Totally unrelated to medicine, but a nice post-holiday story with a happy ending as a break from our routine of grim news.
Kitten rescue from my car fender:
http://thereporteronline.com/articles/2011/07/05/news/doc4e13335f93a76458921720.txt?viewmode=fullstory
-- SS
BLOGSCAN: Forensic Statistics
Several interesting points are raised in the newsletter of the American Association of Physicians and Surgeons (AAPS) in a post entitled "Forensic Statistics" in their July 2011 newsletter headlined "Numbers." Healthcare Renewal is cited:
The "maverick solitaire" data mining issues (to be used, no doubt, in future "comparative effectiveness research" based on EHR data) are a additional concern to those I raised in an essay "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?" in the AAPS journal several years ago (PDF).
I can also add: where are the RCT's of EHR/CPOE systems?
-- SS
Forensic Statistics
While claims from RCTs fail to replicate about 20% of the time, the problem with epidemiology is so bad as to constitute a crisis, writes S. Stanley Young (“Everything Is Dangerous: a Controversy,” National Institute of Statistical Sciences, June 2008, www.niss.org). Fewer than 20% of nonrandomized trials [e.g., observational studies - ed.] replicate; i.e. 80%-90% of epidemiologists’ claims are false.
More than $1 billion in grant/tax money flows to institutions with reproducibility problems, Young states. A fundamental flaw in their methodology is to ask multiple, often hundreds to thousands of questions, of the same data set. It’s like playing “maverick solitaire”: given 25 randomly selected cards from a deck of 52 playing cards, the probability of being able to arrange them into 5 “pat hands” (e.g. a full house) is 98%.
Since data miners are good at concealing their footsteps, critics need full access to the raw data and the code used for the statistical analysis—often not forthcoming.
The EHR software that is supposed to support all this “research” and to guide medical treatment also needs a forensic evaluation, writes Scot Silverstein, M.D., of Drexel University (see http://hcrenewal.blogspot.com). He cites such an evaluation of the Cerner FirstNet system used in New South Wales, Australia, done by Prof. Jon Patrick. The authoritarian implementation processes of the governmental HIT “support” staff were familiar to Silverstein, such as disenfranchising the clinical staff and failing to acknowledge the validity of complaints.
“Healthcare reform” demands acceptance because it claims to be based on science. But then, so did Communism.
The "maverick solitaire" data mining issues (to be used, no doubt, in future "comparative effectiveness research" based on EHR data) are a additional concern to those I raised in an essay "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?" in the AAPS journal several years ago (PDF).
I can also add: where are the RCT's of EHR/CPOE systems?
-- SS
Food Reward: a Dominant Factor in Obesity, Part VIII
Further reading
I didn't come up with the idea that excessive food reward increases calorie intake and can lead to obesity, far from it. The idea has been floating around the scientific literature for decades. In 1976, after conducting an interesting diet study in humans, Dr. Michel Cabanac stated that the "palatability of the diet influences the set point of the ponderostat [system that regulates body fatness]" (1).
Currently there is a growing consensus that food reward/palatability is a major contributor to obesity. This is reflected by the proliferation of review articles appearing in high-profile journals. For the scientists in the audience who want more detail than I provide on my blog, here are some of the reviews I've read and enjoyed. These were written by some of the leading scientists in the study of food reward and hedonics:
Palatability of food and the ponderostat. Michel Cabanac, 1989.
Food reward, hyperphagia and obesity. Hans-Rudolf Berthoud et al., 2011.
Reward mechanisms in obesity: new insights and future directions. Paul J. Kenny, 2011.
Relation of obesity to consummatory and anticipatory food reward. Eric Stice, 2009.
Hedonic and incentive signals for body weight control. Emil Egecioglu et al., 2011.
Homeostatic and hedonic signals interact in the control of food intake. Michael Lutter and Eric J. Nestler, 2009.
Opioids as agents of reward-related feeding: a consideration of the evidence. Allen S. Levine and Charles J. Billington, 2004.
Central opioids and consumption of sweet tastants: when reward outweighs homeostasis. Pawel K. Olszewski and Allen S. Levine, 2007.
Oral and postoral determinants of food reward. Anthony Sclafani, 2004.
Reduced dopaminergic tone in hypothalamic neural circuits: expression of a "thrifty" genotype underlying the metabolic syndrome? Hanno Pijl, 2003.
If you can read all these papers and still not believe in the food reward hypothesis... you deserve some kind of award.
I didn't come up with the idea that excessive food reward increases calorie intake and can lead to obesity, far from it. The idea has been floating around the scientific literature for decades. In 1976, after conducting an interesting diet study in humans, Dr. Michel Cabanac stated that the "palatability of the diet influences the set point of the ponderostat [system that regulates body fatness]" (1).
