Mary Chris Jaklevic, Author at Ñî¹óåú´«Ã½Ò•îl Health News Ñî¹óåú´«Ã½Ò•îl Health News produces in-depth journalism on health issues and is a core operating program of KFF. Thu, 16 Apr 2026 04:12:56 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.6 /wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=32 Mary Chris Jaklevic, Author at Ñî¹óåú´«Ã½Ò•îl Health News 32 32 161476233 Will a ‘National Patient Safety Board,’ Modeled After the NTSB, Actually Fly? /health-industry/will-a-national-patient-safety-board-modeled-after-the-ntsb-actually-fly/ Mon, 05 Jun 2023 09:00:00 +0000 /?post_type=article&p=1695179 People concerned about the safety of patients often compare health care to aviation. Why, they ask, can’t hospitals learn from medical errors the way airlines learn from plane crashes?

That’s the rationale behind calls to create a “National Patient Safety Board,” an independent federal agency that would be loosely modeled after the , which is credited with of skies, railways, and highways by investigating why accidents occur and recommending steps to avoid future mishaps.

But as worker shortages strain the U.S. health care system, heightening concerns about unsafe care, one proposal to create such a board has some patient safety advocates fearing that it wouldn’t provide the transparency and accountability they believe is necessary to drive improvement. One major reason: the power of the hospital industry.

Two measures are underway to create a safety board: A in the U.S. House in December by Rep. (D-Calif.), which is expected to be refiled this session, calls for the creation of a board to help federal agencies monitor safety events, identify conditions under which problems occur, and suggest preventive measures.

However, the board would need permission from health care organizations to probe safety events and could not identify any health care provider or setting in its reports. That differs from the NTSB, which can subpoena both witnesses and evidence, and publish detailed that list locations and companies.

A related measure under review by a would create such a board by executive order. Its details have not been made public.

The push comes as many patients continue to get hurt, according to recent reviews of medical records. The Department of Health and Human Services’ inspector general found that 13% of hospitalized Medicare patients during a hospital stay in October 2018. A New England Journal of Medicine study of patients hospitalized in Massachusetts in 2018 showed that with 1% suffering a preventable injury that was serious, life-threatening, or fatal.

Learning about safety concerns at specific facilities remains difficult. While transportation crashes are public spectacles that make news, creating demand for public accountability, medical errors often remain confidential, sometimes even ordered into silence by court settlements. Meaningful and timely information for consumers can be challenging to find. However, patient advocates said, unsafe providers should not be shielded from reputational consequences.

“People pay vast amounts of money for health care,” said Helen Haskell, president of South Carolina-based Mothers Against Medical Error, an advocacy group she founded because her 15-year-old son died from septic shock following elective surgery in 2000. “Providers shouldn’t be able to sweep things under the rug.”

Barragán’s bill follows to create a national patient safety board to investigate incidents and make more providers’ safety records publicly available. It stemmed from the Institute of Medicine’s that called medical error in hospitals a leading cause of death and recommended a nationwide mandatory reporting system for serious adverse events. That campaign never got enough traction to become a congressional bill.

Patients and their families would still like to know the rate of harm in every hospital, said Lisa McGiffert, president of the , a group discontented with some aspects of the current bill. “We are so far away from that now,” she added.

But Karen Wolk Feinstein, president and CEO of the , a Pittsburgh-based philanthropy that leads more than 70 groups pushing the latest safety board campaign, said during an in January that public reporting would compromise data integrity by leading hospitals to scrub records to hide bad events.

“You’re going to have to protect data for a while — de-identify it,” she said, “so that we can do what needs to be done.”

She said that a patient safety board “will not happen” without broad support, including from hospitals and medical societies. Those groups have long to publicly identify facilities where errors occur.

That industry influence is “the elephant in the room,” said McGiffert. Hospitals, nursing homes, and medical professionals pour hundreds of millions of dollars into federal political campaigns each election cycle and spent $220 million lobbying Congress last year, according to OpenSecrets, a nonprofit that tracks money in U.S. politics.

Moreover, health care is the dominant employer in at least 47 states, , which means that, when legislation is in play, the industry “can always drum up local people to talk about how it affects them,” McGiffert added.

Feinstein agreed that legislators always ask about the position of their local health systems. “That is the first question,” she said during the January forum.

Although patient safety groups represent the interests of millions of people, they don’t have the same financial firepower on hand as the health care industry does. McGiffert said her own organization’s bank balance is $6,000. Feinstein said her foundation is using its endowment — created with proceeds from the sale of a tax-exempt hospital — to fund the patient safety board campaign, among other initiatives. The foundation reported in 2021.

The declined to comment about the patient safety board proposal because it was still reviewing it, said spokesperson Colin Milligan. He provided a statement from the association’s senior director of quality and patient safety policy, Akin Demehin, saying hospitals are “deeply committed” to safety and have urged that “publicly reported measures assess hospitals accurately and fairly while giving patients meaningful information.”

The safety board campaign initially . However, Feinstein said, it now envisions it as “something of a hybrid” of the NTSB and the , a lesser-known government-industry partnership that analyzes a massive amount of data to detect emerging risks.

Christopher Hart, a former NTSB chairperson who serves on the board of the Joint Commission, a health care accrediting body, likened the proposed patient safety board to the , which are statutorily protected from public disclosure. Protecting such tips about non-public events has “enabled a flood of voluntarily provided information” that is “foundational to improving airline safety,” Hart said.

But some consumer advocates argue that in health care, secrecy and voluntarism have fallen short. They point to the 2005 , which lets health care providers submit data confidentially to research groups called patient safety organizations. As of 2018, about 40% of hospitals reimbursed by Medicare didn’t report to such organizations despite liability and public disclosure protections, and most of the organizations didn’t submit data to national research databases, according to .

