Author Archives: patricewendling

OSHA Denial Roils Resident Work-Hour Reformists

Reaction has been mixed to the Occupational Safety and Health Administration’s recent decision to deny a second petition from the Public Citizen Health Research Group and other groups to have OSHA, rather than the Accreditation Council for Graduate Medical Education, regulate resident/fellow work hours.

The American Medical Association, which had worked to keep ACGME at the helm, applauded OSHA’s decision in a recent statement .

“The ACGME is the appropriate body to regulate and monitor resident duty hours, as it is optimally suited to oversee resident and fellow physician duty hours on behalf of both the profession and the public,” AMA president Dr. Peter Carmel said. “We are pleased that OSHA agrees.”

In denying the petition, OSHA officials wrote that resident duty hour standards are “best addressed within the context of resident training and education,” and that new duty hour standards and enforcement mechanisms that took effect in July 2011 “provide an opportunity for ACGME to take meaningful steps to protect the health of resident physicians within the context of their overall residency experience.”

OSHA officials also noted that federal whistleblowers provisions protect residents and interns who voice concerns related to extended work hours.

Public Citizen fired back in a letter to OSHA that the Obama administration was rehashing “the same discredited Bush-era arguments of nine years ago when our first petition was rejected on almost identical grounds.”

The group went on to say that “OSHA has, once again, opted out of its legal obligation to protect residents from excessive work hours, deferring instead to a largely unaccountable private entity, the ACGME.”

Currently, when a resident reports work-hour violations, they risk retaliation from colleagues and put their training programs at risk for probation and even loss of accreditation, Sonia Lazreg, health justice fellow with the American Medical Student Association, said in an interview.

After the 2003 work rules were implemented, more than 80% of residents reported that their programs were in violation when they could report anonymously to an external body, she said. During the same period, ACGME resident survey reporting suggested that only 3% of programs were in violation.

“Only when we have external enforcement, beyond the ACGME, will we see true implementation of duty hours,” she added.

The AMSA co-petitioned OSHA based on what Lazreg described as overwhelming evidence that current schedules cause an increase in mood disorders, motor vehicle accidents, pregnancy complications and needle-stick injuries among residents. As the federal body tasked with ensuring employee safety and health, she said OSHA has a responsibility to intervene when evidence so strongly points to worker harm.

“OSHA’s denial translates into continued employee risk, injury and death,” Lazreg said.

With so much on the line, it’s unlikely that either side will give ground on this contentious issue any time soon. Notably, OSHA said it had received 15 letters in support of OSHA regulating resident hours and 26 letters in opposition.

 Where do you fit it? Let us know.

By Patrice Wendling

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Filed under Health Policy, IMNG, Polls, Practice Trends

TAVI Trek Begins

It took just two days after the Nov. 2 FDA approval of the Edwards SAPIEN transcatheter aortic valve for New York-Presbyterian Hospital/Columbia University Medical Center to claim bragging rights as the first center in the United States to implant the device as an FDA-approved standard of care.

The center will be one of four sites to train U.S. doctors in the procedure, and is promising to lead a live demonstration tomorrow (Nov. 9) at the annual Transcatheter Cardiovascular Therapeutics symposium in San Francisco for those eager to get a front row view of transcatheter aortic valve implantation (TAVI).

Courtesy Edwards Lifesciences

The FDA approval also put the U.S. in the rare position of following the footsteps of some 40 countries that have already approved the SAPIEN valve including Latvia, Iran, and Russia. This fact elicited a good laugh at the recent Heart Valve Summit 2011 in Chicago, but also prompted much dialogue about some of the thorny ethical and economical consequences that still lay ahead.

“Is anyone at the government talking about rationing of care?” asked Dr. Stephen Strelec, an anesthesiologist at University of Pennsylvania Medical Center, at the summit. It’s not just the 92-year-old who says “I want to live,” but the younger patient facing a valve procedure who decides they don’t want to be on anticoagulants and undergo surgery because they can afford this expensive new transcatheter valve in 2 years. “There’s an economic consequence to that decision as well,” he said.

