A small study by researchers at The Ohio State University Wexner Medical Center found that a workplace mindfulness-based intervention reduced stress levels of employees exposed to a highly stressful occupational environment, according to a news release.
Members of a surgical ICU at the academic medical center were randomized to a stress-reduction intervention or a control group. The eight-week group intervention included mindfulness, gentle stretching, yoga, meditation and music therapy in the workplace. Psychological and biological markers of stress were measured one week before and one week after the intervention to see if these coping strategies would help reduce stress and burnout among participants.
Results of this study, published in the April 2015 issue of Journal of Occupational and Environmental Medicine, showed levels of the chemical salivary alpha amylase, were significantly decreased from the first to second assessments in the intervention group. The control group showed no changes. Chronic stress and stress reactivity have been found associated with increased levels of salivary alpha amylase, according to the release. Psychological components of stress and burnout were measured using well-established self-report questionnaires. “Our study shows that this type of mindfulness-based intervention in the workplace could decrease stress levels and the risk of burnout,” one of the study’s authors, Maryanna Klatt, PhD, associate clinical professor in the department of family medicine at Ohio State’s Wexner Medical Center, said in the release. “What’s stressful about the work environment is never going to change. But what we were interested in changing was the nursing personnel’s reaction to those stresses.”
Klatt said salivary alpha amylase, which is a biomarker of the sympathetic nervous system activation, was reduced by 40% in the intervention group.
Klatt, who is a trained mindfulness and certified yoga instructor, developed and led the mindfulness-based intervention for 32 participants in the workplace setting. At baseline, participants scored the level of stress of their work at 7.15 on a scale of 1 to 10, with 10 being the most stressful. The levels of work stress did not change between the first and second set of assessments, but their reaction to the work stress did change, according to the release.
When stress is part of the work environment, it is often difficult to control and can negatively affect employees’ health and ability to function, lead author Anne-Marie Duchemin, PhD, research scientist and associate professor adjunct in the department of psychiatry and behavioral health at Ohio State’s Wexner Medical Center, said in the release. “People who are subjected to chronic stress often will exhibit symptoms of irritability, nervousness, feeling overwhelmed; have difficulty concentrating or remembering; or having changes in appetite, sleep, heart rate and blood pressure,” Duchemin said ih the release. “Although work-related stress often cannot be eliminated, effective coping strategies may help decrease its harmful effects.”
The study was funded in part by the OSU Harding Behavioral Health Stress, Trauma and Resilience Program, part of Ohio State’s Neurological Institute.
Gary Morley and Lisa Cohen
Every time she competes in a race, she knows she'll collapse in a sobbing heap at the finish line.
Unable to feel her legs, she'll crumple into the arms of her athletics coaches. Ice-cold water will be applied to calm the misfiring nerve fibers blazing beneath her numb skin.
The teenager has gone through this post-race trauma for the past five years since being diagnosed with multiple sclerosis.
"Every day that I run, it might be my last day -- I could easily wake up tomorrow and not be able to move," the 19-year-old American tells CNN's Human to Hero series.
"My initial MS attack caused lesions and scarring on my brain and my spine that affects the areas that are in control of how I feel my legs. So when I am overheated the symptoms reappear because my neurones start misfiring more.
"You can never really get used to the lack of feeling and the change of sensation, no matter how long you go through it. Every time it is still a bit of a shock and it's scary -- it freaks me out a little bit."
After five to 10 minutes she's able to get back on her feet again and start walking around, albeit a little stiffly as feeling slowly returns to her lower body.
It sounds like a nightmare ordeal that would put anyone off an athletics career, but Montgomery is determined to pursue her running dream.
She's actually faster now than before her diagnosis -- which, she says, was a painfully long and uncertain process following an accident playing soccer, falling hard on her neck and tailbone.
"It was really scary. I was so young. Most people with MS aren't diagnosed until their mid to late 20s, 30s. There wasn't anybody my age to relate to and understand what I was going through," she recalls.