Currently there is a growing consensus that food reward/palatability is a major contributor to obesity. This is reflected by the proliferation of review articles appearing in high-profile journals. For the scientists in the audience who want more detail than I provide on my blog, here are some of the reviews I've read and enjoyed. These were written by some of the leading scientists in the study of food reward and hedonics:
Palatability of food and the ponderostat. Michel Cabanac, 1989.
Food reward, hyperphagia and obesity. Hans-Rudolf Berthoud et al., 2011.
Reward mechanisms in obesity: new insights and future directions. Paul J. Kenny, 2011.
Relation of obesity to consummatory and anticipatory food reward. Eric Stice, 2009.
Hedonic and incentive signals for body weight control. Emil Egecioglu et al., 2011.
Homeostatic and hedonic signals interact in the control of food intake. Michael Lutter and Eric J. Nestler, 2009.
Opioids as agents of reward-related feeding: a consideration of the evidence. Allen S. Levine and Charles J. Billington, 2004.
Central opioids and consumption of sweet tastants: when reward outweighs homeostasis. Pawel K. Olszewski and Allen S. Levine, 2007.
Oral and postoral determinants of food reward. Anthony Sclafani, 2004.
Reduced dopaminergic tone in hypothalamic neural circuits: expression of a "thrifty" genotype underlying the metabolic syndrome? Hanno Pijl, 2003.
If you can read all these papers and still not believe in the food reward hypothesis... you deserve some kind of award.
The Restless Shade of AHERF and the Return of Merger Mania: Highmark Tries to Buy Another Insurance Company, a Hospital System, a Medical School, and Physicians' Practices
Starting in the 1990s, as US health care became more commercialized, a wave of mergers lead to super-sized hospital systems, insurance companies, and pharmaceutical companies. Not all those mergers, especially involving hospitals, prospered. Although the mergers were justified as drivers of increased efficiency, health care has become decreasingly accessible, increasingly expensive, and of no better quality. However, now a whole new wave of mergers seems to be upon us.
The Proposed Highmark Blue Cross/ West Penn Allegheny Health System Merger
The latest example to get national attention is the proposed combination of already large non-profit health insurer Highmark Inc, a Blue Cross Blue Shield plan, and non-profit hospital system Allegheny Health System. The national attention was in a Wall Street Journal article by Anna Wilde Matthews, which described the proposed transaction:
This deal is unusual because it would unite a health care insurance company/ managed care organization with a hospital system.
The Context: An Already Concentrated Health Care Environment
The deal appears in the context of and may be in response to an already concentrated health care environment. Per the WSJ:
The deal is also more extraordinary because it was accompanied by several other proposed deals that would create quite a sprawling health care entity.
The Extended Scope of the Merger
First, and as noted in the WSJ article, the proposed deal would involve physicians' practices:
That is not all. It seems that while pursuing the merger with Highmark, West Penn Allegheny Health was also pursuing an arrangement with Temple University to set up a branch of its medical school in Western Pennsylvania. As noted by the Pittsburgh Tribune Review:
The Eerie Shadow of AHERF
Maybe all these simultaneous deals, which would apparently create a conglomerate of Highmark Blue Cross, Delaware Blue Cross Blue Shield, West Penn Allegheny Health System, Temple University Medical School, and possibly a large group of doctors' practices, were all being discussed separately because of how they could be seen as a strange shadow of the spectacularly failed Allegheny Health Education and Research Foundation (AHERF) of the late 1990s.
As discussed here, AHERF was a large integrated health care system formed out of multiple mergers. AHERF which went bankrupt in 1998, leading to massive layoffs, hospital closures, and the near dissolution of a medical school (which ended up taken over by Drexel University). The former AHREF CEO, whose high compensation (for the time) was accompanied by an autocratic management style, ended up in the local jail on a plea bargain. Note that West Penn Allegheny Health System was formed from some of the pieces of the failed AHERF, and seems to have never fully recovered from its previous troubles.
Despite the fact that the AHERF bankruptcy was the second largest US bankruptcy up to its time, this vivid case was notably anechoic. The lack of echoes it originally produced made it prototypical of the anechoic effect.
The link to AHERF was briefly noted in the Post-Gazette article:
How Some Executives Would Gain
Perhaps the executives rushing to make a deal are being distracted by the potential for personal gain. The DelawareOnline article noted that current executives of Delaware Blue Cross Blue Shield may be able to pull the ripcords of their golden parachutes if its proposed merger with Highmark goes through:
That article further noted:
One wonders which other executives involved in these potential deals may also have prospects for either larger compensation or golden parachutes. This could include executives in particular current executives of West Penn Allegheny. One also wonders whether the creation of this new conglomerate will produce rationales for big raises for the current executives of all the organizations involved who get to work for the new merged entity. Perhaps someone should ask them.