With safety indicators , supporters of a patient safety board argue the current proposal would be a step forward. It could hasten adoption of surveillance technology, launch a national portal for anyone to report events, and coordinate efforts of states, federal agencies, and accrediting bodies.

Barragán will reintroduce the bill in the current term but declined to give a date, said spokesperson Kevin McGuire. “From our understanding, the stakeholders we are working with are discussing the concerns” raised by advocates, McGuire said.

Sue Sheridan, a co-founder of , became a patient safety advocate after untreated jaundice left her son brain-damaged and her husband died of cancer that went untreated for months because a pathology result was not properly communicated. She now is a member of a working group for the presidential advisory council and said she expects consumer-friendly tweaks to the proposal, including putting patient representatives on the board itself — a step she said she would support. And she backs the overall effort, despite saying the plan needs to be somewhat refined.

“We will be safer with it than without it,” Sheridan said.

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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Comic Relief From COVID-19: Leaders Really Meme It When They Say Stay Home /public-health/comic-relief-from-covid-19-leaders-really-meme-it-when-they-say-stay-home/ Fri, 10 Apr 2020 09:00:10 +0000 https://khn.org/?p=1081788 [UPDATED on April 10]

CHICAGO — As their city confronts a wave of COVID-19 patients, Chicagoans are managing to get some belly laughs. The source? Memes of their leader staring down would-be social-distancing violators.

In one doctored image, a somber Mayor Lori Lightfoot peers down from the roof of the famous Superdawg hotdog stand alongside a pair of wiener statues.

Others shared under the hashtag #whereslightfoot show her at an empty jazz club, from the reflective sculpture known as the Bean and in a treasured impressionist painting that hangs in the city’s Art Institute.

Lightfoot memes proliferated after a March 26 order in which the mayor angrily closed Chicago’s lakefront and other major recreation spots that had become overrun with people.

Rather than get defensive, Lightfoot has played up her hard-nosed image.

She made a lighthearted in which she bakes, sings, cajoles, bargains, talks astrology and fluffs pillows to reinforce her administration’s “Stay Home, Save Lives” mantra.

“Here’s what’s up,” Lightfoot tells viewers in one clip. “If I make this shot, you gotta stay home.” She then dunks a ball into a basketball hoop attached to her fridge and does a victory cheer.

Chicago’s mayor isn’t the only elected leader leveraging humor to prod citizens into complying with COVID-19 directives.

Metuchen, New Jersey, Mayor Jonathan Busch starred in a playful

New York Gov. Andrew Cuomo ridiculed the notion that anyone could simultaneously practice and engaged in witty on-air with his little brother, CNN host Chris Cuomo.

The governor also recruited comedian to do a PSA, while California Gov. Gavin Newsom tapped comic actors (a former doctor) and to put their personal spins on stay-home messaging.

Kentucky Gov. Andy Beshear has encouraged riffs on his COVID-19 warnings, like a and a made by firefighters.

“If it makes people smile right now, I’m for it,” Beshear said during a news conference.

While humor may attract attention to the message, it’s not clear how effective it is at changing behavior. That is especially true with the current pandemic.

“We’ve never had a crisis like this, and so it’s really hard to say that what worked in another setting might work in this setting,” said Susan Polan, associate executive director for public affairs and advocacy at the American Public Health Association.

shows people respond more positively to messages about health threats when they are conveyed with humor.

Funny content often gets shared a lot, which means the message reaches more people, Polan said. For example, an animal calendar caused web traffic to spike in the association’s disaster preparedness campaign.

“The serious messaging is everywhere,” Polan said. The memes and videos constitute “an add-on that is going to appeal to some people.”

However, using humor might be risky, according to , a professor of communication science at the University of Maryland.

In a 2017 , she and a collaborator compared the short-term reactions of 303 undergraduate students to humorous and non-humorous messages about drunken driving and unprotected sex. They found that messages with sarcasm and irony generated more arguments against the implied health advice.

Sarcasm, in particular, led to more pushback, maybe because people don’t want to be made fun of.

Take the irate Italian mayors on a

target=”_blank” rel=”noopener noreferrer”>viral video

. “Where are you going with these incontinent dogs?” one shouts. “You are irresponsible idiots — colossal idiots!” Another threatened to use flamethrowers on partygoers.

A witty approach “may get people’s attention, but that may come at the cost of decreased message strength,” Nan said. “I would tread with caution when it comes to using humor in COVID-19 messaging.”

Kelly Leonard, executive vice president of The Second City, a Chicago-based improvisational comedy troupe that also does training, said it’s about context: “When there’s a need for cold facts in a crisis, you probably don’t want to be cracking jokes.”

But people also need a release valve. “There’s a reason that all of our late-night shows are comedy shows, right after the news,” Leonard said.

Leonard observed that Lightfoot is the first openly queer black woman to be elected mayor of a major U.S. city. She’s also short in stature. Those outsider traits may relate to her skill at wielding humor to deflate tension.

“She’s had to live a life of such ‘othering’ and made it through,” Leonard said. “She IS the mayor of Chicago. It gives her a kind of power, and she’s using it.”

Polan agreed: “She’s making fun of herself and using it to educate people, and that’s powerful.”

[Correction: This story was updated at 12:50 p.m. ET on April 10 to correct the affiliation of Xiaoli Nan. She is a professor at the University of Maryland.]