"It took so long to get back results and we were ruling things out and leaving MS as the last option. For a while they thought maybe it was cancer."
When the diagnosis finally came, it sent Montgomery into a spiral of anger, depression and denial.
She avoided confronting the issue with her parents -- Keith, a salesman, and mom Alysia, recently qualified as a nurse -- and younger sister Courtney.
"I tried to pretend I wasn't sick or anything -- I wanted to go on with life as normal as possible," Kayla says.
"Nobody at school knew, and we were not allowed to talk about it at home. I just avoided it at all costs, and that actually made it a lot harder.
"The first couple of years after my diagnosis were impossibly hard -- I was so alone and still really scared. It was definitely a darker time in my life."
Running has proved to be her salvation. After a short break, in which she received treatment that made the numbness temporary, Montgomery decided she was going to make use of her legs while she still could -- despite knowing that exertion would bring back the symptoms.
"I wasn't amazing by any means but I was eighth on the team, so if somebody got hurt then I was there! And I wanted to be there if they needed me, so I trained so hard all the time and that definitely helped to deal with the things I wouldn't talk about," she says.
Montgomery's determination to succeed won her the North Carolina high school state title in the 3,200 meters last year, as she ran the 21st fastest time in the U.S.
She was team captain at Mount Tabor High School, setting several age-group records, and also excelled off the track in cross-country.
Now a freshman on an athletics scholarship at Nashville's Lipscomb University, she is studying molecular biology and has dreams of becoming a forensic scientist.
But before a career in CSI beckons, Montgomery is making the most of her chance to run for the college team.
"Racing is one of the greatest feelings in the world. I love it," she says.
"Long-distance running is my favorite ... you have to have so much stamina, strength and determination. I like to push myself to my limits for as long as I can."
One of the big challenges is staying on her feet during a race. If she gets knocked over or falls, which sometimes happens, then it's difficult to get up again -- especially in the later stages.
"If it is a track meet you can't grab on to something, whereas cross country there might be a tree close by that you can pull yourself up on," Montgomery explains.
"It all depends on when I fall as to how it will affect the outcome of my race."
Montgomery trains three hours a day, six days a week, covering 60-75 miles.
Without being able to judge pace through her legs, she has learned a new way to run, by focusing on the movement of her arms.
The hard work is paying off. Lipscomb is a Division One university in NCAA competitions, giving her an elite platform on which to impress.
It's a long way from those early high-school days when she asked her coach, mentor and "second father" Patrick Cromwell about her chances of running at college level.
"He said, 'I don't know, you might be lucky if you can be a walk-on.' I was like, 'Well I'll show you, I'm going to run in college and not only that I'm going to run for a D1 school.' And I am!
"Lipscomb is one of the best, it's really awesome to achieve that once really far-fetched dream."
Montgomery was actively recruited by Lipscomb, the first school to contact her -- others also rang "but a lot of them never called back" after she explained her condition.
"They made me feel so welcome," she says of her first visit to Lipscomb's campus. "They all knew my situation and it didn't bother them, and they didn't acknowledge it or ignore it either. It was exactly what I was looking for."
Her debut collegiate cross-country season was a steep learning curve, but Montgomery helped Lipscomb win a fourth successive conference championship in November, placing 13th overall and seventh in her team in the 5 km race.
On the track, she was sixth in the 10,000 meters last weekend as Lipscomb's women's team finished third at the Atlantic Sun championships in Florida, its best result at the event -- and a continuation of its rapid improvement since Bill Taylor, who recruited Montgomery, took over the athletics program in 2007.
She says the coach has given her the confidence to keep pushing herself, having taken a chance on her even though he realizes she may not be able to fulfill the four years of her scholarship if her condition gets worse.
"I keep running because it makes me happy," Montgomery says. "It makes me feel whole and safe, just because I know as long as I am running and still moving, I am still OK."
