DiversityNursing Blog

Researchers are using computed tomography (CT) and 3-D printing technology to recreate life-size models of patients' heads to assist in face transplantation surgery, according to a study presented today at the annual meeting of the Radiological Society of North America (RSNA).

Physicians at Brigham and Women's Hospital in Boston performed the country's first full-face transplantation in 2011 and have subsequently completed four additional face transplants. The procedure is performed on patients who have lost some or all of their face as a result of injury or disease.

In the study, a research team led by Frank J. Rybicki, M.D., radiologist and director of the hospital's Applied Imaging Science Laboratory, Bohdan Pomahac, M.D., lead face transplantation surgeon, and Amir Imanzadeh, M.D., research fellow, assessed the clinical impact of using 3-D printed models of the recipient's head in the planning of face transplantation surgery.

"This is a complex surgery and its success is dependent on surgical planning," Dr. Rybicki said. "Our study demonstrated that if you use this model and hold the skull in your hand, there is no better way to plan the procedure."

Each of the transplant recipients underwent preoperative CT with 3-D visualization. To build each life-size skull model, the CT images of the transplant recipient's head were segmented and processed using customized software, creating specialized data files that were input into a 3-D printer.

"In some patients, we need to modify the recipient's facial bones prior to transplantation," Dr. Imanzadeh said. "The 3-D printed model helps us to prepare the facial structures so when the actual transplantation occurs, the surgery goes more smoothly."

Although the entire transplant procedure lasts as long as 25 hours, the actual vascular connections from the donor face to the recipient typically takes approximately one hour, during which time the patient's blood flow must be stopped.

"If there are absent or missing bony structures needed for reconstruction, we can make modifications based on the 3-D printed model prior to the actual transplantation, instead of taking the time to do alterations during ischemia time," Dr. Rybicki said. "The 3-D model is important for making the transplant cosmetically appealing."

The researchers said they also used the models in the operating room to increase the surgeons' understanding of the anatomy of the recipient's face during the procedure.

"You can spin, rotate and scroll through as many CT images as you want but there's no substitute for having the real thing in your hand," Dr. Rybicki said. "The ability to work with the model gives you an unprecedented level of reassurance and confidence in the procedure."

Senior surgeons and radiologists involved in the five face transplantations agreed that the 3-D printed models provided superior pre-operative data and allowed complex anatomy and bony defects to be better appreciated, reducing total procedure time.

"Less time spent in the operating room is better for overall patient outcomes," Dr. Pomahac added.

Based on the results of this study, 3-D printing is now routinely used for surgical planning for face transplantation procedures at Brigham and Women's Hospital, and 3-D printed models may be implemented in other complex surgeries.

Source: www.sciencedaily.com

By Meera Senthilingam

"It only takes one virus to get through for a person to be infected," explained Dr. John Mascola. This is true of any viral infection, but in this instance, Mascola is referring to HIV and his ongoing efforts to develop a vaccine against the virus. "It's been so difficult to make an HIV/AIDS vaccine."

Those were the words of many working in HIV vaccine development until the results of a 2009 trial in Thailand surprised everyone. "The field is energized," said Mascola, director of the Vaccine Research Center at the U.S. National Institute of Allergy and Infectious Diseases, describing the change in atmosphere in the vaccine community.

The trial included over 16,000 volunteers and was the largest clinical trial ever conducted for a vaccine against HIV. It was also the first to show any protection at all against infection.

Two previously developed vaccines, known as ALVAC-HIV and AIDSVAX, were used in combination, with the first priming an immune response against HIV and the second used as a booster once the immunity waned. The duo reduced the risk of contracting HIV by 31.2% -- a modest reduction, but it was a start.

To date, only four vaccines have made it as far as testing for efficacy to identify their levels of protection against HIV. Only this one showed any protection.

"That trial was pivotal," Mascola said. "Prior to that, it wasn't known whether a vaccine could be possible."

In recent years, there have been parallel findings of an equally pivotal nature in the field of HIV prevention, including the discovery that people regularly taking their antiretroviral treatment reduce their chances of spreading HIV by 96% and that men who are circumcised reduce their risk of becoming infected heterosexually by approximately 60%.

Both improved access to antiretrovirals and campaigns to increase male circumcision in high-risk populations have taken place since the discoveries, and although numbers of new infections are falling, they're not falling fast enough.

In 2013, there were 35 million people estimated to be living with HIV globally. There were still 2.1 million new infections in 2013, and for every person who began treatment for HIV last year, 1.3 people were newly infected with the lifelong virus, according to UNAIDS. A vaccine remains essential to control the epidemic.

A complex beast

Scientists like Mascola have dedicated their careers to finding a vaccine, and their road has been tough due to the inherently complicated nature of the virus, its aptitude for mutating and changing constantly to evade immune attack, and its ability attack the very immune cells that should block it.

There are nine subtypes of HIV circulating in different populations around the world, according to the World Health Organization, and once inside the body, the virus can change continuously.

"Within an individual, you have millions of variants," explained Dr. Wayne Koff, chief scientific officer for the International AIDS Vaccine Alliance.

HIV invades the body by attaching to, and killing, CD4 cells in the immune system. These cells are needed to send signals for other cells to generate antibodies against viruses such as HIV, and destroying those enables HIV to cause chronic lifelong infections in those affected.