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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No Shield From X-Rays: How Science Is Rethinking Lead Aprons /health-industry/no-shield-from-x-rays-how-science-is-rethinking-lead-aprons/ Wed, 15 Jan 2020 10:00:50 +0000 https://khn.org/?p=1037234 CHICAGO — Patients have come to expect a technician to drape their torsos with a heavy lead apron when they get an X-ray, but new thinking among radiologists and medical physicists is upending the decades-old practice of shielding patients from radiation.

Some hospitals are ditching the ritual of covering reproductive organs and fetuses during imaging exams after prominent medical and scientific groups have said it’s a feel-good measure that can impair the quality of diagnostic tests and sometimes inadvertently increase a patient’s radiation exposure.

The about-face is intended to improve care, but it will require a major effort to reassure regulators, health care workers and the public that it’s better not to shield.

Fear of radiation is entrenched in the collective psyche, and many people are surprised to learn that shielding can cause problems. The movement also has yet to gain much traction among dentists, whose offices perform more than half of all X-rays.

“There’s this big psychological component, not only with patients but with staff,” said , a medical physicist at the University of Colorado Anschutz Medical Campus in Aurora, Colorado, who spoke about shielding at a December forum here at the annual meeting of the . “How do you approach something that is so deeply ingrained in the minds of the health care community and the minds of patients?”

Covering testicles and ovaries during X-rays has been recommended since the 1950s, when studies in fruit flies prompted concern that radiation might damage human DNA and cause birth defects. Only in the past decade did radiology professionals start to reassess the practice, based on changes in imaging technology and a better understanding of radiation’s effects.

Lead shields are difficult to position accurately, so they often miss the target area they are supposed to protect. Even when in the right place, they can inadvertently obscure areas of the body a doctor needs to see — the location of a swallowed object, say — resulting in a need to repeat the imaging process, according to the , which represents physicists who work in hospitals.

Shields can also cause automatic exposure controls on an X-ray machine to increase radiation to all parts of the body being examined in an effort to “see through” the lead.

Moreover, shielding doesn’t protect against the greatest radiation effect: “scatter,” which occurs when radiation ricochets inside the body, including under the shield, and eventually deposits its energy in tissues.

Still, Dr. , a radiologist at Chicago’s Ann & Robert H. Lurie Children’s Hospital, called the move away from shielding a “pretty substantial” change. “I don’t think it’s going to happen overnight,” she added.

Sweeping Shift

In April, the physicists’ association that shielding of patients be “discontinued as routine practice.” Its statement was endorsed by several groups, including the American College of Radiology and the Image Gently Alliance, which promotes safe pediatric imaging.

Around the same time, the Food and Drug Administration removing from the federal code a 1970s use shielding. A final rule is expected in September.

In the coming year, the , which gives guidance to regulatory bodies, is expected to release a statement supporting a halt to patient shielding.

However, experts continue to recommend that health care workers in the imaging area protect themselves with leaded barriers as a matter of occupational safety.

Groups in Canada and Australia have endorsed the change, and a movement to abandon lead shields is underway in Great Britain, according to Marsh.

Marsh, who’s helping direct the educational effort, said perhaps a dozen U.S. hospitals have changed their official policies, but “most hospitals are starting to have the conversation.”

Chicago’s Lurie hospital is launching an “Abandon the Shield” campaign to educate staff, patients and caregivers before it stops shielding across the organization this spring, Rigsby said. Shielding is used for most of the 70,000 X-ray procedures performed annually at Lurie in a variety of settings, from orthopedics to the emergency department.

A few miles away, at the University of Chicago Medicine hospitals, the recommendation to stop shielding “came as kind of a shock,” said Dr. , chief of pediatric radiology.

Feinstein said it seems contrary to what radiology professionals are taught, and she’s uncertain how it applies to her department, which already takes steps to reduce the chance that a shield will interfere with an exam. “We apply our shields correctly, and our technologists are incredibly well trained,” she said.

Nevertheless, Feinstein said, her department is weighing a halt to routine shielding.

Some hospitals are concerned about violating state regulations. As of last spring, at least 46 states, including Illinois, required shielding of reproductive organs if they are close to the area being examined, unless shielding would interfere with the diagnostic quality of the exam, according to the medical physicists’ association.

Some states are revising their regulations. In some cases, hospitals have applied for waivers or sidestepped state rules by taking the stance that a shield has the potential to affect diagnostic quality anytime it is used, Marsh said.

No Evidence Of Benefit

The amount of radiation needed for an X-ray is about one-twentieth of what it was in the 1950s, and scientists have found no measurable harm to ovaries and testicles of patients from radiation exposure that comes from diagnostic imaging after decades of looking at data.

“What we know now is that there is likely no [hereditary] risk at all,” said Dr. , a radiologist at Lucile Packard Children’s Hospital Stanford in Palo Alto, California, who chairs the Image Gently Alliance.

There’s also no evidence that fetuses are harmed by even a relatively high amount of radiation exposure, such as that from a CT scan of the abdomen, Marsh said.

Nevertheless, some patients may insist on shielding. The physicists’ group suggested that when hospitals craft their policies they consider that shielding may “calm and comfort.”

“I don’t think any of us are advocating to never use it,” Frush said.

A Need For Outreach

Public confusion might develop if dentists continue to shield while hospitals don’t. An estimated 275 million medical X-ray exams were performed in the U.S. in 2016, but 320 million dental X-rays were done.

Mahadevappa Mahesh, the chief physicist at Johns Hopkins Hospital, said there’s been less outreach to dentists on the topic. “It’s high time we bring them into the discussion,” he said.

The American Dental Association states abdominal shielding “may not be necessary” but has continued to recommend using lead collars to shield the thyroid “whenever possible.”

But Mahesh, who’s on the board of the physicists’ association, cautioned that lead collars to protect the thyroid may not be helpful and could obscure images taken by newer 3D dental imaging machines.