While studying to become a paralegal and working as a temp, Symphonie Dawson kept feeling sick. She found out it was because she was pregnant.
Living with her mom and two siblings near Dallas, Dawson, then 23, worried about what to expect during pregnancy and what giving birth would be like. She also didn't know how she would juggle having a baby with being in school.
At a prenatal visit she learned about a group that offers help for first-time mothers-to-be called the Nurse-Family Partnership. A registered nurse named Ashley Bradley began to visit Dawson at home every week to talk with her about her hopes and fears about pregnancy and parenthood.
Bradley helped Dawson sign up for the Women, Infants and Children Program, which provides nutritional assistance to low-income pregnant women and children. They talked about what to expect every month during pregnancy and watched videos about giving birth. After her son Andrew was born in December 2013, Bradley helped Dawson figure out how to manage her time so she wouldn't fall behind at school.
Dawson graduated with a bachelor's degree in early May. She's looking forward to spending time with Andrew and finding a paralegal job. She and Andrew's father recently became engaged.
Ashley Bradley will keep visiting Dawson until Andrew turns 2.
"Ashley's always been such a great help," Dawson says. "Whenever I have a question like what he should be doing at this age, she has the answers."
Home-visiting programs that help low-income, first-time mothers have been around for decades. Lately, however, they're attracting new fans. They appeal to people of all political stripes because the good ones manage to help families improve their lives and reduce government spending at the same time.
In 2010, the Affordable Care Act created the Maternal, Infant and Early Childhood Home Visiting program and provided $1.5 billion in funding for evidence-based home visits. As a result, there are now 17 home visiting models approved by the Department of Health and Human Services, and Congress reauthorized the program in April with $800 million for the next two years.
The Nurse-Family Partnership that helped Dawson is one of the largest and best-studied programs. Decades of research into how families fare after participating in it have documented reductions in the use of social programs such as Medicaid and food stamps, reductions in child abuse and neglect, better pregnancy outcomes for mothers and better language development and academic performance by their children.
"Seeing follow-up studies 15 years out with enduring outcomes, that's what really gave policymakers comfort," says Karen Howard, vice president for early childhood policy at First Focus, an advocacy group.
But others say the requirements for evidence-based programs are too lenient, and that only a handful of the approved models have as strong a track record as that of the Nurse-Family Partnership.
"If the evidence requirement stays as it is, almost any program will be able to qualify," says Jon Baron, vice president for of evidence-based policy at the Laura and John Arnold Foundation, which supports initiatives that encourage policymakers to make decisions based on data and other reliable evidence. "It threatens to derail the program."
By AnneClaire Stapleton
"I had my own personal tanning bed in my home, and so did a lot of my friends growing up. ... Everyone tanned," Willoughby said. "I didn't really even think about the future or skin cancer at the time."
After one of her classmates in nursing school was diagnosed with melanoma, Willoughby made her first dermatology appointment at age 21. Sure enough, she had skin cancer.
Now 27, Willoughby says she has had basal cell carcinoma five times and squamous cell carcinoma once. She goes to the dermatologist every six to 12 months and usually has a cancerous piece of skin removed at each checkup.
She's become a cautionary tale about the hazards of tanning beds, thanks to a selfie she posted last month on Facebook. The grisly image, taken after one of her cancer treatments, shows her face covered with bloody scabs and blisters. It's since been shared almost 50,000 times.
"If anyone needs a little motivation to not lay in the tanning bed and sun here ya go! This is what skin cancer treatment can look like," she wrote in a post along with the photo. "Wear sunscreen and get a spray tan. You only get one skin and you should take care of it."
One in five Americans will develop skin cancer in their lifetime, according to the American Academy of Dermatology. Exposure to tanning beds increases the risk of melanoma, the deadliest form of skin cancer, said the academy, which reports that more than 419,000 cases of skin cancer in the U.S. each year are linked to indoor tanning.
