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DLPSS|HEALTHCARE NEWS|March 13, 2014

DLPSS|HEALTHCARE NEWS|March 13, 2014



Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information 
from The Division Of Laboratory Programs, Standards And Services

 

March 13, 2014


News Highlights 

 

View Previous Issues - Healthcare News Archive

 

FDA Panel: Roche's DNA Test Can Replace Pap Smear

An FDA advisory committee voted unanimously Wednesday to recommend that the Pap smear be replaced with a human papillomavirus (HPV) test as the first-line standard of care for cancer screening. The FDA's Medical Devices Advisory Committee Microbiology Panel agreed by a vote of 13-0 in each of three successive votes that the cobas viral DNA test for HPV – made by Roche Molecular Systems – was safe and effective for cervical cancer screening, and that the benefits of the tests outweighed the risks.
According to the summary submitted by FDA staff members, "The data show that the proposed primary screening indication for the cobas HPV test detects more women with disease and requires fewer women without disease to go to colposcopy than cytology alone." The staff summary included the following performance characteristics of the cobas test versus cytology in
  • Sensitivity for ≥cervical intraepithelial neoplasia (CIN3) -58 the prospective cohort study: 26% versus 42.63%
  • Positive predictive value -12.25% versus 6.47%
  • Negative predictive value -0.42% versus 0.59%
  • False-positive rate -4.09% versus 6.04%
Benefit-risk analyses favored the HPV DNA test whether expressed in terms of number of cases of high-grade cervical disease per 10,000 women screened or per 100 colposcopy procedures. The FDA is not bound to follow its advisory committees' recommendations, but does so in most cases.
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Bid to Replace Pap Test Goes to FDA Panel

An FDA advisory committee will hear the case for replacing the Pap smear with a viral DNA test as the first-line standard for cervical cancer screening. FDA's Medical Devices Advisory Committee Microbiology Panel will weigh evidence presented by agency staff members and test manufacturer Roche Molecular Systems and then vote for or against a proposal to extend the indication for the cobas test for human papillomavirus (HPV) to first-line screening for cervical cancer. The cobas test currently has approval as a follow-up assessment for women 21 and older who have abnormal Pap tests and as a co-test with the Pap smear to screen for the high-risk p16 and p18 HPV strains in women 30 to 65. The test comprises genotyping for HPV16 and 18 and pooled assessment of 12 additional high-risk HPV strains. According to the proposal submitted by Roche, women who test positive for HPV16 or 18 would proceed directly to colposcopy for further assessment. Patients who test negative for HPV16 or 18 but positive for the other high-risk strains would have a Pap test to determine the need for colposcopy. Women who have a completely negative test would be followed at their physicians' discretion.
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CDC Plans to Map DNA of Disease-Causing Viruses

Many public health experts see the Centers for Disease Control and Prevention as the premier disease detection agency not just for the United States but for the entire planet. Yet when it comes to employing the fastest and most precise method of spotting outbreaks of illness, the CDC is no longer at the cutting edge — and won’t be for years. Centers for Disease Control and Prevention Director Thomas Frieden along with public health and provider groups want to turn that around by investing in a sophisticated technology called “advanced molecular detection” that determines the genetic map of the viruses, bacteria and parasites that cause disease. The effort began paying off early this year. Appropriators for the first time in several years decided to rewrite Labor-HHS-Education spending provisions. In doing so, they included $30 million for the AMD technology in the omnibus spending measure funding the government through the end of fiscal 2014.  But Frieden must still persuade lawmakers to continue such annual funding for the five-year program for four more years. And he’ll be doing it even as he seeks additional funds for other programs.
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Obama's FY15 Budget Proposes Reimbursement Changes Including More Cuts to Clinical Laboratory Services

President Obama's FY15 budget request includes proposed changes to Medicare payment rates for drugs and diagnostics. According to HHS's summary, the White House is proposing to set the payment rate for drugs covered under Medicare Part B -- those administered in a physician office or hospital outpatient setting -- at 103% of the average sales price (ASP) starting in 2015, down from 106% of ASP currently. The budget also includes a proposal to lower Medicare's payment rates under its clinical laboratory fee schedule by 1.75% each year for 2016-23 to "better align Medicare payments with private sector rates." Most molecular diagnostics are reimbursed through the lab fee schedule. The change would save Medicare an estimated $7.9 billion over 10 years.