Contacted for a response, the dental association said its guidance on shielding is under review.

Technologists especially will need support in educating patients and families “so they are not feeling like they are walking into a disastrous conversation,” said Marsh, the medical physicist.

She is doing her part. At the radiology conference, Marsh strummed a banjo and sang her version of the Woody Guthrie ballad “So Long, It’s Been Good to Know Yuh,” with lyrics like: “To get rid of shielding at first may seem strange, but the time is upon us to embrace this change.”

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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Promising Greater Safety, A Tiny Widget Creates Chaos For Tube Feeders /health-industry/promising-greater-safety-a-tiny-widget-creates-chaos-for-tube-feeders/ Mon, 16 Dec 2019 10:00:06 +0000 https://khn.org/?p=1026338 Rachel Glenn loves to puree food and put it in her 4-year-old’s feeding tube. The Arkansas mom said her thick concoctions of fruit, vegetables, meat and grains provide the concentrated nutrition he needs.

When he was on formula, Asher, who can’t swallow due to a brainstem condition, vomited several times a day. Since his mom started making his meals in a blender, when he was about 15 months old, that has stopped and Asher has more energy. Plus: “He gets his two cups of greens a day and he doesn’t argue about it.”

So Glenn was upset to learn about a new type of connector being promoted for feeding-tube equipment that could prevent her son from consuming her home-blended food. It has a one-size-fits-all opening that’s much narrower than the holes on syringes she currently uses to push food through the feeding tube implanted in his abdomen.

(Courtesy of Rachel Glenn)
(Courtesy of Rachel Glenn)
Since Rachel Glenn started making meals in a blender for 4-year-old son Asher, when he was about 15 months old, he has stopped vomiting throughout the day and has more energy. Asher cannot swallow due to a brainstem condition. (Courtesy of Rachel Glenn)
(Courtesy of Rachel Glenn)

When Glenn and her husband tried using a syringe tipped with one of the new plastic connectors, called ENFit, they could barely get Asher’s food to budge. She worries her son’s health will suffer if manufacturers start putting ENFit connectors on all feeding devices.

“We feel being forced back onto formula is unfair to him,” said Glenn. “I don’t see any evidence that they have taken the needs of actual tube-feeding families into consideration.”

As the new connector standard intended to prevent deadly errors in hospitals has been introduced in the niche device industry, patients and their families who use feeding tubes long term at home say their concerns have been largely ignored. The ability to consume normal food and control their nutrition is a precious benefit they fear could vanish.

Some critics say ENFit also creates new risks, including dosing errors and infections among preemie babies.

ENFit sprung from an industry effort backed by patient safety groups and the Food and Drug Administration to create a global system of connectors that would prevent devices with different functions from being linked.

“We feel being forced back onto formula is unfair to him,” says Glenn. “I don’t see any evidence that they have taken the needs of actual tube-feeding families into consideration.” (Courtesy of Rachel Glenn)

Both the Joint Commission, which accredits hospitals, and the World Health Organization flagged such misconnections as a risk more than a decade ago. In 2010, The New York Times with a case of a pregnant woman who died after a bag of formula was connected to her IV port.

An industry committee, led by an FDA official, convened to set a standard for feeding-tube connectors. Some manufacturers began investing in production and marketing years before the standard was approved in 2016.

At some point, “the ‘P’ that stood for patient safety that should have been in the center of decision-making was changed for a ‘P’ that stood for profit,” said , chief nursing officer at Visante, a pharmacy consulting firm based in St. Paul, Minn. Her firm has served as a consultant for Becton Dickinson and Co., a leading syringe maker.

Unintended Consequences

ENFit syringes have an empty space at the tip where medication and food can get trapped, potentially leading to bacterial contamination as well as dosing inaccuracy that can be especially hazardous for tiny infants. One found ENFit syringes delivered the wrong dose about a fifth of the time.

Babies with neonatal abstinence syndrome are weaned off drugs — often with morphine every three hours for 30 days, said Keliana O’Mara, a pharmacist at the University of Florida Health Shands Hospital in Gainesville, Fla., who co-authored the study. “That’s 240 chances to have a problem with dosing accuracy.”

That hasn’t stopped a trade group from pushing hospitals to convert all their equipment — including the feeding tubes implanted in patients as well as tubes and syringes used to deliver food and medicine — to ENFit. In July, the Global Enteral Device Supplier Association startled many people by that its member manufacturers would begin phasing out non-ENFit products next year.

In response to questions, association Executive Director Michael Cusack referred to a on the organization’s “Stay Connected” website that says there have been “no reported misconnections, dosing concerns, or major transition problems” with ENFit in the United Kingdom, where adoption has been widespread.

While the entrance of new connectors is causing distress for home users — who call themselves “tubies” — some experts say it has not done much of anything to address the problem it was supposed to resolve.

“It was poorly designed, it was poorly thought out, and it doesn’t get at the root of the misconnections,” said , who owns a medical device design firm in Massachusetts.

While the suppliers association highlights tragic cases of patients hurt or killed by misconnections, some of its critics say ENFit doesn’t fix any misconnection hazards. They say it would not have prevented any of 23 feeding-tube misconnection events reported to the FDA between 2005 and 2016.

“That’s really a point of outrage for me,” Buma said.

By the time the design was approved, misconnection risks with feeding tubes had largely been mitigated, at least in the U.S., said Buma.

What’s more, she added, ENFit’s design created unnecessary challenges for the growing population of tubies, many of whom use funnel connectors and catheter tip syringes with wide openings that she said have no risk of misconnection with other devices.

Beyond problems with blended food, tubies complain of slower flow rates for formula, the clogging of medication and a screw-on design that’s a barrier for people with limited use of their hands, such as those with arthritis.