Melanoma is the most common form of cancer for adults 25-29 years old and the second-most common form of cancer for adolescents and young adults 15-29 years old, according to the academy. Warning signs include changes in size, shape or color of a mole or other lesion, the appearance of a new growth on the skin or a sore that doesn't heal.
Risk factors for all types of skin cancer include skin that burns easily, blond or red hair and a history of excessive sun exposure, including sunburns and tanning-bed use -- dangers that the blonde, blue-eyed Willoughby now knows all too well.
Willoughby, a registered nurse who now lives in northern Alabama, said she never expected the Facebook picture of her damaged face to go viral.
But she's excited to think her story might save someone's life.
"I've lost count of how many people shared it now and told me I've helped them," she said. "It's really cool to hear people say they won't tan anymore. I've had mothers thank me after sharing my pictures with their daughters. People in my hometown said they are selling their tanning beds.
"I never thought about the future when I was in high school; I just tanned because it was normal to me."
Willoughby knows she'll deal with the consequences of tanning for the rest of her life. She's at high risk for developing melanoma but is now doing everything she can to ensure that she's around for her husband, Cody, and their young son, Kayden, for years to come.
"Learn from other people's mistakes," she wrote on Facebook. "Don't let tanning prevent you from seeing your children grow up. That's my biggest fear now that I have a two-year-old little boy of my own."
BY MAGGIE FOX
Hospital workers wash their hands hundreds of times a day. Nurses are constantly using alcohol gels, chemical wipes and iodine washes on themselves and on patients.
Now that there's a hand sanitizer dispenser at every hospital room door, it's time to check that they actually do work as well as everyone assumes and that they are safe, the Food and Drug Administration says.
Up until now, FDA's just accepted that these products work as intended and are safe. But now, FDA says, there are tests available to actually prove they do. And because of the emphasis on hospital infections, institutions are using the products far more frequently than even 10 years ago and in many different ways.
So FDA issued a proposed plan Thursday for reclassifying some of the products, and for requiring makers to show they are safe and effective.
"We're not asking for any of these products to come off the market at this time."
In the meantime. FDA says, there's nothing for consumers to worry about and hospitals should continue using the products as they have been.
"What it seems they are doing is good due diligence," says Dr. Susan Dolan of Children's Hospital Colorado and the Association of Professionals in Infection Control.
"They are trying to look at the products, look at how they are being used today, how things have changed," she added.
The FDA proposes new rules making companies submit new studies looking at safety issues such as whether heavy, chronic use of the some of the products may cause them to soak in through the skin, or cause resistant bacteria to evolve.
Products that are not shown to be safe and effective by 2018 would have to be reformulated or taken off the market.
"We're not asking for any of these products to come off the market at this time. We're just asking for additional data," Theresa Michele, a director in FDA's drug center, said in an interview with The Associated Press. "And we're likewise not suggesting that people stop using these products."
Alcohol, iodine benzalkonium chloride and other germ-killers have been used for decades. But not to the degree that they are now.
"Twenty years ago you didn't find people using antiseptic gels 100 times a day. It just didn't happen," Michele said.
FDA points to studies that show some of the products might be absorbed into the body at higher levels than previously thought, showing up in blood and urine. Dolan says not all the studies show this, but it's worthwhile doing more checks.
"It's timely and it makes sense," Dolan said. "I do think consumers should not be worried. These are very effective products."
The FDA last updated its review of health care hand cleaners in 1994.
"They are trying to look at the products, look at how they are being used today, how things have changed."
"We emphasize that our proposal for more safety and effectiveness data for health care antiseptic active ingredients does not mean that we believe that health care antiseptic products containing these ingredients are ineffective or unsafe, or that their use should be discontinued," FDA said in its announcement.
The agency agreed to complete its review after a three-year legal battle with the Natural Resources Defense Council, an environmental group that accused the FDA of delaying action on potentially dangerous chemicals. In 2013 the FDA agreed to a legal settlement that included timetables for completing the review of various chemicals, including health care cleaners.