Measles, polio, tetanus, whooping cough -- to name a few -- all have vaccines readily available to protect from their potentially fatal infections. But their biology is seemingly simple in comparison with HIV.

"For the older ones, you identify the virus, either inactivate it or weaken it, and inject it," Koff said. "You trick the body into thinking it is infected with the actual virus, and when you're exposed, you mount a robust immune response."

This is the premise of all vaccines, but the changeability of HIV means the target is constantly changing. A new route is needed, and the true biology of the virus needs to be understood. "In the case of HIV, the old empirical approach isn't going to work," Koff said.

Scientists have identified conserved regions of the virus that don't change as readily, making them prime targets for attack by antibodies. When the success of the Thai trial was studied deep down at the molecular level, the protection seemed to come down to attacking some of these conserved regions. Now it's time to step it up.

In January, the mild success in Thailand will be applied in South Africa, where over 19% of the adult population is living with HIV. The country is second only to bordering Swaziland for having the highest rates of HIV in the world.

"The Thai vaccine was made for strains (of HIV) circulating in Thailand," said Dr. Larry Corey, principal investigator for the HIV Vaccine Trials Network, which is leading the next trial in South Africa. The strain, or subtype, in this case was subtype B. "For South Africa, we've formed a strain with common features to (that) circulating in the population." This region of the world has subtype C.

An additional component, known as an adjuvant, is being added to the mix to stimulate a stronger and hopefully longer-lasting level of immunity. "We know durability in the Thai trial waned," Corey said. If safety trials go well in 2015, larger trials for the protective effect will take place the following year. An ideal vaccine would provide lifelong protection, or at least for a decade, as with the yellow fever vaccine.

A broad attack

The excitement now reinvigorating researchers stems not only from a modestly successful trial but from recent successes in the lab and even from HIV patients themselves.

Some people with HIV naturally produce antibodies that are effective in attacking the HIV virus in many of its forms. Given the great variability of HIV, any means of attacking these conserved parts of the virus will be treasured and the new found gold comes in the form of these antibodies -- known as "broadly neutralizing antibodies." Scientists including Koff set out to identify these antibodies and discover whether they bind to the outer coat of the virus.

The outer envelope, or protein coat, of HIV is what the virus uses to attach to, and enter, cells inside the body. These same coat proteins are what vaccine developers would like our antibodies to attack, in order to prevent the virus from entering our cells. "Broadly neutralizing antibodies" could hold the key because, as their name suggests, they have a broad remit and can attack many subtypes of HIV. "We will have found the Achilles heel of HIV," Koff said.

Out of 1,800 people infected with HIV, Koff and his team found that 10% formed any of these antibodies and just 1% had extremely broad and potent antibodies against HIV. "We called them the elite neutralizers," he said of the latter group. The problem, however, is that these antibodies form too late, when people are already infected. In fact, they usually only form a while after infection. The goal for vaccine teams is to get the body making these ahead of infection.

"We want the antibodies in advance of exposure to HIV," explained Koff. The way to do this goes back to basics: tricking the body into thinking it is infected.

"We can start to make vaccines that are very close mimics of the virus itself," Mascola said.

Teams at his research center have gained detailed insight into the structure of HIV in recent years, particularly the outer coat, where all the action takes place. Synthesizing just the outer coat of a virus in the lab and injecting this into humans as a vaccine could "cause enough of an immune response against a range of types of HIV," Mascola said.

The vaccine would not contain the virus itself, or any of its genetic material, meaning those receiving it have no risk of contracting HIV. But for now, this new area remains just that: new. "We need results in humans," Mascola said.

Rounds of development, safety testing and then formal testing in high-risk populations are needed, but if it goes well, "in 10 years, there could be a first-generation vaccine." If improved protection is seen in South Africa, a first-generation vaccine could be with us sooner.

Making an Impact

When creating vaccines, the desired level of protection is usually 80% to 90%. But the high burden of HIV and potentially beneficial impact of lower levels of protection warrant licensing at a lower percentage.

"Over 50% is worth licensing from a public health perspective," Koff said, meaning that despite less shielding from any contact with the HIV virus, even a partially effective vaccine would save many lives over time.

The next generations will incorporate further advancements, such as inducing neutralizing antibodies, to try to increase protection up to the 80% or 90% desired.

"That's the history of vaccine research; you develop it over time," Corey said. He has worked in the field for over 25 years and has felt the struggle. "I didn't think it would be this long or this hard ... but it's been interesting," he ponders.

But there is light at the end of tunnel. Just.

"There has been no virus controlled without a vaccine," he concluded when explaining why, despite antiretrovirals, circumcision and increased awareness, the need for a one-off intervention like a vaccine remains strong.

"Most people that transmit it don't even know they have it," he said. "To get that epidemic, to say you've controlled it, requires vaccination."

Source: www.cnn.com

By JESSICA FIRGER

When Donna Tookes learned she had breast cancer last winter, the 59-year-old thought she had no choice but to accept one of the most dreaded side-effects of chemotherapy: losing her mane of silver hair, a feature that strangers young and old frequently stopped to admire.

"I had resigned myself," Tookes told CBS News. "I had purchased an array of scarves, about 10. And I actually practiced tying them."

Tookes was diagnosed with breast cancer in January after her annual mammogram, when her doctors detected some mild calcifications in her right breast. These clusters of white flecks visible on her scan indicated there might be something seriously wrong. After a few subsequent tests, Tookes learned she had HER2 breast cancer, an especially aggressive form that can be difficult to treat. Though her doctors caught the cancer early, they wanted to be certain it would never return, which meant a unilateral mastectomy followed by 12 rounds of punishing chemotherapy.