 

Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers

The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers.” The purpose of the public workshop is to discuss the clinical and public health applications and performance validation of these devices, the quality criteria for establishing the accuracy of reference databases for regulatory use and ways to streamline clinical trials for microbial identification. This discussion is essential to establish the safety and effectiveness of high throughput sequencing devices when used to test human specimens or clinical isolates for the diagnosis of infectious diseases and detection of antimicrobial resistance markers. The public workshop will be held on April 1, 2014, from 9 a.m. to 4:30 p.m.

 

International Panel of Pathology Leaders Develop Principles for Patient Safety

An international panel of leaders in the pathology community has announced its support of four principles designed to drive positive change and improve patient safety in the anatomic pathology laboratory. The group, known as the International Pathology Patient Safety Advisory Board, concluded its work with this shared vision:
1. All patients around the globe deserve standardized, high quality pathology services.
2. As patient advocates, to support accurate diagnosis and enable personalized medicine, the International Pathology Patient Safety Advisory Board identifies significant opportunities to improve patient safety by developing and implementing solutions to enhance:
  • tissue preservation
  • specimen/slide identification and tracking; and
  • prevention of tissue contamination
3. We, the members of the International Pathology Patient Safety Advisory Board, find further opportunity to define standardized parameters for data collection and sharing in the assessment of these processes leading to quality measures for laboratory improvement.
4. We call upon the pathology profession to collaborate with laboratory and hospital administrative partners, clinician colleagues, and the laboratory diagnostics industry to address these opportunities to achieve excellence in patient care.
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AACC Calls for Uniformity in Lab Test Results

AACC has released a position statement on harmonization of -or ensuring uniformity among-clinical laboratory test results to help patients receive appropriate diagnoses and medical treatment. With this statement, the association aims to raise awareness about this essential healthcare issue and urge the medical community to work together to make harmonization a reality. The few laboratory tests that have been harmonized to date, such as those for cholesterol, glucose, and hemoglobin A1c, have made a marked positive impact on diagnosis and treatment of heart disease and diabetes. In addition to improved patient care, harmonizing these tests may also lead to reductions in healthcare spending.
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Stanford Bioengineer Develops a 50-Cent Paper Microscope

When Manu Prakash, PhD, wants to impress lab visitors with the durability of his Origami-based paper microscope, he throws it off a three-story balcony, stomps on it with his foot and dunks it into a water-filled beaker. Miraculously, it still works. Even more amazing is that this microscope — a bookmark-sized piece of layered cardstock with a micro-lens — only costs about 50 cents in materials to make. In the videoExternal Web Site Icon, you can see his “Foldscope” being built in just a few minutes, then used to project giant images of plant tissue on the wall of a dark room.
Prakash’s dream is that this ultra-low-cost microscope will someday be distributed widely to detect dangerous blood-borne diseases like malaria, African sleeping sickness, schistosomiasis and Chagas.
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Doctors Often Uncertain in Ordering, Interpreting Lab Tests

A survey of primary care physicians suggests they often face uncertainty in ordering and interpreting clinical laboratory tests, and would welcome better electronic clinical decision support tools. The results of the survey, sponsored by the U.S. Centers for Disease Control and Prevention, were published in the March-April issue of The Journal of the American Board of Family Medicine.“The optimal testing pathways to arrive at correct diagnoses is changing, so it is difficult for primary care physicians to keep up with new and efficient testing algorithms,” says Dr. John Hickner, professor and head of family medicine at the University of Illinois at Chicago College of Medicine, the corresponding author on the paper.  “This is a situation that clearly fosters uncertainty, so the results of the survey are not all that surprising.” Over the past 20 years, the number of laboratory tests available to physicians has doubled, to more than 3,500 tests, Hickner said. Primary care physicians are challenged by the quantity of tests available, many of which are similar to others or rolled into panels with other diagnostic tests, he said. 
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Appropriate Testing

A new online toolkit puts resources in the hands of pathologists and medical laboratory scientists to promote conversations between physicians and patients about which diagnostic tests are appropriate. The online toolkit, part of ASCP's Choosing Wisely initiative, seeks to raise public awareness about appropriate test usage and to assist patients in taking an active role in choosing care that is truly necessary. Approximately 30 percent of U.S. health care is duplicative or unnecessary, according to an Institute of Medicine Report, which estimates that inappropriate or over-utilized medical tests account for nearly $300 billion in medical expenditures in the United States each year.
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Diagnostic Point-of-care Tests in Resource-limited Settings

The aim of diagnostic point-of-care testing is to minimise the time to obtain a test result, thereby allowing clinicians and patients to make a quick clinical decision. Because point-of-care tests are used in resource-limited settings, the benefits need to outweigh the costs. To optimise point-of-care testing in resource-limited settings, diagnostic tests need rigorous assessments focused on relevant clinical outcomes and operational costs, which differ from assessments of conventional diagnostic tests.

