Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Showing posts with label Lucian Leape. Show all posts
Showing posts with label Lucian Leape. Show all posts

Monday, October 31, 2016

Patient Outcomes Research Rejected at Harvard/Mass General 100 Years Ago




DAVID L. RYAN/GLOBE STAFF
Dr. Ernest Amory Codman told his wife before he died in 1940 not to spend money on a headstone. Dr. Andrew Warshaw spent the last two years raising $20,000 from medical organizations for a granite and bronze memorial that will be dedicated Tuesday.
By Liz Kowalczyk GLOBE STAFF  JULY 21, 2014




Dr. Ernest Amory Codman was in his mid-40s when his golden career as a sought-after Harvard surgeon began to unravel. He had quit in exasperation from Massachusetts General Hospital, and when he took his dispute with hospital leaders public, colleagues turned against him. Many stopped sending him patients.

MASSACHUSETTS GENERAL HOSPITAL ARCHIVES
Dr. Ernest Amory Codman.
It was the early 1900s, and Codman was impatiently pushing hospitals and doctors to adopt a practice many considered heretical at the time: Record the “end results’’ for every patient — including harm caused by physicians’ errors — and make them public.

A century later, many of Codman’s ideas are the bedrock of modern medicine. And a group of doctors, including a former Mass. General surgery chief, plans to make sure he gets the wider appreciation he deserves this week.
Codman’s ashes are buried in his wife’s family plot in Mount Auburn Cemetery in Cambridge, with no personal marker. Dr. Andrew Warshaw, the hospital’s chief of surgery from 1997 to 2011, has spent the last two years raising $20,000 from medical organizations for a granite and bronze memorial that will be dedicated Tuesday.
The headstone is “an overdue homage” to Codman and the ideas he pushed at Mass. General and nationally, Warshaw said. “His senior doctors couldn’t be bothered. They said it wasn’t necessary. Of course, people were threatened.’’

Even after Mass. General began tracking some outcomes, making that information public was anathema. “The general executive committee does not consider it advisable,’’ Dr. Joseph Howland, the hospital’s assistant administrator, cryptically wrote Codman in April 1914.
Codman himself lived his beliefs with excruciating honesty.

“I made an error of skill of the most gross character and even failed to recognize that I had made it,’’ he wrote in a published report after a woman died following a gallbladder operation in 1917.
These days, there is little escaping Codman’s notions, as everyone from patient safety groups to President Obama pushes for measurable quality and transparency in medical care.
Codman’s close examination of patient cases led to weekly meetings now held at Mass. General and many other hospitals called “morbidity and mortality’’ conferences, and his insistence on “hospital standards’’ eventually prompted the formation in 1951 of the Joint Commission, a national organization that evaluates hospitals.
“He deserves to be much better recognized,’’ said Dr. William Mallon, a shoulder surgeon who wrote a comprehensive biography of Codman that was published in 1999.
But it was not until another Harvard physician, Dr. Lucian Leape, started publishing studies on the frequency of medical errors in the 1990s that the profession and government began to intently examine the issue.
And it has been only in the past 10 years that regulators, patient safety experts, and some doctors have advocated for making outcomes and errors public, as a way to further encourage improvement. As Mallon pointed out, however, few physicians are as open as Codman about their mistakes, in part because of the threat of lawsuits, and mortality and morbidity conferences remain highly confidential.
Dr. Lamar McGinnis, a cancer surgeon from Georgia who has researched Codman’s career, said it was not only his ideas, but his abrasive personality that hurt him professionally. “He was really stepping on toes,” McGinnis said.
‘He deserves to be much better recognized.’