Environmentalists are mainly concerned about an ingredient called triclosan, which is used in most antibacterial soaps marketed to consumers. The agency issued a separate review of triclosan-containing consumer products in late 2013, saying more data are needed to establish their safety and effectiveness.
Written by Honor Whiteman
Infants born preterm are known to be at greater risk for neurodevelopmental disorders. Now, a new study by researchers from King's College London in the UK brings us closer to understanding why - premature birth reduces connectivity in brain regions linked to cognitive functioning.
First author Dr. Hilary Toulmin, of the Centre for the Developing Brain at King's College, and colleagues publish their findings in the Proceedings of the National Academy of Sciences.
Preterm birth - defined as the birth of an infant before 37 weeks gestation - affected more than 450,000 babies in the US in 2012.
It is a leading cause of neurological disability among children in the US. Babies born preterm are at higher risk of cerebral palsy, autism and attention-deficit hyperactivity disorder (ADHD), among other intellectual and developmental conditions.
For their study, Dr. Toulmin and colleagues set out to gain a better understanding of the brain connectivity among babies born preterm in an attempt to uncover clues as to why preterm babies are more likely to develop neurodevelopmental problems.
The researchers used functional magnetic resonance imaging (fMRI) to analyze the connectivity between two specific brain regions - the thalamus and the cortex - among 66 infants. Of these, 47 were born prior to 33 weeks gestation and 19 were born at full term - between 37 and 42 weeks gestation.
The team says they focused on the connectivity between the thalamus and the cortex because these are the brain connections that develop quickly during preterm infants' care in neonatal units.
Preemies showed reduced connectivity in brain area linked to higher cognitive functioning
Among the babies born at full term, the researchers found the connectivity between the thalamus and the cortex was very similar to that of adults, which the researchers say supports previous findings that infants are born with mature brain connections.
Among the preterm infants, however, the team identified reduced connectivity between areas of the thalamus and areas of the cortex associated with higher cognitive function. This may explain why preterm babies are at greater risk of neurodevelopmental problems later in childhood, say the researchers.
What is more, brain scans of the preterm infants revealed increased connectivity between the thalamus and an area of the primary sensory cortex that plays a role in processing signals from the face, lips, jaw, tongue and throat.
Preterm infants' earlier exposure to breastfeeding and bottle feeding may explain this finding, according to the team.
The team says the earlier a preterm baby was born, the more pronounced the differences were in brain connectivity.
Overall, the team believes their findings bring us a step closer to understanding why infants born preterm are at higher risk of neurodevelopmental problems.
Senior author Prof. David Edwards, also of the Centre for the Developing Brain at King's College, says modern science has allowed the team to assess brain connectivity among preterm infants - something he says would have been "inconceivable" only a few years ago.
"We are now able to observe brain development in babies as they grow, and this is likely to produce remarkable benefits for medicine," he adds.
Dr. Toulmin says the next steps from this research will be to gain a better understanding of how their findings are associated with learning and developmental problems among preterm children as they get older.
Over the last week, Baltimore's unrest has captured the nation's attention. Images of burning cars, the sounds of angry protesters and then peace rallies have dominated the airwaves and headlines.
As the city's health commissioner, I heard other stories. I spoke with a 62-year-old woman who had a heart attack a year ago and who had stopped taking her blood pressure and blood-thinning medications. Her pharmacy was one of the dozen that burned down, and neither she nor the other people in her senior housing building could figure out where to get their prescriptions filled. Her pills ran out two days before, and she'd planned to hold out until the pharmacy reopened.
A 55-year-old man called our health department. His mother was "stringing out" her inhalers and now had a cough and difficulty breathing. He also told us he had difficult-to-control diabetes and was using insulin every other day. He now was urinating frequently and reported blurry vision — symptoms of out-of-control diabetes. We called an ambulance to transport them both to the ER.
