneapolis Heart Institute doctors Barry Maron and Robert Hauser went public with concerns about a Guidant defibrillator called the Ventak Prizm 2 after a 21-year-old patient died when his defibrillator short-circuited and failed to revive him after he went into sudden cardiac arrest.

Guidant had known about the short-circuiting issue since 2002 and had made two attempts to fix the device, according to court documents. The company did not alert the FDA -- even though federal law requires manufacturers to report changes that may pose a health risk to patients.

In early 2004, Guidant discovered a similar short-circuiting problem in different defibrillator models called Contak Renewal 1 and 2. The company ordered its factory to stop making and shipping the models, but potentially faulty products on hospital shelves continued to be implanted in thousands of patients.

Although engineers at Guidant had recommended recalling the Contak Renewal devices, upper management rejected the proposal, court documents state. Instead, Guidant issued the 'least aggressive' form of communication, called a product update, in which sales representatives were told to tell doctors that 'nothing was broken' with the device.

Maron and Hauser met with top Guidant officials in May 2005 and urged the company to communicate the problem to doctors, but Guidant refused. The doctors then went to the New York Times, which published an article indicating that the company had known for three years that the Ventak Prizm model could short-circuit, but did not communicate that to doctors.

In June 2005, Guidant issued a public missive detailing safety issues with the defibrillators, which were later recalled by the FDA.

A longer version from a series of Health Care Renewal posts can be found here.

In 2010, Guidant, now a subsidiary of Boston Scientific, agreed to a settlement which would involve guilty pleas to misdemeanors and payment of a large ($296 million) fine, but the settlement was rejected by a federal judge who found it to be too lenient (see post here). Now the judge has approved a new version, again per the Star-Tribune,

In what is believed to be the largest criminal penalty ever imposed in a medical device case, a federal judge on Wednesday approved an agreement calling for Guidant Corp. to pay $296 million for concealing safety information about several of its heart devices.

The denouement in U.S. District Court in St. Paul ended a difficult chapter for one of the biggest players in Minnesota's signature medical technology industry. Thirteen patient deaths have been associated with faulty devices made by Arden Hills-based Guidant, which is now part of Boston Scientific Corp. The controversy lingered for almost six years and raised questions about how safety issues involving medical devices are communicated to the Food and Drug Administration, doctors and patients.

Last April, U.S. District Judge Donovan Frank rejected a previous $296 million settlement between the Department of Justice and the company. This time that fine remained intact, but Frank also called for Boston Scientific to serve three years' probation.


Boston Scientific will be required to make quarterly reports to the U.S. Probation Office regarding safety and compliance issues, as well as submit to regular, unannounced inspections of its records. Frank also called upon Boston Scientific to continue charitable programs intended to raise awareness about heart disease.

'I believe this serves not only the interests of the community and the interests of justice, but respect for the law and corporate responsibility,' Frank said.

The new wrinkle is, of course, probation. I have not previously heard of a US health care corporation put on probation in a criminal settlement. Presumably, the idea is that probation will involve court supervision of the company that might be less lenient than US Department of Justice oversight via a corporate integrity agreement.

So this is a small step forward, but once again, the extent that this settlement will deter future bad behavior seems small. Once again, although the fine imposed seems large, it is small compared to the money to be made by selling these very expensive devices. Moreover, the cost of the fine can be diffused over the entire company, and ultimately over all its employees, its stockholders, and its customers.

Since no individual will pay a penalty, and since it is likely some individuals made themselves rich or richer from the company's actions, it is likely that other individuals in the future will authorize, direct, and implement similar bad behavior to fatten their bonuses and total compensation.

Last June, we noted that some government officials were starting to talk tough about imposing penalties on individuals for misbehavior by health care corporations. In fact, in 1943, the US Supreme Court found that corporate leaders could be held responsible for corporate bad behavior, the so-called Responsible Corporate Officers doctrine. However, the laissez faire malaise that apparently infected most government officials starting in the 1980s seemed to prevent anyone from invoking this doctrine during the last 30 years of health care dysfunction. That malaise still seems to be rendering US federal law enforcement effete, at least when applied to wrong-doing by big, powerful, rich health care corporations.

So like Cassandra, fated to have her predictions always ignored, I repeat: When it comes to health care's leadership, society seems to have acceded to defining deviancy down. Until we start holding health care leaders to high standards, expect their organizations not to uphold high standards.  Further, expect organizations that did not uphold high standards in one instance to fail to uphold them in other instances.  If we really want high quality accessible, reasonably priced health care, we need true health care reform that reduces concentration of power in large organizations, and makes health care organizations' leadership accountable, ethical, and transparent. That will not be easy.

Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith

Psychiatrist-medical informaticist Dr. Scott Monteith was a guest blogger on the complications of "Meaningful Use of EHR's" in the Dec. 21, 2010 post "Meaningful Use and the Devil in the Details: A Reader's View."

He also testified at the Office of the National Coordinator's Health IT Standards Committee Implementation Workgroup which recently had a meeting, Jan. 10-11, 2010, as I wrote about here.

With his permission I am reproducing his testimony to the Committee (which is supposed to also be posted to the meeting website) without further comment. None is needed.

Emphases in the original:

HIT Testimony in DC January 11, 2011

My name is Scott Monteith, a board-certified psychiatrist and Fellow of the APA from Michigan. I work in private practice and with Community Mental Health (CMH). I also teach in MSU’s medical school.

My 21 year interest in HIT includes:

• being a CCHIT Juror;

• appointed by our Governor to three terms on the Controlled Substances Advisory Commission, which has a role overseeing Michigan’s Automated Prescription System;

• a member of the Business Operations Workgroup for Michigan’s Health Information Network;

• working with malpractice insurance companies to manage growing risks from EHRs;

• and more.

I’m “pro-HIT.” For all intents and purposes, I haven’t handwritten a prescription since 1999.

That said and with all due respect to the capable people who have worked hard to try to improve health care through HIT, here’s my frank message:

ONC’s strategy has put the cart before the horse. HIT is not ready for widespread implementation. The problem isn’t Luddite doctors not adopting; the problem is that HIT isn’t ready, especially if we want safe and efficacious bells and whistles like CDS, interoperability, etc.

To describe ONC’s handling of HIT promotion, let me use an analogy:

It’s as if policy makers said, “Let’s promote a cure for cancer. By curing cancer, we can save money and improve the quality of people’s lives.”

Like our collective fantasy for the benefits of widespread HIT use, which I share, who can argue with the dream of curing cancer, or the good intentions behind it?

The problem is that finding a cure for cancer isn’t as simple as declaring a cure, and then merely getting resistant doctors to start using it.

Continuing the analogy, ARRA dollars are incenting doctors to use Laetrile, the supposed cancer cure that was not evidence-based and didn’t work.

ONC has promoted HIT as if there are clear evidence-based products and processes supporting widespread HIT implementation.

But what’s clear is that we are experimenting…with lives, privacy and careers.

As a clinician, I’m here to report that certified EHRs are not necessarily producing better documentation or improved care.

Yes, EHR-generated documentation is usually more legible, but it’s often “legible gibberish.” And there’s a lot of it, including meaningless data, burying relevant information.

Example:

A colleague requested records for his mother’s nearly two-week hospital stay; this particular hospital is an early adopter of EHRs. He received almost 2,900 pages.

Finding relevant data in the midst of 2,900 pages can be like finding a needle in a haystack.

Here’s another example of EHRs degrading documentation:

In our CMH, administration inserted language into the doctors' treatment plans. The problem is that the language is patently false and untrue.

Unfortunately, administration controls the EHR, and physicians cannot change the untrue language.

“Ghost writing” clinical notes – often incorrectly – is increasingly common, whether through fixed fields, no or limited free text, inserted language that cannot be changed, multi-authored documents, or other means.

I have documented scores of error types with our certified EHR, and literally hundreds of EHR-generated errors, including consistently incorrect diagnoses, ambiguous eRxs, etc.

As a CCHIT Juror, I’ve seen an inadequate process. Don’t get me wrong, the problem is not CCHIT. The problem stems from MU.

EHRs are being certified even though they take 20 minutes to do a simple task that should take about 20 seconds to do in the field. Certification is an “open book” test. How can so many do so poorly?

For example, our EHR is certified, even though it cannot generate eRxs from within the EHR, as required by MU.

To CCHIT’s credit, our EHR vendor did not pass certification. Sadly, our vendor went to another certification body, and now they’re certified.

MU does not address many important issues. Usability has received little more than lip-service. What about safety problems and reporting safety problems? What about computer generated alerts, almost all of which are known to be ignored or overridden (usually for good reason)?

The concept of “unintended consequences” comes to mind.

All that said, the problem really isn’t MU and its gross shortcomings, it is ONC trying to do the impossible:

ONC is trying to artificially force a cure for cancer, basically trying to promote one into being, when in fact we need to let one evolve through an evidence-based, disciplined process of scientific discovery and the marketplace.

Thank you for the opportunity to be a part of this process.

Actually, I will make one comment:

In the current climate of "cybernetics over all" in healthcare, this is not the type of testimony that will get the good Dr. any dinner invitations.

-- SS