Dr. Robert Bonow, director of the center for cardiovascular innovation at Northwestern, said the issue is being looked at by federal agencies and insurers, but added that it is “one of the biggest hot-button items about this whole technology because it’s not going to be cheap.”

Dr. David Adams, chair of cardiothoracic surgery at Mount Sinai Medical Center, said they’ve already had their share of 90-year-olds wheeled in from the nursing home by family members who read about TAVI in the newspaper and want mom to stay alive.

The suggestion was made that surgeons and interventional cardiologists will have to hone their skills in making the very specific diagnosis of medical futility, and that a board-certified palliative care physician will be one of the most valuable members of the multidisciplinary teams treating these patients.

“Every PARTNER site looking back over their patients can name patients that they wish they didn’t enroll in the trial and done the valve on,” said Dr. Howard Herrmann, director of interventional cardiology and cardiac catheterization at the Hospital of the University of Pennsylvania. “The question is how to recognize them up front.”

Edwards Lifesciences and the FDA are setting up an intensive training program with simulations, an expert review of cases and a proctoring system. Still, the challenge for Edwards and other companies that will follow will be enormous in terms of launching this technology outside the clinical trial setting, said Dr. Adams, co-principal investigator of Medtronic’s CoreValve trial.

“You can not overestimate the amount of company support you’re going to need to do these things safely,” he said. “This is not a new widget you can pick up in one or two tries like a new ring or new stent…It’s a whole new process.”

The European experience, albeit the initial experience, suggests there’s a distinct learning curve to TAVI. A meta-analysis of 12 TAVI trials presented at this summer’s European Society of Cardiology Congress, reported a flattening of mortality curves 8 years after the first human case in 2002, with procedural mortality decreasing from 16.7% in 2004 to 0.0-0.6% in 2010 and 30-day mortality plummeting from 67% to 11% over the same time period. The authors, led by Dr. Pablo Salinas, University Hospital La Paz, Madrid, credit technical improvements in the devices, better patient selection and on-site case proctoring as helping to shorten the learning curve.

—by Patrice Wendling

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Filed under Cardiovascular Medicine, Drug And Device Safety, Geriatric Medicine, Health Policy, Hospice and Palliative Care, Surgery, Thoracic Surgery

A.W.O.L. in the Hospital

Ask any new parent to part with her baby in the hospital for even a few moments and it’s likely to set in motion a mental high-speed, Guy Ritchie-like montage, complete with squealing tires, deranged abductors, and shadowy baby-sale rings. (Well, it did for me.)

When it comes to why children go A.W.O.L. in the hospital, however, researchers say we want to look a little closer to home.

It turns out that some parents are taking off the ID bands used to keep track of their child in the hospital.

Photos by Patrice Wendling

A learning collaborative of six hospitals found that the overwhelming (90%) reason for pediatric ID band failure was that the band was simply not in place. The most frequent reasons were that it fell off, was taken off by the parent or the patient, or was put on another object such as a crib,  Dr. Shannon Phillips and her co-authors reported at Pediatric Hospital Medicine 2011.

“A lot of times, the patients had been at the hospital for a long time and the parent would say ‘Everyone knows my child’or ‘I’m always here at the bedside,’ co-author Dr. Michele Saysana explained. “Many of the parents were taking [the ID band] off, but when we educated them on the importance of keeping the ID band on, they had a better understanding.”

In addition to family/patient education, the collaborative staged other interventions including educating front-line staff on the importance of correct ID bands as a safety strategy; conducting audits, often by night nursing administrators; and changing to softer ID bands, including luggage tag-type bands in some NICUs.

“In bigger systems with adults, you must have different bands,” said Dr. Saysana, who directs the pediatric hospitalist program at Riley Hospital for Children in Indianapolis. “The one-size-fits-all doesn’t work for the little guys.”