Further Implications
Of course the various mergers were touted as productive of new efficiencies, as attempts to obtain increased market power usually are. As reported by the Post-Gazette:
And, as we discussed here, the former CEO of AHERF pledged "new forms of organization that are more flexible, more adaptive, and more agile than ever before." But common sense and history suggests that increasing market domination will be good mainly for the market dominators, not their customers, or in this case, their patients, clients and students.
As Dr Westby Fisher asserted about how the new conglomerate will likely own physicians' practices:
So I wonder if this complex merger will get more scrutiny than the many mergers that have preceded it in the last 30 years. Someone who is more likely to get answers than I am should be asking:
- What evidence is there that this merger will lead to any benefits to individual patients or to the public health?
- How will any efficiencies achieved benefit anyone other than the organizations' current and future managers?
- What sorts of management layers will the complexity of the multiple mergers proposed necessitate between current Highmark executives and current management of its new acquisitions?
- If the current problem is existing market concentration, why will these mergers be a better solution than a direct approach to that concentration?
- How will the current leaders of all the organizations involve personally benefit from this merger?
Meanwhile, increasing concentration of power in health care continues to benefit the leaders of the enlarging health care organizations, while reducing the choice of individual patients and the autonomy of health care professionals.
The Proposed Highmark Blue Cross/ West Penn Allegheny Health System Merger
The latest example to get national attention is the proposed combination of already large non-profit health insurer Highmark Inc, a Blue Cross Blue Shield plan, and non-profit hospital system Allegheny Health System. The national attention was in a Wall Street Journal article by Anna Wilde Matthews, which described the proposed transaction:
Pittsburgh insurer Highmark Inc. struck a deal to acquire the second-largest hospital chain in its region, an ambitious, controversial step that would further blur the lines between those who pay for medical care and those who provide it.
Under the tentative plan, nonprofit Highmark will pump as much as $475 million into the five-hospital West Penn Allegheny Health System, which has been operating in the red for the past five years.
If state and federal regulators sign off on the plan, Highmark officials say the deal will allow them to move away from traditional fee models that reward providers for providing unnecessary procedures and services.
Instead they would pay salaries to doctors, offering them incentives to achieve quality and efficiency goals. The integrated model would also rely on primary-care doctors to coordinate patients' care and focus on preventive efforts.
Highmark officials said the deal is the best way to keep West Penn in business. 'It brings our expertise as an insurance company into the provider system,' said Kenneth R. Melani, Highmark's chief executive.
This deal is unusual because it would unite a health care insurance company/ managed care organization with a hospital system.
The Context: An Already Concentrated Health Care Environment
The deal appears in the context of and may be in response to an already concentrated health care environment. Per the WSJ:
The newly combined Highmark-West Penn will face off against the University of Pittsburgh Medical Center, which is officially known by its acronym, UPMC. The prestigious $8 billion,19-hospital network employs 2,881 doctors and has about 56% of the inpatient market share in Allegheny County. It also owns a health plan with about 1.6 million members.UPMC has had its issues, too, as discussed in posts here.
UPMC's current contract with Highmark runs out next June. Paul Wood, the hospital system's vice president for public relations, said the network won't sign a new one after the acquisition. 'In effect, Highmark expects UPMC to subsidize our competitor,' he said.
The deal is also more extraordinary because it was accompanied by several other proposed deals that would create quite a sprawling health care entity.
The Extended Scope of the Merger
First, and as noted in the WSJ article, the proposed deal would involve physicians' practices:
Highmark may also buy or invest in other providers, including doctor practices, Dr. Melani said.However not noted in the WSJ article, or in a contemporaneous Pittsburgh Post-Gazette article, was that since 2010 there has also been a proposal on the table for Highmark to merge with a non-profit Blue Cross Blue plan in neighboring Delaware. The latest discussion of this deal can be found on DelawareOnline, and was just noted in a Philadephia Inquirer commentary.
In Delaware, a bill that would remove a major obstacle to Highmark's proposed affiliation with Blue Cross Blue Shield of Delaware sailed through the legislature, passing the Senate unanimously Tuesday and the House, 34-5, Wednesday.