The Push To Switch

The suppliers association has petitioned for the FDA, the Centers for Medicare & Medicaid Services and the Joint Commission to take steps that would compel universal adoption. So far, that hasn’t happened.

While there’s no mandate, some hospitals came to believe a shift to ENFit was inevitable. “The message most people got was, ‘You have to convert because it’s going to be required in the future,’” said O’Mara, whose own hospital system aborted a switch to ENFit last year after taking a closer look at the effect on patient care.

And reluctance to make the change appears to be widespread. A suppliers association survey in 2018 showed 28% of U.S. hospitals had transitioned to ENFit, though some industry experts said they believe the adoption rate is lower.

Some manufacturers also have resisted a switch to ENFit. Becton Dickinson left the supplier association in 2015 citing ENFit dosing safety. The company said it’s developing an alternative design that will be available to all manufacturers and will comply with the standard without a misdosing risk.

French neonatal manufacturer and association member Vygon and Ohio-based feeding-tube maker Applied Medical Technology have said they will keep non-ENFit devices on the market.

Still, the push for ENFit has left some tubies feeling burned. They are angry that formula makers such as Nestle and Abbott Laboratories served on the standards committee and joined the suppliers association, though it is unclear whether those companies held sway in selecting a design that ultimately appears to serve their interests.

Nestle and Abbott declined to comment on their involvement.

Tubies worry their trusty devices could disappear, forcing them to rely on commercial formula that is costlier and, some believe, less nutritious than regular food.

“It’s my great concern that as more and more unknowing tubies are supplied with ENFit, the demand for legacy products will be diminished,” said David Rowland, an 80-year-old South Carolina resident who co-founded a group called Tubies Against ENFit.

Some, like the Glenn family, say they are hoarding supplies, just in case.

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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Robotic Surgical Tool, Not Medical Evidence, Drives Free Hernia Screenings /health-industry/robotic-surgical-tool-not-medical-evidence-drives-free-hernia-screenings/ Fri, 26 Jul 2019 09:00:32 +0000 https://khn.org/?p=974613 Some hospitals are trying a curious new tactic to attract patients: free hernia screenings.

One Illinois hospital to entice people to get their abdomens checked by a surgeon, while an Indiana hospital offered a chance to win dinner at a chophouse.

Announcements for screening events in and warned about “life-threatening” complications that could arise if hernias are left untreated. And hospitals in and included a chance to “test-drive” a surgical robot.

Hospitals say such screenings provide valuable education about treatment options for the common medical condition, in which part of the intestine protrudes through a weak spot in the abdominal wall.

But no research has been done on hernia screenings, and some experts worry that these outreach efforts — some of which showcase da Vinci robotic surgery devices made by  based in Sunnyvale, Calif. — could lead people to get potentially harmful operations they don’t need.

“My question is: Why are we doing this?” said University of Michigan Medical School associate professor Dr. , the director of Michigan Medicine’s Comprehensive Hernia Program. “Even with the best intent, it makes me worry about the unintended consequences down the line.”

A Common Condition

An estimated 1.6 million groin hernias are diagnosed and 500,000 are surgically repaired annually in the U.S., according to the Centers for Disease Control and Prevention. Some 27% of men and 3% of women are expected to have a groin hernia — the most common type — during their lifetimes.

Hernias can cause pain and abnormal bulges, and many patients eventually opt to get them fixed with surgery. Surgery can also prevent a rare but serious condition called strangulation, in which a hernia can entrap the intestine and cut off blood flow, requiring emergency surgery.

However, complications from hernia surgery are common. While any surgery carries risks, such as infection, groin hernia repairs leave as many as 12% of patients with chronic pain that can be debilitating, according to a 2016 study.

There’s also good evidence that people who have few symptoms can safely opt for rather than go under the knife, according to a 2018 article in JAMA. But such cautionary information is often missing in hospital screening announcements.

In fact, experts, including the American College of Surgeons, say there’s no data to back the use of such hernia screenings.

“A screening for hernia? That makes no sense to me,” said Dr. , director of the Cleveland Clinic’s Hernia Center and medical director of the Americas Hernia Society Quality Collaborative, a consortium that tracks treatment outcomes. “Obviously, it’s just there to drive people to the operating room.”

Promoting Robotic Surgery

Some hospitals say warnings about the risks of letting hernias go untreated are appropriate, and these events educate the public, quell fears about robotic surgery and serve people who otherwise can’t or won’t see a doctor. Several hospitals said their doctors inform patients about all treatment options, not just robotic surgery.

“Unfortunately, you can get people in the door for their own protection with the word ‘free,’” said Victoria Montei, system director of surgical services at Midland-based MidMichigan Health system, which has hosted two hernia screening events that attracted 52 people and detected 33 hernias. “For a lot of people, a $20, $50, $100 copay [to see a doctor] can be a lot. They put it off.”

Some hospitals also use hernia screening to show off their flashy da Vinci surgical robots, often claiming that the robots’ 3D imaging and precision movements lead to reduced pain, and faster recovery times.

Northeast Georgia Health System in Gainesville recently took one of its four da Vinci devices out of commission for three days to demo it at a hernia screening and other community events. Seeing the da Vinci up close “helps explain to the patient the value of it,” said Health System spokeswoman Kristin Grace.

Yet some hospitals seem to be rethinking their strategies. Dr. Sari Nabulsi, the chief medical officer of Medical Center Hospital in Odessa, Texas, which hosted a hernia screening event in 2018, said via email that the hospital “does not promote screening for hernia as there is no clinical value to such tests.” Its 2018 event was for “awareness” and the hospital “does not anticipate repeating the event in 2019,” he added.