Dr. Michele Saysana

Post-intervention, the collaborative saw a 13% absolute reduction, corresponding to a 77% relative reduction, in pediatric band failures between September 2009 and September 2010. Their goal had been to reduce errors across the collaborative by 50% in 12 months.

The keys to sustaining this kind of success?

“The lessons learned are having leadership be involved, having continuous audits, and just doing education every time you catch something,” she said.

—Patrice Wendling

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Filed under Emergency Medicine, Hospital and Critical Care Medicine, IMNG, Pediatrics

Where did all the disclosures go?

 

Each afternoon, the sound of bagpipes drifted through Chicago’s McCormick Place during this year’s Digestive Disease Week.

Pipes & Drums Chicago P.D., image by Wendling

The idea was for the Chicago Police Department’s Pipes & Drums  to serve as “pied pipers” to draw attention to the daily drawings for everything from a brand new Kindle to a free pass to next year’s DDW plus hotel accommodations, explained Rose Horcher, vice president of client services for the Chicago Convention and Tourism Bureau .

Since attendees had to get stickers from 10 different exhibitors before they could put their entry into the giant gold raffle drum, it seemed to have a lot more to do with drumming up exhibit attendance, but I won’t quibble.

The gimmick worked.

Each afternoon, attendees followed the pipers through the exhibit hall, weaving their way round the book stands, past the giant inflated green stomach exhibit and by the instrument table with signs reading “cheap” and “really cheap” scopes.  (Yes, they really said that.)

Some attendees struck a more patriotic note, requesting the National Anthem in honor of Team Six. Even jaded reporters were heard asking about the mysterious, midafternoon melodies.

As the meeting wore on, I couldn’t help but wish for a little assistance from the boys in blue in tracking down which of the very same exhibitors had a hand in the cutting-edge research I was hearing.

Meeting policy required that financial relationships for all individuals with the ability to affect the content of an educational activity be disclosed to the audience.

The financial disclosures were generated by Freeman AV and automatically displayed as the first slide for 6 seconds in the session room before going into the presentation, DDW program manager Crystal Young said in an interview.

I may have been the second to last kid in third grade to learn to tell time properly, but 6 seconds, it was not. Blink and those disclosures were gone.

Even more worrisome was that many of the presentations simply stated that while the lead author had no disclosures, the coauthors did. You just weren’t told what they were.

A line on the screen stated only: “Please visit www.ddw.org to view all DDW speaker disclosures.”

Any journalist worth their salt did just that, but what about the attendees?

Are they really going to go back home and dig up the disclosures before sharing what they’ve learned with their colleagues? The online resource certainly doesn’t make it easy. Coauthors have to be looked up individually by their last names since no single search by abstract number is possible.

Disclosing relevant financial relationships up front provides context for the potentially practice-changing data the physicians are about to hear. If an author or coauthor is an employee or board member of the study sponsor, the physician should know that. If the analyses were conducted by the device or drugmaker, that should be out there, too.

Image courtesy of Wikimedia in the public domain

 

 

Without it, the Pied Piper has a much better chance of leading us astray. 

By Patrice Wendling

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Filed under Family Medicine, Gastroenterology, IMNG, Internal Medicine

Seeing Red: Heart Disease and Women

The Red Dress Campaign has caught women’s attention regarding the very real dangers of cardiovascular disease, but a new study shows they may not be taking the message to heart.

Photo courtesy of The Heart Truth®, NHLBI, NIH

The study, presented at the recent American College of Cardiology meeting, found that the overall incidence of acute MI decreased among 315,246 patients admitted to New Jersey hospitals 1986-2007. The decrease was significant among both men and women, but was more prominent among men.

The incidence of acute MI fell from 598 to 311 per 100,000 men and from 321 to 197 per 100,000 women, according to cardiologist Dr. Liliana Cohen and her colleagues at the Robert Wood Johnson Medical School in New Brunswick, N.J. They also identified a growing gap in the rates of left heart catheterization and percutaneous coronary intervention between men and women.