In the wake of fires and violence, the initial priority for health officials was to make sure that our acute care hospitals were protected and that staff and patients could get to them safely. In the immediate aftermath, our focus was on ensuring that injured patients got triaged and treated.
Nobody knew what lay ahead and how much more violence was to be expected. We worked with hospitals, the Fire Department, and other city and state partners to develop a hospital security plan and to convene daily phone calls with every hospital and health clinic.
As the days went on, we heard from more Baltimoreans. These were not the ones waving signs or appearing on national TV. These were people who were just trying to get by.
There was a 74-year-old woman who had abdominal pain for two days. She stayed in her apartment and put up with the pain rather than seeking care, because she thought she'd heard that her health center was closed. A middle-aged couple worried about their 22-year old son who was suffering from a manic episode. They didn't know who was available to help.
Our health department, under the leadership of Mayor Rawlings-Blake, worked with the Maryland health department and private partners around the city and state to provide these essential services. We set up the Baltimore Healthcare Access List to provide up-to-date and accurate information about closures and hours of operation for hospitals, clinics and pharmacies. We developed and implemented a Mental Health/Recovery Plan that included an around-the-clock mental health crisis line along with teams of licensed mental health professionals who were deployed in affected neighborhoods for group counseling and debriefing.
Things that seemed straightforward often were not. Transferring prescriptions from one pharmacy to another would seem easy. But what happens if the pharmacies are in different chains, or if the one that closed was an independent pharmacy where all records were destroyed? The nearest pharmacy may be just a few blocks away, but what if the patient has limited mobility and even a few blocks are prohibitive?
And, as we saw, what happens when the best-laid plans aren't known to residents? We arranged for individuals affected by pharmacy closures to call one central number — 311. Our health department team would then take care of the rest on a case-by-case basis, arranging for prescription transfers, transportation and medication delivery.
Amid all the news, our public health information wasn't getting through to all our community members. So we mobilized student volunteers from Johns Hopkins and other local universities to go door-to-door in all senior buildings in affected neighborhoods. We visited over 30 churches and knocked on hundreds of doors.
It is now a week after the initial wave of violence and unrest. Our city is quieter, but our work is nowhere near done. As we look to rebuilding and recovery, our efforts must be focused on addressing the needs of all those affected, including the ones whose stories we don't usually hear.
By FREIDA FRISARO
One morning last summer, Tony Smith slipped a multicolor tutu over his scrubs in the pre-op ward of a South Florida hospital to grant the wish of a young patient heading to surgery.
A photo of the tutu-clad Smith quickly became a hit online and within weeks, Tutu Tuesday was born at Joe DiMaggio Children's Hospital.
"That day, it was all about making a patient feel comfortable. Having me put on the tutu made her feel better," said Smith, an operating room assistant who has worked at the Hollywood, Florida, hospital for almost five years. "I never knew I would have that much impact. I didn't expect it to go viral."
But it did. Once employees saw the shot, they started asking Lotsy Dotsy — resident clown and unofficial keeper of the tutu — for their own frilly skirts to wear. Department by department, hospital staff adopted Tutu Tuesday.
It begins outside the hospital named for a baseball legend, where visitors are greeted by a valet whose tutu clashes with his normal uniform — shorts and a baseball jersey.
"People laugh and ask why I'm wearing a skirt," said John Aristizabal, who takes good-natured kidding as he parks cars. "It's all for the kids, to catch a smile."
On Tutu Tuesday, smiles are contagious.
Inside the hospital, tutus are everywhere. Doctors, nurses, technicians and receptionists don the colorful layers of tulle, decorated with polka dots and fancy bows as they go about the business of tending to patients. Even Nutmeg, the in-house therapy dog, has a specially designed pink tutu. Hospital administrators also play along, wearing tutus over their business suits.