 

Bioethicists Urge More Research as They Consider Recommendations for Genomic Testing of Children

A range of ethical questions are being considered as genome and exome sequencing trickles into clinical care. But children pose a unique problem for this fledgling field, and a group of bioethicists has suggested in an article published in the American Journal of Bioethics that more research must be done before consistent and sound guidelines will be developed. The senior author of the study, Ellen Wright Clayton, who is director of Vanderbilt University's Center for Biomedical Ethics and Society and co-chair of the Clinical Sequencing Exploratory Research Pediatric working group of NHGRI, noted that the only two sets of recommendations proposed for addressing clinical sequencing for children – those looking in particular at whether and what kind of genetic findings should be returned to parents – are not in harmony. 
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High-Tech TB Test Fails to Cut Mortality

High technology can't compensate for poorly organized health care. That appears to be the central lesson of a clinical trial comparing a new automated molecular diagnostic test for tuberculosis (TB) to standard sputum microscopy, researchers said. The new device, dubbed Xpert MTB/RIF, can deliver a result in 2 hours and is also able to give an immediate answer on the presence or absence of resistance to rifampin, according to Alison Grant, MBBS, PhD, of the London School of Hygiene and Tropical Medicine. In the lab, Xpert outperforms traditional microscopy, but "we wanted to see if it also makes a difference to patients in a real-world setting," Grant told reporters at the annual Conference on Retroviruses and Opportunistic Infections. The answer was not much, Grant said -- the Xpert system detected more cases of TB, but there was no change in TB mortality and no difference in the proportion of people who did not get treated.
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Blood Test Can Predict Alzheimer's, say Researchers

A blood test can accurately predict the onset of Alzheimer's disease, according to US researchers.  They showed that testing levels of 10 fats in the blood could predict - with 90% accuracy - the risk of the disease coming on in the next three years. Their findings, published in Nature Medicine, will now be tested in larger clinical trials. Experts said the results needed to be confirmed, but such a test would be "a real step forward". The number of people living with dementia stands at 44 million around the globe and is expected to treble by 2050.
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Study Examines Blood Test to Screen for Fatal Variant Creutzfeldt-Jakob Disease

The researchers previously developed a test to detect low levels of prion protein in the blood. In this study, they used the test on samples from national blood collection and prion disease centers in the U.S. and the U.K. to see if it was accurate enough to screen large numbers of people. The test was perfectly specific, meaning it was always negative in negative American donor samples and healthy U.K. patient samples. No samples tested positive from patients with nonprion neurodegenerative disorders. The test found 71.4 percent of patients with vCJD correctly tested positive.

 

'Glow Test' for Anthrax Could Speed Up Bioterror Response

Researchers at the University of Missouri in the US have proved a "glow test" can detect the presence of deadly anthrax bacteria in hours instead of the usual days, promising to significantly cut the time it takes to respond to a potential bioterrorism attack. George Stewart, professor and medical bacteriologist at MU's Bond Life Sciences Center, explains: "Normally to identify whether an organism is present, you have to extract the material, culture it, and then pick colonies to examine that might turn out to be anthrax bacteria. Then you conduct chemical testing which takes some time - a minimum of 24 to 48 hours. Using this newly-identified method, we can reduce that time to about five hours."
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Need More Than Lab Test to Determine Low Testosterone

Limitations of current laboratory tests for testosterone deficiency have led to poor reliability that preclude use of any test as the sole basis for diagnosis, authors of a review concluded. Performance characteristics and diagnostic parameters of the tests lack standardization. Combined with inherent fluctuations in testosterone levels, the limitations mandate a diagnostic approach that relies on clinical signs and symptoms of hypogonadism as much as it does laboratory results, according to an article published online in Urology. "Until such standardization is commonplace in clinical laboratories, the decision to treat should be based on the presence of signs and symptoms in addition to serum testosterone measurements," Darius A. Paduch, MD, of Weill Cornell Medical College in New York City, and co-authors concluded.