The rates of catheterization increased fivefold in women and threefold in men over the 22-year study period, but the likelihood of catheterization remained lower for women. Moreover, the difference among male and female cath patients going on to receive PCI increased from 2.2% in 1986 to 9.4% in 2007.

Finally, both in-hospital and 1-year mortality remained higher among women, and failed to show a significant decrease after 2002 – the year the National Heart Lung and Blood Institute launched the Red Dress campaign.

“Although awareness of cardiovascular disease in women has increased in the general population, there has been much less translation of this into clinical practice,” Dr. Cohen told me.

This may be due to women presenting later because they doubt an MI can happen to them or that physicians still are not treating women as aggressively as they treat men, she said. It also may relate to the fact that women have more difficult cardiac anatomy, so that once they receive cardiac cath, PCI remains difficult.

Photo courtesy of The Heart Truth®, NHLBI, NIH

Dr. Cohen suggests that in its next phase, the campaign needs to continue to focus on public health awareness, but also on research into how to translate public awareness into clinical practice by focusing on physicians and into newer techniques of PCI for the smaller blood vessels in women.

Quibble if you will about the generalizability of data from a single state or the potential impact of a single PR campaign, but it’s hard to ignore these disappointing outcomes.

I once heard a bold and blistering guest lecture at a cancer meeting by Nancy Goodman Brinker, founder and CEO of Susan G. Komen for the Cure, who told several thousand — mostly male — oncologists that a survival rate topping 90% for early stage breast cancer simply wasn’t good enough.  Truer words were never spoken.

— Patrice Wendling

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Filed under Cardiovascular Medicine, IMNG, Internal Medicine, Surgery, Thoracic Surgery

Survival of the Abstinent Teen

Image courtesy of Wikimedia Creative Commons

Having a daughter who’s a “band nerd” may be music to a parent’s ear in more ways than one.

A new survey of 282 adolescent girls aged 12-21 reports that participation in band is significantly associated with current sexual abstinence.

The researchers came to the project with high hopes that potentially intervenable factors such as higher academic achievement, greater involvement in activities, and open family communication about sexual activity would be positively associated with abstinence.

That didn’t really play out, author and fourth-year medical student Kathryn Squires said at the recent meeting of the North American Society for Pediatric and Adolescent Gynecology.

There was no difference in GPA, involvement in sports, or most curricular and non-school-related activities between sexually active and abstinent teens.

Sexual activity, however, was associated with the typical risk factors of age of at least 18 years, having a job, having an increased number of boyfriends or an older recent boyfriend, and risky peer behaviors.

Positive influences on abstinence in all age groups were: participation in band, participation in school clubs, having abstinent friends, and personal and peer avoidance of alcohol and drugs, reported Ms. Squires and her colleagues at Washington University in St. Louis.

So what is it about band that helps adolescents elect to remain sexually abstinent?

Was the study group somehow unique? Not likely. When surveyed during 2008-2009 at a scheduled gynecologic visit with her parent present, 68% of participants reported being abstinent. This falls roughly in line with the 2009 Youth Risk Behavior Surveillance Survey, in which 46% of high school females reported ever being sexually active.

Is it the music? Not likely. Marching bands, like the one at the University of Michigan, are side-stepping the likes of John Philip Sousa today in favor of such hipsters as Lady Gaga.

Is it the geek factor?

“We had a lot of other what could probably be considered geeky things on there, like the newspaper, and those didn’t seem to make a difference,” Ms. Squires said. (I take umbrage at this remark, but then I grew up thinking Woodward & Bernstein were cool.)

“Maybe band is just more involved, but then sports are more involved too, as far as practices. So I don’t think it’s the time commitment.”

Having had any number of band nerds in our house over the years, I asked my two college daughters about the finding. After the giggling stopped, they suggested that band members, quite simply, are a very tight-knit group of kids. I wouldn’t assign a P value to this anecdotal info, but there’s something to be said for having a posse of friends to turn to when an adolescent considers taking that first step toward sex.