Smith said he could have never imagined that such a simple act would catch on.
"It's for the patients," Smith said. "Just seeing you in a tutu brightens their day, and it can keep them from thinking about what's really going on."
That's exactly what pediatric anesthesiologist Dr. Bob Kaye has been doing for years. He's worn a variety of funny hats and wigs to help ease the fears of his young patients. Now he's added a tutu to his routine and has found that his patients and their parents like the distraction.
"If you can dress in a way that it not threatening and silly, maybe, and make the medical professional look not like the last person who gave them a shot in the doctor's office, then it's a lot easier to feel comfortable with them," he said. "I think it's an ice breaker."
On a Tuesday morning in March, Laurel Barnett and her 13-year-old daughter Julia arrived about 5:45 a.m. for surgery.
"Of course, not having any coffee and then coming in and seeing everyone in tutus is quite amusing," Barnett said. "It's not what you expected to see. It does give children a sense of relief that these people are not only here to help them, but there to have fun as well. It kind of takes their mind off of things."
Smith says he's not bothered at all by the stares and giggles as he makes his way through the hospital's corridors every Tuesday. He even offered his tutu to 12-year-old Brayden Wilmsmeyer, who along with his 10-year twin sisters Leah and Lexi spent spring break getting respiratory treatment at Joe DiMaggio.
The twins had borrowed tutus from two nurses for an impromptu photo session.
"Remember, you are a real man," Smith told Brayden as he pulled the tutu over his pants. "Don't let anyone tell you otherwise just because you're wearing a tutu."
After roughly 40 years, U.S. health regulators are seeking data to see if the cocktail of ingredients in antiseptics used in hospitals, clinics and nursing homes are as safe and effective as they were once considered.
The Food and Drug Administration said on Thursday it is asking manufacturers for more data, including on absorption, potential hormonal effects and bacterial resistance of thehe 'active' ingredients in antiseptics, to see if they are still appropriate for use in a health care setting.
Since the review of health care antiseptics in the 1970s, things have changed, the FDA noted, alluding to a shift in frequency of use, hospitals' infection control practices, technology and safety standards. (1.usa.gov/1EUrzCd)
An independent panel of experts to the FDA raised similar concerns last year. In 2013, the regulator issued a warning to manufacturers, saying it was aware of at least four deaths and multiple infections caused by over-the-counter antiseptics. (1.usa.gov/1DNxOSp)
Commonly used active ingredients in health care antiseptics include alcohol and iodine. Data suggests that, for at least some of these ingredients, the systemic exposure is higher than previously thought, the agency noted.
"We're going to try to answer their questions in great detail as called for, but we believe the FDA already has sufficient data on these products," said Brian Sansoni, a spokesman for American Cleaning Institute (ACI), a trade association for the cleaning products industry.
The ACI represents antiseptic ingredient and product makers such as Gojo Industries Inc, the maker of Purell hand sanitizers; Dial Corp, a unit of Germany's Henkel (HNKG_p.DE); Ecolab Inc and Steris Corp.
The FDA said no health care antiseptics were going to be pulled off shelves as of now, and that their review excluded home-use antiseptics such as antibacterial soap and hand sanitizers.
The new data request relates only to health care antiseptics covered by the over-the-counter monograph, a kind of "recipe book" covering acceptable ingredients, doses, formulations and labeling. Once a final monograph is implemented, companies can market their product without having to go through the FDA.
Companies will have one year to submit the data, which the FDA will evaluate before determining if the OTC monograph needs to be revised.
"We're concerned if the FDA takes maybe a too narrow view regarding the safety and effectiveness data – depending how the final rule ends up – they could take effective products or ingredients off the shelves," Sansoni said.
Alexandra Wilson Pecci
Hospitals have a broader responsibility to elderly trauma patients than just the time spent within their walls, and should consider updating their strategies to ensure the best outcomes for these patients, research suggests.