 

Test May Some Day Predict 5-Year Risk of Death

Will you be alive five years from now? New research suggests it might be possible to predict if you’ll die from a medical condition in the next half-decade. How, you ask? With a simple blood test.
According to a recent study published in the journal PLOS Medicine, if your blood registers high levels of four “biomarkers,” biological molecules found in your blood, body fluids, or tissues, you are at a substantially higher risk of dying in the next five years. Researchers from Finland and Estonia followed more than 17,000 people between the ages of 18 and 103 to determine causes of death, tracking them in what is called a prospective cohort study. The researchers first looked at more than 100 components of blood taken from the Estonian group. They found that high levels of four different molecules (naturally present in everyone's blood) - albumin, alpha-1-acid glycoprotein, citrate and very low-density lipoprotein particles — predicted imminent death.
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Pathway Genomics Launches Hereditary Colon Cancer Test

The test, which analyzes DNA from a saliva sample, looks for mutations in a panel of 16 genes – MLH1, MSH2, MSH6, PMS2, EPCAM, APC, BLM, BMPR1A, CDH1, CHEK2, MDM2, MUTYH, PTEN, SMAD4, STK11, and TP53. According to the firm's website, it will not only identify known mutations but will also analyze and interpret "additional genetic changes that are clinically significant." The company also offers patients whom the test reveals carry variants of unknown significance and their families an opportunity to enroll in a "familial studies program" to further investigate those variants.
Source: http://www.genomeweb.com/External Web Site Icon

Detecting Levels of Antibiotics in Blood Paves the Way to Individualised Treatment

A new methodology for rapidly measuring the level of antibiotic drug molecules in human blood serum has been developed, paving the way to applications within drug development and personalised medicine. The study, published in Nature Nanotechnology, describes the exploitation of a sensor for measuring the concentration of effective antibiotics in blood, giving an indication of their efficiency against disease causing pathogens, for instance multidrug resistant hospital "superbugs". This development could potentially give a far greater understanding of the effectiveness of drug dosages required for different individuals, reducing potential toxic effects, allowing personalised treatment for patients and leading to new insights into optimal clinical regimes, such as combination therapies.

 

Declining Nationwide Demand for Blood Products Is a Positive Trend for Hospitals and Their Medical Laboratories

Pathologists and blood bankers in many hospitals are finding it easier to manage costs because, for a variety of reasons, utilization of blood and blood products has declined in recent years Demand for blood products is declining across the nation. This is a positive trend for pathologists and clinical laboratory professionals who manage blood banks in hospitals and health systems throughout the United States. In recent decades, blood banks regularly worried about blood shortages, particularly in light of the aging population. However, a host of new medical technologies and clinical advances has dramatically reduced the utilization of blood products.

 

Quest Diagnostics to Acquire Summit Health

Quest Diagnostics, a provider of diagnostic information services, announced that it has entered into a definitive purchase agreement under which Quest will acquire Summit Health. Terms of the transaction were not disclosed. Summit Health is a leading provider of on-site prevention and wellness programs primarily for employers. 

 

Whole-Genome Data Not Ready for Prime Time

Despite "huge" potential to identify hidden disease risks, whole-genome sequencing is not ready for its close-up. That's the bottom line of a small study that looked at the reliability, accuracy, and medical utility of sequencing all of the DNA of 12 volunteers, according to Thomas Quertermous, MD, of the Stanford Cardiovascular Institute in Stanford, Calif., and colleagues. "Sequencing the whole human genome teaches us a lot, but we're not really ready to do this in prime time with large numbers of humans," Quertermous told MedPage Today.
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A Genetic Entrepreneur Sets His Sights on Aging and Death

J. Craig Venter is the latest wealthy entrepreneur to think he can cheat aging and death. And he hopes to do so by resorting to his first love: sequencing genomes. Dr. Venter announced that he was starting a new company, Human Longevity, which will focus on figuring out how people can live longer and healthier lives. To do that, the company will build what Dr. Venter says will be the largest human DNA sequencing operation in the world, capable of processing 40,000 human genomes a year. The huge amount of DNA data will be combined with huge amounts of other data on the health and body composition of the people whose DNA is sequenced, in the hope of gleaning insights into the molecular causes of aging and age-related illnesses like cancer and heart disease. Slowing aging, if it can be done, could be a way to prevent many diseases, an alternative to treating one disease a time.

