Junk Science Patient Safety research by NASA Scientist

Dr. John T.James PhD Toxicology, is a self-made Patient Safety expert with a junky study on patient safety being quoted by others.
Shame on him.

Dr. James did a meta analysis of four recent (2008 to 2011) studies using a Gobal Trigger tool that he thinks measures the rate of medical negligence. Wrong Dr. James, and wrong tool.
Toxicologists can’t judge medical negligence and the global tool counts events that can be any number of things, and certainly are not always negligence.
Moreover if the counts are done in the cases of inpatient deaths, many global trigger events are not medical care negligence or preventable at all.
But how should a toxicologist know that?
He doesn’t understand that the Global Trigger is not a way to judge negligence.
But what difference when you are on a crusade and you have a sympathetic audience who want to believe that docs and nurses and hospitals kill almost as many people as cancer, 400,000, annually.
http://journals.lww.com/journalpatientsafety/Fulltext/2013/09000/A_New,_Evidence_based_Estimate_of_Patient_Harms.2.aspx#
So Dr. James favorably comments on the New York Study of negligence on his opening page of his advocacy program.

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Which is a little strange to see, considering he works for the Government at NASA.
But assuming his government bosses like his advocacy for revamping and remaking medical care, let us remind him he doesn’t know of what he speaks.
A blistering reminder comes from the study Dr. James quotes as only needing his concerned update, the Harvard Study of New York Hospitals.
Read below from the pages of the premier medical journal in America what Troyen Brennan, MD MPH, lead author in the studies used by the patient safety movement had to say. In the New England Journal of Medicine in response to the IOM claims of a safety epidemic.
This is the pertinent part of what Dr. James doesn’t understand or want to understand, since he is a know it all crusader.
Brennan is a MD MPH JD Harvard Faculty member with multiple appointments, a Former Rhodes Scholar.
He was lead researcher in the New York patient safety study, but he is an honest man.
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 (April 13 2000) in the New England Journal of Medicine (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.”
I (Dunn) 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.
The IOM used the same language that appears in Dr. James web site. on Patient Safety.
Apparently Dr. James is a selective reader and researcher.
Here is the abstract of his patient safety paper.
Dr. James’ Abstract
Objectives: Based on 1984 data developed from reviews of medical records of patients treated in New York hospitals, the Institute of Medicine estimated that up to 98,000 Americans die each year from medical errors. The basis of this estimate is nearly 3 decades old; herein, an updated estimate is developed from modern studies published from 2008 to 2011.
Methods: A literature review identified 4 limited studies that used primarily the Global Trigger Tool to flag specific evidence in medical records, such as medication stop orders or abnormal laboratory results, which point to an adverse event that may have harmed a patient. Ultimately, a physician must concur on the findings of an adverse event and then classify the severity of patient harm.
Results: Using a weighted average of the 4 studies, a lower limit of 210,000 deaths per year was associated with preventable harm in hospitals. Given limitations in the search capability of the Global Trigger Tool and the incompleteness of medical records on which the Tool depends, the true number of premature deaths associated with preventable harm to patients was estimated at more than 400,000 per year. Serious harm seems to be 10- to 20-fold more common than lethal harm.
Conclusions: The epidemic of patient harm in hospitals must be taken more seriously if it is to be curtailed. Fully engaging patients and their advocates during hospital care, systematically seeking the patients’ voice in identifying harms, transparent accountability for harm, and intentional correction of root causes of harm will be necessary to accomplish this goal.
My reaction to the patient safety junk science is here:
http://junkscience.com/2014/03/03/patient-safety-junk-research/
In the case of Dr. James’ research, he doesn’t understand something basic in healthcare, incidents are not preventable–they are in the nature of what happens. To say incidents are preventable and therefore a measure of negligence is to ignore the fact that healthcare is engaged in the care of sick people. Treatments are frought with complications or failures. Patient’s are sick with diseases that produce problems.
The analysis of negligence is not a matter of counting incidents or adverse events.
I can assure the reader that creating a crusade on patient safety was helpful to the single payer crowd that gave us Obamacare.
Dr. James may get a kick out of demonizing the medical community, but he’s not qualified, and the Global Trigger tool as a very unreliable measure. Moreover, Dr. James suffers from a bad case of outcome bias and misrepresentation when he uses the Global Trigger tool in death cases.