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Patient Safety In Hospitals Still A Concern

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Two decades ago, a landmark study by the National Academy of Medicine (NAM) highlighted the prevalence of medical errors and called for a national commitment to reduce patient harm. Despite substantial investment by government and private institutions to increase patient safety, progress has been slow and uneven. A new study, published today in the November issue of the journal Health Affairs, sheds light on what more can be done.

Researchers from the Center for Health Outcomes and Policy Research(CHOPR) of the University of Pennsylvania School of Nursing (Penn Nursing) investigate whether hospitals have implemented a key NAM recommendation—to improve nurse work environments and assure adequate nurse staffing—and whether these changes corresponded to improved patient safety, as reported by patients and nurses.

Between 2005 and 2016, only 21 percent of hospitals substantially improved their clinical work environments; 71 percent made no improvements and 7 percent experienced deteriorating work environments. Hospitals that improved their work environments saw their patient safety indicators improve as well, with favorable nurse and patient appraisals of patient safety increasing by 11-15%. Grades on patient safety remained the same for hospitals in which work environments remained the same, and favorable grades on patient safety fell by 19% in hospitals with worsening care environments.

“A key recommendation of the National Academy of Medicine in 1999 for improving patient safety was to transform nurse work environments in hospitals to ensure adequate nurse staffing and clinical work environments that freed nurses to spend their time in direct patient care,” said lead author Linda Aiken, PhD, RN, the Claire M. Fagin Leadership Professor in Nursing, Director of the Center for Health Outcomes and Policy Research, and Senior Fellow at the Leonard Davis Institute for Health Economics at Penn.

“Our recent study of nurses and patients suggests that those recommendations have not been uniformly adopted by hospitals, which may be hampering progress toward improving patient safety and preventing patient harm.”

The study included 535 hospitals in four large states in two time periods, 2005 and 2016, and reports from 53,644 RNs and 805,881 patients who practiced or received care at these hospitals. Nearly 30 percent of hospital nurses in 2015-16 gave their hospitals unfavorable grades on patient safety, and 55 percent would not definitely recommend their hospital to a family member or friend who needed care.

Patients also expressed concern about quality and safety with 30 percent reporting that they would not definitely recommend their hospital. Nearly 40 percent of patients said that they did not always receive help quickly from hospital staff, and nearly 40% reported that medications were not always explained before given.

“Patients’ and nurses’ appraisals show patient safety in hospitals remains a concern almost 20 years after the NAM originally called for national action to reduce patient harm,” said Aiken.

“Our findings show that clinicians continue to face challenging but modifiable work environments that interfere with their ability to implement safety interventions consistently. Improving work environments through organization and culture change is a comparatively low-cost intervention to improve quality of care and patient safety.”

The study found that:

  • Over 80 percent of nurses rated the clinical work environments in their hospitals less than excellent.
  • Close to 30 percent of nurses gave their hospital an unfavorable grade on infection prevention.
  • Over 30 percent of hospital nurses score in the high burnout range on standardized tests.
  • Thirty-nine percent of patients reported that medications were not always explained before given.
  • Only 21 percent of hospitals significantly improved their clinical work environments over the past decade; most made no improvements and 7 percent experienced deteriorating work environments.
  • Hospitals that significantly improved their care environments experienced much greater improvements in patient safety indicators and implementing a culture of patient safety than hospitals that did not improve clinical care environments as recommended by the National Academy of Medicine.
  • Hospitals in which the work environment worsened exhibited a 25 percent decrease in the percentage of nurses saying that patient safety is a top priority of management.

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Hypertonic Saline May Help Babies with Cystic Fibrosis Breathe Better

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Nov. 9, 2018─Babies with cystic fibrosis may breathe better by inhaling hypertonic saline, according to a randomized controlled trial conducted in Germany and published in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

In “Preventive Inhalation of Hypertonic Saline in Infants with Cystic Fibrosis (PRESIS): A Randomized, Double-blind, Controlled Study,” Mirjam Stahl, MD, and  co-authors describe a study of 40 young infants (average age three months at enrollment) with CF. The babies were randomly assigned to receive either hypertonic saline (saline with a 6 percent salt concentration) or isotonic (.9 percent) saline. They were followed for 12 months.