"You have a consultation before you start chemotherapy," said Tookes, who lives with her husband and children in Stamford, Connecticut, and has worked for more than three decades as a flight attendant. "I was told I would lose my hair. And then the nurse assured me, she told me 'you're beautiful,' and that I was one of the only ones who could carry the bald look because I have that bone structure."

But her family could see that losing her hair would take a serious toll on her psyche. Tookes had heard about some treatment in Europe that helps prevent chemo-related hair loss, though she didn't know many details. Secretly, her husband began to conduct research. He wrote to friends in Sweden, who were able to obtain information about a new and innovative therapy called a scalp cooling cap. He soon found out that Mount Sinai Beth Israel in New York City was involved in a clinical trial on the device, known as the DigniCap System, which is worn by a patient during chemotherapy transfusions.

The snug cap is secured onto a patient's head each time she undergoes chemotherapy. It chills the scalp down to 5 degrees Celsius so that the blood vessels surrounding the hair roots contract, meaning that less of the toxins from chemo enter the hair follicle. This minimizes -- and in some cases completely stops -- a patient's hair from falling out.

At first, Tookes was slightly skeptical, but her family finally convinced her to move her cancer treatment from her hospital in Connecticut to Mount Sinai Beth Israel in New York City.

Dr. Paula Klein, assistant professor of medicine, hematology and medical oncology at the Icahn School of Medicine at Mount Sinai and principal investigator for the clinical trial, told CBS News the device has been effective at limiting hair loss in nearly all of her patients enrolled.

"Unfortunately, in breast cancer the two most active agents are associated with significant hair loss," said Klein. "For many women with early stage breast cancer, they are getting chemotherapy for prevention of recurrence."

Klein said overall, women who use the cap lose just 25 percent of their hair. There are some patients who lose more and a lucky handful who lost no hair at all.

The clinical trial is now in its final phase. The company behind the cap, Dignitana, will be submitting results to the U.S. Food and Drug Administration by the end of November, and hope to win FDA approval for the cap in 2015.

For women struggling through a difficult medical ordeal, the benefit is significant. Research published in 2008 in the journal Psycho-Oncology looked at 38 existing studies on breast cancer treatment and quality of life issues, and found hair loss consistently ranked the most troubling side effect of treatment for women. "Significant alopecia [hair loss] is problematic," said Klein. "Every time you look in the mirror, you remember you're getting cancer treatment."

Many breast cancer survivors report that even when their hair finally grows back after chemotherapy it is often different in color or texture than the hair they had before, due to the period of time it takes the hair follicles to recover from the damage caused by the drugs.

Moreover, the feelings associated with hair loss impact nearly every aspect of a breast cancer patient's life -- from her self-image and sexuality to whether or not she is comfortable at work or even walking into the supermarket to buy a quart of milk.

When she first prepared for treatment, Tookes worried how people would react to her appearance if she lost all of her hair. But it didn't happen. Seven weeks into chemo, she finally felt confident enough to return the unused wardrobe of scarves. She still had a full head of hair. Because the cooling therapy was used only on her scalp, Tookes did still lose her eyebrows and "everything south of there."

Tookes is now cancer-free and says the therapy helped her stay optimistic about her prognosis. "My mother used to say, you just comb your hair and get yourself together and you'll get through hard times," she said.

Source: www.cbsnews.com

By Jeroen Tas

Imagine a time when a device alerts you to the onset of a disease in your body long before it’s a problem. Or when your disease is diagnosed in Shanghai, based on the medical scan you did in Kenya. This future is far closer that you might think due to rapid advances in connected devices and sensors, big data and the integration of health services. Combined, these innovations are introducing a new era in healthcare and personal well-being.

In only a few years, mobile technologies have spawned tremendous innovation of consumer-level health tools. The emerging solutions are focusing on health conditions over a person’s lifetime and on holistic care. They generate constant insights through analytics and algorithms that identify patterns and behaviours. Social technologies enable better collaboration and interconnected digital propositions that reach out to communities of people with similar conditions, engaging them in ways which were never before possible.

We are starting to get a taste of what the consumerization of healthcare will mean in the future. In two to three years, analysing your personal health data will become commonplace for large parts of the population in many countries. Also, it is very likely that for the first time it will not be the chronically ill but the healthy people who will invest the most in managing their health.

Digitization and consumerization will rattle the healthcare industry. It is already tearing at the very fabric of the traditional healthcare companies and providers. Innovation is not only about just adding a new channel or connecting a product. It is also a complete redesign of business models, adjustment of systems and processes and, most importantly, it calls for changing the culture in companies to reflect the new opportunities – and challenges – presented by the digital world.

To drive true industry transformation, companies need to collaborate and continue to learn from each other. Great strides will be made in alliances, which, for example, will deliver open, cloud-based healthcare platforms that combine customer engagement with leading medical technology, and clinical applications and informatics.

The game will not only be played by the traditional healthcare providers. With consumerization, even companies without healthcare expertise, but with strong consumer engagement and trust, could potentially become healthcare companies. Big multinationals invest incremental budgets in developing new propositions and count on their global user bases or professional networks to gain a foothold in the market.