That is not all. It seems that while pursuing the merger with Highmark, West Penn Allegheny Health was also pursuing an arrangement with Temple University to set up a branch of its medical school in Western Pennsylvania. As noted by the Pittsburgh Tribune Review:
West Penn Allegheny Health System leaders expressed optimism on Friday about their partnership prospects with Highmark Inc. as they announced plans with Temple University to establish a four-year medical school campus in the North Side.So it appears that lined up against the UPMC behemoth could be another behemoth combining a large Pennsylvania insurance company, a Delaware insurance company, a good-sized hospital system, physicians' practices, and a branch of a medical school. So we see a new effort to divide the health care supposed "market" among a few large, vertically-integrated health care systems.
The Eerie Shadow of AHERF
Maybe all these simultaneous deals, which would apparently create a conglomerate of Highmark Blue Cross, Delaware Blue Cross Blue Shield, West Penn Allegheny Health System, Temple University Medical School, and possibly a large group of doctors' practices, were all being discussed separately because of how they could be seen as a strange shadow of the spectacularly failed Allegheny Health Education and Research Foundation (AHERF) of the late 1990s.
As discussed here, AHERF was a large integrated health care system formed out of multiple mergers. AHERF which went bankrupt in 1998, leading to massive layoffs, hospital closures, and the near dissolution of a medical school (which ended up taken over by Drexel University). The former AHREF CEO, whose high compensation (for the time) was accompanied by an autocratic management style, ended up in the local jail on a plea bargain. Note that West Penn Allegheny Health System was formed from some of the pieces of the failed AHERF, and seems to have never fully recovered from its previous troubles.
Despite the fact that the AHERF bankruptcy was the second largest US bankruptcy up to its time, this vivid case was notably anechoic. The lack of echoes it originally produced made it prototypical of the anechoic effect.
The link to AHERF was briefly noted in the Post-Gazette article:
'They are well-capitalized, and we're not,' said David L. McClenahan, WPAHS board chairman, speaking of Highmark. 'That's putting it mildly.' In the decade since the collapse of the Allegheny Health Education and Research Foundation, whose bankruptcy eventually bore the West Penn Allegheny Health System, WPAHS has been persistently starved for capital, he said.So far, however, the ominous implications of that previous debacle have not been publicly discussed.
How Some Executives Would Gain
Perhaps the executives rushing to make a deal are being distracted by the potential for personal gain. The DelawareOnline article noted that current executives of Delaware Blue Cross Blue Shield may be able to pull the ripcords of their golden parachutes if its proposed merger with Highmark goes through:
Seven executives at Blue Cross Blue Shield of Delaware, for example, are due a combined $6 million in severance pay -- equal to about three years of salary -- if they lose their jobs.
Details of Blue Cross severance payout packages have attracted attention recently because top executives at Delaware's largest health insurer are busy pressing for a merger with Pittsburgh-based insurer Highmark Inc., which could mean the elimination of some top positions.
Highmark has pledged that Blue Cross President and CEO Tim Constantine will keep his job after the merger's closing, if the deal is approved by state regulators. But Constantine, who has an annual salary of $420,000, would be due a $1.6 million payment if he were to lose his job.
Six other top executives, who earn between $245,000 and $330,000 annually, have potential payouts equal to about $4.3 million. Highmark has not discussed the fate of those officers, who range in position from the company's general counsel to its chief medical and financial officers.
That article further noted:
Some observers worry that the prospect of large severance payments could cloud the judgments of executives working to close the deal.
Considering the size of the Blue Cross payouts in relation to annual salaries, the payout promises deserve attention, said Ethan Rome, executive director of Health Care for America Now, a Washington consumer advocacy group. Severance agreements are typically in place to provide a cushion between jobs, he said. 'Three years is a long time,' Rome said. 'Three years is not a severance. It's a substantial payout.'
One wonders which other executives involved in these potential deals may also have prospects for either larger compensation or golden parachutes. This could include executives in particular current executives of West Penn Allegheny. One also wonders whether the creation of this new conglomerate will produce rationales for big raises for the current executives of all the organizations involved who get to work for the new merged entity. Perhaps someone should ask them.
Further Implications
Of course the various mergers were touted as productive of new efficiencies, as attempts to obtain increased market power usually are. As reported by the Post-Gazette:
While the short-term goal of this partnership is to preserve a 'fragile' Pittsburgh hospital system, the long term goal, said Highmark CEO and President Kenneth Melani, is the creation of a new model of health care, one that is outcomes based, with an integrated delivery and financing system.
;Health care services are becoming less affordable,' he said. 'It's important to have choice. It's important to have a second system.'
And, as we discussed here, the former CEO of AHERF pledged "new forms of organization that are more flexible, more adaptive, and more agile than ever before." But common sense and history suggests that increasing market domination will be good mainly for the market dominators, not their customers, or in this case, their patients, clients and students.