Previous studies in mice found that the salt content of hypertonic saline decreased mucous plugging that can lead to airway obstruction and repeated infections. Other studies found hypertonic saline benefited older infants and children with CF.

 “Several studies from teams worldwide investigating infants and preschool children with CF identified by newborn screening revealed that CF lung disease starts in the first months of life, leaving only a narrow window of opportunity for preventive therapeutic interventions,” said Dr. Stahl, the lead study author and a pediatric pulmonologist at the Cystic Fibrosis Centre and the Translational Lung Research Center at the University of Heidelberg.

“Because lung disease is the most important factor for morbidity and mortality in patients with CF, prevention, or at least delay, of the onset and progression of CF lung disease may be a promising therapeutic strategy.”

The researchers also tested whether lung clearance index and chest magnetic resonance imaging (MRI) could be safely performed on the infants and serve as quantitative outcome measures.

Lung clearance index measures how well air is flowing through the lungs. Mucous obstruction of the smallest airways is one of the earliest features of CF lung disease, and lung clearance index can detect these changes in breathing. MRI can detect early abnormalities in lung structure.

The authors report that both procedures could be safely performed in the infants and were well tolerated, though lung clearance index in this particular study provided a better yardstick to measure the benefits of this treatment.

After one year, the infants who received the hypertonic saline had a better lung clearance index. Furthermore, they gained significantly more weight (500 grams or 1.1 pounds higher mean weight after one year of treatment) and height (1.5 centimeters or just under an inch higher mean height after one year of treatment). The weight gain confirmed previous studies of hypertonic saline in a mouse model for CF lung disease.

Pulmonary exacerbation rates and adverse events between the treatment groups were similar.

Study limitations include the fact that isotonic saline (sodium chloride concentration: .9 percent) is not a true placebo because it may, itself, have therapeutic benefits. The authors added that the infants were followed for only one year, so whether hypertonic saline therapy is beneficial over the long term is unknown.

The study is believed to be the first randomized controlled trial in infants with CF.

“We demonstrated that early studies are feasible in this challenging age group using innovative, sensitive outcome parameters such as lung clearance index,” Dr. Stahl said.

“Treatment with hypertonic saline in infants with CF is safe from diagnosis onwards, and our results suggest this preventive therapy benefits lung function and improves thriving.”

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Tiny Pacemakers Aim To Make Infant Heart Surgeries Less Invasive, While Cutting Operating Costs And Time

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WASHINGTON – At 2:15 p.m. C.T. on Sunday, Nov. 11, Rohan Kumthekar, M.D., a cardiology fellow working in Dr. Charles Berul’s bioengineering lab at the Sheikh Zayed Institute for Pediatric Surgical Innovation, part of Children’s National Health System, presents a prototype for a miniature pacemaker at the American Heart Association’s Scientific Sessions 2018. The prototype, approximately 1 cc, the size of an almond, is designed to make pacemaker procedures for infants less invasive, less painful and more efficient, measured by shorter surgeries, faster recovery times and reduced medical costs.

Kumthekar, a Cardiovascular Disease in the Young Travel Award recipient, will deliver his oral abstract, entitled “Minimally Invasive Percutaneous Epicardial Placement of a Custom Miniature Pacemaker with Leadlet under Direct Visualization,” in S101A as part of the Top Translational Science Abstracts in Pediatric Cardiology session.

“As cardiologists and pediatric surgeons, our goal is to put a child’s health and comfort first,” says Kumthekar.

“Advancements in surgical fields are tending toward procedures that are less and less invasive. There are many laparoscopic surgeries in adults and children that used to be open surgeries, such as appendix and gall bladder removals. However, placing pacemaker leads on infants’ hearts has always been an open surgery. We are trying to bring those surgical advances into our field of pediatric cardiology to benefit our patients.”

Instead of using open-chest surgery, the current standard for implanting pacemakers in children, doctors could implant the tiny pacemakers by making a relatively tiny 1-cm incision just below the ribcage.

“The advantage is that the entire surgery is contained within a tiny 1-cm incision, which is what we find groundbreaking,” says Kumthekar.

With the help of a patented two-channel, self-anchoring access port previously developed by Berul’ s research group, the operator can insert a camera into the chest to directly visualize the entire procedure. They can then insert a sheath (narrow tube) through the second channel to access the pericardial sac, the plastic-like cover around the heart. The leadlet, the short extension of the miniature pacemaker, can be affixed onto the surface of the heart under direct visualization. The final step is to insert the pacemaker into the incision and close the skin, leaving a tiny scar instead of two large suture lines.