Elderly trauma patients are increasingly likely to be discharged to skilled nursing facilities, rather than inpatient rehabilitation facilities (IRF), finds a study in The Journal of Trauma and Acute Care Surgery published in the April issue.
Discharge to skilled nursing facilities for trauma patients has, however, been associated with higher mortality compared with discharge to inpatient rehabilitation facilities or home.
Researchers wanted to "better characterize trends in trauma discharges and compare them with a population that is equally dependent on post-discharge rehabilitation." They not only examined trauma discharges, but also discharges of stroke patients, who have been taking up more inpatient rehabilitation facility beds.
Using data from 2003–2009 data from the National Trauma Data Bank and National Inpatient Sample, the retrospective cohort study found that elderly trauma patients were 34% more likely to be discharged to a skilled nursing facility and 36% less likely to be discharged to an inpatient rehabilitation facility. By comparison, stroke patients were 78% more likely to be discharged to an inpatient rehabilitation facility.
This is despite the findings of a 2011 JAMA study of patients in Washington State showing that "Discharge to a skilled nursing facility at any age following trauma admission was associated with a higher risk of subsequent mortality."
The Journal of Trauma and Acute Care Surgery study notes that "elderly trauma patients are the fastest-growing trauma population," which leads to the question: Where should hospitals be investing their money and time to ensure the best outcomes for these patients?
"I think hospitals should be investing in post-acute care discharge planning," says Patricia Ayoung-Chee, MD, MPH, Assistant Professor, Surgery, NYU School of Medicine, and lead author of the study. "What's the best post-acute care facility for patients? And it may end up needing to be individualized."
She says reimbursement and insurance factors have "played more of a role than anybody sort of thought about" in discharges, rather than what is always necessarily best for patients.
For example, to be classified for payment under Medicare's IRF prospective payment system, at least 60% of all cases at inpatient rehab facilities must have at least one of 13 conditions that CMS has determined typically require intensive rehabilitation therapy, such as stroke and hip fracture.
"I think the unintended consequence is that we may be discharging patients to the best post-acute care setting, but we also may not be," Ayoung-Chee said by email, and that question "is only now being looked at in-depth."
She says hospitals should think about truly appropriate discharge planning upfront.
For instance, at admission, hospitals can find out who the patient lives with, or what their social support system is like. If they have a broken dominant hand after a fall, will they be able to get help with their groceries? Do they live alone? Will they be able to use the bathroom?
Caring for patients also doesn't end when patients leave the hospital, she adds. Hence the study's title: "Beyond the Hospital Doors: Improving Long-term Outcomes for Elderly Trauma Patients."
Ayoung-Chee says the next step in her research is to look at a more longitudinal picture, following individual patients to see what factors play into their function or lack of function.
But hospitals can do some of that work on a smaller scale, with internal audits to determine which facilities have the best post-acute care outcomes. For instance, they could spend time examining which facilities had fewer readmissions compared to others, as well as how long it took patients to get home and their how satisfied they were with their care.
Other research is also trying to determine which facilities are best for elderly trauma patients. For instance, a second study, also published in The Journal of Trauma and Acute Care Surgery, shows that geriatric trauma patients have improved outcomes when they are treated at centers that manage a higher proportion of older patients.
One of the overarching takeaways from Ayoung-Chee's research is the idea that hospitals have a broader responsibility to patients than just the time spent within their walls.
"What we do doesn't just end upon patient discharge. If we truly want to get the biggest bang from our buck, we're going to have to think about the entire continuum," she says.
That could range from working to prevent falls that can cause elderly trauma, to seeing patients through all of the appropriate care needed to expect a good functional outcome. Good healthcare for elderly trauma patients should extend beyond the parameters of morbidity and mortality, and toward returning patients to their original functional status and, ultimately, independence, says Ayoung-Chee.
"Our long-lasting effect as healthcare providers isn't just what we do in the hospital," she says. "And we have to start thinking outside."