And in parallel, a raft of start-ups are attempting to transform the worlds of preventive or curative healthcare – in many cases, limited only by their imaginations. For example, we may see virtual reality technology moving from gaming industry to healthcare for improving patients’ rehabilitation after a stroke. Or we may see facial recognition software become common in monitoring and guiding patients’ daily medical routines.

While these new propositions tackle a number of healthcare industry’s core concerns and provide solutions to completely new areas, these propositions still need to mature. They need to become scalable, reliable, open, and the user experience needs to be harmonized.

But perhaps one of the most important challenges is related to people’s behaviour and preferences. Regardless of whether these new and existing companies are analysing health data, using virtual reality or reading people’s vital signs, they all need ample time to become trusted and accepted in the emerging digital health care space. Especially for the new entrants, obtaining the right level of credibility will be one of the key success factors.

Consumers, patients and professionals alike, will need the right motivation, reassurance and mindsets to adopt these new solutions. The companies that know how to offer us tailored, cutting-edge solutions, combined with meaningful advice and trustworthiness, will be the winners and become our trusted advisers in health.

Source: World Economic Forum

By Michelle Healy

Let them sleep!

That's the message from the nation's largest pediatrician group, which, in a new policy statement, says delaying the start of high school and middle school classes to 8:30 a.m. or later is "an effective countermeasure to chronic sleep loss" and the "epidemic" of delayed, insufficient, and erratic sleep patterns among the nation's teens.

Multiple factors, "including biological changes in sleep associated with puberty, lifestyle choices, and academic demands," negatively impact teens' ability to get enough sleep, and pushing back school start times is key to helping them achieve optimal levels of sleep – 8½ to 9½ hours a night, says the American Academy of Pediatrics statement, released Monday and published online in Pediatrics.

Just 1 in 5 adolescents get nine hours of sleep on school nights, and 45% sleep less than eight hours, according to a 2006 poll by the National Sleep Foundation (NSF).

"As adolescents go up in grade, they're less likely with each passing year to get anything resembling sufficient sleep," says Judith Owens, director of sleep medicine at Children's National Medical Center in Washington, D.C., and lead author of the AAP statement. "By the time they're high school seniors, the NSF data showed they were getting less than seven hours of sleep on average."

Chronic sleep loss in children and adolescents "can, without hyperbole, really be called a public health crisis," Owens says.

Among the consequences of insufficient sleep for teens, according to the statement:

Napping, extending sleep on weekends and caffeine consumption can temporarily counteract sleepiness, but they do not restore optimal alertness and are not a substitute for regular, sufficient sleep, the AAP says.

Delaying school start time is a necessary step, but not the only step needed to help adolescents get enough sleep, Owens says. "Other competing priorities in most teenagers' lives are also components of this problem," she says, including homework, after-school jobs, extracurricular activities and electronic media use. Computers and television screens, she adds, "produce enough light to suppress melatonin levels and make it more difficult to fall asleep."

"The bottom line is if school starts at 7:20 there is no way for the average adolescent to get the 8½ to 9½ hours of sleep they need," Owens says

Research on student performance in schools that have reset the start clock, including Minneapolis Public Schools, "shows benefits across the board," says Kyla Wahlstrom, director of the Center for Applied Research and Education Improvement at the University of Minnesota.

"We've found statistically significant evidence that attendance is improved, tardiness is decreased and academic performance on core subjects, English, math, social studies and science, is improved. And now we have evidence that on national standardized tests such as the ACT, there's improvement there, too," Wahlstrom says.

Obstacles commonly cited to changing school start schedules, include curtailed time for athletic practices and games, reduced after-school employment hours for students and significant impact on bus scheduling and other transportation arrangements, she says, adding, "This is a major policy change that schools have to grapple with if they want to embrace the research about what we know about teens."

According to U.S. Department of Education statistics approximately 43% of the more than 18,000 public high schools in the U.S. have a start time before 8 a.m.; just 15% started at 8:30 a.m. or later.

In some school districts that transport students great distances, buses are picking up students as early as 5:45 a.m., "so there's also a safety element" to early start times, says Terra Ziporyn Snider, executive director of the advocacy group Start School Later.

Other major health organizations, including the American Medical Association and the Centers for Disease Control and Prevention, have all highlighted insufficient sleep in adolescents as a serious health risk, as has U.S. Education Secretary Arne Duncan, Snider says.

"What's unique about the American Academy of Pediatrics' statement is that it's very specific," she says. "It says very clearly that high school and middle schools should not start before 8:30 a.m. for the sake of the health and sleep of our children. They draw the red line."

Source: http://www.usatoday.com

By SYDNEY LUPKIN

At Boston Children’s Hospital, doctors perform practice surgeries with replicas of their patients’ body parts. Though the hospital has had a simulation program for about a decade, it started 3D-printing children’s body parts about a year ago, said Dr. Peter Weinstock, director of the hospital’s simulator program.

“They perfect what they want to do before ever bringing the child into the operating room or putting them to sleep,” Weinstock said.

The models are also used to help parents understand their children’s surgeries before the operation and to educate students afterward, Weinstock said.

The printer is precise, with a resolution of between 16 and 32 microns per layer. That means each layer is about the width of a “filament of cotton,” Weinstock said. And since the printer can print multiple resins or textures, doctors can work on replicas that model different tissue types, like brain matter and blood vessels.