Ben Drew, a spokesman for Walnut Creek, Calif.,-based John Muir Health, which advertised a robot test drive as part of a hernia screening event, said in an email that the robot was “not the focus of the assessment or the information provided to patients” and its announcement “could have been worded more clearly.”

Unclear Outcomes

The robot has been marketed as a way for surgeons to add minimally invasive surgery to their toolkits. Most hernias are repaired by open surgery, which uses large cuts. Conventional laparoscopic surgery, which uses smaller cuts, is technically challenging to learn for hernia repair, Rosen said.

But experts say there’s no firm evidence that robotic surgery provides better outcomes for hernia repair.

In fact, robotic surgery has sometimes been adopted ahead of evidence that it offers a benefit. Claims haven’t panned out for hysterectomies, and the Food and Drug Administration has issued a about the use of robots in cancer surgeries.

A screening for hernia? That makes no sense to me. Obviously, it’s just there to drive people to the operating room.

Dr. Michael Rosen, director of the Cleveland Clinic’s Hernia Center

Results of a pilot to compare robotic hernia repair with conventional laparoscopic surgery are expected to be published this fall, said Rosen, who is leading the study.

The trial will compare the two approaches on patient-reported pain, cost, ergonomics for surgeons and long-term recurrence rates. Still, larger studies will be needed to guide clinical practice, leaving answers years away, said Rosen.

Nevertheless, da Vinci’s manufacturer, Intuitive Surgical, has been pressing ahead with efforts to promote its use for hernia repair. In an email, Intuitive confirmed it has provided demo robots and “educational information” for hernia screenings at the request of surgeons and hospitals.

The company said the information it provides for screening events includes “descriptions of surgical and non-surgical options for hernia repair, including associated risks and benefits,” and it expects that “a large portion of hernia repairs will continue to be performed via different surgical modalities.” In other words, the way they’ve traditionally been done.

Intuitive’s 2018 annual report identified hernia repair as a “significant” growth opportunity, with general surgeries, including hernia repair, becoming the largest category of U.S. procedures in 2018. The company reported net income of $1.1 billion in 2018, up from $671 million in 2017.

The Economics Of Robotic Surgery

General surgery is a mainstay of community hospitals, which have recently begun to invest in robotic systems as a way to market themselves as “up on the latest technology,” said Diane Robertson, director of health technology assessment at , a nonprofit that studies safety and cost-effectiveness of medical interventions.

But ECRI wrote an warning that hospitals’ rapid adoption of robotic systems has outpaced the development of training and credentialing standards for the surgeons who use them.

Hospitals may not be thinking about whether it’s best for the patient or the most cost-effective option, Robertson added. For hernia repairs, she said, “There’s a huge question about why you would need to do them robotically.”

Each da Vinci costs an average of $1.5 million, plus hundreds of thousands of dollars annually to maintain and equip, according to Intuitive’s annual report.

Intuitive advertises in a on its website that the robotic systems help hospitals woo surgeons and win market share. The website says robotic programs can help hospitals become

But robotic surgeries to provide and often are reimbursed by insurers at the same rate as for conventional laparoscopy, according to some experts. A of 510 hernia repairs at the University of Virginia found that the median hospital cost of a robotic hernia repair was $7,162, versus $4,527 for laparoscopic procedures and $4,264 for open surgeries.

Though individual patients may not necessarily pay more for a robotic surgery, Robertson said, the technology contributes to higher overall health care spending and may divert resources from other priorities. In addition, taxpayer-funded Medicare may end up for robotic surgeries.

For at least one hospital, robotic surgery didn’t pay off.

Fifty-bed Massena Memorial Hospital in upstate New York ended its robotic services in June to help slash an operating deficit, according to chief financial officer Patrick Facteau.

The da Vinci didn’t increase the hospital’s surgical volume despite a marketing push that included , Facteau said.

“Part of the is, you will get more surgeries and reduce costs,” he said. “We didn’t really see that.”

Nor, he said, did the da Vinci improve the hospital’s surgical quality measures or reduce lengths of stay. Most hernia procedures are already done on an outpatient basis.

The hospital — in the 12,000-person town of Massena, just south of the St. Lawrence River — was paying about $500,000 a year to lease a da Vinci and cover maintenance and instruments, he said.

Unlike most hospitals, which have bought their systems, Massena had the flexibility to ditch its lease. “Once you purchase it, getting out of it is not so easy,” Facteau said.

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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Popular Charity Heart Screenings For Teens May Cause More Problems Than They Solve /public-health/popular-charity-heart-screenings-for-teens-may-cause-more-problems-than-they-solve/ Wed, 22 Feb 2017 21:10:31 +0000 http://khn.org/?p=702005 Dozens of not-for-profit organizations have formed in the past decade to promote free or low-cost heart screenings for teens. These groups often claim such tests save lives by finding abnormalities that might pose a risk of sudden cardiac death.

But the efforts are raising concerns. There’s no evidence that screening adolescents with (ECG) prevents deaths. Sudden cardiac death is rare in young people, and some physicians worry screening kids with no symptoms or family history of disease could do more harm than good. The tests can set off false alarms that can lead to follow-up tests and risky interventions or force some kids to quit sports unnecessarily.

“There are harms that I don’t think a lot of people realize,” said Dr. Kristin Burns, who oversees a two-year-old  at the National Institutes of Health of sudden deaths in people under 20. It’s one of several efforts aimed at gathering better data about cardiac abnormalities in kids.

Studies using limited data have found between  occur annually per 100,000 kids between ages 1 and 18. By comparison, 22 out of 100,000 U.S. teens are killed in accidents, including those involving motor vehicles, and nine out of 100,000 commit suicide, according to the Centers for Disease Control and Prevention.

