Patient Safety Junk Research

Here’s the typical panicky study on patient safety, this time about skilled nursing facilities.

This study is one of many that are part of the crusade to take down the American Healthcare system and substitute a government controlled healthcare monolith. The mantra goes–not only expensive but negligent and unsafe, then the deceptions begin.
http://www.healthnewsdigest.com/news/nursing0/One-Third-of-Skilled-Nursing-Patients-Harmed-in-Treatment.shtml
The reason that I say it is part of the strategy is that it sets up the public to say–well it’s expensive and it’s unsafe–the government needs to stop in.
The short response is that these patient safety studies are data dredges, and the standard for what is an incident or negligence event is in the control of people who want to buff their numbers so they can announce a crisis, an epidemic of medical care negligence.
These studies are done by people with a clipboard, a red pencil and an agenda–in other words they are politically driven cargo cult science that counts anything and everything that could be criticized by nannies as negligence. And then it puts it in as a harm to the innocent patient.
If you include, for example that every infection is a sign of negligence you can inflate the numbers, and every fall, every missed medication time. Then the “harm” that was prominently included in the title–not true,a lot of the incidents they count have no impact on the patient. A lot of the harm stuff is might or may have harm.
When I first was out of law school a study on patient safety was done in California by a group headed by an MD JD pathologist Don Harper Mills and they found a rate of negligence events much less than 1% and the rate didn’t change in the studies by the Harvard group for New York and then 10 years later, Utah and Colorado.
The Harvard Group research really got the patient safety movement energized. The Group was led by Lucien Leape, a pediatric surgeon and big advocate, and Troyen Brennan, MD JD, Internist and Rhodes Scholar, who now is an exec with Aetna Health Insurance and still on the Harvard Faculty.
I wrote about the deceptiveness of patient safety research beginning in the 1990s, because I studied their methods and results. In human activities a negligence rate of less than 1 % has been considered acceptable, but the safety engineers aim for another order of magnitude, however if the measure of negligence is unreliable the whole project is flawed.
Here is my first published critique of the Harvard studies in the Journal of the Texas Medical Association in October of 2000
http://junksciencearchive2.files.wordpress.com/2013/12/tex-med-2000-with-tables.doc
Then I revisited the issues at the web site of American Council on Science and Health in 2005.
http://junksciencearchive2.files.wordpress.com/2013/12/acsh-pat-safety-art-2005.doc
As a safety expert, I was outraged to read the pre-publication press release in 1999 of what was to be the 2000 final draft of the IOM on patient safety. No peer review opportunity was offered. I had analyzed the 1991 report of the Harvard study in New York that the IOM was relying on and found it to be deeply flawed. Still, the IOM report came out in 1999 announcing an epidemic of patient safety problems, anticipating another report from the Harvard group on the Utah Colorado project also headed by Troyen Brennan.
Organized medicine and hospitals had already quietly agreed to play a supportive role in any government-proposed safety program, fearing the alternative of an even more direct regulatory role for government. Their also were politically active members of the physician and hospital community that had become self promoted Patient Safety Experts and they were already heading up funded projects to address the crisis.
But the patient safety crusade hadn’t counted on an honest Harvard physician/attorney named Brennan.
Within a few months of the big roll out and public relations splash by the Institute of Medicine (a sub of the National Academy of Sciences) on patient safety, announcing that physician/nurse/hospital negligence killed 44 to 98 thousand inpatients a year, Brennan, the lead author of the studies in New York and then Utah Colorado that were the basis for the IOM claim of an epidemic (we here at junkscience know enough to be wary of people like the IOM when they use the word epidemic) asked the NEJM for an opportunity to comment in a sort of Op Ed essay format.
Brennan’s essay appeared on April 13, 2000, 5 months after the release of the IOM report To Err is Human that was greeted with great fanfare as showing that,as USA Today said, doctors kill more people than auto accidents. Nice little sound bite, but misleading.
Even a small negligence rate unavoidable in a complex human activity will produce an impressive number if the denominator is large, and there were tens of millions of hospital admissions a year in the US. 0.25 % negligence with injury found in the studies still projects to a large number nationally.
Troyen Brennan M.D., J.D. — a lead Harvard researcher on the two studies that were the backbone of the IOM report and the source of the negligence death numbers that scared so many — asserted in an essay in NEJM that the research of the Harvard group was weak and was being misused by the IOM. Brennan wrote:
–“I have cautioned against drawing conclusions about the numbers of deaths in these studies.”
–“The ability of identifying errors is methodologically suspect.”
–“In both studies (New York and Utah/Colorado) we agreed among ourselves about whether events should be classified as preventable…these decisions do not necessarily reflect the views of the average physician, and certainly don’t mean that all preventable adverse events were blunders.”(11)
I comment here in my paper on the adverse drug event research:
Another major segment of patient safety research relied on by the IOM in their 1999 announcement of a crisis was research on adverse drug events (ADEs), meaning undiscovered or uncorrected mistakes in prescribing and administration of medications and fluids. However, that research is frequently weak. It is clear that the ADE research dredges for numbers and exaggerates effects by including “possible” drug events and expected-and-unavoidable drug events.
The point is I don’t believe the study on patient safety in Skilled Nursing facilities anymore than I believe or trust the claims of the Institute of Medicine on national patient safety and inpatient negligence research.
I can assure the reader that creating a crusade on patient safety was helpful to the single payer crowd that gave us Obamacare.
The method is to hire experts who declare a problem–in this case private medicine–and announce that something must be done–and they are the ones to do it.
JunkScience research on patient safety was just one element, there were many more to push single payer with the myth that centrally planned healthcare would be great and produce better, more accessible and affordable care
On that bigger issue I have also provided extended in-depth condemnation of the central planners who are devoted to the managed care model.
http://www.americanthinker.com/2010/04/the_myths_of_managing_healthca.html
And I wrote a detailed critique of the myths of managed care and modern healthcare reform strategies
www.jpands.org/jpands1504.htm
Hayek called the problem the “Fatal Conceit.”

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