The printer only takes a few hours to do their work once CT scans and other forms of imaging are collected and rendered into 3D models. A child’s finger might take three hours to print, but a chest replica they made last week took longer, Weinstock said.

The team has already printed about 100 body parts over the last year and demand is growing, Weinstock said, adding that the printer is running around the clock.

Dr. Ed Smith, a pediatric neurosurgeon at Boston Children’s, said he recently used several different 3D models to perform brain surgery on a 15-year-old patient with an abnormal cluster of veins above his optical nerve. One wrong maneuver and the patient could have gone blind.

He even used a see-through replica of the patient’s skull on a light box in the operating room as a reference.

“It’s kind of like being superman with X-ray vision where you can actually hold this up and see right through it,” Smith said.

The surgery, which would have normally taken five or six hours, wound up clocking in at 2 hours and 20 minutes, Smith said.

Though Boston Children’s hasn’t conducted any formal studies of how the models help surgeons, Smith said he’s heard anecdotally that they result in shorter surgeries because doctors know what to expect.

Source: http://abcnews.go.com

By Bill Toland

Pharmacy errors, hard-to-find clinical alerts, “farcical” training, and potentially life-threatening design flaws: Reading through the U.S. Food and Drug Administration’s catalog of electronic medical records malfunctions could be hazardous to your mental health.

If not yours, than that of the physicians and nurses who must work with the records systems, and who are reporting their experiences to the FDA’s adverse event database, otherwise known as MAUDE (the Manufacturer and User Facility Device Experience).

Most of the events submitted to the database involve misfiring medical equipment — broken aerosol compressors, faulty defibrillators — but as electronic records and computerized physician-order entry systems take hold at hospitals and clinics across the country, complaints about those systems are on the rise.  

For decades, electronic patient records systems have been heralded as a potential game-changer for the health care industry, leading to improved patient health outcomes, fewer duplicate tests and, eventually, savings for the health care industry.

While most clinicians and academics still believe the promise is there, the systems are coming under increased scrutiny from doctors, nurses and some on Capitol Hill who say the technology is poorly regulated, often unproven and occasionally unreliable. 

As such, the health records systems haven’t yet lived up the promise that was made when the Obama administration won passage its 2009 stimulus bill, which included $25.8 billion for health IT investments and incentive payments.

“Like with any new technology, there’s going to be unintended consequences,” said William M. Marella, director of Patient Safety Reporting Programs for the suburban Philadelphia Emergency Care Research Institute. He’s also director of the state’s Patient Safety Reporting System, which tracks adverse events and near-misses in Pennsylvania.

“In the long run, [electronic health records] will make us safer than we were” using paper records, Mr. Marella said. “But in the short term, we’ve got a lot of [implementation] issues that need to be addressed before [electronic health records] meet their promise.” 

Last month, the nation’s largest union of registered nurses sent a letter to the FDA asking for broader and more stringent oversight of electronic records systems and of computerized physician-order entry systems, which allow clinicians to log treatment instructions for patients.

The National Nurses United, as part of its broader campaign highlighting the potential dangers of “unproven medical technology,” says FDA officials should test electronic medical records as rigorously as they might a new drug or an artificial hip implant.

“I don’t think that opinion is an outlier opinion,” Mr. Marella said. “Lots of clinicians are unhappy with the way these systems work, and are unhappy with the documentation burden we put on them.”

The nurses union also wants the U.S. Centers for Medicare and Medicaid Services to suspend its “meaningful use” program, which requires providers to start installing electronic medical records systems at the risk losing Medicare funding, “unless and until we have unbiased, robust research showing that [electronic health records] can and do, in fact, improve patient health and save lives.”

To date, since 2011, that CMS program has issued nearly $24 billion to hospitals and physicians clinics seeking to upgrade their electronic records systems and make the transition away from paper records.

Tracking the errors

The letter submitted by the nurses union to the FDA was part of the commentary related to the federal government’s proposed overhaul of its framework for regulating health IT. That draft proposal was published in April, a joint effort of the FDA, the U.S. Department of Health and Human Services, the Federal Communications Commission and the Office of the National Coordinator for Health IT.

Others offered their own responses. The College of Healthcare Information Management Executives and the Association of Medical Directors of Information Systems, in joint comments to the FDA, said that the government needs a retooled electronic health records certification program in order to “identify clear standards and require strict adherence to those standards.”

The report itself noted that “a nationwide health information technology infrastructure can offer tremendous benefits to the American public, including the prevention of medical errors, improved efficiency and health care quality, [and] reduced costs. … However, if health IT is not designed, developed, implemented, maintained, or used properly, it can pose risks to patients.” 

Patient risk was a concern when, last summer, UnitedHealth Group Inc. recalled software that was used in hospital emergency rooms in more than 20 states “because of an error that caused doctor’s notes about patient prescriptions to drop out of their files,” according to Bloomberg News. There were no reports of patient harm, a UnitedHealth spokesman said, but the glitch illustrates the potential pitfalls for digital health records.

The MAUDE system, which accepts voluntary and anonymous incident reports from practitioners, and Mr. Marella’s own reporting have turned up plenty of other glitches. Some involve human error, others involve software and interoperability malfunctions, and many are simply design flaws, such as this example from a 2012 Pennsylvania Patient Safety Authority report:

Patient with documented allergy to penicillin received ampicillin and went into shock, possibly due to anaphylaxis. Allergy written on some order sheets [but] never linked to pharmacy drug dictionary.