Some screening advocates believe sudden cardiac deaths are underreported and not enough is being done to spare families from the fate of losing a child. “We have to acknowledge that every kid who drops dead, they’ve been failed by the current system,” said Darren Sudman, who founded , a screening effort in greater Philadelphia in memory of his infant son, who died of an arrhythmia.

Screening programs say they’re educating parents about the risks. “What we want to emphasize is, make sure your kid is heart-safe,” said Dr. Jonathan Drezner, a sports and family medicine specialist in Seattle at and medical director of the local .

Enthusiasm for ECGs, which measure the electrical activity in the heart to detect abnormalities, grew after a 2006  showed they lowered death rates among athletes in Italy. But research in other countries has not yielded similar results, and the Italian researchers recently refusing to share their data so it could be evaluated independently.

Some 60,000 to 70,000 U.S. teens were screened in 2016, most by foundations created by families who lost a child to sudden cardiac death, said Darren Sudman, who runs an online directory, . It’s unclear whether high school athletes face higher risk than non-athletes, so screening programs usually invite everybody.

Screenings typically are held in high schools and overseen by volunteer cardiologists, with funding from individuals and businesses including hospitals. A handful of hospitals and for-profit companies also run screenings.

It may be presumptuous to claim ECGs save lives, but parents often believe they do, said Sudman. “If I find a heart condition, I promise you there are parents who are thanking me for savings their kid’s life.”

That perception is stoked by tragic stories in the media of children who died suddenly after never reporting a symptom. Meanwhile, the drawbacks of ECGs are seldom depicted. As many as 1 in 10 ECGs detects a potential abnormality, and the emotional and financial toll of such a finding can be significant — especially when they turn out to be wrong.

Following a screening ECG and echocardiogram last fall, Daniel Garza, 16, a talented sophomore basketball player in San Antonio, was told he had , a thickening of the heart muscle and the most common cause of sudden cardiac death in young people. He was advised to quit all exercise, at least temporarily.

“We were shocked, just shocked,” said his mother, Denise. She said her son became depressed when he couldn’t play the sport he enjoyed and excelled at. “He came home and cried himself to sleep. He said, ‘Mom, why did God give me this gift to take it away?’”

The Garzas traveled to the Mayo Clinic in Rochester, Minn., where further tests indicated his enlarged heart was a benign condition known as athletic heart, a result of intense training. His mother estimates that correcting the misdiagnosis cost more than $20,000, including medical costs, travel and lost work.

Daniel has returned to the basketball court. Still, Denise Garza said the emotional toll was rough. “It was one of the hardest things my family has ever endured.”

Several cardiologists said they often see cases like this or worse. Even after follow-up testing, it can be unclear which cases are life-threatening, so kids with low risk could be restricted from exercise or given life-altering interventions such as implantable defibrillators, surgery or anti-arrhythmic medications.

Medical groups have wrestled with the issue. The American Heart Association and the American College of Cardiology  in 2014 against mass ECG screening, noting that sudden cardiac death is rare in teens and false positives generate “excessive and costly second-tier testing.” ECGs also miss at least 1 in 10 cases of hypertrophic cardiomyopathy and more than 9 in 10 cases of congenital anomalies, the second-most-common cause.

But their expert panel accepted voluntary screening “in relatively small cohorts” if there’s physician involvement, quality control and a recognition of unreliable results and ancillary costs.

By contrast, there’s broad support for , which have been shown to prevent deaths at schools and other public places. Some foundations focus their efforts on disseminating the defibrillators.

One problem with ECGs is a lack of good data.

“There’s no evidence we have that ECG screening saves lives,” said Dr. Jonathan Kaltman of the NIH’s National Heart, Lung, and Blood Institute. “There’s never been a controlled clinical trial, which is the only way to answer that question.”

Efforts are underway to improve the accuracy of the screening programs. Some are adding , which use ultrasound to produce images of the heart, to verify potential abnormalities. Advocates say false positives have dropped as a result of better interpretation guidelines, known as the , which are expected to soon be endorsed by cardiology societies in revised form.

But the criteria are not perfect, and there’s a “giant gap” in training cardiologists to use them, said Drezner, one of the developers. He’s also a medical adviser for , a consortium of foundations. “If I was a parent, I’d want to know about the experience of the (cardiologists) and what they’re going to do to help my kid if they have a positive screen.”

At the urging of screening advocates, the NIH partnered with the Centers for Disease Control and Prevention to rigorously track cardiac deaths as part of a Sudden Death in the Young Case Registry. So far a handful of states and counties have joined the effort, which helps local health departments collect better data. The goal is to standardize death investigations and get a firm handle on how often kids die from heart abnormalities as well as the role of factors such as genetics. Initial findings are expected to be available in about two years. The NIH is also funding three university-based research groups to answer key questions about sudden cardiac death in the young.

Some screening organizations are getting behind a nascent initiative with the to harness their own screening data for research. It would require standardizing their practices and tracking outcomes, which organizations aren’t now equipped to do.

“Screening is happening. We can’t avoid that,” said Dr. Salim Idriss, director of pediatric electrophysiology at Duke University and co-chair of the initiative. “We have a really good opportunity to get the data we need to make it better.”

Separately, the UT Southwestern Medical Center in Dallas recently began a involving athletes and band members at eight high schools to determine the feasibility of a full-scale randomized controlled trial.

A valid finding on the overarching question of whether ECG screening saves lives could require at least 800,000 participants and a cost of $15 million, said Dr. Benjamin Levine, a cardiologist and the lead researcher.