The median time from incision to implantation in this thoracoscopic surgery study was 21 minutes, and the entire procedure took less than an hour on average. In contrast, pediatric open-heart surgery could take up to several hours, depending on the child’s medical complexities.

“Placing a pacemaker in a small child is different than operating on an adult, due to their small chest cavity and narrow blood vessels,” says Kumthekar.

“By eliminating the need to cut through the sternum or the ribs and fully open the chest to implant a pacemaker, the current model, we can cut down on surgical time and help alleviate pain.”

The miniature pacemakers and surgical approach may also work well for adult patients with limited vascular access, such as those born with congenital heart disease, or for patients who have had open-heart surgery or multiple previous cardiovascular procedures.

The miniature pacemakers passed a proof-of-concept simulation and the experimental model is now ready for a second phase of testing, which will analyze how the tailored devices hold up over time, prior to clinical testing and availability for infants.

“The concept of inserting a pacemaker with a 1-cm incision in less than an hour demonstrates the power of working with multidisciplinary research teams to quickly solve complex clinical challenges,” says Charles Berul, M.D., a guiding study author, electrophysiologist and the chief of cardiology at Children’s National.

Berul’s team from Children’s National collaborated with Medtronic PLC, developers of the first implantable pacemakers, to develop the prototype and provide resources and technical support to test the minimally-invasive surgery.

The National Institutes of Health provided a grant to Berul’s research team to develop the PeriPath, the all-in-one 1-cm access port, which cut down on the number of incisions by enabling the camera, needle, leadlet and pacemaker to be inserted into one port, through one tiny incision.

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Grief Linked To Sleep Disturbances That Can Be Bad For The Heart

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HOUSTON – (Nov. 9, 2018) – People who have recently lost a spouse are more likely to have sleep disturbances that exacerbate levels of inflammation in the body, according to new research from Rice University and Northwestern University. These elevated levels of inflammation may increase risk for cardiovascular illness and death.

The study, “Bereavement, self-reported sleep disturbances and inflammation: Results from Project HEART,” was recently published in Psychosomatic Medicine. It compared the self-reported sleep habits of recently widowed people to a control group. Both groups had sleep disturbances, such as insomnia.

The researchers found that the link between sleep disturbances and inflammation was two to three times higher for the bereaved spouses. Inflammation was measured by the level of proinflammatory cytokines, which are designed to be short-term fighters of disease but are linked to long-term risk for health problems including cardiovascular disease.

Corresponding author Diana Chirinos, a research assistant professor of preventive medicine at the Northwestern University Feinberg School of Medicine who began examining the topic as a Rice Academy postdoctoral fellow in Rice’s Department of Psychological Sciences, said the study suggests that these bereaved individuals are more susceptible to the negative health effects of poor sleep.

“The death of a spouse is an acutely stressful event and they have to adapt to living without the support of the spouse,” she said. “Add sleep disturbance to their already stressful situation and you double the stressor. As a result, their immune system is more overactivated.”

Chirinos said she and her fellow researchers already knew widowed individuals had higher levels of inflammation. Prior work revealed that in the first six months after the loss of a spouse, widows and widowers are at a 41 percent higher risk of mortality, and 53 percent of this increased risk is due to cardiovascular disease. However, they wanted to find the specific cause.

“Now we know it’s not the grief itself; it is the sleep disturbance that arises from that grief,” Chirinos said.

Chris Fagundes, an assistant professor of psychological sciences at Rice and the principal investigator for Project HEART, said the finding is another revelation in the study of how human behaviors and activities impact inflammation, and it adds to a growing body of work about how bereavement can affect health. His initial work showed why people who have been widowed are at higher risk of cardiovascular problems and premature death by comparing their inflammation with matched controls.

“While working in my laboratory as a post-doctoral fellow, Diana did a great job incorporating her expertise in sleep data collection into this project,” he said.

Ultimately, the researchers hope the findings will help to design better health interventions for those suffering from loss.

The study included 101 people with an average age of 67. Half were bereaved (identified through obituaries), and the rest made up the control group.

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