As Dr Westby Fisher asserted about how the new conglomerate will likely own physicians' practices:
So doctors lose more professional independence and autonomy and have even more chance that clinical decisions will be compromised by bureaucratic dictates. Yet ask patients who they want steering the boat when they get sick: their doctor.
It continues to be clear who the winners and losers are as health care reform unfolds. But when doctors lose autonomy, patients lose autonomy.
It’s that simple.
To argue that the only way to control the health care dollar is to bloat the bureaucratic levels of our system is a fool’s game. However, bureaucrats promote bureaucrats – it’s always been this way. Until doctors and the public speak up, there’s simply nothing to stop this train.
So I wonder if this complex merger will get more scrutiny than the many mergers that have preceded it in the last 30 years. Someone who is more likely to get answers than I am should be asking:
- What evidence is there that this merger will lead to any benefits to individual patients or to the public health?
- How will any efficiencies achieved benefit anyone other than the organizations' current and future managers?
- What sorts of management layers will the complexity of the multiple mergers proposed necessitate between current Highmark executives and current management of its new acquisitions?
- If the current problem is existing market concentration, why will these mergers be a better solution than a direct approach to that concentration?
- How will the current leaders of all the organizations involve personally benefit from this merger?
Meanwhile, increasing concentration of power in health care continues to benefit the leaders of the enlarging health care organizations, while reducing the choice of individual patients and the autonomy of health care professionals.
Hospital system has major computer breakdown with "resultant chaos"; patients not adversely affected (of course)
As mentioned on this blog numerous times. Healthcare IT outages never, but never, adversely affect patients in any manner whatsoever:
Amazing. There must be a cybernetic angel department in heaven that prevents patients from harm - i.e., from missed or delayed treatments or treatment mistakes - during the "resultant chaos" of major systems outages.
I'm sure insurers and risk managers have full confidence in Providence when these mishaps occur.
-- SS
July 1, 2011 update:
The Traverse City Record Eagle has published a memo explaining the outage:
In medicine, or in any complex domain, one must expect the unexpected...
(I hear Kate Winslet humming in the background...)
Anthropomorphism aside, it seems to me that switches and other inanimate objects don't become "confused." The engineers/programmers who designed them just didn't anticipate the event that sinks the Titanic.
But let's roll the technology out nationally, now, rush...rush...rush...before it's too late. Computer bits get stale after awhile, after all....
Re: "Unplanned network downtimes." In the long running TV series Stargate SG-1 there's a character, Walter Harriman, who runs the command console. Just about the only line he gets to say over the base PA system over 10 seasons is ...
... when some person or alien attempts to come through from another Stargate somewhere in our galaxy or others nearby.
Perhaps hospitals can use him as a role model to announce "unscheduled down time"...
Aside from the fact that these "objectives" are obvious, now hospitals need "small armies" to protect patients when a network switch gets "confused." Pen and paper offer no analogous bellicose hostilities.
But no patient was hurt (as they never are when the IT goes down).
Thank god.
Why do such "lessons" need to be "re-learned" - EVER?
In effect, they really don't understand what caused the outage.
This is similar to other cases of outages written about at Healthcare Renewal. There's never certainty, because these IT systems have become so complex and the support relatively diffused (via outsourcing, consultants, etc.)
This is a fertile ground for patient injury and death when luck runs out. As stories like "Failures in care alleged after premature birth - $1,000,000 Settlement" from the Virginia Lawyer's Weekly I referenced here imply, the cost of ownership of HIT will likely go way up once the multimillion dollar lawsuits start adding up.
Considering the track record of health IT as it is in 2011 regarding reliability, risk/benefit and security, spending hundreds of billions of dollars to put patients at risk of life and limb, and risk of potentially career-ending or bankrupting loss of privacy, en masse nationally, is increasingly brainsick.
-- SS
Traverse City Record-Eagle [Michigan - ed.]
June 30, 2011
Munson has 4-hour communications failure
By Bill O'Brien
bobrien@record-eagle.comTRAVERSE CITY — Munson Healthcare officials are trying to figure out how to avoid a repeat of a four-plus-hour data systems crash and "resultant chaos" that gripped local hospitals and clinics this week.
A system failure Tuesday morning shut down computers, telephones, pagers and other telecommunications systems at Munson Medical Center and its Munson Healthcare affiliates in Frankfort and Kalkaska, an incident that administrators described as "unacceptable." [That sounds about right - ed.]
Munson officials still aren't sure why a back-up fiber optic circuit failed during a planned outage that started Tuesday at 7:30 a.m.
"You can rest assured we're looking very carefully at that," Munson Medical Center CEO Kathleen McManus said. "Of course, we need to know what happened."