And this one, from MAUDE: 

Potassium chloride was prescribed twice per day as treatment for hypokalemia. The lab testing revealed a [bad] jump in the potassium level, but the result came to the EHR without alert or warning, and the nurses continued to give the patient potassium anyway [because] the nurse did not know that the potassium level was high. ... Though this patient did not die, others have from this type of defect.

Or this one, from 2013: 

Patient’s medication list and other active orders did not appear on the doctor’s order section on the CPOE system, rendering it impossible for the doctor to confirm, alter, and reconcile the medication list. ... For obvious reasons, this defect in the CPOE is potentially life threatening when the doctor(s) do not have access to the current medication list.

And from April: 

A patient [was] at risk for respiratory arrest due to a narrowing in the trachea. There is no place on the EHR to list such a life-threatening condition that would be visible to each and every care team member who opened the EHR for this patient. ...  Care was delayed due to the above mentioned reasons, [and] the patient sustained a complete respiratory arrest that led to a cardiac arrest and anoxic brain injury.

Human factors 

While examples of electronic health records problems can be retrieved via various state and federal databases, many in the medical field say tracking the issues in a more comprehensive way will lead to better systems. Mandatory reporting would help, too, since only a fraction of adverse events related to electronic health records are actually reported to the FDA or state authorities. 

But health IT vendors are against mandatory reporting, or any other system that would run afoul of the confidentiality clauses that are built into contracts with hospitals and clinics. Public, mandatory confessions of errors might also discourage such reporting, since the clinician who admits the error could be punished by his or her employer. 

“We have felt that reporting by both providers and vendors should be voluntary. That is most consistent with the notion of a learning environment,” said Mark Segal, the chairman of the Electronic Health Records Association, told The Boston Globe.

Clinicians, too, are also wary about striking the right balance. “FDA oversight and regulation could slow innovation,” particularly if electronic health records and related systems are indeed scrutinized like other medical devices, according to a letter to the FDA from American Medical Association CEO James Madara. 

And they have the FDA on their side. The agency does not intend to require the reporting of electronic health records-related adverse events, and does not intend to vet electronic health records in the same way that it reviews drugs and other medical devices.

But when push comes to shove, though, regulators should err on the side of safety, said Dean Kross, a cardiologist in private practice at the Allegheny Health Network and a longtime critic of electronic health record companies and the side effects of health IT adoption. 

“The vendors have not been held accountable for the devices they are manufacturing,” he said. There is negligible pre-installation vetting, or post-market surveillance, for “safety, usability and efficacy,” he said.

And regulators should keep a watchful eye on human usability.

“Ninety percent of [complaints] have got something to do with faulty user-device interaction,” said Robert A. North, chief scientist at Human Centered Strategies, a Colorado company that studies and seeks to reduce risk and error in medical device design. “It’s not that something that is breaking or freezing. ... it’s nothing to do with the electronic circuit board. It’s the human circuit board.”

While Mr. Marella is aware of the design shortcomings of electronic health records, he’s still a believer that the systems can, and are, improving patient and population health.

He points to the example of a Pennsylvania hospital that noticed some its patients were overdosing on narcotic painkillers while in the hospital, and had to be given reversal agents to mitigate the overdose symptoms. When clinicians dug into the electronic records, they saw that the overdoses were happening primarily among people being given painkillers for the first time.

“So they decided that the default dose was actually too high” for first-time opioid recipients, and adjusted the first-time dosage going forward, Mr. Marella said. Identifying a hospital-wide problem, and addressing it quickly, probably couldn’t have happened without electronic health records.

“We really have to do a lot more work in what we call human factors,” so that the systems are intuitive, he said. “We’re quite a long ways from there.”

Source: www.nationalnursesunited.org

By GILLIAN MOHNEY

For all the impressive advancements in medical technology, researchers and scientists still face a daunting challenge when they study the habits of the adorable but uncommunicative subjects called human infants.

In order to study infants without overwhelming them, scientists often try to mask the massive machines needed to view brain activity either by having the child sleep through it or by covering it in kid-friendly decorations. Other researchers have devised decidedly low-tech ways of reading an infant’s interest in a subject, even when they can’t say a single word.

In a study released Monday in the Proceedings of National Academy of Sciences, doctors used a special machine to examine infant brain activity as they start to learn language skills.

Patricia Kuhl, a professor of speech and hearing sciences at University of Washington and the lead author of the study, said the research indicated the area of the infants’ brain that controlled motor skills lit up when they heard certain words. The activity indicated that the infants are trying to mimic adults and speak much earlier before they say their first word.

However, Kuhl said, the study was important because of both the surprising findings and the way researchers were able to get them. To “read” the infant’s brain activity, they used the cutting-edge device called a magnetoencephalograph, that was quiet and nimble enough to read the chaotic world of infants’ brain activity.

Kuhl said unlike an MRI machine, which is extremely loud and requires a patient to be totally still, the magnetoencephalograph is nearly silent. However the infants still had to be strapped into a chair, so to keep them entertained the researchers were tasked with making silly faces and holding up toys all in the name of science.

“You want them to like the lab,” said Kuhl. “It’s decorated with fish and it’s got little stickies [on it.] It’s ... very baby friendly. We wave toys and we’re very aware and of their curiosity and of their desire to play. We do everything to make them comfortable.”