Frustrated with Mass. General’s refusal to fully embrace his ideas, Codman left his full-time job there in 1911 to start his own 12-bed hospital in a Beacon Hill brownstone. He required his doctors to report their results and he tracked his own patients on hundreds of 3 x 5 cards. He advertised the “Medical Ethics of the Codman Hospital’’ — a mission statement of sorts that stated “large fees are only justifiable’’ when a surgeon’s skills have been proven.
Codman continued to pursue changes at Mass. General, and while the hospital began to track patient outcomes, it stopped short of investigating the reasons for poor results, according to letters Codman wrote to hospital administrators. He warned that his ideas were gaining traction in Philadelphia, threatening Mass. General’s position as a national leader.
“It is really easier to overturn a whole city than it is to wake up the trustees of Massachusetts General Hospital,’’ he said in a letter in March 1914, the month he cut ties completely with the hospital to protest the seniority system. Codman urged Mass. General to “do some house-cleaning’’ and stop promoting doctors because of their reputations instead of advancing those with good results.
Codman’s surgical career took a dive in January 1915, when he organized a meeting on hospital standards as chairman of the Suffolk District Surgical Society. Before dozens of colleagues, Codman unveiled a cartoon he had asked a friend to draw.
An ostrich with its head buried in the sand kicked out golden eggs to Back Bay doctors. The heads of Mass. General watched, scratching their heads and asking, “If we let her know the truth about our patients, do you suppose she would still be willing to lay?’’
The audience was aghast, Codman later wrote. He was told to resign as chairman of the group, and as referrals plummeted that year, so did his income — to $5,000 from $8,000 the prior year. He closed his hospital to help treat the injured after two army munitions ships collided and exploded in Halifax, Nova Scotia, in December 1917.
MASSACHUSETTS GENERAL HOSPITAL ARCHIVES
Dr. Ernest Amory Codman shocked colleagues with a cartoon critical of Back Bay doctors.
Still, Codman was hard to ignore back in Boston. He became an expert in shoulder surgery and bone sarcoma, and Mass. General reinstated him as a consultant in 1929. By the time he died in 1940 at his home in Ponkapoag, now Canton, the wounds appeared healed.
Two weeks after his death, trustees at Mass. General, which had begun to adopt his ideas, passed a resolution calling him a “champion of truth’’ who was “willing to sacrifice personal place and standing to achieve what he believed to be right.’’
Codman never recovered financially after his surgery practice dwindled, according to his biographer, and he told his wife before he died of melanoma in 1940 not to spend money on a headstone.
The memorial project took far longer than Warshaw expected.
Codman and his wife, Katherine Putnam Bowditch, did not have children, and doctors were unable to find a relative to give permission for the headstone. So Warshaw contacted Mount Auburn, which began researching the expansive cemetery plot, purchased by the prominent Bowditch family in 1845. Nathaniel Bowditch, Katherine’s great-grandfather and a ship’s captain from Salem, was a pioneer of modern maritime navigation.
Mount Auburn determined that it controlled a portion of the plot, and gave Warshaw permission to move forward with a memorial. Warshaw, who will become president of the American College of Surgeons in October, plans to make Codman’s accomplishments the theme of his opening speech in San Francisco.
A small private ceremony will be held at his gravesite on Tuesday. The memorial, which describes Codman as the “father of outcomes assessment and quality measurement in health care,’’ sits under a shady stand of eight Canadian hemlocks, just behind Nathaniel Bowditch’s grave.
Inscribed under Codman’s name and portrait in bronze are these words: “It may take a hundred years for my ideas to be accepted.’’


Liz Kowalczyk can be reached at kowalczyk@globe.com

Wednesday, December 30, 2015

Harvard public health expert: Patient Safety Needs Federal Regulation

Like aviation, patient safety needs federal regulation

A new federal agency should be established to oversee patient safety at healthcare facilities to reduce medical errors, Lucian Leape, adjunct professor of health policy at Harvard T.H. Chan School of Public Health, said December 10, 2015 at a National Academy of Medicine symposium on advances and challenges in patient safety and healthcare quality.

“We really ought to have a federal patient safety agency like the Federal Aviation Administration (FAA)” that exists for airplane safety, Leape said in his remarks, according to a December 11, 2015 MedPage Today article. “That’s what we need and we should have said that [in the report], and I’ll say it right now,” said Leape, a member of the committee that created the report. “The thing the FAA does is that it sets standards, enforces standards, and works with industry and makes sure the standards are the right ones and that people are all on board.”
Now, he said, “The only people who pay for medical mistakes are patients. There have to be consequences for the failure to do what we know is the right thing to do. We’ve spent 15 years relying on goodwill and persuasion, but there needs to be an element of discipline.”
http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/55192
http://www.hsph.harvard.edu/news/hsph-in-the-news/like-aviation-patient-safety-needs-federal-regulation/?utm_source=Twitter&utm_medium=Social&utm_campaign=Chan-Twitter-General
Expert: More Oversight Needed for Health Facility Safety
Lucian Leape, MD, calls for an 'FAA-like' federal agency
by Joyce Frieden  News Editor, MedPage Today 
WASHINGTON -- The federal government should create a new agency to oversee basic practices at healthcare facilities and cut down on the rate of medical errors, according to Lucian Leape, MD, adjunct professor of health policy emeritus at Harvard School of Public Health, in Boston.
"We really ought to have a federal patient safety agency like the Federal Aviation Administration (FAA)" exists for airplane safety, Leape said Thursday at an event here commemorating the 1999 release of the National Academy of Medicine's landmark report on medical errors, "To Err is Human."