McManus said no patients were adversely affected during the outage. Even with the "resultant chaos" that gripped the local hospitals and clinics, no patients were adversely affected.
Amazing. There must be a cybernetic angel department in heaven that prevents patients from harm - i.e., from missed or delayed treatments or treatment mistakes - during the "resultant chaos" of major systems outages.
I'm sure insurers and risk managers have full confidence in Providence when these mishaps occur.
-- SS
July 1, 2011 update:
The Traverse City Record Eagle has published a memo explaining the outage:
Munson Healthcare officials distributed a memo on Wednesday that explained Tuesday’s systems failure that affected Munson Medical Center, Paul Oliver Memorial Hospital and Kalkaska Memorial Health Center and various clinics. The following memo is attributed to Chris Podges, Munson’s vice president of information systems.
“As you are all aware, we experienced an unplanned network downtime (Tuesday) that had widespread operational and clinical implications. Briefly, here is what happened:
Munson’s data centers’ connectivity to the outside world runs primarily on two redundant high speed fiber optic circuits administered by Traverse City Light and Power. We were informed by them that they needed to take one of the circuits off-line in order for them to do maintenance.
This would leave us operating on one circuit for the duration of their planned, 12-hour downtime. This shouldn’t have been any problem for us and is precisely why we have parallel, redundant technology on our most important systems and infrastructure. We have frequently tested for an event like this (losing one of the circuits) by manually “switching off” a fiber circuit.
In our testing, the remaining circuit took on all the traffic, just as it was architected to do; no hiccups, no instability, no impact on users, no downtime. And that is what we fully expected yesterday morning when one of the circuits was taken off line.
In medicine, or in any complex domain, one must expect the unexpected...
Unfortunately, that isn’t what happened. The core switch of the remaining circuit became confused, couldn’t take over the role as the primary switch (a transition which is measured in milliseconds) and ultimately shut down. Once down, everything running on the network – applications, paging systems, wireless devices, IP phones, etc., went down with it.
(I hear Kate Winslet humming in the background...)
Anthropomorphism aside, it seems to me that switches and other inanimate objects don't become "confused." The engineers/programmers who designed them just didn't anticipate the event that sinks the Titanic.
But let's roll the technology out nationally, now, rush...rush...rush...before it's too late. Computer bits get stale after awhile, after all....
Re: "Unplanned network downtimes." In the long running TV series Stargate SG-1 there's a character, Walter Harriman, who runs the command console. Just about the only line he gets to say over the base PA system over 10 seasons is ...
"UNSCHEDULED OFF-WORLD ACTIVATION!"
... when some person or alien attempts to come through from another Stargate somewhere in our galaxy or others nearby.
Perhaps hospitals can use him as a role model to announce "unscheduled down time"...
... During the downtime, we assembled a small army working on three objectives:
1. Make sure the hospitals and clinics could operate - especially as to the provision of patient care – on downtime procedures
2. Communicate as comprehensively and as often as we could
3. Fix the technical issues
Aside from the fact that these "objectives" are obvious, now hospitals need "small armies" to protect patients when a network switch gets "confused." Pen and paper offer no analogous bellicose hostilities.
While the reports are that all hospitals and clinics did a fantastic job surviving the down-time, we fully understand that it was very difficult to manage the resultant chaos and that downtimes like this are unacceptable.
But no patient was hurt (as they never are when the IT goes down).
Thursday morning at 2 a.m. we are going to re-introduce the second fiber optic circuit into our network architecture. While we expect no issues, we’re planning otherwise. This afternoon your organizations will receive specific instructions on how to prepare for the event of another network outage; What to print in advance of 2 a.m., what resources are available to you during the downtime, how to get needed clinical information without the use of computers, who to call for help, etc.
Thank god.
Again, we do not expect any downtime tomorrow morning, but we did re-learn some valuable lessons yesterday and the safety of our patients is the number one objective should the network experience another issue. We’ll be ready at 2 a.m. and we want your organizations to be ready, too.
Why do such "lessons" need to be "re-learned" - EVER?
We are working diligently to understand what happened yesterday and will share with you what we learn and our plans to remedy whatever may need attention.
In effect, they really don't understand what caused the outage.
This is similar to other cases of outages written about at Healthcare Renewal. There's never certainty, because these IT systems have become so complex and the support relatively diffused (via outsourcing, consultants, etc.)
This is a fertile ground for patient injury and death when luck runs out. As stories like "Failures in care alleged after premature birth - $1,000,000 Settlement" from the Virginia Lawyer's Weekly I referenced here imply, the cost of ownership of HIT will likely go way up once the multimillion dollar lawsuits start adding up.