In a 2013 study published in Psychological Science, researchers used MRI machines to examine baby’s brain activity in response to different stimuli. However, to get the infants into a machine where they could not move, the researchers had the babies go in after they fell asleep naturally. They also used ear coverings so the loud MRI machine didn’t wake the infants.

MRI machines can be so distressing for patients because of claustrophobia or other fears about being in the hospital that a New York Hospital installed a pirate-themed scanner to put children (and some parents) more at ease.

“The genius is in this machine. ... There’s no noise and the baby can listen and can move,” said Kuhl of the magnetoencephalograph. “The ability for the first time to do this kind of recording in this kind of technical advanced machine ... [it’s like] we’re putting [on] a stethoscope.”

Aside from technological advancements, researchers rely on some decidedly low-tech approaches when studying infants.

Fei Xue, a professor of psychology at the University of California Berkeley, has done numerous studies examining how infants learn and react to new toys or information. She said researchers have plenty of tricks to keep babies focused on the tasks at hand.

Xue said most studies only last between 5-10 minutes because the infants will get bored if they're longer. If they want a baby to focus on an object, they darken the room and light up the object to draw the baby's attention.

“In a way, it’s easy to work with infants,” said Xue. “They’re very curious and they’re interested in the world.”

To measure if babies are interested in an object or scene without getting verbal confirmation, Xue and her fellow researchers simply follow the infant’s eye movement. While there are special computer programs, Xue said often it just comes down to a researcher holding a stopwatch and watching the infant through a monitor.

In spite of the infants’ inability to speak, Xue said, understanding their thought process can reveal how they learn, which could eventually help shape education programs.

“When they go to preschool and elementary school ... they will help us to know how to structure the school system,” said Xue of her young subjects. “Understanding these really young humans is important.”

Source: http://abcnews.go.com

By Caitlin Schmidt

When you're sick, sometimes it feels impossible to get out of bed, let alone get to the doctor. And the last thing anyone wants to do is spend hours at the emergency room.

So Silicon Valley is retooling a service that was common almost a century ago: the house call. Several companies have developed smartphone apps that bring doctors to patients, often in less time than it would take to seek treatment elsewhere. With apps like Pager and Medicast, a patient can request a doctor with the push of a button.

In the 1930s, physician house calls accounted for 40% of medical visits, according to a 2011 article in the journal American Academy of Family Physicians. By the 1980s, that number had dropped to 1%, due in part to a lack of funding by insurance carriers.

Elizabeth Krusic, a mother of two young children from Seal Beach, California, knows how difficult it can be to take a sick child to see a doctor. When her daughter developed an eye infection, she took a friend's advice and tried Medicast, calling a doctor into her home and saving the stress of getting her small children ready and out of the house.

The doctor arrived in 30 minutes and had the necessary prescription medication on hand.

"My son was able to sleep during the entire visit, because the doctor came to the house," Krusic said. "The doctor came into my daughter's room and conducted the visit there, where she was comfortable."

The house call also removed the risk that her children would be exposed to illnesses in a waiting room.

Inspired by Uber

In early 2014, Uber co-founder Oscar Salazar saw room for improvement in the health care system and seized the opportunity.

The app he developed, Pager, offers house call services for customers in Manhattan and, starting next week, Brooklyn. Pager's doctors are available from 8 a.m. to 10 p.m., 365 days a year, with an additional after-hour fee for nights and weekends.

Toby Hervey, Pager's head of marketing and business development, said that several aspects of Uber informed Pager's approach. Like Uber, the app is structured as a mobile, location-based service.

"Convenient access to quality health care when you need it is a real problem," he said. "We're using technology to make the house call -- one of the best ways to get personal care -- viable again."

Hervey said customers range from parents not wanting to take a sick child to an emergency room to businesspeople with no time to see a doctor during the day.

A similar company, Medicast, started in South Florida in late 2013, with services now also available in San Diego, Orange County and Los Angeles.

"Long wait times are frustrating for everyone," Sam Zebarjadi, co-founder and CEO of Medicast, said. "With the proliferation of technology and increasing levels of education, we knew there were alternate ways to get amazing health care."

Dr. Kimberly Henderson is a Pager physician and works in the emergency room at New York's Beth Israel Medical Center. For her, the idea of being a part of a new practice of medicine was appealing.

"I believe we will see a shift away from medical practice exclusively in the brick and mortar model," Henderson said. "Medicine will become, or return to being, more mobile."

As the doctor shortage grows and patients struggle to balance their busy lives, telemedicine has become a fast-growing field. Health care professionals offer their services using two-way video, e-mail, smartphones and other forms of technology. Apps, such as Doctor on Demand and Ringadoc, allow patients to speak to a physician via phone or video chat.

Doctors enrolled with the service PINGMD can receive text, photo or video messages from their patients that can be forwarded to colleagues for referrals and are automatically saved to the patient's medical file. Another app, HealthTap, connects patients to 50,000 doctors across the country for verified answers to medical questions. Patients can search the database or ask their own questions and receive responses from multiple doctors, providing them with several opinions.

The American Medical Association says that telemedicine, including house call services, is useful for both patients and the health care industry as a whole, according to its June Report on the Council of Medical Service.

"Telemedicine, a key innovation in support of health care delivery reform, is being used in initiatives to improve access to care, care coordination and quality, as well as reduce the rate of growth in health care spending."

How house call apps work

After a brief video conference, a doctor will assess the patient's need for a home visit. If no visit is necessary or the physician recommends a trip to the emergency room, there's no charge.