 

One Author of a Startling Stem Cell Study Calls for Its Retraction

One of the authors of a study that was claimed to have discovered a simple way to make stem cells said that he was no longer sure of his team’s conclusions, and he called for the study to be retracted. The study, laid out in two papers published by Nature in January, surprised scientists around the world by finding that a simple acid bath might turn cells in the body into multipurpose stem cells. The new technique could be a quicker and easier source of stem cells than methods now in use, the authors said.

 

Exome Sequencing Studies Link Variants in Genes Encoding Meiosis-related Proteins to Infertility

Some cases of premature ovarian failure and related infertility may be due to mutations affecting proteins involved in meiosis, according to a pair of exome sequencing reports published in the New England Journal of Medicine. Researchers led by Eric Vilain, a professor of human genetics, pediatrics, and urology at the University of California, Los Angeles, performed exome sequencing on a set of sisters belonging to a Palestinian family with a history of premature ovarian failure to home in on a deletion in the STAG3 gene, which encodes a subunit of the cohesin ring that regulates the interaction of sister chromatids during meiosis.

 

Stem Cell Scientists Clear Obstacle in Treating Parkinson’s Disease

Japanese scientists have succeeded in efficiently producing nerve cells to treat Parkinson’s disease from human induced pluripotent stem (iPS) cells. Researchers from Kyoto University, Osaka University and other organizations produced more than 20 times as many progenitor cells as was previously possible using an artificial protein called laminin. It is currently difficult to secure large numbers of nerve cells required for treatment of Parkinson’s disease.

 

Promising New Approach Discovered to Treat Leukemia

A group of researchers discovered a promising new approach to treating leukemia by disarming a gene that is responsible for tumor progression. That gene, Brg1, is a key regulator of leukemia stem cells that are the root cause of the disease, its resistance to treatment, and relapse. Principal investigator Julie Lessard, PhD, and her colleagues at the Institute for Research in Immunology and Cancer (IRIC) of Université de Montréal in Quebec, Canada, have spent the past 4 years studying the gene in collaboration with another research group at Stanford University in California. The results of their study were reported in Blood (2014; doi:10.1182/blood-2013-02-483495). "When we removed the Brg1 gene, the leukemia stem cells were unable to divide, survive, and make new tumors. In other words, the cancer was permanently shut down," Lessard said.

 

Early Treatment Is Found to Clear H.I.V. in a 2nd Baby

When scientists made the stunning announcement last year that a baby born with H.I.V. had apparently been cured through aggressive drug treatment just 30 hours after birth, there was immediate skepticism that the child had been infected in the first place. But now, the existence of a second such baby was revealed at an AIDS conference, leaving little doubt that the treatment works. A leading researcher said there might be five more such cases in Canada and three in South Africa. And a clinical trial in which up to 60 babies who are born infected will be put on drugs within 48 hours is set to begin soon, another researcher added.
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Injections Providing Protection Against AIDS in Monkeys, Studies Find

Researchers are reporting that injections of long-lasting AIDS drugs protected monkeys for weeks against infection, a finding that could lead to a major breakthrough in preventing the disease in humans. Two studies by different laboratory groups each found 100 percent protection in monkeys that got monthly injections of antiretroviral drugs, and there was evidence that a single shot every three months might work just as well. If the findings can be replicated in humans, they have the potential to overcome a major problem in AIDS prevention: that many people fail to take their antiretroviral pills regularly.

 

Bristol-Myers’ AIDS Medicine Controls Virus in Study

Bristol-Myers Squibb Co.’s experimental HIV drug controlled the virus as well as the company’s older treatment Reyataz in a study that suggests the medicine may help difficult-to-treat patients. The drug BMS-663068 reduced the AIDS virus to undetectable levels in as many as 80 percent of those who received one of four doses, compared with 75 percent of those who took Reyataz, according to results from a mid-stage trial presented at the Conference on Retroviruses and Opportunistic Infections in Boston. Both medicines were given in combination with New York-based Bristol’s Sustiva and Gilead Sciences Inc.’s Viread.