Considering the track record of health IT as it is in 2011 regarding reliability, risk/benefit and security, spending hundreds of billions of dollars to put patients at risk of life and limb, and risk of potentially career-ending or bankrupting loss of privacy, en masse nationally, is increasingly brainsick.
-- SS
Electronic medication prescribing: The Magic Bullet Theory of IT-Enabled Transformation once again bites the dust in the real world of medicine
Computers once again are proving not to be the plug-and-play-panacea they've been made out to be in the complex world of medicine. The Magic Bullet Theory of IT-Enabled Transformation once again bites the dust in the real world of medicine:
Pens and prescription pads are orders of magnitude less expensive than multimillion dollar computer systems, I might add.
"Expected benefits?" Expected under what assumptions? [The assumptions that computers are a 'magic bullet' of some sort for complex real-world problems, and that technological determinism applies, are my best guesses as to the major ones - ed.]
If health IT are indeed medical devices (as per CDRH Director Shuren, see this link) but they are "not mature", then why are they on the market without pre-marketing validation, post-marketing surveillance and other regulatory requirements faced by other medical devices?
If the technology is this unreliable at this time, then perhaps investing hundreds of billions of dollars in it in 2011 is premature?
Feeling a bit like Harry Markopolos once again, I offer what I am going to call Healthcare Renewal's Rule #1 of Cybernetic Common Sense in Medicine:
Treating "HIT software" as such - as a medical device - with all that implies, would be a first step. Instead - for whatever political reasons - HIT is given special accommodation.
We could do the reverse to achieve regulatory consistency as well. What about de-regulating other medical devices and drugs? Might that not work out well?
One might also ask, if that's a ridiculous option, then why does HIT, even more potentially dangerous than a drug, stent or defibrillator get a pass?
Why is HIT even more potentially dangerous than a drug, stent or defibrillator?
There's a critical, infrequently addressed issue that arises as IT capabilities advance.
HIT is much more than a medical device like a stent or defibrillator, since it increasingly acts as a "coach" in the sports meaning of the term, or a "conductor" of clinicians in the sense of, say, a Herbert von Karajan or Eugene Ormandy as conductor of musicians.
The computer increasingly calls the shots, so it in effect is increasingly a cybernetic intermediary or "proxy" between doctor and patient. (In essence, the "learned intermediary" metaphor is obsolete; for instance when a doctor fired up some expert system, posed a question about what antibiotic to best use, and then either used or ignored the outputs. The computer is now between doctor and patient.)
If a machine is to be given this kind of authority, i.e., as a conductor or governor of clinicians, its competence to do so needs to be extensively and robustly validated.
A neurosurgeon doesn't cut into someone's head before their skills in that regard have been extensively validated.
Why do cybernetic intermediaries get special regulatory accommodation, especially when evidence is increasingly mounting that, as of 2011, they are often deficient?
-- SS
Errors Occur in 12% of Electronic Drug Prescriptions Matching Handwritten
Bloomberg
By Michelle Fay Cortez
Jun 29, 2011
As many as 12 percent of the drug prescriptions sent electronically to pharmacies contain errors, a rate that matches handwritten orders for medicine from physicians, researchers said.
An analysis of 3,850 computer-generated prescriptions written over a four-week period found 452 contained errors, including 163 that could harm the patient, according to a report published today in the Journal of the American Medical Informatics Association. The rate was consistent with past studies reviewing the risk of errors when a doctor writes a prescription and hands it to the patient, the researchers said.
Pens and prescription pads are orders of magnitude less expensive than multimillion dollar computer systems, I might add.
The results undermine the expected safety benefits from computer-generated prescriptions, said the study authors led by Karen Nanji of Massachusetts General Hospital’s anesthesia, critical care and pain department. The U.S. paid more than $158.3 million to doctors and hospitals in the first half of 2011 to encourage adoption of electronic health records, which President Barack Obama has advocated as a way to lower health- care costs and reduce medical errors.
"Expected benefits?" Expected under what assumptions? [The assumptions that computers are a 'magic bullet' of some sort for complex real-world problems, and that technological determinism applies, are my best guesses as to the major ones - ed.]
“Providers appear to be rapidly adopting electronic health records and computerized prescribing, and one of the major anticipated benefits is expected to be through medication-error reduction,” the researchers wrote. “Many of these benefits will not be realized if the electronic prescribing applications are not mature and either do not catch or even cause new medication errors.”
If health IT are indeed medical devices (as per CDRH Director Shuren, see this link) but they are "not mature", then why are they on the market without pre-marketing validation, post-marketing surveillance and other regulatory requirements faced by other medical devices?
