Articles Posted in Clinical guidelines

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After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women.

The agency has  been slow to act on transvaginal mesh, which has been in use since the 1970s, with surgeons increasing its use in the 1990s. That in turn created an avalanche of complaints from safety advocates and women patients, who said the implant and procedure caused pain, bleeding, and scarring. This was not the surgical innovation, they said, that was supposed to remedy the pelvic tissue collapse that can cause the bladder or reproductive organs to slip out of place, causing pain, constipation and urinary leakage.

The FDA issued a series of increasing warnings about mesh, finally reclassifying it in 2016 as high-risk and ordering its makers to produce medical-scientific evidence about the device’s long-term safety.

eyefocus-300x278Although experts estimate medical over-testing adds more than $200 billion in wasted spending in the U.S. health care system, reducing  it can be hard, as we can see from one example in eye surgery.

Let’s zoom in on cataract surgery, a procedure in which eye surgeons (ophthalmologists) aim to relieve the visual clouding that many patients experience as they age, taking out the natural lens and putting in an artificial replacement. The surgery isn’t without risks, but it goes swiftly and with minor inconvenience for most patients, who get to go home the same day.

For healthy seniors undergoing cataract surgery, the professional consensus has seemed clear for not quite two decades: preoperative testing—which may include a complete blood count, chemical analysis, coagulation studies, urinalysis, electrocardiography, echocardiography, cardiac stress tests, chest radiography, and pulmonary-function tests—is unnecessary. This has been established by rigorous studies (see here and here), as well as by the stringent Cochrane review. The American Academy of Ophthalmology has made this a guideline or clinical statement and spread the word, notably through the public Choosing Wisely initiative that counsels patients on key procedures they need to ask their caregivers about if they’re ordered.

breastimplantUncle Sam has paid what critics have called long overdue attention to women’s breasts and how surgeons and diagnosticians treat them.

In an angry and emotional public hearing, women ripped the federal Food and Drug Administration for lax oversight of implants that surgeons use to augment and reconstruct breasts, even as the agency proposed its first changes in 15 years to guidelines about mammograms for patients with dense breast tissue.

The FDA has been under fire for decades over breast implants, mostly banned in 1992 but allowed anew in 2005. Experts long have debated whether materials in the implants, notably silicone and not necessarily saline fillings, may be injurious to women’s health. New concerns have developed over surface texturing on the devices, which are supposed to help in the surgery but may affect tissues around and near the breast, leading to spikes in reported cases of rare cancers.

aspirinlowdose-300x225After persuading as many as 7 in 10 American adults to take a daily low dose of a common painkiller to protect against heart disease and cancer, experts now say it is time for more nuanced advice on who should and who shouldn’t take the daily baby aspirin regimen.

Recent studies have shown that the believed protective benefits of low-dose aspirin need to be balanced against the risks of bleeding caused by the drug, the American Heart Association and the American College of Cardiology have declared.

Here is who should NOT go on low-dose daily aspirin:

Doctors and hospitals finally are owning up to and treating mental and physical damages inflicted on some of the sickest and most vulnerable individuals in their care—the 5 million or so patients who get helped in intensive care units, published research shows.

Although ICU patients may get dramatic emergency care that saves them from deadly infections, major disease, and significant accident or injury, experts only recently have begun to recognize and assist them with a condition associated with their stays: post-intensive care syndrome (PICS). A readable new study in the medical journal JAMA says that ICU patients may suffer a “constellation of symptoms” with PICS that hinders their recovery to their pre-hospitalization well-being, including: “muscle weakness, cognitive impairment, depression, anxiety, and post-traumatic stress disorder (PTSD).”

cdcshots-300x230As doctors and public health officials coast-to-coast battle infectious outbreaks — of measlesmumps,  meningitis, whooping coughinfluenza, as well as typhus, hepatitis, and TB — the nation is also struggling with the right response for yet another contagion: the viral spread of medical misinformation on social media.

Medical nonsense isn’t new, and savvy patient-consumers long have needed to do a little work to protect themselves from what can be its real and significant harms. But a season of rapidly spreading and 100% preventable infectious diseases has forced modern medicine to confront generational dilemmas with health disinformation that is “shared” widely online and especially via social media.

For the rising generation that now parents youngsters who need and should be vaccinated, social media sites like Facebook, YouTube, and Instagram, as well as information searches via Google have become as ordinary and accepted as once were daily newspapers and the 6 o’clock TV news. But cyber world’s ubiquity also has allowed counter factual, unfounded, nonscientific, and extreme notions to proliferate, as users of all kinds “create content” online. This has fueled the dangerous normalizing and further rise of the anti-vaccination or anti-vaxxer movement.

EHRsKHN-300x230Tempting though it may be to dismiss doctors’ howls about electronic health records—maybe they’re Luddites or they’re just another group of high-paid workers beefing about their job tools—the persistent and significant nightmare of the complicated computer systems has been this: Do they harm patient care?

The answer now may be: Yes, billions of taxpayer and private dollars spent on EHRs may be reducing patient safety.

That’s the finding of the independent, nonpartisan Kaiser Health News Service, based on its extensive investigation in partnership with Fortune Magazine. The two media operations reported that:

Kaiserexempt-300x205If a surgical staple gun malfunctioned so seriously that it generated not a few dozen formal complaints but more than 10,000 reported incidents, shouldn’t patients, doctors, and hospitals have the right to know that information from the federal agency overseeing the safety of medical devices?

Apparently not. Or maybe not without a big kick in the pants from journalists.

Instead, the staff at the federal Food and Drug Administration turned a move to ease paperwork and bureaucracy into a giant and little-known system that lets medical device makers hide serious and significant numbers of reports about failures and flaws with at least 100 products, a Kaiser Health News Service investigation found.

dialysis-300x198Diabetics and those with failing kidneys may have gotten a glimmer of relief from the staggering costs of caring for their conditions, as Big Pharma relented a tad with news it will put out a less-costly insulin product and federal officials suggesting Uncle Sam soon may be upsetting the flush profits of the dialysis industry.

DaVita Inc. and Fresenius Medical Care AG run more than 5,000 U.S. dialysis clinics and control around 70 percent of the market, Reuters news service reported in a story describing how Alex Azar, the powerful head of the federal Health and Human Services department, wants “a new payment approach for treating kidney disease that favors lower cost care at home and transplants.”

Why? As Reuters explains, “The goal is to reduce the $114 billion paid by the U.S. government each year to treat chronic kidney disease and end-stage renal disease, a top area of spending.”

davincirobot-300x176The federal Food and Drug Administration finally has pushed back at surgeons and hospitals for experimenting on patients, spending $3 billion a year for surgical robots. The devices should not be used for mastectomies and other cancer-related procedures without caution, regulators warn.

The FDA acted after studies have shown that minimally invasive procedures for early-stage cervical cancer, many robot-aided, were more likely than standard, large-incision surgeries to result in recurrences of the disease and deaths.

Regulators also may have been prodded by their poor history in halting harms to women with so-called keyhole procedures, particularly the nightmares the FDA was slow to react to involving minimally invasive hysterectomies and a tissue-grinding tool called a morcellator.

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