 

Malaria 'Spreading to New Altitudes'

Warmer temperatures are causing malaria to spread to higher altitudes, a study suggests. Researchers have found that people living in the highlands of Africa and South America are at an increased risk of catching the mosquito-borne disease during hotter years. They believe that temperature rises in the future could result in millions of additional cases in some areas. The research is published in the journal Science. Prof Mercedes Pascual, from the University of Michigan in the US, who carried out the research, said: "The impact in terms of increasing the risk of exposure to disease is very large."

 

Allergies Are Everywhere

People hoping to find an allergy-free haven may be out of luck. A new study has found that no region of the United States is allergy-free, but the kind of allergy people are likely to suffer from varies by region, race and socioeconomic status. Researchers gave blood tests to 8,124 people, 856 of them children under 6, to detect immunoglobulin E antibodies, or IgEs. The presence of an IgE antibody that reacts to a specific substance increases the risk of having an allergy-related illness ike allergic asthma, hay fever or rash. The scientists tested people for antibodies to a range of potential allergens, including cats, dogs, milk, cockroaches, peanuts, grass, ragweed and shrimp. No matter where they lived, about 45 percent of people over 6 had positive tests for at least one allergen, and so did 36 percent of the children 1 to 5 years old. “To me, the biggest surprise is that the level of sensitivities didn’t differ region to region,” said the senior author, Dr. Darryl C. Zeldin, a scientific director at the National Institute of Environmental Health Sciences. “This goes completely against what most people would have said. The bottom line is that sensitization patterns differ by region, but overall sensitization rates are high.” 

 

The Fat Drug

IF you walk into a farm-supply store today, you’re likely to find a bag of antibiotic powder that claims to boost the growth of poultry and livestock. That’s because decades of agricultural research has shown that antibiotics seem to flip a switch in young animals’ bodies, helping them pack on pounds. Manufacturers brag about the miraculous effects of feeding antibiotics to chicks and nursing calves. Dusty agricultural journals attest to the ways in which the drugs can act like a kind of superfood to produce cheap meat. But what if that meat is us? Recently, a group of medical investigators have begun to wonder whether antibiotics might cause the same growth promotion in humans. New evidence shows that America’s obesity epidemic may be connected to our high consumption of these drugs.
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Parents’ Fight Against Sepsis Reaches C.D.C.

Sepsis is what happens when the body’s own responses to an infection spin out of control, destroying cells and blood vessels. This leads to shock, organ failure and death. The sooner treatment begins, the better the chances of survival. That and many other aspects of sepsis remain poorly understood. After a campaign by the Stauntons, the New York State Department of Health issued new regulations, which went into effect at the end of 2013, requiring hospitals to adopt techniques for early identification and treatment of sepsis. They are among the most rigorous regulations in the country. In January, the Stauntons wrote to Dr. Thomas Frieden, who as director of the centers is one of the nation’s top public health officials. They detailed the research on successful approaches to reducing sepsis deaths. “The C.D.C. needs to demonstrate a leadership role in the education and treatment of sepsis,” they wrote, adding that the centers were “negligent in their duty to inform the public and to insist on sepsis protocols being in place at all medical facilities throughout the United States

 

Severe Diarrheal Illness in Children Linked to Antibiotics Prescribed in Doctor’s Offices

CDC urges physicians to improve prescribing practices to reduce harm
The majority of pediatric Clostridium difficile infections, which are bacterial infections that cause severe diarrhea and are potentially life-threatening, occur among children in the general community who recently took antibiotics prescribed in doctor’s offices for other conditions, according to a new study by the Centers for Disease Control and Prevention published this week in Pediatrics.  

 

Up to 1000 NIH Investigators Dropped Out Last Year

New data show that after remaining more or less steady for a decade, the number of investigators with National Institutes of Health (NIH) funding dropped sharply last year by at least 500 researchers and as many as 1000. Although not a big surprise—it came the same year that NIH’s budget took a 5% cut—the decline suggests that a long-anticipated contraction in the number of labs supported by NIH may have finally begun.
Although NIH publicizes the number of grants it funds each year, it does not routinely disclose the number of principal investigators—the leaders of the labs these grants support. But in response to a request from ScienceInsider, NIH shared these data for two sets of grants: research project grants (RPGs), which include all research grants, and R01 equivalents, a slightly smaller category that includes the bread-and-butter R01 grants that support most independent labs.