For physicians disinclined to advise parents to push their kids towards the tuba or trombone, Ms. Squires points out that ages 15-17 appear to be a critical period in which teens value their parents’ opinion the most, and it makes the most difference in delaying sexual initiation. “So that might be a good time for parental involvement or a medical intervention,” she said.

That said, I’m not so sure there’s ever a bad time for parental involvement, but then I didn’t ask my girls about that.

By Patrice Wendling

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Filed under Family Medicine, IMNG, Obstetrics and Gynecology, Pediatrics, Primary care

Fort Hood Shooting: A Cautionary Tale for Tucson

    I don’t care how many special news reports I see or read on the shootings in Tucson, I’m convinced we won’t fully understand what happened there for months, if ever. What we can be certain of is that more mass casualties will occur and that there will be missteps by both medical and journalism professionals.

I say this because of a recent post-mortem I heard on the November 2009 shootings at Fort Hood, where in a span of roughly 10 minutes, 32 people were injured and 10 died. Ultimately, 13 individuals lost their lives in that tragedy.

In the rush to report the news, two news helicopters hovered over the Scott & White Hospital, located 30 miles from Fort Hood, and the only level I trauma center in the area. The FAA was called in to clear the airspace, but not before the helicopters interfered with the transport of patients.

Back in Atlanta, CNN broadcast the Scott & White command center referral line, and over a 1-hour period, the hospital received 1,300 phone calls, which “essentially crippled our phone systems,” Dr. Jeff Wild, a surgical resident at that hospital, told his colleagues at the Western Surgical Association meeting.

The overload meant that Darnall Army Hospital in Fort Hood and nearby Metroplex Hospital, both of which were receiving shooting victims, couldn’t reach staff. Communication problems ultimately led to the transfer of two patients from Metroplex to an out-of-region hospital.

Triage was minimally organized and patients were maldistributed, with the closer facilities becoming saturated with shooting victims, he said. Darnall Army Hospital, a level III hospital, evaluated 27 patients and performed five operations on 4 patients, with one death. Scott & White prepared 6 trauma bays, made 16 of its 24 ORs available and posted one trauma surgeon in the OR and another in the ED, which proved invaluable in triaging patients, noted Dr. Wild. Over roughly a 2-hour period, they received 10 patients, of which five were taken urgently to the OR. Metroplex, which had only one emergency department physician and two general surgeons in the level IV facility at the time, received seven patients, including a civilian police officer who helped take down the perpetrator, and had no deaths. “I think we’re quite lucky that none of the patients transferred here had any adverse events,” he said.

I was beginning to squirm in my seat at this point, until Dr. Wild acknowledged the hospitals had alternative means of communication. The only problem was that personnel didn’t know how to properly work the radios and Web-based computer program.

Security was also an issue for the hospital. The alleged perpetrator, psychiatrist Maj. Nidal Hasan, was in the same ICU as six of his shooting victims and their families. The hospital elected to move Hasan to an isolated OR that served as his ICU until he was transported out of the hospital.

Since the shootings, Scott & White has hosted several disaster drills that included the army hospital, which had not been done before, Dr. Wild reported on behalf of senior author Dr. Randall Smith, Scott & White interim chief of trauma, critical and acute care surgery. Staff has been educated on various communication pathways, and twice a month, all the hospitals and EMS agencies in the area talk on the radios to make sure they’re working properly and that staff knows how to use them.

“Scott and White hospital has taken part in four mass casualty events in the past 25 years and, although these are considered somewhat a rarity, they seem to be more commonplace,” Dr. Wild said. “And if you haven’t already, it’s very likely a lot of you will take part in one of these events over your careers.”

From my own perspective, I just hope everyone knows the drill, including my colleagues at the mic.

  Patrice Wendling (on Twitter @pwendl)

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Filed under Emergency Medicine, Hospital and Critical Care Medicine, IMNG, Surgery, Thoracic Surgery