The pilot is partly a response to legislation that would mandate ECGs for student athletes in Texas. A similar bill was also introduced in South Carolina. Both bills failed, but it’s expected there will be more attempts to mandate ECGs, leaving state legislators looking for better guidance.

“We’re not going to solve this by having more debates, but by having more data,” Levine said.

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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Where Are STDs Rampant? Google Wants To Help Researchers Find Out /public-health/where-are-stds-rampant-google-wants-to-help-researchers-find-out/ Thu, 10 Dec 2015 19:22:55 +0000 http://khn.org/?p=585982 With sexually transmitted diseases on the rise, researchers at the University of Illinois at Chicago think they might have a powerful new weapon to fight their spread: Google searches.

The nation’s leading search engine has quietly begun giving researchers access to its data troves to develop analytical models for tracking infectious diseases in real time or close to it. UIC is one of at least four academic institutions that have received access so far, along with the U.S. Centers for Disease Control and Prevention.

Researchers can mine Google data to identify searched phrases that spiked during previous upticks in a particular disease. Then, they measure the frequency of those searches in real time to estimate the number of emerging cases. For instance, a jump in gonorrhea might coincide with more people searching “painful urination” or other symptoms.

“If this works, it could revolutionize STD surveillance,” said Supriya Mehta, an associate professor of epidemiology at the UIC School of Public Health.

Search trends can be broken down by city and state, weighted according to their significance and combined with other data sources to give a snapshot of where disease is spreading well before public health agencies report the number of verified cases.

“We’re hoping for a bit of creativity to flourish around this,” , said during a visit to UIC last month, where he spoke to about 100 people about lessons Google learned in its attempts to mine data for public health. “There’s no shortage of communicable diseases, sadly.”

Sexually transmitted diseases are a growing threat, worsened by the progress of antibiotic-resistant strains, according to the CDC.  The agency reported in November that STDs, including chlamydia, gonorrhea and syphilis, all increased in 2014, with chlamydia reaching a record of more than 1.4 million new cases. Diagnoses are highest in 15- to 24-year olds, an age group where technology use also is high.

Public health advocates have long salivated over the idea of using Internet searches to track all sorts of diseases but were limited to the publicly available Google Trends tool.  It restricts the number of phrases that can be tracked and does not report searches that fall below certain undisclosed volume thresholds.

Google invited infectious disease researchers to apply for access to search data in August as it disbanded its own real-time tracking tool, Flu Trends. Launched in 2008, Flu Trends broke ground but presistently overpredicted cases, and Google came under fire from some researchers for not disclosing its methodology. According to a paper published in Science by some independent researchers, Flu Trends stumbled because it used search terms that correlated with flu season but not actual cases of the flu and failed to adjust after Google introduced “search suggest” and other features to guide users to information.

Google is the most commonly used search engine in the U.S., with a 63.9 percent market share in October, according to , a Reston, Va.-based analytics company.

Google searches can be tracked by city, providing more refined data than the national and multi-state data reported by the CDC. “It’s a phenomenal data  feed to work with, and there’s a lot that can be done with it from a research standpoint,” said Jeffrey Shaman, an associate professor in environmental health sciences at Columbia University’s Mailman School of Public Health, which was given access to the data.

But no matter how great it is, some researchers say they can’t rely on Google alone. Take flu, which is furthest along of any real-time disease-tracking effort, with at least nine teams working with the CDC on 12 forecasting models for the current season. This fall Boston Children’s Hospital and Harvard Medical School launched  a tool that gave one- and two-week predictions by incorporating Google searches with the CDC’s weekly surveillance reports; electronic medical records from athenahealth; and Flu Near You, a website of patient-reported data. On Monday, they will be launching , the site where they will be tracking the flu this season.

In a recent FluCast architects say with multiple data sources they produce “more accurate and robust real-time flu predictions than any other existing system.” Co-founder John Brownstein said in an interview that FluCast will eventually add data from Twitter, though it’s “taking time to get the data in order.”

While flu patients may find it therapeutic to tweet about their high fevers, pounding headaches and extreme exhaustion, people who suspect they have a sexually transmitted illness are unlikely to vent about their symptoms via social media.

“In no way shape or form is someone going to tweet, ‘I have bumps on my vulva. Do you think it’s an STI?’” said Amy Johnson, a UIC PhD candidate who’s been studying the feasibility of using search data for tracking sexually transmitted infections.

Mehta agreed: “Because STDs are so stigmatized and personal, Twitter is not going to work for that.”

Robust STD tracking systems might incorporate additional search engines such as Yahoo! and Bing as well as weekly surveillance reports from local health departments, Johnson said.

Overreliance on one source is particularly risky if it’s a private company such as Google, which could remove access at any time. Even the CDC is hedging its bets; Matthew Biggerstaff, an epidemiologist who leads flu tracking efforts there, said the national health agency is exploring whether it can measure visits to its own website as a reliable disease indicator “so we have something that’s more of a public data set.”

And it remains to be seen just how real-time data could be used by public health agencies and providers. In the coming months, the CDC will be asking state and local health departments what type of flu data they want — real-time versus three-month forecasting, for example — and how they would use it, Biggerstaff said.

“Producing it and showing that it works is different than operationalizing it,” Biggerstaff said. “It’s still new in terms of incorporating it into a public health data stream.”

Then, there’s the issue of public trust. Researchers emphasize that no one’s privacy will be violated. Even with their unprecedented data access, researchers will not be able to tell who performs a query, what their sex or ethnicity is, or even what neighborhood that person lives in, Johnson said.

“I’m not going to knock on their door and tell their wife or their husband they have a sexually transmitted infection,” Johnson said. “It’s important for people on the individual level to know it’s about community health.”

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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