 

Physicians in Congress Can Shape Healthcare Policy

Only 25 doctors served in Congress at various times from 1960 to 2004. But now 20 doctors hold seats in the 113th Congress and their experiences can shape policy, write blog post authors Brian W. Powers, an M.D. candidate at Harvard Medical School and Sachin H. Jain, M.D., a lecturer in healthcare policy at Harvard Medical School. Doctors in Congress bring real-life experience to policy development and provide insight into what patients and providers need, the post argues. 

 

Study Examines Gap in Federal Oversight of Clinical Trials

An analysis of nearly 24,000 active human research clinical trials found that between 5 percent and 16 percent fall into a regulatory gap and are not covered by two major federal regulations, according to a study in JAMA. These trials studied interventions other than drugs or devices (e.g., behavioral, surgical). The primary federal human subjects protections (HSP) policies in the United States, including requirements for institutional review board review and informed consent, are the U.S. Food and Drug Administration (FDA) HSP regulations and the Common Rule.

 

Hospitals Lack Universal Plan for Drug-resistant Bacteria

Hospitals' lack of standardized infection control practices for multidrug-resistant gram-negative bacteria (MDR-GNB) may contribute to an increase in multidrug-resistant bacteria, according to a study from the Society for Healthcare Epidemiology of America Research Network published inInfection Control and Hospital Epidemiology. "Differences in definitions and practices for multidrug-resistant bacteria confuse healthcare workers and hinder communication when patients are transferred between hospitals," lead author Marci Drees, M.D., said in a statement. "The danger these inconsistencies represent affects not only individual hospitals, but the broader community because patients are frequently transferred between healthcare centers, including long-term care facilities, furthering their spread."
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National Institutes of Health Creates Partnership With Big Pharma to Improve Development Success of New Drugs and Diagnostics and Speed FDA Clearance

Pathology groups and clinical laboratories are among the beneficiaries if the Accelerating Medicines Partnership achieves its goals Power players in healthcare are about to invest nearly a quarter of a billion dollars to accelerate the time it takes for new medical discoveries to gain regulatory approval and enter clinical use. The emphasis will be on both therapeutic drugs and diagnostics, making this an important development for in vitro diagnostics companies and medical laboratories. Anchors to this new initiative are the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Their partners are 10 pharmaceutical companies and six nonprofit groups.

 

New Rheumatoid Arthritis Management Guidelines: A Quick and Easy Guide

The March issue of Annals of the Rheumatic Diseases includes updated recommendations issued by the European League Against Rheumatism (EULAR) on the management of rheumatoid arthritis (RA) with synthetic and biologic disease-modifying antirheumatic drugs (DMARDs). The new guidelines were originally published online in October 2013 and update EULAR's 2010 RA management guidelines. The 14 recommendations included in the new document were developed by an international task force that based its decisions primarily on findings from 3 systematic literature reviews and subsequent expert consensus and voting.

 

5 Things to Know About the New NCQA Standards

The National Committee for Quality Assurance (NCQA) is out with its latest patient-centered medical home (PCMH) recognition standards, updating the list for the first time since 2011. Almost 6,800 sites where roughly 35,000 clinicians work have achieved NCQA recognition, the organization said. Many payers across the country plan to pay practices a bonus for meeting NCQA standards. Also NCQA recognition may be pivotal to future Medicare programs like the complex care management billing code coming in 2015.

 

Bad News for 169K After New HIPAA Breach

Some 168,500 people are getting HIPAA breach notification letters after unencrypted computers were stolen from the Los Angeles County public health and health services departments, city officials announced. According to a public notice, third-party billing vendor Sutherland Healthcare Solutions reported a burglary Feb. 5 involving the theft of several unencrypted company computers. Officials confirmed the computers contained patient Social Security numbers, demographic data, billing information, dates of birth and protected health information, including medical diagnoses. 

 

Patentholder on Breast Cancer Tests Denied Injunction in Lawsuit

Myriad Genetics, which lost a closely watched Supreme Court case last year involving the patenting of genes, has suffered another setback in its efforts to protect its main genetic test from competition. A federal judge denied Myriad’s request for a preliminary injunction that would have immediately stopped a rival company, Ambry Genetics, from offering a similar test. Myriad’s lucrative monopoly on testing for mutations in two genes linked to breast cancer risk was shattered last June by the Supreme Court’s ruling that genes were not eligible for patents because they were products of nature.