“With more than 3 billon prescriptions written annually in the U.S. alone, this could amount to 385 million errors each year, with 128 million of them having the potential to cause patient harm, said researcher Jeffrey Rothschild, from the center for patient safety research and practice at Brigham and Women’s Hospital in Boston.
If the technology is this unreliable at this time, then perhaps investing hundreds of billions of dollars in it in 2011 is premature?
Feeling a bit like Harry Markopolos once again, I offer what I am going to call Healthcare Renewal's Rule #1 of Cybernetic Common Sense in Medicine:
"Computers can only solve problems amenable to be being solved by computers, and only when all steps in their design and implementation are led by bona fide, domain-experienced, competent problem solvers."
This will not happen in the Wild-West health IT ecosystem that currently exists.
USB-equipped Magic Bullets. Click to enlarge.
I have been asked what is needed for this industry to mature.
Conceptually, the first step is: regulatory consistency.
USB-equipped Magic Bullets. Click to enlarge.I have been asked what is needed for this industry to mature.
Conceptually, the first step is: regulatory consistency.
As previously mentioned, Jeff Shuren MD JD of FDA's Center for Device & Radiological Health (CDRH), a physician and a lawyer, called health IT a "medical device". On Feb. 25 2010 he stated:
... Under the Federal, Food, Drug, and Cosmetic Act, [that regulates all drug, medical devices, etc. in the United States -ed.] HIT software is a medical device.
Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems).
See links to his quotes at my post at http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html
Treating "HIT software" as such - as a medical device - with all that implies, would be a first step. Instead - for whatever political reasons - HIT is given special accommodation.
We could do the reverse to achieve regulatory consistency as well. What about de-regulating other medical devices and drugs? Might that not work out well?
One might also ask, if that's a ridiculous option, then why does HIT, even more potentially dangerous than a drug, stent or defibrillator get a pass?
Why is HIT even more potentially dangerous than a drug, stent or defibrillator?
There's a critical, infrequently addressed issue that arises as IT capabilities advance.
HIT is much more than a medical device like a stent or defibrillator, since it increasingly acts as a "coach" in the sports meaning of the term, or a "conductor" of clinicians in the sense of, say, a Herbert von Karajan or Eugene Ormandy as conductor of musicians.
The computer increasingly calls the shots, so it in effect is increasingly a cybernetic intermediary or "proxy" between doctor and patient. (In essence, the "learned intermediary" metaphor is obsolete; for instance when a doctor fired up some expert system, posed a question about what antibiotic to best use, and then either used or ignored the outputs. The computer is now between doctor and patient.)
Here are tragic, if accurate, allegations of a computer in control of clinicians: the child death lawsuit complaint #2 at my post "Babies' deaths spotlight safety risks linked to computerized systems" at http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html :
Count 42: Defendants told Plaintiffs that the incorrect date on the image caused the x-ray not to be read by a radiologist in the night the image was taken, and that if the image had been correctly dated February 27, 2010, it would have been reviewed by a radiologist immediately, who would have alerted Defendants that the PICC line was improperly positioned and had to be moved back to a safe position. However, since the film was incorrectly dated February 23, 2010, the film was classified as “old” [BY THE COMPUTER PROGRAM - ed.] and was not put in line for immediate review [BY THE COMPUTER PROGRAM - ed.], and was not reviewed in time to prevent injury to Plaintiffs Decedent.Count 45: Defendants told Plaintiff that the x-ray from the 27th, which was mislabeled as being from the 23rd, would have been reviewed by the neonatologist on duty on the morning of the 28th, but this did not happen because the computer which places films in line to be reviewed would have ignored such an “old” film. [That is, the computer cybernetically made the decision that the radiologists need not read the film, and in doing so exerted deadly interference with the clinicians' work - ed.]
If a machine is to be given this kind of authority, i.e., as a conductor or governor of clinicians, its competence to do so needs to be extensively and robustly validated.
A neurosurgeon doesn't cut into someone's head before their skills in that regard have been extensively validated.
Why do cybernetic intermediaries get special regulatory accommodation, especially when evidence is increasingly mounting that, as of 2011, they are often deficient?
-- SS
Food Reward: a Dominant Factor in Obesity, Part VII
Now that I've explained the importance of food reward to obesity, and you're tired of reading about it, it's time to share my ideas on how to prevent and perhaps reverse fat gain. First, I want to point out that although food reward is important, it's not the only factor. Heritable factors (genetics and epigenetics), developmental factors (uterine environment, childhood diet), lifestyle factors (exercise, sleep, stress) and dietary factors besides reward also play a role. That's why I called this series "a dominant factor in obesity", rather than "the dominant factor in obesity".
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