"That's what we need and we should have said that [in the report], and I'll say it right now," said Leape, who served on the committee that developed the report.
"The thing the FAA does is that it sets standards, enforces standards, and works with industry and makes sure the standards are the right ones and that people are all on board," he told MedPage Today.
Leape acknowledged that human beings are more complicated than airplanes, but he added that right now, "The only people who pay for medical mistakes are patients. There have to be consequences for the failure to do what we know is the right thing to do." Examples of the types of standards the agency would enforce include 100% handwashing, flu vaccines for all employees, and no central line infections, Leape said, adding that this would not involve questioning a physician's judgment regarding a specific patient.
Although "carrots," or positive incentives, would be the preferred way to get health facilities to do the right thing, Leape acknowledged that "sticks" might be needed too. "We've spent 15 years relying on goodwill and persuasion, but there needs to be an element of discipline," he said.
Other speakers at the event, which also celebrated the 2001 release of "Crossing the Quality Chasm: A New Health System for the 21st Century," included Dan Ariely, PhD, a professor of psychology and behavioral economics at Duke University in Durham, N.C. Ariely discussed ways to help patients comply more easily with their treatment regimens.

The basic idea, Ariely explained, is that people are more interested in the short term than in the long term, so providers can use that knowledge to motivate people in the short term to do something that will be good for them in the long term. For example, Ariely said, when he was diagnosed with hepatitis C and had to give himself a shot of interferon three times a week as part of a clinical trial, he dreaded doing it because the side effects were extremely unpleasant.
However, he knew that taking the interferon could cure the disease and prevent the need for a liver transplant down the road, so he rewarded himself immediately after each shot with watching a video that he was really looking forward to. "A year and a half later, I was free of hepatitis C. My physician told me I was the only patient in the protocol that took the medication on time," he said.
Another strategy to help with compliance involves "loss aversion" -- the idea that people hate to lose money or something else they value more than they enjoy gaining something, Ariely continued.
In one experiment, "We gave people $3 a day to take their medication on time. What happened? Absolutely nothing," he said. "What if we took away $3 every time they didn't take their medications on time? The [institutional review board] wouldn't let us do that ... but what they allowed us to do is pre-pay people as if they took the medication for 3 months in advance ... and then take the money back, and that worked better."
During a question-and-answer session, Ariely was asked how motivational techniques could be used to help physicians and other providers comply with rules like handwashing. "I don't think it's about small punishments or rewards. These things we need to treat very differently ... they need to be either habitual or ritualistic," he said.

For instance, "Very few physicians don't wash their hands when they go to the OR. But the OR has a tremendous ritualistic element -- the surgeons stand there, people dress them -- there's a whole ceremony around it that's incredibly addictive."
As with the rituals surrounding religion, "It's not just about the action, but providing a higher-order meaning," he said. "A lot of things in medicine should look like that, but if you have 12-minute appointments and lots of paperwork to fill out, it's a little harder to feel a connection to a higher-order meaning."
Audience members also heard from experts in other industries whose structures might also apply to healthcare. For instance, Conrad Grant, head of the air and missile defense department at Johns Hopkins University Applied Physics, Laboratory, in Laurel, Md., compared hospital intensive care units (ICUs) to defensive weapons systems.
"In the ICU [unlike a weapons system], many systems have been designed for individual purposes, and have not been integrated into a coordinated set of systems," he said. "In certain situations, [these systems] may even be working at cross purposes if they are not correctly configured. There are so many straightforward improvements we could make today with an immediate reduction in preventable harm."
Grant gave one example in response to a question about "alarm fatigue" ICU nurses get from having device alarms -- many of them false -- constantly going off. "In weapons systems we also have alarms ... that go off with threats that present themselves or when the conditions of the ship aren't what we want them to be."

"We have carefully tried to engineer that so they're not so repetitive and constant that they become overwhelming," he said. "Part of the way to eliminate alarms is to cross-correlate systems that trigger the alarm ... if you couple it with second sensors that would recognize the same set of conditions and look to see if both of them are showing that same condition before you trigger the alarm, you have some verification."