 

Hospital to Test Google Glass for Real-time ER Care

Rhode Island Hospital in Providence appears poised to become the first hospital in the nation to test Google Glass for real-time emergency room care, according to a report by the Providence Journal. In a six-month pilot beginning this month, the hospital will use the tool to stream live images of patient medical conditions to remote consulting specialists. In particular, the pilot will focus on ER patients with skin conditions who agree to participate in the study.

 

Proposed HHS Budget Would Increase ONC Funding

While the $75 million allocated for the Office of the National Coordinator for Health IT in President Obama's proposed FY 2015 budget for the U.S. Department of Health & Human Services, unveiled, is $3 million less than what was proposed a year ago, it represents a $15 million increase over funding actually approved for the agency for FY 2014. The funding, according to HHS' budget in brief, "builds upon recent nationwide investments to promote the adoption of health information technology among a critical mass of providers, professionals and consumers."

 

GAO Hits EHR Incentive Program Hard

The GAO recently took a swipe at the government's Meaningful Use EHR Incentive Program, saying it lacked strategy and called for action to establish a strategy in order to achieve its goals, especially those aimed at improving care. Specifically, GAO called for establishing a strategy to better ensure the reliability of clinical quality measures, known as CQM, and collected using EHRs and develop and use outcome oriented performance measures to monitor progress toward goals. The GAO found that "the lack of a comprehensive strategy limits HHS's ability to ensure the department can reliably use the clinical quality measures collected in certified EHRs for quality measurement activities."
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How to Measure the Value of Health IT

There's been a whole lot of capital invested in health information technology these past few years. And some people – especially those who are in charge of spending more of it – want to know whether it's money well spent. It may seem obvious to some in this industry, but it's still a question that bears asking: Is the value of health IT self-evident at this point, five years after HITECH? Or is the jury still out?  "I think in the United States we've passed a tipping point," says John Hoyt, executive vice president of HIMSS Analytics. "People understand that IT can create value."

 

S. Korea Regulators May Rule Samsung Smartphone a Medical Device

South Korean healthcare regulators are taking a closer look at Samsung's (LON:BC94) new Galaxy S5 smartphone in order to determine whether the built-in heart rate sensor turns the phone into a medical device. The technology giant revealed earlier this month that it would include the sensor in the new generation of its Galaxy phones and Gear smart-watches, but South Korean regulators are concerned that doctors may use the sensor for medical purposes. If deemed a medical device, the phones would have to undergo review by the country's Ministry of Food & Drug Safety before allowed on the market, Yonhap News Agency reported.
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"Supermum" Campaign Results in Startling Improvements in People's Handwashing Behaviour

An analysis of a unique "SuperMum" handwashing campaign shows for the first time that using emotional motivators, such as feelings of disgust and nurture, rather than health messages, can result in significant, long-lasting improvements in people's handwashing behaviour, and could in turn help to reduce the risk of infectious diseases. An evaluation of the behaviour-change intervention, published in The Lancet Global Health journal, shows that 6 months after the campaign was rolled out in 14 villages in rural India, rates of handwashing with soap increased by 31%, compared to communities without the programme, and were sustained for 12 months.

 

Children's Diets 'Far Too Salty'

Children in the UK are eating far too much salt, with much of it coming from breads and cereals, research suggests. Children should eat less than a teaspoon of salt a day, but 70% of the 340 children in the study published in Hypertension ate more than this. Breads and cereals accounted for more than one-third of the salt in children's diets. A fifth came from meat and one-tenth from dairy products. This was despite a UK-wide drive to cut salt levels in food.

 

Is the UK Prepared for HIV Home Testing Kits?

In a little over four weeks, it will be legal to pop into the supermarket, buy an HIV home testing kit and within 20 minutes of using it at home, get a result. Surprised? So are many others, yet this legislative change has been made by the Department of Health, and supported by the Scottish Government. Since 1992, legislation has protected the public by stipulating that marketing and sale of test kits is illegal and that the results of an HIV test must be given under clinical supervision.

 

Sugar Tax May Be Necessary, England's Chief Medical Officer Says

A sugar tax may have to be introduced to curb obesity rates, the chief medical officer for England has said. Dame Sally Davies told a committee of MPs that unless the government was strong with food and drink manufacturers, it was unlikely they would reformulate their products. She said she believed "research will find sugar is addictive", and that "we may need to introduce a sugar tax". The food industry said it was working on reducing sugar in products.

Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
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