"With this system, we're able to provide high quality care that goes beyond the issue at hand," Zebarjadi said. "With the doctor visiting patients in their own homes, it's easy to make observations and discuss other health concerns and lifestyle choices."

"I love the concept of bringing our services to people's homes," said Medicast's Dr. Elisa Malin. "It's a convenience factor, both for the patients and for us as physicians, in the sense that I can choose to be on call whenever I'm available."

Malin also works as a pediatric hospitalist for Kaiser Permanente. She said that a typical house call visit lasts about 45 minutes, as opposed to the average 10-minute visit at a clinic.

"The fact that I get the luxury of time with Medicast patients improves the quality of care they receive."

With both apps, physicians follow up with the patient via phone and are available to answer any questions that may have come up since the visit.

Although the apps are only currently available for iPhone, Pager and Medicast are actively working on an Android app. For non-iPhone users, their services are also available by phone and on their websites. They also have plans to move into other markets in the near future.

The house calls are comparable to an urgent care visit, and cost much less than the emergency room, where many people still go to seek treatment for minor ailments. Both companies offer flat rates, starting at $199 for a house call. Customers can also sign up for a monthly plan that allows them two or four visits a year.

The companies aren't able to accept insurance, but are in talks with various providers to make that option available in the future.

House calls have their advantages, such as privacy and convenience, according to Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons. They also can save on office overhead for physicians. But they do have limitations, she said.

"The doctor's black bag won't have all the equipment available in the office," she said.

Both companies' websites have long lists of conditions they treat, such as cold and flu, sprains, eye infections, pneumonia, abdominal pain and cuts that require stitches. But there are also conditions their doctors cannot handle. You should call 911 or go to the emergency room if you are experiencing chest pain, shortness of breath, or have had a head injury and lost consciousness.

Source: www.cnn.com

By SYDNEY LUPKIN

Wyatt Scott turned a year old earlier this summer, but he ate his birthday dinner through a tube in his tummy.

It’s been more than four months since the Scott family launched WhatsWrongWithWyatt.com to find out why their baby boy can’t open his mouth, and though they’ve been flooded with emails, their little boy’s condition remains a mystery.

Wyatt’s lockjaw has baffled doctors since he was born in June 2013 in Ottawa, Canada, and though the Scott family has taken him to every specialist imaginable, they can’t figure out the root of the problem, Andrew Scott said. Wyatt spent the first three months of his life in the hospital, and his parents have had to call 911 several times because he's been choking and unable to open his mouth.

So Wyatt's mother, Amy, decided to create a website, WhatsWrongWithWyatt.com last spring in the hopes that someone would recognize the condition and offer a solution.

Wyatt's doctor, Dr. J. P. Vaccani, told ABC News in April that the condition, congenital trismus, is rare and usually the result of a fused joint or extra band of tissue. But Wyatt’s CT and MRI scans appear to be normal.

"It's an unusual situation where he can’t open his mouth, and there’s no kind of obvious reason for it,” Vaccani, a pediatric otolaryngologist at Children’s Hospital of Eastern Ontario told ABC News. “Otherwise, he’s a healthy boy."

Andrew Scott said he’s sifted through 500 emails submitted to WhatsWrongWithWyatt.com over the last several months, and compiled a list of the most important ideas to give to Wyatt’s doctors. One letter-writer from Virginia told the Scotts that Wyatt’s story made her cry because her now-14-year-old had similar mysterious symptoms.

“She could have written it herself,” Andrew Scott recalled her saying.

Though the Virginia 14-year-old underwent surgery and therapy, Andrew Scott said Wyatt seems to have something different.

“It’s not just that his mouth doesn’t open,” he said.

Wyatt underwent a study in which doctors X-rayed him while he was feeding to see how the muscles in his mouth and throat worked. They found that he has problems with motor function and swallowing in addition to the lockjaw.

“His blinking is erratic,” Andrew Scott added. “He’ll wink on one side a bunch, then the other side and back and forth.”

Their quest for answers has been slow. A recent muscle biopsy came back negative, and Wyatt is awaiting results of his third genetic test.

Since the website launched, Wyatt had a major health scare: he stole a piece of chicken off his mother’s plate and put it in his mouth, Andrew Scott said. His lips were parted just enough to get it in, but neither of his parents could get it out, so they pulled it out in pieces. They thought it was all gone when Wyatt fell asleep.

Then, Wyatt started choking.

“He almost died,” Andrew Scott said. “I ended up just giving him breath.”

Wyatt “came back” just as ambulances and fire trucks arrived, Andrew Scott said. At the hospital, doctors scoped Wyatt’s lungs, but he was still coughing up chicken pieces several days later.

The emergency forced doctors to use anesthesia to put Wyatt to sleep, which they were too afraid to do before because they feared he would stop breathing. While he was out for the lung scope, the also did a muscle biopsy and put in a G-tube. Now, instead of being fed through a tube in his nose that leads to his stomach, Wyatt can “eat” through a tube in his belly.

Wyatt’s birthday party at the end of June was a pig roast that drew 50 people and included a piñata, goats and a trampoline. Though Wyatt didn’t get any mashed-up pig in his G-tube, Andrew Scott said “maybe next time.” By the end of the party, Wyatt was sound asleep in the grass.

“He is a very happy baby,” he said.

Source: http://abcnews.go.com